[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[H.R. 7217 Introduced in House (IH)]
<DOC>
115th CONGRESS
2d Session
H. R. 7217
To amend title XIX of the Social Security Act to provide States with
the option of providing coordinated care for children with complex
medical conditions through a health home, and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
December 6, 2018
Mr. Barton (for himself, Ms. Castor of Florida, Mr. Guthrie, Mrs.
Dingell, and Mr. Upton) introduced the following bill; which was
referred to the Committee on Energy and Commerce, and in addition to
the Committee on Ways and Means, for a period to be subsequently
determined by the Speaker, in each case for consideration of such
provisions as fall within the jurisdiction of the committee concerned
_______________________________________________________________________
A BILL
To amend title XIX of the Social Security Act to provide States with
the option of providing coordinated care for children with complex
medical conditions through a health home, and for other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Improving Medicaid Programs and
Opportunities for Eligible Beneficiaries Act'' or the ``IMPROVE Act''.
TITLE I--ACE KIDS
SEC. 101. STATE OPTION TO PROVIDE COORDINATED CARE THROUGH A HEALTH
HOME FOR CHILDREN WITH MEDICALLY COMPLEX CONDITIONS.
Title XIX of the Social Security Act (42 U.S.C. 1396 et seq.) is
amended by inserting after section 1945 the following new section:
``SEC. 1945A. STATE OPTION TO PROVIDE COORDINATED CARE THROUGH A HEALTH
HOME FOR CHILDREN WITH MEDICALLY COMPLEX CONDITIONS.
``(a) In General.--Notwithstanding section 1902(a)(1) (relating to
statewideness) and section 1902(a)(10)(B) (relating to comparability),
beginning October 1, 2022, a State, at its option as a State plan
amendment, may provide for medical assistance under this title to
children with medically complex conditions who choose to enroll in a
health home under this section by selecting a designated provider, a
team of health care professionals operating with such a provider, or a
health team as the child's health home for purposes of providing the
child with health home services.
``(b) Health Home Qualification Standards.--The Secretary shall
establish standards for qualification as a health home for purposes of
this section. Such standards shall include requiring designated
providers, teams of health care professionals operating with such
providers, and health teams to demonstrate to the State the ability to
do the following:
``(1) Coordinate prompt care for children with medically
complex conditions, including access to pediatric emergency
services at all times.
``(2) Develop an individualized comprehensive pediatric
family-centered care plan for children with medically complex
conditions that accommodates patient preferences.
``(3) Work in a culturally and linguistically appropriate
manner with the family of a child with medically complex
conditions to develop and incorporate into such child's care
plan, in a manner consistent with the needs of the child and
the choices of the child's family, ongoing home care,
community-based pediatric primary care, pediatric inpatient
care, social support services, and local hospital pediatric
emergency care.
``(4) Coordinate access to--
``(A) subspecialized pediatric services and
programs for children with medically complex
conditions, including the most intensive diagnostic,
treatment, and critical care levels as medically
necessary; and
``(B) palliative services if the State provides
such services under the State plan (or a waiver of such
plan).
``(5) Coordinate care for children with medically complex
conditions with out-of-State providers furnishing care to such
children to the maximum extent practicable for the families of
such children and where medically necessary, in accordance with
guidance issued under subsection (e)(1) and section 431.52 of
title 42, Code of Federal Regulations.
``(6) Collect and report information under subsection
(g)(1).
``(c) Payments.--
``(1) In general.--A State shall provide a designated
provider, a team of health care professionals operating with
such a provider, or a health team with payments for the
provision of health home services to each child with medically
complex conditions that selects such provider, team of health
care professionals, or health team as the child's health home.
Payments made to a designated provider, a team of health care
professionals operating with such a provider, or a health team
for such services shall be treated as medical assistance for
purposes of section 1903(a), except that, during the first 2
fiscal year quarters that the State plan amendment is in
effect, the Federal medical assistance percentage applicable to
such payments shall be increased by 15 percentage points, but
in no case may exceed 90 percent.
