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116th Congress } { Rept. 116-332
HOUSE OF REPRESENTATIVES
1st Session } { Part 1
_______________________________________________________________________
REAUTHORIZING AND EXTENDING AMERICA'S COMMUNITY HEALTH ACT
----------
R E P O R T
of the
COMMITTEE ON ENERGY AND COMMERCE
December 9, 2019.--Ordered to be printed
REAUTHORIZING AND EXTENDING AMERICA'S COMMUNITY HEALTH ACT
116th Congress } { Rept. 116-332
HOUSE OF REPRESENTATIVES
1st Session } { Part 1
_______________________________________________________________________
REAUTHORIZING AND EXTENDING AMERICA'S COMMUNITY HEALTH ACT
__________
R E P O R T
of the
COMMITTEE ON ENERGY AND COMMERCE
December 9, 2019.--Ordered to be printed
______
U.S. GOVERNMENT PUBLISHING OFFICE
38-564 WASHINGTON : 2019
CONTENTS
Page
I. Purpose and Summary.............................................28
II. Background and Need for the Legislation.........................28
III. Committee Hearings..............................................35
IV. Committee Consideration.........................................36
V. Committee Votes.................................................37
VI. Oversight Findings..............................................37
VII. New Budget Authority, Entitlement Authority, and Tax Expenditure37
VIII.Federal Mandates Statement......................................37
IX. Statement of General Performance Goals and Objectives...........38
X. Duplication of Federal Programs.................................38
XI. Committee Cost Estimate.........................................38
XII. Earmarks, Limited Tax Benefits, and Limited Tariff Benefits.....38
XIII.Advisory Committee Statement....................................38
XIV. Applicability to Legislative Branch.............................38
XV. Section-by-Section Analysis of the Legislation..................38
XVI. Changes in Existing Law Made by the Bill, as Reported...........45
116th Congress } { Rept. 116-332
HOUSE OF REPRESENTATIVES
1st Session } { Part 1
======================================================================
REAUTHORIZING AND EXTENDING AMERICA'S COMMUNITY HEALTH ACT
_______
December 9, 2019.--Ordered to be printed
_______
Mr. Pallone, from the Committee on Energy and Commerce, submitted the
following
R E P O R T
[To accompany H.R. 2328]
The Committee on Energy and Commerce, to whom was referred
the bill (H.R. 2328) to reauthorize and extend funding for
community health centers and the National Health Service Corps,
having considered the same, report favorably thereon with
amendments and recommend that the bill as amended do pass.
The amendments are as follows:
Strike all after the enacting clause and insert the
following:
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.
(a) Short Title.--This Act may be cited as the ``Reauthorizing and
Extending America's Community Health Act'' or the ``REACH Act''.
(b) Table of Contents.--The table of contents for this Act is as
follows:
Sec. 1. Short title; table of contents.
TITLE I--PUBLIC HEALTH EXTENDERS
Sec. 101. Extension for community health centers, the National Health
Service Corps, and teaching health centers that operate GME programs.
Sec. 102. Extension for special diabetes programs.
Sec. 103. Extension of Personal Responsibility Education Program.
Sec. 104. Extension of sexual risk avoidance education program.
TITLE II--MEDICARE EXTENDERS
Sec. 201. Extension of the work geographic index floor under the
Medicare program.
Sec. 202. Extension of funding outreach and assistance for low-income
programs.
Sec. 203. Extension of funding for quality measure endorsement, input,
and selection under the Medicare program.
Sec. 204. Extension of the Independence at Home Medical Practice
Demonstration Program under the Medicare program.
Sec. 205. Extension of appropriations and transfers to the Patient-
Centered Outcomes Research Trust Fund; extension of certain health
insurance fees.
Sec. 206. Transitional coverage and retroactive Medicare part D
coverage for certain low-income beneficiaries.
Sec. 207. Health Equity and Access for Returning Troops and
Servicemembers Act of 2019.
Sec. 208. Exclusion of complex rehabilitative manual wheelchairs from
Medicare competitive acquisition program; Non-application of Medicare
fee-schedule adjustments for certain wheelchair accessories and
cushions.
TITLE III--MEDICAID PROVISIONS
Sec. 301. Modification of reductions in Medicaid DSH allotments.
Sec. 302. Public availability of hospital upper payment limit
demonstrations.
Sec. 303. Report by Comptroller General.
Sec. 304. Sense of Congress regarding the need to develop a more
permanent legislative solution to provide the territories with a
reliable and consistent source of Federal funding under the Medicaid
program.
TITLE IV--NO SURPRISES ACT
Sec. 401. Short title.
Sec. 402. Preventing surprise medical bills.
Sec. 403. Government Accountability Office study on profit- and
revenue-sharing in health care.
Sec. 404. State All Payer Claims Databases.
Sec. 405. Air ambulance cost data reporting program.
Sec. 406. Report by Secretary of Labor.
Sec. 407. Billing statute of limitations.
Sec. 408. GAO report on impact of surprise billing provisions.
Sec. 409. Report by the Secretary of Health and Human Services.
TITLE V--TERRITORIES HEALTH CARE IMPROVEMENT ACT
Sec. 501. Short title.
Sec. 502. Medicaid payments for Puerto Rico and the other territories
for certain fiscal years.
Sec. 503. Application of certain requirements under Medicaid program to
certain territories.
Sec. 504. Additional program integrity requirements.
TITLE I--PUBLIC HEALTH EXTENDERS
SEC. 101. EXTENSION FOR COMMUNITY HEALTH CENTERS, THE NATIONAL HEALTH
SERVICE CORPS, AND TEACHING HEALTH CENTERS THAT
OPERATE GME PROGRAMS.
(a) Community Health Centers.--Section 10503(b)(1)(F) of the Patient
Protection and Affordable Care Act (42 U.S.C. 254b-2(b)(1)(F)) is
amended by striking ``fiscal year 2019'' and inserting ``each of fiscal
years 2019 through 2023''.
(b) National Health Service Corps.--Section 10503(b)(2)(F) of the
Patient Protection and Affordable Care Act (42 U.S.C. 254b-2(b)(2)(F))
is amended by striking ``2018 and 2019'' and inserting ``2019 through
2023''.
(c) Teaching Health Centers That Operate Graduate Medical Education
Programs.--Section 340H(g)(1) of the Public Health Service Act (42
U.S.C. 256h(g)(1)) is amended by striking ``2018 and 2019'' and
inserting ``2019 through 2023''.
(d) Application.--Amounts appropriated for a program pursuant to the
amendments made by subsection (a), (b), or (c) for fiscal years 2020
through 2023 are subject to the requirements and limitations of the
most recently enacted regular or full-year continuing appropriations
Act or resolution (as of the date of obligation of current funds)
applicable to the respective program.
SEC. 102. EXTENSION FOR SPECIAL DIABETES PROGRAMS.
(a) Reauthorization of Special Diabetes Programs for Type I
Diabetes.--Section 330B(b)(2)(D) of the Public Health Service Act (42
U.S.C. 254c-2(b)(2)(D)) is amended by striking ``each of fiscal years
2018 and 2019'' and inserting ``fiscal years 2019 through 2023''.
(b) Reauthorization of Special Diabetes Programs for Indians for
Diabetes Services.--Section 330C(c)(2)(D) of the Public Health Service
Act (42 U.S.C. 254c-3(c)(2)(D)) is amended by striking ``fiscal years
2018 and 2019'' and inserting ``fiscal years 2019 through 2023''.
SEC. 103. EXTENSION OF PERSONAL RESPONSIBILITY EDUCATION PROGRAM.
Section 513 of the Social Security Act (42 U.S.C. 713) is amended--
(1) in paragraphs (1)(A) and (4)(A) of subsection (a), by
striking ``2019'' and inserting ``2023'' each place it appears;
(2) in subsection (a)(4)(B)(i), by striking ``2019'' and
inserting ``2023''; and
(3) in subsection (f), by striking ``2019'' and inserting
``2023''.
SEC. 104. EXTENSION OF SEXUAL RISK AVOIDANCE EDUCATION PROGRAM.
Section 510 of the Social Security Act (42 U.S.C. 710) is amended by
striking ``fiscal years 2018 and 2019'' each place it appears in
subsections (a)(1), (a)(2)(A), (f)(1) and (f)(2) and inserting ``fiscal
years 2019 through 2023''.
TITLE II--MEDICARE EXTENDERS
SEC. 201. EXTENSION OF THE WORK GEOGRAPHIC INDEX FLOOR UNDER THE
MEDICARE PROGRAM.
Section 1848(e)(1)(E) of the Social Security Act (42 U.S.C. 1395w-
4(e)(1)(E)) is amended by striking ``2020'' and inserting ``2023''.
SEC. 202. EXTENSION OF FUNDING OUTREACH AND ASSISTANCE FOR LOW-INCOME
PROGRAMS.
(a) Additional Funding for State Health Insurance Programs.--
Subsection (a)(1)(B) of section 119 of the Medicare Improvements for
Patients and Providers Act of 2008 (42 U.S.C. 1395b-3 note), as amended
by section 3306 of the Patient Protection and Affordable Care Act
(Public Law 111-148), section 610 of the American Taxpayer Relief Act
of 2012 (Public Law 112-240), section 1110 of the Pathway for SGR
Reform Act of 2013 (Public Law 113-67), section 110 of the Protecting
Access to Medicare Act of 2014 (Public Law 113-93), section 208 of the
Medicare Access and CHIP Reauthorization Act of 2015 (Public Law 114-
10), and section 50207 of the Bipartisan Budget Act of 2018 (Public Law
115-123), is amended--
(1) in clause (vii), by striking ``and'' at the end;
(2) in clause (viii), by striking ``and'' at the end;
(3) in clause (ix), by striking the period at the end and
inserting ``; and''; and
(4) by inserting after clause (ix) the following new clause:
``(x) for each of fiscal years 2020 through
2022, of $15,000,000.''.
(b) Additional Funding for Area Agencies on Aging.--Subsection
(b)(1)(B) of such section 119, as so amended, is amended--
(1) in clause (vii), by striking ``and'' at the end;
(2) in clause (viii), by striking ``and'' at the end;
(3) in clause (ix), by striking the period at the end and
inserting ``; and''; and
(4) by inserting after clause (ix) the following new clause:
``(x) for each of fiscal years 2020 through
2022, of $15,000,000.''.
(c) Additional Funding for Aging and Disability Resource Centers.--
Subsection (c)(1)(B) of such section 119, as so amended, is amended--
(1) in clause (vii), by striking ``and'' at the end;
(2) in clause (viii), by striking ``and'' at the end;
(3) in clause (ix), by striking the period at the end and
inserting ``; and''; and
(4) by inserting after clause (ix) the following new clause:
``(x) for each of fiscal years 2020 through
2022, of $5,000,000.''.
(d) Additional Funding for Contract With the National Center for
Benefits and Outreach Enrollment.--Subsection (d)(2) of such section
119, as so amended, is amended--
(1) in clause (vii), by striking ``and'' at the end;
(2) in clause (viii), by striking ``and'' at the end;
(3) in clause (ix), by striking the period at the end and
inserting ``; and''; and
(4) by inserting after clause (ix) the following new clause:
``(x) for each of fiscal years 2020 through
2022, of $15,000,000.''.
SEC. 203. EXTENSION OF FUNDING FOR QUALITY MEASURE ENDORSEMENT, INPUT,
AND SELECTION UNDER THE MEDICARE PROGRAM.
(a) In General.--Section 1890(d)(2) of the Social Security Act (42
U.S.C. 1395aaa(d)(2)) is amended--
(1) by striking ``and $7,500,000'' and inserting
``$7,500,000''; and
(2) by striking ``and 2019.'' and inserting ``and 2019, and
$30,000,000 for each of fiscal years 2020 through 2022.''.
(b) Input for Removal of Measures.--Section 1890(b) of the Social
Security Act (42 U.S.C. 1395aaa(b)) is amended by inserting after
paragraph (3) the following:
``(4) Removal of measures.--The entity may, through the
multistakeholder groups convened under paragraph (7)(A),
provide input to the Secretary on quality and efficiency
measures described in paragraph (7)(B) that could be considered
for removal.''.
(c) Prioritization of Measure Endorsement.--Section 1890(b) of the
Social Security Act (42 U.S.C. 1395aaa(b)), as amended by subsection
(b), is further amended by adding at the end the following:
``(9) Prioritization of measure endorsement.--The entity--
``(A) during the period beginning on the date of the
enactment of this paragraph and ending on December 31,
2023, shall prioritize the endorsement of measures
relating to maternal morbidity and mortality by the
entity with a contract under subsection (a) in
connection with endorsement of measures described in
paragraph (2); and
``(B) on and after January 1, 2024, may prioritize
the endorsement of such measures by such entity.''.
SEC. 204. EXTENSION OF THE INDEPENDENCE AT HOME MEDICAL PRACTICE
DEMONSTRATION PROGRAM UNDER THE MEDICARE PROGRAM.
(a) In General.--Section 1866E(e)(1) of the Social Security Act (42
U.S.C. 1395cc-5(e)(1)) is amended by striking ``7-year'' and inserting
``10-year''.
(b) Effective Date.--The amendment made by subsection (a) shall take
effect as if included in the enactment of Public Law 111-148.
SEC. 205. EXTENSION OF APPROPRIATIONS AND TRANSFERS TO THE PATIENT-
CENTERED OUTCOMES RESEARCH TRUST FUND; EXTENSION OF
CERTAIN HEALTH INSURANCE FEES.
(a) In General.--
(1) Internal revenue code.--Section 9511 of the Internal
Revenue Code of 1986 is amended--
(A) in subsection (b)(1)(E), by striking ``2014'' and
all that follows through ``2019'' and inserting ``2014
through 2022'';
(B) in subsection (d)(2)(A), by striking ``2019'' and
inserting ``2022''; and
(C) in subsection (f), by striking ``2019'' and
inserting ``2022''.
(2) Title xi.--Section 1183(a)(2) of the Social Security Act
(42 U.S.C. 1320e-2(a)(2)) is amended by striking ``2014'' and
all that follows through ``2019'' and inserting ``2014 through
2022''.
(b) Extension of Certain Health Insurance Fees.--
(1) Health insurance policies.--Section 4375(e) of the
Internal Revenue Code of 1986 is amended by striking ``2019''
and inserting ``2022''.
(2) Self-insured health plans.--Section 4376(e) of the
Internal Revenue Code of 1986 is amended by striking ``2019''
and inserting ``2022''.
SEC. 206. TRANSITIONAL COVERAGE AND RETROACTIVE MEDICARE PART D
COVERAGE FOR CERTAIN LOW-INCOME BENEFICIARIES.
Section 1860D-14 of the Social Security Act (42 U.S.C. 1395w-114) is
amended--
(1) by redesignating subsection (e) as subsection (f); and
(2) by adding after subsection (d) the following new
subsection:
``(e) Limited Income Newly Eligible Transition Program.--
``(1) In general.--Beginning not later than January 1, 2021,
the Secretary shall carry out a program to provide transitional
coverage for covered part D drugs for LI NET eligible
individuals in accordance with this subsection.
``(2) LI net eligible individual defined.--For purposes of
this subsection, the term `LI NET eligible individual' means a
part D eligible individual who--
``(A) meets the requirements of clauses (ii) and
(iii) of subsection (a)(3)(A); and
``(B) has not yet enrolled in a prescription drug
plan or an MA-PD plan, or, who has so enrolled, but
with respect to whom coverage under such plan has not
yet taken effect.
``(3) Transitional coverage.--For purposes of this
subsection, the term `transitional coverage' means, with
respect to an LI NET eligible individual--
``(A) immediate access to covered part D drugs at the
point of sale during the period that begins on the
first day of the month such individual is determined to
meet the requirements of clauses (ii) and (iii) of
subsection (a)(3)(A) and ends on the date that coverage
under a prescription drug plan or MA-PD plan takes
effect with respect to such individual; and
``(B) in the case of an LI NET eligible individual
who is a full-benefit dual eligible individual (as
defined in section 1935(c)(6)) or a recipient of
supplemental security income benefits under title XVI,
retroactive coverage (in the form of reimbursement of
the amounts that would have been paid under this part
had such individual been enrolled in a prescription
drug plan or MA-PD plan) of covered part D drugs
purchased by such individual during the period that
begins on the date that is the later of--
``(i) the date that such individual was first
eligible for a low-income subsidy under this
part; or
``(ii) the date that is 36 months prior to
the date such individual enrolls in a
prescription drug plan or MA-PD plan,
and ends on the date that coverage under such plan
takes effect.
``(4) Program administration.--
``(A) Single point of contact.--The Secretary shall,
to the extent feasible, administer the program under
this subsection through a contract with a single
program administrator.
``(B) Benefit design.--The Secretary shall ensure
that the transitional coverage provided to LI NET
eligible individuals under this subsection--
``(i) provides access to all covered part D
drugs under an open formulary;
``(ii) permits all pharmacies determined by
the Secretary to be in good standing to process
claims under the program;
``(iii) is consistent with such requirements
as the Secretary considers necessary to improve
patient safety and ensure appropriate
dispensing of medication; and
``(iv) meets such other requirements as the
Secretary may establish.
``(5) Relationship to other provisions of this title; waiver
authority.--
``(A) In general.--The following provisions shall not
apply with respect to the program under this
subsection:
``(i) Paragraphs (1) and (3)(B) of section
1860D-4(a) (relating to dissemination of
general information; availability of
information on changes in formulary through the
internet).
``(ii) Subparagraphs (A) and (B) of section
1860D-4(b)(3) (relating to requirements on
development and application of formularies;
formulary development).
``(iii) Paragraphs (1)(C) and (2) of section
1860D-4(c) (relating to medication therapy
management program).
``(B) Waiver authority.--The Secretary may waive such
other requirements of titles XI and this title as may
be necessary to carry out the purposes of the program
established under this subsection.''.
SEC. 207. HEALTH EQUITY AND ACCESS FOR RETURNING TROOPS AND
SERVICEMEMBERS ACT OF 2019.
(a) Modification of Requirement for Certain Former Members of the
Armed Forces to Enroll in Medicare Part B to Be Eligible for TRICARE
for Life.--
(1) TRICARE eligibility.--
(A) In general.--Subsection (d) of section 1086 of
title 10, United States Code, is amended by adding at
the end the following new paragraph:
``(6)(A) The requirement in paragraph (2)(A) to enroll in the
supplementary medical insurance program under part B of title XVIII of
the Social Security Act (42 U.S.C. 1395j et seq.) shall not apply to a
person described in subparagraph (B) during any month in which such
person is not entitled to a benefit described in subparagraph (A) of
section 226(b)(2) of the Social Security Act (42 U.S.C. 426(b)(2)) if
such person has received the counseling and information under
subparagraph (C).
``(B) A person described in this subparagraph is a person--
``(i) who is under 65 years of age;
``(ii) who is entitled to hospital insurance benefits under
part A of title XVIII of the Social Security Act pursuant to
subparagraph (A) or (C) of section 226(b)(2) of such Act (42
U.S.C. 426(b)(2));
``(iii) whose entitlement to a benefit described in
subparagraph (A) of such section has terminated due to
performance of substantial gainful activity; and
``(iv) who is retired under chapter 61 of this title.
``(C) The Secretary of Defense shall coordinate with the Secretary of
Health and Human Services and the Commissioner of Social Security to
notify persons described in subparagraph (B) of, and provide
information and counseling regarding, the effects of not enrolling in
the supplementary medical insurance program under part B of title XVIII
of the Social Security Act (42 U.S.C. 1395j et seq.), as described in
subparagraph (A).''.
(B) Conforming amendment.--Paragraph (2)(A) of such
subsection is amended by striking ``is enrolled'' and
inserting ``except as provided by paragraph (6), is
enrolled''.
(C) Identification of persons.--Section 1110a of such
title is amended by adding at the end the following new
subsection:
``(c) Certain Individuals Not Required To Enroll in Medicare Part
B.--In carrying out subsection (a), the Secretary of Defense shall
coordinate with the Secretary of Health and Human Services and the
Commissioner of Social Security to--
``(1) identify persons described in subparagraph (B) of
section 1086(d)(6) of this title; and
``(2) provide information and counseling pursuant to
subparagraph (C) of such section.''.
(2) Non-application of medicare part b late enrollment
penalty.--Section 1839(b) of the Social Security Act (42 U.S.C.
1395r(b)) is amended, in the second sentence, by inserting ``or
months for which the individual can demonstrate that the
individual is an individual described in paragraph (6)(B) of
section 1086(d) of title 10, United States Code, who is
enrolled in the TRICARE program pursuant to such section''
after ``an individual described in section 1837(k)(3)''.
(3) Report.--Not later than October 1, 2024, the Secretary of
Defense, the Secretary of Health and Human Services, and the
Commissioner of Social Security shall jointly submit to the
Committees on Armed Services of the House of Representatives
and the Senate, the Committee on Ways and Means and the
Committee on Energy and Commerce of the House of
Representatives, and the Committee on Finance of the Senate a
report on the implementation of section 1086(d)(6) of title 10,
United States Code, as added by paragraph (1). Such report
shall include, with respect to the period covered by the
report--
(A) the number of individuals enrolled in TRICARE for
Life who are not enrolled in the supplementary medical
insurance program under part B of title XVIII of the
Social Security Act (42 U.S.C. 1395j et seq.) by reason
of such section 1086(d)(6); and
(B) the number of individuals who--
(i) are retired from the Armed Forces under
chapter 61 of title 10, United States Code;
(ii) are entitled to hospital insurance
benefits under part A of title XVIII of the
Social Security Act pursuant to receiving
benefits for 24 months as described in
subparagraph (A) or (C) of section 226(b)(2) of
such Act (42 U.S.C. 426(b)(2)); and
(iii) because of such entitlement, are no
longer enrolled in TRICARE Standard, TRICARE
Prime, TRICARE Extra, or TRICARE Select under
chapter 55 of title 10, United States Code.
(4) Deposit of savings into medicare improvement fund.--
Section 1898(b)(1) of the Social Security Act (42 U.S.C.
1395iii(b)(1)) is amended by striking ``during and after fiscal
year 2021, $0'' and inserting ``during and after fiscal year
2024, $5,000,000''.
(5) Application.--The amendments made by paragraphs (1) and
(2) shall apply with respect to a person who, on or after
October 1, 2023, is a person described in section 1086(d)(6)(B)
of title 10, United States Code, as added by paragraph (1).
(b) Coverage of Certain DNA Specimen Provenance Assay Tests Under
Medicare.--
(1) Benefit.--
(A) Coverage.--Section 1861 of the Social Security
Act (42 U.S.C. 1395x) is amended--
(i) in subsection (s)(2)--
(I) in subparagraph (GG), by striking
``and'' at the end;
(II) in subparagraph (HH), by
striking the period and inserting ``;
and''; and
(III) by adding at the end the
following new subparagraph:
``(II) a prostate cancer DNA Specimen Provenance Assay test
(DSPA test) (as defined in subsection (kkk));''; and
(ii) by adding at the end the following new
subsection:
``(kkk) Prostate Cancer DNA Specimen Provenance Assay Test.--The term
`prostate cancer DNA Specimen Provenance Assay Test' (DSPA test) means
a test that, after a determination of cancer in one or more prostate
biopsy specimens obtained from an individual, assesses the identity of
the DNA in such specimens by comparing such DNA with the DNA that was
separately taken from such individual at the time of the biopsy.''.
(B) Exclusion from coverage.--Section 1862(a)(1) of
the Social Security Act (42 U.S.C. 1395y(a)(1)) is
amended--
(i) in subparagraph (O), by striking ``and''
at the end;
(ii) in subparagraph (P), by striking the
semicolon at the end and inserting ``, and'';
and
(iii) by adding at the end the following new
subparagraph:
``(Q) in the case of a prostate cancer DNA Specimen
Provenance Assay test (DSPA test) (as defined in section
1861(kkk)), unless such test is furnished on or after January
1, 2021, and before January 1, 2026, and such test is ordered
by the physician who furnished the prostate cancer biopsy that
obtained the specimen tested;''.
(2) Payment amount and related requirements.--Section 1834 of
the Social Security Act (42 U.S.C. 1395m) is amended by adding
at the end the following new subsection:
``(x) Prostate Cancer DNA Specimen Provenance Assay Tests.--
``(1) Payment for covered tests.--
``(A) In general.--Subject to subparagraph (B), the
payment amount for a prostate cancer DNA Specimen
Provenance Assay test (DSPA test) (as defined in
section 1861(kkk)) shall be $200. Such payment shall be
payment for all of the specimens obtained from the
biopsy furnished to an individual that are tested.
``(B) Limitation.--Payment for a DSPA test under
subparagraph (A) may only be made on an assignment-
related basis.
``(C) Prohibition on separate payment.--No separate
payment shall be made for obtaining DNA that was
separately taken from an individual at the time of a
biopsy described in subparagraph (A).
``(2) HCPCS code and modifier assignment.--
``(A) In general.--The Secretary shall assign one or
more HCPCS codes to a prostate cancer DNA Specimen
Provenance Assay test and may use a modifier to
facilitate making payment under this section for such
test.
``(B) Identification of dna match on claim.--The
Secretary shall require an indication on a claim for a
prostate cancer DNA Specimen Provenance Assay test of
whether the DNA of the prostate biopsy specimens match
the DNA of the individual diagnosed with prostate
cancer. Such indication may be made through use of a
HCPCS code, a modifier, or other means, as determined
appropriate by the Secretary.
``(3) DNA match review.--
``(A) In general.--The Secretary shall review at
least three years of claims under part B for prostate
cancer DNA Specimen Provenance Assay tests to identify
whether the DNA of the prostate biopsy specimens match
the DNA of the individuals diagnosed with prostate
cancer.
``(B) Posting on internet website.--Not later than
July 1, 2023, the Secretary shall post on the internet
website of the Centers for Medicare & Medicaid Services
the findings of the review conducted under subparagraph
(A).''.
(3) Cost-sharing.--Section 1833(a)(1) of the Social Security
Act (42 U.S.C. 1395l(a)(1)) is amended--
(A) by striking ``and (CC)'' and inserting ``(CC)'';
and
(B) by inserting before the semicolon at the end the
following: ``, and (DD) with respect to a prostate
cancer DNA Specimen Provenance Assay test (DSPA test)
(as defined in section 1861(kkk)), the amount paid
shall be an amount equal to 80 percent of the lesser of
the actual charge for the test or the amount specified
under section 1834(x)''.
SEC. 208. EXCLUSION OF COMPLEX REHABILITATIVE MANUAL WHEELCHAIRS FROM
MEDICARE COMPETITIVE ACQUISITION PROGRAM; NON-
APPLICATION OF MEDICARE FEE-SCHEDULE ADJUSTMENTS
FOR CERTAIN WHEELCHAIR ACCESSORIES AND CUSHIONS.
(a) Exclusion of Complex Rehabilitative Manual Wheelchairs From
Competitive Acquisition Program.--Section 1847(a)(2)(A) of the Social
Security Act (42 U.S.C. 1395w-3(a)(2)(A)) is amended--
(1) by inserting ``, complex rehabilitative manual
wheelchairs (as determined by the Secretary), and certain
manual wheelchairs (identified, as of October 1, 2018, by HCPCS
codes E1235, E1236, E1237, E1238, and K0008 or any successor to
such codes)'' after ``group 3 or higher''; and
(2) by striking ``such wheelchairs'' and inserting ``such
complex rehabilitative power wheelchairs, complex
rehabilitative manual wheelchairs, and certain manual
wheelchairs''.
(b) Non-Application of Medicare Fee Schedule Adjustments for
Wheelchair Accessories and Seat and Back Cushions When Furnished in
Connection With Complex Rehabilitative Manual Wheelchairs.--
(1) In general.--Notwithstanding any other provision of law,
the Secretary of Health and Human Services shall not, during
the period beginning on January 1, 2020, and ending on December
31, 2020, use information on the payment determined under the
competitive acquisition programs under section 1847 of the
Social Security Act (42 U.S.C. 1395w-3) to adjust the payment
amount that would otherwise be recognized under section
1834(a)(1)(B)(ii) of such Act (42 U.S.C. 1395m(a)(1)(B)(ii))
for wheelchair accessories (including seating systems) and seat
and back cushions when furnished in connection with complex
rehabilitative manual wheelchairs (as determined by the
Secretary), and certain manual wheelchairs (identified, as of
October 1, 2018, by HCPCS codes E1235, E1236, E1237, E1238, and
K0008 or any successor to such codes).
(2) Implementation.--Notwithstanding any other provision of
law, the Secretary may implement this subsection by program
instruction or otherwise.
TITLE III--MEDICAID PROVISIONS
SEC. 301. MODIFICATION OF REDUCTIONS IN MEDICAID DSH ALLOTMENTS.
Section 1923(f)(7)(A) of the Social Security Act (42 U.S.C. 1396r-
4(f)(7)(A)) is amended--
(1) in clause (i), in the matter preceding subclause (I), by
striking ``2020'' and inserting ``2022''; and
(2) in clause (ii)--
(A) in subclause (I), by striking ``2020'' and
inserting ``2022''; and
(B) in subclause (II), by striking ``for each of
fiscal years 2021 through 2025'' and inserting ``for
each of fiscal years 2023 through 2025''.
SEC. 302. PUBLIC AVAILABILITY OF HOSPITAL UPPER PAYMENT LIMIT
DEMONSTRATIONS.
Section 1903 of the Social Security Act (42 U.S.C. 1396b) is amended
by adding at the end the following new subsection:
``(bb) Public Availability of Hospital Upper Payment Limit
Demonstrations.--The Secretary shall make publicly available upper
payment limit demonstrations for hospital services that a State submits
with respect to a fiscal year of the State (beginning with State fiscal
year 2022) to the Administrator of the Centers for Medicare & Medicaid
Services.''.
SEC. 303. REPORT BY COMPTROLLER GENERAL.
Not later than the date that is 21 months after the date of the
enactment of this Act, the Comptroller General of the United States
shall identify and report to Congress policy considerations for
legislative action with respect to establishing an equitable formula
for determining disproportionate share hospital allotments for States
under section 1923 of the Social Security Act (42 U.S.C. 1396r-4) that
takes into account the following factors:
(1) The level of uncompensated care costs of hospitals in a
State.
(2) Expenditures of a State with respect to hospitals,
including payment adjustments made under such section 1923 to
disproportionate share hospitals (as defined under the State
plan under title XIX of such Act (42 U.S.C. 1396 et seq.)
pursuant to subsection (a)(1)(A) of such section 1923), upper
payment limit supplemental payments, and other related payments
that hospitals may receive from the State.
(3) State policy decisions that may affect the level of
uncompensated care costs of hospitals in a State.
SEC. 304. SENSE OF CONGRESS REGARDING THE NEED TO DEVELOP A MORE
PERMANENT LEGISLATIVE SOLUTION TO PROVIDE THE
TERRITORIES WITH A RELIABLE AND CONSISTENT SOURCE
OF FEDERAL FUNDING UNDER THE MEDICAID PROGRAM.
It is the sense of Congress that--
(1) the territories of American Samoa, the Commonwealth of
the Northern Mariana Islands, Guam, Puerto Rico, and the United
States Virgin Islands are currently subject to Federal funding
caps for their Medicaid programs;
(2) as a result of these Federal funding caps, which have not
been adjusted over time, the territories continue to struggle
in managing their Medicaid programs, including planning for
their respective financial obligations and managing health care
services for low-income adults, children, pregnant women,
elderly adults, and persons with disabilities;
(3) to address this disparate funding treatment and to
provide the territories with some measure of relief, Congress
has had to enact legislation six times in the last 15 years,
including multiple temporary increases in the Federal funding
caps, higher Federal medical assistance percentage rates, and
billions of dollars in supplemental block grants;
(4) the supplemental funding provided to the territories
under title V with respect to their Medicaid programs continues
Congress' commitment to ensuring the sustainability of these
critically important programs and the people these programs
serve; and
(5) a more permanent legislative solution must be developed
in order to provide the territories with a reliable and
consistent source of Federal funding under their Medicaid
programs so that the territories can continue to meet the
health care needs of vulnerable populations.
TITLE IV--NO SURPRISES ACT
SEC. 401. SHORT TITLE.
This title may be cited as the ``No Surprises Act''.
SEC. 402. PREVENTING SURPRISE MEDICAL BILLS.
(a) Coverage of Emergency Services.--Section 2719A(b) of the Public
Health Service Act (42 U.S.C. 300gg-19a(b)) is amended--
(1) in paragraph (1)--
(A) in the matter preceding subparagraph (A)--
(i) by striking ``a group health plan, or a
health insurance issuer offering group or
individual health insurance issuer,'' and
inserting ``a health plan (as defined in
subsection (e)(2)(A))'';
(ii) by inserting ``or, for plan year 2021 or
a subsequent plan year, with respect to
emergency services in an independent
freestanding emergency department (as defined
in paragraph (3)(D))'' after ``emergency
department of a hospital'';
(iii) by striking ``the plan or issuer'' and
inserting ``the plan''; and
(iv) by striking ``paragraph (2)(B)'' and
inserting ``paragraph (3)(C)'';
(B) in subparagraph (B), by inserting ``or a
participating emergency facility, as applicable,''
after ``participating provider''; and
(C) in subparagraph (C)--
(i) in the matter preceding clause (i), by
inserting ``by a nonparticipating provider or a
nonparticipating emergency facility'' after
``enrollee'';
(ii) by striking clause (i);
(iii) by striking ``(ii)(I) such services''
and inserting ``(i) such services'';
(iv) by striking ``where the provider of
services does not have a contractual
relationship with the plan for the providing of
services'';
(v) by striking ``emergency department
services received from providers who do have
such a contractual relationship with the plan;
and'' and inserting ``emergency services
received from participating providers and
participating emergency facilities with respect
to such plan;'';
(vi) by striking ``(II) if such services''
and all that follows through ``were provided
in-network;'' and inserting the following:
``(ii) the cost-sharing requirement
(expressed as a copayment amount or coinsurance
rate) is not greater than the requirement that
would apply if such services were provided by a
participating provider or a participating
emergency facility;''; and
(vii) by adding at the end the following new
clauses:
``(iii) such requirement is calculated as if
the total amount that would have been charged
for such services by such participating
provider or participating emergency facility
were equal to--
``(I) in the case of such services
furnished in a State described in
paragraph (3)(H)(ii), the median
contracted rate (as defined in
paragraph (3)(E)(i)) for such services;
and
``(II) in the case of such services
furnished in a State described in
paragraph (3)(H)(i), the lesser of--
``(aa) the amount determined
by such State for such services
in accordance with the method
described in such paragraph;
and
``(bb) the median contracted
rate (as so defined) for such
services;
``(iv) the health plan pays to such provider
or facility, respectively, the amount by which
the recognized amount (as defined in paragraph
(3)(H)) for such services exceeds the cost-
sharing amount for such services (as determined
in accordance with clauses (ii) and (iii)); and
``(v) any cost-sharing payments made by the
participant, beneficiary, or enrollee with
respect to such emergency services so furnished
shall be counted toward any in-network
deductible or out-of-pocket maximums applied
under the plan (and such in-network deductible
shall be applied) in the same manner as if such
cost-sharing payments were with respect to
emergency services furnished by a participating
provider and a participating emergency
facility; and'';
(2) by redesignating paragraph (2) as paragraph (3);
(3) by inserting after paragraph (1) the following new
paragraph:
``(2) Audit process for median contracted rates.--
``(A) In general.--Not later than July 1, 2020, the
Secretary, in consultation with appropriate State
agencies, shall establish through rulemaking a process,
in accordance with subparagraph (B), under which health
plans are audited by such Secretaries to ensure that--
``(i) such plans are in compliance with the
requirement of applying a median contracted
rate under this section; and
``(ii) that such median contracted rate so
applied satisfies the definition under
paragraph (3)(E) with respect to the year
involved, including with respect to a health
plan described in clause (ii) of such
paragraph.
``(B) Audit samples.--Under the process established
pursuant to subparagraph (A), the Secretary--
``(i) shall conduct audits described in such
subparagraph, with respect to a year (beginning
with 2021), of a sample with respect to such
year of claims data from not more than 25
health plans; and
``(ii) may audit any health plan if the
Secretary has received any complaint about such
plan that involves the compliance of the plan
with either of the requirements described in
clauses (i) and (ii) of such subparagraph.'';
and
(4) in paragraph (3), as redesignated by paragraph (2) of
this subsection--
(A) in the matter preceding subparagraph (A), by
inserting ``and subsection (e)'' after ``this
subsection'';
(B) by redesignating subparagraphs (A) through (C) as
subparagraphs (B) through (D), respectively;
(C) by inserting before subparagraph (B), as
redesignated by subparagraph (B) of this paragraph, the
following new subparagraph:
``(A) Emergency department of a hospital.--The term
`emergency department of a hospital' includes a
hospital outpatient department that provides emergency
services.'';
(D) by amending subparagraph (C), as redesignated by
subparagraph (B) of this paragraph, to read as follows:
``(C) Emergency services.--
``(i) In general.--The term `emergency
services', with respect to an emergency medical
condition, means--
``(I) a medical screening examination
(as required under section 1867 of the
Social Security Act, or as would be
required under such section if such
section applied to an independent
freestanding emergency department) that
is within the capability of the
emergency department of a hospital or
of an independent freestanding
emergency department, as applicable,
including ancillary services routinely
available to the emergency department
to evaluate such emergency medical
condition; and
``(II) within the capabilities of the
staff and facilities available at the
hospital or the independent
freestanding emergency department, as
applicable, such further medical
examination and treatment as are
required under section 1867 of such
Act, or as would be required under such
section if such section applied to an
independent freestanding emergency
department, to stabilize the patient.
``(ii) Inclusion of poststabilization
services.--For purposes of this subsection and
section 2799, in the case of an individual
enrolled in a health plan who is furnished
services described in clause (i) by a provider
or facility to stabilize such individual with
respect to an emergency medical condition, the
term `emergency services' shall include such
items and services in addition to those
described in clause (i) that such a provider or
facility determines are needed to be furnished
(after such stabilization but during such visit
in which such individual is so stabilized) to
such individual, unless each of the following
conditions are met:
``(I) Such a provider or facility
determines such individual is able to
travel using nonmedical transportation
or nonemergency medical transportation.
``(II) Such provider furnishing such
additional items and services is in
compliance with section 2799A(d) with
respect to such items and services.'';
(E) by redesignating subparagraph (D), as
redesignated by subparagraph (B) of this paragraph, as
subparagraph (I); and
(F) by inserting after subparagraph (C), as
redesignated by subparagraph (B) of this paragraph, the
following new subparagraphs:
``(D) Independent freestanding emergency
department.--The term `independent freestanding
emergency department' means a facility that--
``(i) is geographically separate and distinct
and licensed separately from a hospital under
applicable State law; and
``(ii) provides emergency services.
``(E) Median contracted rate.--
``(i) In general.--The term `median
contracted rate' means, with respect to an item
or service and a health plan (as defined in
subsection (e)(2)(A))--
``(I) for 2021, the median of the
negotiated rates recognized by the
sponsor or issuer of such plan
(determined with respect to all such
plans of such sponsor or such issuer
that are within the same line of
business) as the total maximum payment
(including the cost-sharing amount
imposed for such services (as
determined in accordance with clauses
(ii) and (iii) of paragraph (1)(C) or
subparagraphs (A) and (B) of subsection
(e)(1), as applicable) and the amount
to be paid by the plan or issuer) under
such plans in 2019 for the same or a
similar item or service that is
provided by a provider in the same or
similar specialty and provided in the
geographic region in which the item or
service is furnished, consistent with
the methodology established by the
Secretary under section 402(e) of the
No Surprises Act, increased by the
percentage increase in the consumer
price index for all urban consumers
(United States city average) over 2019
and 2020; and
``(II) for 2022 and each subsequent
year, the median contracted rate
determined under this clause for the
previous year, increased by the
percentage increase in the consumer
price index for all urban consumers
(United States city average) over such
previous year.
``(ii) Special rule.--The Secretary shall
provide pursuant to rulemaking described in
section 402(e) of the No Surprises Act that--
``(I) if the sponsor or issuer of a
health plan does not have sufficient
information to calculate a median
contracted rate for an item or service
or provider type, or amount of, claims
for items or services (as determined by
the Secretary) provided in a particular
geographic area (other than in a case
described in item (bb)), such sponsor
or issuer shall demonstrate that such
sponsor or issuer will use any database
free of conflicts of interest that has
sufficient information reflecting
allowed amounts paid to a health care
provider for relevant services provided
in the applicable geographic region
(such as State All Payer Claims
Databases (as defined in section 404(d)
of such Act)), and that such sponsor or
issuer will use any such database to
determine a median contracted rate and
cover the cost of accessing any such
database; and
``(II) in the case of a sponsor or
issuer offering a health plan in a
geographic region that did not offer
any health plan in such region during
2019, such sponsor or issuer shall use
a methodology established by the
Secretary for determining the median
contracted rate for items and services
covered by such plan for the first year
in which such plan is offered in such
region, and that, for each succeeding
year, the median contracted rate for
such items and services under such plan
shall be the median contracted rate for
such items and services under such plan
for the previous year, increased by the
percentage increase in the consumer
price index for all urban consumers
(United States city average) over such
previous year.
``(F) Nonparticipating emergency facility;
participating emergency facility.--
``(i) Nonparticipating emergency facility.--
The term `nonparticipating emergency facility'
means, with respect to an item or service and a
health plan, an emergency department of a
hospital, or an independent freestanding
emergency department, that does not have a
contractual relationship with the plan (or, if
applicable, issuer offering the plan) for
furnishing such item or service under the plan.
``(ii) Participating emergency facility.--The
term `participating emergency facility' means,
with respect to an item or service and a health
plan, an emergency department of a hospital, or
an independent freestanding emergency
department, that has a contractual relationship
with the plan (or, if applicable, issuer
offering the plan) for furnishing such item or
service under the plan.
``(G) Nonparticipating providers; participating
providers.--
``(i) Nonparticipating provider.--The term
`nonparticipating provider' means, with respect
to an item or service and a health plan, a
physician or other health care provider who is
acting within the scope of practice of that
provider's license or certification under
applicable State law and who does not have a
contractual relationship with the plan (or, if
applicable, issuer offering the plan) for
furnishing such item or service under the plan.
``(ii) Participating provider.--The term
`participating provider' means, with respect to
an item or service and a health plan, a
physician or other health care provider who is
acting within the scope of practice of that
provider's license or certification under
applicable State law and who has a contractual
relationship with the plan (or, if applicable,
issuer offering the plan) for furnishing such
item or service under the plan.
``(H) Recognized amount.--The term `recognized
amount' means, with respect to an item or service--
``(i) in the case of such item or service
furnished in a State that has in effect a State
law that provides for a method for determining
the amount of payment that is required to be
covered by a health plan regulated by such
State in the case of a participant,
beneficiary, or enrollee covered under such
plan and receiving such item or service from a
nonparticipating provider or facility, not more
than the amount determined in accordance with
such law plus the cost-sharing amount imposed
under the plan for such item or service (as
determined in accordance with clauses (ii) and
(iii) of paragraph (1)(C) or subparagraphs (A)
and (B) of subsection (e)(1), as applicable);
or
``(ii) in the case of such item or service
furnished in a State that does not have in
effect such a law, an amount that is at least
the median contracted rate (as defined in
subparagraph (E)(i) and determined in
accordance with rulemaking described in section
402(e) of the No Surprises Act) for such item
or service.''.
(b) Coverage of Non-emergency Services Performed by Nonparticipating
Providers at Certain Participating Facilities; Independent Dispute
Resolution Process.--Section 2719A of the Public Health Service Act (42
U.S.C. 300gg-19a) is amended by adding at the end the following new
subsections:
``(e) Coverage of Non-emergency Services Performed by
Nonparticipating Providers at Certain Participating Facilities.--
``(1) In general.--Subject to paragraph (3), in the case of
items or services (other than emergency services to which
subsection (b) applies) furnished to a participant,
beneficiary, or enrollee of a health plan (as defined in
paragraph (2)(A)) by a nonparticipating provider (as defined in
subsection (b)(3)(G)(i)) during a visit (as defined by the
Secretary in accordance with paragraph (2)(C)) at a
participating health care facility (as defined in paragraph
(2)(B)), with respect to such plan, the plan--
``(A) shall not impose on such participant,
beneficiary, or enrollee a cost-sharing amount
(expressed as a copayment amount or coinsurance rate)
for such items and services so furnished that is
greater than the cost-sharing amount that would apply
under such plan had such items or services been
furnished by a participating provider (as defined in
subsection (b)(3)(G)(ii));
``(B) shall calculate such cost-sharing amount as if
the amount that would have been charged for such items
and services by such participating provider were equal
to--
``(i) in the case of such items and services
furnished in a State described in subsection
(b)(3)(H)(ii), the median contracted rate (as
defined in subsection (b)(3)(E)(i)) for such
items and services; and
``(ii) in the case of such items and services
furnished in a State described in subsection
(b)(3)(H)(i), the lesser of--
``(I) the amount determined by such
State for such items and services in
accordance with the method described in
such subsection; and
``(II) the median contracted rate (as
so defined) for such items and
services;
``(C) shall pay to such provider furnishing such
items and services to such participant, beneficiary, or
enrollee the amount by which the recognized amount (as
defined in subsection (b)(3)(H)) for such items and
services exceeds the cost-sharing amount imposed under
the plan for such items and services (as determined in
accordance with subparagraphs (A) and (B)); and
``(D) shall count toward any in-network deductible or
out-of-pocket maximums applied under the plan any cost-
sharing payments made by the participant, beneficiary,
or enrollee (and such in-network deductible shall be
applied) with respect to such items and services so
furnished in the same manner as if such cost-sharing
payments were with respect to items and services
furnished by a participating provider.
``(2) Definitions.--In this subsection and subsection (b):
``(A) Health plan.--The term `health plan' means a
group health plan and health insurance coverage offered
by a heath insurance issuer in the group or individual
market and includes a grandfathered health plan (as
defined in section 1251(e) of the Patient Protection
and Affordable Care Act).
``(B) Participating health care facility.--
``(i) In general.--The term `participating
health care facility' means, with respect to an
item or service and a health plan, a health
care facility described in clause (ii) that has
a contractual relationship with the plan (or,
if applicable, issuer offering the plan) for
furnishing such item or service.
``(ii) Health care facility described.--A
health care facility described in this clause
is each of the following:
``(I) A hospital (as defined in
1861(e) of the Social Security Act).
``(II) A critical access hospital (as
defined in section 1861(mm) of such
Act).
``(III) An ambulatory surgical center
(as defined in section 1833(i)(1)(A) of
such Act).
``(IV) A laboratory.
``(V) A radiology facility or imaging
center.
``(C) During a visit.--The term `during a visit'
shall, with respect to items and services furnished to
an individual at a participating health care facility,
include equipment and devices, telemedicine services,
imaging services, laboratory services, and such other
items and services as the Secretary may specify,
regardless of whether or not the provider furnishing
such items or services is at the facility.
``(3) Exception.--Paragraph (1) shall not apply to a health
plan in the case of items or services (other than emergency
services to which subsection (b) applies) furnished to a
participant, beneficiary, or enrollee of a health plan (as
defined in paragraph (2)(A)) by a nonparticipating provider (as
defined in subsection (b)(3)(G)(i)) during a visit (as defined
by the Secretary in accordance with paragraph (2)(C)) at a
participating health care facility (as defined in paragraph
(2)(B)) if such provider is in compliance with section 2799A(d)
with respect to such items and services.
``(f) Independent Dispute Resolution Process.--
``(1) Establishment.--
``(A) In general.--Not later than 1 year after the
date of the enactment of this subsection, the
Secretary, in consultation with the Secretary of Labor,
shall establish by regulation an independent dispute
resolution process (referred to in this subsection as
the `IDR process') under which--
``(i) a nonparticipating provider (as defined
in subparagraph (G) of subsection (b)(3)),
nonparticipating emergency facility (as defined
in subparagraph (F) of such subsection), or
health plan (as defined in subsection
(e)(2)(A)) may submit a request for resolution
by an entity certified under paragraph (2) (in
this subsection referred to as a `certified IDR
entity') of a specified claim; and
``(ii) in the case a settlement described in
subparagraph (B) of paragraph (4) is not
reached with respect to such claim, such entity
so resolves such claim in accordance with such
paragraph.
``(B) Definitions.--In this subsection:
``(i) Specified claim.--
``(I) In general.--Subject to
subclause (II), the term `specified
claim' means a claim by a
nonparticipating provider, a
nonparticipating emergency facility, or
a health plan with respect to
qualifying items and services (as
defined in clause (ii)) furnished by
such provider or facility in a State
described in subparagraph (H)(ii) of
subsection (b)(3) for which a health
plan is required to make payment
pursuant to subsection (b)(1) or
subsection (e)(1)--
``(aa) that such payment
should be increased or
decreased; and
``(bb) that is made not later
than--
``(AA) in the case of
such a claim filed by
such a provider or
facility, the date on
which the appeal with
respect to such items
and services described
in clause
(ii)(I)(aa)(AA) has
been resolved (or the
date that is 30 days
after such appeal is
filed, whichever is
earlier); or
``(BB) in the case of
such a claim filed by
such plan, the date on
which the period
described in clause
(ii)(I)(bb)(BB) with
respect to such items
and services elapses.
``(II) Limitation on packaging of
items and services in a specified
claim.--The term `specified claim'
shall not include, in the case such
claim is made by such provider,
facility, or plan with respect to
multiple items and services, any claim
with respect to items and services
furnished by such provider or facility
if--
``(aa) such items and
services were not furnished by
the same provider or facility;
``(bb) payment for such items
and services made pursuant to
subsection (b)(1) or subsection
(e)(1) was made by multiple
health plans;
``(cc) such items and
services are not related to the
treatment of the same
condition; or
``(dd) such items and
services were not furnished
within 30 days of the date of
the earliest item or service
furnished that is included in
such claim.
``(ii) Qualifying items and services.--
``(I) In general.--Subject to
subclause (II), the term `qualifying
items and services' means--
``(aa) with respect to a
specified claim made by a
nonparticipating provider or
nonparticipating emergency
facility, items and services
furnished by such provider or
facility for which a health
plan is required to make
payment pursuant to subsection
(b)(1) or subsection (e)(1),
but only if--
``(AA) such items and
services are included
in an appeal filed
under such plan's
internal appeals
process not later than
30 days after such
payment is received;
and
``(BB) such appeal
under such plan's
internal appeals
process has been
resolved, or a 30-day
period has elapsed
since such appeal was
so filed; and
``(bb) with respect to a
specified claim made by a
health plan, items and services
furnished by such a provider or
facility for which such health
plan is required to make
payment pursuant to subsection
(b)(1) or subsection (e)(1),
but only if--
``(AA) such plan
submits a notice to
such provider or
facility not later than
30 days after such
provider or facility
receives such payment
that such plan disputes
the amount of such
payment with respect to
such items and
services; and
``(BB) a 30-day
period has elapsed
since the submission of
such notice.
``(II) Limitation.--The term
`qualifying items and services' shall
not include an item or service
furnished in a geographic area during a
year by such provider or facility for
which a health plan is required to make
payment pursuant to subsection (b)(1)
or subsection (e)(1) if the median
contracted rate (as defined in
subsection (b)(3)(E)) under such plan
for such year with respect to such item
or service furnished by such a provider
or such a facility in such area does
not exceed--
``(aa) with respect to an
item or service furnished
during 2021, $1,250; and
``(bb) with respect to an
item or service furnished
during a subsequent year, the
amount specified under this
subclause for the previous
year, increased by the
percentage increase in the
consumer price index for all
urban consumers (United States
city average) over such
previous year.
``(2) Certification of entities.--
``(A) Process of certification.--The process
described in paragraph (1) shall include a
certification process under which eligible entities may
be certified to carry out the IDR process.
``(B) Eligibility.--
``(i) In general.--For purposes of
subparagraph (A), an eligible entity is an
entity that is a nongovernmental entity that
agrees to comply with the fee limitations
described in clause (ii).
``(ii) Fee limitation.--For purposes of
clause (i), the fee limitations described in
this clause are limitations established by the
Secretary on the amount a certified IDR entity
may charge a nonparticipating provider,
nonparticipating emergency facility, or health
plan for services furnished by such entity with
respect to the resolution of a specified claim
of such provider, facility, or plan under the
process described in paragraph (1).
``(3) Selection of certified idr entity for a specified
claim.--With respect to the resolution of a specified claim
under the IDR process, the health plan and the nonparticipating
provider or the nonparticipating emergency facility (as
applicable) involved shall agree on a certified IDR entity to
resolve such claim. In the case that such plan and such
provider or facility (as applicable) cannot so agree, such an
entity shall be selected by the Secretary at random.
``(4) Payment determination.--
``(A) Timing.--A certified IDR entity selected under
paragraph (3) by a health plan and a nonparticipating
provider or a nonparticipating emergency facility (as
applicable) with respect to a specified claim shall,
subject to subparagraph (B), not later than 30 days
after being so selected, determine the total
reimbursement that should have been made for items and
services included in such claim in accordance with
subparagraph (C).
``(B) Settlement.--
``(i) In general.--If such entity determines
that a settlement between the health plan and
the provider or facility is likely with respect
to a specified claim, the entity may direct the
parties to attempt, for a period not to exceed
10 days, a good faith negotiation for a
settlement of such claim.
``(ii) Timing.--The period for a settlement
described in clause (i) shall accrue towards
the 30-day period described in subparagraph
(A).
``(C) Determination of amount.--
``(i) In general.--The health plan and the
nonparticipating provider or nonparticipating
emergency facility (as applicable) shall, with
respect to a specified claim, each submit to
the certified IDR entity a final offer of
payment or reimbursement (as applicable) with
respect to items and services which are the
subject of the specified claim. Such entity
shall determine which such offer is the most
reasonable in accordance with clause (ii).
``(ii) Considerations in determination.--
``(I) In general.--In determining
which final offer is the most
reasonable under clause (i), the
certified IDR entity shall consider--
``(aa) the median contracted
rates (as defined in subsection
(b)(3)(E)) for items or
services that are comparable to
the items and services included
in the specified claim and that
are furnished in the same
geographic area (as defined by
the Secretary for purposes of
such subsection) as such items
and services (not including any
facility fees with respect to
such rates); and
``(bb) the circumstances
described in subclause (II), if
any information with respect to
such circumstances is submitted
by either party.
``(II) Additional circumstances.--For
purposes of subclause (I)(bb), the
circumstances described in this
subclause are, with respect to items
and services included in the specified
claim of a nonparticipating provider,
nonparticipating emergency facility, or
health plan, the following:
``(aa) The level of training,
education, experience, and
quality and outcomes
measurements of the provider or
facility that furnished such
items and services.
``(bb) Any other extenuating
circumstances with respect to
the furnishing of such items
and services that relate to the
acuity of the individual
receiving such items and
services or the complexity of
furnishing such items and
services to such individual.
``(III) Prohibition on consideration
of billed charges.--In determining
which final offer is the most
reasonable under clause (i) with
respect to items and services furnished
by a provider or facility and included
in a specified claim, the certified IDR
entity may not consider the amount that
would have been billed by such provider
or facility with respect to such items
and services had the provisions of
section 2799 or 2799A (as applicable)
not applied.
``(iii) Effect of determination.--A
determination of a certified IDR entity under
clause (i)--
``(I) shall be binding; and
``(II) shall not be subject to
judicial review, except in a case
described in any of paragraphs (1)
through (4) of section 10(a) of title
9, United States Code.
``(iv) Costs of independent dispute
resolution process.--In the case of a specified
claim made by a nonparticipating provider,
nonparticipating emergency facility, or health
plan and submitted to a certified IDR entity--
``(I) if such entity makes a
determination with respect to such
claim under clause (i), the party whose
offer is not chosen under such clause
shall be responsible for paying all
fees charged by such entity; and
``(II) if the parties reach a
settlement with respect to such claim
prior to such a determination, such
fees shall be divided equally between
the parties, unless the parties
otherwise agree.
``(v) Payment.--Not later than 30 days after
a determination described in clause (i) is made
with respect to a specified claim of a
nonparticipating provider, nonparticipating
emergency facility, or health plan--
``(I) in the case that such
determination finds that the amount
paid with respect to such specified
claim by the health plan should have
been greater than the amount so paid,
such plan shall pay directly to the
provider or facility (as applicable)
the difference between the amount so
paid and the amount so determined; and
``(II) in the case that such
determination finds that the amount
paid with respect to such specified
claim by the health plan should have
been less than the amount so paid, the
provider or facility (as applicable)
shall pay directly to the plan the
difference between the amount so paid
and the amount so determined.
``(5) Publication of information relating to disputes.--
``(A) In general.--For 2021 and each subsequent year,
the Secretary and the Secretary of Labor shall publish
on the public website of the Department of Health and
Human Services and the Department of Labor,
respectively--
``(i) the number of specified claims filed
during such year;
``(ii) the number of such claims with respect
to which a final determination was made under
paragraph (4)(C)(i); and
``(iii) the information described in
subparagraph (B) with respect to each specified
claim with respect to which such a decision was
so made.
``(B) Information with respect to specified claims.--
For purposes of subparagraph (A), the information
described in this subparagraph is, with respect to a
specified claim of a nonparticiapting provider,
nonparticipating emergency facility, or health plan--
``(i) a description of each item and service
included in such claim;
``(ii) the amount of the offer submitted
under paragraph (4)(C)(i) by the health plan
and by the nonparticipating provider or
nonparticipating emergency facility (as
applicable);
``(iii) whether the offer selected by the
certified IDR entity under such paragraph was
the offer submitted by such plan or by such
provider or facility (as applicable) and the
amount of such offer so selected; and
``(iv) the category and practice specialty of
each such provider or facility involved in
furnishing such items and services.
``(C) Confidentiality of parties.--None of the
information published under this paragraph may specify
the identity of a health plan, provider, facility, or
individual with respect to a specified claim.''.
(c) Provider Directory Requirements; Disclosure on Patient
Protections.--Section 2719A of the Public Health Service Act, as
amended by subsection (b), is further amended by adding at the end the
following new subsections:
``(g) Provider Directory Information Requirements.--
``(1) In general.--Not later than 1 year after the date of
the enactment of this subsection, each group health plan and
health insurance issuer offering group or individual health
insurance coverage shall--
``(A) establish the verification process described in
paragraph (2);
``(B) establish the response protocol described in
paragraph (3);
``(C) establish the database described in paragraph
(4); and
``(D) include in any print directory containing
provider directory information with respect to such
plan or such coverage the information described in
paragraph (5).
``(2) Verification process.--The verification process
described in this paragraph is, with respect to a group health
plan or a health insurance issuer offering group or individual
health insurance coverage, a process--
``(A) under which not less frequently than once every
90 days, such plan or such issuer (as applicable)
verifies and updates the provider directory information
included on the database described in paragraph (4) of
such plan or issuer of each health care provider and
health care facility included in such database; and
``(B) that establishes a procedure for the removal of
such a provider or facility with respect to which such
plan or issuer has been unable to verify such
information during a period specified by the plan or
issuer.
``(3) Response protocol.--The response protocol described in
this paragraph is, in the case of an individual enrolled under
a group health plan or group or individual health insurance
coverage offered by a health insurance issuer who requests
information on whether a health care provider or health care
facility has a contractual relationship to furnish items and
services under such plan or such coverage, a protocol under
which such plan or such issuer (as applicable), in the case
such request is made through a telephone call--
``(A) responds to such individual as soon as
practicable and in no case later than 1 business day
after such call is received through a written
electronic communication; and
``(B) retains such communication in such individual's
file for at least 2 years following such response.
``(4) Database.--The database described in this paragraph is,
with respect to a group health plan or health insurance issuer
offering group or individual health insurance coverage, a
database on the public website of such plan or issuer that
contains--
``(A) a list of each health care provider and health
care facility with which such plan or such issuer has a
contractual relationship for furnishing items and
services under such plan or such coverage; and
``(B) provider directory information with respect to
each such provider and facility.
``(5) Information.--The information described in this
paragraph is, with respect to a print directory containing
provider directory information with respect to a group health
plan or individual or group health insurance coverage offered
by a health insurance issuer, a notification that such
information contained in such directory was accurate as of the
date of publication of such directory and that an individual
enrolled under such plan or such coverage should consult the
database described in paragraph (4) with respect to such plan
or such coverage or contact such plan or the issuer of such
coverage to obtain the most current provider directory
information with respect to such plan or such coverage.
``(6) Definition.--For purposes of this subsection, the term
`provider directory information' includes, with respect to a
group health plan and a health insurance issuer offering group
or individual health insurance coverage, the name, address,
specialty, and telephone number of each health care provider or
health care facility with which such plan or such issuer has a
contractual relationship for furnishing items and services
under such plan or such coverage.
``(h) Disclosure on Patient Protections.--Each group health plan and
health insurance issuer offering group or individual health insurance
coverage shall make publicly available, and (if applicable) post on a
public website of such plan or issuer--
``(1) information in plain language on--
``(A) the requirements and prohibitions applied under
sections 2799 and 2799A (relating to prohibitions on
balance billing in certain
``(B) if provided for under applicable State law, any
other requirements on providers and facilities
regarding the amounts such providers and facilities
may, with respect to an item or service, charge a
participant, beneficiary, or enrollee of such plan or
coverage with respect to which such a provider or
facility does not have a contractual relationship for
furnishing such item or service under the plan or
coverage after receiving payment from the plan or
coverage for such item or service and any applicable
cost-sharing payment from such participant,
beneficiary, or enrollee; and
``(C) the requirements applied under subsections (b)
and (e); and
``(2) information on contacting appropriate State and Federal
agencies in the case that an individual believes that such a
provider or facility has violated any requirement described in
paragraph (1) with respect to such individual.''.
