[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2298 Introduced in House (IH)]
114th CONGRESS
1st Session
H. R. 2298
To amend title XVIII of the Social Security Act to provide for programs
to prevent prescription drug abuse under parts C and D of the Medicare
program.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
May 13, 2015
Mr. Bilirakis (for himself, Mr. Ben Ray Lujan of New Mexico, and Mr.
Long) 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 XVIII of the Social Security Act to provide for programs
to prevent prescription drug abuse under parts C and D of the Medicare
program.
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 ``Medicare Patient Safety and Drug
Abuse Prevention Act''.
SEC. 2. PROGRAMS TO PREVENT PRESCRIPTION DRUG ABUSE UNDER MEDICARE
PARTS C AND D.
(a) Drug Management Program for At-Risk Beneficiaries.--
(1) In general.--Section 1860D-4(c) of the Social Security
Act (42 U.S.C. 1395w-10(c)) is amended by adding at the end the
following:
``(5) Drug management program for at-risk beneficiaries.--
``(A) Authority to establish.--A PDP sponsor may
establish a drug management program for at-risk
beneficiaries under which, subject to subparagraph (B),
the PDP sponsor may, in the case of an at-risk
beneficiary for prescription drug abuse who is an
enrollee in a prescription drug plan of such PDP
sponsor, limit such beneficiary's access to coverage
for frequently abused drugs under such plan to
frequently abused drugs that are prescribed for such
beneficiary by a prescriber selected under subparagraph
(D), and dispensed for such beneficiary by a pharmacy
selected under such subparagraph.
``(B) Requirement for notices.--
``(i) In general.--A PDP sponsor may not
limit the access of an at-risk beneficiary for
prescription drug abuse to coverage for
frequently abused drugs under a prescription
drug plan until such sponsor--
``(I) provides to the beneficiary
an initial notice described in clause
(ii) and a second notice described in
clause (iii); and
``(II) verifies with the providers
of the beneficiary that the beneficiary
is an at-risk beneficiary for
prescription drug abuse.
``(ii) Initial notice.--An initial notice
described in this clause is a notice that
provides to the beneficiary--
``(I) notice that the PDP sponsor
has identified the beneficiary as
potentially being an at-risk
beneficiary for prescription drug
abuse;
``(II) information describing all
State and Federal public health
resources that are designed to address
prescription drug abuse to which the
beneficiary has access, including
mental health services and other
counseling services;
``(III) notice of, and information
about, the right of the beneficiary to
appeal such identification under
subsection (h) and the option of an
automatic escalation to external
review;
``(IV) a request for the
beneficiary to submit to the PDP
sponsor preferences for which
prescribers and pharmacies the
beneficiary would prefer the PDP
sponsor to select under subparagraph
(D) in the case that the beneficiary is
identified as an at-risk beneficiary
for prescription drug abuse as
described in clause (iii)(I);
``(V) an explanation of the meaning
and consequences of the identification
of the beneficiary as potentially being
an at-risk beneficiary for prescription
drug abuse, including an explanation of
the drug management program established
by the PDP sponsor pursuant to
subparagraph (A);
``(VI) clear instructions that
explain how the beneficiary can contact
the PDP sponsor in order to submit to
the PDP sponsor the preferences
described in subclause (IV) and any
other communications relating to the
drug management program for at-risk
beneficiaries established by the PDP
sponsor; and
``(VII) contact information for
other organizations that can provide
the beneficiary with assistance
regarding such drug management program
(similar to the information provided by
the Secretary in other standardized
notices provided to part D eligible
individuals enrolled in prescription
drug plans under this part).
``(iii) Second notice.--A second notice
described in this clause is a notice that
provides to the beneficiary notice--
``(I) that the PDP sponsor has
identified the beneficiary as an at-
risk beneficiary for prescription drug
abuse;
``(II) that such beneficiary is
subject to the requirements of the drug
management program for at-risk
beneficiaries established by such PDP
sponsor for such plan;
``(III) of the prescriber and
pharmacy selected for such individual
under subparagraph (D);
``(IV) of, and information about,
the beneficiary's right to appeal such
identification under subsection (h) and
the option of an automatic escalation
to external review;
``(V) that the beneficiary can, in
the case that the beneficiary has not
previously submitted to the PDP sponsor
preferences for which prescribers and
pharmacies the beneficiary would prefer
the PDP sponsor select under
subparagraph (D), submit such
preferences to the PDP sponsor; and
``(VI) that includes clear
instructions that explain how the
beneficiary can contact the PDP
sponsor.
``(iv) Timing of notices.--
``(I) In general.--Subject to
subclause (II), a second notice
described in clause (iii) shall be
provided to the beneficiary on a date
that is not less than 60 days after an
initial notice described in clause (ii)
is provided to the beneficiary.