``(2) Methodology.--
``(A) In general.--The State shall specify in the
State plan amendment the methodology the State will use
for determining payment for the provision of health
home services. Such methodology for determining
payment--
``(i) may be tiered to reflect, with
respect to each child with medically complex
conditions provided such services by a
designated provider, a team of health care
professionals operating with such a provider,
or a health team, the severity or number of
each such child's chronic conditions, life-
threatening illnesses, disabilities, or rare
diseases, or the specific capabilities of the
provider, team of health care professionals, or
health team; and
``(ii) shall be established consistent with
section 1902(a)(30)(A).
``(B) Alternate models of payment.--The methodology
for determining payment for provision of health home
services under this section shall not be limited to a
per-member per-month basis and may provide (as proposed
by the State and subject to approval by the Secretary)
for alternate models of payment.
``(3) Planning grants.--
``(A) In general.--Beginning October 1, 2022, the
Secretary may award planning grants to States for
purposes of developing a State plan amendment under
this section. A planning grant awarded to a State under
this paragraph shall remain available until expended.
``(B) State contribution.--A State awarded a
planning grant shall contribute an amount equal to the
State percentage determined under section 1905(b)
(without regard to section 5001 of Public Law 111-5)
for each fiscal year for which the grant is awarded.
``(C) Limitation.--The total amount of payments
made to States under this paragraph shall not exceed
$5,000,000.
``(d) Coordinating Care.--
``(1) Hospital notification.--A State with a State plan
amendment approved under this section shall require each
hospital that is a participating provider under the State plan
(or a waiver of such plan) to establish procedures for, in the
case of a child with medically complex conditions who is
enrolled in a health home pursuant to this section and seeks
treatment in the emergency department of such hospital,
notifying the health home of such child of such treatment.
``(2) Education with respect to availability of health home
services.--In order for a State plan amendment to be approved
under this section, a State shall include in the State plan
amendment a description of the State's process for educating
providers participating in the State plan (or a waiver of such
plan) on the availability of health home services for children
with medically complex conditions, including the process by
which such providers can refer such children to a designated
provider, team of health care professionals operating such a
provider, or health team for the purpose of establishing a
health home through which such children may receive such
services.
``(3) Family education.--In order for a State plan
amendment to be approved under this section, a State shall
include in the State plan amendment a description of the
State's process for educating families with children eligible
to receive health home services pursuant to this section of the
availability of such services. Such process shall include the
participation of family-to-family entities or other public or
private organizations or entities who provide outreach and
information on the availability of health care items and
services to families of individuals eligible to receive medical
assistance under the State plan (or a waiver of such plan).
``(4) Mental health coordination.--A State with a State
plan amendment approved under this section shall consult and
coordinate, as appropriate, with the Secretary in addressing
issues regarding the prevention and treatment of mental illness
and substance use among children with medically complex
conditions receiving health home services under this section.
``(e) Guidance on Coordinating Care From Out-of-State Providers.--
``(1) In general.--Not later than October 1, 2020, the
Secretary shall issue (and update as the Secretary determines
necessary) guidance to State Medicaid directors on--
``(A) best practices for using out-of-State
providers to provide care to children with medically
complex conditions;
``(B) coordinating care for such children provided
by such out-of-State providers (including when provided
in emergency and non-emergency situations);
``(C) reducing barriers for such children receiving
care from such providers in a timely fashion; and
``(D) processes for screening and enrolling such
providers in the respective State plan (or a waiver of
such plan), including efforts to streamline such
processes or reduce the burden of such processes on
such providers.
``(2) Stakeholder input.--In carrying out paragraph (1),
the Secretary shall issue a request for information to seek
input from children with medically complex conditions and their
families, States, providers (including children's hospitals,
hospitals, pediatricians, and other providers), managed care
plans, children's health groups, family and beneficiary
advocates, and other stakeholders with respect to coordinating
the care for such children provided by out-of-State providers.