(d) Preventing Certain Cases of Balance Billing.--Title XXVII of the
Public Health Service Act is amended by adding at the end the following
new part:
``PART D--PREVENTING CERTAIN CASES OF BALANCE BILLING
``SEC. 2799. BALANCE BILLING IN CASES OF EMERGENCY SERVICES.
``(a) In General.--In the case of a participant, beneficiary, or
enrollee with benefits under a health plan who is furnished on or after
January 1, 2021, emergency services with respect to an emergency
medical condition during a visit at an emergency department of a
hospital or an independent freestanding emergency department--
``(1) the emergency department of a hospital or independent
freestanding emergency department shall not hold the
participant, beneficiary, or enrollee liable for a payment
amount for such emergency services so furnished that is more
than the cost-sharing amount for such services (as determined
in accordance with clauses (ii) and (iii) of section
2719A(b)(1)(C)); and
``(2) a health care provider shall not hold such participant,
beneficiary, or enrollee liable for a payment amount for an
emergency service furnished to such individual by such provider
with respect to such emergency medical condition and visit for
which the individual receives emergency services at the
hospital or emergency department that is more than the cost-
sharing amount for such services furnished by the provider (as
determined in accordance with clauses (ii) and (iii) of section
2719A(b)(1)(C)).
``(b) Definitions.--In this section:
``(1) The terms `emergency department of a hospital',
`emergency medical condition', `emergency services', and
`independent freestanding emergency department' have the
meanings given such terms, respectively, in section
2719A(b)(3).
``(2) The term `health plan' has the meaning given such term
in section 2719A(e).
``(3) The term `during a visit' shall have such meaning as
applied to such term for purposes of section 2719A(e).
``SEC. 2799A. BALANCE BILLING IN CASES OF NON-EMERGENCY SERVICES
PERFORMED BY NONPARTICIPATING PROVIDERS AT CERTAIN
PARTICIPATING FACILITIES.
``(a) In General.--Subject to subsection (b), in the case of a
participant, beneficiary, or enrollee with benefits under a health plan
(as defined in section 2799(b)) who is furnished on or after January 1,
2021, items or services (other than emergency services to which section
2799 applies) at a participating health care facility by a
nonparticipating provider, such provider shall not hold such
participant, beneficiary, or enrollee liable for a payment amount for
such an item or service furnished by such provider during a visit at
such facility that is more than the cost-sharing amount for such item
or service (as determined in accordance with subparagraphs (A) and (B)
of section 2719A(e)(1)).
``(b) Exception.--
``(1) In general.--Subsection (a) shall not apply to a
nonparticipating provider (other than a specified provider at a
participating health care facility), with respect to items or
services furnished by the provider to a participant,
beneficiary, or enrollee of a health plan, if the provider is
in compliance with the notice and consent requirements of
subsection (d).
``(2) Specified provider defined.--For purposes of paragraph
(1), the term `specified provider', with respect to a
participating health care facility--
``(A) means a facility-based provider, including
emergency medicine providers, anesthesiologists,
pathologists, radiologists, neonatologists, assistant
surgeons, hospitalists, intensivists, or other
providers as determined by the Secretary; and
``(B) includes, with respect to an item or service, a
nonparticipating provider if there is no participating
provider at such facility who can furnish such item or
service.
``(c) Clarification.--In the case of a nonparticipating provider
(other than a specified provider at a participating health care
facility) that complies with the notice and consent requirements of
subsection (d) with respect to an item or service (referred to in this
subsection as a `covered item or service'), such notice and consent
requirements may not be construed as applying with respect to any item
or service that is furnished as a result of unforeseen medical needs
that arise at the time such covered item or service is furnished.
``(d) Compliance With Notice and Consent Requirements.--
``(1) In general.--A nonparticipating provider or
nonparticipating facility is in compliance with this
subsection, with respect to items or services furnished by the
provider or facility to a participant, beneficiary, or enrollee
of a health plan, if the provider (or, if applicable, the
participating health care facility on behalf of such provider)
or nonparticipating facility--
``(A) provides to the participant, beneficiary, or
enrollee (or to an authorized representative of the
participant, beneficiary, or enrollee) on the date on
which the individual is furnished such items or
services and, in the case that the participant,
beneficiary, or enrollee makes an appointment to be
furnished such items or services, on such date the
appointment is made--
``(i) an oral explanation of the written
notice described in clause (ii); and
``(ii) a written notice specified by the
Secretary, not later than July 1, 2020, through
guidance (which shall be updated as determined
necessary by the Secretary) that--
``(I) contains the information
required under paragraph (2); and
``(II) is signed and dated by the
participant, beneficiary, or enrollee
(or by an authorized representative of
the participant, beneficiary, or
enrollee) and, with respect to items or
services to be furnished by such a
provider that are not poststabilization
services described in section
2719A(b)(3)(C)(ii), is so signed and
dated not less than 72 hours prior to
the participant, beneficiary, or
enrollee being furnished such items or
services by such provider; and
``(B) obtains from the participant, beneficiary, or
enrollee (or from such an authorized representative)
the consent described in paragraph (3).
``(2) Information required under written notice.--For
purposes of paragraph (1)(A)(ii)(I), the information described
in this paragraph, with respect to a nonparticipating provider
or nonparticipating facility and a participant, beneficiary, or
enrollee of a health plan, is each of the following:
``(A) Notification, as applicable, that the health
care provider is a nonparticipating provider with
respect to the health plan or the health care facility
is a nonparticipating facility with respect to the
health plan.
``(B) Notification of the estimated amount that such
provider or facility may charge the participant,
beneficiary, or enrollee for such items and services
involved.
``(C) In the case of a nonparticipating facility, a
list of any participating providers at the facility who
are able to furnish such items and services involved
and notification that the participant, beneficiary, or
enrollee may be referred, at their option, to such a
participating provider.
``(3) Consent described.--For purposes of paragraph (1)(B),
the consent described in this paragraph, with respect to a
participant, beneficiary, or enrollee of a health plan who is
to be furnished items or services by a nonparticipating
provider or nonparticipating facility, is a document specified
by the Secretary through rulemaking that--
``(A) is signed by the participant, beneficiary, or
enrollee (or by an authorized representative of the
participant, beneficiary, or enrollee) and, with
respect to items or services to be furnished by such a
provider or facility that are not poststabilization
services described in section 2719A(b)(3)(C)(ii), is so
signed not less than 72 hours prior to the participant,
beneficiary, or enrollee being furnished such items or
services by such provider or facility;
``(B) acknowledges that the participant, beneficiary,
or enrollee has been--
``(i) provided with a written estimate and an
oral explanation of the charge that the
participant, beneficiary, or enrollee will be
assessed for the items or services anticipated
to be furnished to the participant,
beneficiary, or enrollee by such provider or
facility; and
``(ii) informed that the payment of such
charge by the participant, beneficiary, or
enrollee may not accrue toward meeting any
limitation that the health plan places on cost-
sharing; and
``(C) documents the consent of the participant,
beneficiary, or enrollee to--
``(i) be furnished with such items or
services by such provider or facility; and
``(ii) in the case that the individual is so
furnished such items or services, be charged an
amount that may be greater than the amount that
would otherwise be charged the individual if
furnished by a participating provider or
participating facility with respect to such
items or services and plan.
``(e) Retention of Certain Documents.--A nonparticipating provider
(or, in the case of a nonparticipating provider at a participating
health care facility, such facility) or nonparticipating facility that
obtains from a participant, beneficiary, or enrollee of a health plan
(or an authorized representative of such participant, beneficiary, or
enrollee) a written notice in accordance with subsection (c)(1)(ii),
with respect to furnishing an item or service to such participant,
beneficiary, or enrollee, shall retain such notice for at least a 2-
year period after the date on which such item or service is so
furnished.
``(f) Definitions.--In this section:
``(1) The terms `nonparticipating provider' and
`participating provider' have the meanings given such terms,
respectively, in subsection (b)(3) of section 2719A.
``(2) The terms `participating health care facility' and
`health plan' have the meanings given such terms, respectively,
in subsection (e)(2) of section 2719A.
``(3) The term `nonparticipating facility' means--
``(A) with respect to emergency services (as defined
in section 2719A(b)(3)(C)(i)) and a health plan, an
emergency department of a hospital, or an independent
freestanding emergency department, that does not have a
contractual relationship with the plan (or, if
applicable, issuer offering the plan) for furnishing
such services under the plan; and
``(B) with respect to poststabilization services
described in section 2719A(b)(3)(C)(ii) and a health
plan, an emergency department of a hospital (or other
department of such hospital), or an independent
freestanding emergency department, that does not have a
contractual relationship with the plan (or, if
applicable, issuer offering the plan) for furnishing
such services under the plan.
``(4) The term `participating facility' means--
``(A) with respect to emergency services (as defined
in section 2719A(b)(3)(C)(i)) and a health plan, an
emergency department of a hospital, or an independent
freestanding emergency department, that has a
contractual relationship with the plan (or, if
applicable, issuer offering the plan) for furnishing
such services under the plan; and
``(B) with respect to poststabilization services
described in section 2719A(b)(3)(C)(ii) and a health
plan, an emergency department of a hospital (or other
department of such hospital), or an independent
freestanding emergency department, that has a
contractual relationship with the plan (or, if
applicable, issuer offering the plan) for furnishing
such services under the plan.
``SEC. 2799B. PROVIDER REQUIREMENTS WITH RESPECT TO PROVIDER DIRECTORY
INFORMATION.
``Not later than 1 year after the date of the enactment of this
section, each health care provider and health care facility shall
establish a process under which such provider or facility transmits, to
each health insurance issuer offering group or individual health
insurance coverage and group health plan with which such provider or
facility has in effect a contractual relationship for furnishing items
and services under such coverage or such plan, provider directory
information (as defined in section 2719A(g)(6)) with respect to such
provider or facility, as applicable. Such provider or facility shall so
transmit such information to such issuer offering such coverage or such
group health plan--
``(1) when the provider or facility enters into such a
relationship with respect to such coverage offered by such
issuer or with respect to such plan;
``(2) when the provider or facility terminates such
relationship with respect to such coverage offered by such
issuer or with respect to such plan;
``(3) when there are any other material changes to such
provider directory information of the provider or facility with
respect to such coverage offered by such issuer or with respect
to such plan; and
``(4) at any other time (including upon the request of such
issuer or plan) determined appropriate by the provider,
facility, or the Secretary.
``SEC. 2799C. PROVIDER REQUIREMENT WITH RESPECT TO PUBLIC PROVISION OF
INFORMATION.
``Each health care provider and health care facility shall make
publicly available, and (if applicable) post on a public website of
such provider or facility--
``(1) information in plain language on--
``(A) the requirements and prohibitions of such
provider or facility under sections 2799 and 2799A
(relating to prohibitions on balance billing in certain
circumstances); and
``(B) if provided for under applicable State law, any
other requirements on such provider or facility
regarding the amounts such provider or facility may,
with respect to an item or service, charge a
participant, beneficiary, or enrollee of a health plan
(as defined in section 2719A(e)(2)) with respect to
which such provider or facility does not have a
contractual relationship for furnishing such item or
service under the plan after receiving payment from the
plan for such item or service and any applicable cost-
sharing payment from such participant, beneficiary, or
enrollee; and
``(2) information on contacting appropriate State and Federal
agencies in the case that an individual believes that such
provider or facility has violated any requirement described in
paragraph (1) with respect to such individual.
``SEC. 2799D. ENFORCEMENT.
``(a) State Enforcement.--
``(1) State authority.--Each State may require a provider or
health care facility subject to the requirements of sections
2719A(f), 2799, 2799A, 2799B, or 2799C to satisfy such
requirements applicable to the provider or facility.
``(2) Failure to implement requirements.--In the case of a
determination by the Secretary that a State has failed to
substantially enforce the requirements specified in paragraph
(1) with respect to applicable providers and facilities in the
State, the Secretary shall enforce such requirements under
subsection (b) insofar as they relate to violations of such
requirements occurring in such State.
``(b) Secretarial Enforcement Authority.--
``(1) In general.--If a provider or facility is found to be
in violation specified in subsection (a)(1) by the Secretary,
the Secretary may apply a civil monetary penalty with respect
to such provider or facility in an amount not to exceed $10,000
per violation. The provisions of subsections (c), (d), (e),
(g), (h), (k), and (l) of section 1128A of the Social Security
Act shall apply to a civil monetary penalty or assessment under
this subsection in the same manner as such provisions apply to
a penalty, assessment, or proceeding under subsection (a) of
such section.
``(2) Limitation.--The provisions of paragraph (1) shall
apply to enforcement of a provision (or provisions) specified
in subsection (a)(1) only as provided under subsection (a)(2).
``(3) Complaint process.--The Secretary shall, through
rulemaking, establish a process to receive consumer complaints
of violations of such provisions and resolve such complaints
within 60 days of receipt of such complaints.
``(4) Exception.--The Secretary shall waive the penalties
described under paragraph (1) with respect to a facility or
provider who does not knowingly violate, and should not have
reasonably known it violated, section 2799 or 2799A with
respect to a participant, beneficiary, or enrollee, if such
facility or practitioner, within 30 days of the violation,
withdraws the bill that was in violation of such provision and
reimburses the health plan or enrollee, as applicable, in an
amount equal to the difference between the amount billed and
the amount allowed to be billed under the provision, plus
interest, at an interest rate determined by the Secretary.
``(5) Hardship exemption.--The Secretary may establish a
hardship exemption to the penalties under this subsection.
``(c) Continued Applicability of State Law.--The sections specified
in subsection (a)(1) shall not be construed to supersede any provision
of State law which establishes, implements, or continues in effect any
requirement or prohibition except to the extent that such requirement
or prohibition prevents the application of a requirement or prohibition
of such a section.''.
(e) Rulemaking for Median Contracted Rates.--Not later than July 1,
2020, the Secretary of Health and Human Services, jointly with the
Secretary of Labor, shall establish through rulemaking--
(1) the methodology the sponsor or issuer of a health plan
(as defined in subsection (e) of section 2719A of the Public
Health Service Act (42 U.S.C. 300gg-19a), as added by
subsection (b) of this section) shall use to determine the
median contracted rate (as defined in section 2719A(b) of such
Act, as amended by subsection (a) of this section),
differentiating by business line;
(2) the information such sponsor or issuer shall share with
the nonparticipating provider (as defined in such section)
involved when making such a determination; and
(3) the geographic regions applied for purposes of
subparagraph (E) of section 2719A(b)(3), as amended by
subsection (a) of this section, taking into account the needs
of rural and underserved areas, including health professional
shortage areas.
Such rulemaking shall take into account payments that are made by such
sponsor or issuer that are not on a fee-for-service basis. Such
methodology may account for relevant payment adjustments that take into
account facility type (including higher acuity settings and the case-
mix of various facility types) that are otherwise taken into account
for purposes of determining payment amounts with respect to
participating facilities.
(f) Effective Date.--The amendments made by subsections (a) and (b)
shall apply with respect to plan years beginning on or after January 1,
2021.
SEC. 403. GOVERNMENT ACCOUNTABILITY OFFICE STUDY ON PROFIT- AND
REVENUE-SHARING IN HEALTH CARE.
(a) Study.--The Comptroller General of the United States shall
conduct a study to--
(1) describe what is known about profit- and revenue-sharing
relationships in the commercial health care markets, including
those relationships that--
(A) involve one or more--
(i) physician groups that practice within a
hospital included in the profit- or revenue-
sharing relationship, or refer patients to such
hospital;
(ii) laboratory, radiology, or pharmacy
services that are delivered to privately
insured patients of such hospital;
(iii) surgical services;
(iv) hospitals or group purchasing
organizations; or
(v) rehabilitation or physical therapy
facilities or services; and
(B) include revenue- or profit-sharing whether
through a joint venture, management or professional
services agreement, or other form of gain-sharing
contract;
(2) describe Federal oversight of such relationships,
including authorities of the Department of Health and Human
Services and the Federal Trade Commission to review such
relationships and their potential to increase costs for
patients, and identify limitations in such oversight; and
(3) as appropriate, make recommendations to improve Federal
oversight of such relationships.
(b) Report.--Not later than 2 years after the date of the enactment
of this Act, the Comptroller General of the United States shall prepare
and submit a report on the study conducted under subsection (a) to the
Committee on Health, Education, Labor, and Pensions of the Senate and
the Committee on Education and Labor and Committee on Energy and
Commerce of the House of Representatives.
SEC. 404. STATE ALL PAYER CLAIMS DATABASES.
(a) In General.--The Secretary of Health and Human Services shall
make one-time grants to eligible States for the purposes described in
subsection (b).
(b) Uses.--A State may use a grant received under subsection (a) for
one of the following purposes:
(1) To establish an All Payer Claims Database for the State.
(2) To maintain an existing All Payer Claims Databases for
the State.
(c) Eligibility.--To be eligible to receive a grant under subsection
(a), a State shall submit to the Secretary an application at such time,
in such manner, and containing such information as the Secretary
specifies. Such information shall include, with respect to an All Payer
Claims Database for the State, at least specifics on how the State will
ensure uniform data collection through the database and the security of
such data submitted to and maintained in the database.
(d) All Payer Claims Database.--For purposes of this section, the
term ``All Payer Claims Database'' means, with respect to a State, a
State database that may include medical claims, pharmacy claims, dental
claims, and eligibility and provider files, which are collected from
private and public payers.
(e) Authorization of Appropriations.--To carry out this section,
there are authorized to be appropriated $50,000,000, to remain
available until expended.
SEC. 405. AIR AMBULANCE COST DATA REPORTING PROGRAM.
(a) Cost Data Reporting Program.--
(1) In general.--Not later than 6 months after the date of
the promulgation of the rule under subsection (c), and annually
thereafter, a provider of emergency air medical services shall
submit to the Secretary of Health and Human Services the
information specified in subsection (b) with respect to the
preceding 180-day period (in the case of the initial period)
and the preceding 1-year period (in each subsequent period).
(2) Publication.--Not later than 180 days after the date the
Secretary of Health and Human Services receives from a provider
described in paragraph (1) the information specified in
subsection (b), the Secretary shall make publicly available
such information.
(b) Specified Information.--Information described in subsection (a)
is--
(1) information, with respect to a claim for an item or
service--
(A) identified as paid by health insurance coverage
offered in the group or individual market or a group
health plan (including a self-insured plan);
(B) identified as paid for non-emergent transport
requiring prior authorization and emergent transport;
(C) identified as paid for hospital-affiliated
providers and independent providers;
(D) identified as paid for rural transport and urban
transport;
(E) identified as provided using rotor transport and
fixed wing transport; and
(F) identified as furnished by a provider of
emergency air medical services that has a contractual
relationship with the plan or coverage of an individual
for which such item or service is provided and such a
provider that does not have a contractual relationship
with the plan or coverage or such an individual; and
(2) cost data for an air ambulance service furnished by such
a provider of emergency air medical services that the Secretary
of Health and Human Services, in consultation with suppliers
and providers of such services, determines appropriate,
separated by the cost of air travel and the cost of emergency
medical services and supplies.
(c) Rulemaking.--Not later than 1 year after the date of the
enactment of this Act, the Secretary of Health and Human Services shall
determine the form and manner for submitting the information described
in subsection (b) through notice and comment rulemaking.
(d) Civil Monetary Penalties.--
(1) In general.--A provider of emergency air medical services
who violates the requirements of subsection (a)(1) shall be
subject to a civil monetary penalty of not more than $10,000
for each act constituting such violation.
(2) Procedure.--The provisions of section 1128A of the Social
Security Act (42 U.S.C. 1320a-7a), other than subsections (a)
and (b) and the first sentence of subsection (c)(1) of such
subsection, shall apply to civil monetary penalties under this
subsection in the same manner as such provisions apply to a
penalty or proceeding under such section.
(e) Reporting.--
(1) Secretary of health and human services.--Not later than
July 1, 2023, the Secretary of Health and Human Services shall
submit to Congress a report summarizing the information and
data specified in subsection (b).
(2) Comptroller general.--Not later than July 1, 2023, the
Comptroller General of the United States shall submit to
Congress a report that includes--
(A) an analysis of the cost variation of providers of
emergency air ambulance services by geography and
status; and
(B) any other recommendations the Comptroller General
determines appropriate, which may include a
recommendation of an adequate amount of reimbursement
for such services that reflects operational costs of
such providers in order to preserve access to emergency
air ambulance services.
(f) Limitation.--The information publicly disclosed under subsection
(a) and the reports under subsection (f) may not contain any
proprietary information.
SEC. 406. REPORT BY SECRETARY OF LABOR.
Not later than one year after the date of the enactment of this Act,
and annually thereafter for each of the following 5 years, the
Secretary of Labor shall--
(1) conduct a study of--
(A) the effects of the provisions of, including
amendments made by, this Act on premiums and out-of-
pocket costs in group health plans, including out-of-
pocket costs that are permitted by reason of compliance
with section 2799A(d) of the Public Health Service Act,
as added by section 2(d);
(B) the adequacy of provider networks in group health
plans; and
(C) such other effects of such provisions, and
amendments, as the Secretary deems relevant; and
(2) submit a report on such study to the Committee on Health,
Education, Labor, and Pensions of the Senate and the Committee
on Education and Labor and the Committee on Energy and Commerce
of the House of Representatives.
SEC. 407. BILLING STATUTE OF LIMITATIONS.
Notwithstanding any other provision of law, a health care provider or
health care facility (or health insurance issuer offering health
insurance coverage or group health plan) may not initiate a process to
seek reimbursement from an individual for a service furnished by such
provider or facility to such individual more than a year after such
date of service. Any provider, facility, issuer, or plan that bills an
individual in violation of the previous sentence shall be subject to a
civil monetary penalty in such amount as specified by the Secretary of
Health and Human Services.
SEC. 408. GAO REPORT ON IMPACT OF SURPRISE BILLING PROVISIONS.
Not later than 3 years after the date of the enactment of this Act,
the Comptroller General of the United States shall submit to Congress a
report containing the following:
(1) What is known about the impacts of the provisions of this
Act, including the amendments made by this Act, on the
incidence and prevalence of the furnishing of items and
services to individuals enrolled under a group health plan or
health insurance coverage by health care providers and health
care facilities that do not have a contractual relationship
with such plan or such coverage (as applicable) for furnishing
such items and services to such an individual.
(2) What is known about such impacts on provider shortages
and accessibility to such providers, focusing on rural and
medically underserved communities.
(3) The number of grants that have been awarded under section
404 (relating to State All Payer Claims Databases) and for what
purposes States have used funds made available under such
grants.
(4) An analysis of how data made available through State All
Payer Claims Databases receiving funding under such grants has
been used.
SEC. 409. REPORT BY THE SECRETARY OF HEALTH AND HUMAN SERVICES.
Not later than one year after the date of the enactment of this Act,
and annually thereafter for each of the following 5 years, the
Secretary of Health and Human Services shall--
(1) conduct a study of--
(A) the effects of the provisions of, including
amendments made by, this Act on premiums and out-of-
pocket costs with respect to individual health
insurance coverage and small group health plans;
(B) the adequacy of provider networks with respect to
individual health insurance coverage and small group
health plans, taking into consideration maximum travel
time and distance; and
(C) such other effects of such provisions, and
amendments, as the Secretary deems relevant; and
(2) submit a report on such study to the Committee on Health,
Education, Labor, and Pensions of the Senate and the Committee
on Education and Labor and the Committee on Energy and Commerce
of the House of Representatives.
TITLE V--TERRITORIES HEALTH CARE IMPROVEMENT ACT
SEC. 501. SHORT TITLE.
This title may be cited as the ``Territories Health Care Improvement
Act''.
SEC. 502. MEDICAID PAYMENTS FOR PUERTO RICO AND THE OTHER TERRITORIES
FOR CERTAIN FISCAL YEARS.
(a) Treatment of Cap.--Section 1108(g) of the Social Security Act (42
U.S.C. 1308(g)) is amended--
(1) in paragraph (2)--
(A) in the matter preceding subparagraph (A), by
striking ``subject to and section 1323(a)(2) of the
Patient Protection and Affordable Care Act paragraphs
(3) and (5)'' and inserting ``subject to section
1323(a)(2) of the Patient Protection and Affordable
Care Act and paragraphs (3) and (5)'';
(B) in subparagraph (A)--
(i) by striking ``Puerto Rico shall not
exceed the sum of'' and inserting ``Puerto Rico
shall not exceed--
``(i) except as provided in clause (ii), the
sum of'';
(ii) by striking ``$100,000;'' and inserting
``$100,000; and''; and
(iii) by adding at the end the following new
clause:
``(ii) for each of fiscal years 2020 through
2023, the amount specified in paragraph (6) for
each such fiscal year;'';
(C) in subparagraph (B)--
(i) by striking ``the Virgin Islands shall
not exceed the sum of'' and inserting ``the
Virgin Islands shall not exceed--
``(i) except as provided in clause (ii), the
sum of'';
(ii) by striking ``$10,000;'' and inserting
``$10,000; and''; and
(iii) by adding at the end the following new
clause:
``(ii) for each of fiscal years 2020 through
2025, $126,000,000;'';
(D) in subparagraph (C)--
(i) by striking ``Guam shall not exceed the
sum of'' and inserting ``Guam shall not
exceed--
``(i) except as provided in clause (ii), the
sum of'';
(ii) by striking ``$10,000;'' and inserting
``$10,000; and''; and
(iii) by adding at the end the following new
clause:
``(ii) for each of fiscal years 2020 through
2025, $127,000,000;'';
(E) in subparagraph (D)--
(i) by striking ``the Northern Mariana
Islands shall not exceed the sum of'' and
inserting ``the Northern Mariana Islands shall
not exceed--
``(i) except as provided in clause (ii), the
sum of''; and
(ii) by adding at the end the following new
clause:
``(ii) for each of fiscal years 2020 through
2025, $60,000,000; and''; and
(F) in subparagraph (E)--
(i) by striking ``American Samoa shall not
exceed the sum of'' and inserting ``American
Samoa shall not exceed--
``(i) except as provided in clause (ii), the
sum of'';
(ii) by striking ``$10,000.'' and inserting
``$10,000; and''; and
(iii) by adding at the end the following new
clause:
``(ii) for each of fiscal years 2020 through
2025, $84,000,000.''; and
(2) by adding at the end the following new paragraph:
``(6) Application to puerto rico for fiscal years 2020
through 2023.--For purposes of paragraph (2)(A)(ii), the amount
specified in this paragraph is--
``(A) for fiscal year 2020, $2,823,188,000;
``(B) for fiscal year 2021, $2,919,072,000;
``(C) for fiscal year 2022, $3,012,610,000; and
``(D) for fiscal year 2023, $3,114,331,000.''.
(b) Treatment of Funding Under Enhanced Allotment Program.--Section
1935(e) of the Social Security Act (42 U.S.C. 1396u-5(e)) is amended--
(1) in paragraph (1)(B), by striking ``if the State'' and
inserting ``subject to paragraph (4), if the State'';
(2) by redesignating paragraph (4) as paragraph (5); and
(3) by inserting after paragraph (3) the following new
paragraph:
``(4) Treatment of funding for certain fiscal years.--
``(A) Puerto rico.--Notwithstanding paragraph (1)(B),
in the case that Puerto Rico establishes and submits to
the Secretary a plan described in paragraph (2) with
respect to any of fiscal years 2020 through 2023, the
amount specified in paragraph (3) for Puerto Rico for
such a year shall be taken into account in applying
subparagraph (A)(ii) of section 1108(g)(2) for such
year.
``(B) Other territories.--Notwithstanding paragraph
(1)(B), in the case that the Virgin Islands, Guam, the
Northern Mariana Islands, or American Samoa establishes
and submits to the Secretary a plan described in
paragraph (2) with respect to any of fiscal years 2020
through 2025, the amount specified in paragraph (3) for
the Virgin Islands, Guam, the Northern Mariana Islands,
or American Samoa, as the case may be, shall be taken
into account in applying, as applicable, subparagraph
(B)(ii), (C)(ii), (D)(ii), or (E)(ii) of section
1108(g)(2) for such year.''.
(c) Increased FMAP.--Section 1905 of the Social Security Act (42
U.S.C. 1396d(b)) is amended--
(1) in subsection (b), by striking ``and (aa)'' and inserting
``(aa), and (ff)''; and
(2) by adding at the end the following new subsection:
``(ff) Temporary Increase in FMAP for Territories for Certain Fiscal
Years.--
``(1) Puerto rico.--Notwithstanding subsection (b) and
subject to subsection (z)(2), the Federal medical assistance
percentage for Puerto Rico shall be equal to--
``(A) 83 percent for fiscal years 2020 and 2021; and
``(B) 76 percent for fiscal years 2022 and 2023.
``(2) Virgin islands.--Notwithstanding subsection (b) and
subject to subsection (z)(2), the Federal medical assistance
percentage for the Virgin Islands shall be equal to--
``(A) 100 percent for fiscal year 2020;
``(B) 83 percent for fiscal years 2021 through 2024;
and
``(C) 76 percent for fiscal year 2025.
``(3) Other territories.--Notwithstanding subsection (b) and
subject to subsection (z)(2), the Federal medical assistance
percentage for Guam, the Northern Mariana Islands, and American
Samoa shall be equal to--
``(A) 100 percent for fiscal years 2020 and 2021;
``(B) 83 percent for fiscal years 2022 through 2024;
and
``(C) 76 percent for fiscal year 2025.''.
(d) Annual Report.--Section 1108(g) of the Social Security Act (42
U.S.C. 1308(g)), as amended by subsection (a), is further amended by
adding at the end the following new paragraph:
``(7) Annual report.--
``(A) In general.--Not later than the date that is
180 days after the end of each fiscal year (beginning
with fiscal year 2020 and ending with fiscal year
2025), in the case that a specified territory receives
a Medicaid cap increase, or an increase in the Federal
medical assistance percentage for such territory under
section 1905(ff), for such fiscal year, such territory
shall submit to the Chair and Ranking Member of the
Committee on Energy and Commerce of the House of
Representatives and the Chair and Ranking Member of the
Committee on Finance of the Senate a report that
describes how such territory has used such Medicaid cap
increase, or such increase in the Federal medical
assistance percentage, as applicable, to increase
access to health care under the State Medicaid plan of
such territory under title XIX (or a waiver of such
plan). Such report may include--
``(i) the extent to which such territory has,
with respect to such plan (or waiver)--
``(I) increased payments to health
care providers;
``(II) increased covered benefits;
``(III) expanded health care provider
networks; or
``(IV) improved in any other manner
the carrying out of such plan (or
waiver); and
``(ii) any other information as determined
necessary by such territory.
``(B) Definitions.--In this paragraph:
``(i) Medicaid cap increase.--The term
`Medicaid cap increase' means, with respect to
a specified territory and fiscal year, any
increase in the amounts otherwise determined
under this subsection for such territory for
such fiscal year by reason of the amendments
made by section 502(a) of the Territories
Health Care Improvement Act.
``(ii) Specified territory.--The term
`specified territory' means Puerto Rico, the
Virgin Islands, Guam, the Northern Mariana
Islands, and American Samoa.''.
SEC. 503. APPLICATION OF CERTAIN REQUIREMENTS UNDER MEDICAID PROGRAM TO
CERTAIN TERRITORIES.
(a) Application of Payment Error Rate Measurement Requirements to
Puerto Rico.--Section 1903(u)(4) of the Social Security Act (42 U.S.C.
1396b(u)(4)) is amended--
(1) by striking ``to Puerto Rico, Guam'' and inserting ``to
Guam''; and
(2) by striking ``or American Samoa.'' and inserting ``or
American Samoa, or, for fiscal years before fiscal year 2023,
to Puerto Rico.''.
(b) Application of Asset Verification Program Requirements to Puerto
Rico and Virgin Islands.--Section 1940(a) of the Social Security Act
(42 U.S.C. 1396w(a)) is amended--
(1) in paragraph (3)(A), by adding at the end the following
new clause:
``(iii) Implementation in puerto rico and
virgin islands.--The Secretary shall require
Puerto Rico to implement an asset verification
program under this subsection by the end of
fiscal year 2022 and the Virgin Islands to
implement such a program by the end of fiscal
year 2023.''; and
(2) in paragraph (4)--
(A) in the paragraph heading, by striking ``Exemption
of territories'' and inserting ``Exemption of certain
territories''; and
(B) by striking ``and the District of Columbia'' and
inserting ``, the District of Columbia, Puerto Rico,
and the Virgin Islands''.
(c) Application of Certain Data Reporting and Program Integrity
Requirements to Northern Mariana Islands, American Samoa, and Guam.--
(1) In general.--Section 1902 of the Social Security Act (42
U.S.C. 1396a) is amended by adding at the end the following new
subsection:
``(qq) Application of Certain Data Reporting and Program Integrity
Requirements to Northern Mariana Islands, American Samoa, and Guam.--
Not later than October 1, 2023, the Northern Mariana Islands, American
Samoa, and Guam shall--
``(1) implement methods, satisfactory to the Secretary, for
the collection and reporting of reliable data to the
Transformed Medicaid Statistical Information System (T-MSIS)
(or a successor system); and
``(2) demonstrate progress in establishing a State medicaid
fraud control unit described in section 1903(q).''.
(2) Conforming amendment.--Section 1902(j) of the Social
Security Act (42 U.S.C. 1396a(j)) is amended--
(A) by striking ``or the requirement'' and inserting
``, the requirement''; and
(B) by inserting before the period at the end the
following: ``, or the requirement under subsection
(qq)(1) (relating to data reporting)''.
SEC. 504. ADDITIONAL PROGRAM INTEGRITY REQUIREMENTS.
(a) Audit Relating to Fraud, Waste, and Abuse.--Not sooner than the
date that is one year after the date of the enactment of this Act, the
Inspector General of the Department of Health and Human Services
(referred to in this section as the ``Inspector General'') shall
conduct an audit of Puerto Rico with respect to any part of the
administration of Puerto Rico's State plan under title XIX of the
Social Security Act (42 U.S.C. 1396 et seq.) (or a waiver of such
plan), such as contracting protocols, denials of care, and financial
management, that the Inspector General determines to be at high risk
for waste, fraud, or abuse.
(b) Plan for Audits and Investigations of Contracting Practices.--Not
later than the date that is one year after the date of the enactment of
this Act, the Inspector General shall develop and submit to Congress a
plan for auditing and investigating contracting practices relating to
Puerto Rico's State plan under title XIX of the Social Security Act (42
U.S.C. 1396 et seq.) (or a waiver of such plan).
(c) Report on Contracting Oversight and Approval.--Not later than the
date that is two years after the date of the enactment of this Act, the
Comptroller General of the United States shall issue, and submit to the
Chair and Ranking Member of the Committee on Energy and Commerce of the
House of Representatives and the Chair and Ranking Member of the
Committee on Finance of the Senate, a report on contracting oversight
and approval with respect to Puerto Rico's State plan under title XIX
of the Social Security Act (42 U.S.C. 1396 et seq.) (or a waiver of
such plan). Such report shall--
(1) examine--
(A) the process used by Puerto Rico to evaluate bids
and award contracts under such plan (or waiver);
(B) which contracts are not subject to competitive
bidding or requests for proposals under such plan (or
waiver); and
(C) oversight by the Centers for Medicare & Medicaid
Services of contracts awarded under such plan (or
waiver); and
(2) include any recommendations for Congress, the Secretary
of Health and Human Services, or Puerto Rico relating to
changes that the Inspector General determines necessary to
improve the program integrity of such plan (or waiver).
(d) Reevaluation of Waivers of Medicaid Fraud Control Unit
Requirement.--Not later than the date that is one year after the date
of the enactment of this Act, the Secretary of Health and Human
Services shall--
(1) reevaluate any waiver approved (and in effect as of the
date of the enactment of this Act) for Guam, the Northern
Mariana Islands, or American Samoa under subsection (a)(61) or
subsection (j) of section 1902 of the Social Security Act (42
U.S.C. 1396a) with respect to the requirement to establish a
State medicaid fraud control unit (as described in section
1903(q) of such Act (42 U.S.C. 1396b(q)); and
(2) determine whether any such waiver should continue to be
approved with respect to Guam, the Northern Mariana Islands, or
American Samoa, respectively, after October 1, 2023.
(e) System for Tracking Federal Funding Provided to Puerto Rico.--
Section 1902 of the Social Security Act (42 U.S.C. 1396a), as amended
by section 503(c), is further amended by adding at the end the
following new subsection:
``(rr) Program Integrity Requirements for Puerto Rico.--
``(1) System for tracking federal funding provided to puerto
rico.--
``(A) In general.--Puerto Rico shall establish and
maintain a system for tracking any amounts paid by the
Federal Government to Puerto Rico with respect to the
State plan of Puerto Rico (or a waiver of such plan).
Under such system, Puerto Rico shall ensure that
information is available, with respect to each quarter
in a fiscal year (beginning with the first quarter
beginning on or after the date that is one year after
the date of the enactment of this subsection), on the
following:
``(i) In the case of a quarter other than the
first quarter of such fiscal year--
``(I) the total amount expended by
Puerto Rico during any previous quarter
of such fiscal year under the State
plan of Puerto Rico (or a waiver of
such plan); and
``(II) a description of how such
amount was so expended.
``(ii) The total amount that Puerto Rico
expects to expend during the quarter under the
State plan of Puerto Rico (or a waiver of such
plan), and a description of how Puerto Rico
expects to expend such amount.
``(B) Report to cms.--For each quarter with respect
to which Puerto Rico is required under subparagraph (A)
to ensure that information described in such
subparagraph is available, Puerto Rico shall submit to
the Administrator of the Centers for Medicare &
Medicaid Services a report on such information for such
quarter.
``(2) Submission of documentation on contracts upon
request.--Puerto Rico shall, upon request, submit to the
Administrator of the Centers for Medicare & Medicaid Services
all documentation requested with respect to contracts awarded
under the State plan of Puerto Rico (or a waiver of such
plan).''.
Amend the title so as to read:
A bill to reauthorize and extend funding for critical
public health programs that improve access to health care and
strengthen the health care workforce, to extend provisions of
the Medicare program, to strengthen the Medicaid program in the
territories, to protect health care consumers from surprise
billing practices, and for other purposes.
I. Purpose and Summary
H.R. 2328, the ``Reauthorizing and Extending America's
Community Health Act'' or the ``REACH Act'', was introduced on
April 15, 2019, by Reps. Tom O'Halleran (D-AZ) and Elise
Stefanik (R-NY), originally with the short title of the
``Community Health Investment, Modernization, and Excellence
Act of 2019''. The bill was referred to the Committee on Energy
and Commerce. H.R. 2328 would extend funding for vital public
health programs, including the Community Health Centers Fund
(CHCF), the National Health Service Corps (NHSC), the Teaching
Health Center Graduate Medical Education (THCGME) Program,
special diabetes programs, the State Personal Responsibility
Education Program (PREP), and the Title V State Sexual Risk
Avoidance Education (SRAE) Grant Program. The legislation also
would enhance Medicaid funding for the U.S. territories, while
strengthening program integrity and oversight of these
programs. H.R. 2328 would also adjust the Medicaid
disproportionate share hospital (DSH) allotment reductions and
require greater transparency and disclosure of hospital upper
payment limit (UPL) data. The bill would lower healthcare costs
for Americans by establishing new and comprehensive protections
to protect consumers from surprise medical bills. Finally, the
bill also would fund critical programs to improve quality and
access for Medicare beneficiaries.
II. Background and Need for Legislation
TITLE I--PUBLIC HEALTH EXTENDERS
Title I of H.R. 2328 provides direct health services,
research, and education funding and bolsters the health care
workforce, especially in urban, rural, and tribal community-
based settings. Funding for these programs was last extended in
the Bipartisan Budget Act of 2018 and expires at the end of FY
2019.\1\
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\1\Pub. L. No. 115-123
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The Health Center Program provides grant funding to health
centers that serve medically underserved populations. These
grants provided 18 percent of total revenue for health centers
in 2017, the most recent year for which data is available.\2\
Health centers also rely on other Federal funding sources
including Medicaid and Medicare, which provided 45 percent and
7 percent of health center revenue respectively in 2017.\3\
Funding for health centers was augmented with the creation of
the CHCF as part of the Affordable Care Act (ACA) in 2010. The
increased funding provided to the CHCF has increased the number
of health center locations in the Health Center Program from
8,156 locations in FY 2010 to nearly 12,000 locations today.\4\
The CHCF also increased the number of patients served by health
centers. In FY 2017, health centers served 27.2 million
patients and provided approximately 110 million patient
visits.\5\
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\2\Sara Rosenbaum et al., Community Health Center Financing: The
Role of Medicaid and Section 330 Grant Funding, Kaiser Family
Foundation (March 26, 2019) (www.kff.org/report-section/community-
health-center-financing-the-role-of-medicaid-and-section-330-grant-
funding-explained-issue-brief-9291/).
\3\Id.
\4\Congressional Research Service, Federal Health Centers: An
Overview (May 2017) (R43937).
\5\Department of Health and Human Services, Fiscal Year 2020 Health
Resources and Services Administration Justification of Estimates for
Appropriations Committees, 62.
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The NHSC Program strengthens the health care workforce
throughout the country by providing financial support to health
professional students and primary care providers who commit to
serve in medically underserved communities in urban, rural, and
tribal areas, in the form of scholarships and loan repayment
assistance. As of September 2018, NHSC field strength included
10,939 care providers, with physicians, nurse practitioners,
and mental and behavioral health professionals among the
highest represented disciplines.\6\
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\6\Department of Health and Human Services, Fiscal Year 2020 Health
Resources and Services Administration Justification of Estimates for
Appropriations Committees, 63.
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Section 101 also extends for four years (through FY 2023)
the THCGME program. The THCGME program was established to
increase training of primary care medical and dental residents
in community-based settings, such as Federally Qualified Health
Centers (FQHCs) or Rural Health Clinics (RHCs). THCGME is
administered by the Health Resources and Services
Administration (HRSA), and currently supports approximately 728
residents at 56 teaching health centers across the country.\7\
Physicians trained under teaching health center programs are
more likely to practice in underserved communities compared to
traditional GME residents. In academic year 2017-2018, 82
percent of THCGME residents trained in a medically underserved
and/or rural community compared to 23 percent of traditional
GME residents.\8\ Since 2011 the program has supported the
training of more than 880 new primary care physicians and
dentists.\9\
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\7\Health Resources and Services Administration, Teaching Health
Center Graduate Medical Education Program (accessed: May 23, 2019)
(bhw.hrsa.gov/grants/medicine/thcgme).
\8\American Association of Teaching Health Centers (accessed: May
23, 2019) (aathc.org/know-the-facts/).
\9\Supra note 7.
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The Special Diabetes Program (SDP) supports research on the
prevention and cure for type 1 diabetes. The program is
administered by the National Institute of Diabetes and
Digestive and Kidney Diseases at the National Institutes of
Health (NIH), along with other NIH institutes and the Centers
for Disease Control and Prevention. The Special Diabetes
Program for Indians (SDP-I) is a separate program to address
the diabetes epidemic among American Indians and Alaska
Natives. Coordinated by the Indian Health Service (IHS)
Division of Diabetes, with guidance from the Tribal Leaders
Diabetes Committee, SDP-I provides funds for diabetes treatment
and prevention to IHS, Tribal, and Urban Indian Health
programs.
The State Personal Responsibility Education Program (PREP)
provides grants to states, organizations, tribal organizations,
and communities to fund evidence-based education programs that
inform adolescents about the prevention of teen pregnancy and
sexually-transmitted infections, as well as adulthood
preparation topics such as healthy relationships and financial
literacy. Additionally, the Title V State Sexual Risk Avoidance
Education (SRAE) Grant Program provides grants to implement
programs that educate adolescents on healthy relationships,
goal setting, avoiding risky behaviors such as underage
drinking and illicit drug use, resisting sexual coercion, and
voluntarily refraining from non-marital sexual activity.
TITLE II--MEDICARE EXTENDERS
Title II of H.R. 2328 extends critical Medicare programs
that were last extended in the Bipartisan Budget Act (BBA) of
2018, including the physician work geographic practice cost
index (GPCI) floor, outreach and education programs for low-
income seniors, funding for quality measure development, and
the Independence at Home Medical Practice Demonstration. Title
II also reauthorizes the Patient-Centered Outcomes Research
Trust Fund (PCORTF) and permanently authorizes the Limited
Income Newly Eligible Transition (LI NET) program. Finally, it
exempts manual complex rehabilitative technology (CRT)
wheelchair accessories from competitive bidding for one year
and improves the interaction between TRICARE and Medicare
benefits for certain severely disabled servicemembers.
Section 201 extends for three years (through December 31,
2023) a provision that raises the physician work GPCI to 1.000
for all localities that have a physician work GPCI of less than
1.000 (i.e. below the national average for physician payment).
Payments under the Medicare physician fee schedule are adjusted
geographically by three factors to reflect differences in the
cost of physician services: (1) physician work; (2) practice
expense; and (3) medical malpractice insurance. The ``physician
work'' geographic practice cost index (GPCI) is intended to
reflect the cost of physician labor in different geographic
areas. This provision was originally enacted in the Medicare
Modernization Act (MMA) and last extended through December 31,
2019 in the BBA of 2018. The extension of the physician work
GPCI floor increases payment to physicians in low cost of
living areas and, as a result, reduces disparities in physician
payment between high cost of living and low cost of living
areas.
Section 202 extends funding for three years (through FY
2022) for State Health Insurance Assistance Programs (at $15
million per year), Area Agencies on Aging (at $15 million per
year), Aging and Disability Resource Centers (at $5 million per
year), and the contract with the National Center for Benefits
and Outreach and Enrollment (at $15 million per year); an
increase of $12.5 million from current funding for these
programs. This provision was originally enacted under Section
119 of the Medicare Improvements for Patients and Providers Act
of 2008 (MIPPA) to improve outreach, enrollment, and education
activities for low-income Medicare beneficiaries. Funding for
this provision was last extended under the BBA of 2018 at $37.5
million per year through FY 2019.
Section 203 extends funding for three years (through FY
2022) for the contract with a consensus-based entity, such as
the National Quality Forum (NQF), at $30 million per year.
Section 183 of MIPPA directed the Secretary of Health and Human
Services (HHS) to ``contract with a consensus-based entity,
such as the National Quality Forum'' to support activities
related to quality measurement and performance improvement.\10\
NQF currently reviews and endorses healthcare quality measures
for use in private and public reporting and incentive payment
programs, including annual guidance on measures that should be
included in, or excluded from the Medicare and Medicaid
programs.\11\ The BBA of 2018 authorized $7.5 million in
funding through FY 2019 to support the contract between the
Centers for Medicare & Medicaid Services (CMS) and NQF. This
funding, supplemented by unobligated funds from previous years,
allowed for approximately $30 million per year to support the
contract (consistent with the $30 million in funding authorized
for FY 2015 through 2017 under the Medicare Access and CHIP
Reauthorization Act of 2015 (MACRA)).
---------------------------------------------------------------------------
\10\42 U.S.C. 1395aaa.
\11\Douglas Henley et al., Making Measurement Count: The Importance
of NQF, Health Affairs (September 20, 2017) (www.healthaffairs.org/do/
10.1377/hblog20170920.062052/full/).
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Section 204 extends for three years (through December 31,
2023) the Independence at Home Medical Practice Demonstration
Program. The program allows seniors with multiple, advanced and
often expensive chronic conditions to receive home based
primary care from a team of providers. Home based treatment
increases access to care for seniors and allows for seniors to
be treated in a setting where they are most comfortable. The
program rewards providers that deliver quality care while also
reducing costs. Analysis of the demonstration also found that
participants had fewer hospital readmissions, better medication
management and care planning, and improved follow up. The
demonstration's first cohort began in June 2012.
Section 205 extends for three years (through FY 2022)
annual appropriations and transfers to PCORTF. PCORTF funds the
Patient-Centered Outcomes Research Institute (PCORI), a
private, non-profit funder of comparative clinical
effectiveness research, which compares at least two alternative
health care options. The program is intended to assist
patients, clinicians, purchasers, and policy-makers in making
informed health decisions by advancing the quality and
relevance of clinical evidence. PCORTF receives an annual
appropriation and additionally receives a per-covered-life
assessment from the Medicare trust fund, commercial insurance
plans, and self-insured plans.
Section 206 permanently authorizes the Limited Income Newly
Eligible Transition (LI NET) program, which provides
transitional coverage to certain low-income Medicare Part D
beneficiaries not already enrolled in a Medicare drug program.
In 2010, CMS began the Limited Income Newly Eligible Transition
(LI NET) program as a demonstration to provide temporary Part D
prescription drug coverage to low-income Medicare beneficiaries
who are not already enrolled in a Medicare drug plan as well as
uncovered low-income subsidy (LIS) eligible beneficiaries at
the pharmacy counter. The low-income Medicare beneficiaries
include full benefit dual eligible and supplemental security
income (SSI)-only beneficiaries on a retroactive basis.
Enrollment in the LI NET program is temporary until CMS enrolls
these individuals into a Part D plan, but ensures the
beneficiary has drug coverage in the interim.
Section 207 allows military disability retirees under the
age of 65 to decline to enroll in Medicare Part B in situations
where their Social Security Disability Insurance Payments have
been terminated because they regained employment, as well as
allow them to continue to access their TRICARE benefits
eliminating a current disincentive for severely wounded
servicemembers to rejoin the workforce. Currently, injured
servicemembers eligible for TRICARE but who return to the
workforce must pay Medicare premiums in order to retain their
TRICARE coverage. Enrolling in Medicare would lead to these
servicemembers paying higher rates than they would with their
traditional TRICARE plan. It also provides for Medicare
coverage of a DNA Specimen Provenance Assay clinical diagnostic
laboratory test following a positive prostate cancer biopsy.
Section 208 exempts manual complex rehabilitative
technology (CRT) wheelchair accessories from the Medicare
durable medical equipment (DME) competitive bidding program for
one year (through December 31, 2020). CRT wheelchairs are used
primarily by Medicare beneficiaries with significant
disabilities such as ALS, multiple sclerosis, muscular
dystrophy, spinal cord injury, and traumatic brain injury. CRT
wheelchairs are customizable with different accessories that
may be necessary for individuals with disabilities. These
accessories are paid for separately under the Medicare program.
In 2017, CMS announced its decision to exempt power CRT
wheelchair accessories from competitive bidding. However, the
issue of manual CRT wheelchairs accessories remains outstanding
and requires congressional action to exempt from competitive
bidding.
TITLE III--MEDICAID PROVISIONS
Title III of H.R. 2328 adjusts the magnitude of the
reductions to Medicaid DSH allotments for FY 2020, FY 2021, and
FY 2022. Federal law requires states to provide Medicaid DSH
payments to hospitals to help offset uncompensated care costs
attributable to patients who are uninsured or enrolled in
Medicaid. Hospitals often do not receive payment for services
rendered to uninsured patients, and Medicaid provider payment
rates are generally lower than the rates paid by Medicare and
private insurance. In FY 2017, Medicaid DSH payments totaled
$18.1 billion, which includes $10.4 billion in Federal funds
and $7.7 billion in state funds.\12\
---------------------------------------------------------------------------
\12\Medicaid and CHIP Payment and Access Commission,
Disproportionate share hospital payments (www.macpac.gov/subtopic/
disproportionate-share-hospital-payments/).
---------------------------------------------------------------------------
The ACA directed the Secretary of HHS to reduce Federal
Medicaid DSH allotments beginning FY 2014. The ACA included
these reductions expecting that the law's mandatory Medicaid
expansion and expansion of private insurance coverage would
lead to a decrease in hospital uncompensated care costs.
However, only 33 states and the District of Columbia have
expanded Medicaid; and even in Medicaid expansion states,
uncompensated care costs remain a challenge for many hospitals
serving low-income individuals. Congress delayed the Medicaid
DSH reductions four times from 2013 to 2018. The reductions are
currently scheduled to begin in FY 2020. Under current law, DSH
allotments will be reduced by $4 billion in FY 2020 and $8
billion in FYs 2021-2025. H.R. 2328 eliminates the Medicaid DSH
allotments for FY 2020 and FY 2021 and reduces the Medicaid DSH
allotments for FY 2022 to $4 billion.
TITLE IV--NO SURPRISES ACT
Title IV of H.R. 2328 protects consumers from receiving
surprise medical bills. Surprise billing, also referred to as
balance billing, is when a patient receives a bill from a
provider (other than the cost-sharing required under their
insurance) for any difference between the amount the provider
charged and the payment from the patient's insurance plan for
that service. This occurs because the provider and the
insurance plan have not contracted for a rate which the
provider will accept as payment in full for the contracted
services (i.e. the in-network rate). When a patient is treated
by a provider outside of their plan's network, the plan may
only be required under the terms of the plan to pay for a
portion of the service or may not be required to pay for any
out-of-network services. Under current law, providers are
permitted to bill privately-insured patients for the balance
not paid by the insurance plan.
Surprise bills occur primarily in two scenarios; when an
individual receives emergency services and therefore has no
ability to ensure they are treated by in-network providers, or
when an individual goes to an in-network hospital but certain
providers at that same hospital, that the patient may not have
been aware would be involved in their care, are out-of-network.
For example, patients usually have little ability to choose
certain ``facility-based'' providers such as anesthesiologists,
pathologists, radiologists and emergency providers. As
described by the National Association of Insurance
Commissioners (NAIC), services by these providers are typically
arranged by the facility as part of the facility's general
business operations and the insurance plan or patient generally
``does not specifically select or have a choice of providers
from which to receive such services within the facility.''\13\
Surprise billing occurs across all insurance plan types, even
those with larger, more generous networks.\14\ Research has
found that around one in five emergency department visits and
about nine percent of elective inpatient care at in-network
facilities results in a surprise bill.\15\
---------------------------------------------------------------------------
\13\National Association of Insurance Commissioners, Health Benefit
Plan Network Access and Adequacy Model Act (www.naic.org/store/free/
MDL-74.pdf).
\14\The Commonwealth Fund, Americans' Experiences with ACA
Marketplace Coverage: Affordability and Provider Network Satisfaction,
Exhibit 8 (July 2016) www.commonwealthfund.org/sites/default/files/
documents/
___media_files_publications_issue_brief_2016_jul_1883_gunja_amer-
icans_experience_aca_marketplace_affordability_v2.pdf).
\15\Christopher Garmon and Benjamin Chartock, One In Five Inpatient
Emergency Department Cases May Lead To Surprise Bills (Jan. 2017)
(www.healthaffairs.org/doi/abs/10.1377/hlthaff.2016.0970).
---------------------------------------------------------------------------
Individuals covered by Federal healthcare programs are
largely protected from surprise medical bills. Federal law,
however, does not prohibit balance billing in the private
insurance market.\16\ For example, in the Medicare program,
non-participating providers (only about four percent of
providers in the program) are permitted to balance bill, but
the bill cannot exceed 15 percent of Medicare's established
payment for that service.\17\
---------------------------------------------------------------------------
\16\Loren Adler et.al., Stopping Surprise Medical Bills: Federal
Action Is Needed, Health Affairs (Feb. 1, 2017) (www.healthaffairs.org/
do/10.1377/hblog20170201.058570/full/).
\17\AARP, Medicare's Financial Protections for Consumers: Limits on
Balance Billing and Private Contracting by Physicians (Jan. 2017)
(www.aarp.org/content/dam/aarp/ppi/2017-01/medicare-limits-on-balance-
billing-and-private-contracting-ppi.pdf).
---------------------------------------------------------------------------
About half of states have some form of protections from
surprise medical bills for patients in state regulated plans
(i.e. fully insured plans).\18\ However, the ability of states
to regulate surprise medical bills is constrained by the
Employee Retirement Income Security Act of 1974 (ERISA). ERISA
precludes states from regulating self-funded employer plans
(which currently cover about 100 million Americans). Therefore,
millions remain unprotected absent a Federal solution even
though a growing number of states have enacted surprise billing
laws.
---------------------------------------------------------------------------
\18\The Commonwealth Fund, State Efforts to Protect Consumers from
Balance Billing (Jan. 18, 2019) (www.commonwealthfund.org/blog/2019/
state-efforts-protect-consumers-balance-billing).
---------------------------------------------------------------------------
Title IV ensures that consumers with all types of private
insurance are protected from surprise medical bills in the
following situations:
When a patient receives out-of-network
emergency services;
When a patient receives additional out-of-
network services after they are stabilized but before
they can travel to an in-network provider without
medical transport (i.e. post-stabilization services);
When a patient receives services from a
facility-based provider (such as anesthesiologists,
radiologists, pathologists, neonatologists, assistant
surgeons, or hospitalists);
For scheduled, non-emergency care--when a
patient does not receive written and oral notice of the
provider's network status and charges at the time they
schedule the care and specifically consent to receiving
out-of-network services at least 72 hours in advance of
those services being provided (including laboratory
services or imaging services sent off-site). This
consent requirement would not apply to any unforeseen
medical needs that may arise during the course of
treatment;
When an in-network provider is unavailable
at the facility.
Consumers in these situations could not be balance billed
and would only be required to pay what they would have paid if
the service were provided in-network. The health plan would be
required to pay the out-of-network provider the median
contracted (in-network) rate for the service in the geographic
area the service was delivered. The median contracted rate
would be based on the insurer's rates in 2019 and indexed to
the Consumer Price Index for All Urban Consumers (CPI-U).
Providers would have the option of entering an independent
dispute resolution process for claims where the median
contracted rate paid for the service is greater than $1,250.
TITLE V--TERRITORIES HEALTH CARE IMPROVEMENT ACT
Title V of H.R. 2328 provides additional funding to the
U.S. territories Medicaid programs and makes changes to improve
oversight and program integrity. Each of the five U.S.
territories--Puerto Rico, the U.S. Virgin Islands (USVI), Guam,
American Samoa, and the Commonwealth of the Northern Mariana
Islands (CNMI)--operates a Medicaid program and a Children's
Health Insurance Program (CHIP). Medicaid programs in the
territories differ from Medicaid programs in the 50 states and
the District of Columbia in several aspects. The most notable
differences are the funding structure and the Federal medical
assistance percentage (the matching rate, or FMAP). Territorial
Medicaid programs receive capped funding from the Federal
Government, as opposed to the open-ended funding structure of
state Medicaid programs. Under this structure, the Federal
Government provides matching funds to each territory for
Medicaid expenditures up to a cap. Once a territory reaches its
cap, however, no additional Federal funds are available, and
the territory must fund their programs using only territorial
funds.\19\
---------------------------------------------------------------------------
\19\Government Accountability Office, Medicaid and CHIP: Increased
Funding in U.S. Territories Merits Improved Program Integrity Efforts,
(Apr. 8, 2016) (www.gao.gov/products/GAO-16-324).
---------------------------------------------------------------------------
Congress has provided increased Federal Medicaid funding
and FMAP for the territories several times over the last
decade. The ACA provided additional funds to the territories.
The Consolidated Appropriations Act of 2017 provided Puerto
Rico with nearly $300 million in additional Medicaid funds, and
the Bipartisan Budget Act of 2018 (BBA) provided Puerto Rico
and USVI with increased funds and an FMAP of 100 percent.\20\
The Additional Supplemental Appropriations for Disaster Relief
Act of 2019 (the Disaster Supplemental) provided CNMI with
additional funds for the remainder of FY 2019.\21\ It further
allowed American Samoa and Guam to draw down their Section 1323
funds at an FMAP of 100 percent for expenditures after January
1, 2019.
---------------------------------------------------------------------------
\20\Kaiser Family Foundation, Medicaid Financing Cliff:
Implications for the Health Care Systems in Puerto Rico and USVI (May
2019) (www.kff.org/report-section/medicaid-financingcliff-implications-
for-the-health-care-systems-in-puerto-rico-and-usvi-issue-brief/).
\21\Pub. L. No. 116-20.
---------------------------------------------------------------------------
When the additional funds for the territories expire,
Federal Medicaid funding levels will revert to the historical
Section 1108 allotments. This will be a significant downward
departure in Federal funding for the territories. The
expiration of the additional Federal Medicaid funds is expected
to create significant funding shortfalls in the territories. It
is unclear how territories will adjust to these funding
shortfalls.
III. Committee Hearings
For the purposes of section 103(i) of H. Res. 6 of the
116th Congress--the following hearings were used to develop or
consider H.R. 2328, as amended:
The Subcommittee on Health held a legislative hearing on
June 4, 2019, entitled, ``Investing in America's Health Care''
to consider H.R. 2328, the ``Community Health Investment,
Modernization, and Excellence Act of 2019'' and 11 other bills.
The Subcommittee received testimony from the following
witnesses:
Dean Germano, Chief Executive Officer,
Shasta Community Health Center;
Diana Autin, Executive Co-Director, SPAN
Parent Advocacy Network;
Aaron Kowalski, President and Chief
Executive Officer, JDRF;
Lisa Cooper, Professor of Medicine, Johns
Hopkins University School of Medicine;
Thomas Barker, Partner and Co-Chair of
Healthcare Practice, Foley Hoag;
Mary-Catherine Bohan, Vice President of
Outpatient Services, Rutgers University Behavioral
Health Care;
Michael Waldrum, Chief Executive Officer,
Vidant Health; and,
Fred Riccardi, President, Medicare Rights
Center.
The Subcommittee on Health held a hearing on June 12, 2019,
entitled, ``No More Surprises: Protecting Patients from
Surprise Medical Bills'' to consider the ``No Surprises Act.''