``(II) Exception.--In the case that
the PDP sponsor, in conjunction with
the Secretary, determines that concerns
identified through rulemaking by the
Secretary regarding the health or
safety of the beneficiary or regarding
significant drug diversion activities
require the PDP sponsor to provide a
second notice described in clause (iii)
to the beneficiary on a date that is
earlier than the date described in
subclause (II), the PDP sponsor may
provide such second notice on such
earlier date.
``(C) At-risk beneficiary for prescription drug
abuse.--
``(i) In general.--For purposes of this
paragraph, the term `at-risk beneficiary for
prescription drug abuse' means a part D
eligible individual who is not an exempted
individual described in clause (ii) and--
``(I) who is identified through the
use of clinical guidelines developed by
the Secretary in consultation with PDP
sponsors and other stakeholders
described in subsection (f)(2)(A); or
``(II) with respect to whom the PDP
sponsor of a prescription drug plan,
upon enrolling such individual in such
plan, received notice from the
Secretary that such individual was
identified under this paragraph to be
an at-risk beneficiary for prescription
drug abuse under the prescription drug
plan in which such individual was most
recently previously enrolled and such
identification has not been terminated
under subparagraph (F).
``(ii) Exempted individual described.--An
exempted individual described in this clause is
an individual who--
``(I) an individual who receives
hospice care under this title; or
``(II) an individual, such as an
individual who is a resident of a long-
term care facility, who the Secretary
elects to treat as an exempted
individual for purposes of clause (i).
``(D) Selection of prescribers.--
``(i) In general.--With respect to each at-
risk beneficiary for prescription drug abuse
enrolled in a prescription drug plan offered by
such sponsor, a PDP sponsor shall, based on the
preferences submitted to the PDP sponsor by the
beneficiary pursuant to clauses (ii)(IV) and
(iii)(V) of subparagraph (B), select--
``(I) one or more individuals who
are authorized to prescribe frequently
abused drugs (referred to in this
paragraph as `prescribers') who may
write prescriptions for such drugs for
such beneficiary; and
``(II) one or more pharmacies that
may dispense such drugs to such
beneficiary.
``(ii) Reasonable access.--In making the
selection under this subparagraph, a PDP
sponsor shall ensure that the beneficiary
continues to have reasonable access to drugs
described in subparagraph (G), taking into
account geographic location, beneficiary
preference, impact on cost-sharing, and
reasonable travel time.
``(iii) Beneficiary preferences.--
``(I) In general.--If an at-risk
beneficiary for prescription drug abuse
submits preferences for which in-
network prescribers and pharmacies the
beneficiary would prefer the PDP
sponsor select in response to a notice
under subparagraph (B), the PDP sponsor
shall--
``(aa) review such
preferences;
``(bb) select or change the
selection of a prescriber or
pharmacy for the beneficiary
based on such preferences; and
``(cc) inform the
beneficiary of such selection
or change of selection.
``(II) Exception.--In the case that
the PDP sponsor determines that a
change to the selection of a prescriber
or pharmacy under item (bb) by the PDP
sponsor is contributing or would
contribute to prescription drug abuse
or drug diversion by the beneficiary,
the PDP sponsor may change the
selection of a prescriber or pharmacy
for the beneficiary without regard to
the preferences of the beneficiary
described in subclause (I).
``(iv) Confirmation.--Before selecting a
prescriber or pharmacy under this subparagraph,
a PDP sponsor must request and receive
confirmation from the prescriber or pharmacy
acknowledging and accepting that the
beneficiary involved is in the drug management
program for at-risk beneficiaries.
``(E) Terminations and appeals.--The identification
of an individual as an at-risk beneficiary for
prescription drug abuse under this paragraph, a
coverage determination made under a drug management
program for at-risk beneficiaries, and the selection of
a prescriber or pharmacy under subparagraph (D) with
respect to such individual shall be subject to
reconsideration and appeal under subsection (h) and the
option of an automatic escalation to external review to
the extent provided by the Secretary.
``(F) Termination of identification.--
``(i) In general.--The Secretary shall
develop standards for the termination of
identification of an individual as an at-risk
beneficiary for prescription drug abuse under
this paragraph. Under such standards such
identification shall terminate as of the
earlier of--
``(I) the date the individual
demonstrates that the individual is no
longer likely, in the absence of the
restrictions under this paragraph, to
be an at-risk beneficiary for
prescription drug abuse described in
subparagraph (C)(i); or
``(II) the end of such maximum
period of identification as the
Secretary may specify.
``(ii) Rule of construction.--Nothing in
clause (i) shall be construed as preventing a
plan from identifying an individual as an at-
risk beneficiary for prescription drug abuse
under subparagraph (C)(i) after such
termination on the basis of additional
information on drug use occurring after the
date of notice of such termination.