``(f) Monitoring.--A State shall include in the State plan
amendment--
``(1) a methodology for tracking avoidable hospital
readmissions and calculating savings that result from improved
care coordination and management under this section;
``(2) a proposal for use of health information technology
in providing health home services under this section and
improving service delivery and coordination across the care
continuum (including the use of wireless patient technology to
improve coordination and management of care and patient
adherence to recommendations made by their provider); and
``(3) a methodology for tracking prompt and timely access
to medically necessary care for children with medically complex
conditions from out-of-State providers.
``(g) Data Collection.--
``(1) Provider reporting requirements.--In order to receive
payments from a State under subsection (c), a designated
provider, a team of health care professionals operating with
such a provider, or a health team shall report to the State, at
such time and in such form and manner as may be required by the
State, the following information:
``(A) With respect to each such provider, team of
health care professionals, or health team, the name,
National Provider Identification number, address, and
specific health care services offered to be provided to
children with medically complex conditions who have
selected such provider, team of health care
professionals, or health team as the health home of
such children.
``(B) Information on all applicable measures for
determining the quality of health home services
provided by such provider, team of health care
professionals, or health team, including, to the extent
applicable, child health quality measures and measures
for centers of excellence for children with complex
needs developed under this title, title XXI, and
section 1139A.
``(C) Such other information as the Secretary shall
specify in guidance.
When appropriate and feasible, such provider, team of health
care professionals, or health team, as the case may be, shall
use health information technology in providing the State with
such information.
``(2) State reporting requirements.--
``(A) Comprehensive report.--A State with a State
plan amendment approved under this section shall report
to the Secretary (and, upon request, to the Medicaid
and CHIP Payment and Access Commission), at such time
and in such form and manner determined by the Secretary
to be reasonable and minimally burdensome, the
following information:
``(i) Information reported under paragraph
(1).
``(ii) The number of children with
medically complex conditions who have selected
a health home pursuant to this section.
``(iii) The nature, number, and prevalence
of chronic conditions, life-threatening
illnesses, disabilities, or rare diseases that
such children have.
``(iv) The type of delivery systems and
payment models used to provide services to such
children under this section.
``(v) The number and characteristics of
designated providers, teams of health care
professionals operating with such providers,
and health teams selected as health homes
pursuant to this section, including the number
and characteristics of out-of-State providers,
teams of health care professionals operating
with such providers, and health teams who have
provided health care items and services to such
children.
``(vi) The extent to which such children
receive health care items and services under
the State plan.
``(vii) Quality measures developed
specifically with respect to health care items
and services provided to children with
medically complex conditions.
``(B) Report on best practices.--Not later than 90
days after a State has a State plan amendment approved
under this section, such State shall submit to the
Secretary, and make publicly available on the
appropriate State website, a report on how the State is
implementing guidance issued under subsection (e)(1),
including through any best practices adopted by the
State.
``(h) Rule of Construction.--Nothing in this section may be
construed--
``(1) to require a child with medically complex conditions
to enroll in a health home under this section;
``(2) to limit the choice of a child with medically complex
conditions in selecting a designated provider, team of health
care professionals operating with such a provider, or health
team that meets the health home qualification standards
established under subsection (b) as the child's health home; or
``(3) to reduce or otherwise modify--
``(A) the entitlement of children with medically
complex conditions to early and periodic screening,
diagnostic, and treatment services (as defined in
section 1905(r)); or
``(B) the informing, providing, arranging, and
reporting requirements of a State under section
1902(a)(43).
``(i) Definitions.--In this section:
``(1) Child with medically complex conditions.--
``(A) In general.--Subject to subparagraph (B), the
term `child with medically complex conditions' means an
individual under 21 years of age who--
``(i) is eligible for medical assistance
under the State plan (or under a waiver of such
plan); and
``(ii) has at least--
``(I) one or more chronic
conditions that cumulatively affect
three or more organ systems and
severely reduces cognitive or physical
functioning (such as the ability to
eat, drink, or breathe independently)
and that also requires the use of
medication, durable medical equipment,
therapy, surgery, or other treatments;
or
``(II) one life-limiting illness or
rare pediatric disease (as defined in
section 529(a)(3) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C.