The Subcommittee received testimony from the following
witnesses:
Sonji Wilkes, Patient Advocate;
Sherif Zaafran, M.D., FASA, Chair,
Physicians for Fair Coverage;
Rick Sherlock, President and Chief Executive
Officer, Association of Air Medical Services;
James Gelfand, Senior Vice President, Health
Policy, The ERISA Industry Committee;
Thomas Nickels, Executive Vice President,
American Hospital Association;
Jeanette Thornton, Senior Vice President of
Product, Employer, and Commercial Policy, America's
Health Insurance Plans;
Claire McAndrew, Director of Campaigns and
Partnerships, Families USA; and
Vidor E. Friedman, M.D., FACEP, President,
American College of Emergency Physicians.
The Subcommittee on Health also held a related hearing on
June 20, 2019, entitled, ``Strengthening Health Care in the
U.S. Territories for Today and Into the Future.'' The
Subcommittee received testimony from the following witnesses:
Anne Schwartz, Executive Director, Medicaid
and CHIP Payment and Access Commission;
Angela Avila, Executive Director,
Administracion de Seguros de Salud de Puerto Rico,
Puerto Rico Health Insurance Administration;
Sandra King Young, Medicaid Director,
American Samoa State Agency;
Maria Theresa Arcangel, Chief Administrator,
Guam Division of Public Welfare;
Michal Rymer-Browne, Assistant Commissioner,
Department of Human Services, U.S. Virgin Islands; and
Helen C. Sablan, Medicaid Director,
Commonwealth of the Northern Mariana Islands State
Medicaid Agency.
IV. Committee Consideration
H.R. 2328, the ``Reauthorizing and Extending America's
Community Health Act'' or the ``REACH Act'', was introduced on
April 15, 2019, by Reps. Tom O'Halleran (D-AZ) and Elise
Stefanik (R-NY), originally introduced with the short title of
the ``Community Health Investment, Modernization, and
Excellence Act of 2019''. The bill was referred to the
Committee on Energy and Commerce. Subsequently, H.R. 2328 was
referred to the Subcommittee on Health on April 16, 2019.
Following several hearings, the Subcommittee on Health met in
open markup session, pursuant to notice, on Thursday, July 11,
2019, to consider H.R. 2328. During consideration and markup of
the bill, an amendment in the nature of a substitute (AINS) was
offered by Mr. Butterfield. Mr. Kennedy offered an amendment to
the Butterfield AINS, which was agreed to by a voice vote. The
Subcommittee agreed to the Butterfield AINS, amended, by a
voice vote. A motion made by Ms. Eshoo, chairwoman of the
subcommittee, to favorably forward H.R. 2328 to the full
Committee, amended, was agreed to by a voice vote, a quorum
being present.
The Committee on Energy and Commerce met in open markup
session, pursuant to notice, on Wednesday, July 17, 2019, to
consider a committee print of H.R. 2328 that reflecting the
changes approved by the Subcommittee on Health. An amendment in
the nature of a substitute was first offered by Mr. Pallone,
Chairman of the full Committee, to H.R. 2328, as amended.
During consideration and markup of the Pallone AINS, 11
amendments were offered to the Pallone AINS. Amendments offered
by Reps. Walden, Pallone, Gianforte, Matsui, Kuster, Blunt
Rochester, Lujan, Ruiz, Schrader, and Ruiz were all agreed to
by a voice vote. An amendment offered to the AINS by Ms.
Schakowsky was withdrawn. The Pallone Amendment in the Nature
of a Substitute, amended, to H.R. 2328 was then agreed to by a
voice vote. A motion by Mr. Pallone to order H.R. 2328, the
``REACH Act'' reported favorably to the House, amended, was
agreed to by a voice vote, a quorum being present.
V. Committee Votes
Clause 3(b) of rule XIII of the Rules of the House of
Representatives requires the Committee to list each record vote
on the motion to report legislation and amendments thereto. The
Committee advises that there were no record votes taken on H.R.
2328, including the motion by Mr. Pallone ordering H.R. 2328
favorably reported to the House, amended.
VI. Oversight Findings
Pursuant to clause 3(c)(1) of rule XIII and clause 2(b)(1)
of rule X of the Rules of the House of Representatives, the
Committee's oversight findings and recommendations are
reflected in the descriptive portion of the report.
VII. New Budget Authority, Entitlement Authority, and Tax Expenditures
Pursuant to 3(c)(2) of rule XIII of the Rules of the House
of Representatives, the Committee adopts as its own the
estimate of new budget authority, entitlement authority, or tax
expenditures or revenues contained in the cost estimate
prepared by the Director of the Congressional Budget Office
pursuant to section 402 of the Congressional Budget Act of
1974.
The Committee has requested by not received from the
Director of the Congressional Budget Office a statement as to
whether this bill contains any new budget authority, credit
authority, or an increase or decrease in revenues or tax
expenditures.
VIII. Federal Mandates Statement
The Committee adopts as its own the estimate of Federal
mandates prepared by the Director of the Congressional Budget
Office pursuant to section 423 of the Unfunded Mandates Reform
Act.
IX. Statement of General Performance Goals and Objectives
Pursuant to clause 3(c)(4) of rule XIII, the general
performance goal or objective of this legislation is to
reauthorize and extend funding for critical public health
programs that improve access to health care and strengthen the
health care workforce, to extend provisions of the Medicare
program, to strengthen the Medicaid program in the territories,
to protect health care consumers from surprise billing
practices, and to improve health outcomes and affordability.
X. Duplication of Federal Programs
Pursuant to clause 3(c)(5) of rule XIII, no provision of
H.R. 2328 is known to be duplicative of another Federal
program, including any program that was included in a report to
Congress pursuant to section 21 of Public Law 111-139 or the
most recent Catalog of Federal Domestic Assistance.
XI. Committee Cost Estimate
Pursuant to clause 3(d)(1) of rule XIII, the Committee
adopts as its own the cost estimate prepared by the Director of
the Congressional Budget Office pursuant to section 402 of the
Congressional Budget Act of 1974.
XII. Earmarks, Limited Tax Benefits, and Limited Tariff Benefits
Pursuant to clause 9(e), 9(f), and 9(g) of rule XXI, the
Committee finds that H.R. 2328 contains no earmarks, limited
tax benefits, or limited tariff benefits.
XIII. Advisory Committee Statement
No advisory committee within the meaning of section 5(b) of
the Federal Advisory Committee Act was created by this
legislation.
XIV. Applicability to Legislative Branch
The Committee finds that the legislation does not relate to
the terms and conditions of employment or access to public
services or accommodations within the meaning of section
102(b)(3) of the Congressional Accountability Act.
XV. Section-by-Section Analysis of the Legislation
Section 1. Short title
Section 1 designates that the short title may be cited as
the ``Reauthorizing and Extending America's Community Health
Act'' or the ``REACH Act''.
TITLE I--PUBLIC HEALTH EXTENDERS
Sec. 101. Extension for community health centers, the National Health
Service Corps, and teaching health centers that operate GME
programs
Section 101 extends funding through FY 2023 for the
Community Health Center Fund (at $4 billion per year), the
National Health Service Corps (at $310 million per year), and
the Teaching Health Center Graduate Medical Education Program
(at $126.5 million per year).
Sec. 102. Extension for special diabetes programs
Section 102 extends funding through FY 2023 for the Special
Diabetes Program and the Special Diabetes Program for Indians,
each at $150 million per year.
Sec. 103. Extension of Personal Responsibility Education Program
Section 103 extends funding through FY 2023 for the
Personal Responsibility Education Program at $75 million per
year.
Sec. 104. Extension of sexual risk avoidance education program
Section 104 extends funding through FY 2023 for the Sexual
Risk Avoidance Education Program at $75 million per year.
TITLE II--MEDICARE EXTENDERS
Sec. 201. Extension of the work geographic index floor under the
Medicare program
Section 201 extends for three years (through December 31,
2023) a provision that raises the physician work GPCI to 1.000
for all localities that have a physician work GPCI of less than
1.000 (i.e. below the national average for physician payment).
Sec. 202. Extension of funding outreach and assistance for low-income
programs
Section 202 extends funding for three years (through FY
2022) for State Health Insurance Assistance Programs (at $15
million per year), Area Agencies on Aging (at $15 million per
year), Aging and Disability Resource Centers (at $5 million per
year), and the contract with the National Center for Benefits
and Outreach and Enrollment (at $15 million per year); an
increase of $12.5 million from current funding for these
programs.
Sec. 203. Extension of funding for quality measure endorsement, input,
and selection under the Medicare program
Section 203 extends funding for three years (through FY
2022) for the contract with a consensus-based entity, such as
the NQF, at $30 million per year.
Sec. 204. Extension of the Independence at Home Medical Practice
Demonstration Program under the Medicare program
Section 204 extends for three years (through December 31,
2023) the Independence at Home Medical Practice Demonstration
Program.
Sec. 205. Extension of appropriations and transfers to the Patient-
Centered Outcomes Research Trust Fund; extension of certain
health insurance fees
Section 205 extends the annual appropriation and transfers
from the per-covered life assessments on the Medicare trust
fund, private insurance plans, and self-funded insurance plans
for three years, through FY 2022.
Sec. 206. Transitional coverage and retroactive Medicare Part D
coverage for certain low-income beneficiaries
Section 206 permanently authorizes the Limited Income Newly
Eligible Transition (LI NET) program, which provides
transitional coverage to certain low-income Medicare Part D
beneficiaries not already enrolled in a Medicare drug program.
Sec. 207. Health Equity and Access for Returning Troops and
Servicemembers Act of 2019
Section 207 allows military disability retirees under the
age of 65 to decline to enroll in Medicare Part B in situations
where their Social Security Disability Insurance Payments have
been terminated because they are gainfully employed, as well as
allow them to continue to access their TRICARE benefits. It
also provides for Medicare coverage of a DNA Specimen
Provenance Assay clinical diagnostic laboratory test following
a positive prostate cancer biopsy.
Sec. 208. Exclusion of complex rehabilitative manual wheelchairs from
Medicare competitive acquisition program; Non-application of
Medicare fee-schedule adjustments for certain wheelchair
accessories and cushions.
Section 208 exempts manual CRT wheelchair accessories from
the Medicare durable DME competitive bidding program for one
year (through December 31, 2020).
TITLE III--MEDICAID PROVISIONS
Section 301. Modification in reductions in Medicaid DSH allotments
Section 301 eliminates the Medicaid DSH allotment
reductions for FY 2020 and FY 2021. It reduces the Medicaid DSH
allotment reductions in FY 2022 from $8 billion to $4 billion.
Section 302. Public availability of hospital upper payment limit
demonstrations
Section 302 directs the Secretary of HHS to make publicly
available the upper payment limit demonstrations that a state
submits to the Administrator for CMS, beginning in state fiscal
year 2022.
Section 303. Report by Comptroller General
Section 303 requires no later than 21 months after the date
of enactment, a report by the Comptroller General to Congress
on policy considerations for establishing an equitable formula
for determining Medicaid disproportionate share hospital
allotments to states.
Section 304. Sense of Congress regarding the need to develop a more
permanent legislative solution to provide the territories with
a reliable and consistent source of Federal funding under the
Medicaid program
Section 304 indicates it is the sense of Congress that the
Federal funding caps to the Medicaid programs of the
territories have not been adjusted over time and, accordingly,
have impaired the ability of the territories to manage their
Medicaid programs, including their ability to provide services
to beneficiaries. Furthermore, that the temporary increases to
the caps and the Federal medical assistance percentage
indicates not only the commitment of Congress to ensuring the
sustainability of these programs, but also that a more
permanent legislative solution must be developed to provide the
territories with a consistent source of Federal funding for
their Medicaid programs.
TITLE IV--NO SURPRISES ACT
Sec. 401. Short title
Section 401 designates that the short title may be cited as
the ``No Surprises Act''.
Sec. 402. Preventing surprise medical bills
The ``No Surprises Act'' would ensure that consumers with
all types of private insurance are protected by prohibiting
surprise billing and limiting the patient's cost-sharing to
what it would have been if the services were received in-
network. These protections apply in the following situations:
When a patient receives out-of-network
emergency services;
When a patient receives additional out-of-
network services after they are stabilized but before
they can travel to an in-network provider without
medical transport (i.e. post-stabilization services);
When a patient receives services from a
facility-based provider (such as anesthesiologists,
radiologists, pathologists, neonatologists, assistant
surgeons, or hospitalists);
For scheduled, non-emergency care--when a
patient does not receive written and oral notice of the
provider's network status and charges at the time they
schedule the care and specifically consent to receiving
out-of-network services at least 72 hours in advance of
those services being provided (including laboratory
services or imaging services sent off-site). This
consent requirement would not apply to any unforeseen
medical needs that may arise during the course of
treatment; or
When an in-network provider is unavailable
at the facility.
In addition to requiring facilities and providers to give
patients clear written notices that include information on
network status and cost prior to scheduled care, section 402
requires insurers and providers to better maintain accurate
consumer-facing provider directories. It also requires
providers and insurers to publicly post information regarding
the patient protections that would exist under this legislation
and/or state legislation.
The legislation establishes a minimum payment benchmark set
at the median contracted (in-network) rate for the service in
the geographic area the service was delivered. That rate may
also account for differences in sites of care. It also
preserves a state's ability to determine their own payment
standards for plans regulated by the state. The median
contracted rate would be based on the insurer's rates in 2019
and increased by CPI-U each year. The Secretary of HHS would
conduct audits of the median contracted rate to ensure its
accuracy.
Finally, this section establishes an independent resolution
process. Providers and hospitals would receive the median in-
network payment and have 30 days within which to file an appeal
with the health plan. The plan would then have up to 30 days to
adjudicate the appeal through their plan's usual internal
process, after which the provider could initiate a 30-day
independent dispute resolution process with a neutral arbiter.
In order for a claim to qualify for independent dispute
resolution, the benchmark payment made by the plan (i.e. the
median contracted rate or the rate determined by state law)
must be greater than $1,250--so that only complex cases would
qualify for dispute resolution. The $1,250 threshold would be
indexed to CPI-U. The dispute resolution process would be
``baseball-style,'' meaning that each party will submit a best
and final offer and the arbiter will choose the most reasonable
of the two offers based on certain considerations. The arbiter
would be permitted to consider the following set of objective
facts and circumstances in resolving the dispute: the median
contracted rate; provider's level of training, education,
experience, and quality and outcomes measurements of the
provider or facility; and, any other extenuating circumstances
with respect to the complexity of services or acuity of the
patient.
Sec. 403. Government Accountability Office study on profit- and
revenue-sharing in health care
Section 403 requires the Government Accountability Office
(GAO) to study profit sharing relationships between hospitals,
contract management groups, and providers.
Sec. 404. State All Payer Claims Databases
Section 404 provides $50 million in grants for states
looking to develop or maintain an all-payer claims database.
Sec. 405. Air ambulance cost data reporting program
Section 405 requires air ambulance providers to report to
the Secretary of HHS their costs, broken out by the cost of air
travel and the cost of emergency medical services delivered.
Sec. 406. Report by Secretary of Labor
Section 406 requires the Secretary of Labor to conduct a
report one year after the date of the enactment and annually
thereafter for each of the following five years on the effects
of Title IV on premiums and out-of-pocket costs in group health
plans, the adequacy of provider networks in group health plans,
and other relevant effects.
Sec. 407. Billing statute of limitations
Section 407 states that a health care provider or health
care facility (or health insurance issuer offering health
insurance coverage or group health plan) may not initiate a
process to seek reimbursement from an individual for a service
furnished by such provider or facility to such individual more
than a year after such date of service.
Sec. 408. GAO report on impact of surprise billing provisions
Section 408 requires the Government Accountability Office
to report not later than three years after enactment on: (1)
the incidence and prevalence of the furnishing of items and
services to individuals enrolled under a group health plan or
health insurance coverage by health care providers and health
care facilities that do not have a contractual relationship
with such plan or such coverage (as applicable) for furnishing
such items and services to such an individual; (2) the impacts
on provider shortages and accessibility to such providers,
focusing on rural and medically underserved communities; (3)
the number of grants that have been awarded under section 404
(relating to State All Payer Claims Databases) and for what
purposes states have used funds made available under such
grants; and (4) an analysis of how data made available through
State All Payer Claims Databases receiving funding under such
grants has been used.
Sec. 409. Report by the Secretary of Health and Human Services
Section 409 requires the Secretary of HHS to conduct a
report not later than one year after the date of the enactment
and annually thereafter for each of the following five years on
the impact of this Act on: premiums and out-of-pocket costs
with respect to individual health insurance coverage and small
group health plans; the adequacy of provider networks with
respect to individual health insurance coverage and small group
health plans, taking into consideration maximum travel time and
distance; and other relevant effects.
TITLE V--TERRITORIES HEALTH CARE IMPROVEMENT ACT
Section 501. Short title
Section 501 designates that the short title may be cited as
the ``Territories Health Care Improvement Act''.
Section 502. Medicaid payments for Puerto Rico and the other
territories for certain fiscal years
Section 502 increases the annual Federal Medicaid
allotments to Puerto Rico for FY 2020 through FY 2023 to the
following amounts:
FY 2020: $2,823,188,000
FY 2021: $2,919,072,000
FY 2022: $3,012,610,000
FY 2023: $3,114,331,000.
This section also increases the Federal Medicaid allotments
to the U.S. Virgin Islands to $126,000,000 for each fiscal year
for FY 2020 through FY 2025. It increases the Federal Medicaid
allotments to Guam to $127,000,000 for each fiscal year for FY
2020 through FY 2025. It increases the Federal Medicaid
allotments to the Northern Mariana Islands to $60,000,000 for
each fiscal year for FY 2020 through FY 2025. It increases the
Federal Medicaid allotments to American Samoa to $84,000,000
for each fiscal year for FY 2020 through FY 2025.
Subsection (c) increases the Federal medical assistance
percentage (FMAP) for the territories in the following manner:
For Puerto Rico, for FY 2020 and FY 2021, the FMAP shall be
83 percent; for FY 2022 and FY 2023, the FMAP shall be 76
percent. For the U.S. Virgin Islands, for FY 2020, the FMAP
shall be 100 percent; for FY 2021 through FY 2024, the FMAP
shall be 83 percent; for FY 2025, the FMAP shall be 76 percent.
For Guam, the Northern Mariana Islands, and American Samoa, for
FY 2020 and FY 2021, the FMAP shall be 100 percent; for FY 2022
through FY 2024, the FMAP shall be 83 percent; for FY 2025, the
FMAP shall be 76 percent.
Subsection (d) requires each territory to submit an annual
report, no later than 180 days after the end of each fiscal
year, to the Chair and Ranking Member of the Committee on
Energy and Commerce of the House of Representatives and the
Chair and Ranking Member of the Committee on Finance of the
Senate, that describes how the territory has used the increase
to its FMAP to increase provider payments, increase covered
benefits, expand provider networks, or any other improvements
to its Medicaid program.
Section 503. Application of certain requirements under Medicaid program
to certain territories
Section 503 requires the territories to comply with
different provisions of the Medicaid statute from which they
are currently excluded. Subsection (a) applies the payment
error rate measurement requirements to Puerto Rico, effective
FY 2023. Subsection (b) requires Puerto Rico to implement an
asset verification program by the end of FY 2022 and requires
the U.S. Virgin Islands to implement an asset verification
program by the end of FY 2023. Subsection (c) requires, no
later than FY 2024, the Northern Mariana Islands, American
Samoa, and Guam to implement methods satisfactory to the
Secretary of Health and Human Services for collecting and
reporting data to the Transformed Medicaid Statistical
Information System (T-MSIS), and to demonstrate progress in
establishing a Medicaid fraud control unit.
Section 504. Additional program integrity requirements
Subsection (a) of Section 504 requires no sooner than one
year after the date of enactment, that the Inspector General of
the Department of Health and Human Services conduct an audit of
areas of Puerto Rico's Medicaid program that it determines to
be at high risk for waste, fraud, or abuse; including
contracting protocols, denials of care, and financial
management.
Subsection (b) requires no later than one year after the
date of enactment that the Inspector General develop and submit
to Congress, a plan for auditing and investigating contracting
practices related to Puerto Rico's Medicaid program.
Subsection (c) requires no later than two years after the
date of enactment, that the Comptroller General issue, to the
Chair and Ranking Member of the Committee on Energy and
Commerce of the House of Representatives and the Chair and
Ranking Member of the Committee on Finance of the Senate, a
report that examines the contracting practices of Puerto Rico's
Medicaid program.
Subsection (d) requires no later than one year after the
date of enactment, that the Secretary reevaluate any waivers
granted to Guam, the Northern Mariana Islands, or American
Samoa for establishing a Medicaid fraud control unit, and
determine whether such waivers should continue to be approved.
Subsection (e) requires Puerto Rico to establish a system
for tracking all Federal Medicaid funds in Puerto Rico. It
requires Puerto Rico to track and report CMS the total amount
expended by Puerto Rico during the previous quarter and the
amount Puerto Rico expects to spend on the next quarter. It
further requires, upon request, that Puerto Rico submit to CMS
all documents related to contracts awarded under the Puerto
Rico Medicaid program.
XVI. Changes in Existing Law Made by the Bill, as Reported
Changes in Existing Law Made by the Bill, as Reported
In compliance with clause 3(e) of rule XIII of the Rules of
the House of Representatives, changes in existing law made by
the bill, as reported, are shown as follows (existing law
proposed to be omitted is enclosed in black brackets, new
matter is printed in italic, and existing law in which no
change is proposed is shown in roman):
PATIENT PROTECTION AND AFFORDABLE CARE ACT
* * * * * * *
TITLE X--STRENGTHENING QUALITY, AFFORDABLE HEALTH CARE FOR ALL
AMERICANS
* * * * * * *
Subtitle E--Provisions Relating to Title V
* * * * * * *
SEC. 10503. COMMUNITY HEALTH CENTERS AND THE NATIONAL HEALTH SERVICE
CORPS FUND.
(a) Purpose.--It is the purpose of this section to establish
a Community Health Center Fund (referred to in this section as
the ``CHC Fund''), to be administered through the Office of the
Secretary of the Department of Health and Human Services to
provide for expanded and sustained national investment in
community health centers under section 330 of the Public Health
Service Act and the National Health Service Corps.
(b) Funding.--There is authorized to be appropriated, and
there is appropriated, out of any monies in the Treasury not
otherwise appropriated, to the CHC Fund--
(1) to be transferred to the Secretary of Health and
Human Services to provide enhanced funding for the
community health center program under section 330 of
the Public Health Service Act--
(A) $1,000,000,000 for fiscal year 2011;
(B) $1,200,000,000 for fiscal year 2012;
(C) $1,500,000,000 for fiscal year 2013;
(D) $2,200,000,000 for fiscal year 2014;
(E) $3,600,000,000 for each of fiscal years
2015 through 2017; and
(F) $3,800,000,000 for fiscal year 2018 and
$4,000,000,000 for [fiscal year 2019] each of
fiscal years 2019 through 2023.
(2) to be transferred to the Secretary of Health and
Human Services to provide enhanced funding for the
National Health Service Corps--
(A) $290,000,000 for fiscal year 2011;
(B) $295,000,000 for fiscal year 2012;
(C) $300,000,000 for fiscal year 2013;
(D) $305,000,000 for fiscal year 2014;
(E) $310,000,000 for each of fiscal years
2015 through 2017; and
(F) $310,000,000 for each of fiscal years
[2018 and 2019] 2019 through 2023.
(c) Construction.--There is authorized to be appropriated,
and there is appropriated, out of any monies in the Treasury
not otherwise appropriated, $1,500,000,000 to be available for
fiscal years 2011 through 2015 to be used by the Secretary of
Health and Human Services for the construction and renovation
of community health centers.
(d) Use of Fund.--The Secretary of Health and Human Services
shall transfer amounts in the CHC Fund to accounts within the
Department of Health and Human Services to increase funding,
over the fiscal year 2008 level, for community health centers
and the National Health Service Corps.
(e) Availability.--Amounts appropriated under subsections (b)
and (c) shall remain available until expended.
* * * * * * *
----------
PUBLIC HEALTH SERVICE ACT
* * * * * * *
TITLE III--GENERAL POWERS AND DUTIES OF PUBLIC HEALTH SERVICE
* * * * * * *
Part D--Primary Health Care
Subpart I--Health Centers
* * * * * * *
SEC. 330B. SPECIAL DIABETES PROGRAMS FOR TYPE I DIABETES.
(a) In General.--The Secretary, directly or through grants,
shall provide for research into the prevention and cure of Type
I diabetes.
(b) Funding.--
(1) Transferred funds.--Notwithstanding section
2104(a) of the Social Security Act, from the amounts
appropriated in such section for each of fiscal years
1998 through 2002, $30,000,000 is hereby transferred
and made available in such fiscal year for grants under
this section.
(2) Appropriations.--For the purpose of making grants
under this section, there is appropriated, out of any
funds in the Treasury not otherwise appropriated--
(A) $70,000,000 for each of fiscal years 2001
and 2002 (which shall be combined with amounts
transferred under paragraph (1) for each such
fiscal years);
(B) $100,000,000 for fiscal year 2003;
(C) $150,000,000 for each of fiscal years
2004 through 2017; and
(D) $150,000,000 for [each of fiscal years
2018 and 2019] fiscal years 2019 through 2023,
to remain available until expended.
SEC. 330C. SPECIAL DIABETES PROGRAMS FOR INDIANS.
(a) In General.--The Secretary shall make grants for
providing services for the prevention and treatment of diabetes
in accordance with subsection (b).
(b) Services Through Indian Health Facilities.--For purposes
of subsection (a), services under such subsection are provided
in accordance with this subsection if the services are provided
through any of the following entities:
(1) The Indian Health Service.
(2) An Indian health program operated by an Indian
tribe or tribal organization pursuant to a contract,
grant, cooperative agreement, or compact with the
Indian Health Service pursuant to the Indian Self-
Determination Act.
(3) An urban Indian health program operated by an
urban Indian organization pursuant to a grant or
contract with the Indian Health Service pursuant to
title V of the Indian Health Care Improvement Act.
(c) Funding.--
(1) Transferred funds.--Notwithstanding section
2104(a) of the Social Security Act, from the amounts
appropriated in such section for each of fiscal years
1998 through 2002, $30,000,000, to remain available
until expended, is hereby transferred and made
available in such fiscal year for grants under this
section.
(2) Appropriations.--For the purpose of making grants
under this section, there is appropriated, out of any
money in the Treasury not otherwise appropriated--
(A) $70,000,000 for each of fiscal years 2001
and 2002 (which shall be combined with amounts
transferred under paragraph (1) for each such
fiscal years);
(B) $100,000,000 for fiscal year 2003;
(C) $150,000,000 for each of fiscal years
2004 through 2017; and
(D) $150,000,000 for each of [fiscal years
2018 and 2019] fiscal years 2019 through 2023,
to remain available until expended.
* * * * * * *
Subpart XI --Support of Graduate Medical Education in Qualified
Teaching Health Centers
SEC. 340H. PROGRAM OF PAYMENTS TO TEACHING HEALTH CENTERS THAT OPERATE
GRADUATE MEDICAL EDUCATION PROGRAMS.
(a) Payments.--
(1) In general.--Subject to subsection (h)(2), the
Secretary shall make payments under this section for
direct expenses and indirect expenses to qualified
teaching health centers that are listed as sponsoring
institutions by the relevant accrediting body for, as
appropriate--
(A) maintenance of filled positions at
existing approved graduate medical residency
training programs;
(B) expansion of existing approved graduate
medical residency training programs; and
(C) establishment of new approved graduate
medical residency training programs.
(2) Per resident amount.--In making payments under
paragraph (1), the Secretary shall consider the cost of
training residents at teaching health centers and the
implications of the per resident amount on approved
graduate medical residency training programs at
teaching health centers.
(3) Priority.--In making payments under paragraph
(1)(C), the Secretary shall give priority to qualified
teaching health centers that--
(A) serve a health professional shortage area
with a designation in effect under section 332
or a medically underserved community (as
defined in section 799B); or
(B) are located in a rural area (as defined
in section 1886(d)(2)(D) of the Social Security
Act).
(b) Amount of Payments.--
(1) In general.--Subject to paragraph (2), the
amounts payable under this section to qualified
teaching health centers for an approved graduate
medical residency training program for a fiscal year
are each of the following amounts:
(A) Direct expense amount.--The amount
determined under subsection (c) for direct
expenses associated with sponsoring approved
graduate medical residency training programs.
(B) Indirect expense amount.--The amount
determined under subsection (d) for indirect
expenses associated with the additional costs
relating to teaching residents in such
programs.
(2) Capped amount.--
(A) In general.--The total of the payments
made to qualified teaching health centers under
paragraph (1)(A) or paragraph (1)(B) in a
fiscal year shall not exceed the amount of
funds appropriated under subsection (g) for
such payments for that fiscal year.
(B) Limitation.--The Secretary shall limit
the funding of full-time equivalent residents
in order to ensure the direct and indirect
payments as determined under subsection (c) and
(d) do not exceed the total amount of funds
appropriated in a fiscal year under subsection
(g).
(c) Amount of Payment for Direct Graduate Medical
Education.--
(1) In general.--The amount determined under this
subsection for payments to qualified teaching health
centers for direct graduate expenses relating to
approved graduate medical residency training programs
for a fiscal year is equal to the product of--
(A) the updated national per resident amount
for direct graduate medical education, as
determined under paragraph (2); and
(B) the average number of full-time
equivalent residents in the teaching health
center's graduate approved medical residency
training programs as determined under section
1886(h)(4) of the Social Security Act (without
regard to the limitation under subparagraph (F)
of such section) during the fiscal year.
(2) Updated national per resident amount for direct
graduate medical education.--The updated per resident
amount for direct graduate medical education for a
qualified teaching health center for a fiscal year is
an amount determined as follows:
(A) Determination of qualified teaching
health center per resident amount.--The
Secretary shall compute for each individual
qualified teaching health center a per resident
amount--
(i) by dividing the national average
per resident amount computed under
section 340E(c)(2)(D) into a wage-
related portion and a non-wage related
portion by applying the proportion
determined under subparagraph (B);
(ii) by multiplying the wage-related
portion by the factor applied under
section 1886(d)(3)(E) of the Social
Security Act (but without application
of section 4410 of the Balanced Budget
Act of 1997 (42 U.S.C. 1395ww note))
during the preceding fiscal year for
the teaching health center's area; and
(iii) by adding the non-wage-related
portion to the amount computed under
clause (ii).
(B) Updating rate.--The Secretary shall
update such per resident amount for each such
qualified teaching health center as determined
appropriate by the Secretary.
(d) Amount of Payment for Indirect Medical Education.--
(1) In general.--The amount determined under this
subsection for payments to qualified teaching health
centers for indirect expenses associated with the
additional costs of teaching residents for a fiscal
year is equal to an amount determined appropriate by
the Secretary.
(2) Factors.--In determining the amount under
paragraph (1), the Secretary shall--
(A) evaluate indirect training costs relative
to supporting a primary care residency program
in qualified teaching health centers; and
(B) based on this evaluation, assure that the
aggregate of the payments for indirect expenses
under this section and the payments for direct
graduate medical education as determined under
subsection (c) in a fiscal year do not exceed
the amount appropriated for such expenses as
determined in subsection (g).
(3) Interim payment.--Before the Secretary makes a
payment under this subsection pursuant to a
determination of indirect expenses under paragraph (1),
the Secretary may provide to qualified teaching health
centers a payment, in addition to any payment made
under subsection (c), for expected indirect expenses
associated with the additional costs of teaching
residents for a fiscal year, based on an estimate by
the Secretary.
(e) Clarification Regarding Relationship to Other Payments
for Graduate Medical Education.--Payments under this section--
(1) shall be in addition to any payments--
(A) for the indirect costs of medical
education under section 1886(d)(5)(B) of the
Social Security Act;
(B) for direct graduate medical education
costs under section 1886(h) of such Act; and
(C) for direct costs of medical education
under section 1886(k) of such Act;
(2) shall not be taken into account in applying the
limitation on the number of total full-time equivalent
residents under subparagraphs (F) and (G) of section
1886(h)(4) of such Act and clauses (v), (vi)(I), and
(vi)(II) of section 1886(d)(5)(B) of such Act for the
portion of time that a resident rotates to a hospital;
and
(3) shall not include the time in which a resident is
counted toward full-time equivalency by a hospital
under paragraph (2) or under section 1886(d)(5)(B)(iv)
of the Social Security Act, section 1886(h)(4)(E) of
such Act, or section 340E of this Act.
(f) Reconciliation.--The Secretary shall determine any
changes to the number of residents reported by a teaching
health center in the application of the teaching health center
for the current fiscal year to determine the final amount
payable to the teaching health center for the current fiscal
year for both direct expense and indirect expense amounts.
Based on such determination, the Secretary shall recoup any
overpayments made to pay any balance due to the extent
possible. The final amount so determined shall be considered a
final intermediary determination for the purposes of section
1878 of the Social Security Act and shall be subject to
administrative and judicial review under that section in the
same manner as the amount of payment under section 1186(d) of
such Act is subject to review under such section.
(g) Funding.--
(1) In general.--To carry out this section, there are
appropriated such sums as may be necessary, not to
exceed $230,000,000, for the period of fiscal years
2011 through 2015, $60,000,000 for each of fiscal years
2016 and 2017, and $126,500,000 for each of fiscal
years [2018 and 2019] 2019 through 2023, to remain
available until expended.
(2) Administrative expenses.--Of the amount made
available to carry out this section for any fiscal
year, the Secretary may not use more than 5 percent of
such amount for the expenses of administering this
section.
(h) Annual Reporting Required.--
(1) Annual report.--The report required under this
paragraph for a qualified teaching health center for a
fiscal year is a report that includes (in a form and
manner specified by the Secretary) the following
information for the residency academic year completed
immediately prior to such fiscal year:
(A) The types of primary care resident
approved training programs that the qualified
teaching health center provided for residents.
(B) The number of approved training positions
for residents described in paragraph (4).
(C) The number of residents described in
paragraph (4) who completed their residency
training at the end of such residency academic
year and care for vulnerable populations living
in underserved areas.
(D) The number of patients treated by
residents described in paragraph (4).
(E) The number of visits by patients treated
by residents described in paragraph (4).
(F) Of the number of residents described in
paragraph (4) who completed their residency
training at the end of such residency academic
year, the number and percentage of such
residents entering primary care practice
(meaning any of the areas of practice listed in
the definition of a primary care residency
program in section 749A).
(G) Of the number of residents described in
paragraph (4) who completed their residency
training at the end of such residency academic
year, the number and percentage of such
residents who entered practice at a health care
facility--
(i) primarily serving a health
professional shortage area with a
designation in effect under section 332
or a medically underserved community
(as defined in section 799B); or
(ii) located in a rural area (as
defined in section 1886(d)(2)(D) of the
Social Security Act).
(H) Other information as deemed appropriate
by the Secretary.
(2) Audit authority; limitation on payment.--
(A) Audit authority.--The Secretary may audit
a qualified teaching health center to ensure
the accuracy and completeness of the
information submitted in a report under
paragraph (1).
(B) Limitation on payment.--A teaching health
center may only receive payment in a cost
reporting period for a number of such resident
positions that is greater than the base level
of primary care resident positions, as
determined by the Secretary. For purposes of
this subparagraph, the ``base level of primary
care residents'' for a teaching health center
is the level of such residents as of a base
period.
(3) Reduction in payment for failure to report.--
(A) In general.--The amount payable under
this section to a qualified teaching health
center for a fiscal year shall be reduced by at
least 25 percent if the Secretary determines
that--
(i) the qualified teaching health
center has failed to provide the
Secretary, as an addendum to the
qualified teaching health center's
application under this section for such
fiscal year, the report required under
paragraph (1) for the previous fiscal
year; or
(ii) such report fails to provide
complete and accurate information
required under any subparagraph of such
paragraph.
(B) Notice and opportunity to provide
accurate and missing information.--Before
imposing a reduction under subparagraph (A) on
the basis of a qualified teaching health
center's failure to provide complete and
accurate information described in subparagraph
(A)(ii), the Secretary shall provide notice to
the teaching health center of such failure and
the Secretary's intention to impose such
reduction and shall provide the teaching health
center with the opportunity to provide the
required information within the period of 30
days beginning on the date of such notice. If
the teaching health center provides such
information within such period, no reduction
shall be made under subparagraph (A) on the
basis of the previous failure to provide such
information.
(4) Residents.--The residents described in this
paragraph are those who are in part-time or full-time
equivalent resident training positions at a qualified
teaching health center in any approved graduate medical
residency training program.
(i) Regulations.--The Secretary shall promulgate regulations
to carry out this section.
(j) Definitions.--In this section:
(1) Approved graduate medical residency training
program.--The term ``approved graduate medical
residency training program'' means a residency or other
postgraduate medical training program--
(A) participation in which may be counted
toward certification in a specialty or
subspecialty and includes formal postgraduate
training programs in geriatric medicine
approved by the Secretary; and
(B) that meets criteria for accreditation (as
established by the Accreditation Council for
Graduate Medical Education, the American
Osteopathic Association, or the American Dental
Association).
(2) New approved graduate medical residency training
program.--The term ``new approved graduate medical
residency training program'' means an approved graduate
medical residency training program for which the
sponsoring qualified teaching health center has not
received a payment under this section for a previous
fiscal year (other than pursuant to subsection
(a)(1)(C)).
(3) Primary care residency program.--The term
``primary care residency program'' has the meaning
given that term in section 749A.
(4) Qualified teaching health center.--The term
``qualified teaching health center'' has the meaning
given the term ``teaching health center'' in section
749A.
* * * * * * *
TITLE XXVII--REQUIREMENTS RELATING TO HEALTH INSURANCE COVERAGE
PART A--INDIVIDUAL AND GROUP MARKET REFORMS
* * * * * * *
Subpart II--Improving Coverage
* * * * * * *
SEC. 2719A. PATIENT PROTECTIONS.
(a) Choice of Health Care Professional.--If a group health
plan, or a health insurance issuer offering group or individual
health insurance coverage, requires or provides for designation
by a participant, beneficiary, or enrollee of a participating
primary care provider, then the plan or issuer shall permit
each participant, beneficiary, and enrollee to designate any
participating primary care provider who is available to accept
such individual.
(b) Coverage of Emergency Services.--
(1) In general.--If [a group health plan, or a health
insurance issuer offering group or individual health
insurance issuer,] a health plan (as defined in
subsection (e)(2)(A)) provides or covers any benefits
with respect to services in an emergency department of
a hospital or, for plan year 2021 or a subsequent plan
year, with respect to emergency services in an
independent freestanding emergency department (as
defined in paragraph (3)(D)), [the plan or issuer] the
plan shall cover emergency services (as defined in
[paragraph (2)(B)] paragraph (3)(C))--
(A) without the need for any prior
authorization determination;
(B) whether the health care provider
furnishing such services is a participating
provider or a participating emergency facility,
as applicable, with respect to such services;
(C) in a manner so that, if such services are
provided to a participant, beneficiary, or
enrollee by a nonparticipating provider or a
nonparticipating emergency facility--
[(i) by a nonparticipating health
care provider with or without prior
authorization; or]
[(ii)(I) such services] (i) such
services will be provided without
imposing any requirement under the plan
for prior authorization of services or
any limitation on coverage [where the
provider of services does not have a
contractual relationship with the plan
for the providing of services] that is
more restrictive than the requirements
or limitations that apply to [emergency
department services received from
providers who do have such a
contractual relationship with the plan;
and] emergency services received from
participating providers and
participating emergency facilities with
respect to such plan;
[(II) if such services are provided
out-of-network, the cost-sharing
requirement (expressed as a copayment
amount or coinsurance rate) is the same
requirement that would apply if such
services were provided in-network;]
(ii) the cost-sharing requirement
(expressed as a copayment amount or
coinsurance rate) is not greater than
the requirement that would apply if
such services were provided by a
participating provider or a
participating emergency facility;
(iii) such requirement is calculated
as if the total amount that would have
been charged for such services by such
participating provider or participating
emergency facility were equal to--
(I) in the case of such
services furnished in a State
described in paragraph
(3)(H)(ii), the median
contracted rate (as defined in
paragraph (3)(E)(i)) for such
services; and
(II) in the case of such
services furnished in a State
described in paragraph
(3)(H)(i), the lesser of--
(aa) the amount
determined by such
State for such services
in accordance with the
method described in
such paragraph; and
(bb) the median
contracted rate (as so
defined) for such
services;
(iv) the health plan pays to such
provider or facility, respectively, the
amount by which the recognized amount
(as defined in paragraph (3)(H)) for
such services exceeds the cost-sharing
amount for such services (as determined
in accordance with clauses (ii) and
(iii)); and
(v) any cost-sharing payments made by
the participant, beneficiary, or
enrollee with respect to such emergency
services so furnished shall be counted
toward any in-network deductible or
out-of-pocket maximums applied under
the plan (and such in-network
deductible shall be applied) in the
same manner as if such cost-sharing
payments were with respect to emergency
services furnished by a participating
provider and a participating emergency
facility; and
(D) without regard to any other term or
condition of such coverage (other than
exclusion or coordination of benefits, or an
affiliation or waiting period, permitted under
section 2701 of this Act, section 701 of the
Employee Retirement Income Security Act of
1974, or section 9801 of the Internal Revenue
Code of 1986, and other than applicable cost-
sharing).
(2) Audit process for median contracted rates.--
(A) In general.--Not later than July 1, 2020,
the Secretary, in consultation with appropriate
State agencies, shall establish through
rulemaking a process, in accordance with
subparagraph (B), under which health plans are
audited by such Secretaries to ensure that--
(i) such plans are in compliance with
the requirement of applying a median
contracted rate under this section; and
(ii) that such median contracted rate
so applied satisfies the definition
under paragraph (3)(E) with respect to
the year involved, including with
respect to a health plan described in
clause (ii) of such paragraph.
(B) Audit samples.--Under the process
established pursuant to subparagraph (A), the
Secretary--
(i) shall conduct audits described in
such subparagraph, with respect to a
year (beginning with 2021), of a sample
with respect to such year of claims
data from not more than 25 health
plans; and
(ii) may audit any health plan if the
Secretary has received any complaint
about such plan that involves the
compliance of the plan with either of
the requirements described in clauses
(i) and (ii) of such subparagraph.
[(2)] (3) Definitions.--In this subsection and
subsection (e):
(A) Emergency department of a hospital.--The
term ``emergency department of a hospital''
includes a hospital outpatient department that
provides emergency services.
[(A)] (B) Emergency medical condition.--The
term ``emergency medical condition'' means a
medical condition manifesting itself by acute
symptoms of sufficient severity (including
severe pain) such that a prudent layperson, who
possesses an average knowledge of health and
medicine, could reasonably expect the absence
of immediate medical attention to result in a
condition described in clause (i), (ii), or
(iii) of section 1867(e)(1)(A) of the Social
Security Act.
[(B) Emergency services.--The term
``emergency services'' means, with respect to
an emergency medical condition--
[(i) a medical screening examination
(as required under section 1867 of the
Social Security Act) that is within the
capability of the emergency department
of a hospital, including ancillary
services routinely available to the
emergency department to evaluate such
emergency medical condition, and
[(ii) within the capabilities of the
staff and facilities available at the
hospital, such further medical
examination and treatment as are
required under section 1867 of such Act
to stabilize the patient.]
(C) Emergency services.--
(i) In general.--The term ``emergency
services'', with respect to an
emergency medical condition, means--
(I) a medical screening
examination (as required under
section 1867 of the Social
Security Act, or as would be
required under such section if
such section applied to an
independent freestanding
emergency department) that is
within the capability of the
emergency department of a
hospital or of an independent
freestanding emergency
department, as applicable,
including ancillary services
routinely available to the
emergency department to
evaluate such emergency medical
condition; and
(II) within the capabilities
of the staff and facilities
available at the hospital or
the independent freestanding
emergency department, as
applicable, such further
medical examination and
treatment as are required under
section 1867 of such Act, or as
would be required under such
section if such section applied
to an independent freestanding
emergency department, to
stabilize the patient.
(ii) Inclusion of poststabilization
services.--For purposes of this
subsection and section 2799, in the
case of an individual enrolled in a
health plan who is furnished services
described in clause (i) by a provider
or facility to stabilize such
individual with respect to an emergency
medical condition, the term ``emergency
services'' shall include such items and
services in addition to those described
in clause (i) that such a provider or
facility determines are needed to be
furnished (after such stabilization but
during such visit in which such
individual is so stabilized) to such
individual, unless each of the
following conditions are met:
(I) Such a provider or
facility determines such
individual is able to travel
using nonmedical transportation
or nonemergency medical
transportation.
(II) Such provider furnishing
such additional items and
services is in compliance with
section 2799A(d) with respect
to such items and services.
(D) Independent freestanding emergency
department.--The term ``independent
freestanding emergency department'' means a
facility that--
(i) is geographically separate and
distinct and licensed separately from a
hospital under applicable State law;
and
(ii) provides emergency services.
(E) Median contracted rate.--
(i) In general.--The term ``median
contracted rate'' means, with respect
to an item or service and a health plan
(as defined in subsection (e)(2)(A))--
(I) for 2021, the median of
the negotiated rates recognized
by the sponsor or issuer of
such plan (determined with
respect to all such plans of
such sponsor or such issuer
that are within the same line
of business) as the total
maximum payment (including the
cost-sharing amount imposed for
such services (as determined in
accordance with clauses (ii)
and (iii) of paragraph (1)(C)
or subparagraphs (A) and (B) of
subsection (e)(1), as
applicable) and the amount to
be paid by the plan or issuer)
under such plans in 2019 for
the same or a similar item or
service that is provided by a
provider in the same or similar
specialty and provided in the
geographic region in which the
item or service is furnished,
consistent with the methodology
established by the Secretary
under section 402(e) of the No
Surprises Act, increased by the
percentage increase in the
consumer price index for all
urban consumers (United States
city average) over 2019 and
2020; and
(II) for 2022 and each
subsequent year, the median
contracted rate determined
under this clause for the
previous year, increased by the
percentage increase in the
consumer price index for all
urban consumers (United States
city average) over such
previous year.
(ii) Special rule.--The Secretary
shall provide pursuant to rulemaking
described in section 402(e) of the No
Surprises Act that--
(I) if the sponsor or issuer
of a health plan does not have
sufficient information to
calculate a median contracted
rate for an item or service or
provider type, or amount of,
claims for items or services
(as determined by the
Secretary) provided in a
particular geographic area
(other than in a case described
in item (bb)), such sponsor or
issuer shall demonstrate that
such sponsor or issuer will use
any database free of conflicts
of interest that has sufficient
information reflecting allowed
amounts paid to a health care
provider for relevant services
provided in the applicable
geographic region (such as
State All Payer Claims
Databases (as defined in
section 404(d) of such Act)),
and that such sponsor or issuer
will use any such database to
determine a median contracted
rate and cover the cost of
accessing any such database;
and
(II) in the case of a sponsor
or issuer offering a health
plan in a geographic region
that did not offer any health
plan in such region during
2019, such sponsor or issuer
shall use a methodology
established by the Secretary
for determining the median
contracted rate for items and
services covered by such plan
for the first year in which
such plan is offered in such
region, and that, for each
succeeding year, the median
contracted rate for such items
and services under such plan
shall be the median contracted
rate for such items and
services under such plan for
the previous year, increased by
the percentage increase in the
consumer price index for all
urban consumers (United States
city average) over such
previous year.
(F) Nonparticipating emergency facility;
participating emergency facility.--
(i) Nonparticipating emergency
facility.--The term ``nonparticipating
emergency facility'' means, with
respect to an item or service and a
health plan, an emergency department of
a hospital, or an independent
freestanding emergency department, that
does not have a contractual
relationship with the plan (or, if
applicable, issuer offering the plan)
for furnishing such item or service
under the plan.
(ii) Participating emergency
facility.--The term ``participating
emergency facility'' means, with
respect to an item or service and a
health plan, an emergency department of
a hospital, or an independent
freestanding emergency department, that
has a contractual relationship with the
plan (or, if applicable, issuer
offering the plan) for furnishing such
item or service under the plan.
(G) Nonparticipating providers; participating
providers.--
(i) Nonparticipating provider.--The
term ``nonparticipating provider''
means, with respect to an item or
service and a health plan, a physician
or other health care provider who is
acting within the scope of practice of
that provider's license or
certification under applicable State
law and who does not have a contractual
relationship with the plan (or, if
applicable, issuer offering the plan)
for furnishing such item or service
under the plan.
(ii) Participating provider.--The
term ``participating provider'' means,
with respect to an item or service and
a health plan, a physician or other
health care provider who is acting
within the scope of practice of that
provider's license or certification
under applicable State law and who has
a contractual relationship with the
plan (or, if applicable, issuer
offering the plan) for furnishing such
item or service under the plan.
(H) Recognized amount.--The term ``recognized
amount'' means, with respect to an item or
service--
(i) in the case of such item or
service furnished in a State that has
in effect a State law that provides for
a method for determining the amount of
payment that is required to be covered
by a health plan regulated by such
State in the case of a participant,
beneficiary, or enrollee covered under
such plan and receiving such item or
service from a nonparticipating
provider or facility, not more than the
amount determined in accordance with
such law plus the cost-sharing amount
imposed under the plan for such item or
service (as determined in accordance
with clauses (ii) and (iii) of
paragraph (1)(C) or subparagraphs (A)
and (B) of subsection (e)(1), as
applicable); or
(ii) in the case of such item or
service furnished in a State that does
not have in effect such a law, an
amount that is at least the median
contracted rate (as defined in
subparagraph (E)(i) and determined in
accordance with rulemaking described in
section 402(e) of the No Surprises Act)
for such item or service.
[(C)] (I) Stabilize.--The term ``to
stabilize'', with respect to an emergency
medical condition (as defined in subparagraph
(A)), has the meaning give in section
1867(e)(3) of the Social Security Act (42
U.S.C. 1395dd(e)(3)).
(c) Access to Pediatric Care.--
(1) Pediatric care.--In the case of a person who has
a child who is a participant, beneficiary, or enrollee
under a group health plan, or health insurance coverage
offered by a health insurance issuer in the group or
individual market, if the plan or issuer requires or
provides for the designation of a participating primary
care provider for the child, the plan or issuer shall
permit such person to designate a physician (allopathic
or osteopathic) who specializes in pediatrics as the
child's primary care provider if such provider
participates in the network of the plan or issuer.
(2) Construction.--Nothing in paragraph (1) shall be
construed to waive any exclusions of coverage under the
terms and conditions of the plan or health insurance
coverage with respect to coverage of pediatric care.
(d) Patient Access to Obstetrical and Gynecological Care.--
(1) General rights.--
(A) Direct access.--A group health plan, or
health insurance issuer offering group or
individual health insurance coverage, described
in paragraph (2) may not require authorization
or referral by the plan, issuer, or any person
(including a primary care provider described in
paragraph (2)(B)) in the case of a female
participant, beneficiary, or enrollee who seeks
coverage for obstetrical or gynecological care
provided by a participating health care
professional who specializes in obstetrics or
gynecology. Such professional shall agree to
otherwise adhere to such plan's or issuer's
policies and procedures, including procedures
regarding referrals and obtaining prior
authorization and providing services pursuant
to a treatment plan (if any) approved by the
plan or issuer.
(B) Obstetrical and gynecological care.--A
group health plan or health insurance issuer
described in paragraph (2) shall treat the
provision of obstetrical and gynecological
care, and the ordering of related obstetrical
and gynecological items and services, pursuant
to the direct access described under
subparagraph (A), by a participating health
care professional who specializes in obstetrics
or gynecology as the authorization of the
primary care provider.
(2) Application of paragraph.--A group health plan,
or health insurance issuer offering group or individual
health insurance coverage, described in this paragraph
is a group health plan or coverage that--
(A) provides coverage for obstetric or
gynecologic care; and
(B) requires the designation by a
participant, beneficiary, or enrollee of a
participating primary care provider.
(3) Construction.--Nothing in paragraph (1) shall be
construed to--
(A) waive any exclusions of coverage under
the terms and conditions of the plan or health
insurance coverage with respect to coverage of
obstetrical or gynecological care; or
(B) preclude the group health plan or health
insurance issuer involved from requiring that
the obstetrical or gynecological provider
notify the primary care health care
professional or the plan or issuer of treatment
decisions.
(e) Coverage of Non-emergency Services Performed by
Nonparticipating Providers at Certain Participating
Facilities.--
(1) In general.--Subject to paragraph (3), in the
case of items or services (other than emergency
services to which subsection (b) applies) furnished to
a participant, beneficiary, or enrollee of a health
plan (as defined in paragraph (2)(A)) by a
nonparticipating provider (as defined in subsection
(b)(3)(G)(i)) during a visit (as defined by the
Secretary in accordance with paragraph (2)(C)) at a
participating health care facility (as defined in
paragraph (2)(B)), with respect to such plan, the
plan--
(A) shall not impose on such participant,
beneficiary, or enrollee a cost-sharing amount
(expressed as a copayment amount or coinsurance
rate) for such items and services so furnished
that is greater than the cost-sharing amount
that would apply under such plan had such items
or services been furnished by a participating
provider (as defined in subsection
(b)(3)(G)(ii));
(B) shall calculate such cost-sharing amount
as if the amount that would have been charged
for such items and services by such
participating provider were equal to--
(i) in the case of such items and
services furnished in a State described
in subsection (b)(3)(H)(ii), the median
contracted rate (as defined in
subsection (b)(3)(E)(i)) for such items
and services; and
(ii) in the case of such items and
services furnished in a State described
in subsection (b)(3)(H)(i), the lesser
of--
(I) the amount determined by
such State for such items and
services in accordance with the
method described in such
subsection; and
(II) the median contracted
rate (as so defined) for such
items and services;
(C) shall pay to such provider furnishing
such items and services to such participant,
beneficiary, or enrollee the amount by which
the recognized amount (as defined in subsection
(b)(3)(H)) for such items and services exceeds
the cost-sharing amount imposed under the plan
for such items and services (as determined in
accordance with subparagraphs (A) and (B)); and
(D) shall count toward any in-network
deductible or out-of-pocket maximums applied
under the plan any cost-sharing payments made
by the participant, beneficiary, or enrollee
(and such in-network deductible shall be
applied) with respect to such items and
services so furnished in the same manner as if
such cost-sharing payments were with respect to
items and services furnished by a participating
provider.
(2) Definitions.--In this subsection and subsection
(b):
(A) Health plan.--The term ``health plan''
means a group health plan and health insurance
coverage offered by a heath insurance issuer in
the group or individual market and includes a
grandfathered health plan (as defined in
section 1251(e) of the Patient Protection and
Affordable Care Act).
(B) Participating health care facility.--
(i) In general.--The term
``participating health care facility''
means, with respect to an item or
service and a health plan, a health
care facility described in clause (ii)
that has a contractual relationship
with the plan (or, if applicable,
issuer offering the plan) for
furnishing such item or service.
(ii) Health care facility
described.--A health care facility
described in this clause is each of the
following:
(I) A hospital (as defined in
1861(e) of the Social Security
Act).
(II) A critical access
hospital (as defined in section
1861(mm) of such Act).
(III) An ambulatory surgical
center (as defined in section
1833(i)(1)(A) of such Act).
(IV) A laboratory.
(V) A radiology facility or
imaging center.
(C) During a visit.--The term ``during a
visit'' shall, with respect to items and
services furnished to an individual at a
participating health care facility, include
equipment and devices, telemedicine services,
imaging services, laboratory services, and such
other items and services as the Secretary may
specify, regardless of whether or not the
provider furnishing such items or services is
at the facility.
(3) Exception.--Paragraph (1) shall not apply to a
health plan in the case of items or services (other
than emergency services to which subsection (b)
applies) furnished to a participant, beneficiary, or
enrollee of a health plan (as defined in paragraph
(2)(A)) by a nonparticipating provider (as defined in
subsection (b)(3)(G)(i)) during a visit (as defined by
the Secretary in accordance with paragraph (2)(C)) at a
participating health care facility (as defined in
paragraph (2)(B)) if such provider is in compliance
with section 2799A(d) with respect to such items and
services.
(f) Independent Dispute Resolution Process.--
(1) Establishment.--
(A) In general.--Not later than 1 year after
the date of the enactment of this subsection,
the Secretary, in consultation with the
Secretary of Labor, shall establish by
regulation an independent dispute resolution
process (referred to in this subsection as the
``IDR process'') under which--
(i) a nonparticipating provider (as
defined in subparagraph (G) of
subsection (b)(3)), nonparticipating
emergency facility (as defined in
subparagraph (F) of such subsection),
or health plan (as defined in
subsection (e)(2)(A)) may submit a
request for resolution by an entity
certified under paragraph (2) (in this
subsection referred to as a ``certified
IDR entity'') of a specified claim; and
(ii) in the case a settlement
described in subparagraph (B) of
paragraph (4) is not reached with
respect to such claim, such entity so
resolves such claim in accordance with
such paragraph.
(B) Definitions.--In this subsection:
(i) Specified claim.--
(I) In general.--Subject to
subclause (II), the term
``specified claim'' means a
claim by a nonparticipating
provider, a nonparticipating
emergency facility, or a health
plan with respect to qualifying
items and services (as defined
in clause (ii)) furnished by
such provider or facility in a
State described in subparagraph
(H)(ii) of subsection (b)(3)
for which a health plan is
required to make payment
pursuant to subsection (b)(1)
or subsection (e)(1)--
(aa) that such
payment should be
increased or decreased;
and
(bb) that is made not
later than--
(AA) in the
case of such a
claim filed by
such a provider
or facility,
the date on
which the
appeal with
respect to such
items and
services
described in
clause
(ii)(I)(aa)(AA)
has been
resolved (or
the date that
is 30 days
after such
appeal is
filed,
whichever is
earlier); or
(BB) in the
case of such a
claim filed by
such plan, the
date on which
the period
described in
clause
(ii)(I)(bb)(BB)
with respect to
such items and
services
elapses.
(II) Limitation on packaging
of items and services in a
specified claim.--The term
``specified claim'' shall not
include, in the case such claim
is made by such provider,
facility, or plan with respect
to multiple items and services,
any claim with respect to items
and services furnished by such
provider or facility if--
(aa) such items and
services were not
furnished by the same
provider or facility;
(bb) payment for such
items and services made
pursuant to subsection
(b)(1) or subsection
(e)(1) was made by
multiple health plans;
(cc) such items and
services are not
related to the
treatment of the same
condition; or
(dd) such items and
services were not
furnished within 30
days of the date of the
earliest item or
service furnished that
is included in such
claim.
(ii) Qualifying items and services.--
(I) In general.--Subject to
subclause (II), the term
``qualifying items and
services'' means--
(aa) with respect to
a specified claim made
by a nonparticipating
provider or
nonparticipating
emergency facility,
items and services
furnished by such
provider or facility
for which a health plan
is required to make
payment pursuant to
subsection (b)(1) or
subsection (e)(1), but
only if--
(AA) such
items and
services are
included in an
appeal filed
under such
plan's internal
appeals process
not later than
30 days after
such payment is
received; and
(BB) such
appeal under
such plan's
internal
appeals process
has been
resolved, or a
30-day period
has elapsed
since such
appeal was so
filed; and
(bb) with respect to
a specified claim made
by a health plan, items
and services furnished
by such a provider or
facility for which such
health plan is required
to make payment
pursuant to subsection
(b)(1) or subsection
(e)(1), but only if--
(AA) such
plan submits a
notice to such
provider or
facility not
later than 30
days after such
provider or
facility
receives such
payment that
such plan
disputes the
amount of such
payment with
respect to such
items and
services; and
(BB) a 30-day
period has
elapsed since
the submission
of such notice.
(II) Limitation.--The term
``qualifying items and
services'' shall not include an
item or service furnished in a
geographic area during a year
by such provider or facility
for which a health plan is
required to make payment
pursuant to subsection (b)(1)
or subsection (e)(1) if the
median contracted rate (as
defined in subsection
(b)(3)(E)) under such plan for
such year with respect to such
item or service furnished by
such a provider or such a
facility in such area does not
exceed--
(aa) with respect to
an item or service
furnished during 2021,
$1,250; and
(bb) with respect to
an item or service
furnished during a
subsequent year, the
amount specified under
this subclause for the
previous year,
increased by the
percentage increase in
the consumer price
index for all urban
consumers (United
States city average)
over such previous
year.
(2) Certification of entities.--
(A) Process of certification.--The process
described in paragraph (1) shall include a
certification process under which eligible
entities may be certified to carry out the IDR
process.
(B) Eligibility.--
(i) In general.--For purposes of
subparagraph (A), an eligible entity is
an entity that is a nongovernmental
entity that agrees to comply with the
fee limitations described in clause
(ii).
(ii) Fee limitation.--For purposes of
clause (i), the fee limitations
described in this clause are
limitations established by the
Secretary on the amount a certified IDR
entity may charge a nonparticipating
provider, nonparticipating emergency
facility, or health plan for services
furnished by such entity with respect
to the resolution of a specified claim
of such provider, facility, or plan
under the process described in
paragraph (1).
(3) Selection of certified idr entity for a specified
claim.--With respect to the resolution of a specified
claim under the IDR process, the health plan and the
nonparticipating provider or the nonparticipating
emergency facility (as applicable) involved shall agree
on a certified IDR entity to resolve such claim. In the
case that such plan and such provider or facility (as
applicable) cannot so agree, such an entity shall be
selected by the Secretary at random.
(4) Payment determination.--
(A) Timing.--A certified IDR entity selected
under paragraph (3) by a health plan and a
nonparticipating provider or a nonparticipating
emergency facility (as applicable) with respect
to a specified claim shall, subject to
subparagraph (B), not later than 30 days after
being so selected, determine the total
reimbursement that should have been made for
items and services included in such claim in
accordance with subparagraph (C).
(B) Settlement.--
(i) In general.--If such entity
determines that a settlement between
the health plan and the provider or
facility is likely with respect to a
specified claim, the entity may direct
the parties to attempt, for a period
not to exceed 10 days, a good faith
negotiation for a settlement of such
claim.
