[Congressional Record Volume 165, Number 166 (Monday, October 21, 2019)]
[Senate]
[Pages S5924-S5926]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
By Mr. DURBIN (for himself and Mr. Brown):
S. 2650. A bill to amend part D of title XVIII of the Social Security
Act to deliver a meaningful benefit and lower prescription drug prices
under the Medicare program; to the Committee on Finance.
Mr. DURBIN. Mr. President, I ask unanimous consent that the text of
the bill be printed in the Record.
There being no objection, the text of the bill was ordered to be
printed in the Record, as follows:
S. 2650
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 Prescription Drug
Savings and Choice Act of 2019''.
SEC. 2. ESTABLISHMENT OF MEDICARE OPERATED PRESCRIPTION DRUG
PLAN OPTION.
(a) In General.--Subpart 2 of part D of title XVIII of the
Social Security Act is amended by inserting after section
1860D-11 (42 U.S.C. 1395w-111) the following new section:
``medicare operated prescription drug plan option
``Sec. 1860D-11A. (a) In General.--Notwithstanding any
other provision of this part, for each year (beginning with
2021), in addition to any plans offered under section 1860D-
11, the Secretary shall offer one or more Medicare operated
prescription drug plans (as defined in subsection (d)) with a
service area that consists of the entire United States and
shall enter into negotiations in accordance with subsection
(c) with pharmaceutical manufacturers to reduce the purchase
cost of covered part D drugs for eligible part D individuals
who enroll in such a plan.
``(b) Enrollment.--Notwithstanding subparagraphs (C) and
(D) of section 1860D-1(b)(1), a Medicare operated
prescription drug plan offered under this section shall serve
as the default prescription drug plan for all part D
enrollees unless another prescription drug plan is selected.
``(c) Negotiations.--Notwithstanding section 1860D-11(i),
for purposes of offering a Medicare operated prescription
drug plan under this section, the Secretary shall negotiate
with pharmaceutical manufacturers with respect to the
purchase price of covered part D drugs in a Medicare operated
prescription drug plan and shall encourage the use of more
affordable therapeutic equivalents to the extent such
practices do not override medical necessity as determined by
the prescribing physician. To the extent practicable and
consistent with the previous sentence, the Secretary shall
implement negotiation and incentive strategies similar to
those used by other Federal purchasers of prescription drugs
to reduce the purchase cost of covered Part D drugs, and
other strategies, as described in subsection (f), which may
include the use of a pricing scale based on an international
price index.
``(d) Medicare Operated Prescription Drug Plan Defined.--
For purposes of this part, the term `Medicare operated
prescription drug plan' means a comprehensive prescription
drug plan that offers qualified prescription drug coverage
and access to negotiated prices described in section 1860D-
2(a)(1)(A). Such a plan may offer supplemental prescription
drug coverage in the same manner as other qualified
prescription drug coverage offered by other prescription drug
plans.
``(e) Monthly Beneficiary Premium.--
``(1) Qualified prescription drug coverage.--The monthly
beneficiary premium for qualified prescription drug coverage
and access to negotiated prices described in section 1860D-
2(a)(1)(A) to be charged under a Medicare operated
prescription drug plan shall be uniform nationally. Such
premium for months in 2021 and each succeeding year shall be
based on the average monthly per capita actuarial cost of
offering the Medicare operated prescription drug plan for the
year involved, including administrative expenses.
``(2) Supplemental prescription drug coverage.--Insofar as
a Medicare operated prescription drug plan offers
supplemental prescription drug coverage, the Secretary may
adjust the amount of the premium charged under paragraph (1).
``(f) Use of Negotiation and Benefit Design Incentives.--
``(1) In general.--With respect to the operation of a
Medicare operated prescription drug plan and in negotiating
with respect to the purchase price of covered part D drugs in
such plan, the Secretary shall reward value, increase
appropriate use of drugs, and ensure patient safety and
access to medications.
``(2) Role of ahrq.--The Director of the Agency for
Healthcare Research and Quality,
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in coordination with the Administrator of the Centers for
Medicare & Medicaid Services, shall be responsible for
assessing the clinical benefit of covered part D drugs and
making recommendations to the Secretary regarding the
negotiated prices of covered drugs and any appropriate
tiering or incentive strategies under the plan. In conducting
such assessments and making such recommendations, the
Director shall carry out the following activities:
``(A) Consider the comparable international price of such
drugs based upon the median retail list price of such drug
(which shall be, as practicable, the volume-weighted price
for comparable units and dosage forms) among a category of at
least the following peer reference countries: Canada, the
United Kingdom, France, Japan, Australia, and Germany.
``(B) Consider safety concerns and post-market data,
including those identified by the Food and Drug
Administration and from national health registries.
``(C) Use available data and evaluations, including from
research supported by the National Institutes of Health, with
priority given to randomized controlled trials, to examine
clinical effectiveness, comparative effectiveness, safety,
and enhanced compliance with a drug regimen.