360ff(a)(3))).
``(B) Rule of construction.--Nothing in this
paragraph shall prevent the Secretary from establishing
higher levels as to the number or severity of chronic,
life threatening illnesses, disabilities, rare diseases
or mental health conditions for purposes of determining
eligibility for receipt of health home services under
this section.
``(2) Chronic condition.--The term `chronic condition'
means a serious, long-term physical, mental, or developmental
disability or disease, including the following:
``(A) Cerebral palsy.
``(B) Cystic fibrosis.
``(C) HIV/AIDS.
``(D) Blood diseases, such as anemia or sickle cell
disease.
``(E) Muscular dystrophy.
``(F) Spina bifida.
``(G) Epilepsy.
``(H) Severe autism spectrum disorder.
``(I) Serious emotional disturbance or serious
mental health illness.
``(3) Health home.--The term `health home' means a
designated provider (including a provider that operates in
coordination with a team of health care professionals) or a
health team selected by a child with medically complex
conditions (or the family of such child) to provide health home
services.
``(4) Health home services.--
``(A) In general.--The term `health home services'
means comprehensive and timely high-quality services
described in subparagraph (B) that are provided by a
designated provider, a team of health care
professionals operating with such a provider, or a
health team.
``(B) Services described.--The services described
in this subparagraph shall include--
``(i) comprehensive care management;
``(ii) care coordination, health promotion,
and providing access to the full range of
pediatric specialty and subspecialty medical
services, including services from out-of-State
providers, as medically necessary;
``(iii) comprehensive transitional care,
including appropriate follow-up, from inpatient
to other settings;
``(iv) patient and family support
(including authorized representatives);
``(v) referrals to community and social
support services, if relevant; and
``(vi) use of health information technology
to link services, as feasible and appropriate.
``(5) Designated provider.--The term `designated provider'
means a physician (including a pediatrician or a pediatric
specialty or subspecialty provider), children's hospital,
clinical practice or clinical group practice, prepaid inpatient
health plan or prepaid ambulatory health plan (as defined by
the Secretary), rural clinic, community health center,
community mental health center, home health agency, or any
other entity or provider that is determined by the State and
approved by the Secretary to be qualified to be a health home
for children with medically complex conditions on the basis of
documentation evidencing that the entity has the systems,
expertise, and infrastructure in place to provide health home
services. Such term may include providers who are employed by,
or affiliated with, a children's hospital.
``(6) Team of health care professionals.--The term `team of
health care professionals' means a team of health care
professionals (as described in the State plan amendment under
this section) that may--
``(A) include--
``(i) physicians and other professionals,
such as pediatricians or pediatric specialty or
subspecialty providers, nurse care
coordinators, dietitians, nutritionists, social
workers, behavioral health professionals,
physical therapists, occupational therapists,
speech pathologists, nurses, individuals with
experience in medical supportive technologies,
or any professionals determined to be
appropriate by the State and approved by the
Secretary;
``(ii) an entity or individual who is
designated to coordinate such a team; and
``(iii) community health workers,
translators, and other individuals with
culturally-appropriate expertise; and
``(B) be freestanding, virtual, or based at a
children's hospital, hospital, community health center,
community mental health center, rural clinic, clinical
practice or clinical group practice, academic health
center, or any entity determined to be appropriate by
the State and approved by the Secretary.
``(7) Health team.--The term `health team' has the meaning
given such term for purposes of section 3502 of Public Law 111-
148.''.
TITLE II--OTHER MEDICAID
SEC. 201. EXTENSION OF MONEY FOLLOWS THE PERSON REBALANCING
DEMONSTRATION.