(ii) Timing.--The period for a
settlement described in clause (i)
shall accrue towards the 30-day period
described in subparagraph (A).
(C) Determination of amount.--
(i) In general.--The health plan and
the nonparticipating provider or
nonparticipating emergency facility (as
applicable) shall, with respect to a
specified claim, each submit to the
certified IDR entity a final offer of
payment or reimbursement (as
applicable) with respect to items and
services which are the subject of the
specified claim. Such entity shall
determine which such offer is the most
reasonable in accordance with clause
(ii).
(ii) Considerations in
determination.--
(I) In general.--In
determining which final offer
is the most reasonable under
clause (i), the certified IDR
entity shall consider--
(aa) the median
contracted rates (as
defined in subsection
(b)(3)(E)) for items or
services that are
comparable to the items
and services included
in the specified claim
and that are furnished
in the same geographic
area (as defined by the
Secretary for purposes
of such subsection) as
such items and services
(not including any
facility fees with
respect to such rates);
and
(bb) the
circumstances described
in subclause (II), if
any information with
respect to such
circumstances is
submitted by either
party.
(II) Additional
circumstances.--For purposes of
subclause (I)(bb), the
circumstances described in this
subclause are, with respect to
items and services included in
the specified claim of a
nonparticipating provider,
nonparticipating emergency
facility, or health plan, the
following:
(aa) The level of
training, education,
experience, and quality
and outcomes
measurements of the
provider or facility
that furnished such
items and services.
(bb) Any other
extenuating
circumstances with
respect to the
furnishing of such
items and services that
relate to the acuity of
the individual
receiving such items
and services or the
complexity of
furnishing such items
and services to such
individual.
(III) Prohibition on
consideration of billed
charges.--In determining which
final offer is the most
reasonable under clause (i)
with respect to items and
services furnished by a
provider or facility and
included in a specified claim,
the certified IDR entity may
not consider the amount that
would have been billed by such
provider or facility with
respect to such items and
services had the provisions of
section 2799 or 2799A (as
applicable) not applied.
(iii) Effect of determination.--A
determination of a certified IDR entity
under clause (i)--
(I) shall be binding; and
(II) shall not be subject to
judicial review, except in a
case described in any of
paragraphs (1) through (4) of
section 10(a) of title 9,
United States Code.
(iv) Costs of independent dispute
resolution process.--In the case of a
specified claim made by a
nonparticipating provider,
nonparticipating emergency facility, or
health plan and submitted to a
certified IDR entity--
(I) if such entity makes a
determination with respect to
such claim under clause (i),
the party whose offer is not
chosen under such clause shall
be responsible for paying all
fees charged by such entity;
and
(II) if the parties reach a
settlement with respect to such
claim prior to such a
determination, such fees shall
be divided equally between the
parties, unless the parties
otherwise agree.
(v) Payment.--Not later than 30 days
after a determination described in
clause (i) is made with respect to a
specified claim of a nonparticipating
provider, nonparticipating emergency
facility, or health plan--
(I) in the case that such
determination finds that the
amount paid with respect to
such specified claim by the
health plan should have been
greater than the amount so
paid, such plan shall pay
directly to the provider or
facility (as applicable) the
difference between the amount
so paid and the amount so
determined; and
(II) in the case that such
determination finds that the
amount paid with respect to
such specified claim by the
health plan should have been
less than the amount so paid,
the provider or facility (as
applicable) shall pay directly
to the plan the difference
between the amount so paid and
the amount so determined.
(5) Publication of information relating to
disputes.--
(A) In general.--For 2021 and each subsequent
year, the Secretary and the Secretary of Labor
shall publish on the public website of the
Department of Health and Human Services and the
Department of Labor, respectively--
(i) the number of specified claims
filed during such year;
(ii) the number of such claims with
respect to which a final determination
was made under paragraph (4)(C)(i); and
(iii) the information described in
subparagraph (B) with respect to each
specified claim with respect to which
such a decision was so made.
(B) Information with respect to specified
claims.--For purposes of subparagraph (A), the
information described in this subparagraph is,
with respect to a specified claim of a
nonparticiapting provider, nonparticipating
emergency facility, or health plan--
(i) a description of each item and
service included in such claim;
(ii) the amount of the offer
submitted under paragraph (4)(C)(i) by
the health plan and by the
nonparticipating provider or
nonparticipating emergency facility (as
applicable);
(iii) whether the offer selected by
the certified IDR entity under such
paragraph was the offer submitted by
such plan or by such provider or
facility (as applicable) and the amount
of such offer so selected; and
(iv) the category and practice
specialty of each such provider or
facility involved in furnishing such
items and services.
(C) Confidentiality of parties.--None of the
information published under this paragraph may
specify the identity of a health plan,
provider, facility, or individual with respect
to a specified claim.
(g) Provider Directory Information Requirements.--
(1) In general.--Not later than 1 year after the date
of the enactment of this subsection, each group health
plan and health insurance issuer offering group or
individual health insurance coverage shall--
(A) establish the verification process
described in paragraph (2);
(B) establish the response protocol described
in paragraph (3);
(C) establish the database described in
paragraph (4); and
(D) include in any print directory containing
provider directory information with respect to
such plan or such coverage the information
described in paragraph (5).
(2) Verification process.--The verification process
described in this paragraph is, with respect to a group
health plan or a health insurance issuer offering group
or individual health insurance coverage, a process--
(A) under which not less frequently than once
every 90 days, such plan or such issuer (as
applicable) verifies and updates the provider
directory information included on the database
described in paragraph (4) of such plan or
issuer of each health care provider and health
care facility included in such database; and
(B) that establishes a procedure for the
removal of such a provider or facility with
respect to which such plan or issuer has been
unable to verify such information during a
period specified by the plan or issuer.
(3) Response protocol.--The response protocol
described in this paragraph is, in the case of an
individual enrolled under a group health plan or group
or individual health insurance coverage offered by a
health insurance issuer who requests information on
whether a health care provider or health care facility
has a contractual relationship to furnish items and
services under such plan or such coverage, a protocol
under which such plan or such issuer (as applicable),
in the case such request is made through a telephone
call--
(A) responds to such individual as soon as
practicable and in no case later than 1
business day after such call is received
through a written electronic communication; and
(B) retains such communication in such
individual's file for at least 2 years
following such response.
(4) Database.--The database described in this
paragraph is, with respect to a group health plan or
health insurance issuer offering group or individual
health insurance coverage, a database on the public
website of such plan or issuer that contains--
(A) a list of each health care provider and
health care facility with which such plan or
such issuer has a contractual relationship for
furnishing items and services under such plan
or such coverage; and
(B) provider directory information with
respect to each such provider and facility.
(5) Information.--The information described in this
paragraph is, with respect to a print directory
containing provider directory information with respect
to a group health plan or individual or group health
insurance coverage offered by a health insurance
issuer, a notification that such information contained
in such directory was accurate as of the date of
publication of such directory and that an individual
enrolled under such plan or such coverage should
consult the database described in paragraph (4) with
respect to such plan or such coverage or contact such
plan or the issuer of such coverage to obtain the most
current provider directory information with respect to
such plan or such coverage.
(6) Definition.--For purposes of this subsection, the
term ``provider directory information'' includes, with
respect to a group health plan and a health insurance
issuer offering group or individual health insurance
coverage, the name, address, specialty, and telephone
number of each health care provider or health care
facility with which such plan or such issuer has a
contractual relationship for furnishing items and
services under such plan or such coverage.
(h) Disclosure on Patient Protections.--Each group health
plan and health insurance issuer offering group or individual
health insurance coverage shall make publicly available, and
(if applicable) post on a public website of such plan or
issuer--
(1) information in plain language on--
(A) the requirements and prohibitions applied
under sections 2799 and 2799A (relating to
prohibitions on balance billing in certain
circumstances);
(B) if provided for under applicable State
law, any other requirements on providers and
facilities regarding the amounts such providers
and facilities may, with respect to an item or
service, charge a participant, beneficiary, or
enrollee of such plan or coverage with respect
to which such a provider or facility does not
have a contractual relationship for furnishing
such item or service under the plan or coverage
after receiving payment from the plan or
coverage for such item or service and any
applicable cost-sharing payment from such
participant, beneficiary, or enrollee; and
(C) the requirements applied under
subsections (b) and (e); and
(2) information on contacting appropriate State and
Federal agencies in the case that an individual
believes that such a provider or facility has violated
any requirement described in paragraph (1) with respect
to such individual.
* * * * * * *
PART D--PREVENTING CERTAIN CASES OF BALANCE BILLING
SEC. 2799. BALANCE BILLING IN CASES OF EMERGENCY SERVICES.
(a) In General.--In the case of a participant, beneficiary,
or enrollee with benefits under a health plan who is furnished
on or after January 1, 2021, emergency services with respect to
an emergency medical condition during a visit at an emergency
department of a hospital or an independent freestanding
emergency department--
(1) the emergency department of a hospital or
independent freestanding emergency department shall not
hold the participant, beneficiary, or enrollee liable
for a payment amount for such emergency services so
furnished that is more than the cost-sharing amount for
such services (as determined in accordance with clauses
(ii) and (iii) of section 2719A(b)(1)(C)); and
(2) a health care provider shall not hold such
participant, beneficiary, or enrollee liable for a
payment amount for an emergency service furnished to
such individual by such provider with respect to such
emergency medical condition and visit for which the
individual receives emergency services at the hospital
or emergency department that is more than the cost-
sharing amount for such services furnished by the
provider (as determined in accordance with clauses (ii)
and (iii) of section 2719A(b)(1)(C)).
(b) Definitions.--In this section:
(1) The terms ``emergency department of a hospital'',
``emergency medical condition'', ``emergency
services'', and ``independent freestanding emergency
department'' have the meanings given such terms,
respectively, in section 2719A(b)(3).
(2) The term ``health plan'' has the meaning given
such term in section 2719A(e).
(3) The term ``during a visit'' shall have such
meaning as applied to such term for purposes of section
2719A(e).
SEC. 2799A. BALANCE BILLING IN CASES OF NON-EMERGENCY SERVICES
PERFORMED BY NONPARTICIPATING PROVIDERS AT CERTAIN
PARTICIPATING FACILITIES.
(a) In General.--Subject to subsection (b), in the case of a
participant, beneficiary, or enrollee with benefits under a
health plan (as defined in section 2799(b)) who is furnished on
or after January 1, 2021, items or services (other than
emergency services to which section 2799 applies) at a
participating health care facility by a nonparticipating
provider, such provider shall not hold such participant,
beneficiary, or enrollee liable for a payment amount for such
an item or service furnished by such provider during a visit at
such facility that is more than the cost-sharing amount for
such item or service (as determined in accordance with
subparagraphs (A) and (B) of section 2719A(e)(1)).
(b) Exception.--
(1) In general.--Subsection (a) shall not apply to a
nonparticipating provider (other than a specified
provider at a participating health care facility), with
respect to items or services furnished by the provider
to a participant, beneficiary, or enrollee of a health
plan, if the provider is in compliance with the notice
and consent requirements of subsection (d).
(2) Specified provider defined.--For purposes of
paragraph (1), the term ``specified provider'', with
respect to a participating health care facility--
(A) means a facility-based provider,
including emergency medicine providers,
anesthesiologists, pathologists, radiologists,
neonatologists, assistant surgeons,
hospitalists, intensivists, or other providers
as determined by the Secretary; and
(B) includes, with respect to an item or
service, a nonparticipating provider if there
is no participating provider at such facility
who can furnish such item or service.
(c) Clarification.--In the case of a nonparticipating
provider (other than a specified provider at a participating
health care facility) that complies with the notice and consent
requirements of subsection (d) with respect to an item or
service (referred to in this subsection as a ``covered item or
service''), such notice and consent requirements may not be
construed as applying with respect to any item or service that
is furnished as a result of unforeseen medical needs that arise
at the time such covered item or service is furnished.
(d) Compliance With Notice and Consent Requirements.--
(1) In general.--A nonparticipating provider or
nonparticipating facility is in compliance with this
subsection, with respect to items or services furnished
by the provider or facility to a participant,
beneficiary, or enrollee of a health plan, if the
provider (or, if applicable, the participating health
care facility on behalf of such provider) or
nonparticipating facility--
(A) provides to the participant, beneficiary,
or enrollee (or to an authorized representative
of the participant, beneficiary, or enrollee)
on the date on which the individual is
furnished such items or services and, in the
case that the participant, beneficiary, or
enrollee makes an appointment to be furnished
such items or services, on such date the
appointment is made--
(i) an oral explanation of the
written notice described in clause
(ii); and
(ii) a written notice specified by
the Secretary, not later than July 1,
2020, through guidance (which shall be
updated as determined necessary by the
Secretary) that--
(I) contains the information
required under paragraph (2);
and
(II) is signed and dated by
the participant, beneficiary,
or enrollee (or by an
authorized representative of
the participant, beneficiary,
or enrollee) and, with respect
to items or services to be
furnished by such a provider
that are not poststabilization
services described in section
2719A(b)(3)(C)(ii), is so
signed and dated not less than
72 hours prior to the
participant, beneficiary, or
enrollee being furnished such
items or services by such
provider; and
(B) obtains from the participant,
beneficiary, or enrollee (or from such an
authorized representative) the consent
described in paragraph (3).
(2) Information required under written notice.--For
purposes of paragraph (1)(A)(ii)(I), the information
described in this paragraph, with respect to a
nonparticipating provider or nonparticipating facility
and a participant, beneficiary, or enrollee of a health
plan, is each of the following:
(A) Notification, as applicable, that the
health care provider is a nonparticipating
provider with respect to the health plan or the
health care facility is a nonparticipating
facility with respect to the health plan.
(B) Notification of the estimated amount that
such provider or facility may charge the
participant, beneficiary, or enrollee for such
items and services involved.
(C) In the case of a nonparticipating
facility, a list of any participating providers
at the facility who are able to furnish such
items and services involved and notification
that the participant, beneficiary, or enrollee
may be referred, at their option, to such a
participating provider.
(3) Consent described.--For purposes of paragraph
(1)(B), the consent described in this paragraph, with
respect to a participant, beneficiary, or enrollee of a
health plan who is to be furnished items or services by
a nonparticipating provider or nonparticipating
facility, is a document specified by the Secretary
through rulemaking that--
(A) is signed by the participant,
beneficiary, or enrollee (or by an authorized
representative of the participant, beneficiary,
or enrollee) and, with respect to items or
services to be furnished by such a provider or
facility that are not poststabilization
services described in section
2719A(b)(3)(C)(ii), is so signed not less than
72 hours prior to the participant, beneficiary,
or enrollee being furnished such items or
services by such provider or facility;
(B) acknowledges that the participant,
beneficiary, or enrollee has been--
(i) provided with a written estimate
and an oral explanation of the charge
that the participant, beneficiary, or
enrollee will be assessed for the items
or services anticipated to be furnished
to the participant, beneficiary, or
enrollee by such provider or facility;
and
(ii) informed that the payment of
such charge by the participant,
beneficiary, or enrollee may not accrue
toward meeting any limitation that the
health plan places on cost-sharing; and
(C) documents the consent of the participant,
beneficiary, or enrollee to--
(i) be furnished with such items or
services by such provider or facility;
and
(ii) in the case that the individual
is so furnished such items or services,
be charged an amount that may be
greater than the amount that would
otherwise be charged the individual if
furnished by a participating provider
or participating facility with respect
to such items or services and plan.
(e) Retention of Certain Documents.--A nonparticipating
provider (or, in the case of a nonparticipating provider at a
participating health care facility, such facility) or
nonparticipating facility that obtains from a participant,
beneficiary, or enrollee of a health plan (or an authorized
representative of such participant, beneficiary, or enrollee) a
written notice in accordance with subsection (c)(1)(ii), with
respect to furnishing an item or service to such participant,
beneficiary, or enrollee, shall retain such notice for at least
a 2-year period after the date on which such item or service is
so furnished.
(f) Definitions.--In this section:
(1) The terms ``nonparticipating provider'' and
``participating provider'' have the meanings given such
terms, respectively, in subsection (b)(3) of section
2719A.
(2) The terms ``participating health care facility''
and ``health plan'' have the meanings given such terms,
respectively, in subsection (e)(2) of section 2719A.
(3) The term ``nonparticipating facility'' means--
(A) with respect to emergency services (as
defined in section 2719A(b)(3)(C)(i)) and a
health plan, an emergency department of a
hospital, or an independent freestanding
emergency department, that does not have a
contractual relationship with the plan (or, if
applicable, issuer offering the plan) for
furnishing such services under the plan; and
(B) with respect to poststabilization
services described in section
2719A(b)(3)(C)(ii) and a health plan, an
emergency department of a hospital (or other
department of such hospital), or an independent
freestanding emergency department, that does
not have a contractual relationship with the
plan (or, if applicable, issuer offering the
plan) for furnishing such services under the
plan.
(4) The term ``participating facility'' means--
(A) with respect to emergency services (as
defined in section 2719A(b)(3)(C)(i)) and a
health plan, an emergency department of a
hospital, or an independent freestanding
emergency department, that has a contractual
relationship with the plan (or, if applicable,
issuer offering the plan) for furnishing such
services under the plan; and
(B) with respect to poststabilization
services described in section
2719A(b)(3)(C)(ii) and a health plan, an
emergency department of a hospital (or other
department of such hospital), or an independent
freestanding emergency department, that has a
contractual relationship with the plan (or, if
applicable, issuer offering the plan) for
furnishing such services under the plan.
SEC. 2799B. PROVIDER REQUIREMENTS WITH RESPECT TO PROVIDER DIRECTORY
INFORMATION.
Not later than 1 year after the date of the enactment of this
section, each health care provider and health care facility
shall establish a process under which such provider or facility
transmits, to each health insurance issuer offering group or
individual health insurance coverage and group health plan with
which such provider or facility has in effect a contractual
relationship for furnishing items and services under such
coverage or such plan, provider directory information (as
defined in section 2719A(g)(6)) with respect to such provider
or facility, as applicable. Such provider or facility shall so
transmit such information to such issuer offering such coverage
or such group health plan--
(1) when the provider or facility enters into such a
relationship with respect to such coverage offered by
such issuer or with respect to such plan;
(2) when the provider or facility terminates such
relationship with respect to such coverage offered by
such issuer or with respect to such plan;
(3) when there are any other material changes to such
provider directory information of the provider or
facility with respect to such coverage offered by such
issuer or with respect to such plan; and
(4) at any other time (including upon the request of
such issuer or plan) determined appropriate by the
provider, facility, or the Secretary.
SEC. 2799C. PROVIDER REQUIREMENT WITH RESPECT TO PUBLIC PROVISION OF
INFORMATION.
Each health care provider and health care facility shall make
publicly available, and (if applicable) post on a public
website of such provider or facility--
(1) information in plain language on--
(A) the requirements and prohibitions of such
provider or facility under sections 2799 and
2799A (relating to prohibitions on balance
billing in certain circumstances); and
(B) if provided for under applicable State
law, any other requirements on such provider or
facility regarding the amounts such provider or
facility may, with respect to an item or
service, charge a participant, beneficiary, or
enrollee of a health plan (as defined in
section 2719A(e)(2)) with respect to which such
provider or facility does not have a
contractual relationship for furnishing such
item or service under the plan after receiving
payment from the plan for such item or service
and any applicable cost-sharing payment from
such participant, beneficiary, or enrollee; and
(2) information on contacting appropriate State and
Federal agencies in the case that an individual
believes that such provider or facility has violated
any requirement described in paragraph (1) with respect
to such individual.
SEC. 2799D. ENFORCEMENT.
(a) State Enforcement.--
(1) State authority.--Each State may require a
provider or health care facility subject to the
requirements of sections 2719A(f), 2799, 2799A, 2799B,
or 2799C to satisfy such requirements applicable to the
provider or facility.
(2) Failure to implement requirements.--In the case
of a determination by the Secretary that a State has
failed to substantially enforce the requirements
specified in paragraph (1) with respect to applicable
providers and facilities in the State, the Secretary
shall enforce such requirements under subsection (b)
insofar as they relate to violations of such
requirements occurring in such State.
(b) Secretarial Enforcement Authority.--
(1) In general.--If a provider or facility is found
to be in violation specified in subsection (a)(1) by
the Secretary, the Secretary may apply a civil monetary
penalty with respect to such provider or facility in an
amount not to exceed $10,000 per violation. The
provisions of subsections (c), (d), (e), (g), (h), (k),
and (l) of section 1128A of the Social Security Act
shall apply to a civil monetary penalty or assessment
under this subsection in the same manner as such
provisions apply to a penalty, assessment, or
proceeding under subsection (a) of such section.
(2) Limitation.--The provisions of paragraph (1)
shall apply to enforcement of a provision (or
provisions) specified in subsection (a)(1) only as
provided under subsection (a)(2).
(3) Complaint process.--The Secretary shall, through
rulemaking, establish a process to receive consumer
complaints of violations of such provisions and resolve
such complaints within 60 days of receipt of such
complaints.
(4) Exception.--The Secretary shall waive the
penalties described under paragraph (1) with respect to
a facility or provider who does not knowingly violate,
and should not have reasonably known it violated,
section 2799 or 2799A with respect to a participant,
beneficiary, or enrollee, if such facility or
practitioner, within 30 days of the violation,
withdraws the bill that was in violation of such
provision and reimburses the health plan or enrollee,
as applicable, in an amount equal to the difference
between the amount billed and the amount allowed to be
billed under the provision, plus interest, at an
interest rate determined by the Secretary.
(5) Hardship exemption.--The Secretary may establish
a hardship exemption to the penalties under this
subsection.
(c) Continued Applicability of State Law.--The sections
specified in subsection (a)(1) shall not be construed to
supersede any provision of State law which establishes,
implements, or continues in effect any requirement or
prohibition except to the extent that such requirement or
prohibition prevents the application of a requirement or
prohibition of such a section.
* * * * * * *
----------
SOCIAL SECURITY ACT
* * * * * * *
TITLE V--MATERNAL AND CHILD HEALTH SERVICES BLOCK GRANT
* * * * * * *
SEC. 510. SEXUAL RISK AVOIDANCE EDUCATION.
(a) In General.--
(1) Allotments to states.--For the purpose described
in subsection (b), the Secretary shall, for each of
[fiscal years 2018 and 2019] fiscal years 2019 through
2023, allot to each State which has transmitted an
application for the fiscal year under section 505(a) an
amount equal to the product of--
(A) the amount appropriated pursuant to
subsection (f)(1) for the fiscal year, minus
the amount reserved under subsection (f)(2) for
the fiscal year; and
(B) the proportion that the number of low-
income children in the State bears to the total
of such numbers of children for all the States.
(2) Other allotments.--
(A) Other entities.--For the purpose
described in subsection (b), the Secretary
shall, for each of [fiscal years 2018 and 2019]
fiscal years 2019 through 2023, for any State
which has not transmitted an application for
the fiscal year under section 505(a), allot to
one or more entities in the State the amount
that would have been allotted to the State
under paragraph (1) if the State had submitted
such an application.
(B) Process.--The Secretary shall select the
recipients of allotments under subparagraph (A)
by means of a competitive grant process under
which--
(i) not later than 30 days after the
deadline for the State involved to
submit an application for the fiscal
year under section 505(a), the
Secretary publishes a notice soliciting
grant applications; and
(ii) not later than 120 days after
such deadline, all such applications
must be submitted.
(b) Purpose.--
(1) In general.--Except for research under paragraph
(5) and information collection and reporting under
paragraph (6), the purpose of an allotment under
subsection (a) to a State (or to another entity in the
State pursuant to subsection (a)(2)) is to enable the
State or other entity to implement education
exclusively on sexual risk avoidance (meaning
voluntarily refraining from sexual activity).
(2) Required components.--Education on sexual risk
avoidance pursuant to an allotment under this section
shall--
(A) ensure that the unambiguous and primary
emphasis and context for each topic described
in paragraph (3) is a message to youth that
normalizes the optimal health behavior of
avoiding nonmarital sexual activity;
(B) be medically accurate and complete;
(C) be age-appropriate;
(D) be based on adolescent learning and
developmental theories for the age group
receiving the education; and
(E) be culturally appropriate, recognizing
the experiences of youth from diverse
communities, backgrounds, and experiences.
(3) Topics.--Education on sexual risk avoidance
pursuant to an allotment under this section shall
address each of the following topics:
(A) The holistic individual and societal
benefits associated with personal
responsibility, self-regulation, goal setting,
healthy decisionmaking, and a focus on the
future.
(B) The advantage of refraining from
nonmarital sexual activity in order to improve
the future prospects and physical and emotional
health of youth.
(C) The increased likelihood of avoiding
poverty when youth attain self-sufficiency and
emotional maturity before engaging in sexual
activity.
(D) The foundational components of healthy
relationships and their impact on the formation
of healthy marriages and safe and stable
families.
(E) How other youth risk behaviors, such as
drug and alcohol usage, increase the risk for
teen sex.
(F) How to resist and avoid, and receive help
regarding, sexual coercion and dating violence,
recognizing that even with consent teen sex
remains a youth risk behavior.
(4) Contraception.--Education on sexual risk
avoidance pursuant to an allotment under this section
shall ensure that--
(A) any information provided on contraception
is medically accurate and complete and ensures
that students understand that contraception
offers physical risk reduction, but not risk
elimination; and
(B) the education does not include
demonstrations, simulations, or distribution of
contraceptive devices.
(5) Research.--
(A) In general.--A State or other entity
receiving an allotment pursuant to subsection
(a) may use up to 20 percent of such allotment
to build the evidence base for sexual risk
avoidance education by conducting or supporting
research.
(B) Requirements.--Any research conducted or
supported pursuant to subparagraph (A) shall
be--
(i) rigorous;
(ii) evidence-based; and
(iii) designed and conducted by
independent researchers who have
experience in conducting and publishing
research in peer-reviewed outlets.
(6) Information collection and reporting.--A State or
other entity receiving an allotment pursuant to
subsection (a) shall, as specified by the Secretary--
(A) collect information on the programs and
activities funded through the allotment; and
(B) submit reports to the Secretary on the
data from such programs and activities.
(c) National Evaluation.--
(1) In general.--The Secretary shall--
(A) in consultation with appropriate State
and local agencies, conduct one or more
rigorous evaluations of the education funded
through this section and associated data; and
(B) submit a report to the Congress on the
results of such evaluations, together with a
summary of the information collected pursuant
to subsection (b)(6).
(2) Consultation.--In conducting the evaluations
required by paragraph (1), including the establishment
of rigorous evaluation methodologies, the Secretary
shall consult with relevant stakeholders and evaluation
experts.
(d) Applicability of Certain Provisions.--
(1) Sections 503, 507, and 508 apply to allotments
under subsection (a) to the same extent and in the same
manner as such sections apply to allotments under
section 502(c), except that section 503(a) shall be
applied by substituting ``the total of the sums'' for
``four-sevenths of the total of the sums''.
(2) Sections 505 and 506 apply to allotments under
subsection (a) to the extent determined by the
Secretary to be appropriate.
(e) Definitions.--In this section:
(1) The term ``age-appropriate'' means suitable (in
terms of topics, messages, and teaching methods) to the
developmental and social maturity of the particular age
or age group of children or adolescents, based on
developing cognitive, emotional, and behavioral
capacity typical for the age or age group.
(2) The term ``medically accurate and complete''
means verified or supported by the weight of research
conducted in compliance with accepted scientific
methods and--
(A) published in peer-reviewed journals,
where applicable; or
(B) comprising information that leading
professional organizations and agencies with
relevant expertise in the field recognize as
accurate, objective, and complete.
(3) The term ``rigorous'', with respect to research
or evaluation, means using--
(A) established scientific methods for
measuring the impact of an intervention or
program model in changing behavior
(specifically sexual activity or other sexual
risk behaviors), or reducing pregnancy, among
youth; or
(B) other evidence-based methodologies
established by the Secretary for purposes of
this section.
(4) The term ``youth'' refers to one or more
individuals who have attained age 10 but not age 20.
(f) Funding.--
(1) In general.--To carry out this section, there is
appropriated, out of any money in the Treasury not
otherwise appropriated, $75,000,000 for each of [fiscal
years 2018 and 2019] fiscal years 2019 through 2023.
(2) Reservation.--The Secretary shall reserve, for
each of [fiscal years 2018 and 2019] fiscal years 2019
through 2023, not more than 20 percent of the amount
appropriated pursuant to paragraph (1) for
administering the program under this section, including
the conducting of national evaluations and the
provision of technical assistance to the recipients of
allotments.
* * * * * * *
SEC. 513. PERSONAL RESPONSIBILITY EDUCATION.
(a) Allotments to States.--
(1) Amount.--
(A) In general.--For the purpose described in
subsection (b), subject to the succeeding
provisions of this section, for each of fiscal
years 2010 through [2019] 2023, the Secretary
shall allot to each State an amount equal to
the product of--
(i) the amount appropriated under
subsection (f) for the fiscal year and
available for allotments to States
after the application of subsection
(c); and
(ii) the State youth population
percentage determined under paragraph
(2).
(B) Minimum allotment.--
(i) In general.--Each State allotment
under this paragraph for a fiscal year
shall be at least $250,000.
(ii) Pro rata adjustments.--The
Secretary shall adjust on a pro rata
basis the amount of the State
allotments determined under this
paragraph for a fiscal year to the
extent necessary to comply with clause
(i).
(C) Application required to access
allotments.--
(i) In general.--A State shall not be
paid from its allotment for a fiscal
year unless the State submits an
application to the Secretary for the
fiscal year and the Secretary approves
the application (or requires changes to
the application that the State
satisfies) and meets such additional
requirements as the Secretary may
specify.
(ii) Requirements.--The State
application shall contain an assurance
that the State has complied with the
requirements of this section in
preparing and submitting the
application and shall include the
following as well as such additional
information as the Secretary may
require:
(I) Based on data from the
Centers for Disease Control and
Prevention National Center for
Health Statistics, the most
recent pregnancy rates for the
State for youth ages 10 to 14
and youth ages 15 to 19 for
which data are available, the
most recent birth rates for
such youth populations in the
State for which data are
available, and trends in those
rates for the most recently
preceding 5-year period for
which such data are available.
(II) State-established goals
for reducing the pregnancy
rates and birth rates for such
youth populations.
(III) A description of the
State's plan for using the
State allotments provided under
this section to achieve such
goals, especially among youth
populations that are the most
high-risk or vulnerable for
pregnancies or otherwise have
special circumstances,
including youth in foster care,
homeless youth, youth with HIV/
AIDS, pregnant youth who are
under 21 years of age, mothers
who are under 21 years of age,
and youth residing in areas
with high birth rates for
youth.
(2) State youth population percentage.--
(A) In general.--For purposes of paragraph
(1)(A)(ii), the State youth population
percentage is, with respect to a State, the
proportion (expressed as a percentage) of--
(i) the number of individuals who
have attained age 10 but not attained
age 20 in the State; to
(ii) the number of such individuals
in all States.
(B) Determination of number of youth.--The
number of individuals described in clauses (i)
and (ii) of subparagraph (A) in a State shall
be determined on the basis of the most recent
Bureau of the Census data.
(3) Availability of state allotments.--Subject to
paragraph (4)(A), amounts allotted to a State pursuant
to this subsection for a fiscal year shall remain
available for expenditure by the State through the end
of the second succeeding fiscal year.
(4) Authority to award grants from state allotments
to local organizations and entities in nonparticipating
states.--
(A) Grants from unexpended allotments.--If a
State does not submit an application under this
section for fiscal year 2010 or 2011, the State
shall no longer be eligible to submit an
application to receive funds from the amounts
allotted for the State for each of fiscal years
2010 through [2019] 2023 and such amounts shall
be used by the Secretary to award grants under
this paragraph for each of fiscal years 2012
through [2019] 2023. The Secretary also shall
use any amounts from the allotments of States
that submit applications under this section for
a fiscal year that remain unexpended as of the
end of the period in which the allotments are
available for expenditure under paragraph (3)
for awarding grants under this paragraph.
(B) Competitive prep grants.--
(i) In general.--The Secretary shall
continue through fiscal year [2019]
2023 grants awarded for any of fiscal
years 2015 through 2017 to local
organizations and entities to conduct,
consistent with subsection (b),
programs and activities in States that
do not submit an application for an
allotment under this section for fiscal
year 2010 or 2011.
(ii) Faith-based organizations or
consortia.--The Secretary may solicit
and award grants under this paragraph
to faith-based organizations or
consortia.
(C) Evaluation.--An organization or entity
awarded a grant under this paragraph shall
agree to participate in a rigorous Federal
evaluation.
(5) Maintenance of effort.--No payment shall be made
to a State from the allotment determined for the State
under this subsection or to a local organization or
entity awarded a grant under paragraph (4), if the
expenditure of non-federal funds by the State,
organization, or entity for activities, programs, or
initiatives for which amounts from allotments and
grants under this subsection may be expended is less
than the amount expended by the State, organization, or
entity for such programs or initiatives for fiscal year
2009.
(6) Data collection and reporting.--A State or local
organization or entity receiving funds under this
section shall cooperate with such requirements relating
to the collection of data and information and reporting
on outcomes regarding the programs and activities
carried out with such funds, as the Secretary shall
specify.
(b) Purpose.--
(1) In general.--The purpose of an allotment under
subsection (a)(1) to a State is to enable the State
(or, in the case of grants made under subsection
(a)(4)(B), to enable a local organization or entity) to
carry out personal responsibility education programs
consistent with this subsection.
(2) Personal responsibility education programs.--
(A) In general.--In this section, the term
``personal responsibility education program''
means a program that is designed to educate
adolescents on--
(i) both abstinence and contraception
for the prevention of pregnancy and
sexually transmitted infections,
including HIV/AIDS, consistent with the
requirements of subparagraph (B); and
(ii) at least 3 of the adulthood
preparation subjects described in
subparagraph (C).
(B) Requirements.--The requirements of this
subparagraph are the following:
(i) The program replicates evidence-
based effective programs or
substantially incorporates elements of
effective programs that have been
proven on the basis of rigorous
scientific research to change behavior,
which means delaying sexual activity,
increasing condom or contraceptive use
for sexually active youth, or reducing
pregnancy among youth.
(ii) The program is medically-
accurate and complete.
(iii) The program includes activities
to educate youth who are sexually
active regarding responsible sexual
behavior with respect to both
abstinence and the use of
contraception.
(iv) The program places substantial
emphasis on both abstinence and
contraception for the prevention of
pregnancy among youth and sexually
transmitted infections.
(v) The program provides age-
appropriate information and activities.
(vi) The information and activities
carried out under the program are
provided in the cultural context that
is most appropriate for individuals in
the particular population group to
which they are directed.
(C) Adulthood preparation subjects.--The
adulthood preparation subjects described in
this subparagraph are the following:
(i) Healthy relationships, including
marriage and family interactions.
(ii) Adolescent development, such as
the development of healthy attitudes
and values about adolescent growth and
development, body image, racial and
ethnic diversity, and other related
subjects.
(iii) Financial literacy.
(iv) Parent-child communication.
(v) Educational and career success,
such as developing skills for
employment preparation, job seeking,
independent living, financial self-
sufficiency, and workplace
productivity.
(vi) Healthy life skills, such as
goal-setting, decision making,
negotiation, communication and
interpersonal skills, and stress
management.
(c) Reservations of Funds.--
(1) Grants to implement innovative strategies.--From
the amount appropriated under subsection (f) for the
fiscal year, the Secretary shall reserve $10,000,000 of
such amount for purposes of awarding grants to entities
to implement innovative youth pregnancy prevention
strategies and target services to high-risk,
vulnerable, and culturally under-represented youth
populations, including youth in foster care, homeless
youth, youth with HIV/AIDS, victims of human
trafficking, pregnant women who are under 21 years of
age and their partners, mothers who are under 21 years
of age and their partners, and youth residing in areas
with high birth rates for youth. An entity awarded a
grant under this paragraph shall agree to participate
in a rigorous Federal evaluation of the activities
carried out with grant funds.
(2) Other reservations.--From the amount appropriated
under subsection (f) for the fiscal year that remains
after the application of paragraph (1), the Secretary
shall reserve the following amounts:
(A) Grants for indian tribes or tribal
organizations.--The Secretary shall reserve 5
percent of such remainder for purposes of
awarding grants to Indian tribes and tribal
organizations in such manner, and subject to
such requirements, as the Secretary, in
consultation with Indian tribes and tribal
organizations, determines appropriate.
(B) Secretarial responsibilities.--
(i) Reservation of funds.--The
Secretary shall reserve 10 percent of
such remainder for expenditures by the
Secretary for the activities described
in clauses (ii) and (iii).
(ii) Program support.--The Secretary
shall provide, directly or through a
competitive grant process, research,
training and technical assistance,
including dissemination of research and
information regarding effective and
promising practices, providing
consultation and resources on a broad
array of teen pregnancy prevention
strategies, including abstinence and
contraception, and developing resources
and materials to support the activities
of recipients of grants and other
State, tribal, and community
organizations working to reduce teen
pregnancy. In carrying out such
functions, the Secretary shall
collaborate with a variety of entities
that have expertise in the prevention
of teen pregnancy, HIV and sexually
transmitted infections, healthy
relationships, financial literacy, and
other topics addressed through the
personal responsibility education
programs.
(iii) Evaluation.--The Secretary
shall evaluate the programs and
activities carried out with funds made
available through allotments or grants
under this section.
(d) Administration.--
(1) In general.--The Secretary shall administer this
section through the Assistant Secretary for the
Administration for Children and Families within the
Department of Health and Human Services.
(2) Application of other provisions of title.--
(A) In general.--Except as provided in
subparagraph (B), the other provisions of this
title shall not apply to allotments or grants
made under this section.
(B) Exceptions.--The following provisions of
this title shall apply to allotments and grants
made under this section to the same extent and
in the same manner as such provisions apply to
allotments made under section 502(c):
(i) Section 504(b)(6) (relating to
prohibition on payments to excluded
individuals and entities).
(ii) Section 504(c) (relating to the
use of funds for the purchase of
technical assistance).
(iii) Section 504(d) (relating to a
limitation on administrative
expenditures).
(iv) Section 506 (relating to reports
and audits), but only to the extent
determined by the Secretary to be
appropriate for grants made under this
section.
(v) Section 507 (relating to
penalties for false statements).
(vi) Section 508 (relating to
nondiscrimination).
(e) Definitions.--In this section:
(1) Age-appropriate.--The term ``age-appropriate'',
with respect to the information in pregnancy
prevention, means topics, messages, and teaching
methods suitable to particular ages or age groups of
children and adolescents, based on developing
cognitive, emotional, and behavioral capacity typical
for the age or age group.
(2) Medically accurate and complete.--The term
``medically accurate and complete'' means verified or
supported by the weight of research conducted in
compliance with accepted scientific methods and--
(A) published in peer-reviewed journals,
where applicable; or
(B) comprising information that leading
professional organizations and agencies with
relevant expertise in the field recognize as
accurate, objective, and complete.
(3) Indian tribes; tribal organizations.--The terms
``Indian tribe'' and ``Tribal organization'' have the
meanings given such terms in section 4 of the Indian
Health Care Improvement Act (25 U.S.C. 1603)).
(4) Youth.--The term ``youth'' means an individual
who has attained age 10 but has not attained age 20.
(f) Appropriation.--For the purpose of carrying out this
section, there is appropriated, out of any money in the
Treasury not otherwise appropriated, $75,000,000 for each of
fiscal years 2010 through [2019] 2023. Amounts appropriated
under this subsection shall remain available until expended.
* * * * * * *
TITLE XI--GENERAL PROVISIONS, PEER REVIEW, AND ADMINISTRATIVE
SIMPLIFICATION
* * * * * * *
Part A--General Provisions
* * * * * * *
SEC. 1108. ADDITIONAL GRANTS TO PUERTO RICO, THE VIRGIN ISLANDS, GUAM,
AND AMERICAN SAMOA; LIMITATION ON TOTAL PAYMENTS.
(a) Limitation on Total Payments to Each Territory.--
(1) In general.--Notwithstanding any other provision
of this Act (except for paragraph (2) of this
subsection), the total amount certified by the
Secretary of Health and Human Services under titles I,
X, XIV, and XVI, under parts A and E of title IV, and
under subsection (b) of this section, for payment to
any territory for a fiscal year shall not exceed the
ceiling amount for the territory for the fiscal year.
(2) Certain payments disregarded.--Paragraph (1) of
this subsection shall be applied without regard to any
payment made under section 403(a)(2), 403(a)(4),
403(a)(5), 406, or 413(f).
(b) Entitlement to Matching Grant.--
(1) In general.--Each territory shall be entitled to
receive from the Secretary for each fiscal year a grant
in an amount equal to 75 percent of the amount (if any)
by which--
(A) the total expenditures of the territory
during the fiscal year under the territory
programs funded under parts A and E of title
IV, including any amount paid to the State
under part A of title IV that is transferred in
accordance with section 404(d) and expended
under the program to which transferred; exceeds
(B) the sum of--
(i) the amount of the family
assistance grant payable to the
territory without regard to section
409; and
(ii) the total amount expended by the
territory during fiscal year 1995
pursuant to parts A and F of title IV
(as so in effect), other than for child
care.
(2) Appropriation.--Out of any money in the Treasury
of the United States not otherwise appropriated, there
are appropriated for each of fiscal years 2017 and
2018, such sums as are necessary for grants under this
paragraph.
(c) Definitions.--As used in this section:
(1) Territory.--The term ``territory'' means Puerto
Rico, the Virgin Islands, Guam, and American Samoa.
(2) Ceiling amount.--The term ``ceiling amount''
means, with respect to a territory and a fiscal year,
the mandatory ceiling amount with respect to the
territory, reduced for the fiscal year in accordance
with subsection (e), and reduced by the amount of any
penalty imposed on the territory under any provision of
law specified in subsection (a) during the fiscal year.
(3) Family assistance grant.--The term ``family
assistance grant'' has the meaning given such term by
section 403(a)(1)(B).
(4) Mandatory ceiling amount.--The term ``mandatory
ceiling amount'' means--
(A) $107,255,000 with respect to Puerto Rico;
(B) $4,686,000 with respect to Guam;
(C) $3,554,000 with respect to the Virgin
Islands; and
(D) $1,000,000 with respect to American
Samoa.
(5) Total amount expended by the territory.--The term
``total amount expended by the territory''--
(A) does not include expenditures during the
fiscal year from amounts made available by the
Federal Government; and
(B) when used with respect to fiscal year
1995, also does not include--
(i) expenditures during fiscal year
1995 under subsection (g) or (i) of
section 402 (as in effect on September
30, 1995); or
(ii) any expenditures during fiscal
year 1995 for which the territory (but
for section 1108, as in effect on
September 30, 1995) would have received
reimbursement from the Federal
Government.
(d) Authority To Transfer Funds to Certain Programs.--A
territory to which an amount is paid under subsection (b) of
this section may use the amount in accordance with section
404(d).
(f) Subject to subsection (g) and section 1935(e)(1)(B), the
total amount certified by the Secretary under title XIX with
respect to a fiscal year for payment to--
(1) Puerto Rico shall not exceed (A) $116,500,000 for
fiscal year 1994 and (B) for each succeeding fiscal
year the amount provided in this paragraph for the
preceding fiscal year increased by the percentage
increase in the medical care component of the consumer
price index for all urban consumers (as published by
the Bureau of Labor Statistics) for the twelve-month
period ending in March preceding the beginning of the
fiscal year, rounded to the nearest $100,000;
(2) the Virgin Islands shall not exceed (A)
$3,837,500 for fiscal year 1994, and (B) for each
succeeding fiscal year the amount provided in this
paragraph for the preceding fiscal year increased by
the percentage increase referred to in paragraph
(1)(B), rounded to the nearest $10,000;
(3) Guam shall not exceed (A) $3,685,000 for fiscal
year 1994, and (B) for each succeeding fiscal year the
amount provided in this paragraph for the preceding
fiscal year increased by the percentage increase
referred to in paragraph (1)(B), rounded to the nearest
$10,000;
(4) Northern Mariana Islands shall not exceed (A)
$1,110,000 for fiscal year 1994, and (B) for each
succeeding fiscal year the amount provided in this
paragraph for the preceding fiscal year increased by
the percentage increase referred to in paragraph
(1)(B), rounded to the nearest $10,000; and
(5) American Samoa shall not exceed (A) $2,140,000
for fiscal year 1994, and (B) for each succeeding
fiscal year the amount provided in this paragraph for
the preceding fiscal year increased by the percentage
increase referred to in paragraph (1)(B), rounded to
the nearest $10,000.
(g) Medicaid Payments to Territories for Fiscal Year 1998 and
Thereafter.--
(1) Fiscal year 1998.--With respect to fiscal year
1998, the amounts otherwise determined for Puerto Rico,
the Virgin Islands, Guam, the Northern Mariana Islands,
and American Samoa under subsection (f) for such fiscal
year shall be increased by the following amounts:
(A) For Puerto Rico, $30,000,000.
(B) For the Virgin Islands, $750,000.
(C) For Guam, $750,000.
(D) For the Northern Mariana Islands,
$500,000.
(E) For American Samoa, $500,000.
(2) Fiscal year 1999 and thereafter.--Notwithstanding
subsection (f) and [subject to and section 1323(a)(2)
of the Patient Protection and Affordable Care Act
paragraphs (3) and (5)] subject to section 1323(a)(2)
of the Patient Protection and Affordable Care Act and
paragraphs (3) and (5), with respect to fiscal year
1999 and any fiscal year thereafter, the total amount
certified by the Secretary under title XIX for payment
to--
(A) [Puerto Rico shall not exceed the sum of]
Puerto Rico shall not exceed--
(i) except as provided in clause
(ii), the sum of the amount provided
in this subsection for the preceding
fiscal year increased by the percentage
increase in the medical care component
of the Consumer Price Index for all
urban consumers (as published by the
Bureau of Labor Statistics) for the 12-
month period ending in March preceding
the beginning of the fiscal year,
rounded to the nearest [$100,000;]
$100,000; and
(ii) for each of fiscal years 2020
through 2023, the amount specified in
paragraph (6) for each such fiscal
year;
(B) [the Virgin Islands shall not exceed the
sum of] the Virgin Islands shall not exceed--
(i) except as provided in clause
(ii), the sum of the amount provided
in this subsection for the preceding
fiscal year increased by the percentage
increase referred to in subparagraph
(A), rounded to the nearest [$10,000;]
$10,000; and
(ii) for each of fiscal years 2020
through 2025, $126,000,000;
(C) [Guam shall not exceed the sum of] Guam
shall not exceed--
(i) except as provided in clause
(ii), the sum of the amount provided
in this subsection for the preceding
fiscal year increased by the percentage
increase referred to in subparagraph
(A), rounded to the nearest [$10,000;]
$10,000; and
(ii) for each of fiscal years 2020
through 2025, $127,000,000;
(D) [the Northern Mariana Islands shall not
exceed the sum of] the Northern Mariana Islands
shall not exceed--
(i) except as provided in clause
(ii), the sum of the amount provided
in this subsection for the preceding
fiscal year increased by the percentage
increase referred to in subparagraph
(A), rounded to the nearest $10,000;
and
(ii) for each of fiscal years 2020
through 2025, $60,000,000; and
(E) [American Samoa shall not exceed the sum
of] American Samoa shall not exceed--
(i) except as provided in clause
(ii), the sum of the amount provided
in this subsection for the preceding
fiscal year increased by the percentage
increase referred to in subparagraph
(A), rounded to the nearest [$10,000.]
$10,000; and
(ii) for each of fiscal years 2020
through 2025, $84,000,000.
(3) Fiscal years 2006 and 2007 for certain insular
areas.--The amounts otherwise determined under this
subsection for Puerto Rico, the Virgin Islands, Guam,
the Northern Mariana Islands, and American Samoa for
fiscal year 2006 and fiscal year 2007 shall be
increased by the following amounts:
(A) For Puerto Rico, $12,000,000 for fiscal
year 2006 and $12,000,000 for fiscal year 2007.
(B) For the Virgin Islands, $2,500,000 for
fiscal year 2006 and $5,000,000 for fiscal year
2007.
(C) For Guam, $2,500,000 for fiscal year 2006
and $5,000,000 for fiscal year 2007.
(D) For the Northern Mariana Islands,
$1,000,000 for fiscal year 2006 and $2,000,000
for fiscal year 2007.
(E) For American Samoa, $2,000,000 for fiscal
year 2006 and $4,000,000 for fiscal year 2007.
Such amounts shall not be taken into account in
applying paragraph (2) for fiscal year 2007 but shall
be taken into account in applying such paragraph for
fiscal year 2008 and subsequent fiscal years.
(4) Exclusion of certain expenditures from payment
limits.--With respect to fiscal years beginning with
fiscal year 2009, if Puerto Rico, the Virgin Islands,
Guam, the Northern Mariana Islands, or American Samoa
qualify for a payment under subparagraph (A)(i), (B),
or (F) of section 1903(a)(3) for a calendar quarter of
such fiscal year, and with respect to fiscal years
beginning with fiscal year 2017, if Puerto Rico
qualifies for a payment under section 1903(a)(6) for a
calendar quarter (beginning on or after July 1, 2017)
of such fiscal year, and with respect to fiscal years
beginning with fiscal year 2018, if the Virgin Islands
qualifies for a payment under section 1903(a)(6) for a
calendar quarter (beginning on or after January 1,
2018) of such fiscal year, the payment shall not be
taken into account in applying subsection (f) (as
increased in accordance with paragraphs (1), (2), (3),
and (4) of this subsection) to such commonwealth or
territory for such fiscal year.
(5) Additional increase.--(A) Subject to
subparagraphs (B), (C), (D), (E), and (F), the
Secretary shall increase the amounts otherwise
determined under this subsection for Puerto Rico, the
Virgin Islands, Guam, the Northern Mariana Islands, and
American Samoa (after the application of subsection (f)
and the preceding paragraphs of this subsection) for
the period beginning July 1, 2011, and ending on
September 30, 2019, by such amounts that the total
additional payments under title XIX to such territories
equals $6,300,000,000 for such period. The Secretary
shall increase such amounts in proportion to the
amounts applicable to such territories under this
subsection and subsection (f) on the date of enactment
of this paragraph.
(B) The amount of the increase otherwise provided
under subparagraph (A) for Puerto Rico shall be further
increased by $295,900,000.
(C) Subject to subparagraphs (D) and (F), for the
period beginning January 1, 2018, and ending September
30, 2019--
(i) the amount of the increase otherwise
provided under subparagraphs (A) and (B) for
Puerto Rico shall be further increased by
$3,600,000,000; and
(ii) the amount of the increase otherwise
provided under subparagraph (A) for the Virgin
Islands shall be further increased by
$106,931,000.
(D) For the period described in subparagraph (C), the
amount of the increase otherwise provided under
subparagraph (A)--
(i) for Puerto Rico shall be further
increased by $1,200,000,000 if the Secretary
certifies that Puerto Rico has taken reasonable
and appropriate steps during such period, in
accordance with a timeline established by the
Secretary, to--
(I) implement methods, satisfactory
to the Secretary, for the collection
and reporting of reliable data to the
Transformed Medicaid Statistical
Information System (T-MSIS) (or a
successor system); and
(II) demonstrate progress in
establishing a State medicaid fraud
control unit described in section
1903(q); and
(ii) for the Virgin Islands shall be further
increased by $35,644,000 if the Secretary
certifies that the Virgin Islands has taken
reasonable and appropriate steps during such
period, in accordance with a timeline
established by the Secretary, to meet the
conditions for certification specified in
subclauses (I) and (II) of clause (i).
(E) Subject to subparagraph (F), for the
period beginning January 1, 2019, and ending
September 30, 2019, the amount of the increase
otherwise provided under subparagraph (A) for
the Northern Mariana Islands shall be further
increased by $36,000,000.
(F) Notwithstanding any other provision of title
XIX--
(i) during the period in which the additional
funds provided under subparagraphs (C), (D),
and (E) are available for Puerto Rico, the
Virgin Islands, and the Northern Mariana
Islands, respectively, with respect to payments
from such additional funds for amounts expended
by Puerto Rico, the Virgin Islands, and the
Northern Mariana Islands under such title, the
Secretary shall increase the Federal medical
assistance percentage or other rate that would
otherwise apply to such payments to 100
percent; and
(ii) for the period beginning January 1,
2019, and ending September 30, 2019, with
respect to payments to Guam and American Samoa
from the additional funds provided under
subparagraph (A), the Secretary shall increase
the Federal medical assistance percentage or
other rate that would otherwise apply to such
payments to 100 percent.
(G) Not later than September 30, 2019, Guam
and American Samoa shall each submit a plan to
the Secretary outlining the steps each such
territory shall take to collect and report
reliable data to the Transformed Medicaid
Statistical Information System (T-MSIS) (or a
successor system).
(6) Application to puerto rico for fiscal years 2020
through 2023.--For purposes of paragraph (2)(A)(ii),
the amount specified in this paragraph is--
(A) for fiscal year 2020, $2,823,188,000;
(B) for fiscal year 2021, $2,919,072,000;
(C) for fiscal year 2022, $3,012,610,000; and
(D) for fiscal year 2023, $3,114,331,000.
(7) Annual report.--
(A) In general.--Not later than the date that
is 180 days after the end of each fiscal year
(beginning with fiscal year 2020 and ending
with fiscal year 2025), in the case that a
specified territory receives a Medicaid cap
increase, or an increase in the Federal medical
assistance percentage for such territory under
section 1905(ff), for such fiscal year, such
territory shall submit to the Chair and Ranking
Member of the Committee on Energy and Commerce
of the House of Representatives and the Chair
and Ranking Member of the Committee on Finance
of the Senate a report that describes how such
territory has used such Medicaid cap increase,
or such increase in the Federal medical
assistance percentage, as applicable, to
increase access to health care under the State
Medicaid plan of such territory under title XIX
(or a waiver of such plan). Such report may
include--
(i) the extent to which such
territory has, with respect to such
plan (or waiver)--
(I) increased payments to
health care providers;
(II) increased covered
benefits;
(III) expanded health care
provider networks; or
(IV) improved in any other
manner the carrying out of such
plan (or waiver); and
(ii) any other information as
determined necessary by such territory.
(B) Definitions.--In this paragraph:
(i) Medicaid cap increase.--The term
``Medicaid cap increase'' means, with
respect to a specified territory and
fiscal year, any increase in the
amounts otherwise determined under this
subsection for such territory for such
fiscal year by reason of the amendments
made by section 502(a) of the
Territories Health Care Improvement
Act.
(ii) Specified territory.--The term
``specified territory'' means Puerto
Rico, the Virgin Islands, Guam, the
Northern Mariana Islands, and American
Samoa.
* * * * * * *
Part D--Comparative Clinical Effectiveness Research
* * * * * * *
trust fund transfers to patient-centered outcomes research trust fund
Sec. 1183. (a) In General.--The Secretary shall provide for
the transfer, from the Federal Hospital Insurance Trust Fund
under section 1817 and the Federal Supplementary Medical
Insurance Trust Fund under section 1841, in proportion (as
estimated by the Secretary) to the total expenditures during
such fiscal year that are made under title XVIII from the
respective trust fund, to the Patient-Centered Outcomes
Research Trust Fund (referred to in this section as the
``PCORTF'') under section 9511 of the Internal Revenue Code of
1986, of the following:
(1) For fiscal year 2013, an amount equal to $1
multiplied by the average number of individuals
entitled to benefits under part A, or enrolled under
part B, of title XVIII during such fiscal year.
(2) For each of fiscal years [2014, 2015, 2016, 2017,
2018, and 2019] 2014 through 2022, an amount equal to
$2 multiplied by the average number of individuals
entitled to benefits under part A, or enrolled under
part B, of title XVIII during such fiscal year.
(b) Adjustments for Increases in Health Care Spending.--In
the case of any fiscal year beginning after September 30, 2014,
the dollar amount in effect under subsection (a)(2) for such
fiscal year shall be equal to the sum of such dollar amount for
the previous fiscal year (determined after the application of
this subsection), plus an amount equal to the product of--
(1) such dollar amount for the previous fiscal year,
multiplied by
(2) the percentage increase in the projected per
capita amount of National Health Expenditures, as most
recently published by the Secretary before the
beginning of the fiscal year.