``(G) Frequently abused drug.--For purposes of this
subsection, the term `frequently abused drug' means a
drug that is a controlled substance that the Secretary
determines to be frequently abused or diverted.
``(H) Data disclosure.--In the case of an at-risk
beneficiary for prescription drug abuse whose access to
coverage for frequently abused drugs under a
prescription drug plan has been limited by a PDP
sponsor under this paragraph, such PDP sponsor shall
disclose data, including any necessary individually
identifiable health information, in a form and manner
specified by the Secretary, about the decision to
impose such limitations and the limitations imposed by
the sponsor under this part.
``(I) Education.--The Secretary shall provide
education to enrollees in prescription drug plans of
PDP sponsors and providers regarding the drug
management program for at-risk beneficiaries described
in this paragraph, including education--
``(i) provided by medicare administrative
contractors through the improper payment
outreach and education program described in
section 1874A(h); and
``(ii) through current education efforts
(such as State health insurance assistance
programs described in subsection (a)(1)(A) of
section 119 of the Medicare Improvements for
Patients and Providers Act of 2008 (42 U.S.C.
1395b-3 note)) and materials directed toward
such enrollees.
``(J) Application under ma-pd plans.--Pursuant to
section 1860D-21(c)(1), the provisions of this
paragraph apply under part D to MA organizations
offering MA-PD plans to MA eligible individuals in the
same manner as such provisions apply under this part to
a PDP sponsor offering a prescription drug plan to a
part D eligible individual.''.
(2) Information for consumers.--Section 1860D-4(a)(1)(B) of
the Social Security Act (42 U.S.C. 1395w-104(a)(1)(B)) is
amended by adding at the end the following:
``(v) The drug management program for at-
risk beneficiaries under subsection (c)(5).''.
(b) Utilization Management Programs.--Section 1860D-4(c) of the
Social Security Act (42 U.S.C. 1395w-104(c)), as amended by subsection
(a)(1), is further amended--
(1) in paragraph (1), by inserting after subparagraph (D)
the following new subparagraph:
``(E) A utilization management tool to prevent drug
abuse (as described in paragraph (6)(A)).''; and
(2) by adding at the end the following new paragraph:
``(6) Utilization management tool to prevent drug abuse.--
``(A) In general.--A tool described in this
paragraph is any of the following:
``(i) A utilization tool designed to
prevent the abuse of frequently abused drugs by
individuals and to prevent the diversion of
such drugs at pharmacies.
``(ii) Retrospective utilization review to
identify--
``(I) individuals that receive
frequently abused drugs at a frequency
or in amounts that are not clinically
appropriate; and
``(II) providers of services or
suppliers that may facilitate the abuse
or diversion of frequently abused drugs
by beneficiaries.
``(iii) Consultation with the Contractor
described in subparagraph (B) to verify if an
individual enrolling in a prescription drug
plan offered by a PDP sponsor has been
previously identified by another PDP sponsor as
an individual described in clause (ii)(I).
``(B) Reporting.--A PDP sponsor offering a
prescription drug plan (and an MA organization offering
an MA-PD plan) in a State shall submit to the Secretary
and the Medicare drug integrity contractor with which
the Secretary has entered into a contract under section
1893 with respect to such State a report, on a monthly
basis, containing information on--
``(i) any provider of services or supplier
described in subparagraph (A)(ii)(II) that is
identified by such plan sponsor (or
organization) during the 30-day period before
such report is submitted; and
``(ii) the name and prescription records of
individuals described in paragraph (5)(C).''.
(c) Expanding Activities of Medicare Drug Integrity Contractors
(MEDICs).--
(1) In general.--Section 1893 of the Social Security Act
(42 U.S.C. 1395ddd) is amended by adding at the end the
following new subsection:
``(j) Expanding Activities of Medicare Drug Integrity Contractors
(MEDICs).--
``(1) Access to information.--Under contracts entered into
under this section with Medicare drug integrity contractors,
the Secretary shall authorize such contractors to directly
accept prescription and necessary medical records from entities
such as pharmacies, prescription drug plans, MA-PD plans, and
physicians with respect to an individual in order for such
contractors to provide information relevant to the
determination of whether such individual is an at-risk
beneficiary for prescription drug abuse, as defined in section
1860D-4(c)(5)(C).
``(2) Requirement for acknowledgment of referrals.--If a
PDP sponsor or MA organization refers information to a
contractor described in paragraph (1) in order for such
contractor to assist in the determination described in such
paragraph, the contractor shall--
``(A) acknowledge to the sponsor or organization
receipt of the referral; and
``(B) in the case that any PDP sponsor or MA
organization contacts the contractor requesting to know
the determination by the contractor of whether or not
an individual has been determined to be an individual
described such paragraph, shall inform such sponsor or
organization of such determination on a date that is
not later than 15 days after the date on which the
sponsor or organization contacts the contractor.