(a) General Funding.--Section 6071(h) of the Deficit Reduction Act
of 2005 (42 U.S.C. 1396a note) is amended--
(1) in paragraph (1)--
(A) in subparagraph (D), by striking ``and'' after
the semicolon;
(B) in subparagraph (E), by striking the period at
the end and inserting ``; and''; and
(C) by adding at the end the following:
``(F) subject to paragraph (3), $112,000,000 for
fiscal year 2019.'';
(2) in paragraph (2)--
(A) by striking ``Amounts made'' and inserting
``Subject to paragraph (3), amounts made''; and
(B) by striking ``September 30, 2016'' and
inserting ``September 30, 2021''; and
(3) by adding at the end the following new paragraph:
``(3) Special rule for fy 2019.--Funds appropriated under
paragraph (1)(F) shall be made available for grants to States
only if such States have an approved MFP demonstration project
under this section as of December 31, 2018.''.
(b) Funding for Quality Assurance and Improvement; Technical
Assistance; Oversight.--Section 6071(f) of the Deficit Reduction Act of
2005 (42 U.S.C. 1396a note) is amended by striking paragraph (2) and
inserting the following:
``(2) Funding.--From the amounts appropriated under
subsection (h)(1)(F) for fiscal year 2019, $500,000 shall be
available to the Secretary for such fiscal year to carry out
this subsection.''.
(c) Technical Amendment.--Section 6071(b) of the Deficit Reduction
Act of 2005 (42 U.S.C. 1396a note) is amended by adding at the end the
following:
``(10) Secretary.--The term `Secretary' means the Secretary
of Health and Human Services.''.
SEC. 202. EXTENSION OF PROTECTION FOR MEDICAID RECIPIENTS OF HOME AND
COMMUNITY-BASED SERVICES AGAINST SPOUSAL IMPOVERISHMENT.
(a) In General.--Section 2404 of Public Law 111-148 (42 U.S.C.
1396r-5 note) is amended by striking ``the 5-year period that begins on
January 1, 2014,'' and inserting ``the period beginning on January 1,
2014, and ending on March 31, 2019,''.
(b) Rule of Construction.--
(1) Protecting state spousal income and asset disregard
flexibility under waivers and plan amendments.--Nothing in
section 2404 of Public Law 111-148 (42 U.S.C. 1396r-5 note) or
section 1924 of the Social Security Act (42 U.S.C. 1396r-5)
shall be construed as prohibiting a State from disregarding an
individual's spousal income and assets under a State waiver or
plan amendment described in paragraph (2) for purposes of
making determinations of eligibility for home and community-
based services or home and community-based attendant services
and supports under such waiver or plan amendment.
(2) State waiver or plan amendment described.--A State
waiver or plan amendment described in this paragraph is any of
the following:
(A) A waiver or plan amendment to provide medical
assistance for home and community-based services under
a waiver or plan amendment under subsection (c), (d),
or (i) of section 1915 of the Social Security Act (42
U.S.C. 1396n) or under section 1115 of such Act (42
U.S.C. 1315).
(B) A plan amendment to provide medical assistance
for home and community-based services for individuals
by reason of being determined eligible under section
1902(a)(10)(C) of such Act (42 U.S.C. 1396a(a)(10)(C))
or by reason of section 1902(f) of such Act (42 U.S.C.
1396a(f)) or otherwise on the basis of a reduction of
income based on costs incurred for medical or other
remedial care under which the State disregarded the
income and assets of the individual's spouse in
determining the initial and ongoing financial
eligibility of an individual for such services in place
of the spousal impoverishment provisions applied under
section 1924 of such Act (42 U.S.C. 1396r-5).
(C) A plan amendment to provide medical assistance
for home and community-based attendant services and
supports under section 1915(k) of such Act (42 U.S.C.
1396n(k)).
SEC. 203. REDUCTION IN FMAP AFTER 2020 FOR STATES WITHOUT ASSET
VERIFICATION PROGRAM.