* * * * * * *
TITLE XVIII--HEALTH INSURANCE FOR THE AGED AND DISABLED
* * * * * * *
Part B--Supplementary Medical Insurance Benefits for the Aged and
Disabled
* * * * * * *
PAYMENT OF BENEFITS
Sec. 1833. (a) Except as provided in section 1876, and
subject to the succeeding provisions of this section, there
shall be paid from the Federal Supplementary Medical Insurance
Trust Fund, in the case of each individual who is covered under
the insurance program established by this part and incurs
expenses for services with respect to which benefits are
payable under this part, amounts equal to--(1) in the case of
services described in section 1832(a)(1)--80 percent of the
reasonable charges for the services; except that (A) an
organization which provides medical and other health services
(or arranges for their availability) on a prepayment basis (and
either is sponsored by a union or employer, or does not
provide, or arrange for the provision of, any inpatient
hospital services) may elect to be paid 80 percent of the
reasonable cost of services for which payment may be made under
this part on behalf of individuals enrolled in such
organization in lieu of 80 percent of the reasonable charges
for such services if the organization undertakes to charge such
individuals no more than 20 percent of such reasonable cost
plus any amounts payable by them as a result of subsection (b),
(B) with respect to items and services described in section
1861(s)(10)(A), the amounts paid shall be 100 percent of the
reasonable charges for such items and services, (C) with
respect to expenses incurred for those physicians' services for
which payment may be made under this part that are described in
section 1862(a)(4), the amounts paid shall be subject to such
limitations as may be prescribed by regulations, (D) with
respect to clinical diagnostic laboratory tests for which
payment is made under this part (i)(I) on the basis of a fee
schedule under subsection (h)(1) (for tests furnished before
January 1, 2017) or section 1834(d)(1), the amount paid shall
be equal to 80 percent (or 100 percent, in the case of such
tests for which payment is made on an assignment-related basis)
of the lesser of the amount determined under such fee schedule,
the limitation amount for that test determined under subsection
(h)(4)(B), or the amount of the charges billed for the tests,
or (II) undersection 1834A (for tests furnished on or after
January1, 2017), the amount paid shall be equal to 80
percent(or 100 percent, in the case of such tests for
whichpayment is made on an assignment-related basis) ofthe
lesser of the amount determined under such sectionor the amount
of the charges billed for the tests, or (ii) for tests
furnished before January 1, 2017,on the basis of a negotiated
rate established under subsection (h)(6), the amount paid shall
be equal to 100 percent of such negotiated rate,,(E) with
respect to services furnished to individuals who have been
determined to have end stage renal disease, the amounts paid
shall be determined subject to the provisions of section
1881,(F) with respect to clinical social worker services under
section 1861(s)(2)(N), the amounts paid shall be 80 percent of
the lesser of (i) the actual charge for the services or (ii) 75
percent of the amount determined for payment of a psychologist
under clause (L),
(G) with respect to facility services
furnished in connection with a surgical
procedure specified pursuant to subsection
(i)(1)(A) and furnished to an individual in an
ambulatory surgical center described in such
subsection, for services furnished beginning
with the implementation date of a revised
payment system for such services in such
facilities specified in subsection (i)(2)(D),
the amounts paid shall be 80 percent of the
lesser of the actual charge for the services or
the amount determined by the Secretary under
such revised payment system,
(H) with respect to services of a certified
registered nurse anesthetist under section 1861(s)(11),
the amounts paid shall be 80 percent of the least of
the actual charge, the prevailing charge that would be
recognized (or, for services furnished on or after
January 1, 1992, the fee schedule amount provided under
section 1848) if the services had been performed by an
anesthesiologist, or the fee schedule for such services
established by the Secretary in accordance with
subsection (l), (I) with respect to covered items
(described in section 1834(a)(13)), the amounts paid
shall be the amounts described in section 1834(a)(1),
and(J) with respect to expenses incurred for
radiologist services (as defined in section
1834(b)(6)), subject to section 1848, the amounts paid
shall be 80 percent of the lesser of the actual charge
for the services or the amount provided under the fee
schedule established under section 1834(b), (K) with
respect to certified nurse-midwife services under
section 1861(s)(2)(L), the amounts paid shall be 80
percent of the lesser of the actual charge for the
services or the amount determined by a fee schedule
established by the Secretary for the purposes of this
subparagraph (but in no event shall such fee schedule
exceed 65 percent of the prevailing charge that would
be allowed for the same service performed by a
physician, or, for services furnished on or after
January 1, 1992, 65 percent (or 100 percent for
services furnished on or after January 1, 2011) of the
fee schedule amount provided under section 1848 for the
same service performed by a physician), (L) with
respect to qualified psychologist services under
section 1861(s)(2)(M), the amounts paid shall be 80
percent of the lesser of the actual charge for the
services or the amount determined by a fee schedule
established by the Secretary for the purposes of this
subparagraph, (M) with respect to prosthetic devices
and orthotics and prosthetics (as defined in section
1834(h)(4)), the amounts paid shall be the amounts
described in section 1834(h)(1), (N) with respect to
expenses incurred for physicians' services (as defined
in section 1848(j)(3)) other than personalized
prevention plan services (as defined in section
1861(hhh)(1)), the amounts paid shall be 80 percent of
the payment basis determined under section 1848(a)(1),
(O) with respect to services described in section
1861(s)(2)(K) (relating to services furnished by
physician assistants, nurse practitioners, or clinic
nurse specialists), the amounts paid shall be equal to
80 percent of (i) the lesser of the actual charge or 85
percent of the fee schedule amount provided under
section 1848, or (ii) in the case of services as an
assistant at surgery, the lesser of the actual charge
or 85 percent of the amount that would otherwise be
recognized if performed by a physician who is serving
as an assistant at surgery, (P) with respect to
surgical dressings, the amounts paid shall be the
amounts determined under section 1834(i), (Q) with
respect to items or services for which fee schedules
are established pursuant to section 1842(s), the
amounts paid shall be 80 percent of the lesser of the
actual charge or the fee schedule established in such
section, (R) with respect to ambulance services, (i)
the amounts paid shall be 80 percent of the lesser of
the actual charge for the services or the amount
determined by a fee schedule established by the
Secretary under section 1834(l) and (ii) with respect
to ambulance services described in section 1834(l)(8),
the amounts paid shall be the amounts determined under
section 1834(g) for outpatient critical access hospital
services, (S) with respect to drugs and biologicals
(including intravenous immune globulin (as defined in
section 1861(zz))) not paid on a cost or prospective
payment basis as otherwise provided in this part (other
than items and services described in subparagraph (B)),
the amounts paid shall be 80 percent of the lesser of
the actual charge or the payment amount established in
section 1842(o) (or, if applicable, under section 1847,
1847A, or 1847B), (T) with respect to medical nutrition
therapy services (as defined in section 1861(vv)), the
amount paid shall be 80 percent (or 100 percent if such
services are recommended with a grade of A or B by the
United States Preventive Services Task Force for any
indication or population and are appropriate for the
individual) of the lesser of the actual charge for the
services or 85 percent of the amount determined under
the fee schedule established under section 1848(b) for
the same services if furnished by a physician, (U) with
respect to facility fees described in section
1834(m)(2)(B), the amounts paid shall be 80 percent of
the lesser of the actual charge or the amounts
specified in such section, (V) notwithstanding
subparagraphs (I) (relating to durable medical
equipment), (M) (relating to prosthetic devices and
orthotics and prosthetics), and (Q) (relating to
1842(s) items), with respect to competitively priced
items and services (described in section 1847(a)(2))
that are furnished in a competitive area, the amounts
paid shall be the amounts described in section
1847(b)(5), (W) with respect to additional preventive
services (as defined in section 1861(ddd)(1)), the
amount paid shall be (i) in the case of such services
which are clinical diagnostic laboratory tests, the
amount determined under subparagraph (D) (if such
subparagraph were applied, by substituting ``100
percent'' for ``80 percent''), and (ii) in the case of
all other such services, 100 percent of the lesser of
the actual charge for the service or the amount
determined under a fee schedule established by the
Secretary for purposes of this subparagraph, (X) with
respect to personalized prevention plan services (as
defined in section 1861(hhh)(1)), the amount paid shall
be 100 percent of the lesser of the actual charge for
the services or the amount determined under the payment
basis determined under section 1848, (Y) with respect
to preventive services described in subparagraphs (A)
and (B) of section 1861(ddd)(3) that are appropriate
for the individual and, in the case of such services
described in subparagraph (A), are recommended with a
grade of A or B by the United States Preventive
Services Task Force for any indication or population,
the amount paid shall be 100 percent of (i) except as
provided in clause (ii), the lesser of the actual
charge for the services or the amount determined under
the fee schedule that applies to such services under
this part, and (ii) in the case of such services that
are covered OPD services (as defined in subsection
(t)(1)(B)), the amount determined under subsection (t),
(Z) with respect to Federally qualified health center
services for which payment is made under section
1834(o), the amounts paid shall be 80 percent of the
lesser of the actual charge or the amount determined
under such section, (AA) with respect to an applicable
disposable device (as defined in paragraph (2) of
section 1834(s)) furnished to an individual pursuant to
paragraph (1) of such section, the amount paid shall be
equal to 80 percent of the lesser of the actual charge
or the amount determined under paragraph (3) of such
section, (BB) with respect to home infusion therapy,
the amount paid shall be an amount equal to 80 percent
of the lesser of the actual charge for the services or
the amount determined under section 1834(u), [and (CC)]
(CC) with respect to opioid use disorder treatment
services furnished during an episode of care, the
amount paid shall be equal to the amount payable under
section 1834(w) less any copayment required as
specified by the Secretary, and (DD) with respect to a
prostate cancer DNA Specimen Provenance Assay test
(DSPA test) (as defined in section 1861(kkk)), the
amount paid shall be an amount equal to 80 percent of
the lesser of the actual charge for the test or the
amount specified under section 1834(x);
(2) in the case of services described in section
1832(a)(2) (except those services described in
subparagraphs (C), (D), (E), (F), (G), (H), and (I) of
such section and unless otherwise specified in section
1881)--
(A) with respect to home health services
(other than a covered osteoporosis drug) (as
defined in section 1861(kk)), the amount
determined under the prospective payment system
under section 1895;
(B) with respect to other items and services
(except those described in subparagraph (C),
(D), or (E) of this paragraph and except as may
be provided in section 1886 or section
1888(e)(9))--
(i) furnished before January 1, 1999,
the lesser of--
(I) the reasonable cost of
such services, as determined
under section 1861(v), or
(II) the customary charges
with respect to such
services,--less the amount a
provider may charge as
described in clause (ii) of
section 1866(a)(2)(A), but in
no case may the payment for
such other services exceed 80
percent of such reasonable
cost, or
(ii) if such services are furnished
before January 1, 1999, by a public
provider of services, or by another
provider which demonstrates to the
satisfaction of the Secretary that a
significant portion of its patients are
low-income (and requests that payment
be made under this clause), free of
charge or at nominal charges to the
public, 80 percent of the amount
determined in accordance with section
1814(b)(2), or
(iii) if such services are furnished
on or after January 1, 1999, the amount
determined under subsection (t), or
(iv) if (and for so long as) the
conditions described in section
1814(b)(3) are met, the amounts
determined under the reimbursement
system described in such section;
(C) with respect to services described in the
second sentence of section 1861(p), 80 percent
of the reasonable charges for such services;
(D) with respect to clinical diagnostic
laboratory tests for which payment is made
under this part (i)(I)on the basis of a fee
schedule determined under subsection(h)(1) (for
tests furnished before January 1, 2017) or
section 1834(d)(1), the amount paid shall be
equal to 80 percent (or 100 percent, in the
case of such tests for which payment is made on
an assignment-related basis or to a provider
having an agreement under section 1866) of the
lesser of the amount determined under such fee
schedule, the limitation amount for that test
determined under subsection (h)(4)(B), or the
amount of the charges billed for the tests, or
(II) under section 1834A (for tests furnished
on or after January 1, 2017), the amount paid
shall be equal to 80 percent (or 100 percent,
in the case of such tests for which payment is
made on an assignment-related basis or to a
provider having an agreement under section
1866) of the lesser of the amount determined
under such section or the amount of the charges
billed for the tests, or (ii) for tests
furnished before January 1, 2017, on the basis
of a negotiated rate established under
subsection (h)(6), the amount paid shall be
equal to 100 percent of such negotiated rate
for such tests;
(E) with respect to--
(i) outpatient hospital radiology
services (including diagnostic and
therapeutic radiology, nuclear medicine
and CAT scan procedures, magnetic
resonance imaging, and ultrasound and
other imaging services, but excluding
screening mammography and, for services
furnished on or after January 1, 2005,
diagnostic mammography), and
(ii) effective for procedures
performed on or after October 1, 1989,
diagnostic procedures (as defined by
the Secretary) described in section
1861(s)(3) (other than diagnostic x-ray
tests and diagnostic laboratory tests),
the amount determined under subsection (n) or,
for services or procedures performed on or
after January 1, 1999, subsection (t);
(F) with respect to a covered osteoporosis
drug (as defined in section 1861(kk)) furnished
by a home health agency, 80 percent of the
reasonable cost of such service, as determined
under section 1861(v);
(G) with respect to items and services
described in section 1861(s)(10)(A), the lesser
of--
(i) the reasonable cost of such
services, as determined under section
1861(v), or
(ii) the customary charges with
respect to such services; and
(H) with respect to personalized prevention
plan services (as defined in section
1861(hhh)(1)) furnished by an outpatient
department of a hospital, the amount determined
under paragraph (1)(X),
or, if such services are furnished by a public
provider of services, or by another provider
which demonstrates to the satisfaction of the
Secretary that a significant portion of its
patients are low-income (and requests that
payment be made under this provision), free of
charge or at nominal charges to the public, the
amount determined in accordance with section
1814(b)(2);
(3) in the case of services described in section
1832(a)(2)(D)--
(A) except as provided in subparagraph (B),
the costs which are reasonable and related to
the cost of furnishing such services or which
are based on such other tests of reasonableness
as the Secretary may prescribe in regulations,
including those authorized under section
1861(v)(1)(A), less the amount a provider may
charge as described in clause (ii) of section
1866(a)(2)(A), but in no case may the payment
for such services (other than for items and
services described in section 1861(s)(10)(A))
exceed 80 percent of such costs; or
(B) with respect to the services described in
clause (ii) of section 1832(a)(2)(D) that are
furnished to an individual enrolled with a MA
plan under part C pursuant to a written
agreement described in section 1853(a)(4), the
amount (if any) by which--
(i) the amount of payment that would
have otherwise been provided (I) under
subparagraph (A) (calculated as if
``100 percent'' were substituted for
``80 percent'' in such subparagraph)
for such services if the individual had
not been so enrolled, or (II) in the
case of such services furnished on or
after the implementation date of the
prospective payment system under
section 1834(o), under such section
(calculated as if ``100 percent'' were
substituted for ``80 percent'' in such
section) for such services if the
individual had not been so enrolled;
exceeds
(ii) the amount of the payments
received under such written agreement
for such services (not including any
financial incentives provided for in
such agreement such as risk pool
payments, bonuses, or withholds),
less the amount the federally qualified health
center may charge as described in section
1857(e)(3)(B);
(4) in the case of facility services described in
section 1832(a)(2)(F), and outpatient hospital facility
services furnished in connection with surgical
procedures specified by the Secretary pursuant to
section 1833(i)(1)(A), the applicable amount as
determined under paragraph (2) or (3) of subsection (i)
or subsection (t);
(5) in the case of covered items (described in
section 1834(a)(13)) the amounts described in section
1834(a)(1);
(6) in the case of outpatient critical access
hospital services, the amounts described in section
1834(g);
(7) in the case of prosthetic devices and orthotics
and prosthetics (as described in section 1834(h)(4)),
the amounts described in section 1834(h);
(8) in the case of--
(A) outpatient physical therapy services,
outpatient speech-language pathology services,
and outpatient occupational therapy services
furnished--
(i) by a rehabilitation agency,
public health agency, clinic,
comprehensive outpatient rehabilitation
facility, or skilled nursing facility,
(ii) by a home health agency to an
individual who is not homebound, or
(iii) by another entity under an
arrangement with an entity described in
clause (i) or (ii); and
(B) outpatient physical therapy services,
outpatient speech-language pathology services,
and outpatient occupational therapy services
furnished--
(i) by a hospital to an outpatient or
to a hospital inpatient who is entitled
to benefits under part A but has
exhausted benefits for inpatient
hospital services during a spell of
illness or is not so entitled to
benefits under part A, or
(ii) by another entity under an
arrangement with a hospital described
in clause (i),
the amounts described in section 1834(k); and
(9) in the case of services described in section
1832(a)(2)(E) that are not described in paragraph (8),
the amounts described in section 1834(k).
Paragraph (3)(A) shall not apply to Federally
qualified health center services furnished on or after
the implementation date of the prospective payment
system under section 1834(0).
(b) Before applying subsection (a) with respect to expenses
incurred by an individual during any calendar year, the total
amount of the expenses incurred by such individual during such
year (which would, except for this subsection, constitute
incurred expenses from which benefits payable under subsection
(a) are determinable) shall be reduced by a deductible of $75
for calendar years before 1991, $100 for 1991 through 2004,
$110 for 2005, and for a subsequent year the amount of such
deductible for the previous year increased by the annual
percentage increase in the monthly actuarial rate under section
1839(a)(1) ending with such subsequent year (rounded to the
nearest $1); except that (1) such total amount shall not
include expenses incurred for preventive services described in
subparagraph (A) of section 1861(ddd)(3) that are recommended
with a grade of A or B by the United States Preventive Services
Task Force for any indication or population and are appropriate
for the individual., (2) such deductible shall not apply with
respect to home health services (other than a covered
osteoporosis drug (as defined in section 1861(kk))), (3) such
deductible shall not apply with respect to clinical diagnostic
laboratory tests for which payment is made under this part (A)
under subsection (a)(1)(D)(i) or (a)(2)(D)(i) on an assignment-
related basis, or to a provider having an agreement under
section 1866, or (B) for tests furnished before January 1,
2017,on the basis of a negotiated rate determined under
subsection (h)(6), (4) such deductible shall not apply to
Federally qualified health center services, (5) such deductible
shall not apply with respect to screening mammography (as
described in section 1861(jj)), (6) such deductible shall not
apply with respect to screening pap smear and screening pelvic
exam (as described in section 1861(nn)), (7) such deductible
shall not apply with respect to ultrasound screening for
abdominal aortic aneurysm (as defined in section 1861(bbb)),
(8) such deductible shall not apply with respect to colorectal
cancer screening tests (as described in section 1861(pp)(1)),
(9) such deductible shall not apply with respect to an initial
preventive physical examination (as defined in section
1861(ww)), and (10) such deductible shall not apply with
respect to personalized prevention plan services (as defined in
section 1861(hhh)(1)). The total amount of the expenses
incurred by an individual as determined under the preceding
sentence shall, after the reduction specified in such sentence,
be further reduced by an amount equal to the expenses incurred
for the first three pints of whole blood (or equivalent
quantities of packed red blood cells, as defined under
regulations) furnished to the individual during the calendar
year, except that such deductible for such blood shall in
accordance with regulations be appropriately reduced to the
extent that there has been a replacement of such blood (or
equivalent quantities of packed red blood cells, as so
defined); and for such purposes blood (or equivalent quantities
of packed red blood cells, as so defined) furnished such
individual shall be deemed replaced when the institution or
other person furnishing such blood (or such equivalent
quantities of packed red blood cells, as so defined) is given
one pint of blood for each pint of blood (or equivalent
quantities of packed red blood cells, as so defined) furnished
such individual with respect to which a deduction is made under
this sentence. The deductible under the previous sentence for
blood or blood cells furnished an individual in a year shall be
reduced to the extent that a deductible has been imposed under
section 1813(a)(2) to blood or blood cells furnished the
individual in the year. Paragraph (1) of the first sentence of
this subsection shall apply with respect to a colorectal cancer
screening test regardless of the code that is billed for the
establishment of a diagnosis as a result of the test, or for
the removal of tissue or other matter or other procedure that
is furnished in connection with, as a result of, and in the
same clinical encounter as the screening test.
(c)(1) Notwithstanding any other provision of this part, with
respect to expenses incurred in a calendar year in connection
with the treatment of mental, psychoneurotic, and personality
disorders of an individual who is not an inpatient of a
hospital at the time such expenses are incurred, there shall be
considered as incurred expenses for purposes of subsections (a)
and (b)--
(A) for expenses incurred in years prior to 2010,
only 62\1/2\ percent of such expenses;
(B) for expenses incurred in 2010 or 2011, only 68\3/
4\ percent of such expenses;
(C) for expenses incurred in 2012, only 75 percent of
such expenses;
(D) for expenses incurred in 2013, only 81\1/4\
percent of such expenses; and
(E) for expenses incurred in 2014 or any subsequent
calendar year, 100 percent of such expenses.
(2) For purposes of subparagraphs (A) through (D) of
paragraph (1), the term ``treatment'' does not include brief
office visits (as defined by the Secretary) for the sole
purpose of monitoring or changing drug prescriptions used in
the treatment of such disorders or partial hospitalization
services that are not directly provided by a physician
(d) No payment may be made under this part with respect to
any services furnished an individual to the extent that such
individual is entitled (or would be entitled except for section
1813) to have payment made with respect to such services under
part A.
(e) No payment shall be made to any provider of services or
other person under this part unless there has been furnished
such information as may be necessary in order to determine the
amounts due such provider or other person under this part for
the period with respect to which the amounts are being paid or
for any prior period.
(f) In establishing limits under subsection (a) on payment
for rural health clinic services provided by rural health
clinics (other than such clinics in hospitals with less than 50
beds), the Secretary shall establish such limit, for services
provided--
(1) in 1988, after March 31, at $46 per visit, and
(2) in a subsequent year, at the limit established
under this subsection for the previous year increased
by the percentage increase in the MEI (as defined in
section 1842(i)(3)) applicable to primary care services
(as defined in section 1842(i)(4)) furnished as of the
first day of that year.
(g)(1)(A) Subject to paragraphs (4) and (5), in the case of
physical therapy services of the type described in section
1861(p) and speech-language pathology services of the type
described in such section through the application of section
1861(ll)(2), but (except as provided in paragraph (6)) not
described in subsection (a)(8)(B), and physical therapy
services and speech-language pathology services of such type
which are furnished by a physician or as incident to
physicians' services, with respect to expenses incurred in any
calendar year, no more than the amount specified in paragraph
(2) for the year shall be considered as incurred expenses for
purposes of subsections (a) and (b). The preceding sentence
shall not apply to expenses incurred with respect to services
furnished after December 31, 2017.
(B) With respect to services furnished during 2018 or a
subsequent year, in the case of physical therapy services of
the type described in section 1861(p), speech-language
pathology services of the type described in such section
through the application of section 1861(ll)(2), and physical
therapy services and speech-language pathology services of such
type which are furnished by a physician or as incident to
physicians' services, with respect to expenses incurred in any
calendar year, any amount that is more than the amount
specified in paragraph (2) for the year shall not be considered
as incurred expenses for purposes of subsections (a) and (b)
unless the applicable requirements of paragraph (7) are met.
(2) The amount specified in this paragraph--
(A) for 1999, 2000, and 2001, is $1,500, and
(B) for a subsequent year is the amount specified in
this paragraph for the preceding year increased by the
percentage increase in the MEI (as defined in section
1842(i)(3)) for such subsequent year;
except that if an increase under subparagraph (B) for a year is
not a multiple of $10, it shall be rounded to the nearest
multiple of $10.
(3)(A) Subject to paragraphs (4) and (5), in the case of
occupational therapy services (of the type that are described
in section 1861(p) (but (except as provided in paragraph (6))
not described in subsection (a)(8)(B)) through the operation of
section 1861(g) and of such type which are furnished by a
physician or as incident to physicians' services), with respect
to expenses incurred in any calendar year, no more than the
amount specified in paragraph (2) for the year shall be
considered as incurred expenses for purposes of subsections (a)
and (b). The preceding sentence shall not apply to expenses
incurred with respect to services furnished after December 31,
2017.
(B) With respect to services furnished during 2018 or a
subsequent year, in the case of occupational therapy services
(of the type that are described in section 1861(p) through the
operation of section 1861(g) and of such type which are
furnished by a physician or as incident to physicians'
services), with respect to expenses incurred in any calendar
year, any amount that is more than the amount specified in
paragraph (2) for the year shall not be considered as incurred
expenses for purposes of subsections (a) and (b) unless the
applicable requirements of paragraph (7) are met.
(4) This subsection shall not apply to expenses incurred with
respect to services furnished during 2000, 2001, 2002, 2004,
and 2005.
(5)(A) With respect to expenses incurred during the period
beginning on January 1, 2006, and ending on December 31, 2017,
for services, the Secretary shall implement a process under
which an individual enrolled under this part may, upon request
of the individual or a person on behalf of the individual,
obtain an exception from the uniform dollar limitation
specified in paragraph (2), for services described in
paragraphs (1) and (3) if the provision of such services is
determined to be medically necessary and if the requirement of
subparagraph (B) is met. Under such process, if the Secretary
does not make a decision on such a request for an exception
within 10 business days of the date of the Secretary's receipt
of the request made in accordance with such requirement, the
Secretary shall be deemed to have found the services to be
medically necessary.
(B) In the case of outpatient therapy services for which an
exception is requested under the first sentence of subparagraph
(A), the claim for such services shall contain an appropriate
modifier (such as the KX modifier used as of the date of the
enactment of this subparagraph) indicating that such services
are medically necessary as justified by appropriate
documentation in the medical record involved.
(C)(i) In applying this paragraph with respect to a request
for an exception with respect to expenses that would be
incurred for outpatient therapy services (including services
described in subsection (a)(8)(B)) that would exceed the
threshold described in clause (ii) for a year, the request for
such an exception, for services furnished on or after October
1, 2012, shall be subject to a manual medical review process
that, subject to subparagraph (E), is similar to the manual
medical review process used for certain exceptions under this
paragraph in 2006.
(ii) The threshold under this clause for a year is $3,700.
Such threshold shall be applied separately--
(I) for physical therapy services and speech-language
pathology services; and
(II) for occupational therapy services.
(E)(i) In place of the manual medical review process under
subparagraph (C)(i), the Secretary shall implement a process
for medical review under this subparagraph under which the
Secretary shall identify and conduct medical review for
services described in subparagraph (C)(i) furnished by a
provider of services or supplier (in this subparagraph referred
to as a ``therapy provider'') using such factors as the
Secretary determines to be appropriate.
(ii) Such factors may include the following:
(I) The therapy provider has had a high claims denial
percentage for therapy services under this part or is
less compliant with applicable requirements under this
title.
(II) The therapy provider has a pattern of billing
for therapy services under this part that is aberrant
compared to peers or otherwise has questionable billing
practices for such services, such as billing medically
unlikely units of services in a day.
(III) The therapy provider is newly enrolled under
this title or has not previously furnished therapy
services under this part.
(IV) The services are furnished to treat a type of
medical condition.
(V) The therapy provider is part of group that
includes another therapy provider identified using the
factors determined under this subparagraph.
(iii) For purposes of carrying out this subparagraph, the
Secretary shall provide for the transfer, from the Federal
Supplementary Medical Insurance Trust Fund under section 1841,
of $5,000,000 to the Centers for Medicare & Medicaid Services
Program Management Account for fiscal years 2015 and 2016, to
remain available until expended. Such funds may not be used by
a contractor under section 1893(h) for medical reviews under
this subparagraph.
(iv) The targeted review process under this subparagraph
shall not apply to services for which expenses are incurred
beyond the period for which the exceptions process under
subparagraph (A) is implemented, except as such process is
applied under paragraph (7)(B).
(6)(A) In applying paragraphs (1) and (3) to services
furnished during the period beginning not later than October 1,
2012, and ending on December 31, 2017, the exclusion of
services described in subsection (a)(8)(B) from the uniform
dollar limitation specified in paragraph (2) shall not apply to
such services furnished during 2012 through 2017.
(B)(i) With respect to outpatient therapy services furnished
beginning on or after January 1, 2013, and before January 1,
2014, for which payment is made under section 1834(g), the
Secretary shall count toward the uniform dollar limitations
described in paragraphs (1) and (3) and the threshold described
in paragraph (5)(C) the amount that would be payable under this
part if such services were paid under section 1834(k)(1)(B)
instead of being paid under section 1834(g).
(ii) Nothing in clause (i) shall be construed as changing the
method of payment for outpatient therapy services under section
1834(g).
(7) For purposes of paragraphs (1)(B) and (3)(B), with
respect to services described in such paragraphs, the
requirements described in this paragraph are as follows:
(A) Inclusion of appropriate modifier.--The claim for
such services contains an appropriate modifier (such as
the KX modifier described in paragraph (5)(B))
indicating that such services are medically necessary
as justified by appropriate documentation in the
medical record involved.
(B) Targeted medical review for certain services
above threshold.--
(i) In general.--In the case where expenses
that would be incurred for such services would
exceed the threshold described in clause (ii)
for the year, such services shall be subject to
the process for medical review implemented
under paragraph (5)(E).
(ii) Threshold.--The threshold under this
clause for--
(I) a year before 2028, is $3,000;
(II) 2028, is the amount specified in
subclause (I) increased by the
percentage increase in the MEI (as
defined in section 1842(i)(3)) for
2028; and
(III) a subsequent year, is the
amount specified in this clause for the
preceding year increased by the
percentage increase in the MEI (as
defined in section 1842(i)(3)) for such
subsequent year;
except that if an increase under subclause (II)
or (III) for a year is not a multiple of $10,
it shall be rounded to the nearest multiple of
$10.
(iii) Application.--The threshold under
clause (ii) shall be applied separately--
(I) for physical therapy services and
speech-language pathology services; and
(II) for occupational therapy
services.
(iv) Funding.--For purposes of carrying out
this subparagraph, the Secretary shall provide
for the transfer, from the Federal
Supplementary Medical Insurance Trust Fund
under section 1841 to the Centers for Medicare
& Medicaid Services Program Management Account,
of $5,000,000 for each fiscal year beginning
with fiscal year 2018, to remain available
until expended. Such funds may not be used by a
contractor under section 1893(h) for medical
reviews under this subparagraph.
(8) With respect to services furnished on or after January 1,
2013, where payment may not be made as a result of application
of paragraphs (1) and (3), section 1879 shall apply in the same
manner as such section applies to a denial that is made by
reason of section 1862(a)(1).
(h)(1)(A) Subject to section 1834(d)(1), the Secretary shall
establish fee schedules for clinical diagnostic laboratory
tests (including prostate cancer screening tests under section
1861(oo) consisting of prostate-specific antigen blood tests)
for which payment is made under this part, other than such
tests performed by a provider of services for an inpatient of
such provider.
(B) In the case of clinical diagnostic laboratory tests
performed by a physician or by a laboratory (other than tests
performed by a qualified hospital laboratory (as defined in
subparagraph (D)) for outpatients of such hospital), the fee
schedules established under subparagraph (A) shall be
established on a regional, statewide, or carrier service area
basis (as the Secretary may determine to be appropriate) for
tests furnished on or after July 1, 1984.
(C) In the case of clinical diagnostic laboratory tests
performed by a qualified hospital laboratory (as defined in
subparagraph (D)) for outpatients of such hospital, the fee
schedules established under subparagraph (A) shall be
established on a regional, statewide, or carrier service area
basis (as the Secretary may determine to be appropriate) for
tests furnished on or after July 1, 1984.
(D) In this subsection, the term ``qualified hospital
laboratory'' means a hospital laboratory, in a sole community
hospital (as defined in section 1886(d)(5)(D)(iii)), which
provides some clinical diagnostic laboratory tests 24 hours a
day in order to serve a hospital emergency room which is
available to provide services 24 hours a day and 7 days a week.
(2)(A)(i) Except as provided in clause (v), subparagraph (B),
and paragraph (4), the Secretary shall set the fee schedules at
60 percent (or, in the case of a test performed by a qualified
hospital laboratory (as defined in paragraph (1)(D)) for
outpatients of such hospital, 62 percent) of the prevailing
charge level determined pursuant to the third and fourth
sentences of section 1842(b)(3) for similar clinical diagnostic
laboratory tests for the applicable region, State, or area for
the 12-month period beginning July 1, 1984, adjusted annually
(to become effective on January 1 of each year) by, subject to
clause (iv), a percentage increase or decrease equal to the
percentage increase or decrease in the Consumer Price Index for
All Urban Consumers (United States city average) minus, for
each of the years 2009 and 2010, 0.5 percentage points, and,
for tests furnished before the dateof enactment of section
1834A, subject to such other adjustments as the Secretary
determines are justified by technological changes.
(ii) Notwithstanding clause (i)--
(I) any change in the fee schedules which would have
become effective under this subsection for tests
furnished on or after January 1, 1988, shall not be
effective for tests furnished during the 3-month period
beginning on January 1, 1988,
(II) the Secretary shall not adjust the fee schedules
under clause (i) to take into account any increase in
the consumer price index for 1988,
(III) the annual adjustment in the fee schedules
determined under clause (i) for each of the years 1991,
1992, and 1993 shall be 2 percent, and
(IV) the annual adjustment in the fee schedules
determined under clause (i) for each of the years 1994
and 1995, 1998 through 2002, and 2004 through 2008
shall be 0 percent.
(iii) In establishing fee schedules under clause (i) with
respect to automated tests and tests (other than cytopathology
tests) which before July 1, 1984, the Secretary made subject to
a limit based on lowest charge levels under the sixth sentence
of section 1842(b)(3) performed after March 31, 1988, the
Secretary shall reduce by 8.3 percent the fee schedules
otherwise established for 1988, and such reduced fee schedules
shall serve as the base for 1989 and subsequent years.
(iv) After determining the adjustment to the fee schedules
under clause (i), the Secretary shall reduce such adjustment--
(I) for 2011 and each subsequent year, by the
productivity adjustment described in section
1886(b)(3)(B)(xi)(II); and
(II) for each of 2011 through 2015, by 1.75
percentage points.
Subclause (I) shall not apply in a year where the adjustment to
the fee schedules determined under clause (i) is 0.0 or a
percentage decrease for a year. The application of the
productivity adjustment under subclause (I) shall not result in
an adjustment to the fee schedules under clause (i) being less
than 0.0 for a year. The application of subclause (II) may
result in an adjustment to the fee schedules under clause (i)
being less than 0.0 for a year, and may result in payment rates
for a year being less than such payment rates for the preceding
year.
(v) The Secretary shall reduce by 2 percent the fee schedules
otherwise determined under clause (i) for 2013, and such
reduced fee schedules shall serve as the base for 2014 and
subsequent years.
(B) The Secretary may make further adjustments or exceptions
to the fee schedules to assure adequate reimbursement of (i)
emergency laboratory tests needed for the provision of bona
fide emergency services, and (ii) certain low volume high-cost
tests where highly sophisticated equipment or extremely skilled
personnel are necessary to assure quality.
(3) In addition to the amounts provided under the fee
schedules (for tests furnished before January 1, 2017)or under
section 1834A (for tests furnished on or afterJanuary 1, 2017),
subject to subsection (b)(5) of such section, the Secretary
shall provide for and establish (A) a nominal fee to cover the
appropriate costs in collecting the sample on which a clinical
diagnostic laboratory test was performed and for which payment
is made under this part, except that not more than one such fee
may be provided under this paragraph with respect to samples
collected in the same encounter, and (B) a fee to cover the
transportation and personnel expenses for trained personnel to
travel to the location of an individual to collect the sample,
except that such a fee may be provided only with respect to an
individual who is homebound or an inpatient in an inpatient
facility (other than a hospital). In establishing a fee to
cover the transportation and personnel expenses for trained
personnel to travel to the location of an individual to collect
a sample, the Secretary shall provide a method for computing
the fee based on the number of miles traveled and the personnel
costs associated with the collection of each individual sample,
but the Secretary shall only be required to apply such method
in the case of tests furnished during the period beginning on
April 1, 1989, and ending on December 31, 1990, by a laboratory
that establishes to the satisfaction of the Secretary (based on
data for the 12-month period ending June 30, 1988) that (i) the
laboratory is dependent upon payments under this title for at
least 80 percent of its collected revenues for clinical
diagnostic laboratory tests, (ii) at least 85 percent of its
gross revenues for such tests are attributable to tests
performed with respect to individuals who are homebound or who
are residents in a nursing facility, and (iii) the laboratory
provided such tests for residents in nursing facilities
representing at least 20 percent of the number of such
facilities in the State in which the laboratory is located.
(4)(A) In establishing any fee schedule under this
subsection, the Secretary may provide for an adjustment to take
into account, with respect to the portion of the expenses of
clinical diagnostic laboratory tests attributable to wages, the
relative difference between a region's or local area's wage
rates and the wage rate presumed in the data on which the
schedule is based.
(B) For purposes of subsections (a)(1)(D)(i) and
(a)(2)(D)(i), the limitation amount for a clinical diagnostic
laboratory test performed--
(i) on or after July 1, 1986, and before April 1,
1988, is equal to 115 percent of the median of all the
fee schedules established for that test for that
laboratory setting under paragraph (1),
(ii) after March 31, 1988, and before January 1,
1990, is equal to the median of all the fee schedules
established for that test for that laboratory setting
under paragraph (1),
(iii) after December 31, 1989, and before January 1,
1991, is equal to 93 percent of the median of all the
fee schedules established for that test for that
laboratory setting under paragraph (1),
(iv) after December 31, 1990, and before January 1,
1994, is equal to 88 percent of such median,
(v) after December 31, 1993, and before January 1,
1995, is equal to 84 percent of such median,
(vi) after December 31, 1994, and before January 1,
1996, is equal to 80 percent of such median,
(vii) after December 31, 1995, and before January 1,
1998, is equal to 76 percent of such median, and
(viii) after December 31, 1997, is equal to 74
percent of such median (or 100 percent of such median
in the case of a clinical diagnostic laboratory test
performed on or after January 1, 2001, that the
Secretary determines is a new test for which no
limitation amount has previously been established under
this subparagraph).
(5)(A) In the case of a bill or request for payment for a
clinical diagnostic laboratory test for which payment may
otherwise be made under this part on an assignment-related
basis or under a provider agreement under section 1866, payment
may be made only to the person or entity which performed or
supervised the performance of such test; except that--
(i) if a physician performed or supervised the
performance of such test, payment may be made to
another physician with whom he shares his practice,
(ii) in the case of a test performed at the request
of a laboratory by another laboratory, payment may be
made to the referring laboratory but only if--
(I) the referring laboratory is located in,
or is part of, a rural hospital,
(II) the referring laboratory is wholly owned
by the entity performing such test, the
referring laboratory wholly owns the entity
performing such test, or both the referring
laboratory and the entity performing such test
are wholly-owned by a third entity, or
(III) not more than 30 percent of the
clinical diagnostic laboratory tests for which
such referring laboratory (but not including a
laboratory described in subclause (II)),
receives requests for testing during the year
in which the test is performed are performed by
another laboratory, and
(iii) in the case of a clinical diagnostic laboratory
test provided under an arrangement (as defined in
section 1861(w)(1)) made by a hospital, critical access
hospital, or skilled nursing facility, payment shall be
made to the hospital or skilled nursing facility.
(B) In the case of such a bill or request for payment for a
clinical diagnostic laboratory test for which payment may
otherwise be made under this part, and which is not described
in subparagraph (A), payment may be made to the beneficiary
only on the basis of the itemized bill of the person or entity
which performed or supervised the performance of the test.
(C) Payment for a clinical diagnostic laboratory test,
including a test performed in a physician's office but
excluding a test performed by a rural health clinic may only be
made on an assignment-related basis or to a provider of
services with an agreement in effect under section 1866.
(D) A person may not bill for a clinical diagnostic
laboratory test, including a test performed in a physician's
office but excluding a test performed by a rural health clinic,
other than on an assignment-related basis. If a person
knowingly and willfully and on a repeated basis bills for a
clinical diagnostic laboratory test in violation of the
previous sentence, the Secretary may apply sanctions against
the person in the same manner as the Secretary may apply
sanctions against a physician in accordance with paragraph (2)
of section 1842(j) in the same manner such paragraphs apply
with respect to a physician. Paragraph (4) of such section
shall apply in this subparagraph in the same manner as such
paragraph applies to such section.
(6) For tests furnished before January 1, 2017, inthe case of
any diagnostic laboratory test payment for which is not made on
the basis of a fee schedule under paragraph (1), the Secretary
may establish a payment rate which is acceptable to the person
or entity performing the test and which would be considered the
full charge for such tests. Such negotiated rate shall be
limited to an amount not in excess of the total payment that
would have been made for the services in the absence of such
rate.
(7) Notwithstanding paragraphs (1) and (4)and section 1834A,
the Secretary shall establish a national minimum payment amount
under this part for a diagnostic or screening pap smear
laboratory test (including all cervical cancer screening
technologies that have been approved by the Food and Drug
Administration as a primary screening method for detection of
cervical cancer) equal to $14.60 for tests furnished in 2000.
For such tests furnished in subsequent years, such national
minimum payment amount shall be adjusted annually as provided
in paragraph (2).
(8)(A) The Secretary shall establish by regulation procedures
for determining the basis for, and amount of, payment under
this subsection for any clinical diagnostic laboratory test
with respect to which a new or substantially revised HCPCS code
is assigned on or after January 1, 2005 (in this paragraph
referred to as ``new tests'').
(B) Determinations under subparagraph (A) shall be made only
after the Secretary--
(i) makes available to the public (through an
Internet website and other appropriate mechanisms) a
list that includes any such test for which
establishment of a payment amount under this subsection
is being considered for a year;
(ii) on the same day such list is made available,
causes to have published in the Federal Register notice
of a meeting to receive comments and recommendations
(and data on which recommendations are based) from the
public on the appropriate basis under this subsection
for establishing payment amounts for the tests on such
list;
(iii) not less than 30 days after publication of such
notice convenes a meeting, that includes
representatives of officials of the Centers for
Medicare & Medicaid Services involved in determining
payment amounts, to receive such comments and
recommendations (and data on which the recommendations
are based);
(iv) taking into account the comments and
recommendations (and accompanying data) received at
such meeting, develops and makes available to the
public (through an Internet website and other
appropriate mechanisms) a list of proposed
determinations with respect to the appropriate basis
for establishing a payment amount under this subsection
for each such code, together with an explanation of the
reasons for each such determination, the data on which
the determinations are based, and a request for public
written comments on the proposed determination; and
(v) taking into account the comments received during
the public comment period, develops and makes available
to the public (through an Internet website and other
appropriate mechanisms) a list of final determinations
of the payment amounts for such tests under this
subsection, together with the rationale for each such
determination, the data on which the determinations are
based, and responses to comments and suggestions
received from the public.
(C) Under the procedures established pursuant to subparagraph
(A), the Secretary shall--
(i) set forth the criteria for making determinations
under subparagraph (A); and
(ii) make available to the public the data (other
than proprietary data) considered in making such
determinations.
(D) The Secretary may convene such further public meetings to
receive public comments on payment amounts for new tests under
this subsection as the Secretary deems appropriate.
(E) For purposes of this paragraph:
(i) The term ``HCPCS'' refers to the Health Care
Procedure Coding System.
(ii) A code shall be considered to be ``substantially
revised'' if there is a substantive change to the
definition of the test or procedure to which the code
applies (such as a new analyte or a new methodology for
measuring an existing analyte-specific test).
(9) Notwithstanding any other provision in this part, in the
case of any diagnostic laboratory test for HbA1c that is
labeled by the Food and Drug Administration for home use and is
furnished on or after April 1, 2008, the payment rate for such
test shall be the payment rate established under this part for
a glycated hemoglobin test (identified as of October 1, 2007,
by HCPCS code 83036 (and any succeeding codes)).
(i)(1) The Secretary shall, in consultation with appropriate
medical organizations--
(A) specify those surgical procedures which are
appropriately (when considered in terms of the proper
utilization of hospital inpatient facilities) performed
on an inpatient basis in a hospital but which also can
be performed safely on an ambulatory basis in an
ambulatory surgical center (meeting the standards
specified under section 1832(a)(2)(F)(i)), critical
access hospital, or hospital outpatient department, and
(B) specify those surgical procedures which are
appropriately (when considered in terms of the proper
utilization of hospital inpatient facilities) performed
on an inpatient basis in a hospital but which also can
be performed safely on an ambulatory basis in a
physician's office.
The lists of procedures established under subparagraphs (A) and
(B) shall be reviewed and updated not less often than every 2
years, in consultation with appropriate trade and professional
organizations.
(2)(A) For services furnished prior to the implementation of
the system described in subparagraph (D), subject to
subparagraph (E), the amount of payment to be made for facility
services furnished in connection with a surgical procedure
specified pursuant to paragraph (1)(A) and furnished to an
individual in an ambulatory surgical center described in such
paragraph shall be equal to 80 percent of a standard overhead
amount established by the Secretary (with respect to each such
procedure) on the basis of the Secretary's estimate of a fair
fee which--
(i) takes into account the costs incurred by such
centers, or classes of centers, generally in providing
services furnished in connection with the performance
of such procedure, as determined in accordance with a
survey (based upon a representative sample of
procedures and facilities) of the actual audited costs
incurred by such centers in providing such services,
(ii) takes such costs into account in such a manner
as will assure that the performance of the procedure in
such a center will result in substantially less amounts
paid under this title than would have been paid if the
procedure had been performed on an inpatient basis in a
hospital, and
(iii) in the case of insertion of an intraocular lens
during or subsequent to cataract surgery includes
payment which is reasonable and related to the cost of
acquiring the class of lens involved.
Each amount so established shall be reviewed and updated not
later than July 1, 1987, and annually thereafter to take
account of varying conditions in different areas.
(B) The amount of payment to be made under this part for
facility services furnished, in connection with a surgical
procedure specified pursuant to paragraph (1)(B), in a
physician's office shall be equal to 80 percent of a standard
overhead amount established by the Secretary (with respect to
each such procedure) on the basis of the Secretary's estimate
of a fair fee which--
(i) takes into account additional costs, not usually
included in the professional fee, incurred by
physicians in securing, maintaining, and staffing the
facilities and ancillary services appropriate for the
performance of such procedure in the physician's
office, and
(ii) takes such items into account in such a manner
which will assure that the performance of such
procedure in the physician's office will result in
substantially less amounts paid under this title than
would have been paid if the services had been furnished
on an inpatient basis in a hospital.
Each amount so established shall be reviewed and updated not
later than July 1, 1987, and annually thereafter to take
account of varying conditions in different areas.
(C)(i) Notwithstanding the second sentence of each of
subparagraphs (A) and (B), except as otherwise specified in
clauses (ii), (iii), and (iv), if the Secretary has not updated
amounts established under such subparagraphs or under
subparagraph (D), with respect to facility services furnished
during a fiscal year (beginning with fiscal year 1986 or a
calendar year (beginning with 2006)), such amounts shall be
increased by the percentage increase in the Consumer Price
Index for all urban consumers (U.S. city average) as estimated
by the Secretary for the 12-month period ending with the
midpoint of the year involved.
(ii) In each of the fiscal years 1998 through 2002, the
increase under this subparagraph shall be reduced (but not
below zero) by 2.0 percentage points.
(iii) In fiscal year 2004, beginning with April 1, 2004, the
increase under this subparagraph shall be the Consumer Price
Index for all urban consumers (U.S. city average) as estimated
by the Secretary for the 12-month period ending with March 31,
2003, minus 3.0 percentage points.
(iv) In fiscal year 2005, the last quarter of calendar year
2005, and each of calendar years 2006 through 2009, the
increase under this subparagraph shall be 0 percent.
(D)(i) Taking into account the recommendations in the report
under section 626(d) of Medicare Prescription Drug,
Improvement, and Modernization Act of 2003, the Secretary shall
implement a revised payment system for payment of surgical
services furnished in ambulatory surgical centers.
(ii) In the year the system described in clause (i) is
implemented, such system shall be designed to result in the
same aggregate amount of expenditures for such services as
would be made if this subparagraph did not apply, as estimated
by the Secretary and taking into account reduced expenditures
that would apply if subparagraph (E) were to continue to apply,
as estimated by the Secretary.
(iii) The Secretary shall implement the system described in
clause (i) for periods in a manner so that it is first
effective beginning on or after January 1, 2006, and not later
than January 1, 2008.
(iv) The Secretary may implement such system in a manner so
as to provide for a reduction in any annual update for failure
to report on quality measures in accordance with paragraph (7).
(v) In implementing the system described in clause
(i) for 2011 and each subsequent year, any annual
update under such system for the year, after
application of clause (iv), shall be reduced by the
productivity adjustment described in section
1886(b)(3)(B)(xi)(II). The application of the preceding
sentence may result in such update being less than 0.0
for a year, and may result in payment rates under the
system described in clause (i) for a year being less
than such payment rates for the preceding year.
(vi) There shall be no administrative or judicial review
under section 1869, 1878, or otherwise, of the classification
system, the relative weights, payment amounts, and the
geographic adjustment factor, if any, under this subparagraph.
(E) With respect to surgical procedures furnished on or after
January 1, 2007, and before the effective date of the
implementation of a revised payment system under subparagraph
(D), if--
(i) the standard overhead amount under subparagraph
(A) for a facility service for such procedure, without
the application of any geographic adjustment, exceeds
(ii) the Medicare OPD fee schedule amount established
under the prospective payment system for hospital
outpatient department services under paragraph (3)(D)
of section 1833(t) for such service for such year,
determined without regard to geographic adjustment
under paragraph (2)(D) of such section,
the Secretary shall substitute under subparagraph (A) the
amount described in clause (ii) for the standard overhead
amount for such service referred to in clause (i).
(3)(A) The aggregate amount of the payments to be made under
this part for outpatient hospital facility services or critical
access hospital services furnished before January 1, 1999, in
connection with surgical procedures specified under paragraph
(1)(A) shall be equal to the lesser of--
(i) the amount determined with respect to such
services under subsection (a)(2)(B); or
(ii) the blend amount (described in subparagraph
(B)).
(B)(i) The blend amount for a cost reporting period is the
sum of--
(I) the cost proportion (as defined in clause
(ii)(I)) of the amount described in subparagraph
(A)(i), and
(II) the ASC proportion (as defined in clause
(ii)(II)) of the standard overhead amount payable with
respect to the same surgical procedure as if it were
provided in an ambulatory surgical center in the same
area, as determined under paragraph (2)(A), less the
amount a provider may charge as described in clause
(ii) of section 1866(a)(2)(A).
(ii) Subject to paragraph (4), in this paragraph:
(I) The term ``cost proportion'' means 75 percent for
cost reporting periods beginning in fiscal year 1988,
50 percent for portions of cost reporting periods
beginning on or after October 1, 1988, and ending on or
before December 31, 1990, and 42 percent for portions
of cost reporting periods beginning on or after January
1, 1991.
(II) The term ``ASC proportion'' means 25 percent for
cost reporting periods beginning in fiscal year 1988,
50 percent for portions of cost reporting periods
beginning on or after October 1, 1988, and ending on or
before December 31, 1990, and 58 percent for portions
of cost reporting periods beginning on or after January
1, 1991.
(4)(A) In the case of a hospital that--
(i) makes application to the Secretary and
demonstrates that it specializes in eye services or eye
and ear services (as determined by the Secretary),
(ii) receives more than 30 percent of its total
revenues from outpatient services, and
(iii) on October 1, 1987--
(I) was an eye specialty hospital or an eye
and ear specialty hospital, or
(II) was operated as an eye or eye and ear
unit (as defined in subparagraph (B)) of a
general acute care hospital which, on the date
of the application described in clause (i),
operates less than 20 percent of the beds that
the hospital operated on October 1, 1987, and
has sold or otherwise disposed of a substantial
portion of the hospital's other acute care
operations,
the cost proportion and ASC proportion in effect under
subclauses (I) and (II) of paragraph (3)(B)(ii) for cost
reporting periods beginning in fiscal year 1988 shall remain in
effect for cost reporting periods beginning on or after October
1, 1988, and before January 1, 1995.
(B) For purposes of this subparagraph (A)(iii)(II), the term
``eye or eye and ear unit'' means a physically separate or
distinct unit containing separate surgical suites devoted
solely to eye or eye and ear services.
(5)(A) The Secretary is authorized to provide by regulations
that in the case of a surgical procedure, specified by the
Secretary pursuant to paragraph (1)(A), performed in an
ambulatory surgical center described in such paragraph, there
shall be paid (in lieu of any amounts otherwise payable under
this part) with respect to the facility services furnished by
such center and with respect to all related services (including
physicians' services, laboratory, X-ray, and diagnostic
services) a single all-inclusive fee established pursuant to
subparagraph (B), if all parties furnishing all such services
agree to accept such fee (to be divided among the parties
involved in such manner as they shall have previously agreed
upon) as full payment for the services furnished.
(B) In implementing this paragraph, the Secretary shall
establish with respect to each surgical procedure specified
pursuant to paragraph (1)(A) the amount of the all-inclusive
fee for such procedure, taking into account such factors as may
be appropriate. The amount so established with respect to any
surgical procedure shall be reviewed periodically and may be
adjusted by the Secretary, when appropriate, to take account of
varying conditions in different areas.
(6) Any person, including a facility having an agreement
under section 1832(a)(2)(F)(i), who knowingly and willfully
presents, or causes to be presented, a bill or request for
payment, for an intraocular lens inserted during or subsequent
to cataract surgery for which payment may be made under
paragraph (2)(A)(iii), is subject to a civil money penalty of
not to exceed $2,000. The provisions of section 1128A (other
than subsections (a) and (b)) shall apply to a civil money
penalty under the previous sentence in the same manner as such
provisions apply to a penalty or proceeding under section
1128A(a).
(7)(A) For purposes of paragraph (2)(D)(iv), the Secretary
may provide, in the case of an ambulatory surgical center that
does not submit, to the Secretary in accordance with this
paragraph, data required to be submitted on measures selected
under this paragraph with respect to a year, any annual
increase provided under the system established under paragraph
(2)(D) for such year shall be reduced by 2.0 percentage points.
A reduction under this subparagraph shall apply only with
respect to the year involved and the Secretary shall not take
into account such reduction in computing any annual increase
factor for a subsequent year.
(B) Except as the Secretary may otherwise provide, the
provisions of subparagraphs (B), (C), (D), and (E) of paragraph
(17) of section 1833(t) shall apply with respect to services of
ambulatory surgical centers under this paragraph in a similar
manner to the manner in which they apply under such paragraph
and, for purposes of this subparagraph, any reference to a
hospital, outpatient setting, or outpatient hospital services
is deemed a reference to an ambulatory surgical center, the
setting of such a center, or services of such a center,
respectively.
(8) The Secretary shall conduct a similar type of review as
required under paragraph (22) of section 1833(t)), including
the second sentence of subparagraph (C) of such paragraph, to
payment for services under this subsection, and make such
revisions under this paragraph, in an appropriate manner (as
determined by the Secretary).
(j) Whenever a final determination is made that the amount of
payment made under this part either to a provider of services
or to another person pursuant to an assignment under section
1842(b)(3)(B)(ii) was in excess of or less than the amount of
payment that is due, and payment of such excess or deficit is
not made (or effected by offset) within 30 days of the date of
the determination, interest shall accrue on the balance of such
excess or deficit not paid or offset (to the extent that the
balance is owed by or owing to the provider) at a rate
determined in accordance with the regulations of the Secretary
of the Treasury applicable to charges for late payments.
(k) With respect to services described in section
1861(s)(10)(B), the Secretary may provide, instead of the
amount of payment otherwise provided under this part, for
payment of such an amount or amounts as reasonably reflects the
general cost of efficiently providing such services.
(l)(1)(A) The Secretary shall establish a fee schedule for
services of certified registered nurse anesthetists under
section 1861(s)(11).
(B) In establishing the fee schedule under this paragraph the
Secretary may utilize a system of time units, a system of base
and time units, or any appropriate methodology.
(C) The provisions of this subsection shall not apply to
certain services furnished in certain hospitals in rural areas
under the provisions of section 9320(k) of the Omnibus Budget
Reconciliation Act of 1986, as amended by section 6132 of the
Omnibus Budget Reconciliation Act of 1989.
(2) Except as provided in paragraph (3), the fee schedule
established under paragraph (1) shall be initially based on
audited data from cost reporting periods ending in fiscal year
1985 and such other data as the Secretary determines necessary.
(3)(A) In establishing the initial fee schedule for those
services, the Secretary shall adjust the fee schedule to the
extent necessary to ensure that the estimated total amount
which will be paid under this title for those services plus
applicable coinsurance in 1989 will equal the estimated total
amount which would be paid under this title for those services
in 1989 if the services were included as inpatient hospital
services and payment for such services was made under part A in
the same manner as payment was made in fiscal year 1987,
adjusted to take into account changes in prices and technology
relating to the administration of anesthesia.
(B) The Secretary shall also reduce the prevailing charge of
physicians for medical direction of a certified registered
nurse anesthetist, or the fee schedule for services of
certified registered nurse anesthetists, or both, to the extent
necessary to ensure that the estimated total amount which will
be paid under this title plus applicable coinsurance for such
medical direction and such services in 1989 and 1990 will not
exceed the estimated total amount which would have been paid
plus applicable coinsurance but for the enactment of the
amendments made by section 9320 of the Omnibus Budget
Reconciliation Act of 1986. A reduced prevailing charge under
this subparagraph shall become the prevailing charge but for
subsequent years for purposes of applying the economic index
under the fourth sentence of section 1842(b)(3).
(4)(A) Except as provided in subparagraphs (C) and (D), in
determining the amount paid under the fee schedule under this
subsection for services furnished on or after January 1, 1991,
by a certified registered nurse anesthetist who is not
medically directed--
(i) the conversion factor shall be--
(I) for services furnished in 1991, $15.50,
(II) for services furnished in 1992, $15.75,
(III) for services furnished in 1993, $16.00,
(IV) for services furnished in 1994, $16.25,
(V) for services furnished in 1995, $16.50,
(VI) for services furnished in 1996, $16.75,
and
(VII) for services furnished in calendar
years after 1996, the previous year's
conversion factor increased by the update
determined under section 1848(d) for physician
anesthesia services for that year;
(ii) the payment areas to be used shall be the fee
schedule areas used under section 1848 (or, in the case
of services furnished during 1991, the localities used
under section 1842(b)) for purposes of computing
payments for physicians' services that are anesthesia
services;
(iii) the geographic adjustment factors to be applied
to the conversion factor under clause (i) for services
in a fee schedule area or locality is--
(I) in the case of services furnished in
1991, the geographic work index value and the
geographic practice cost index value specified
in section 1842(q)(1)(B) for physicians'
services that are anesthesia services furnished
in the area or locality, and
(II) in the case of services furnished after
1991, the geographic work index value, the
geographic practice cost index value, and the
geographic malpractice index value used for
determining payments for physicians' services
that are anesthesia services under section
1848,
with 70 percent of the conversion factor treated as
attributable to work and 30 percent as attributable to
overhead for services furnished in 1991 (and the
portions attributable to work, practice expenses, and
malpractice expenses in 1992 and thereafter being the
same as is applied under section 1848).
(B)(i) Except as provided in clause (ii) and subparagraph
(D), in determining the amount paid under the fee schedule
under this subsection for services furnished on or after
January 1, 1991, and before January 1, 1994, by a certified
registered nurse anesthetist who is medically directed, the
Secretary shall apply the same methodology specified in
subparagraph (A).
(ii) The conversion factor used under clause (i) shall be--
(I) for services furnished in 1991, $10.50,
(II) for services furnished in 1992, $10.75, and
(III) for services furnished in 1993, $11.00.
(iii) In the case of services of a certified registered nurse
anesthetist who is medically directed or medically supervised
by a physician which are furnished on or after January 1, 1994,
the fee schedule amount shall be one-half of the amount
described in section 1848(a)(5)(B) with respect to the
physician.
(C) Notwithstanding subclauses (I) through (V) of
subparagraph (A)(i)--
(i) in the case of a 1990 conversion factor that is
greater than $16.50, the conversion factor for a
calendar year after 1990 and before 1996 shall be the
1990 conversion factor reduced by the product of the
last digit of the calendar year and one-fifth of the
amount by which the 1990 conversion factor exceeds
$16.50; and
(ii) in the case of a 1990 conversion factor that is
greater than $15.49 but less than $16.51, the
conversion factor for a calendar year after 1990 and
before 1996 shall be the greater of--
(I) the 1990 conversion factor, or
(II) the conversion factor specified in
subparagraph (A)(i) for the year involved.
(D) Notwithstanding subparagraph (C), in no case may the
conversion factor used to determine payment for services in a
fee schedule area or locality under this subsection, as
adjusted by the adjustment factors specified in subparagraphs
(A)(iii), exceed the conversion factor used to determine the
amount paid for physicians' services that are anesthesia
services in the area or locality.
(5)(A) Payment for the services of a certified registered
nurse anesthetist (for which payment may otherwise be made
under this part) may be made on the basis of a claim or request
for payment presented by the certified registered nurse
anesthetist furnishing such services, or by a hospital,
critical access hospital, physician, group practice, or
ambulatory surgical center with which the certified registered
nurse anesthetist furnishing such services has an employment or
contractual relationship that provides for payment to be made
under this part for such services to such hospital, critical
access hospital, physician, group practice, or ambulatory
surgical center.
(B) No hospital or critical access hospital that presents a
claim or request for payment for services of a certified nurse
anesthetist under this part may treat any uncollected
coinsurance amount imposed under this part with respect to such
services as a bad debt of such hospital or critical access
hospital for purposes of this title.
(6) If an adjustment under paragraph (3)(B) results in a
reduction in the reasonable charge for a physicians' service
and a nonparticipating physician furnishes the service to an
individual entitled to benefits under this part after the
effective date of the reduction, the physician's actual charge
is subject to a limit under section 1842(j)(1)(D).
(m)(1) In the case of physicians' services furnished in a
year to an individual, who is covered under the insurance
program established by this part and who incurs expenses for
such services, in an area that is designated (under section
332(a)(1)(A) of the Public Health Service Act) as a health
professional shortage area as identified by the Secretary prior
to the beginning of such year, in addition to the amount
otherwise paid under this part, there also shall be paid to the
physician (or to an employer or facility in the cases described
in clause (A) of section 1842(b)(6)) (on a monthly or quarterly
basis) from the Federal Supplementary Medical Insurance Trust
Fund an amount equal to 10 percent of the payment amount for
the service under this part.
(2) For each health professional shortage area identified in
paragraph (1) that consists of an entire county, the Secretary
shall provide for the additional payment under paragraph (1)
without any requirement on the physician to identify the health
professional shortage area involved. The Secretary may
implement the previous sentence using the method specified in
subsection (u)(4)(C).
(3) The Secretary shall post on the Internet website of the
Centers for Medicare & Medicaid Services a list of the health
professional shortage areas identified in paragraph (1) that
consist of a partial county to facilitate the additional
payment under paragraph (1) in such areas.
(4) There shall be no administrative or judicial review under
section 1869, section 1878, or otherwise, respecting--
(A) the identification of a county or area;
(B) the assignment of a specialty of any physician
under this paragraph;
(C) the assignment of a physician to a county under
this subsection; or
(D) the assignment of a postal ZIP Code to a county
or other area under this subsection.
(n)(1)(A) The aggregate amount of the payments to be made for
all or part of a cost reporting period for services described
in subsection (a)(2)(E)(i) furnished under this part on or
after October 1, 1988, and before January 1, 1999, and for
services described in subsection (a)(2)(E)(ii) furnished under
this part on or after October 1, 1989, and before January 1,
1999, shall be equal to the lesser of--
(i) the amount determined with respect to such
services under subsection (a)(2)(B), or
(ii) the blend amount for radiology services and
diagnostic procedures determined in accordance with
subparagraph (B).
(B)(i) The blend amount for radiology services and diagnostic
procedures for a cost reporting period is the sum of--
(I) the cost proportion (as defined in clause (ii))
of the amount described in subparagraph (A)(i); and
(II) the charge proportion (as defined in clause
(ii)(II)) of 62 percent (for services described in
subsection (a)(2)(E)(i)), or (for procedures described
in subsection (a)(2)(E)(ii)), 42 percent or such other
percent established by the Secretary (or carriers
acting pursuant to guidelines issued by the Secretary)
based on prevailing charges established with actual
charge data, of the prevailing charge or (for services
described in subsection (a)(2)(E)(i) furnished on or
after January 1, 1989) the fee schedule amount
established for participating physicians for the same
services as if they were furnished in a physician's
office in the same locality as determined under section
1842(b), less the amount a provider may charge as
described in clause (ii) of section 1866(a)(2)(A).
(ii) In this subparagraph:
(I) The term ``cost proportion'' means 50 percent,
except that such term means 65 percent in the case of
outpatient radiology services for portions of cost
reporting periods which occur in fiscal year 1989 and
in the case of diagnostic procedures described in
subsection (a)(2)(E)(ii) for portions of cost reporting
periods which occur in fiscal year 1990, and such term
means 42 percent in the case of outpatient radiology
services for portions of cost reporting periods
beginning on or after January 1, 1991.
(II) The term ``charge proportion'' means 100 percent
minus the cost proportion.
(o)(1) In the case of shoes described in section
1861(s)(12)--
(A) no payment may be made under this part, with
respect to any individual for any year, for the
furnishing of--
(i) more than one pair of custom molded shoes
(including inserts provided with such shoes)
and 2 additional pairs of inserts for such
shoes, or
(ii) more than one pair of extra-depth shoes
(not including inserts provided with such
shoes) and 3 pairs of inserts for such shoes,
and
(B) with respect to expenses incurred in any calendar
year, no more than the amount of payment applicable
under paragraph (2) shall be considered as incurred
expenses for purposes of subsections (a) and (b).
Payment for shoes (or inserts) under this part shall be
considered to include payment for any expenses for the fitting
of such shoes (or inserts).
(2)(A) Except as provided by the Secretary under
subparagraphs (B) and (C), the amount of payment under this
paragraph for custom molded shoes, extra-depth shoes, and
inserts shall be the amount determined for such items by the
Secretary under section 1834(h).
(B) The Secretary may establish payment amounts for shoes and
inserts that are lower than the amount established under
section 1834(h) if the Secretary finds that shoes and inserts
of an appropriate quality are readily available at or below the
amount established under such section.
(C) In accordance with procedures established by the
Secretary, an individual entitled to benefits with respect to
shoes described in section 1861(s)(12) may substitute
modification of such shoes instead of obtaining one (or more,
as specified by the Secretary) pair of inserts (other than the
original pair of inserts with respect to such shoes). In such
case, the Secretary shall substitute, for the payment amount
established under section 1834(h), a payment amount that the
Secretary estimates will assure that there is no net increase
in expenditures under this subsection as a result of this
subparagraph.
(3) In this title, the term ``shoes'' includes, except for
purposes of subparagraphs (A)(ii) and (B) of paragraph (2),
inserts for extra-depth shoes.
(q)(1) Each request for payment, or bill submitted, for an
item or service furnished by an entity for which payment may be
made under this part and for which the entity knows or has
reason to believe there has been a referral by a referring
physician (within the meaning of section 1877) shall include
the name and unique physician identification number for the
referring physician.