``(3) Making data available to other entities.--
``(A) In general.--For purposes of carrying out
this subsection, subject to subparagraph (B), the
Secretary shall authorize MEDICs to respond to requests
for information from PDP sponsors and MA organizations,
State prescription drug monitoring programs, and other
entities delegated by such sponsors or organizations
using available programs and systems in the effort to
prevent fraud, waste, and abuse.
``(B) HIPAA compliant information only.--
Information may only be disclosed by a MEDIC under
subparagraph (A) if the disclosure of such information
is permitted under the Federal regulations (concerning
the privacy of individually identifiable health
information) promulgated under section 264(c) of the
Health Insurance Portability and Accountability Act of
1996 (42 U.S.C. 1320d-2 note).''.
(2) OIG study and report on effectiveness of medics.--
(A) Study.--The Inspector General of the Department
of Health and Human Services shall conduct a study on
the effectiveness of Medicare drug integrity
contractors in identifying combating, and preventing
fraud under the Medicare program, including under the
authority provided under section 1893(j) of the Social
Security Act, as added by paragraph (1).
(B) Report.--Not later than 1 year after the date
of the enactment of this Act, the Inspector General
shall submit to Congress a report on the study
conducted under subparagraph (A). Such report shall
include such recommendations for improvements in the
effectiveness of such contractors as the Inspector
General determines appropriate.
(d) Treatment of Certain Complaints for Purposes of Quality or
Performance Assessment.--Section 1860D-42 of the Social Security Act
(42 U.S.C. 1395w-152) is amended by adding at the end the following new
subsection:
``(d) Treatment of Certain Complaints for Purposes of Quality or
Performance Assessment.--In conducting a quality or performance
assessment of a PDP sponsor, the Secretary shall develop or utilize
existing screening methods for reviewing and considering complaints
that are received from enrollees in a prescription drug plan offered by
such PDP sponsor and that are complaints regarding the lack of access
by the individual to prescription drugs due to a drug management
program for at-risk beneficiaries.''.
(e) Sense of Congress Regarding Use of Technology Tools To Combat
Fraud.--It is the sense of Congress that MA organizations and PDP
sponsors should consider using e-prescribing and other health
information technology tools to support combating fraud under MA-PD
plans and prescription drug plans under parts C and D of the Medicare
program.
(f) Effective Date.--
(1) In general.--The amendments made by this section shall
apply to prescription drug plans (and MA-PD plans) for plan
years beginning more than 1 year after the date of the
enactment of this Act.
(2) Stakeholder meetings prior to effective date.--
(A) In general.--Not later than January 1, 2016,
the Secretary of Health and Human Services shall
convene stakeholders, including individuals entitled to
benefits under part A of title XVIII of the Social
Security Act or enrolled under part B of such title of
such Act, advocacy groups representing such
individuals, clinicians, plan sponsors, entities
delegated by plan sponsors, and biopharmaceutical
manufacturers for input regarding the topics described
in subparagraph (B).
(B) Topics described.--The topics described in this
subparagraph are the topics of--
(i) the impact on cost-sharing and ensuring
accessibility to prescription drugs for
enrollees in prescription drug plans of PDP
sponsors, and enrollees in MA-PD plans, who are
at-risk beneficiaries for prescription drug
abuse (as defined in subparagraph (C) of
paragraph (5) of section 1860D-4(c) of the
Social Security Act (42 U.S.C. 1395w-104(c)));
(ii) the use of an expedited appeals
process under which such an enrollee may appeal
an identification of such enrollee as an at-
risk beneficiary for prescription drug abuse
under such paragraph (similar to the processes
established under the Medicare Advantage
program under part C of title XVIII of the
Social Security Act that allow an automatic
escalation to external review of claims
submitted under such part);
(iii) the types of enrollees that should be
treated as exempted individuals, as described
in subparagraph (C)(ii) of such paragraph;
(iv) the manner in which terms and
definitions in such paragraph should be
applied, such as the use of clinical
appropriateness in determining whether an
enrollee is an at-risk beneficiary for
prescription drug abuse as defined in
subparagraph (C) of such paragraph;
(v) the information to be included in the
notices described in subparagraph (B) of such
paragraph and the standardization of such
notices; and
(vi) with respect to a PDP sponsor (or
Medicare Advantage organization) that
establishes a drug management program for at-
risk beneficiaries under such paragraph, the
responsibilities of such PDP sponsor (or
organization) with respect to the
implementation of such program.
(g) Rulemaking.--The Secretary of Health and Human Services shall
promulgate regulations based on the input gathered pursuant to
subsection (f)(2)(A).
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