Section 1940 of the Social Security Act (42 U.S.C. 1396w) is
amended by adding at the end the following new subsection:
``(k) Reduction in FMAP After 2020 for Non-Compliant States.--
``(1) In general.--With respect to a calendar quarter
beginning on or after January 1, 2021, the Federal medical
assistance percentage otherwise determined under section
1905(b) for a non-compliant State shall be reduced--
``(A) for calendar quarters in 2021 and 2022, by
0.12 percentage points;
``(B) for calendar quarters in 2023, by 0.25
percentage points;
``(C) for calendar quarters in 2024, by 0.35
percentage points; and
``(D) for calendar quarters in 2025 and each year
thereafter, by 0.5 percentage points.
``(2) Non-compliant state defined.--For purposes of this
subsection, the term `non-compliant State' means a State--
``(A) that is one of the 50 States or the District
of Columbia;
``(B) with respect to which the Secretary has not
approved a State plan amendment submitted under
subsection (a)(2); and
``(C) that is not operating, on an ongoing basis,
an asset verification program in accordance with this
section.''.
SEC. 204. DENIAL OF FFP FOR CERTAIN EXPENDITURES RELATING TO VACUUM
ERECTION SYSTEMS AND PENILE PROSTHETIC IMPLANTS.
(a) In General.--Section 1903(i) of the Social Security Act (42
U.S.C. 1396b(i)) is amended by inserting after paragraph (11) the
following:
``(12) with respect to any amounts expended for--
``(A) a vacuum erection system that is not
medically necessary; or
``(B) the insertion, repair, or removal and
replacement of a penile prosthetic implant (unless such
insertion, repair, or removal and replacement is
medically necessary); or''.
(b) Effective Date.--The amendment made by subsection (a) shall
apply with respect to items and services furnished on or after January
1, 2019.
SEC. 205. MEDICAID IMPROVEMENT FUND.
Section 1941(b)(1) of the Social Security Act (42 U.S.C. 1396w-
1(b)(1)) is amended by striking ``$31,000,000'' and inserting
``$9,000,000''.
SEC. 206. PREVENTING THE MISCLASSIFICATION OF DRUGS UNDER THE MEDICAID
DRUG REBATE PROGRAM.
(a) Application of Civil Money Penalty for Misclassification of
Covered Outpatient Drugs.--
(1) In general.--Section 1927(b)(3) of the Social Security
Act (42 U.S.C. 1396r-8(b)(3)) is amended--
(A) in the paragraph heading, by inserting ``and
drug product'' after ``price'';
(B) in subparagraph (A)--
(i) in clause (ii), by striking ``; and''
at the end and inserting a semicolon;
(ii) in clause (iii), by striking the
period at the end and inserting a semicolon;
(iii) in clause (iv), by striking the
semicolon at the end and inserting ``; and'';
and
(iv) by inserting after clause (iv) the
following new clause:
``(v) not later than 30 days after the last
day of each month of a rebate period under the
agreement, such drug product information as the
Secretary shall require for each of the
manufacturer's covered outpatient drugs.''; and
(C) in subparagraph (C)--
(i) in clause (ii), by inserting ``,
including information related to drug pricing,
drug product information, and data related to
drug pricing or drug product information,''
after ``provides false information''; and
(ii) by adding at the end the following new
clauses:
``(iii) Misclassified or misreported
information.--
``(I) In general.--Any manufacturer
with an agreement under this section
that knowingly (as defined in section
1003.110 of title 42, Code of Federal
Regulations (or any successor
regulation)) misclassifies a covered
outpatient drug, such as by knowingly
submitting incorrect drug category
information, is subject to a civil
money penalty for each covered
outpatient drug that is misclassified
in an amount not to exceed 2 times the
amount of the difference, as determined
by the Secretary, between--
``(aa) the total amount of
rebates that the manufacturer
paid with respect to the drug
to all States for all rebate
periods during which the drug
was misclassified; and
``(bb) the total amount of
rebates that the manufacturer
would have been required to
pay, as determined by the
Secretary, with respect to the
drug to all States for all
rebate periods during which the
drug was misclassified if the
drug had been correctly
classified.