(2)(A) In the case of a request for payment for an item or
service furnished by an entity under this part on an
assignment-related basis and for which information is required
to be provided under paragraph (1) but not included, payment
may be denied under this part.
(B) In the case of a request for payment for an item or
service furnished by an entity under this part not submitted on
an assignment-related basis and for which information is
required to be provided under paragraph (1) but not included--
(i) if the entity knowingly and willfully fails to
provide such information promptly upon request of the
Secretary or a carrier, the entity may be subject to a
civil money penalty in an amount not to exceed $2,000,
and
(ii) if the entity knowingly, willfully, and in
repeated cases fails, after being notified by the
Secretary of the obligations and requirements of this
subsection to provide the information required under
paragraph (1), the entity may be subject to exclusion
from participation in the programs under this Act for a
period not to exceed 5 years, in accordance with the
procedures of subsections (c), (f), and (g) of section
1128.
The provisions of section 1128A (other than subsections (a) and
(b)) shall apply to civil money penalties under clause (i) in
the same manner as they apply to a penalty or proceeding under
section 1128A(a).
(r)(1) With respect to services described in section
1861(s)(2)(K)(ii) (relating to nurse practitioner or clinical
nurse specialist services), payment may be made on the basis of
a claim or request for payment presented by the nurse
practitioner or clinical nurse specialist furnishing such
services, or by a hospital, critical access hospital, skilled
nursing facility or nursing facility (as defined in section
1919(a)), physician, group practice, or ambulatory surgical
center with which the nurse practitioner or clinical nurse
specialist has an employment or contractual relationship that
provides for payment to be made under this part for such
services to such hospital, physician, group practice, or
ambulatory surgical center.
(2) No hospital or critical access hospital that presents a
claim or request for payment under this part for services
described in section 1861(s)(2)(K)(ii) may treat any
uncollected coinsurance amount imposed under this part with
respect to such services as a bad debt of such hospital for
purposes of this title.
(s) The Secretary may not provide for payment under
subsection (a)(1)(A) with respect to an organization unless the
organization provides assurances satisfactory to the Secretary
that the organization meets the requirement of section 1866(f)
(relating to maintaining written policies and procedures
respecting advance directives).
(t) Prospective Payment System for Hospital Outpatient
Department Services.--
(1) Amount of payment.--
(A) In general.--With respect to covered OPD
services (as defined in subparagraph (B))
furnished during a year beginning with 1999,
the amount of payment under this part shall be
determined under a prospective payment system
established by the Secretary in accordance with
this subsection.
(B) Definition of covered opd services.--For
purposes of this subsection, the term ``covered
OPD services''--
(i) means hospital outpatient
services designated by the Secretary;
(ii) subject to clause (iv), includes
inpatient hospital services designated
by the Secretary that are covered under
this part and furnished to a hospital
inpatient who (I) is entitled to
benefits under part A but has exhausted
benefits for inpatient hospital
services during a spell of illness, or
(II) is not so entitled;
(iii) includes implantable items
described in paragraph (3), (6), or (8)
of section 1861(s);
(iv) does not include any therapy
services described in subsection (a)(8)
or ambulance services, for which
payment is made under a fee schedule
described in section 1834(k) or section
1834(l) and does not include screening
mammography (as defined in section
1861(jj)), diagnostic mammography, or
personalized prevention plan services
(as defined in section 1861(hhh)(1));
and
(v) does not include applicable items
and services (as defined in
subparagraph (A) of paragraph (21))
that are furnished on or after January
1, 2017, by an off-campus outpatient
department of a provider (as defined in
subparagraph (B) of such paragraph).
(2) System requirements.--Under the payment system--
(A) the Secretary shall develop a
classification system for covered OPD services;
(B) the Secretary may establish groups of
covered OPD services, within the classification
system described in subparagraph (A), so that
services classified within each group are
comparable clinically and with respect to the
use of resources and so that an implantable
item is classified to the group that includes
the service to which the item relates;
(C) the Secretary shall, using data on claims
from 1996 and using data from the most recent
available cost reports, establish relative
payment weights for covered OPD services (and
any groups of such services described in
subparagraph (B)) based on median (or, at the
election of the Secretary, mean) hospital costs
and shall determine projections of the
frequency of utilization of each such service
(or group of services) in 1999;
(D) subject to paragraph (19), the Secretary
shall determine a wage adjustment factor to
adjust the portion of payment and coinsurance
attributable to labor-related costs for
relative differences in labor and labor-related
costs across geographic regions in a budget
neutral manner;
(E) the Secretary shall establish, in a
budget neutral manner, outlier adjustments
under paragraph (5) and transitional pass-
through payments under paragraph (6) and other
adjustments as determined to be necessary to
ensure equitable payments, such as adjustments
for certain classes of hospitals;
(F) the Secretary shall develop a method for
controlling unnecessary increases in the volume
of covered OPD services;
(G) the Secretary shall create additional
groups of covered OPD services that classify
separately those procedures that utilize
contrast agents from those that do not; and
(H) with respect to devices of brachytherapy
consisting of a seed or seeds (or radioactive
source), the Secretary shall create additional
groups of covered OPD services that classify
such devices separately from the other services
(or group of services) paid for under this
subsection in a manner reflecting the number,
isotope, and radioactive intensity of such
devices furnished, including separate groups
for palladium-103 and iodine-125 devices and
for stranded and non-stranded devices furnished
on or after July 1, 2007.
For purposes of subparagraph (B), items and services
within a group shall not be treated as ``comparable
with respect to the use of resources'' if the highest
median cost (or mean cost, if elected by the Secretary
under subparagraph (C)) for an item or service within
the group is more than 2 times greater than the lowest
median cost (or mean cost, if so elected) for an item
or service within the group; except that the Secretary
may make exceptions in unusual cases, such as low
volume items and services, but may not make such an
exception in the case of a drug or biological that has
been designated as an orphan drug under section 526 of
the Federal Food, Drug and Cosmetic Act.
(3) Calculation of base amounts.--
(A) Aggregate amounts that would be payable
if deductibles were disregarded.--The Secretary
shall estimate the sum of--
(i) the total amounts that would be
payable from the Trust Fund under this
part for covered OPD services in 1999,
determined without regard to this
subsection, as though the deductible
under section 1833(b) did not apply,
and
(ii) the total amounts of copayments
estimated to be paid under this
subsection by beneficiaries to
hospitals for covered OPD services in
1999, as though the deductible under
section 1833(b) did not apply.
(B) Unadjusted copayment amount.--
(i) In general.--For purposes of this
subsection, subject to clause (ii), the
``unadjusted copayment amount''
applicable to a covered OPD service (or
group of such services) is 20 percent
of the national median of the charges
for the service (or services within the
group) furnished during 1996, updated
to 1999 using the Secretary's estimate
of charge growth during the period.
(ii) Adjusted to be 20 percent when
fully phased in.--If the pre-deductible
payment percentage for a covered OPD
service (or group of such services)
furnished in a year would be equal to
or exceed 80 percent, then the
unadjusted copayment amount shall be 20
percent of amount determined under
subparagraph (D).
(iii) Rules for new services.--The
Secretary shall establish rules for
establishment of an unadjusted
copayment amount for a covered OPD
service not furnished during 1996,
based upon its classification within a
group of such services.
(C) Calculation of conversion factors.--
(i) For 1999.--
(I) In general.--The
Secretary shall establish a
1999 conversion factor for
determining the medicare OPD
fee schedule amounts for each
covered OPD service (or group
of such services) furnished in
1999. Such conversion factor
shall be established on the
basis of the weights and
frequencies described in
paragraph (2)(C) and in such a
manner that the sum for all
services and groups of the
products (described in
subclause (II) for each such
service or group) equals the
total projected amount
described in subparagraph (A).
(II) Product described.--The
Secretary shall determine for
each service or group the
product of the medicare OPD fee
schedule amounts (taking into
account appropriate adjustments
described in paragraphs (2)(D)
and (2)(E)) and the estimated
frequencies for such service or
group.
(ii) Subsequent years.--Subject to
paragraph (8)(B), the Secretary shall
establish a conversion factor for
covered OPD services furnished in
subsequent years in an amount equal to
the conversion factor established under
this subparagraph and applicable to
such services furnished in the previous
year increased by the OPD fee schedule
increase factor specified under clause
(iv) for the year involved.
(iii) Adjustment for service mix
changes.--Insofar as the Secretary
determines that the adjustments for
service mix under paragraph (2) for a
previous year (or estimates that such
adjustments for a future year) did (or
are likely to) result in a change in
aggregate payments under this
subsection during the year that are a
result of changes in the coding or
classification of covered OPD services
that do not reflect real changes in
service mix, the Secretary may adjust
the conversion factor computed under
this subparagraph for subsequent years
so as to eliminate the effect of such
coding or classification changes.
(iv) OPD fee schedule increase
factor.--For purposes of this
subparagraph, subject to paragraph (17)
and subparagraph (F) of this paragraph,
the ``OPD fee schedule increase
factor'' for services furnished in a
year is equal to the market basket
percentage increase applicable under
section 1886(b)(3)(B)(iii) to hospital
discharges occurring during the fiscal
year ending in such year, reduced by 1
percentage point for such factor for
services furnished in each of 2000 and
2002. In applying the previous sentence
for years beginning with 2000, the
Secretary may substitute for the market
basket percentage increase an annual
percentage increase that is computed
and applied with respect to covered OPD
services furnished in a year in the
same manner as the market basket
percentage increase is determined and
applied to inpatient hospital services
for discharges occurring in a fiscal
year.
(D) Calculation of medicare opd fee schedule
amounts.--The Secretary shall compute a
medicare OPD fee schedule amount for each
covered OPD service (or group of such services)
furnished in a year, in an amount equal to the
product of--
(i) the conversion factor computed
under subparagraph (C) for the year,
and
(ii) the relative payment weight
(determined under paragraph (2)(C)) for
the service or group.
(E) Pre-deductible payment percentage.--The
pre-deductible payment percentage for a covered
OPD service (or group of such services)
furnished in a year is equal to the ratio of--
(i) the medicare OPD fee schedule
amount established under subparagraph
(D) for the year, minus the unadjusted
copayment amount determined under
subparagraph (B) for the service or
group, to
(ii) the medicare OPD fee schedule
amount determined under subparagraph
(D) for the year for such service or
group.
(F) Productivity and other adjustment.--After
determining the OPD fee schedule increase
factor under subparagraph (C)(iv), the
Secretary shall reduce such increase factor--
(i) for 2012 and subsequent years, by
the productivity adjustment described
in section 1886(b)(3)(B)(xi)(II); and
(ii) for each of 2010 through 2019,
by the adjustment described in
subparagraph (G).
The application of this subparagraph may result
in the increase factor under subparagraph
(C)(iv) being less than 0.0 for a year, and may
result in payment rates under the payment
system under this subsection for a year being
less than such payment rates for the preceding
year.
(G) Other adjustment.--For purposes of
subparagraph (F)(ii), the adjustment described
in this subparagraph is--
(i) for each of 2010 and 2011, 0.25
percentage point;
(ii) for each of 2012 and 2013, 0.1
percentage point;
(iii) for 2014, 0.3 percentage point;
(iv) for each of 2015 and 2016, 0.2
percentage point; and
(v) for each of 2017, 2018, and 2019,
0.75 percentage point.
(4) Medicare payment amount.--The amount of payment
made from the Trust Fund under this part for a covered
OPD service (and such services classified within a
group) furnished in a year is determined, subject to
paragraph (7), as follows:
(A) Fee schedule adjustments.--The medicare
OPD fee schedule amount (computed under
paragraph (3)(D)) for the service or group and
year is adjusted for relative differences in
the cost of labor and other factors determined
by the Secretary, as computed under paragraphs
(2)(D) and (2)(E).
(B) Subtract applicable deductible.--Reduce
the adjusted amount determined under
subparagraph (A) by the amount of the
deductible under section 1833(b), to the extent
applicable.
(C) Apply payment proportion to remainder.--
The amount of payment is the amount so
determined under subparagraph (B) multiplied by
the pre-deductible payment percentage (as
determined under paragraph (3)(E)) for the
service or group and year involved, plus the
amount of any reduction in the copayment amount
attributable to paragraph (8)(C).
(5) Outlier adjustment.--
(A) In general.--Subject to subparagraph (D),
the Secretary shall provide for an additional
payment for each covered OPD service (or group
of services) for which a hospital's charges,
adjusted to cost, exceed--
(i) a fixed multiple of the sum of--
(I) the applicable medicare
OPD fee schedule amount
determined under paragraph
(3)(D), as adjusted under
paragraph (4)(A) (other than
for adjustments under this
paragraph or paragraph (6));
and
(II) any transitional pass-
through payment under paragraph
(6); and
(ii) at the option of the Secretary,
such fixed dollar amount as the
Secretary may establish.
(B) Amount of adjustment.--The amount of the
additional payment under subparagraph (A) shall
be determined by the Secretary and shall
approximate the marginal cost of care beyond
the applicable cutoff point under such
subparagraph.
(C) Limit on aggregate outlier adjustments.--
(i) In general.--The total of the
additional payments made under this
paragraph for covered OPD services
furnished in a year (as estimated by
the Secretary before the beginning of
the year) may not exceed the applicable
percentage (specified in clause (ii))
of the total program payments estimated
to be made under this subsection for
all covered OPD services furnished in
that year. If this paragraph is first
applied to less than a full year, the
previous sentence shall apply only to
the portion of such year.
(ii) Applicable percentage.--For
purposes of clause (i), the term
``applicable percentage'' means a
percentage specified by the Secretary
up to (but not to exceed)--
(I) for a year (or portion of
a year) before 2004, 2.5
percent; and
(II) for 2004 and thereafter,
3.0 percent.
(D) Transitional authority.--In applying
subparagraph (A) for covered OPD services
furnished before January 1, 2002, the Secretary
may--
(i) apply such subparagraph to a bill
for such services related to an
outpatient encounter (rather than for a
specific service or group of services)
using OPD fee schedule amounts and
transitional pass-through payments
covered under the bill; and
(ii) use an appropriate cost-to-
charge ratio for the hospital involved
(as determined by the Secretary),
rather than for specific departments
within the hospital.
(E) Exclusion of separate drug and biological
apcs from outlier payments.--No additional
payment shall be made under subparagraph (A) in
the case of ambulatory payment classification
groups established separately for drugs or
biologicals.
(6) Transitional pass-through for additional costs of
innovative medical devices, drugs, and biologicals.--
(A) In general.--The Secretary shall provide
for an additional payment under this paragraph
for any of the following that are provided as
part of a covered OPD service (or group of
services):
(i) Current orphan drugs.--A drug or
biological that is used for a rare
disease or condition with respect to
which the drug or biological has been
designated as an orphan drug under
section 526 of the Federal Food, Drug
and Cosmetic Act if payment for the
drug or biological as an outpatient
hospital service under this part was
being made on the first date that the
system under this subsection is
implemented.
(ii) Current cancer therapy drugs and
biologicals and brachytherapy.--A drug
or biological that is used in cancer
therapy, including (but not limited to)
a chemotherapeutic agent, an
antiemetic, a hematopoietic growth
factor, a colony stimulating factor, a
biological response modifier, a
bisphosphonate, and a device of
brachytherapy or temperature monitored
cryoablation, if payment for such drug,
biological, or device as an outpatient
hospital service under this part was
being made on such first date.
(iii) Current radiopharmaceutical
drugs and biological products.--A
radiopharmaceutical drug or biological
product used in diagnostic, monitoring,
and therapeutic nuclear medicine
procedures if payment for the drug or
biological as an outpatient hospital
service under this part was being made
on such first date.
(iv) New medical devices, drugs, and
biologicals.--A medical device, drug,
or biological not described in clause
(i), (ii), or (iii) if--
(I) payment for the device,
drug, or biological as an
outpatient hospital service
under this part was not being
made as of December 31, 1996;
and
(II) the cost of the drug or
biological or the average cost
of the category of devices is
not insignificant in relation
to the OPD fee schedule amount
(as calculated under paragraph
(3)(D)) payable for the service
(or group of services)
involved.
(B) Use of categories in determining
eligibility of a device for pass-through
payments.--The following provisions apply for
purposes of determining whether a medical
device qualifies for additional payments under
clause (ii) or (iv) of subparagraph (A):
(i) Establishment of initial
categories.--
(I) In general.--The
Secretary shall initially
establish under this clause
categories of medical devices
based on type of device by
April 1, 2001. Such categories
shall be established in a
manner such that each medical
device that meets the
requirements of clause (ii) or
(iv) of subparagraph (A) as of
January 1, 2001, is included in
such a category and no such
device is included in more than
one category. For purposes of
the preceding sentence, whether
a medical device meets such
requirements as of such date
shall be determined on the
basis of the program memoranda
issued before such date.
(II) Authorization of
implementation other than
through regulations.--The
categories may be established
under this clause by program
memorandum or otherwise, after
consultation with groups
representing hospitals,
manufacturers of medical
devices, and other affected
parties.
(ii) Establishing criteria for
additional categories.--
(I) In general.--The
Secretary shall establish
criteria that will be used for
creation of additional
categories (other than those
established under clause (i))
through rulemaking (which may
include use of an interim final
rule with comment period).
(II) Standard.--Such
categories shall be established
under this clause in a manner
such that no medical device is
described by more than one
category. Such criteria shall
include a test of whether the
average cost of devices that
would be included in a category
and are in use at the time the
category is established is not
insignificant, as described in
subparagraph (A)(iv)(II).
(III) Deadline.--Criteria
shall first be established
under this clause by July 1,
2001. The Secretary may
establish in compelling
circumstances categories under
this clause before the date
such criteria are established.
(IV) Adding categories.--The
Secretary shall promptly
establish a new category of
medical devices under this
clause for any medical device
that meets the requirements of
subparagraph (A)(iv) and for
which none of the categories in
effect (or that were previously
in effect) is appropriate.
(iii) Period for which category is in
effect.--A category of medical devices
established under clause (i) or (ii)
shall be in effect for a period of at
least 2 years, but not more than 3
years, that begins--
(I) in the case of a category
established under clause (i),
on the first date on which
payment was made under this
paragraph for any device
described by such category
(including payments made during
the period before April 1,
2001); and
(II) in the case of any other
category, on the first date on
which payment is made under
this paragraph for any medical
device that is described by
such category.
(iv) Requirements treated as met.--A
medical device shall be treated as
meeting the requirements of
subparagraph (A)(iv), regardless of
whether the device meets the
requirement of subclause (I) of such
subparagraph, if--
(I) the device is described
by a category established and
in effect under clause (i); or
(II) the device is described
by a category established and
in effect under clause (ii) and
an application under section
515 of the Federal Food, Drug,
and Cosmetic Act has been
approved with respect to the
device, or the device has been
cleared for market under
section 510(k) of such Act, or
the device is exempt from the
requirements of section 510(k)
of such Act pursuant to
subsection (l) or (m) of
section 510 of such Act or
section 520(g) of such Act.
Nothing in this clause shall be
construed as requiring an application
or prior approval (other than that
described in subclause (II)) in order
for a covered device described by a
category to qualify for payment under
this paragraph.
(C) Limited period of payment.--
(i) Drugs and biologicals.--Subject
to subparagraph (G), the payment under
this paragraph with respect to a drug
or biological shall only apply during a
period of at least 2 years, but not
more than 3 years, that begins--
(I) on the first date this
subsection is implemented in
the case of a drug or
biological described in clause
(i), (ii), or (iii) of
subparagraph (A) and in the
case of a drug or biological
described in subparagraph
(A)(iv) and for which payment
under this part is made as an
outpatient hospital service
before such first date; or
(II) in the case of a drug or
biological described in
subparagraph (A)(iv) not
described in subclause (I), on
the first date on which payment
is made under this part for the
drug or biological as an
outpatient hospital service.
(ii) Medical devices.--Payment shall
be made under this paragraph with
respect to a medical device only if
such device--
(I) is described by a
category of medical devices
established and in effect under
subparagraph (B); and
(II) is provided as part of a
service (or group of services)
paid for under this subsection
and provided during the period
for which such category is in
effect under such subparagraph.
(D) Amount of additional payment.--Subject to
subparagraph (E)(iii), the amount of the
payment under this paragraph with respect to a
device, drug, or biological provided as part of
a covered OPD service is--
(i) subject to subparagraph (H), in
the case of a drug or biological, the
amount by which the amount determined
under section 1842(o) (or if the drug
or biological is covered under a
competitive acquisition contract under
section 1847B, an amount determined by
the Secretary equal to the average
price for the drug or biological for
all competitive acquisition areas and
year established under such section as
calculated and adjusted by the
Secretary for purposes of this
paragraph) for the drug or biological
exceeds the portion of the otherwise
applicable medicare OPD fee schedule
that the Secretary determines is
associated with the drug or biological;
or
(ii) in the case of a medical device,
the amount by which the hospital's
charges for the device, adjusted to
cost, exceeds the portion of the
otherwise applicable medicare OPD fee
schedule that the Secretary determines
is associated with the device.
(E) Limit on aggregate annual adjustment.--
(i) In general.--The total of the
additional payments made under this
paragraph for covered OPD services
furnished in a year (as estimated by
the Secretary before the beginning of
the year) may not exceed the applicable
percentage (specified in clause (ii))
of the total program payments estimated
to be made under this subsection for
all covered OPD services furnished in
that year. If this paragraph is first
applied to less than a full year, the
previous sentence shall apply only to
the portion of such year. This clause
shall not apply for 2018.
(ii) Applicable percentage.--For
purposes of clause (i), the term
``applicable percentage'' means--
(I) for a year (or portion of
a year) before 2004, 2.5
percent; and
(II) for 2004 and thereafter,
a percentage specified by the
Secretary up to (but not to
exceed) 2.0 percent.
(iii) Uniform prospective reduction
if aggregate limit projected to be
exceeded.--If the Secretary estimates
before the beginning of a year that the
amount of the additional payments under
this paragraph for the year (or portion
thereof) as determined under clause (i)
without regard to this clause will
exceed the limit established under such
clause, the Secretary shall reduce pro
rata the amount of each of the
additional payments under this
paragraph for that year (or portion
thereof) in order to ensure that the
aggregate additional payments under
this paragraph (as so estimated) do not
exceed such limit.
(F) Limitation of application of functional
equivalence standard.--
(i) In general.--The Secretary may
not publish regulations that apply a
functional equivalence standard to a
drug or biological under this
paragraph.
(ii) Application.--Clause (i) shall
apply to the application of a
functional equivalence standard to a
drug or biological on or after the date
of enactment of the Medicare
Prescription Drug, Improvement, and
Modernization Act of 2003 unless--
(I) such application was
being made to such drug or
biological prior to such date
of enactment; and
(II) the Secretary applies
such standard to such drug or
biological only for the purpose
of determining eligibility of
such drug or biological for
additional payments under this
paragraph and not for the
purpose of any other payments
under this title.
(iii) Rule of construction.--Nothing
in this subparagraph shall be construed
to effect the Secretary's authority to
deem a particular drug to be identical
to another drug if the 2 products are
pharmaceutically equivalent and
bioequivalent, as determined by the
Commissioner of Food and Drugs.
(G) Pass-through extension for certain drugs
and biologicals.--In the case of a drug or
biological whose period of pass-through status
under this paragraph ended on December 31,
2017, and for which payment under this
subsection was packaged into a payment for a
covered OPD service (or group of services)
furnished beginning January 1, 2018, such pass-
through status shall be extended for a 2-year
period beginning on October 1, 2018.
(H) Temporary payment rule for certain drugs
and biologicals.--In the case of a drug or
biological whose period of pass-through status
under this paragraph ended on December 31,
2017, and for which payment under this
subsection was packaged into a payment for a
covered OPD service (or group of services)
furnished beginning January 1, 2018, the
payment amount for such drug or biological
under this subsection that is furnished during
the period beginning on October 1, 2018, and
ending on March 31, 2019, shall be the greater
of--
(i) the payment amount that would
otherwise apply under subparagraph
(D)(i) for such drug or biological
during such period; or
(ii) the payment amount that applied
under such subparagraph (D)(i) for such
drug or biological on December 31,
2017.
(I) Special payment adjustment rules for last
quarter of 2018.--In the case of a drug or
biological whose period of pass-through status
under this paragraph ended on December 31,
2017, and for which payment under this
subsection was packaged into a payment amount
for a covered OPD service (or group of
services) beginning January 1, 2018, the
following rules shall apply with respect to
payment amounts under this subsection for
covered a OPD service (or group of services)
furnished during the period beginning on
October 1, 2018, and ending on December 31,
2018:
(i) The Secretary shall remove the
packaged costs of such drug or
biological (as determined by the
Secretary) from the payment amount
under this subsection for the covered
OPD service (or group of services) with
which it is packaged.
(ii) The Secretary shall not make any
adjustments to payment amounts under
this subsection for a covered OPD
service (or group of services) for
which no costs were removed under
clause (i).
(7) Transitional adjustment to limit decline in
payment.--
(A) Before 2002.--Subject to subparagraph
(D), for covered OPD services furnished before
January 1, 2002, for which the PPS amount (as
defined in subparagraph (E)) is--
(i) at least 90 percent, but less
than 100 percent, of the pre-BBA amount
(as defined in subparagraph (F)), the
amount of payment under this subsection
shall be increased by 80 percent of the
amount of such difference;
(ii) at least 80 percent, but less
than 90 percent, of the pre-BBA amount,
the amount of payment under this
subsection shall be increased by the
amount by which (I) the product of 0.71
and the pre-BBA amount, exceeds (II)
the product of 0.70 and the PPS amount;
(iii) at least 70 percent, but less
than 80 percent, of the pre-BBA amount,
the amount of payment under this
subsection shall be increased by the
amount by which (I) the product of 0.63
and the pre-BBA amount, exceeds (II)
the product of 0.60 and the PPS amount;
or
(iv) less than 70 percent of the pre-
BBA amount, the amount of payment under
this subsection shall be increased by
21 percent of the pre-BBA amount.
(B) 2002.--Subject to subparagraph (D), for
covered OPD services furnished during 2002, for
which the PPS amount is--
(i) at least 90 percent, but less
than 100 percent, of the pre-BBA
amount, the amount of payment under
this subsection shall be increased by
70 percent of the amount of such
difference;
(ii) at least 80 percent, but less
than 90 percent, of the pre-BBA amount,
the amount of payment under this
subsection shall be increased by the
amount by which (I) the product of 0.61
and the pre-BBA amount, exceeds (II)
the product of 0.60 and the PPS amount;
or
(iii) less than 80 percent of the
pre-BBA amount, the amount of payment
under this subsection shall be
increased by 13 percent of the pre-BBA
amount.
(C) 2003.--Subject to subparagraph (D), for
covered OPD services furnished during 2003, for
which the PPS amount is--
(i) at least 90 percent, but less
than 100 percent, of the pre-BBA
amount, the amount of payment under
this subsection shall be increased by
60 percent of the amount of such
difference; or
(ii) less than 90 percent of the pre-
BBA amount, the amount of payment under
this subsection shall be increased by 6
percent of the pre-BBA amount.
(D) Hold harmless provisions.--
(i) Temporary treatment for certain
rural hospitals.--(I) In the case of a
hospital located in a rural area and
that has not more than 100 beds or a
sole community hospital (as defined in
section 1886(d)(5)(D)(iii)) located in
a rural area, for covered OPD services
furnished before January 1, 2006, for
which the PPS amount is less than the
pre-BBA amount, the amount of payment
under this subsection shall be
increased by the amount of such
difference.
(II) In the case of a hospital
located in a rural area and that has
not more than 100 beds and that is not
a sole community hospital (as defined
in section 1886(d)(5)(D)(iii)), for
covered OPD services furnished on or
after January 1, 2006, and before
January 1, 2013, for which the PPS
amount is less than the pre-BBA amount,
the amount of payment under this
subsection shall be increased by the
applicable percentage of the amount of
such difference. For purposes of the
preceding sentence, the applicable
percentage shall be 95 percent with
respect to covered OPD services
furnished in 2006, 90 percent with
respect to such services furnished in
2007, and 85 percent with respect to
such services furnished in 2008, 2009,
2010, 2011, or 2012.
(III) In the case of a sole community
hospital (as defined in section
1886(d)(5)(D)(iii)) that has not more
than 100 beds, for covered OPD services
furnished on or after January 1, 2009,
and before January 1, 2013, for which
the PPS amount is less than the pre-BBA
amount, the amount of payment under
this subsection shall be increased by
85 percent of the amount of such
difference. In the case of covered OPD
services furnished on or after January
1, 2010, and before March 1, 2012, the
preceding sentence shall be applied
without regard to the 100-bed
limitation.
(ii) Permanent treatment for cancer
hospitals and children's hospitals.--In
the case of a hospital described in
clause (iii) or (v) of section
1886(d)(1)(B), for covered OPD services
for which the PPS amount is less than
the pre-BBA amount, the amount of
payment under this subsection shall be
increased by the amount of such
difference.
(E) PPS amount defined.--In this paragraph,
the term ``PPS amount'' means, with respect to
covered OPD services, the amount payable under
this title for such services (determined
without regard to this paragraph), including
amounts payable as copayment under paragraph
(8), coinsurance under section
1866(a)(2)(A)(ii), and the deductible under
section 1833(b).
(F) Pre-BBA amount defined.--
(i) In general.--In this paragraph,
the ``pre-BBA amount'' means, with
respect to covered OPD services
furnished by a hospital in a year, an
amount equal to the product of the
reasonable cost of the hospital for
such services for the portions of the
hospital's cost reporting period (or
periods) occurring in the year and the
base OPD payment-to-cost ratio for the
hospital (as defined in clause (ii)).
(ii) Base payment-to-cost-ratio
defined.--For purposes of this
subparagraph, the ``base payment-to-
cost ratio'' for a hospital means the
ratio of--
(I) the hospital's
reimbursement under this part
for covered OPD services
furnished during the cost
reporting period ending in 1996
(or in the case of a hospital
that did not submit a cost
report for such period, during
the first subsequent cost
reporting period ending before
2001 for which the hospital
submitted a cost report),
including any reimbursement for
such services through cost-
sharing described in
subparagraph (E), to
(II) the reasonable cost of
such services for such period.
The Secretary shall determine such
ratios as if the amendments made by
section 4521 of the Balanced Budget Act
of 1997 were in effect in 1996.
(G) Interim payments.--The Secretary shall
make payments under this paragraph to hospitals
on an interim basis, subject to retrospective
adjustments based on settled cost reports.
(H) No effect on copayments.--Nothing in this
paragraph shall be construed to affect the
unadjusted copayment amount described in
paragraph (3)(B) or the copayment amount under
paragraph (8).
(I) Application without regard to budget
neutrality.--The additional payments made under
this paragraph--
(i) shall not be considered an
adjustment under paragraph (2)(E); and
(ii) shall not be implemented in a
budget neutral manner.
(8) Copayment amount.--
(A) In general.--Except as provided in
subparagraphs (B) and (C), the copayment amount
under this subsection is the amount by which
the amount described in paragraph (4)(B)
exceeds the amount of payment determined under
paragraph (4)(C).
(B) Election to offer reduced copayment
amount.--The Secretary shall establish a
procedure under which a hospital, before the
beginning of a year (beginning with 1999), may
elect to reduce the copayment amount otherwise
established under subparagraph (A) for some or
all covered OPD services to an amount that is
not less than 20 percent of the medicare OPD
fee schedule amount (computed under paragraph
(3)(D)) for the service involved. Under such
procedures, such reduced copayment amount may
not be further reduced or increased during the
year involved and the hospital may disseminate
information on the reduction of copayment
amount effected under this subparagraph.
(C) Limitation on copayment amount.--
(i) To inpatient hospital deductible
amount.--In no case shall the copayment
amount for a procedure performed in a
year exceed the amount of the inpatient
hospital deductible established under
section 1813(b) for that year.
(ii) To specified percentage.--The
Secretary shall reduce the national
unadjusted copayment amount for a
covered OPD service (or group of such
services) furnished in a year in a
manner so that the effective copayment
rate (determined on a national
unadjusted basis) for that service in
the year does not exceed the following
percentage:
(I) For procedures performed
in 2001, on or after April 1,
2001, 57 percent.
(II) For procedures performed
in 2002 or 2003, 55 percent.
(III) For procedures
performed in 2004, 50 percent.
(IV) For procedures performed
in 2005, 45 percent.
(V) For procedures performed
in 2006 and thereafter, 40
percent.
(D) No impact on deductibles.--Nothing in
this paragraph shall be construed as affecting
a hospital's authority to waive the charging of
a deductible under section 1833(b).
(E) Computation ignoring outlier and pass-
through adjustments.--The copayment amount
shall be computed under subparagraph (A) as if
the adjustments under paragraphs (5) and (6)
(and any adjustment made under paragraph (2)(E)
in relation to such adjustments) had not
occurred.
(9) Periodic review and adjustments components of
prospective payment system.--
(A) Periodic review.--The Secretary shall
review not less often than annually and revise
the groups, the relative payment weights, and
the wage and other adjustments described in
paragraph (2) to take into account changes in
medical practice, changes in technology, the
addition of new services, new cost data, and
other relevant information and factors. The
Secretary shall consult with an expert outside
advisory panel composed of an appropriate
selection of representatives of providers to
review (and advise the Secretary concerning)
the clinical integrity of the groups and
weights. Such panel may use data collected or
developed by entities and organizations (other
than the Department of Health and Human
Services) in conducting such review.
(B) Budget neutrality adjustment.--If the
Secretary makes adjustments under subparagraph
(A), then the adjustments for a year may not
cause the estimated amount of expenditures
under this part for the year to increase or
decrease from the estimated amount of
expenditures under this part that would have
been made if the adjustments had not been made.
In determining adjustments under the preceding
sentence for 2004 and 2005, the Secretary shall
not take into account under this subparagraph
or paragraph (2)(E) any expenditures that would
not have been made but for the application of
paragraph (14).
(C) Update factor.--If the Secretary
determines under methodologies described in
paragraph (2)(F) that the volume of services
paid for under this subsection increased beyond
amounts established through those
methodologies, the Secretary may appropriately
adjust the update to the conversion factor
otherwise applicable in a subsequent year.
(10) Special rule for ambulance services.--The
Secretary shall pay for hospital outpatient services
that are ambulance services on the basis described in
section 1861(v)(1)(U), or, if applicable, the fee
schedule established under section 1834(l).
(11) Special rules for certain hospitals.--In the
case of hospitals described in clause (iii) or (v) of
section 1886(d)(1)(B)--
(A) the system under this subsection shall
not apply to covered OPD services furnished
before January 1, 2000; and
(B) the Secretary may establish a separate
conversion factor for such services in a manner
that specifically takes into account the unique
costs incurred by such hospitals by virtue of
their patient population and service intensity.
(12) Limitation on review.--There shall be no
administrative or judicial review under section 1869,
1878, or otherwise of--
(A) the development of the classification
system under paragraph (2), including the
establishment of groups and relative payment
weights for covered OPD services, of wage
adjustment factors, other adjustments, and
methods described in paragraph (2)(F);
(B) the calculation of base amounts under
paragraph (3);
(C) periodic adjustments made under paragraph
(6);
(D) the establishment of a separate
conversion factor under paragraph (8)(B); and
(E) the determination of the fixed multiple,
or a fixed dollar cutoff amount, the marginal
cost of care, or applicable percentage under
paragraph (5) or the determination of
insignificance of cost, the duration of the
additional payments, the determination and
deletion of initial and new categories
(consistent with subparagraphs (B) and (C) of
paragraph (6)), the portion of the medicare OPD
fee schedule amount associated with particular
devices, drugs, or biologicals, and the
application of any pro rata reduction under
paragraph (6).
(13) Authorization of adjustment for rural
hospitals.--
(A) Study.--The Secretary shall conduct a
study to determine if, under the system under
this subsection, costs incurred by hospitals
located in rural areas by ambulatory payment
classification groups (APCs) exceed those costs
incurred by hospitals located in urban areas.
(B) Authorization of adjustment.--Insofar as
the Secretary determines under subparagraph (A)
that costs incurred by hospitals located in
rural areas exceed those costs incurred by
hospitals located in urban areas, the Secretary
shall provide for an appropriate adjustment
under paragraph (2)(E) to reflect those higher
costs by January 1, 2006.
(14) Drug apc payment rates.--
(A) In general.--The amount of payment under
this subsection for a specified covered
outpatient drug (defined in subparagraph (B))
that is furnished as part of a covered OPD
service (or group of services)--
(i) in 2004, in the case of--
(I) a sole source drug shall
in no case be less than 88
percent, or exceed 95 percent,
of the reference average
wholesale price for the drug;
(II) an innovator multiple
source drug shall in no case
exceed 68 percent of the
reference average wholesale
price for the drug; or
(III) a noninnovator multiple
source drug shall in no case
exceed 46 percent of the
reference average wholesale
price for the drug;
(ii) in 2005, in the case of--
(I) a sole source drug shall
in no case be less than 83
percent, or exceed 95 percent,
of the reference average
wholesale price for the drug;
(II) an innovator multiple
source drug shall in no case
exceed 68 percent of the
reference average wholesale
price for the drug; or
(III) a noninnovator multiple
source drug shall in no case
exceed 46 percent of the
reference average wholesale
price for the drug; or
(iii) in a subsequent year, shall be
equal, subject to subparagraph (E)--
(I) to the average
acquisition cost for the drug
for that year (which, at the
option of the Secretary, may
vary by hospital group (as
defined by the Secretary based
on volume of covered OPD
services or other relevant
characteristics)), as
determined by the Secretary
taking into account the
hospital acquisition cost
survey data under subparagraph
(D); or
(II) if hospital acquisition
cost data are not available,
the average price for the drug
in the year established under
section 1842(o), section 1847A,
or section 1847B, as the case
may be, as calculated and
adjusted by the Secretary as
necessary for purposes of this
paragraph.
(B) Specified covered outpatient drug
defined.--
(i) In general.--In this paragraph,
the term ``specified covered outpatient
drug'' means, subject to clause (ii), a
covered outpatient drug (as defined in
section 1927(k)(2)) for which a
separate ambulatory payment
classification group (APC) has been
established and that is--
(I) a radiopharmaceutical; or
(II) a drug or biological for
which payment was made under
paragraph (6) (relating to
pass-through payments) on or
before December 31, 2002.
(ii) Exception.--Such term does not
include--
(I) a drug or biological for
which payment is first made on
or after January 1, 2003, under
paragraph (6);
(II) a drug or biological for
which a temporary HCPCS code
has not been assigned; or
(III) during 2004 and 2005,
an orphan drug (as designated
by the Secretary).
(C) Payment for designated orphan drugs
during 2004 and 2005.--The amount of payment
under this subsection for an orphan drug
designated by the Secretary under subparagraph
(B)(ii)(III) that is furnished as part of a
covered OPD service (or group of services)
during 2004 and 2005 shall equal such amount as
the Secretary may specify.
(D) Acquisition cost survey for hospital
outpatient drugs.--
(i) Annual gao surveys in 2004 and
2005.--
(I) In general.--The
Comptroller General of the
United States shall conduct a
survey in each of 2004 and 2005
to determine the hospital
acquisition cost for each
specified covered outpatient
drug. Not later than April 1,
2005, the Comptroller General
shall furnish data from such
surveys to the Secretary for
use in setting the payment
rates under subparagraph (A)
for 2006.
(II) Recommendations.--Upon
the completion of such surveys,
the Comptroller General shall
recommend to the Secretary the
frequency and methodology of
subsequent surveys to be
conducted by the Secretary
under clause (ii).
(ii) Subsequent secretarial
surveys.--The Secretary, taking into
account such recommendations, shall
conduct periodic subsequent surveys to
determine the hospital acquisition cost
for each specified covered outpatient
drug for use in setting the payment
rates under subparagraph (A).
(iii) Survey requirements.--The
surveys conducted under clauses (i) and
(ii) shall have a large sample of
hospitals that is sufficient to
generate a statistically significant
estimate of the average hospital
acquisition cost for each specified
covered outpatient drug. With respect
to the surveys conducted under clause
(i), the Comptroller General shall
report to Congress on the justification
for the size of the sample used in
order to assure the validity of such
estimates.
(iv) Differentiation in cost.--In
conducting surveys under clause (i),
the Comptroller General shall determine
and report to Congress if there is (and
the extent of any) variation in
hospital acquisition costs for drugs
among hospitals based on the volume of
covered OPD services performed by such
hospitals or other relevant
characteristics of such hospitals (as
defined by the Comptroller General).
(v) Comment on proposed rates.--Not
later than 30 days after the date the
Secretary promulgated proposed rules
setting forth the payment rates under
subparagraph (A) for 2006, the
Comptroller General shall evaluate such
proposed rates and submit to Congress a
report regarding the appropriateness of
such rates based on the surveys the
Comptroller General has conducted under
clause (i).
(E) Adjustment in payment rates for overhead
costs.--
(i) Medpac report on drug apc
design.--The Medicare Payment Advisory
Commission shall submit to the
Secretary, not later than July 1, 2005,
a report on adjustment of payment for
ambulatory payment classifications for
specified covered outpatient drugs to
take into account overhead and related
expenses, such as pharmacy services and
handling costs. Such report shall
include--
(I) a description and
analysis of the data available
with regard to such expenses;
(II) a recommendation as to
whether such a payment
adjustment should be made; and
(III) if such adjustment
should be made, a
recommendation regarding the
methodology for making such an
adjustment.
(ii) Adjustment authorized.--The
Secretary may adjust the weights for
ambulatory payment classifications for
specified covered outpatient drugs to
take into account the recommendations
contained in the report submitted under
clause (i).
(F) Classes of drugs.--For purposes of this
paragraph:
(i) Sole source drugs.--The term
``sole source drug'' means--
(I) a biological product (as
defined under section
1861(t)(1)); or
(II) a single source drug (as
defined in section
1927(k)(7)(A)(iv)).
(ii) Innovator multiple source
drugs.--The term ``innovator multiple
source drug'' has the meaning given
such term in section 1927(k)(7)(A)(ii).
(iii) Noninnovator multiple source
drugs.--The term ``noninnovator
multiple source drug'' has the meaning
given such term in section
1927(k)(7)(A)(iii).
(G) Reference average wholesale price.--The
term ``reference average wholesale price''
means, with respect to a specified covered
outpatient drug, the average wholesale price
for the drug as determined under section
1842(o) as of May 1, 2003.
(H) Inapplicability of expenditures in
determining conversion, weighting, and other
adjustment factors.--Additional expenditures
resulting from this paragraph shall not be
taken into account in establishing the
conversion, weighting, and other adjustment
factors for 2004 and 2005 under paragraph (9),
but shall be taken into account for subsequent
years.
(15) Payment for new drugs and biologicals until
hcpcs code assigned.--With respect to payment under
this part for an outpatient drug or biological that is
covered under this part and is furnished as part of
covered OPD services for which a HCPCS code has not
been assigned, the amount provided for payment for such
drug or biological under this part shall be equal to 95
percent of the average wholesale price for the drug or
biological.
(16) Miscellaneous provisions.--
(A) Application of reclassification of
certain hospitals.--If a hospital is being
treated as being located in a rural area under
section 1886(d)(8)(E), that hospital shall be
treated under this subsection as being located
in that rural area.
(B) Threshold for establishment of separate
apcs for drugs.--The Secretary shall reduce the
threshold for the establishment of separate
ambulatory payment classification groups (APCs)
with respect to drugs or biologicals to $50 per
administration for drugs and biologicals
furnished in 2005 and 2006.
(C) Payment for devices of brachytherapy and
therapeutic radiopharmaceuticals at charges
adjusted to cost.--Notwithstanding the
preceding provisions of this subsection, for a
device of brachytherapy consisting of a seed or
seeds (or radioactive source) furnished on or
after January 1, 2004, and before January 1,
2010, and for therapeutic radiopharmaceuticals
furnished on or after January 1, 2008, and
before January 1, 2010, the payment basis for
the device or therapeutic radiopharmaceutical
under this subsection shall be equal to the
hospital's charges for each device or
therapeutic radiopharmaceutical furnished,
adjusted to cost. Charges for such devices or
therapeutic radiopharmaceuticals shall not be
included in determining any outlier payment
under this subsection.
(D) Special payment rule.--
(i) In general.--In the case of
covered OPD services furnished on or
after April 1, 2013, in a hospital
described in clause (ii), if--
(I) the payment rate that
would otherwise apply under
this subsection for
stereotactic radiosurgery,
complete course of treatment of
cranial lesion(s) consisting of
1 session that is multi-source
Cobalt 60 based (identified as
of January 1, 2013, by HCPCS
code 77371 (and any succeeding
code) and reimbursed as of such
date under APC 0127 (and any
succeeding classification
group)); exceeds
(II) the payment rate that
would otherwise apply under
this subsection for linear
accelerator based stereotactic
radiosurgery, complete course
of therapy in one session
(identified as of January 1,
2013, by HCPCS code G0173 (and
any succeeding code) and
reimbursed as of such date
under APC 0067 (and any
succeeding classification
group)),
the payment rate for the service
described in subclause (I) shall be
reduced to an amount equal to the
payment rate for the service described
in subclause (II).
(ii) Hospital described.--A hospital
described in this clause is a hospital
that is not--
(I) located in a rural area
(as defined in section
1886(d)(2)(D));
(II) classified as a rural
referral center under section
1886(d)(5)(C); or
(III) a sole community
hospital (as defined in section
1886(d)(5)(D)(iii)).
(iii) Not budget neutral.--In making
any budget neutrality adjustments under
this subsection for 2013 (with respect
to covered OPD services furnished on or
after April 1, 2013, and before January
1, 2014) or a subsequent year, the
Secretary shall not take into account
the reduced expenditures that result
from the application of this
subparagraph.
(E) Application of appropriate use criteria
for certain imaging services.--For provisions
relating to the application of appropriate use
criteria for certain imaging services, see
section 1834(q).
(F) Payment incentive for the transition from
traditional x-ray imaging to digital
radiography.--Notwithstanding the previous
provisions of this subsection:
(i) Limitation on payment for film x-
ray imaging services.--In the case of
an imaging service that is an X-ray
taken using film and that is furnished
during 2017 or a subsequent year, the
payment amount for such service
(including the X-ray component of a
packaged service) that would otherwise
be determined under this section
(without application of this paragraph
and before application of any other
adjustment under this subsection) for
such year shall be reduced by 20
percent.
(ii) Phased-in limitation on payment
for computed radiography imaging
services.--In the case of an imaging
service that is an X-ray taken using
computed radiography technology (as
defined in section 1848(b)(9)(C))--
(I) in the case of such a
service furnished during 2018,
2019, 2020, 2021, or 2022, the
payment amount for such service
(including the X-ray component
of a packaged service) that
would otherwise be determined
under this section (without
application of this paragraph
and before application of any
other adjustment under this
subsection) for such year shall
be reduced by 7 percent; and
(II) in the case of such a
service furnished during 2023
or a subsequent year, the
payment amount for such service
(including the X-ray component
of a packaged service) that
would otherwise be determined
under this section (without
application of this paragraph
and before application of any
other adjustment under this
subsection) for such year shall
be reduced by 10 percent.
(iii) Application without regard to
budget neutrality.--The reductions made
under this subparagraph--
(I) shall not be considered
an adjustment under paragraph
(2)(E); and
(II) shall not be implemented
in a budget neutral manner.
(iv) Implementation.--In order to
implement this subparagraph, the
Secretary shall adopt appropriate
mechanisms which may include use of
modifiers.
(17) Quality reporting.--
(A) Reduction in update for failure to
report.--
(i) In general.--For purposes of
paragraph (3)(C)(iv) for 2009 and each
subsequent year, in the case of a
subsection (d) hospital (as defined in
section 1886(d)(1)(B)) that does not
submit, to the Secretary in accordance
with this paragraph, data required to
be submitted on measures selected under
this paragraph with respect to such a
year, the OPD fee schedule increase
factor under paragraph (3)(C)(iv) for
such year shall be reduced by 2.0
percentage points.
(ii) Non-cumulative application.--A
reduction under this subparagraph shall
apply only with respect to the year
involved and the Secretary shall not
take into account such reduction in
computing the OPD fee schedule increase
factor for a subsequent year.
(B) Form and manner of submission.--Each
subsection (d) hospital shall submit data on
measures selected under this paragraph to the
Secretary in a form and manner, and at a time,
specified by the Secretary for purposes of this
paragraph.
(C) Development of outpatient measures.--
(i) In general.--The Secretary shall
develop measures that the Secretary
determines to be appropriate for the
measurement of the quality of care
(including medication errors) furnished
by hospitals in outpatient settings and
that reflect consensus among affected
parties and, to the extent feasible and
practicable, shall include measures set
forth by one or more national consensus
building entities.
(ii) Construction.--Nothing in this
paragraph shall be construed as
preventing the Secretary from selecting
measures that are the same as (or a
subset of) the measures for which data
are required to be submitted under
section 1886(b)(3)(B)(viii).
(D) Replacement of measures.--For purposes of
this paragraph, the Secretary may replace any
measures or indicators in appropriate cases,
such as where all hospitals are effectively in
compliance or the measures or indicators have
been subsequently shown not to represent the
best clinical practice.
(E) Availability of data.--The Secretary
shall establish procedures for making data
submitted under this paragraph available to the
public. Such procedures shall ensure that a
hospital has the opportunity to review the data
that are to be made public with respect to the
hospital prior to such data being made public.
The Secretary shall report quality measures of
process, structure, outcome, patients'
perspectives on care, efficiency, and costs of
care that relate to services furnished in
outpatient settings in hospitals on the
Internet website of the Centers for Medicare &
Medicaid Services.
(18) Authorization of adjustment for cancer
hospitals.--
(A) Study.--The Secretary shall conduct a
study to determine if, under the system under
this subsection, costs incurred by hospitals
described in section 1886(d)(1)(B)(v) with
respect to ambulatory payment classification
groups exceed those costs incurred by other
hospitals furnishing services under this
subsection (as determined appropriate by the
Secretary). In conducting the study under this
subparagraph, the Secretary shall take into
consideration the cost of drugs and biologicals
incurred by such hospitals.
(B) Authorization of adjustment.--Insofar as
the Secretary determines under subparagraph (A)
that costs incurred by hospitals described in
section 1886(d)(1)(B)(v) exceed those costs
incurred by other hospitals furnishing services
under this subsection, the Secretary shall,
subject to subparagraph (C), provide for an
appropriate adjustment under paragraph (2)(E)
to reflect those higher costs effective for
services furnished on or after January 1, 2011.
(C) Target pcr adjustment.--In applying
section 419.43(i) of title 42 of the Code of
Federal Regulations to implement the
appropriate adjustment under this paragraph for
services furnished on or after January 1, 2018,
the Secretary shall use a target PCR that is
1.0 percentage points less than the target PCR
that would otherwise apply. In addition to the
percentage point reduction under the previous
sentence, the Secretary may consider making an
additional percentage point reduction to such
target PCR that takes into account payment
rates for applicable items and services
described in paragraph (21)(C) other than for
services furnished by hospitals described in
section 1886(d)(1)(B)(v). In making any budget
neutrality adjustments under this subsection
for 2018 or a subsequent year, the Secretary
shall not take into account the reduced
expenditures that result from the application
of this subparagraph.
(19) Floor on area wage adjustment factor for
hospital outpatient department services in frontier
states.--
(A) In general.--Subject to subparagraph (B),
with respect to covered OPD services furnished
on or after January 1, 2011, the area wage
adjustment factor applicable under the payment
system established under this subsection to any
hospital outpatient department which is located
in a frontier State (as defined in section
1886(d)(3)(E)(iii)(II)) may not be less than
1.00. The preceding sentence shall not be
applied in a budget neutral manner.
(B) Limitation.--This paragraph shall not
apply to any hospital outpatient department
located in a State that receives a non-labor
related share adjustment under section
1886(d)(5)(H).
(20) Not budget neutral application of reduced
expenditures resulting from quality incentives for
computed tomography.--The Secretary shall not take into
account the reduced expenditures that result from the
application of section 1834(p) in making any budget
neutrality adjustments this subsection.
(21) Services furnished by an off-campus outpatient
department of a provider.--
(A) Applicable items and services.--For
purposes of paragraph (1)(B)(v) and this
paragraph, the term ``applicable items and
services'' means items and services other than
items and services furnished by a dedicated
emergency department (as defined in section
489.24(b) of title 42 of the Code of Federal
Regulations).
(B) Off-campus outpatient department of a
provider.--
(i) In general.--For purposes of
paragraph (1)(B)(v) and this paragraph,
subject to the subsequent provisions of
this subparagraph, the term ``off-
campus outpatient department of a
provider'' means a department of a
provider (as defined in section
413.65(a)(2) of title 42 of the Code of
Federal Regulations, as in effect as of
the date of the enactment of this
paragraph) that is not located--
(I) on the campus (as defined
in such section 413.65(a)(2))
of such provider; or
(II) within the distance
(described in such definition
of campus) from a remote
location of a hospital facility
(as defined in such section
413.65(a)(2)).
(ii) Exception.--For purposes of
paragraph (1)(B)(v) and this paragraph,
the term ``off-campus outpatient
department of a provider'' shall not
include a department of a provider (as
so defined) that was billing under this
subsection with respect to covered OPD
services furnished prior to the date of
the enactment of this paragraph.
(iii) Deemed treatment for 2017.--For
purposes of applying clause (ii) with
respect to applicable items and
services furnished during 2017, a
department of a provider (as so
defined) not described in such clause
is deemed to be billing under this
subsection with respect to covered OPD
services furnished prior to November 2,
2015, if the Secretary received from
the provider prior to December 2, 2015,
an attestation (pursuant to section
413.65(b)(3) of title 42 of the Code of
Federal Regulations) that such
department was a department of a
provider (as so defined).
(iv) Alternative exception beginning
with 2018.--For purposes of paragraph
(1)(B)(v) and this paragraph with
respect to applicable items and
services furnished during 2018 or a
subsequent year, the term ``off-campus
outpatient department of a provider''
also shall not include a department of
a provider (as so defined) that is not
described in clause (ii) if--
(I) the Secretary receives
from the provider an
attestation (pursuant to such
section 413.65(b)(3)) not later
than December 31, 2016 (or, if
later, 60 days after the date
of the enactment of this
clause), that such department
met the requirements of a
department of a provider
specified in section 413.65 of
title 42 of the Code of Federal
Regulations;
(II) the provider includes
such department as part of the
provider on its enrollment form
in accordance with the
enrollment process under
section 1866(j); and
(III) the department met the
mid-build requirement of clause
(v) and the Secretary receives,
not later than 60 days after
the date of the enactment of
this clause, from the chief
executive officer or chief
operating officer of the
provider a written
certification that the
department met such
requirement.
(v) Mid-build requirement
described.--The mid-build requirement
of this clause is, with respect to a
department of a provider, that before
November 2, 2015, the provider had a
binding written agreement with an
outside unrelated party for the actual
construction of such department.
(vi) Exclusion for certain cancer
hospitals.--For purposes of paragraph
(1)(B)(v) and this paragraph with
respect to applicable items and
services furnished during 2017 or a
subsequent year, the term ``off-campus
outpatient department of a provider''
also shall not include a department of
a provider (as so defined) that is not
described in clause (ii) if the
provider is a hospital described in
section 1886(d)(1)(B)(v) and--
(I) in the case of a
department that met the
requirements of section 413.65
of title 42 of the Code of
Federal Regulations after
November 1, 2015, and before
the date of the enactment of
this clause, the Secretary
receives from the provider an
attestation that such
department met such
requirements not later than 60
days after such date of
enactment; or
(II) in the case of a
department that meets such
requirements after such date of
enactment, the Secretary
receives from the provider an
attestation that such
department meets such
requirements not later than 60
days after the date such
requirements are first met with
respect to such department.
(vii) Audit.--Not later than December
31, 2018, the Secretary shall audit the
compliance with requirements of clause
(iv) with respect to each department of
a provider to which such clause
applies. Not later than 2 years after
the date the Secretary receives an
attestation under clause (vi) relating
to compliance of a department of a
provider with requirements referred to
in such clause, the Secretary shall
audit the compliance with such
requirements with respect to the
department. If the Secretary finds as a
result of an audit under this clause
that the applicable requirements were
not met with respect to such
department, the department shall not be
excluded from the term ``off-campus
outpatient department of a provider''
under such clause.
(viii) Implementation.--For purposes
of implementing clauses (iii) through
(vii):
(I) Notwithstanding any other
provision of law, the Secretary
may implement such clauses by
program instruction or
otherwise.
(II) Subchapter I of chapter
35 of title 44, United States
Code, shall not apply.
(III) For purposes of
carrying out this subparagraph
with respect to clauses (iii)
and (iv) (and clause (vii)
insofar as it relates to clause
(iv)), $10,000,000 shall be
available from the Federal
Supplementary Medical Insurance
Trust Fund under section 1841,
to remain available until
December 31, 2018. For purposes
of carrying out this
subparagraph with respect to
clause (vi) (and clause (vii)
insofar as it relates to such
clause), $2,000,000 shall be
available from the Federal
Supplementary Medical Insurance
Trust Fund under section 1841,
to remain available until
expended.
(C) Availability of payment under other
payment systems.--Payments for applicable items
and services furnished by an off-campus
outpatient department of a provider that are
described in paragraph (1)(B)(v) shall be made
under the applicable payment system under this
part (other than under this subsection) if the
requirements for such payment are otherwise
met.
(D) Information needed for implementation.--
Each hospital shall provide to the Secretary
such information as the Secretary determines
appropriate to implement this paragraph and
paragraph (1)(B)(v) (which may include
reporting of information on a hospital claim
using a code or modifier and reporting
information about off-campus outpatient
departments of a provider on the enrollment
form described in section 1866(j)).
(E) Limitations.--There shall be no
administrative or judicial review under section
1869, section 1878, or otherwise of the
following:
(i) The determination of the
applicable items and services under
subparagraph (A) and applicable payment
systems under subparagraph (C).
(ii) The determination of whether a
department of a provider meets the term
described in subparagraph (B).
(iii) Any information that hospitals
are required to report pursuant to
subparagraph (D).
(iv) The determination of an audit
under subparagraph (B)(vii).
(22) Review and revisions of payments for non-opioid
alternative treatments.--
(A) In general.--With respect to payments
made under this subsection for covered OPD
services (or groups of services), including
covered OPD services assigned to a
comprehensive ambulatory payment
classification, the Secretary--
(i) shall, as soon as practicable,
conduct a review (part of which may
include a request for information) of
payments for opioids and evidence-based
non-opioid alternatives for pain
management (including drugs and
devices, nerve blocks, surgical
injections, and neuromodulation) with a
goal of ensuring that there are not
financial incentives to use opioids
instead of non-opioid alternatives;
(ii) may, as the Secretary determines
appropriate, conduct subsequent reviews
of such payments; and
(iii) shall consider the extent to
which revisions under this subsection
to such payments (such as the creation
of additional groups of covered OPD
services to classify separately those
procedures that utilize opioids and
non-opioid alternatives for pain
management) would reduce payment
incentives to use opioids instead of
non-opioid alternatives for pain
management.
(B) Priority.--In conducting the review under
clause (i) of subparagraph (A) and considering
revisions under clause (iii) of such
subparagraph, the Secretary shall focus on
covered OPD services (or groups of services)
assigned to a comprehensive ambulatory payment
classification, ambulatory payment
classifications that primarily include surgical
services, and other services determined by the
Secretary which generally involve treatment for
pain management.
(C) Revisions.--If the Secretary identifies
revisions to payments pursuant to subparagraph
(A)(iii), the Secretary shall, as determined
appropriate, begin making such revisions for
services furnished on or after January 1, 2020.
Revisions under the previous sentence shall be
treated as adjustments for purposes of
application of paragraph (9)(B).
(D) Rules of construction.--Nothing in this
paragraph shall be construed to preclude the
Secretary--
(i) from conducting a demonstration
before making the revisions described
in subparagraph (C); or
(ii) prior to implementation of this
paragraph, from changing payments under
this subsection for covered OPD
services (or groups of services) which
include opioids or non-opioid
alternatives for pain management.
(u) Incentive Payments for Physician Scarcity Areas.--
(1) In general.--In the case of physicians' services
furnished on or after January 1, 2005, and before July
1, 2008--
(A) by a primary care physician in a primary
care scarcity county (identified under
paragraph (4)); or
(B) by a physician who is not a primary care
physician in a specialist care scarcity county
(as so identified),
in addition to the amount of payment that would
otherwise be made for such services under this part,
there also shall be paid an amount equal to 5 percent
of the payment amount for the service under this part.
(2) Determination of ratios of physicians to medicare
beneficiaries in area.--Based upon available data, the
Secretary shall establish for each county or equivalent
area in the United States, the following:
(A) Number of physicians practicing in the
area.--The number of physicians who furnish
physicians' services in the active practice of
medicine or osteopathy in that county or area,
other than physicians whose practice is
exclusively for the Federal Government,
physicians who are retired, or physicians who
only provide administrative services. Of such
number, the number of such physicians who are--
(i) primary care physicians; or
(ii) physicians who are not primary
care physicians.
(B) Number of medicare beneficiaries residing
in the area.--The number of individuals who are
residing in the county and are entitled to
benefits under part A or enrolled under this
part, or both (in this subsection referred to
as ``individuals'').
(C) Determination of ratios.--
(i) Primary care ratio.--The ratio
(in this paragraph referred to as the
``primary care ratio'') of the number
of primary care physicians (determined
under subparagraph (A)(i)), to the
number of individuals determined under
subparagraph (B).
(ii) Specialist care ratio.--The
ratio (in this paragraph referred to as
the ``specialist care ratio'') of the
number of other physicians (determined
under subparagraph (A)(ii)), to the
number of individuals determined under
subparagraph (B).
(3) Ranking of counties.--The Secretary shall rank
each such county or area based separately on its
primary care ratio and its specialist care ratio.
(4) Identification of counties.--
(A) In general.--The Secretary shall
identify--
(i) those counties and areas (in this
paragraph referred to as ``primary care
scarcity counties'') with the lowest
primary care ratios that represent, if
each such county or area were weighted
by the number of individuals determined
under paragraph (2)(B), an aggregate
total of 20 percent of the total of the
individuals determined under such
paragraph; and
(ii) those counties and areas (in
this subsection referred to as
``specialist care scarcity counties'')
with the lowest specialist care ratios
that represent, if each such county or
area were weighted by the number of
individuals determined under paragraph
(2)(B), an aggregate total of 20
percent of the total of the individuals
determined under such paragraph.
(B) Periodic revisions.--The Secretary shall
periodically revise the counties or areas
identified in subparagraph (A) (but not less
often than once every three years) unless the
Secretary determines that there is no new data
available on the number of physicians
practicing in the county or area or the number
of individuals residing in the county or area,
as identified in paragraph (2).
(C) Identification of counties where service
is furnished.--For purposes of paying the
additional amount specified in paragraph (1),
if the Secretary uses the 5-digit postal ZIP
Code where the service is furnished, the
dominant county of the postal ZIP Code (as
determined by the United States Postal Service,
or otherwise) shall be used to determine
whether the postal ZIP Code is in a scarcity
county identified in subparagraph (A) or
revised in subparagraph (B).
(D) Special rule.--With respect to
physicians' services furnished on or after
January 1, 2008, and before July 1, 2008, for
purposes of this subsection, the Secretary
shall use the primary care scarcity counties
and the specialty care scarcity counties (as
identified under the preceding provisions of
this paragraph) that the Secretary was using
under this subsection with respect to
physicians' services furnished on December 31,
2007.
(E) Judicial review.--There shall be no
administrative or judicial review under section
1869, 1878, or otherwise, respecting--
116.(i) the identification of a
county or area;
(ii) the assignment of a specialty of
any physician under this paragraph;
(iii) the assignment of a physician
to a county under paragraph (2); or
(iv) the assignment of a postal ZIP
Code to a county or other area under
this subsection.
(5) Rural census tracts.--To the extent feasible, the
Secretary shall treat a rural census tract of a
metropolitan statistical area (as determined under the
most recent modification of the Goldsmith Modification,
originally published in the Federal Register on
February 27, 1992 (57 Fed. Reg. 6725)), as an
equivalent area for purposes of qualifying as a primary
care scarcity county or specialist care scarcity county
under this subsection.
(6) Physician Defined.--For purposes of this
paragraph, the term ``physician'' means a physician
described in section 1861(r)(1) and the term ``primary
care physician'' means a physician who is identified in
the available data as a general practitioner, family
practice practitioner, general internist, or
obstetrician or gynecologist.
(7) Publication of list of counties; posting on
website.--With respect to a year for which a county or
area is identified or revised under paragraph (4), the
Secretary shall identify such counties or areas as part
of the proposed and final rule to implement the
physician fee schedule under section 1848 for the
applicable year. The Secretary shall post the list of
counties identified or revised under paragraph (4) on
the Internet website of the Centers for Medicare &
Medicaid Services.
(v) Increase of FQHC Payment Limits.--In the case of services
furnished by Federally qualified health centers (as defined in
section 1861(aa)(4)), the Secretary shall establish payment
limits with respect to such services under this part for
services furnished--
(1) in 2010, at the limits otherwise established
under this part for such year increased by $5; and
(2) in a subsequent year, at the limits established
under this subsection for the previous year increased
by the percentage increase in the MEI (as defined in
section 1842(i)(3)) for such subsequent year.
(w) Methods of Payment.--The Secretary may develop
alternative methods of payment for items and services provided
under clinical trials and comparative effectiveness studies
sponsored or supported by an agency of the Department of Health
and Human Services, as determined by the Secretary, to those
that would otherwise apply under this section, to the extent
such alternative methods are necessary to preserve the
scientific validity of such trials or studies, such as in the
case where masking the identity of interventions from patients
and investigators is necessary to comply with the particular
trial or study design.
(x) Incentive Payments for Primary Care Services.--
(1) In general.--In the case of primary care services
furnished on or after January 1, 2011, and before
January 1, 2016, by a primary care practitioner, in
addition to the amount of payment that would otherwise
be made for such services under this part, there also
shall be paid (on a monthly or quarterly basis) an
amount equal to 10 percent of the payment amount for
the service under this part.
(2) Definitions.--In this subsection:
(A) Primary care practitioner.--The term
``primary care practitioner'' means an
individual--
(i) who--
(I) is a physician (as
described in section
1861(r)(1)) who has a primary
specialty designation of family
medicine, internal medicine,
geriatric medicine, or
pediatric medicine; or
(II) is a nurse practitioner,
clinical nurse specialist, or
physician assistant (as those
terms are defined in section
1861(aa)(5)); and
(ii) for whom primary care services
accounted for at least 60 percent of
the allowed charges under this part for
such physician or practitioner in a
prior period as determined appropriate
by the Secretary.
(B) Primary care services.--The term
``primary care services'' means services
identified, as of January 1, 2009, by the
following HCPCS codes (and as subsequently
modified by the Secretary):
(i) 99201 through 99215.
(ii) 99304 through 99340.
(iii) 99341 through 99350.
(3) Coordination with other payments.--The amount of
the additional payment for a service under this
subsection and subsection (m) shall be determined
without regard to any additional payment for the
service under subsection (m) and this subsection,
respectively. The amount of the additional payment for
a service under this subsection and subsection (z)
shall be determined without regard to any additional
payment for the service under subsection (z) and this
subsection, respectively.
(4) Limitation on review.--There shall be no
administrative or judicial review under section 1869,
1878, or otherwise, respecting the identification of
primary care practitioners under this subsection.
(y) Incentive Payments for Major Surgical Procedures
Furnished in Health Professional Shortage Areas.--
(1) In general.--In the case of major surgical
procedures furnished on or after January 1, 2011, and
before January 1, 2016, by a general surgeon in an area
that is designated (under section 332(a)(1)(A) of the
Public Health Service Act) as a health professional
shortage area as identified by the Secretary prior to
the beginning of the year involved, in addition to the
amount of payment that would otherwise be made for such
services under this part, there also shall be paid (on
a monthly or quarterly basis) an amount equal to 10
percent of the payment amount for the service under
this part.
(2) Definitions.--In this subsection:
(A) General surgeon.--In this subsection, the
term ``general surgeon'' means a physician (as
described in section 1861(r)(1)) who has
designated CMS specialty code 02-General
Surgery as their primary specialty code in the
physician's enrollment under section 1866(j).
(B) Major surgical procedures.--The term
``major surgical procedures'' means physicians'
services which are surgical procedures for
which a 10-day or 90-day global period is used
for payment under the fee schedule under
section 1848(b).
(3) Coordination with other payments.--The amount of
the additional payment for a service under this
subsection and subsection (m) shall be determined
without regard to any additional payment for the
service under subsection (m) and this subsection,
respectively. The amount of the additional payment for
a service under this subsection and subsection (z)
shall be determined without regard to any additional
payment for the service under subsection (z) and this
subsection, respectively.
(4) Application.--The provisions of paragraph (2) and
(4) of subsection (m) shall apply to the determination
of additional payments under this subsection in the
same manner as such provisions apply to the
determination of additional payments under subsection
(m).
(z) Incentive Payments for Participation in Eligible
Alternative Payment Models.--
(1) Payment incentive.--
(A) In general.--In the case of covered
professional services furnished by an eligible
professional during a year that is in the
period beginning with 2019 and ending with 2024
and for which the professional is a qualifying
APM participant with respect to such year, in
addition to the amount of payment that would
otherwise be made for such covered professional
services under this part for such year, there
also shall be paid to such professional an
amount equal to 5 percent of the estimated
aggregate payment amounts for such covered
professional services under this part for the
preceding year. For purposes of the previous
sentence, the payment amount for the preceding
year may be an estimation for the full
preceding year based on a period of such
preceding year that is less than the full year.
The Secretary shall establish policies to
implement this subparagraph in cases in which
payment for covered professional services
furnished by a qualifying APM participant in an
alternative payment model--
(i) is made to an eligible
alternative payment entity rather than
directly to the qualifying APM
participant; or
(ii) is made on a basis other than a
fee-for-service basis (such as payment
on a capitated basis).
(B) Form of payment.--Payments under this
subsection shall be made in a lump sum, on an
annual basis, as soon as practicable.
(C) Treatment of payment incentive.--Payments
under this subsection shall not be taken into
account for purposes of determining actual
expenditures under an alternative payment model
and for purposes of determining or rebasing any
benchmarks used under the alternative payment
model.
(D) Coordination.--The amount of the
additional payment under this subsection or
subsection (m) shall be determined without
regard to any additional payment under
subsection (m) and this subsection,
respectively. The amount of the additional
payment under this subsection or subsection (x)
shall be determined without regard to any
additional payment under subsection (x) and
this subsection, respectively. The amount of
the additional payment under this subsection or
subsection (y) shall be determined without
regard to any additional payment under
subsection (y) and this subsection,
respectively.
(2) Qualifying apm participant.--For purposes of this
subsection, the term ``qualifying APM participant''
means the following:
(A) 2019 and 2020.--With respect to 2019 and
2020, an eligible professional for whom the
Secretary determines that at least 25 percent
of payments under this part for covered
professional services furnished by such
professional during the most recent period for
which data are available (which may be less
than a year) were attributable to such services
furnished under this part through an eligible
alternative payment entity.
(B) 2021 and 2022.--With respect to 2021 and
2022, an eligible professional described in
either of the following clauses:
(i) Medicare payment threshold
option.--An eligible professional for
whom the Secretary determines that at
least 50 percent of payments under this
part for covered professional services
furnished by such professional during
the most recent period for which data
are available (which may be less than a
year) were attributable to such
services furnished under this part
through an eligible alternative payment
entity.
(ii) Combination all-payer and
medicare payment threshold option.--An
eligible professional--
(I) for whom the Secretary
determines, with respect to
items and services furnished by
such professional during the
most recent period for which
data are available (which may
be less than a year), that at
least 50 percent of the sum
of--
(aa) payments
described in clause
(i); and
(bb) all other
payments, regardless of
payer (other than
payments made by the
Secretary of Defense or
the Secretary of
Veterans Affairs and
other than payments
made under title XIX in
a State in which no
medical home or
alternative payment
model is available
under the State program
under that title),
meet the requirement described
in clause (iii)(I) with respect
to payments described in item
(aa) and meet the requirement
described in clause (iii)(II)
with respect to payments
described in item (bb);
(II) for whom the Secretary
determines at least 25 percent
of payments under this part for
covered professional services
furnished by such professional
during the most recent period
for which data are available
(which may be less than a year)
were attributable to such
services furnished under this
part through an eligible
alternative payment entity; and
(III) who provides to the
Secretary such information as
is necessary for the Secretary
to make a determination under
subclause (I), with respect to
such professional.
(iii) Requirement.--For purposes of
clause (ii)(I)--
(I) the requirement described
in this subclause, with respect
to payments described in item
(aa) of such clause, is that
such payments are made to an
eligible alternative payment
entity; and
(II) the requirement
described in this subclause,
with respect to payments
described in item (bb) of such
clause, is that such payments
are made under arrangements in
which--
(aa) quality measures
comparable to measures
under the performance
category described in
section
1848(q)(2)(B)(i) apply;
(bb) certified EHR
technology is used; and
(cc) the eligible
professional
participates in an
entity that--
(AA) bears
more than
nominal
financial risk
if actual
aggregate
expenditures
exceeds
expected
aggregate
expenditures;
or
(BB) with
respect to
beneficiaries
under title
XIX, is a
medical home
that meets
criteria
comparable to
medical homes
expanded under
section
1115A(c).
(C) Beginning in 2023.--With respect to 2023
and each subsequent year, an eligible
professional described in either of the
following clauses:
(i) Medicare payment threshold
option.--An eligible professional for
whom the Secretary determines that at
least 75 percent of payments under this
part for covered professional services
furnished by such professional during
the most recent period for which data
are available (which may be less than a
year) were attributable to such
services furnished under this part
through an eligible alternative payment
entity.
(ii) Combination all-payer and
medicare payment threshold option.--An
eligible professional--
(I) for whom the Secretary
determines, with respect to
items and services furnished by
such professional during the
most recent period for which
data are available (which may
be less than a year), that at
least 75 percent of the sum
of--
(aa) payments
described in clause
(i); and
(bb) all other
payments, regardless of
payer (other than
payments made by the
Secretary of Defense or
the Secretary of
Veterans Affairs and
other than payments
made under title XIX in
a State in which no
medical home or
alternative payment
model is available
under the State program
under that title),
meet the requirement described
in clause (iii)(I) with respect
to payments described in item
(aa) and meet the requirement
described in clause (iii)(II)
with respect to payments
described in item (bb);
(II) for whom the Secretary
determines at least 25 percent
of payments under this part for
covered professional services
furnished by such professional
during the most recent period
for which data are available
(which may be less than a year)
were attributable to such
services furnished under this
part through an eligible
alternative payment entity; and
(III) who provides to the
Secretary such information as
is necessary for the Secretary
to make a determination under
subclause (I), with respect to
such professional.
(iii) Requirement.--For purposes of
clause (ii)(I)--
(I) the requirement described
in this subclause, with respect
to payments described in item
(aa) of such clause, is that
such payments are made to an
eligible alternative payment
entity; and
(II) the requirement
described in this subclause,
with respect to payments
described in item (bb) of such
clause, is that such payments
are made under arrangements in
which--
(aa) quality measures
comparable to measures
under the performance
category described in
section
1848(q)(2)(B)(i) apply;
(bb) certified EHR
technology is used; and
(cc) the eligible
professional
participates in an
entity that--
(AA) bears
more than
nominal
financial risk
if actual
aggregate
expenditures
exceeds
expected
aggregate
expenditures;
or
(BB) with
respect to
beneficiaries
under title
XIX, is a
medical home
that meets
criteria
comparable to
medical homes
expanded under
section
1115A(c).
(D) Use of patient approach.--The Secretary
may base the determination of whether an
eligible professional is a qualifying APM
participant under this subsection and the
determination of whether an eligible
professional is a partial qualifying APM
participant under section 1848(q)(1)(C)(iii) by
using counts of patients in lieu of using
payments and using the same or similar
percentage criteria (as specified in this
subsection and such section, respectively), as
the Secretary determines appropriate.
(3) Additional definitions.--In this subsection:
(A) Covered professional services.--The term
``covered professional services'' has the
meaning given that term in section
1848(k)(3)(A).
(B) Eligible professional.--The term
``eligible professional'' has the meaning given
that term in section 1848(k)(3)(B) and includes
a group that includes such professionals.
(C) Alternative payment model (apm).--The
term ``alternative payment model'' means, other
than for purposes of subparagraphs
(B)(ii)(I)(bb) and (C)(ii)(I)(bb) of paragraph
(2), any of the following:
(i) A model under section 1115A
(other than a health care innovation
award).
(ii) The shared savings program under
section 1899.
(iii) A demonstration under section
1866C.
(iv) A demonstration required by
Federal law.
(D) Eligible alternative payment entity.--The
term ``eligible alternative payment entity''
means, with respect to a year, an entity that--
(i) participates in an alternative
payment model that--
(I) requires participants in
such model to use certified EHR
technology (as defined in
subsection (o)(4)); and
(II) provides for payment for
covered professional services
based on quality measures
comparable to measures under
the performance category
described in section
1848(q)(2)(B)(i); and
(ii)(I) bears financial risk for
monetary losses under such alternative
payment model that are in excess of a
nominal amount; or
(II) is a medical home expanded under
section 1115A(c).
(4) Limitation.--There shall be no administrative or
judicial review under section 1869, 1878, or otherwise,
of the following:
(A) The determination that an eligible
professional is a qualifying APM participant
under paragraph (2) and the determination that
an entity is an eligible alternative payment
entity under paragraph (3)(D).
(B) The determination of the amount of the 5
percent payment incentive under paragraph
(1)(A), including any estimation as part of
such determination.
(aa) Medical Review of Spinal Subluxation Services.--
(1) In general.--The Secretary shall implement a
process for the medical review (as described in
paragraph (2)) of treatment by a chiropractor described
in section 1861(r)(5) by means of manual manipulation
of the spine to correct a subluxation (as described in
such section) of an individual who is enrolled under
this part and apply such process to such services
furnished on or after January 1, 2017, focusing on
services such as--
(A) services furnished by a such a
chiropractor whose pattern of billing is
aberrant compared to peers; and
(B) services furnished by such a chiropractor
who, in a prior period, has a services denial
percentage in the 85th percentile or greater,
taking into consideration the extent that
service denials are overturned on appeal.
(2) Medical review.--
(A) Prior authorization medical review.--
(i) In general.--Subject to clause
(ii), the Secretary shall use prior
authorization medical review for
services described in paragraph (1)
that are furnished to an individual by
a chiropractor described in section
1861(r)(5) that are part of an episode
of treatment that includes more than 12
services. For purposes of the preceding
sentence, an episode of treatment shall
be determined by the underlying cause
that justifies the need for services,
such as a diagnosis code.
(ii) Ending application of prior
authorization medical review.--The
Secretary shall end the application of
prior authorization medical review
under clause (i) to services described
in paragraph (1) by such a chiropractor
if the Secretary determines that the
chiropractor has a low denial rate
under such prior authorization medical
review. The Secretary may subsequently
reapply prior authorization medical
review to such chiropractor if the
Secretary determines it to be
appropriate and the chiropractor has,
in the time period subsequent to the
determination by the Secretary of a low
denial rate with respect to the
chiropractor, furnished such services
described in paragraph (1).
(iii) Early request for prior
authorization review permitted.--
Nothing in this subsection shall be
construed to prevent such a
chiropractor from requesting prior
authorization for services described in
paragraph (1) that are to be furnished
to an individual before the
chiropractor furnishes the twelfth such
service to such individual for an
episode of treatment.
(B) Type of review.--The Secretary may use
pre-payment review or post-payment review of
services described in section 1861(r)(5) that
are not subject to prior authorization medical
review under subparagraph (A).
(C) Relationship to law enforcement
activities.--The Secretary may determine that
medical review under this subsection does not
apply in the case where potential fraud may be
involved.
(3) No payment without prior authorization.--With
respect to a service described in paragraph (1) for
which prior authorization medical review under this
subsection applies, the following shall apply:
(A) Prior authorization determination.--The
Secretary shall make a determination, prior to
the service being furnished, of whether the
service would or would not meet the applicable
requirements of section 1862(a)(1)(A).
(B) Denial of payment.--Subject to paragraph
(5), no payment may be made under this part for
the service unless the Secretary determines
pursuant to subparagraph (A) that the service
would meet the applicable requirements of such
section 1862(a)(1)(A).
(4) Submission of information.--A chiropractor
described in section 1861(r)(5) may submit the
information necessary for medical review by fax, by
mail, or by electronic means. The Secretary shall make
available the electronic means described in the
preceding sentence as soon as practicable.
(5) Timeliness.--If the Secretary does not make a
prior authorization determination under paragraph
(3)(A) within 14 business days of the date of the
receipt of medical documentation needed to make such
determination, paragraph (3)(B) shall not apply.
(6) Application of limitation on beneficiary
liability.--Where payment may not be made as a result
of the application of paragraph (2)(B), section 1879
shall apply in the same manner as such section applies
to a denial that is made by reason of section
1862(a)(1).
(7) Review by contractors.--The medical review
described in paragraph (2) may be conducted by medicare
administrative contractors pursuant to section
1874A(a)(4)(G) or by any other contractor determined
appropriate by the Secretary that is not a recovery
audit contractor.
(8) Multiple services.--The Secretary shall, where
practicable, apply the medical review under this
subsection in a manner so as to allow an individual
described in paragraph (1) to obtain, at a single time
rather than on a service-by-service basis, an
authorization in accordance with paragraph (3)(A) for
multiple services.
(9) Construction.--With respect to a service
described in paragraph (1) that has been affirmed by
medical review under this subsection, nothing in this
subsection shall be construed to preclude the
subsequent denial of a claim for such service that does
not meet other applicable requirements under this Act.
(10) Implementation.--
(A) Authority.--The Secretary may implement
the provisions of this subsection by interim
final rule with comment period.
(B) Administration.--Chapter 35 of title 44,
United States Code, shall not apply to medical
review under this subsection.
(bb) Additional Payments for Certain Rural Health Clinics
With Physicians or Practitioners Receiving DATA 2000 Waivers.--
(1) In general.--In the case of a rural health clinic
with respect to which, beginning on or after January 1,
2019, rural health clinic services (as defined in
section 1861(aa)(1)) are furnished for the treatment of
opioid use disorder by a physician or practitioner who
meets the requirements described in paragraph (3), the
Secretary shall, subject to availability of funds under
paragraph (4), make a payment (at such time and in such
manner as specified by the Secretary) to such rural
health clinic after receiving and approving an
application described in paragraph (2). Such payment
shall be in an amount determined by the Secretary,
based on an estimate of the average costs of training
for purposes of receiving a waiver described in
paragraph (3)(B). Such payment may be made only one
time with respect to each such physician or
practitioner.
(2) Application.--In order to receive a payment
described in paragraph (1), a rural health clinic shall
submit to the Secretary an application for such a
payment at such time, in such manner, and containing
such information as specified by the Secretary. A rural
health clinic may apply for such a payment for each
physician or practitioner described in paragraph (1)
furnishing services described in such paragraph at such
clinic.
(3) Requirements.--For purposes of paragraph (1), the
requirements described in this paragraph, with respect
to a physician or practitioner, are the following:
(A) The physician or practitioner is employed
by or working under contract with a rural
health clinic described in paragraph (1) that
submits an application under paragraph (2).
(B) The physician or practitioner first
receives a waiver under section 303(g) of the
Controlled Substances Act on or after January
1, 2019.
(4) Funding.--For purposes of making payments under
this subsection, there are appropriated, out of amounts
in the Treasury not otherwise appropriated, $2,000,000,
which shall remain available until expended.
SPECIAL PAYMENT RULES FOR PARTICULAR ITEMS AND SERVICES
Sec. 1834. (a) Payment for Durable Medical Equipment.--
(1) General rule for payment.--
(A) In general.--With respect to a covered
item (as defined in paragraph (13)) for which
payment is determined under this subsection,
payment shall be made in the frequency
specified in paragraphs (2) through (7) and in
an amount equal to 80 percent of the payment
basis described in subparagraph (B).
(B) Payment basis.--Subject to subparagraph
(F)(i), the payment basis described in this
subparagraph is the lesser of--
(i) the actual charge for the item,
or
(ii) the payment amount recognized
under paragraphs (2) through (7) of
this subsection for the item;
except that clause (i) shall not apply if the
covered item is furnished by a public home
health agency (or by another home health agency
which demonstrates to the satisfaction of the
Secretary that a significant portion of its
patients are low income) free of charge or at
nominal charges to the public.
(C) Exclusive payment rule.--Subject to
subparagraph (F)(ii), this subsection shall
constitute the exclusive provision of this
title for payment for covered items under this
part or under part A to a home health agency.
(D) Reduction in fee schedules for certain
items.--With respect to a seat-lift chair or
transcutaneous electrical nerve stimulator
furnished on or after April 1, 1990, the
Secretary shall reduce the payment amount
applied under subparagraph (B)(ii) for such an
item by 15 percent, and, in the case of a
transcutaneous electrical nerve stimulator
furnished on or after January 1, 1991, the
Secretary shall further reduce such payment
amount (as previously reduced) by 45 percent.
(E) Clinical conditions for coverage.--
(i) In general.--The Secretary shall
establish standards for clinical
conditions for payment for covered
items under this subsection.
(ii) Requirements.--The standards
established under clause (i) shall
include the specification of types or
classes of covered items that require,
as a condition of payment under this
subsection, a face-to-face examination
of the individual by a physician (as
defined in section 1861(r)), a
physician assistant, nurse
practitioner, or a clinical nurse
specialist (as those terms are defined
in section 1861(aa)(5)) and a
prescription for the item.
(iii) Priority of establishment of
standards.--In establishing the
standards under this subparagraph, the
Secretary shall first establish
standards for those covered items for
which the Secretary determines there
has been a proliferation of use,
consistent findings of charges for
covered items that are not delivered,
or consistent findings of falsification
of documentation to provide for payment
of such covered items under this part.
(iv) Standards for power
wheelchairs.--Effective on the date of
the enactment of this subparagraph, in
the case of a covered item consisting
of a motorized or power wheelchair for
an individual, payment may not be made
for such covered item unless a
physician (as defined in section
1861(r)(1)), a physician assistant,
nurse practitioner, or a clinical nurse
specialist (as those terms are defined
in section 1861(aa)(5)) has conducted a
face-to-face examination of the
individual and written a prescription
for the item.
(v) Limitation on payment for covered
items.--Payment may not be made for a
covered item under this subsection
unless the item meets any standards
established under this subparagraph for
clinical condition of coverage.
(F) Application of competitive acquisition;
limitation of inherent reasonableness
authority.--In the case of covered items
furnished on or after January 1, 2011, subject
to subparagraphs (G) and (H), that are included
in a competitive acquisition program in a
competitive acquisition area under section
1847(a)--
(i) the payment basis under this
subsection for such items and services
furnished in such area shall be the
payment basis determined under such
competitive acquisition program;
(ii) the Secretary may (and, in the
case of covered items furnished on or
after January 1, 2016, subject to
clause (iii), shall) use information on
the payment determined under such
competitive acquisition programs to
adjust the payment amount otherwise
recognized under subparagraph (B)(ii)
for an area that is not a competitive
acquisition area under section 1847 and
in the case of such adjustment,
paragraph (10)(B) shall not be applied;
and
(iii) in the case of covered items
furnished on or after January 1, 2016,
the Secretary shall continue to make
such adjustments described in clause
(ii) as, under such competitive
acquisition programs, additional
covered items are phased in or
information is updated as contracts
under section 1847 are recompeted in
accordance with section 1847(b)(3)(B).
(G) Use of information on competitive bid
rates.--The Secretary shall specify by
regulation the methodology to be used in
applying the provisions of subparagraph (F)(ii)
and subsection (h)(1)(H)(ii). In promulgating
such regulation, the Secretary shall consider
the costs of items and services in areas in
which such provisions would be applied compared
to the payment rates for such items and
services in competitive acquisition areas.In
the case of items and services furnished on or
after January 1, 2019, in making any
adjustments under clause (ii) or (iii) of
subparagraph (F), under subsection
(h)(1)(H)(ii), or under section 1842(s)(3)(B),
the Secretary shall--
(i) solicit and take into account
stakeholder input; and
(ii) take into account the highest
amount bid by a winning supplier in a
competitive acquisition area and a
comparison of each of the following
with respect to non-competitive
acquisition areas and competitive
acquisition areas:
(I) The average travel
distance and cost associated
with furnishing items and
services in the area.
(II) The average volume of
items and services furnished by
suppliers in the area.
(III) The number of suppliers
in the area.
(H) Diabetic supplies.--
(i) In general.--On or after the date
described in clause (ii), the payment
amount under this part for diabetic
supplies, including testing strips,
that are non-mail order items (as
defined by the Secretary) shall be
equal to the single payment amounts
established under the national mail
order competition for diabetic supplies
under section 1847.
(ii) Date described.--The date
described in this clause is the date of
the implementation of the single
payment amounts under the national mail
order competition for diabetic supplies
under section 1847.
(I) Treatment of vacuum erection systems.--
Effective for items and services furnished on
and after July 1, 2015, vacuum erection systems
described as prosthetic devices described in
section 1861(s)(8) shall be treated in the same
manner as erectile dysfunction drugs are
treated for purposes of section 1860D-
2(e)(2)(A).
(2) Payment for inexpensive and other routinely
purchased durable medical equipment.--
(A) In general.--Payment for an item of
durable medical equipment (as defined in
paragraph (13))--
(i) the purchase price of which does
not exceed $150,
(ii) which the Secretary determines
is acquired at least 75 percent of the
time by purchase,
(iii) which is an accessory used in
conjunction with a nebulizer,
aspirator, or a ventilator excluded
under paragraph (3)(A), or
(iv) in the case of devices furnished
on or after October 1, 2015, which
serves as a speech generating device or
which is an accessory that is needed
for the individual to effectively
utilize such a device,
shall be made on a rental basis or in a lump-
sum amount for the purchase of the item. The
payment amount recognized for purchase or
rental of such equipment is the amount
specified in subparagraph (B) for purchase or
rental, except that the total amount of
payments with respect to an item may not exceed
the payment amount specified in subparagraph
(B) with respect to the purchase of the item.
(B) Payment amount.--For purposes of
subparagraph (A), the amount specified in this
subparagraph, with respect to the purchase or
rental of an item furnished in a carrier
service area--
(i) in 1989 and in 1990 is the
average reasonable charge in the area
for the purchase or rental,
respectively, of the item for the 12-
month period ending on June 30, 1987,
increased by the percentage increase in
the consumer price index for all urban
consumers (U.S. city average) for the
6-month period ending with December
1987;
(ii) in 1991 is the sum of (I) 67
percent of the local payment amount for
the item or device computed under
subparagraph (C)(i)(I) for 1991, and
(II) 33 percent of the national limited
payment amount for the item or device
computed under subparagraph (C)(ii) for
1991;
(iii) in 1992 is the sum of (I) 33
percent of the local payment amount for
the item or device computed under
subparagraph (C)(i)(II) for 1992, and
(II) 67 percent of the national limited
payment amount for the item or device
computed under subparagraph (C)(ii) for
1992; and
(iv) in 1993 and each subsequent year
is the national limited payment amount
for the item or device computed under
subparagraph (C)(ii) for that year
(reduced by 10 percent, in the case of
a blood glucose testing strip furnished
after 1997 for an individual with
diabetes).
(C) Computation of local payment amount and
national limited payment amount.--For purposes
of subparagraph (B)--
(i) the local payment amount for an
item or device for a year is equal to--
(I) for 1991, the amount
specified in subparagraph
(B)(i) for 1990 increased by
the covered item update for
1991, and
(II) for 1992, 1993, and 1994
the amount determined under
this clause for the preceding
year increased by the covered
item update for the year; and
(ii) the national limited payment
amount for an item or device for a year
is equal to--
(I) for 1991, the local
payment amount determined under
clause (i) for such item or
device for that year, except
that the national limited
payment amount may not exceed
100 percent of the weighted
average of all local payment
amounts determined under such
clause for such item for that
year and may not be less than
85 percent of the weighted
average of all local payment
amounts determined under such
clause for such item,
(II) for 1992 and 1993, the
amount determined under this
clause for the preceding year
increased by the covered item
update for such subsequent
year,
(III) for 1994, the local
payment amount determined under
clause (i) for such item or
device for that year, except
that the national limited
payment amount may not exceed
100 percent of the median of
all local payment amounts
determined under such clause
for such item for that year and
may not be less than 85 percent
of the median of all local
payment amounts determined
under such clause for such item
or device for that year, and
(IV) for each subsequent
year, the amount determined
under this clause for the
preceding year increased by the
covered item update for such
subsequent year.
(3) Payment for items requiring frequent and
substantial servicing.--
(A) In general.--Payment for a covered item
(such as IPPB machines and ventilators,
excluding ventilators that are either
continuous airway pressure devices or
intermittent assist devices with continuous
airway pressure devices) for which there must
be frequent and substantial servicing in order
to avoid risk to the patient's health shall be
made on a monthly basis for the rental of the
item and the amount recognized is the amount
specified in subparagraph (B).
(B) Payment amount.--For purposes of
subparagraph (A), the amount specified in this
subparagraph, with respect to an item or device
furnished in a carrier service area--
(i) in 1989 and in 1990 is the
average reasonable charge in the area
for the rental of the item or device
for the 12-month period ending with
June 1987, increased by the percentage
increase in the consumer price index
for all urban consumers (U.S. city
average) for the 6-month period ending
with December 1987;
(ii) in 1991 is the sum of (I) 67
percent of the local payment amount for
the item or device computed under
subparagraph (C)(i)(I) for 1991, and
(II) 33 percent of the national limited
payment amount for the item or device
computed under subparagraph (C)(ii) for
1991;
(iii) in 1992 is the sum of (I) 33
percent of the local payment amount for
the item or device computed under
subparagraph (C)(i)(II) for 1992, and
(II) 67 percent of the national limited
payment amount for the item or device
computed under subparagraph (C)(ii) for
1992; and
(iv) in 1993 and each subsequent year
is the national limited payment amount
for the item or device computed under
subparagraph (C)(ii) for that year.
(C) Computation of local payment amount and
national limited payment amount.--For purposes
of subparagraph (B)--
(i) the local payment amount for an
item or device for a year is equal to--
(I) for 1991, the amount
specified in subparagraph
(B)(i) for 1990 increased by
the covered item update for
1991, and
(II) for 1992, 1993, and 1994
the amount determined under
this clause for the preceding
year increased by the covered
item update for the year; and
(ii) the national limited payment
amount for an item or device for a year
is equal to--
(I) for 1991, the local
payment amount determined under
clause (i) for such item or
device for that year, except
that the national limited
payment amount may not exceed
100 percent of the weighted
average of all local payment
amounts determined under such
clause for such item for that
year and may not be less than
85 percent of the weighted
average of all local payment
amounts determined under such
clause for such item,
(II) for 1992 and 1993, the
amount determined under this
clause for the preceding year
increased by the covered item
update for such subsequent
year,
(III) for 1994, the local
payment amount determined under
clause (i) for such item or
device for that year, except
that the national limited
payment amount may not exceed
100 percent of the median of
all local payment amounts
determined under such clause
for such item for that year and
may not be less than 85 percent
of the median of all local
payment amounts determined
under such clause for such item
or device for that year, and
(IV) for each subsequent
year, the amount determined
under this clause for the
preceding year increased by the
covered item update for such
subsequent year.
(4) Payment for certain customized items.--Payment
with respect to a covered item that is uniquely
constructed or substantially modified to meet the
specific needs of an individual patient, and for that
reason cannot be grouped with similar items for
purposes of payment under this title, shall be made in
a lump-sum amount (A) for the purchase of the item in a
payment amount based upon the carrier's individual
consideration for that item, and (B) for the reasonable
and necessary maintenance and servicing for parts and
labor not covered by the supplier's or manufacturer's
warranty, when necessary during the period of medical
need, and the amount recognized for such maintenance
and servicing shall be paid on a lump-sum, as needed
basis based upon the carrier's individual consideration
for that item. In the case of a wheelchair furnished on
or after January 1, 1992, the wheelchair shall be
treated as a customized item for purposes of this
paragraph if the wheelchair has been measured, fitted,
or adapted in consideration of the patient's body size,
disability, period of need, or intended use, and has
been assembled by a supplier or ordered from a
manufacturer who makes available customized features,
modifications, or components for wheelchairs that are
intended for an individual patient's use in accordance
with instructions from the patient's physician.
(5) Payment for oxygen and oxygen equipment.--
(A) In general.--Payment for oxygen and
oxygen equipment shall be made on a monthly
basis in the monthly payment amount recognized
under paragraph (9) for oxygen and oxygen
equipment (other than portable oxygen
equipment), subject to subparagraphs (B), (C),
(E), and (F).
(B) Add-on for portable oxygen equipment.--
When portable oxygen equipment is used, but
subject to subparagraph (D), the payment amount
recognized under subparagraph (A) shall be
increased by the monthly payment amount
recognized under paragraph (9) for portable
oxygen equipment.
(C) Volume adjustment.--When the attending
physician prescribes an oxygen flow rate--
(i) exceeding 4 liters per minute,
the payment amount recognized under
subparagraph (A), subject to
subparagraph (D), shall be increased by
50 percent, or
(ii) of less than 1 liter per minute,
the payment amount recognized under
subparagraph (A) shall be decreased by
50 percent.
(D) Limit on adjustment.--When portable
oxygen equipment is used and the attending
physician prescribes an oxygen flow rate
exceeding 4 liters per minute, there shall only
be an increase under either subparagraph (B) or
(C), whichever increase is larger, and not
under both such subparagraphs.
(E) Recertification for patients receiving
home oxygen therapy.--In the case of a patient
receiving home oxygen therapy services who, at
the time such services are initiated, has an
initial arterial blood gas value at or above a
partial pressure of 56 or an arterial oxygen
saturation at or above 89 percent (or such
other values, pressures, or criteria as the
Secretary may specify) no payment may be made
under this part for such services after the
expiration of the 90-day period that begins on
the date the patient first receives such
services unless the patient's attending
physician certifies that, on the basis of a
follow-up test of the patient's arterial blood
gas value or arterial oxygen saturation
conducted during the final 30 days of such 90-
day period, there is a medical need for the
patient to continue to receive such services.
(F) Rental Cap.--
(i) In general.--Payment for oxygen
equipment (including portable oxygen
equipment) under this paragraph may not
extend over a period of continuous use
(as determined by the Secretary) of
longer than 36 months.
(ii) Payments and rules after rental
cap.--After the 36th continuous month
during which payment is made for the
equipment under this paragraph--
(I) the supplier furnishing
such equipment under this
subsection shall continue to
furnish the equipment during
any period of medical need for
the remainder of the reasonable
useful lifetime of the
equipment, as determined by the
Secretary;
(II) payments for oxygen
shall continue to be made in
the amount recognized for
oxygen under paragraph (9) for
the period of medical need; and
(III) maintenance and
servicing payments shall, if
the Secretary determines such
payments are reasonable and
necessary, be made (for parts
and labor not covered by the
supplier's or manufacturer's
warranty, as determined by the
Secretary to be appropriate for
the equipment), and such
payments shall be in an amount
determined to be appropriate by
the Secretary.
(6) Payment for other covered items (other than
durable medical equipment).--Payment for other covered
items (other than durable medical equipment and other
covered items described in paragraph (3), (4), or (5))
shall be made in a lump-sum amount for the purchase of
the item in the amount of the purchase price recognized
under paragraph (8).
(7) Payment for other items of durable medical
equipment.--
(A) Payment.--In the case of an item of
durable medical equipment not described in
paragraphs (2) through (6), the following rules
shall apply:
(i) Rental.--
(I) In general.--Except as
provided in clause (iii),
payment for the item shall be
made on a monthly basis for the
rental of the item during the
period of medical need (but
payments under this clause may
not extend over a period of
continuous use (as determined
by the Secretary) of longer
than 13 months).
(II) Payment amount.--Subject
to subclause (III) and
subparagraph (B), the amount
recognized for the item, for
each of the first 3 months of
such period, is 10 percent of
the purchase price recognized
under paragraph (8) with
respect to the item, and, for
each of the remaining months of
such period, is 7.5 percent of
such purchase price.
(III) Special rule for power-
driven wheelchairs.--For
purposes of payment for power-
driven wheelchairs, subclause
(II) shall be applied by
substituting ``15 percent'' and
``6 percent'' for ``10
percent'' and ``7.5 percent'',
respectively.
(ii) Ownership after rental.--On the
first day that begins after the 13th
continuous month during which payment
is made for the rental of an item under
clause (i), the supplier of the item
shall transfer title to the item to the
individual.
(iii) Purchase agreement option for
complex, rehabilitative power-driven
wheelchairs.--In the case of a complex,
rehabilitative power-driven wheelchair,
at the time the supplier furnishes the
item, the supplier shall offer the
individual the option to purchase the
item, and payment for such item shall
be made on a lump-sum basis if the
individual exercises such option.
(iv) Maintenance and servicing.--
After the supplier transfers title to
the item under clause (ii) or in the
case of a power-driven wheelchair for
which a purchase agreement has been
entered into under clause (iii),
maintenance and servicing payments
shall, if the Secretary determines such
payments are reasonable and necessary,
be made (for parts and labor not
covered by the supplier's or
manufacturer's warranty, as determined
by the Secretary to be appropriate for
the particular type of durable medical
equipment), and such payments shall be
in an amount determined to be
appropriate by the Secretary.
(B) Range for rental amounts.--
(i) For 1989.--For items furnished
during 1989, the payment amount
recognized under subparagraph (A)(i)
shall not be more than 115 percent, and
shall not be less than 85 percent, of
the prevailing charge established for
rental of the item in January 1987,
increased by the percentage increase in
the consumer price index for all urban
consumers (U.S. city average) for the
6-month period ending with December
1987.
(ii) For 1990.--For items furnished
during 1990, clause (i) shall apply in
the same manner as it applies to items
furnished during 1989.
(C) Replacement of items.--
(i) Establishment of reasonable
useful lifetime.--In accordance with
clause (iii), the Secretary shall
determine and establish a reasonable
useful lifetime for items of durable
medical equipment for which payment may
be made under this paragraph.
(ii) Payment for replacement items.--
If the reasonable lifetime of such an
item, as so established, has been
reached during a continuous period of
medical need, or the carrier determines
that the item is lost or irreparably
damaged, the patient may elect to have
payment for an item serving as a
replacement for such item made--
(I) on a monthly basis for
the rental of the replacement
item in accordance with
subparagraph (A); or
(II) in the case of an item
for which a purchase agreement
has been entered into under
subparagraph (A)(iii), in a
lump-sum amount for the
purchase of the item.
(iii) Length of reasonable useful
lifetime.--The reasonable useful
lifetime of an item of durable medical
equipment under this subparagraph shall
be equal to 5 years, except that, if
the Secretary determines that, on the
basis of prior experience in making
payments for such an item under this
title, a reasonable useful lifetime of
5 years is not appropriate with respect
to a particular item, the Secretary
shall establish an alternative
reasonable lifetime for such item.
(8) Purchase price recognized for miscellaneous
devices and items.--For purposes of paragraphs (6) and
(7), the amount that is recognized under this paragraph
as the purchase price for a covered item is the amount
described in subparagraph (C) of this paragraph,
determined as follows:
(A) Computation of local purchase price.--
Each carrier under section 1842 shall compute a
base local purchase price for the item as
follows:
(i) The carrier shall compute a base
local purchase price, for each item
described--
(I) in paragraph (6) equal to
the average reasonable charge
in the locality for the
purchase of the item for the
12-month period ending with
June 1987, or
(II) in paragraph (7) equal
to the average of the purchase
prices on the claims submitted
on an assignment-related basis
for the unused item supplied
during the 6-month period
ending with December 1986.
(ii) The carrier shall compute a
local purchase price, with respect to
the furnishing of each particular
item--
(I) in 1989 and 1990, equal
to the base local purchase
price computed under clause (i)
increased by the percentage
increase in the consumer price
index for all urban consumers
(U.S. city average) for the 6-
month period ending with
December 1987,
(II) in 1991, equal to the
local purchase price computed
under this clause for the
previous year, increased by the
covered item update for 1991,
and decreased by the percentage
by which the average of the
reasonable charges for claims
paid for all items described in
paragraph (7) is lower than the
average of the purchase prices
submitted for such items during
the final 9 months of 1988; or
(III) in 1992, 1993, and 1994
equal to the local purchase
price computed under this
clause for the previous year
increased by the covered item
update for the year.
(B) Computation of national limited purchase
price.--With respect to the furnishing of a
particular item in a year, the Secretary shall
compute a national limited purchase price--
(i) for 1991, equal to the local
purchase price computed under
subparagraph (A)(ii) for the item for
the year, except that such national
limited purchase price may not exceed
100 percent of the weighted average of
all local purchase prices for the item
computed under such subparagraph for
the year, and may not be less than 85
percent of the weighted average of all
local purchase prices for the item
computed under such subparagraph for
the year;
(ii) for 1992 and 1993, the amount
determined under this subparagraph for
the preceding year increased by the
covered item update for such subsequent
year;
(iii) for 1994, the local purchase
price computed under subparagraph
(A)(ii) for the item for the year,
except that such national limited
purchase price may not exceed 100
percent of the median of all local
purchase prices computed for the item
under such subparagraph for the year
and may not be less than 85 percent of
the median of all local purchase prices
computed under such subparagraph for
the item for the year; and
(iv) for each subsequent year, equal
to the amount determined under this
subparagraph for the preceding year
increased by the covered item update
for such subsequent year.
(C) Purchase price recognized.--For purposes
of paragraphs (6) and (7), the amount that is
recognized under this paragraph as the purchase
price for each item furnished--
(i) in 1989 or 1990, is 100 percent
of the local purchase price computed
under subparagraph (A)(ii)(I);
(ii) in 1991, is the sum of (I) 67
percent of the local purchase price
computed under subparagraph (A)(ii)(II)
for 1991, and (II) 33 percent of the
national limited purchase price
computed under subparagraph (B) for
1991;
(iii) in 1992, is the sum of (I) 33
percent of the local purchase price
computed under subparagraph
(A)(ii)(III) for 1992, and (II) 67
percent of the national limited
purchase price computed under
subparagraph (B) for 1992; and
(iv) in 1993 or a subsequent year, is
the national limited purchase price
computed under subparagraph (B) for
that year.
(9) Monthly payment amount recognized with respect to
oxygen and oxygen equipment.--For purposes of paragraph
(5), the amount that is recognized under this paragraph
for payment for oxygen and oxygen equipment is the
monthly payment amount described in subparagraph (C) of
this paragraph. Such amount shall be computed
separately (i) for all items of oxygen and oxygen
equipment (other than portable oxygen equipment) and
(ii) for portable oxygen equipment (each such group
referred to in this paragraph as an ``item'').
(A) Computation of local monthly payment
rate.--Each carrier under this section shall
compute a base local payment rate for each item
as follows:
(i) The carrier shall compute a base
local average monthly payment rate per
beneficiary as an amount equal to (I)
the total reasonable charges for the
item during the 12-month period ending
with December 1986, divided by (II) the
total number of months for all
beneficiaries receiving the item in the
area during the 12-month period for
which the carrier made payment for the
item under this title.
(ii) The carrier shall compute a
local average monthly payment rate for
the item applicable--
(I) to 1989 and 1990, equal
to 95 percent of the base local
average monthly payment rate
computed under clause (i) for
the item increased by the
percentage increase in the
consumer price index for all
urban consumers (U.S. city
average) for the 6-month period
ending with December 1987, or
(II) to 1991, 1992, 1993, and
1994 equal to the local average
monthly payment rate computed
under this clause for the item
for the previous year increased
by the covered item increase
for the year.
(B) Computation of national limited monthly
payment rate.--With respect to the furnishing
of an item in a year, the Secretary shall
compute a national limited monthly payment rate
equal to--
(i) for 1991, the local monthly
payment rate computed under
subparagraph (A)(ii)(II) for the item
for the year, except that such national
limited monthly payment rate may not
exceed 100 percent of the weighted
average of all local monthly payment
rates computed for the item under such
subparagraph for the year, and may not
be less than 85 percent of the weighted
average of all local monthly payment
rates computed for the item under such
subparagraph for the year;
(ii) for 1992 and 1993, the amount
determined under this subparagraph for
the preceding year increased by the
covered item update for such subsequent
year;
(iii) for 1994, the local monthly
payment rate computed under
subparagraph (A)(ii) for the item for
the year, except that such national
limited monthly payment rate may not
exceed 100 percent of the median of all
local monthly payment rates computed
for the item under such subparagraph
for the year and may not be less than
85 percent of the median of all local
monthly payment rates computed for the
item under such subparagraph for the
year;
(iv) for 1995, 1996, and 1997, equal
to the amount determined under this
subparagraph for the preceding year
increased by the covered item update
for such subsequent year;
(v) for 1998, 75 percent of the
amount determined under this
subparagraph for 1997; and
(vi) for 1999 and each subsequent
year, 70 percent of the amount
determined under this subparagraph for
1997.
(C) Monthly payment amount recognized.--For
purposes of paragraph (5), the amount that is
recognized under this paragraph as the base
monthly payment amount for each item
furnished--
(i) in 1989 and in 1990, is 100
percent of the local average monthly
payment rate computed under
subparagraph (A)(ii) for the item;
(ii) in 1991, is the sum of (I) 67
percent of the local average monthly
payment rate computed under
subparagraph (A)(ii)(II) for the item
for 1991, and (II) 33 percent of the
national limited monthly payment rate
computed under subparagraph (B)(i) for
the item for 1991;
(iii) in 1992, is the sum of (I) 33
percent of the local average monthly
payment rate computed under
subparagraph (A)(ii)(II) for the item
for 1992, and (II) 67 percent of the
national limited monthly payment rate
computed under subparagraph (B)(ii) for
the item for 1992; and
(iv) in a subsequent year, is the
national limited monthly payment rate
computed under subparagraph (B) for the
item for that year.
(10) Exceptions and adjustments.--
(A) Areas outside continental united
states.--Exceptions to the amounts recognized
under the previous provisions of this
subsection shall be made to take into account
the unique circumstances of covered items
furnished in Alaska, Hawaii, or Puerto Rico.
(B) Adjustment for inherent reasonableness.--
The Secretary is authorized to apply the
provisions of paragraphs (8) and (9) of section
1842(b) to covered items and suppliers of such
items and payments under this subsection in an
area and with respect to covered items and
services for which the Secretary does not make
a payment amount adjustment under paragraph
(1)(F).
(C) Transcutaneous electrical nerve
stimulator (tens).--In order to permit an
attending physician time to determine whether
the purchase of a transcutaneous electrical
nerve stimulator is medically appropriate for a
particular patient, the Secretary may determine
an appropriate payment amount for the initial
rental of such item for a period of not more
than 2 months. If such item is subsequently
purchased, the payment amount with respect to
such purchase is the payment amount determined
under paragraph (2).
(11) Improper billing and requirement of physician
order.--
(A) Improper billing for certain rental
items.--Notwithstanding any other provision of
this title, a supplier of a covered item for
which payment is made under this subsection and
which is furnished on a rental basis shall
continue to supply the item without charge
(other than a charge provided under this
subsection for the maintenance and servicing of
the item) after rental payments may no longer
be made under this subsection. If a supplier
knowingly and willfully violates the previous
sentence, the Secretary may apply sanctions
against the supplier under section 1842(j)(2)
in the same manner such sanctions may apply
with respect to a physician.
(B) Requirement of physician order.--
(i) In general.--The Secretary is
authorized to require, for specified
covered items, that payment may be made
under this subsection with respect to
the item only if a physician enrolled
under section 1866(j) or an eligible
professional under section
1848(k)(3)(B) that is enrolled under
section 1866(j) has communicated to the
supplier, before delivery of the item,
a written order for the item.
(ii) Requirement for face to face
encounter.--The Secretary shall require
that such an order be written pursuant
to a physician, a physician assistant,
a nurse practitioner, or a clinical
nurse specialist (as those terms are
defined in section 1861(aa)(5))
documenting such physician, physician
assistant, practitioner, or specialist
has had a face-to-face encounter
(including through use of telehealth
under subsection (m) and other than
with respect to encounters that are
incident to services involved) with the
individual involved during the 6-month
period preceding such written order, or
other reasonable timeframe as
determined by the Secretary.
(12) Regional carriers.--The Secretary may designate,
by regulation under section 1842, one carrier for one
or more entire regions to process all claims within the
region for covered items under this section.
(13) Covered item.--In this subsection, the term
``covered item'' means durable medical equipment (as
defined in section 1861(n)), including such equipment
described in section 1861(m)(5), but not including
implantable items for which payment may be made under
section 1833(t).
(14) Covered item update.--In this subsection, the
term ``covered item update'' means, with respect to a
year--
(A) for 1991 and 1992, the percentage
increase in the consumer price index for all
urban consumers (U.S. city average) for the 12-
month period ending with June of the previous
year reduced by 1 percentage point;
(B) for 1993, 1994, 1995, 1996, and 1997, the
percentage increase in the consumer price index
for all urban consumers (U.S. city average) for
the 12-month period ending with June of the
previous year;
(C) for each of the years 1998 through 2000,
0 percentage points;
(D) for 2001, the percentage increase in the
consumer price index for all urban consumers
(U.S. city average) for the 12-month period
ending with June 2000;
(E) for 2002, 0 percentage points;
(F) for 2003, the percentage increase in the
consumer price index for all urban consumers
(U.S. urban average) for the 12-month period
ending with June of 2002;
(G) for 2004 through 2006--
(i) subject to clause (ii), in the
case of class III medical devices
described in section 513(a)(1)(C) of
the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 360(c)(1)(C)), the
percentage increase described in
subparagraph (B) for the year involved;
and
(ii) in the case of covered items not
described in clause (i), 0 percentage
points;
(H) for 2007--
(i) subject to clause (ii), in the
case of class III medical devices
described in section 513(a)(1)(C) of
the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 360(c)(1)(C)), the
percentage change determined by the
Secretary to be appropriate taking into
account recommendations contained in
the report of the Comptroller General
of the United States under section
302(c)(1)(B) of the Medicare
Prescription Drug, Improvement, and
Modernization Act of 2003; and
(ii) in the case of covered items not
described in clause (i), 0 percentage
points;
(I) for 2008--
(i) subject to clause (ii), in the
case of class III medical devices
described in section 513(a)(1)(C) of
the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 360(c)(1)(C)), the
percentage increase described in
subparagraph (B) (as applied to the
payment amount for 2007 determined
after the application of the percentage
change under subparagraph (H)(i)); and
(ii) in the case of covered items not
described in clause (i), 0 percentage
points;
(J) for 2009--
(i) in the case of items and services
furnished in any geographic area, if
such items or services were selected
for competitive acquisition in any area
under the competitive acquisition
program under section
1847(a)(1)(B)(i)(I) before July 1,
2008, including related accessories but
only if furnished with such items and
services selected for such competition
and diabetic supplies but only if
furnished through mail order, - 9.5
percent; or
(ii) in the case of other items and
services, the percentage increase in
the consumer price index for all urban
consumers (U.S. urban average) for the
12-month period ending with June 2008;
(K) for 2010, the percentage increase in the
consumer price index for all urban consumers
(U.S. urban average) for the 12-month period
ending with June of the previous year; and
(L) for 2011 and each subsequent year--
(i) the percentage increase in the
consumer price index for all urban
consumers (United States city average)
for the 12-month period ending with
June of the previous year, reduced by--
(ii) the productivity adjustment
described in section
1886(b)(3)(B)(xi)(II).
The application of subparagraph (L)(ii) may result in
the covered item update under this paragraph being less
than 0.0 for a year, and may result in payment rates
under this subsection for a year being less than such
payment rates for the preceding year.
(15) Advance determinations of coverage for certain
items.--
(A) Development of lists of items by
secretary.--The Secretary may develop and
periodically update a list of items for which
payment may be made under this subsection that
the Secretary determines, on the basis of prior
payment experience, are frequently subject to
unnecessary utilization throughout a carrier's
entire service area or a portion of such area.
(B) Development of lists of suppliers by
secretary.--The Secretary may develop and
periodically update a list of suppliers of
items for which payment may be made under this
subsection with respect to whom--
(i) the Secretary has found that a
substantial number of claims for
payment under this part for items
furnished by the supplier have been
denied on the basis of the application
of section 1862(a)(1); or
(ii) the Secretary has identified a
pattern of overutilization resulting
from the business practice of the
supplier.
(C) Determinations of coverage in advance.--A
carrier shall determine in advance of delivery
of an item whether payment for the item may not
be made because the item is not covered or
because of the application of section
1862(a)(1) if--
(i) the item is included on the list
developed by the Secretary under
subparagraph (A);
(ii) the item is furnished by a
supplier included on the list developed
by the Secretary under subparagraph
(B); or
(iii) the item is a customized item
(other than inexpensive items specified
by the Secretary) and the patient to
whom the item is to be furnished or the
supplier requests that such advance
determination be made.
(16) Disclosure of information and surety bond.--The
Secretary shall not provide for the issuance (or
renewal) of a provider number for a supplier of durable
medical equipment, for purposes of payment under this
part for durable medical equipment furnished by the
supplier, unless the supplier provides the Secretary on
a continuing basis--
(A) with--
(i) full and complete information as
to the identity of each person with an
ownership or control interest (as
defined in section 1124(a)(3)) in the
supplier or in any subcontractor (as
defined by the Secretary in
regulations) in which the supplier
directly or indirectly has a 5 percent
or more ownership interest; and
(ii) to the extent determined to be
feasible under regulations of the
Secretary, the name of any disclosing
entity (as defined in section
1124(a)(2)) with respect to which a
person with such an ownership or
control interest in the supplier is a
person with such an ownership or
control interest in the disclosing
entity; and
(B) with a surety bond in a form specified by
the Secretary and in an amount that is not less
than $50,000 that the Secretary determines is
commensurate with the volume of the billing of
the supplier.
The Secretary may waive the requirement of a bond under
subparagraph (B) in the case of a supplier that
provides a comparable surety bond under State law. The
Secretary, at the Secretary's discretion, may impose
the requirements of the first sentence with respect to
some or all providers of items or services under part A
or some or all suppliers or other persons (other than
physicians or other practitioners, as defined in
section 1842(b)(18)(C)) who furnish items or services
under this part.
(17) Prohibition against unsolicited telephone
contacts by suppliers.--
(A) In general.--A supplier of a covered item
under this subsection may not contact an
individual enrolled under this part by
telephone regarding the furnishing of a covered
item to the individual unless 1 of the
following applies:
(i) The individual has given written
permission to the supplier to make
contact by telephone regarding the
furnishing of a covered item.
(ii) The supplier has furnished a
covered item to the individual and the
supplier is contacting the individual
only regarding the furnishing of such
covered item.
(iii) If the contact is regarding the
furnishing of a covered item other than
a covered item already furnished to the
individual, the supplier has furnished
at least 1 covered item to the
individual during the 15-month period
preceding the date on which the
supplier makes such contact.
(B) Prohibiting payment for items furnished
subsequent to unsolicited contacts.--If a
supplier knowingly contacts an individual in
violation of subparagraph (A), no payment may
be made under this part for any item
subsequently furnished to the individual by the
supplier.
(C) Exclusion from program for suppliers
engaging in pattern of unsolicited contacts.--
If a supplier knowingly contacts individuals in
violation of subparagraph (A) to such an extent
that the supplier's conduct establishes a
pattern of contacts in violation of such
subparagraph, the Secretary shall exclude the
supplier from participation in the programs
under this Act, in accordance with the
procedures set forth in subsections (c), (f),
and (g) of section 1128.
(18) Refund of amounts collected for certain
disallowed items.--
(A) In general.--If a nonparticipating
supplier furnishes to an individual enrolled
under this part a covered item for which no
payment may be made under this part by reason
of paragraph (17)(B), the supplier shall refund
on a timely basis to the patient (and shall be
liable to the patient for) any amounts
collected from the patient for the item,
unless--
(i) the supplier establishes that the
supplier did not know and could not
reasonably have been expected to know
that payment may not be made for the
item by reason of paragraph (17)(B), or
(ii) before the item was furnished,
the patient was informed that payment
under this part may not be made for
that item and the patient has agreed to
pay for that item.
(B) Sanctions.--If a supplier knowingly and
willfully fails to make refunds in violation of
subparagraph (A), the Secretary may apply
sanctions against the supplier in accordance
with section 1842(j)(2).
(C) Notice.--Each carrier with a contract in
effect under this part with respect to
suppliers of covered items shall send any
notice of denial of payment for covered items
by reason of paragraph (17)(B) and for which
payment is not requested on an assignment-
related basis to the supplier and the patient
involved.
(D) Timely basis defined.--A refund under
subparagraph (A) is considered to be on a
timely basis only if--
(i) in the case of a supplier who
does not request reconsideration or
seek appeal on a timely basis, the
refund is made within 30 days after the
date the supplier receives a denial
notice under subparagraph (C), or
(ii) in the case in which such a
reconsideration or appeal is taken, the
refund is made within 15 days after the
date the supplier receives notice of an
adverse determination on
reconsideration or appeal.
(19) Certain upgraded items.--
(A) Individual's right to choose upgraded
item.--Notwithstanding any other provision of
this title, the Secretary may issue regulations
under which an individual may purchase or rent
from a supplier an item of upgraded durable
medical equipment for which payment would be
made under this subsection if the item were a
standard item.
(B) Payments to supplier.--In the case of the
purchase or rental of an upgraded item under
subparagraph (A)--
(i) the supplier shall receive
payment under this subsection with
respect to such item as if such item
were a standard item; and
(ii) the individual purchasing or
renting the item shall pay the supplier
an amount equal to the difference
between the supplier's charge and the
amount under clause (i).
In no event may the supplier's charge for an
upgraded item exceed the applicable fee
schedule amount (if any) for such item.
(C) Consumer protection safeguards.--Any
regulations under subparagraph (A) shall
provide for consumer protection standards with
respect to the furnishing of upgraded equipment
under subparagraph (A). Such regulations shall
provide for--
(i) determination of fair market
prices with respect to an upgraded
item;
(ii) full disclosure of the
availability and price of standard
items and proof of receipt of such
disclosure information by the
beneficiary before the furnishing of
the upgraded item;
(iii) conditions of participation for
suppliers in the billing arrangement;
(iv) sanctions of suppliers who are
determined to engage in coercive or
abusive practices, including exclusion;
and
(v) such other safeguards as the
Secretary determines are necessary.
(20) Identification of quality standards.--
(A) In general.--Subject to subparagraph (C),
the Secretary shall establish and implement
quality standards for suppliers of items and
services described in subparagraph (D) to be
applied by recognized independent accreditation
organizations (as designated under subparagraph
(B)) and with which such suppliers shall be
required to comply in order to--
(i) furnish any such item or service
for which payment is made under this
part; and
(ii) receive or retain a provider or
supplier number used to submit claims
for reimbursement for any such item or
service for which payment may be made
under this title.