``(II) Other penalties and recovery
of underpaid rebates.--The civil money
penalties described in subclause (I)
are in addition to other penalties as
may be prescribed by law and any other
recovery of the underlying underpayment
for rebates due under this section or
the terms of the rebate agreement as
determined by the Secretary.
``(iv) Increasing oversight and
enforcement.--Each year the Secretary shall
retain, in addition to any amount retained by
the Secretary to recoup investigation and
litigation costs related to the enforcement of
the civil money penalties under this
subparagraph and subsection (c)(4)(B)(ii)(III),
an amount equal to 25 percent of the total
amount of civil money penalties collected under
this subparagraph and subsection
(c)(4)(B)(ii)(III) for the year, and such
retained amount shall be available to the
Secretary, without further appropriation and
until expended, for activities related to the
oversight and enforcement of this section and
agreements under this section, including--
``(I) improving drug data reporting
systems;
``(II) evaluating and ensuring
manufacturer compliance with rebate
obligations; and
``(III) oversight and enforcement
related to ensuring that manufacturers
accurately and fully report drug
information, including data related to
drug classification.''; and
(iii) in subparagraph (D)--
(I) in clause (iv), by striking ``,
and'' and inserting a comma;
(II) in clause (v), by striking
``subsection (f).'' and inserting
``subsection (f), and''; and
(III) by inserting after clause (v)
the following new clause:
``(vi) in the case of categories of drug
product or classification information that were
not considered confidential by the Secretary on
the day before the date of the enactment of the
IMPROVE Act.''.
(2) Technical amendments.--
(A) Section 1903(i)(10) of the Social Security Act
(42 U.S.C. 1396b(i)(10)) is amended--
(i) in subparagraph (C)--
(I) by adjusting the left margin so
as to align with the left margin of
subparagraph (B); and
(II) by striking ``, and'' and
inserting a semicolon;
(ii) in subparagraph (D), by striking ``;
or'' and inserting ``; and''; and
(iii) by adding at the end the following
new subparagraph:
``(E) with respect to any amount expended for a
covered outpatient drug for which a suspension under
section 1927(c)(4)(B)(ii)(II) is in effect; or''.
(B) Section 1927(b)(3)(C)(ii) of the Social
Security Act (42 U.S.C. 1396r-8(b)(3)(C)(ii)) is
amended by striking ``subsections (a) and (b)'' and
inserting ``subsections (a), (b), (f)(3), and (f)(4)''.
(b) Recovery of Unpaid Rebate Amounts Due to Misclassification of
Covered Outpatient Drugs.--
(1) In general.--Section 1927(c) of the Social Security Act
(42 U.S.C. 1396r-8(c)) is amended by adding at the end the
following new paragraph:
``(4) Recovery of unpaid rebate amounts due to
misclassification of covered outpatient drugs.--
``(A) In general.--If the Secretary determines that
a manufacturer with an agreement under this section
paid a lower per-unit rebate amount to a State for a
rebate period as a result of the misclassification by
the manufacturer of a covered outpatient drug (without
regard to whether the manufacturer knowingly made the
misclassification or should have known that the
misclassification would be made) than the per-unit
rebate amount that the manufacturer would have paid to
the State if the drug had been correctly classified,
the manufacturer shall pay to the State an amount equal
to the product of--
``(i) the difference between--
``(I) the per-unit rebate amount
paid to the State for the period; and
``(II) the per-unit rebate amount
that the manufacturer would have paid
to the State for the period, as
determined by the Secretary, if the
drug had been correctly classified; and
``(ii) the total units of the drug paid for
under the State plan in the period.
``(B) Authority to correct misclassifications.--
``(i) In general.--If the Secretary
determines that a manufacturer with an
agreement under this section has misclassified
a covered outpatient drug (without regard to
whether the manufacturer knowingly made the
misclassification or should have known that the
misclassification would be made), the Secretary
shall notify the manufacturer of the
misclassification and require the manufacturer
to correct the misclassification in a timely
manner.