(B) Designation of independent accreditation
organizations.--Not later than the date that is
1 year after the date on which the Secretary
implements the quality standards under
subparagraph (A), notwithstanding section
1865(a), the Secretary shall designate and
approve one or more independent accreditation
organizations for purposes of such
subparagraph.
(C) Quality standards.--The quality standards
described in subparagraph (A) may not be less
stringent than the quality standards that would
otherwise apply if this paragraph did not apply
and shall include consumer services standards.
(D) Items and services described.--The items
and services described in this subparagraph are
the following items and services, as the
Secretary determines appropriate:
(i) Covered items (as defined in
paragraph (13)) for which payment may
otherwise be made under this
subsection.
(ii) Prosthetic devices and orthotics
and prosthetics described in section
1834(h)(4).
(iii) Items and services described in
section 1842(s)(2).
(E) Implementation.--The Secretary may
establish by program instruction or otherwise
the quality standards under this paragraph,
including subparagraph (F), after consultation
with representatives of relevant parties. Such
standards shall be applied prospectively and
shall be published on the Internet website of
the Centers for Medicare & Medicaid Services.
(F) Application of accreditation
requirement.--In implementing quality standards
under this paragraph--
(i) subject to clause (ii) and
subparagraph (G), the Secretary shall
require suppliers furnishing items and
services described in subparagraph (D)
on or after October 1, 2009, directly
or as a subcontractor for another
entity, to have submitted to the
Secretary evidence of accreditation by
an accreditation organization
designated under subparagraph (B) as
meeting applicable quality standards,
except that the Secretary shall not
require under this clause pharmacies to
obtain such accreditation before
January 1, 2010, except that the
Secretary shall not require a pharmacy
to have submitted to the Secretary such
evidence of accreditation prior to
January 1, 2011; and
(ii) in applying such standards and
the accreditation requirement of clause
(i) with respect to eligible
professionals (as defined in section
1848(k)(3)(B)), and including such
other persons, such as orthotists and
prosthetists, as specified by the
Secretary, furnishing such items and
services--
(I) such standards and
accreditation requirement shall
not apply to such professionals
and persons unless the
Secretary determines that the
standards being applied are
designed specifically to be
applied to such professionals
and persons; and
(II) the Secretary may exempt
such professionals and persons
from such standards and
requirement if the Secretary
determines that licensing,
accreditation, or other
mandatory quality requirements
apply to such professionals and
persons with respect to the
furnishing of such items and
services.
(G) Application of accreditation requirement
to certain pharmacies.--
(i) In general.--With respect to
items and services furnished on or
after January 1, 2011, in implementing
quality standards under this
paragraph--
(I) subject to subclause
(II), in applying such
standards and the accreditation
requirement of subparagraph
(F)(i) with respect to
pharmacies described in clause
(ii) furnishing such items and
services, such standards and
accreditation requirement shall
not apply to such pharmacies;
and
(II) the Secretary may apply
to such pharmacies an
alternative accreditation
requirement established by the
Secretary if the Secretary
determines such alternative
accreditation requirement is
more appropriate for such
pharmacies.
(ii) Pharmacies described.--A
pharmacy described in this clause is a
pharmacy that meets each of the
following criteria:
(I) The total billings by the
pharmacy for such items and
services under this title are
less than 5 percent of total
pharmacy sales, as determined
based on the average total
pharmacy sales for the previous
3 calendar years, 3 fiscal
years, or other yearly period
specified by the Secretary.
(II) The pharmacy has been
enrolled under section 1866(j)
as a supplier of durable
medical equipment, prosthetics,
orthotics, and supplies, has
been issued (which may include
the renewal of) a provider
number for at least 5 years,
and for which a final adverse
action (as defined in section
424.57(a) of title 42, Code of
Federal Regulations) has not
been imposed in the past 5
years.
(III) The pharmacy submits to
the Secretary an attestation,
in a form and manner, and at a
time, specified by the
Secretary, that the pharmacy
meets the criteria described in
subclauses (I) and (II). Such
attestation shall be subject to
section 1001 of title 18,
United States Code.
(IV) The pharmacy agrees to
submit materials as requested
by the Secretary, or during the
course of an audit conducted on
a random sample of pharmacies
selected annually, to verify
that the pharmacy meets the
criteria described in
subclauses (I) and (II).
Materials submitted under the
preceding sentence shall
include a certification by an
accountant on behalf of the
pharmacy or the submission of
tax returns filed by the
pharmacy during the relevant
periods, as requested by the
Secretary.
(21) Special payment rule for specified items and
supplies.--
(A) In general.--Notwithstanding the
preceding provisions of this subsection, for
specified items and supplies (described in
subparagraph (B)) furnished during 2005, the
payment amount otherwise determined under this
subsection for such specified items and
supplies shall be reduced by the percentage
difference between--
(i) the amount of payment otherwise
determined for the specified item or
supply under this subsection for 2002,
and
(ii) the amount of payment for the
specified item or supply under chapter
89 of title 5, United States Code, as
identified in the column entitled
``Median FEHP Price'' in the table
entitled ``SUMMARY OF MEDICARE PRICES
COMPARED TO VA, MEDICAID, RETAIL, AND
FEHP PRICES FOR 16 ITEMS'' included in
the Testimony of the Inspector General
before the Senate Committee on
Appropriations, June 12, 2002, or any
subsequent report by the Inspector
General.
(B) Specified item or supply described.--For
purposes of subparagraph (A), a specified item
or supply means oxygen and oxygen equipment,
standard wheelchairs (including standard power
wheelchairs), nebulizers, diabetic supplies
consisting of lancets and testing strips,
hospital beds, and air mattresses, but only if
the HCPCS code for the item or supply is
identified in a table referred to in
subparagraph (A)(ii).
(C) Application of update to special payment
amount.--The covered item update under
paragraph (14) for specified items and supplies
for 2006 and each subsequent year shall be
applied to the payment amount under
subparagraph (A) unless payment is made for
such items and supplies under section 1847.
(22) Special payment rule for diabetic supplies.--
Notwithstanding the preceding provisions of this
subsection, for purposes of determining the payment
amount under this subsection for diabetic supplies
furnished on or after the first day of the calendar
quarter during 2013 that is at least 30 days after the
date of the enactment of this paragraph and before the
date described in paragraph (1)(H)(ii), the Secretary
shall recalculate and apply the covered item update
under paragraph (14) as if subparagraph (J)(i) of such
paragraph was amended by striking ``but only if
furnished through mail order''.
(b) Fee Schedules for Radiologist Services.--
(1) Development.--The Secretary shall develop--
(A) a relative value scale to serve as the
basis for the payment for radiologist services
under this part, and
(B) using such scale and appropriate
conversion factors and subject to subsection
(c)(1)(A), fee schedules (on a regional,
statewide, locality, or carrier service area
basis) for payment for radiologist services
under this part, to be implemented for such
services furnished during 1989.
(2) Consultation.--In carrying out paragraph (1), the
Secretary shall regularly consult closely with the
Physician Payment Review Commission, the American
College of Radiology, and other organizations
representing physicians or suppliers who furnish
radiologist services and shall share with them the data
and data analysis being used to make the determinations
under paragraph (1), including data on variations in
current medicare payments by geographic area, and by
service and physician specialty.
(3) Considerations.--In developing the relative value
scale and fee schedules under paragraph (1), the
Secretary--
(A) shall take into consideration variations
in the cost of furnishing such services among
geographic areas and among different sites
where services are furnished, and
(B) may also take into consideration such
other factors respecting the manner in which
physicians in different specialties furnish
such services as may be appropriate to assure
that payment amounts are equitable and designed
to promote effective and efficient provision of
radiologist services by physicians in the
different specialties.
(4) Savings.--
(A) Budget neutral fee schedules.--The
Secretary shall develop preliminary fee
schedules for 1989, which are designed to
result in the same amount of aggregate payments
(net of any coinsurance and deductibles under
sections 1833(a)(1)(J) and 1833(b)) for
radiologist services furnished in 1989 as would
have been made if this subsection had not been
enacted.
(B) Initial savings.--The fee schedules
established for payment purposes under this
subsection for services furnished in 1989 shall
be 97 percent of the amounts permitted under
these preliminary fee schedules developed under
subparagraph (A).
(C) 1990 fee schedules.--For radiologist
services (other than portable X-ray services)
furnished under this part during 1990, after
March 31 of such year, the conversion factors
used under this subsection shall be 96 percent
of the conversion factors that applied under
this subsection as of December 31, 1989.
(D) 1991 fee schedules.--For radiologist
services (other than portable X-ray services)
furnished under this part during 1991, the
conversion factors used in a locality under
this subsection shall, subject to clause (vii),
be reduced to the adjusted conversion factor
for the locality determined as follows:
(i) National weighted average
conversion factor.--The Secretary shall
estimate the national weighted average
of the conversion factors used under
this subsection for services furnished
during 1990 beginning on April 1, using
the best available data.
(ii) Reduced national weighted
average.--The national weighted average
estimated under clause (i) shall be
reduced by 13 percent.
(iii) Computation of 1990 locality
index relative to national average.--
The Secretary shall establish an index
which reflects, for each locality, the
ratio of the conversion factor used in
the locality under this subsection to
the national weighted average estimated
under clause (i).
(iv) Adjusted conversion factor.--The
adjusted conversion factor for the
professional or technical component of
a service in a locality is the sum of
\1/2\ of the locally-adjusted amount
determined under clause (v) and \1/2\
of the GPCI-adjusted amount determined
under clause (vi).
(v) Locally-adjusted amount.--For
purposes of clause (iv), the locally
adjusted amount determined under this
clause is the product of (I) the
national weighted average conversion
factor computed under clause (ii), and
(II) the index value established under
clause (iii) for the locality.
(vi) GPCI-adjusted amount.--For
purposes of clause (iv), the GPCI-
adjusted amount determined under this
clause is the sum of--
(I) the product of (a) the
portion of the reduced national
weighted average conversion
factor computed under clause
(ii) which is attributable to
physician work and (b) the
geographic work index value for
the locality (specified in
Addendum C to the Model Fee
Schedule for Physician Services
(published on September 4,
1990, 55 Federal Register pp.
36238-36243)); and
(II) the product of (a) the
remaining portion of the
reduced national weighted
average conversion factor
computed under clause (ii), and
(b) the geographic practice
cost index value specified in
section 1842(b)(14)(C)(iv) for
the locality.
In applying this clause with respect to
the professional component of a
service, 80 percent of the conversion
factor shall be considered to be
attributable to physician work and with
respect to the technical component of
the service, 0 percent shall be
considered to be attributable to
physician work.
(vii) Limits on conversion factor.--
The conversion factor to be applied to
a locality to the professional or
technical component of a service shall
not be reduced under this subparagraph
by more than 9.5 percent below the
conversion factor applied in the
locality under subparagraph (C) to such
component, but in no case shall the
conversion factor be less than 60
percent of the national weighted
average of the conversion factors
(computed under clause (i)).
(E) Rule for certain scanning services.--In
the case of the technical components of
magnetic resonance imaging (MRI) services and
computer assisted tomography (CAT) services
furnished after December 31, 1990, the amount
otherwise payable shall be reduced by 10
percent.
(F) Subsequent updating.--For radiologist
services furnished in subsequent years, the fee
schedules shall be the schedules for the
previous year updated by the percentage
increase in the MEI (as defined in section
1842(i)(3)) for the year.
(G) Nonparticipating physicians and
suppliers.--Each fee schedule so established
shall provide that the payment rate recognized
for nonparticipating physicians and suppliers
is equal to the appropriate percent (as defined
in section 1842(b)(4)(A)(iv)) of the payment
rate recognized for participating physicians
and suppliers.
(5) Limiting charges of nonparticipating physicians
and suppliers.--
(A) In general.--In the case of radiologist
services furnished after January 1, 1989, for
which payment is made under a fee schedule
under this subsection, if a nonparticipating
physician or supplier furnishes the service to
an individual entitled to benefits under this
part, the physician or supplier may not charge
the individual more than the limiting charge
(as defined in subparagraph (B)).
(B) Limiting charge defined.--In subparagraph
(A), the term ``limiting charge'' means, with
respect to a service furnished--
(i) in 1989, 125 percent of the
amount specified for the service in the
appropriate fee schedule established
under paragraph (1),
(ii) in 1990, 120 percent of the
amount specified for the service in the
appropriate fee schedule established
under paragraph (1), and
(iii) after 1990, 115 percent of the
amount specified for the service in the
appropriate fee schedule established
under paragraph (1).
(C) Enforcement.--If a physician or supplier
knowingly and willfully bills in violation of
subparagraph (A), the Secretary may apply
sanctions against such physician or supplier in
accordance with section 1842(j)(2) in the same
manner as such sanctions may apply to a
physician.
(6) Radiologist services defined.--For the purposes
of this subsection and section 1833(a)(1)(J), the term
``radiologist services'' only includes radiology
services performed by, or under the direction or
supervision of, a physician--
(A) who is certified, or eligible to be
certified, by the American Board of Radiology,
or
(B) for whom radiology services account for
at least 50 percent of the total amount of
charges made under this part.
(c) Payment and Standards for Screening Mammography.--
(1) In general.--With respect to expenses incurred
for screening mammography (as defined in section
1861(jj)), payment may be made only--
(A) for screening mammography conducted
consistent with the frequency permitted under
paragraph (2); and
(B) if the screening mammography is conducted
by a facility that has a certificate (or
provisional certificate) issued under section
354 of the Public Health Service Act.
(2) Frequency covered.--
(A) In general.--Subject to revision by the
Secretary under subparagraph (B)--
(i) no payment may be made under this
part for screening mammography
performed on a woman under 35 years of
age;
(ii) payment may be made under this
part for only one screening mammography
performed on a woman over 34 years of
age, but under 40 years of age; and
(iii) in the case of a woman over 39
years of age, payment may not be made
under this part for screening
mammography performed within 11 months
following the month in which a previous
screening mammography was performed.
(B) Revision of frequency.--
(i) Review.--The Secretary, in
consultation with the Director of the
National Cancer Institute, shall review
periodically the appropriate frequency
for performing screening mammography,
based on age and such other factors as
the Secretary believes to be pertinent.
(ii) Revision of frequency.--The
Secretary, taking into consideration
the review made under clause (i), may
revise from time to time the frequency
with which screening mammography may be
paid for under this subsection.
(d) Frequency Limits and Payment for Colorectal Cancer
Screening Tests.--
(1) Screening fecal-occult blood tests.--
(A) Payment amount.--The payment amount for
colorectal cancer screening tests consisting of
screening fecal-occult blood tests is equal to
the payment amount established for diagnostic
fecal-occult blood tests under section 1833(h).
(B) Frequency limit.--No payment may be made
under this part for a colorectal cancer
screening test consisting of a screening fecal-
occult blood test--
(i) if the individual is under 50
years of age; or
(ii) if the test is performed within
the 11 months after a previous
screening fecal-occult blood test.
(2) Screening flexible sigmoidoscopies.--
(A) Fee schedule.--With respect to colorectal
cancer screening tests consisting of screening
flexible sigmoidoscopies, payment under section
1848 shall be consistent with payment under
such section for similar or related services.
(B) Payment limit.--In the case of screening
flexible sigmoidoscopy services, payment under
this part shall not exceed such amount as the
Secretary specifies, based upon the rates
recognized for diagnostic flexible
sigmoidoscopy services.
(C) Facility payment limit.--
(i) In general.--Notwithstanding
subsections (i)(2)(A) and (t) of
section 1833, in the case of screening
flexible sigmoidoscopy services
furnished on or after January 1, 1999,
that--
(I) in accordance with
regulations, may be performed
in an ambulatory surgical
center and for which the
Secretary permits ambulatory
surgical center payments under
this part, and
(II) are performed in an
ambulatory surgical center or
hospital outpatient department,
payment under this part shall be based
on the lesser of the amount under the
fee schedule that would apply to such
services if they were performed in a
hospital outpatient department in an
area or the amount under the fee
schedule that would apply to such
services if they were performed in an
ambulatory surgical center in the same
area.
(ii) Limitation on coinsurance.--
Notwithstanding any other provision of
this title, in the case of a
beneficiary who receives the services
described in clause (i)--
(I) in computing the amount
of any applicable copayment,
the computation of such
coinsurance shall be based upon
the fee schedule under which
payment is made for the
services, and
(II) the amount of such
coinsurance is equal to 25
percent of the payment amount
under the fee schedule
described in subclause (I).
(D) Special rule for detected lesions.--If
during the course of such screening flexible
sigmoidoscopy, a lesion or growth is detected
which results in a biopsy or removal of the
lesion or growth, payment under this part shall
not be made for the screening flexible
sigmoidoscopy but shall be made for the
procedure classified as a flexible
sigmoidoscopy with such biopsy or removal.
(E) Frequency limit.--No payment may be made
under this part for a colorectal cancer
screening test consisting of a screening
flexible sigmoidoscopy--
(i) if the individual is under 50
years of age; or
(ii) if the procedure is performed
within the 47 months after a previous
screening flexible sigmoidoscopy or, in
the case of an individual who is not at
high risk for colorectal cancer, if the
procedure is performed within the 119
months after a previous screening
colonoscopy.
(3) Screening colonoscopy.--
(A) Fee schedule.--With respect to colorectal
cancer screening test consisting of a screening
colonoscopy, payment under section 1848 shall
be consistent with payment amounts under such
section for similar or related services.
(B) Payment limit.--In the case of screening
colonoscopy services, payment under this part
shall not exceed such amount as the Secretary
specifies, based upon the rates recognized for
diagnostic colonoscopy services.
(C) Facility payment limit.--
(i) In general.--Notwithstanding
subsections (i)(2)(A) and (t) of
section 1833, in the case of screening
colonoscopy services furnished on or
after January 1, 1999, that are
performed in an ambulatory surgical
center or a hospital outpatient
department, payment under this part
shall be based on the lesser of the
amount under the fee schedule that
would apply to such services if they
were performed in a hospital outpatient
department in an area or the amount
under the fee schedule that would apply
to such services if they were performed
in an ambulatory surgical center in the
same area.
(ii) Limitation on coinsurance.--
Notwithstanding any other provision of
this title, in the case of a
beneficiary who receives the services
described in clause (i)--
(I) in computing the amount
of any applicable coinsurance,
the computation of such
coinsurance shall be based upon
the fee schedule under which
payment is made for the
services, and
(II) the amount of such
coinsurance is equal to 25
percent of the payment amount
under the fee schedule
described in subclause (I).
(D) Special rule for detected lesions.--If
during the course of such screening
colonoscopy, a lesion or growth is detected
which results in a biopsy or removal of the
lesion or growth, payment under this part shall
not be made for the screening colonoscopy but
shall be made for the procedure classified as a
colonoscopy with such biopsy or removal.
(E) Frequency limit.--No payment may be made
under this part for a colorectal cancer
screening test consisting of a screening
colonoscopy for individuals at high risk for
colorectal cancer if the procedure is performed
within the 23 months after a previous screening
colonoscopy or for other individuals if the
procedure is performed within the 119 months
after a previous screening colonoscopy or
within 47 months after a previous screening
flexible sigmoidoscopy.
(e) Accreditation Requirement for Advanced Diagnostic Imaging
Services.--
(1) In general.--
(A) In general.--Beginning with January 1,
2012, with respect to the technical component
of advanced diagnostic imaging services for
which payment is made under the fee schedule
established under section 1848(b) and that are
furnished by a supplier, payment may only be
made if such supplier is accredited by an
accreditation organization designated by the
Secretary under paragraph (2)(B)(i).
(B) Advanced diagnostic imaging services
defined.--In this subsection, the term
``advanced diagnostic imaging services''
includes--
(i) diagnostic magnetic resonance
imaging, computed tomography, and
nuclear medicine (including positron
emission tomography); and
(ii) such other diagnostic imaging
services, including services described
in section 1848(b)(4)(B) (excluding X-
ray, ultrasound, and fluoroscopy), as
specified by the Secretary in
consultation with physician specialty
organizations and other stakeholders.
(C) Supplier defined.--In this subsection,
the term ``supplier'' has the meaning given
such term in section 1861(d).
(2) Accreditation organizations.--
(A) Factors for designation of accreditation
organizations.--The Secretary shall consider
the following factors in designating
accreditation organizations under subparagraph
(B)(i) and in reviewing and modifying the list
of accreditation organizations designated
pursuant to subparagraph (C):
(i) The ability of the organization
to conduct timely reviews of
accreditation applications.
(ii) Whether the organization has
established a process for the timely
integration of new advanced diagnostic
imaging services into the
organization's accreditation program.
(iii) Whether the organization uses
random site visits, site audits, or
other strategies for ensuring
accredited suppliers maintain adherence
to the criteria described in paragraph
(3).
(iv) The ability of the organization
to take into account the capacities of
suppliers located in a rural area (as
defined in section 1886(d)(2)(D)).
(v) Whether the organization has
established reasonable fees to be
charged to suppliers applying for
accreditation.
(vi) Such other factors as the
Secretary determines appropriate.
(B) Designation.--Not later than January 1,
2010, the Secretary shall designate
organizations to accredit suppliers furnishing
the technical component of advanced diagnostic
imaging services. The list of accreditation
organizations so designated may be modified
pursuant to subparagraph (C).
(C) Review and modification of list of
accreditation organizations.--
(i) In general.--The Secretary shall
review the list of accreditation
organizations designated under
subparagraph (B) taking into account
the factors under subparagraph (A).
Taking into account the results of such
review, the Secretary may, by
regulation, modify the list of
accreditation organizations designated
under subparagraph (B).
(ii) Special rule for accreditations
done prior to removal from list of
designated accreditation
organizations.--In the case where the
Secretary removes an organization from
the list of accreditation organizations
designated under subparagraph (B), any
supplier that is accredited by the
organization during the period
beginning on the date on which the
organization is designated as an
accreditation organization under
subparagraph (B) and ending on the date
on which the organization is removed
from such list shall be considered to
have been accredited by an organization
designated by the Secretary under
subparagraph (B) for the remaining
period such accreditation is in effect.
(3) Criteria for accreditation.--The Secretary shall
establish procedures to ensure that the criteria used
by an accreditation organization designated under
paragraph (2)(B) to evaluate a supplier that furnishes
the technical component of advanced diagnostic imaging
services for the purpose of accreditation of such
supplier is specific to each imaging modality. Such
criteria shall include--
(A) standards for qualifications of medical
personnel who are not physicians and who
furnish the technical component of advanced
diagnostic imaging services;
(B) standards for qualifications and
responsibilities of medical directors and
supervising physicians, including standards
that recognize the considerations described in
paragraph (4);
(C) procedures to ensure that equipment used
in furnishing the technical component of
advanced diagnostic imaging services meets
performance specifications;
(D) standards that require the supplier have
procedures in place to ensure the safety of
persons who furnish the technical component of
advanced diagnostic imaging services and
individuals to whom such services are
furnished;
(E) standards that require the establishment
and maintenance of a quality assurance and
quality control program by the supplier that is
adequate and appropriate to ensure the
reliability, clarity, and accuracy of the
technical quality of diagnostic images produced
by such supplier; and
(F) any other standards or procedures the
Secretary determines appropriate.
(4) Recognition in standards for the evaluation of
medical directors and supervising physicians.--The
standards described in paragraph (3)(B) shall recognize
whether a medical director or supervising physician--
(A) in a particular specialty receives
training in advanced diagnostic imaging
services in a residency program;
(B) has attained, through experience, the
necessary expertise to be a medical director or
a supervising physician;
(C) has completed any continuing medical
education courses relating to such services; or
(D) has met such other standards as the
Secretary determines appropriate.
(5) Rule for accreditations made prior to
designation.--In the case of a supplier that is
accredited before January 1, 2010, by an accreditation
organization designated by the Secretary under
paragraph (2)(B) as of January 1, 2010, such supplier
shall be considered to have been accredited by an
organization designated by the Secretary under such
paragraph as of January 1, 2012, for the remaining
period such accreditation is in effect.
(f) Reduction in Payments for Physician Pathology Services
During 1991.--
(1) In general.--For physician pathology services
furnished under this part during 1991, the prevailing
charges used in a locality under this part shall be 7
percent below the prevailing charges used in the
locality under this part in 1990 after March 31.
(2) Limitation.--The prevailing charge for the
technical and professional components of an physician
pathology service furnished by a physician through an
independent laboratory shall not be reduced pursuant to
paragraph (1) to the extent that such reduction would
reduce such prevailing charge below 115 percent of the
prevailing charge for the professional component of
such service when furnished by a hospital-based
physician in the same locality. For purposes of the
preceding sentence, an independent laboratory is a
laboratory that is independent of a hospital and
separate from the attending or consulting physicians'
office.
(g) Payment for Outpatient Critical Access Hospital
Services.--
(1) In general.--The amount of payment for outpatient
critical access hospital services of a critical access
hospital is equal to 101 percent of the reasonable
costs of the hospital in providing such services,
unless the hospital makes the election under paragraph
(2).
(2) Election of cost-based hospital outpatient
service payment plus fee schedule for professional
services.--A critical access hospital may elect to be
paid for outpatient critical access hospital services
amounts equal to the sum of the following, less the
amount that such hospital may charge as described in
section 1866(a)(2)(A):
(A) Facility fee.--With respect to facility
services, not including any services for which
payment may be made under subparagraph (B), 101
percent of the reasonable costs of the critical
access hospital in providing such services.
(B) Fee schedule for professional services.--
With respect to professional services otherwise
included within outpatient critical access
hospital services, 115 percent of such amounts
as would otherwise be paid under this part if
such services were not included in outpatient
critical access hospital services. Subsections
(x) and (y) of section 1833 shall not be taken
into account in determining the amounts that
would otherwise be paid pursuant to the
preceding sentence.
The Secretary may not require, as a condition for
applying subparagraph (B) with respect to a critical
access hospital, that each physician or other
practitioner providing professional services in the
hospital must assign billing rights with respect to
such services, except that such subparagraph shall not
apply to those physicians and practitioners who have
not assigned such billing rights.
(3) Disregarding charges.--The payment amounts under
this subsection shall be determined without regard to
the amount of the customary or other charge.
(4) Treatment of clinical diagnostic laboratory
services.--No coinsurance, deductible, copayment, or
other cost-sharing otherwise applicable under this part
shall apply with respect to clinical diagnostic
laboratory services furnished as an outpatient critical
access hospital service. Nothing in this title shall be
construed as providing for payment for clinical
diagnostic laboratory services furnished as part of
outpatient critical access hospital services, other
than on the basis described in this subsection. For
purposes of the preceding sentence and section
1861(mm)(3), clinical diagnostic laboratory services
furnished by a critical access hospital shall be
treated as being furnished as part of outpatient
critical access services without regard to whether the
individual with respect to whom such services are
furnished is physically present in the critical access
hospital, or in a skilled nursing facility or a clinic
(including a rural health clinic) that is operated by a
critical access hospital, at the time the specimen is
collected.
(5) Coverage of costs for certain emergency room on-
call providers.--In determining the reasonable costs of
outpatient critical access hospital services under
paragraphs (1) and (2)(A), the Secretary shall
recognize as allowable costs, amounts (as defined by
the Secretary) for reasonable compensation and related
costs for physicians, physician assistants, nurse
practitioners, and clinical nurse specialists who are
on-call (as defined by the Secretary) to provide
emergency services but who are not present on the
premises of the critical access hospital involved, and
are not otherwise furnishing services covered under
this title and are not on-call at any other provider or
facility.
(h) Payment for Prosthetic Devices and Orthotics and
Prosthetics.--
(1) General rule for payment.--
(A) In general.--Payment under this
subsection for prosthetic devices and orthotics
and prosthetics shall be made in a lump-sum
amount for the purchase of the item in an
amount equal to 80 percent of the payment basis
described in subparagraph (B).
(B) Payment basis.--Except as provided in
subparagraphs (C), (E), and (H)(i), the payment
basis described in this subparagraph is the
lesser of--
(i) the actual charge for the item;
or
(ii) the amount recognized under
paragraph (2) as the purchase price for
the item.
(C) Exception for certain public home health
agencies.--Subparagraph (B)(i) shall not apply
to an item furnished by a public home health
agency (or by another home health agency which
demonstrates to the satisfaction of the
Secretary that a significant portion of its
patients are low income) free of charge or at
nominal charges to the public.
(D) Exclusive payment rule.--Subject to
subparagraph (H)(ii), this subsection shall
constitute the exclusive provision of this
title for payment for prosthetic devices,
orthotics, and prosthetics under this part or
under part A to a home health agency.
(E) Exception for certain items.--Payment for
ostomy supplies, tracheostomy supplies, and
urologicals shall be made in accordance with
subparagraphs (B) and (C) of section
1834(a)(2).
(F) Special payment rules for certain
prosthetics and custom-fabricated orthotics.--
(i) In general.--No payment shall be
made under this subsection for an item
of custom-fabricated orthotics
described in clause (ii) or for an item
of prosthetics unless such item is--
(I) furnished by a qualified
practitioner; and
(II) fabricated by a
qualified practitioner or a
qualified supplier at a
facility that meets such
criteria as the Secretary
determines appropriate.
(ii) Description of custom-fabricated
item.--
(I) In general.--An item
described in this clause is an
item of custom-fabricated
orthotics that requires
education, training, and
experience to custom-fabricate
and that is included in a list
established by the Secretary in
subclause (II). Such an item
does not include shoes and shoe
inserts.
(II) List of items.--The
Secretary, in consultation with
appropriate experts in
orthotics (including national
organizations representing
manufacturers of orthotics),
shall establish and update as
appropriate a list of items to
which this subparagraph
applies. No item may be
included in such list unless
the item is individually
fabricated for the patient over
a positive model of the
patient.
(iii) Qualified practitioner
defined.--In this subparagraph, the
term ``qualified practitioner'' means a
physician or other individual who--
(I) is a qualified physical
therapist or a qualified
occupational therapist;
(II) in the case of a State
that provides for the licensing
of orthotics and prosthetics,
is licensed in orthotics or
prosthetics by the State in
which the item is supplied; or
(III) in the case of a State
that does not provide for the
licensing of orthotics and
prosthetics, is specifically
trained and educated to provide
or manage the provision of
prosthetics and custom-designed
or -fabricated orthotics, and
is certified by the American
Board for Certification in
Orthotics and Prosthetics, Inc.
or by the Board for Orthotist/
Prosthetist Certification, or
is credentialed and approved by
a program that the Secretary
determines, in consultation
with appropriate experts in
orthotics and prosthetics, has
training and education
standards that are necessary to
provide such prosthetics and
orthotics.
(iv) Qualified supplier defined.--In
this subparagraph, the term ``qualified
supplier'' means any entity that is
accredited by the American Board for
Certification in Orthotics and
Prosthetics, Inc. or by the Board for
Orthotist/Prosthetist Certification, or
accredited and approved by a program
that the Secretary determines has
accreditation and approval standards
that are essentially equivalent to
those of such Board.
(G) Replacement of prosthetic devices and
parts.--
(i) In general.--Payment shall be
made for the replacement of prosthetic
devices which are artificial limbs, or
for the replacement of any part of such
devices, without regard to continuous
use or useful lifetime restrictions if
an ordering physician determines that
the provision of a replacement device,
or a replacement part of such a device,
is necessary because of any of the
following:
(I) A change in the
physiological condition of the
patient.
(II) An irreparable change in
the condition of the device, or
in a part of the device.
(III) The condition of the
device, or the part of the
device, requires repairs and
the cost of such repairs would
be more than 60 percent of the
cost of a replacement device,
or, as the case may be, of the
part being replaced.
(ii) Confirmation may be required if
device or part being replaced is less
than 3 years old.--If a physician
determines that a replacement device,
or a replacement part, is necessary
pursuant to clause (i)--
(I) such determination shall
be controlling; and
(II) such replacement device
or part shall be deemed to be
reasonable and necessary for
purposes of section
1862(a)(1)(A);
except that if the device, or part,
being replaced is less than 3 years old
(calculated from the date on which the
beneficiary began to use the device or
part), the Secretary may also require
confirmation of necessity of the
replacement device or replacement part,
as the case may be.
(H) Application of competitive acquisition to
orthotics; limitation of inherent
reasonableness authority.--In the case of
orthotics described in paragraph (2)(C) of
section 1847(a) furnished on or after January
1, 2009, subject to subsection (a)(1)(G), that
are included in a competitive acquisition
program in a competitive acquisition area under
such section--
(i) the payment basis under this
subsection for such orthotics furnished
in such area shall be the payment basis
determined under such competitive
acquisition program; and
(ii) subject to subsection (a)(1)(G),
the Secretary may use information on
the payment determined under such
competitive acquisition programs to
adjust the payment amount otherwise
recognized under subparagraph (B)(ii)
for an area that is not a competitive
acquisition area under section 1847,
and in the case of such adjustment,
paragraphs (8) and (9) of section
1842(b) shall not be applied.
(2) Purchase price recognized.--For purposes of
paragraph (1), the amount that is recognized under this
paragraph as the purchase price for prosthetic devices,
orthotics, and prosthetics is the amount described in
subparagraph (C) of this paragraph, determined as
follows:
(A) Computation of local purchase price.--
Each carrier under section 1842 shall compute a
base local purchase price for the item as
follows:
(i) The carrier shall compute a base
local purchase price for each item
equal to the average reasonable charge
in the locality for the purchase of the
item for the 12-month period ending
with June 1987.
(ii) The carrier shall compute a
local purchase price, with respect to
the furnishing of each particular
item--
(I) in 1989 and 1990, equal
to the base local purchase
price computed under clause (i)
increased by the percentage
increase in the consumer price
index for all urban consumers
(United States city average)
for the 6-month period ending
with December 1987, or
(II) in 1991, 1992 or 1993,
equal to the local purchase
price computed under this
clause for the previous year
increased by the applicable
percentage increase for the
year.
(B) Computation of regional purchase price.--
With respect to the furnishing of a particular
item in each region (as defined by the
Secretary), the Secretary shall compute a
regional purchase price--
(i) for 1992, equal to the average
(weighted by relative volume of all
claims among carriers) of the local
purchase prices for the carriers in the
region computed under subparagraph
(A)(ii)(II) for the year, and
(ii) for each subsequent year, equal
to the regional purchase price computed
under this subparagraph for the
previous year increased by the
applicable percentage increase for the
year.
(C) Purchase price recognized.--For purposes
of paragraph (1) and subject to subparagraph
(D), the amount that is recognized under this
paragraph as the purchase price for each item
furnished--
(i) in 1989, 1990, or 1991, is 100
percent of the local purchase price
computed under subparagraph (A)(ii);
(ii) in 1992, is the sum of (I) 75
percent of the local purchase price
computed under subparagraph (A)(ii)(II)
for 1992, and (II) 25 percent of the
regional purchase price computed under
subparagraph (B) for 1992;
(iii) in 1993, is the sum of (I) 50
percent of the local purchase price
computed under subparagraph (A)(ii)(II)
for 1993, and (II) 50 percent of the
regional purchase price computed under
subparagraph (B) for 1993; and
(iv) in 1994 or a subsequent year, is
the regional purchase price computed
under subparagraph (B) for that year.
(D) Range on amount recognized.--The amount
that is recognized under subparagraph (C) as
the purchase price for an item furnished--
(i) in 1992, may not exceed 125
percent, and may not be lower than 85
percent, of the average of the purchase
prices recognized under such
subparagraph for all the carrier
service areas in the United States in
that year; and
(ii) in a subsequent year, may not
exceed 120 percent, and may not be
lower than 90 percent, of the average
of the purchase prices recognized under
such subparagraph for all the carrier
service areas in the United States in
that year.
(3) Applicability of certain provisions relating to
durable medical equipment.--Paragraphs (12) and (17)
and subparagraphs (A) and (B) of paragraph (10) and
paragraph (11) of subsection (a) shall apply to
prosthetic devices, orthotics, and prosthetics in the
same manner as such provisions apply to covered items
under such subsection.
(4) Definitions.--In this subsection--
(A) the term ``applicable percentage
increase'' means--
(i) for 1991, 0 percent;
(ii) for 1992 and 1993, the
percentage increase in the consumer
price index for all urban consumers
(United States city average) for the
12-month period ending with June of the
previous year;
(iii) for 1994 and 1995, 0 percent;
(iv) for 1996 and 1997, the
percentage increase in the consumer
price index for all urban consumers
(United States city average) for the
12-month period ending with June of the
previous year;
(v) for each of the years 1998
through 2000, 1 percent;
(vi) for 2001, the percentage
increase in the consumer price index
for all urban consumers (U.S. city
average) for the 12-month period ending
with June 2000;
(vii) for 2002, 1 percent;
(viii) for 2003, the percentage
increase in the consumer price index
for all urban consumers (United States
city average) for the 12-month period
ending with June of the previous year;
(ix) for 2004, 2005, and 2006, 0
percent;
(x) for for each of 2007 through
2010, the percentage increase in the
consumer price index for all urban
consumers (United States city average)
for the 12-month period ending with
June of the previous year; and
(xi) for 2011 and each subsequent
year--
(I) the percentage increase
in the consumer price index for
all urban consumers (United
States city average) for the
12-month period ending with
June of the previous year,
reduced by--
(II) the productivity
adjustment described in section
1886(b)(3)(B)(xi)(II).
(B) the term ``prosthetic devices'' has the
meaning given such term in section 1861(s)(8),
except that such term does not include
parenteral and enteral nutrition nutrients,
supplies, and equipment and does not include an
implantable item for which payment may be made
under section 1833(t); and
(C) the term ``orthotics and prosthetics''
has the meaning given such term in section
1861(s)(9) (and includes shoes described in
section 1861(s)(12)), but does not include
intraocular lenses or medical supplies
(including catheters, catheter supplies, ostomy
bags, and supplies related to ostomy care)
furnished by a home health agency under section
1861(m)(5).
The application of subparagraph (A)(xi)(II) may result
in the applicable percentage increase under
subparagraph (A) being less than 0.0 for a year, and
may result in payment rates under this subsection for a
year being less than such payment rates for the
preceding year.
(5) Documentation created by orthotists and
prosthetists.--For purposes of determining the
reasonableness and medical necessity of orthotics and
prosthetics, documentation created by an orthotist or
prosthetist shall be considered part of the
individual's medical record to support documentation
created by eligible professionals described in section
1848(k)(3)(B).
(i) Payment for Surgical Dressings.--
(1) In general.--Payment under this subsection for
surgical dressings (described in section 1861(s)(5))
shall be made in a lump sum amount for the purchase of
the item in an amount equal to 80 percent of the lesser
of--
(A) the actual charge for the item; or
(B) a payment amount determined in accordance
with the methodology described in subparagraphs
(B) and (C) of subsection (a)(2) (except that
in applying such methodology, the national
limited payment amount referred to in such
subparagraphs shall be initially computed based
on local payment amounts using average
reasonable charges for the 12-month period
ending December 31, 1992, increased by the
covered item updates described in such
subsection for 1993 and 1994).
(2) Exceptions.--Paragraph (1) shall not apply to
surgical dressings that are--
(A) furnished as an incident to a physician's
professional service; or
(B) furnished by a home health agency.
(j) Requirements for Suppliers of Medical Equipment and
Supplies.--
(1) Issuance and renewal of supplier number.--
(A) Payment.--Except as provided in
subparagraph (C), no payment may be made under
this part after the date of the enactment of
the Social Security Act Amendments of 1994 for
items furnished by a supplier of medical
equipment and supplies unless such supplier
obtains (and renews at such intervals as the
Secretary may require) a supplier number.
(B) Standards for possessing a supplier
number.--A supplier may not obtain a supplier
number unless--
(i) for medical equipment and
supplies furnished on or after the date
of the enactment of the Social Security
Act Amendments of 1994 and before
January 1, 1996, the supplier meets
standards prescribed by the Secretary
in regulations issued on June 18, 1992;
and
(ii) for medical equipment and
supplies furnished on or after January
1, 1996, the supplier meets revised
standards prescribed by the Secretary
(in consultation with representatives
of suppliers of medical equipment and
supplies, carriers, and consumers) that
shall include requirements that the
supplier--
(I) comply with all
applicable State and Federal
licensure and regulatory
requirements;
(II) maintain a physical
facility on an appropriate
site;
(III) have proof of
appropriate liability
insurance; and
(IV) meet such other
requirements as the Secretary
may specify.
(C) Exception for items furnished as incident
to a physician's service.--Subparagraph (A)
shall not apply with respect to medical
equipment and supplies furnished incident to a
physician's service.
(D) Prohibition against multiple supplier
numbers.--The Secretary may not issue more than
one supplier number to any supplier of medical
equipment and supplies unless the issuance of
more than one number is appropriate to identify
subsidiary or regional entities under the
supplier's ownership or control.
(E) Prohibition against delegation of
supplier determinations.--The Secretary may not
delegate (other than by contract under section
1842) the responsibility to determine whether
suppliers meet the standards necessary to
obtain a supplier number.
(2) Certificates of medical necessity.--
(A) Limitation on information provided by
suppliers on certificates of medical
necessity.--
(i) In general.--Effective 60 days
after the date of the enactment of the
Social Security Act Amendments of 1994,
a supplier of medical equipment and
supplies may distribute to physicians,
or to individuals entitled to benefits
under this part, a certificate of
medical necessity for commercial
purposes which contains no more than
the following information completed by
the supplier:
(I) An identification of the
supplier and the beneficiary to
whom such medical equipment and
supplies are furnished.
(II) A description of such
medical equipment and supplies.
(III) Any product code
identifying such medical
equipment and supplies.
(IV) Any other administrative
information (other than
information relating to the
beneficiary's medical
condition) identified by the
Secretary.
(ii) Information on payment amount
and charges.--If a supplier distributes
a certificate of medical necessity
containing any of the information
permitted to be supplied under clause
(i), the supplier shall also list on
the certificate of medical necessity
the fee schedule amount and the
supplier's charge for the medical
equipment or supplies being furnished
prior to distribution of such
certificate to the physician.
(iii) Penalty.--Any supplier of
medical equipment and supplies who
knowingly and willfully distributes a
certificate of medical necessity in
violation of clause (i) or fails to
provide the information required under
clause (ii) is subject to a civil money
penalty in an amount not to exceed
$1,000 for each such certificate of
medical necessity so distributed. The
provisions of section 1128A (other than
subsections (a) and (b)) shall apply to
civil money penalties under this
subparagraph in the same manner as they
apply to a penalty or proceeding under
section 1128A(a).
(B) Definition.--For purposes of this
paragraph, the term ``certificate of medical
necessity'' means a form or other document
containing information required by the carrier
to be submitted to show that an item is
reasonable and necessary for the diagnosis or
treatment of illness or injury or to improve
the functioning of a malformed body member.
(3) Coverage and review criteria.--The Secretary
shall annually review the coverage and utilization of
items of medical equipment and supplies to determine
whether such items should be made subject to coverage
and utilization review criteria, and if appropriate,
shall develop and apply such criteria to such items.
(4) Limitation on patient liability.--If a supplier
of medical equipment and supplies (as defined in
paragraph (5))--
(A) furnishes an item or service to a
beneficiary for which no payment may be made by
reason of paragraph (1);
(B) furnishes an item or service to a
beneficiary for which payment is denied in
advance under subsection (a)(15); or
(C) furnishes an item or service to a
beneficiary for which payment is denied under
section 1862(a)(1);
any expenses incurred for items and services furnished
to an individual by such a supplier not on an assigned
basis shall be the responsibility of such supplier. The
individual shall have no financial responsibility for
such expenses and the supplier shall refund on a timely
basis to the individual (and shall be liable to the
individual for) any amounts collected from the
individual for such items or services. The provisions
of subsection (a)(18) shall apply to refunds required
under the previous sentence in the same manner as such
provisions apply to refunds under such subsection.
(5) Definition.--The term ``medical equipment and
supplies'' means--
(A) durable medical equipment (as defined in
section 1861(n));
(B) prosthetic devices (as described in
section 1861(s)(8));
(C) orthotics and prosthetics (as described
in section 1861(s)(9));
(D) surgical dressings (as described in
section 1861(s)(5));
(E) such other items as the Secretary may
determine; and
(F) for purposes of paragraphs (1) and (3)--
(i) home dialysis supplies and
equipment (as described in section
1861(s)(2)(F)),
(ii) immunosuppressive drugs (as
described in section 1861(s)(2)(J)),
(iii) therapeutic shoes for diabetics
(as described in section 1861(s)(12)),
(iv) oral drugs prescribed for use as
an anticancer therapeutic agent (as
described in section 1861(s)(2)(Q)),
and
(v) self-administered erythropoetin
(as described in section
1861(s)(2)(P)).
(k) Payment for Outpatient Therapy Services and Comprehensive
Outpatient Rehabilitation Services.--
(1) In general.--With respect to services described
in section 1833(a)(8) or 1833(a)(9) for which payment
is determined under this subsection, the payment basis
shall be--
(A) for services furnished during 1998, the
amount determined under paragraph (2); or
(B) for services furnished during a
subsequent year, 80 percent of the lesser of--
(i) the actual charge for the
services, or
(ii) the applicable fee schedule
amount (as defined in paragraph (3))
for the services.
(2) Payment in 1998 based upon adjusted reasonable
costs.--The amount under this paragraph for services is
the lesser of--
(A) the charges imposed for the services, or
(B) the adjusted reasonable costs (as defined
in paragraph (4)) for the services,
less 20 percent of the amount of the charges imposed
for such services.
(3) Applicable fee schedule amount.--In this
subsection, the term ``applicable fee schedule amount''
means, with respect to services furnished in a year,
the amount determined under the fee schedule
established under section 1848 for such services
furnished during the year or, if there is no such fee
schedule established for such services, the amount
determined under the fee schedule established for such
comparable services as the Secretary specifies.
(4) Adjusted reasonable costs.--In paragraph (2), the
term ``adjusted reasonable costs'' means, with respect
to any services, reasonable costs determined for such
services, reduced by 10 percent. The 10-percent
reduction shall not apply to services described in
section 1833(a)(8)(B) (relating to services provided by
hospitals).
(5) Uniform coding.--For claims for services
submitted on or after April 1, 1998, for which the
amount of payment is determined under this subsection,
the claim shall include a code (or codes) under a
uniform coding system specified by the Secretary that
identifies the services furnished.
(6) Restraint on billing.--The provisions of
subparagraphs (A) and (B) of section 1842(b)(18) shall
apply to therapy services for which payment is made
under this subsection in the same manner as they apply
to services provided by a practitioner described in
section 1842(b)(18)(C).
(7) Adjustment in discount for certain multiple
therapy services.--In the case of therapy services
furnished on or after April 1, 2013, and for which
payment is made under this subsection pursuant to the
applicable fee schedule amount (as defined in paragraph
(3)), instead of the 25 percent multiple procedure
payment reduction specified in the final rule published
by the Secretary in the Federal Register on November
29, 2010, the reduction percentage shall be 50 percent.
(l) Establishment of Fee Schedule for Ambulance Services.--
(1) In general.--The Secretary shall establish a fee
schedule for payment for ambulance services whether
provided directly by a supplier or provider or under
arrangement with a provider under this part through a
negotiated rulemaking process described in title 5,
United States Code, and in accordance with the
requirements of this subsection.
(2) Considerations.--In establishing such fee
schedule, the Secretary shall--
(A) establish mechanisms to control increases
in expenditures for ambulance services under
this part;
(B) establish definitions for ambulance
services which link payments to the type of
services provided;
(C) consider appropriate regional and
operational differences;
(D) consider adjustments to payment rates to
account for inflation and other relevant
factors; and
(E) phase in the application of the payment
rates under the fee schedule in an efficient
and fair manner consistent with paragraph (11),
except that such phase-in shall provide for
full payment of any national mileage rate for
ambulance services provided by suppliers that
are paid by carriers in any of the 50 States
where payment by a carrier for such services
for all such suppliers in such State did not,
prior to the implementation of the fee
schedule, include a separate amount for all
mileage within the county from which the
beneficiary is transported.
(3) Savings.--In establishing such fee schedule, the
Secretary shall--
(A) ensure that the aggregate amount of
payments made for ambulance services under this
part during 2000 does not exceed the aggregate
amount of payments which would have been made
for such services under this part during such
year if the amendments made by section 4531(a)
of the Balanced Budget Act of 1997 continued in
effect, except that in making such
determination the Secretary shall assume an
update in such payments for 2002 equal to
percentage increase in the consumer price index
for all urban consumers (U.S. city average) for
the 12-month period ending with June of the
previous year reduced in the case of 2002 by
1.0 percentage points;
(B) set the payment amounts provided under
the fee schedule for services furnished in 2001
and each subsequent year at amounts equal to
the payment amounts under the fee schedule for
services furnished during the previous year,
increased, subject to subparagraph (C) and the
succeeding sentence of this paragraph, by the
percentage increase in the consumer price index
for all urban consumers (U.S. city average) for
the 12-month period ending with June of the
previous year reduced in the case of 2002 by
1.0 percentage points; and
(C) for 2011 and each subsequent year, after
determining the percentage increase under
subparagraph (B) for the year, reduce such
percentage increase by the productivity
adjustment described in section
1886(b)(3)(B)(xi)(II).
The application of subparagraph (C) may result in the
percentage increase under subparagraph (B) being less
than 0.0 for a year, and may result in payment rates
under the fee schedule under this subsection for a year
being less than such payment rates for the preceding
year.
(4) Consultation.--In establishing the fee schedule
for ambulance services under this subsection, the
Secretary shall consult with various national
organizations representing individuals and entities who
furnish and regulate ambulance services and share with
such organizations relevant data in establishing such
schedule.
(5) Limitation on review.--There shall be no
administrative or judicial review under section 1869 or
otherwise of the amounts established under the fee
schedule for ambulance services under this subsection,
including matters described in paragraph (2).
(6) Restraint on billing.--The provisions of
subparagraphs (A) and (B) of section 1842(b)(18) shall
apply to ambulance services for which payment is made
under this subsection in the same manner as they apply
to services provided by a practitioner described in
section 1842(b)(18)(C).
(7) Coding system.--The Secretary may require the
claim for any services for which the amount of payment
is determined under this subsection to include a code
(or codes) under a uniform coding system specified by
the Secretary that identifies the services furnished.
(8) Services furnished by critical access
hospitals.--Notwithstanding any other provision of this
subsection, the Secretary shall pay 101 percent of the
reasonable costs incurred in furnishing ambulance
services if such services are furnished--
(A) by a critical access hospital (as defined
in section 1861(mm)(1)), or
(B) by an entity that is owned and operated
by a critical access hospital,
but only if the critical access hospital or entity is
the only provider or supplier of ambulance services
that is located within a 35-mile drive of such critical
access hospital.
(9) Transitional assistance for rural providers.--In
the case of ground ambulance services furnished on or
after July 1, 2001, and before January 1, 2004, for
which the transportation originates in a rural area (as
defined in section 1886(d)(2)(D)) or in a rural census
tract of a metropolitan statistical area (as determined
under the most recent modification of the Goldsmith
Modification, originally published in the Federal
Register on February 27, 1992 (57 Fed. Reg. 6725)), the
fee schedule established under this subsection shall
provide that, with respect to the payment rate for
mileage for a trip above 17 miles, and up to 50 miles,
the rate otherwise established shall be increased by
not less than \1/2\ of the additional payment per mile
established for the first 17 miles of such a trip
originating in a rural area.
(10) Phase-in providing floor using blend of fee
schedule and regional fee schedules.--In carrying out
the phase-in under paragraph (2)(E) for each level of
ground service furnished in a year, the portion of the
payment amount that is based on the fee schedule shall
be the greater of the amount determined under such fee
schedule (without regard to this paragraph) or the
following blended rate of the fee schedule under
paragraph (1) and of a regional fee schedule for the
region involved:
(A) For 2004 (for services furnished on or
after July 1, 2004), the blended rate shall be
based 20 percent on the fee schedule under
paragraph (1) and 80 percent on the regional
fee schedule.
(B) For 2005, the blended rate shall be based
40 percent on the fee schedule under paragraph
(1) and 60 percent on the regional fee
schedule.
(C) For 2006, the blended rate shall be based
60 percent on the fee schedule under paragraph
(1) and 40 percent on the regional fee
schedule.
(D) For 2007, 2008, and 2009, the blended
rate shall be based 80 percent on the fee
schedule under paragraph (1) and 20 percent on
the regional fee schedule.
(E) For 2010 and each succeeding year, the
blended rate shall be based 100 percent on the
fee schedule under paragraph (1).
For purposes of this paragraph, the Secretary shall
establish a regional fee schedule for each of the nine
census divisions (referred to in section 1886(d)(2))
using the methodology (used in establishing the fee
schedule under paragraph (1)) to calculate a regional
conversion factor and a regional mileage payment rate
and using the same payment adjustments and the same
relative value units as used in the fee schedule under
such paragraph.
(11) Adjustment in payment for certain long trips.--
In the case of ground ambulance services furnished on
or after July 1, 2004, and before January 1, 2009,
regardless of where the transportation originates, the
fee schedule established under this subsection shall
provide that, with respect to the payment rate for
mileage for a trip above 50 miles the per mile rate
otherwise established shall be increased by \1/4\ of
the payment per mile otherwise applicable to miles in
excess of 50 miles in such trip.
(12) Assistance for rural providers furnishing
services in low population density areas.--
(A) In general.--In the case of ground
ambulance services furnished on or after July
1, 2004, and before January 1, 2023, for which
the transportation originates in a qualified
rural area (identified under subparagraph
(B)(iii)), the Secretary shall provide for a
percent increase in the base rate of the fee
schedule for a trip established under this
subsection. In establishing such percent
increase, the Secretary shall estimate the
average cost per trip for such services (not
taking into account mileage) in the lowest
quartile as compared to the average cost per
trip for such services (not taking into account
mileage) in the highest quartile of all rural
county populations.
(B) Identification of qualified rural
areas.--
(i) Determination of population
density in area.--Based upon data from
the United States decennial census for
the year 2000, the Secretary shall
determine, for each rural area, the
population density for that area.
(ii) Ranking of areas.--The Secretary
shall rank each such area based on such
population density.
(iii) Identification of qualified
rural areas.--The Secretary shall
identify those areas (in subparagraph
(A) referred to as ``qualified rural
areas'') with the lowest population
densities that represent, if each such
area were weighted by the population of
such area (as used in computing such
population densities), an aggregate
total of 25 percent of the total of the
population of all such areas.
(iv) Rural area.--For purposes of
this paragraph, the term ``rural area''
has the meaning given such term in
section 1886(d)(2)(D). If feasible, the
Secretary shall treat a rural census
tract of a metropolitan statistical
area (as determined under the most
recent modification of the Goldsmith
Modification, originally published in
the Federal Register on February 27,
1992 (57 Fed. Reg. 6725) as a rural
area for purposes of this paragraph.
(v) Judicial review.--There shall be
no administrative or judicial review
under section 1869, 1878, or otherwise,
respecting the identification of an
area under this subparagraph.
(13) Temporary increase for ground ambulance
services.--
(A) In general.--After computing the rates
with respect to ground ambulance services under
the other applicable provisions of this
subsection, in the case of such services
furnished on or after July 1, 2004, and before
January 1, 2007, and for such services
furnished on or after July 1, 2008, and before
January 1, 2023, for which the transportation
originates in--
(i) a rural area described in
paragraph (9) or in a rural census
tract described in such paragraph, the
fee schedule established under this
section shall provide that the rate for
the service otherwise established,
after the application of any increase
under paragraphs (11) and (12), shall
be increased by 2 percent (or 3 percent
if such service is furnished on or
after July 1, 2008, and before January
1, 2023); and
(ii) an area not described in clause
(i), the fee schedule established under
this subsection shall provide that the
rate for the service otherwise
established, after the application of
any increase under paragraph (11),
shall be increased by 1 percent (or 2
percent if such service is furnished on
or after July 1, 2008, and before
January 1, 2023).
(B) Application of increased payments after
applicable period.--The increased payments
under subparagraph (A) shall not be taken into
account in calculating payments for services
furnished after the applicable period specified
in such subparagraph.
(14) Providing appropriate coverage of rural air
ambulance services.--
(A) In general.--The regulations described in
section 1861(s)(7) shall provide, to the extent
that any ambulance services (whether ground or
air) may be covered under such section, that a
rural air ambulance service (as defined in
subparagraph (C)) is reimbursed under this
subsection at the air ambulance rate if the air
ambulance service--
(i) is reasonable and necessary based
on the health condition of the
individual being transported at or
immediately prior to the time of the
transport; and
(ii) complies with equipment and crew
requirements established by the
Secretary.
(B) Satisfaction of requirement of medically
necessary.--The requirement of subparagraph
(A)(i) is deemed to be met for a rural air
ambulance service if--
(i) subject to subparagraph (D), such
service is requested by a physician or
other qualified medical personnel (as
specified by the Secretary) who
certifies or reasonably determines that
the individual's condition is such that
the time needed to transport the
individual by land or the instability
of transportation by land poses a
threat to the individual's survival or
seriously endangers the individual's
health; or
(ii) such service is furnished
pursuant to a protocol that is
established by a State or regional
emergency medical service (EMS) agency
and recognized or approved by the
Secretary under which the use of an air
ambulance is recommended, if such
agency does not have an ownership
interest in the entity furnishing such
service.
(C) Rural air ambulance service defined.--For
purposes of this paragraph, the term ``rural
air ambulance service'' means fixed wing and
rotary wing air ambulance service in which the
point of pick up of the individual occurs in a
rural area (as defined in section
1886(d)(2)(D)) or in a rural census tract of a
metropolitan statistical area (as determined
under the most recent modification of the
Goldsmith Modification, originally published in
the Federal Register on February 27, 1992 (57
Fed. Reg. 6725)).
(D) Limitation.--
(i) In general.--Subparagraph (B)(i)
shall not apply if there is a financial
or employment relationship between the
person requesting the rural air
ambulance service and the entity
furnishing the ambulance service, or an
entity under common ownership with the
entity furnishing the air ambulance
service, or a financial relationship
between an immediate family member of
such requester and such an entity.
(ii) Exception.--Where a hospital and
the entity furnishing rural air
ambulance services are under common
ownership, clause (i) shall not apply
to remuneration (through employment or
other relationship) by the hospital of
the requester or immediate family
member if the remuneration is for
provider-based physician services
furnished in a hospital (as described
in section 1887) which are reimbursed
under part A and the amount of the
remuneration is unrelated directly or
indirectly to the provision of rural
air ambulance services.
(15) Payment adjustment for non-emergency ambulance
transports for esrd beneficiaries.--The fee schedule
amount otherwise applicable under the preceding
provisions of this subsection shall be reduced by 10
percent for ambulance services furnished during the
period beginning on October 1, 2013, and ending on
September 30, 2018, and by 23 percent for such services
furnished on or after October 1, 2018, consisting of
non-emergency basic life support services involving
transport of an individual with end-stage renal disease
for renal dialysis services (as described in section
1881(b)(14)(B)) furnished other than on an emergency
basis by a provider of services or a renal dialysis
facility.
(16) Prior authorization for repetitive scheduled
non-emergent ambulance transports.--
(A) In general.--Beginning January 1, 2017,
if the expansion to all States of the model of
prior authorization described in paragraph (2)
of section 515(a) of the Medicare Access and
CHIP Reauthorization Act of 2015 meets the
requirements described in paragraphs (1)
through (3) of section 1115A(c), then the
Secretary shall expand such model to all
States.
(B) Funding.--The Secretary shall use funds
made available under section 1893(h)(10) to
carry out this paragraph.
(C) Clarification regarding budget
neutrality.--Nothing in this paragraph may be
construed to limit or modify the application of
section 1115A(b)(3)(B) to models described in
such section, including with respect to the
model described in subparagraph (A) and
expanded beginning on January 1, 2017, under
such subparagraph.
(17) Submission of cost and other information.--
(A) Development of data collection system.--
The Secretary shall develop a data collection
system (which may include use of a cost survey)
to collect cost, revenue, utilization, and
other information determined appropriate by the
Secretary with respect to providers of services
(in this paragraph referred to as
``providers'') and suppliers of ground
ambulance services. Such system shall be
designed to collect information--
(i) needed to evaluate the extent to
which reported costs relate to payment
rates under this subsection;
(ii) on the utilization of capital
equipment and ambulance capacity,
including information consistent with
the type of information described in
section 1121(a); and
(iii) on different types of ground
ambulance services furnished in
different geographic locations,
including rural areas and low
population density areas described in
paragraph (12).
(B) Specification of data collection
system.--
(i) In general.--The Secretary
shall--
(I) not later than December
31, 2019, specify the data
collection system under
subparagraph (A); and
(II) identify the providers
and suppliers of ground
ambulance services that would
be required to submit
information under such data
collection system, including
the representative sample
described in clause (ii).
(ii) Determination of representative
sample.--
(I) In general.--Not later
than December 31, 2019, with
respect to the data collection
for the first year under such
system, and for each subsequent
year through 2024, the
Secretary shall determine a
representative sample to submit
information under the data
collection system.
(II) Requirements.--The
sample under subclause (I)
shall be representative of the
different types of providers
and suppliers of ground
ambulance services (such as
those providers and suppliers
that are part of an emergency
service or part of a government
organization) and the
geographic locations in which
ground ambulance services are
furnished (such as urban,
rural, and low population
density areas).
(III) Limitation.--The
Secretary shall not include an
individual provider or supplier
of ground ambulance services in
the sample under subclause (I)
in 2 consecutive years, to the
extent practicable.
(C) Reporting of cost information.--For each
year, a provider or supplier of ground
ambulance services identified by the Secretary
under subparagraph (B)(i)(II) as being required
to submit information under the data collection
system with respect to a period for the year
shall submit to the Secretary information
specified under the system. S