``(ii) Enforcement.--If, after receiving
notice of a misclassification from the
Secretary under clause (i), a manufacturer
fails to correct the misclassification by such
time as the Secretary shall require, until the
manufacturer makes such correction, the
Secretary may--
``(I) correct the misclassification
on behalf of the manufacturer;
``(II) suspend the misclassified
drug and the drug's status as a covered
outpatient drug under the
manufacturer's national rebate
agreement; or
``(III) impose a civil money
penalty (which shall be in addition to
any other recovery or penalty which may
be available under this section or any
other provision of law) for each rebate
period during which the drug is
misclassified not to exceed an amount
equal to the product of--
``(aa) the total number of
units of each dosage form and
strength of such misclassified
drug paid for under any State
plan during such a rebate
period; and
``(bb) 23.1 percent of the
average manufacturer price for
the dosage form and strength of
such misclassified drug.
``(C) Reporting and transparency.--
``(i) In general.--The Secretary shall
submit a report to Congress on at least an
annual basis that includes information on the
covered outpatient drugs that have been
identified as misclassified, the steps taken to
reclassify such drugs, the actions the
Secretary has taken to ensure the payment of
any rebate amounts which were unpaid as a
result of such misclassification, and a
disclosure of expenditures from the fund
created in subsection (b)(3)(C)(iv), including
an accounting of how such funds have been
allocated and spent in accordance with such
subsection.
``(ii) Public access.--The Secretary shall
make the information contained in the report
required under clause (i) available to the
public on a timely basis.
``(D) Other penalties and actions.--Actions taken
and penalties imposed under this paragraph shall be in
addition to other remedies available to the Secretary
including terminating the manufacturer's rebate
agreement for noncompliance with the terms of such
agreement and shall not exempt a manufacturer from, or
preclude the Secretary from pursuing, any civil money
penalty under this title or title XI, or any other
penalty or action as may be prescribed by law.''.
(2) Offset of recovered amounts against medical
assistance.--Section 1927(b)(1)(B) of the Social Security Act
(42 U.S.C. 1396r-8(b)(1)(B)) is amended by inserting ``,
including amounts received by a State under subsection
(c)(4),'' after ``in any quarter''.
(c) Clarifying Definitions.--Section 1927(k)(7)(A) of the Social
Security Act (42 U.S.C. 1396r-8(k)(7)(A)) is amended--
(1) by striking ``an original new drug application'' and
inserting ``a new drug application'' each place it appears;
(2) in clause (i), by inserting ``but including a drug
product approved for marketing as a non-prescription drug that
is regarded as a covered outpatient drug under paragraph (4)''
after ``drug described in paragraph (5)'';
(3) in clause (ii), by striking ``was originally marketed''
and inserting ``is marketed''; and
(4) in clause (iv)--
(A) by inserting ``, including a drug product
approved for marketing as a non-prescription drug that
is regarded as a covered outpatient drug under
paragraph (4),'' after ``covered outpatient drug''; and
(B) by adding at the end the following new
sentence: ``Such term also includes a covered
outpatient drug that is a biological product licensed,
produced, or distributed under a biologics license
application approved by the Food and Drug
Administration.''.
(d) Exclusion of Manufacturers for Knowing Misclassification of
Covered Outpatient Drugs.--Section 1128(b) of the Social Security Act
(42 U.S.C. 1320a-7(b)) is amended by adding at the end the following
new paragraph:
``(17) Knowingly misclassifying covered outpatient drugs.--
Any manufacturer or officer, director, agent, or managing
employee of such manufacturer that knowingly misclassifies a
covered outpatient drug under an agreement under section 1927,
knowingly fails to correct such misclassification, or knowingly
provides false information related to drug pricing, drug
product information, or data related to drug pricing or drug
product information.''.
(e) Effective Date.--The amendments made by this section shall take
effect on the date of the enactment of this Act, and shall apply to
covered outpatient drugs supplied by manufacturers under agreements
under section 1927 of the Social Security Act (42 U.S.C. 1396r-8) on or
after such date.
TITLE III--MEDICARE
SEC. 301. 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, 2019, and ending on
June 30, 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.
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