``(D) Use the same classes of drugs developed by United
States Pharmacopeia for this part.
``(E) Consider evaluations made by--
``(i) the Director under section 1013 of the Medicare
Prescription Drug, Improvement, and Modernization Act of
2003;
``(ii) other Federal entities, such as the Secretary of
Veterans Affairs; and
``(iii) other private and public entities, which may
include the Drug Effectiveness Review Project and Medicaid
programs.
``(F) Consider recommendations made by the advisory
committee pursuant to paragraph (3)(F).
``(G) Recommend to the Secretary those drugs in a class
that provide a greater clinical benefit, including fewer
safety concerns or less risk of side-effects, than another
drug in the same class.
``(3) Use of advisory committee.--
``(A) In general.--The Secretary shall establish and
appoint an advisory committee (in this paragraph referred to
as the `advisory committee')--
``(i) to review petitions from drug manufacturers, health
care provider organizations, patient groups, and other
entities regarding negotiated prices; and
``(ii) to recommend any changes in order to further
negotiations with respect to such prices.
``(B) Composition.--Subject to subparagraph (C), the
advisory committee shall be composed of 9 members and shall
include representatives of physicians, pharmacists,
consumers, and others with expertise in evaluating
prescription drugs. The Secretary shall select members based
on their knowledge of pharmaceuticals and the Medicare
population. Members shall be deemed to be special Government
employees for purposes of applying the conflict of interest
provisions under section 208 of title 18, United States Code,
and no waiver of such provisions for such a member shall be
permitted.
``(C) Banned individuals.--
``(i) Drug company lobbyists.--No former registered drug
manufacturer lobbyist--
``(I) may be appointed to the advisory committee; or
``(II) may be employed by the advisory committee during the
6-year period beginning on the date on which the registered
lobbyist terminates its registration in accordance with
section 4(d) of the Lobbying Disclosure Act of 1995 (2 U.S.C.
1603(d)) or the agent terminates its status, as applicable.
``(ii) Senior executives of law-breaking companies.--No
former senior executive of a covered entity (as defined in
clause (iii))--
``(I) may be appointed to the Advisory Committee; or
``(II) may be employed by the Advisory Committee during the
6-year period beginning on the later of--
``(aa) the date of the settlement described in item (aa) of
clause (iii)(II); or
``(bb) the date on which the enforcement action described
in item (bb) of such clause has concluded.
``(iii) Covered entity.--The term `covered entity' means
any entity that is--
``(I) a drug manufacturer; and
``(II)(aa) operating under Federal settlement including a
Federal consent decree; or
``(bb) the subject of an enforcement action in a court of
the United States or by an agency.
``(D) Consultation.--The advisory committee shall consult,
as necessary, with physicians who are specialists in treating
the disease for which a drug is being considered.
``(E) Request for studies.--The advisory committee may
request the Agency for Healthcare Research and Quality or an
academic or research institution to study and make a report
on a petition described in subparagraph (A)(i) in order to
assess cost-effectiveness, clinical effectiveness,
comparative effectiveness, safety, and compliance with a drug
regimen.
``(F) Recommendations.--The advisory committee shall make
recommendations to the Director of the Agency for Healthcare
Research and Quality regarding the appropriate price at which
to begin negotiations on a part D drug pursuant to this
section.
``(G) Limitations on review of manufacturer petitions.--The
advisory committee shall not review a petition of a drug
manufacturer under subparagraph (A)(i) with respect to a
covered part D drug unless the petition is accompanied by the
following:
``(i) Raw data from clinical trials on the safety and
effectiveness of the drug.
``(ii) Any data from clinical trials conducted using active
controls on the drug or drugs that are the current standard
of care.
``(iii) Any available data on comparative effectiveness of
the drug.
``(iv) Any other information the Secretary requires for the
advisory committee to complete its review.
``(g) Informing Beneficiaries.--The Secretary shall take
steps to inform part D eligible individuals not previously
enrolled in a Medicare operated drug plan (including such
individuals who are newly eligible to enroll under this part)
regarding the enrollment of such individual in a Medicare
operated drug plan in accordance with this section, including
providing information in the annual handbook and adding
information to the official public Medicare website related
to prescription drug coverage available through this part.
``(h) Application of All Other Requirements for
Prescription Drug Plans.--Except as specifically provided in
this section, any Medicare operated drug plan shall meet the
same requirements as apply to any other prescription drug
plan, including the requirements of section 1860D-4(b)(1)
relating to assuring pharmacy access.''.
(b) Conforming Amendments.--
(1) Section 1860D-3(a) of the Social Security Act (42
U.S.C. 1395w-103(a)) is amended by adding at the end the
following new paragraph:
``(4) Availability of the medicare operated prescription
drug plan.--A Medicare operated prescription drug plan (as
defined in section 1860D-11A(d)) shall be offered nationally
in accordance with section 1860D-11A.''.
(2)(A) Section 1860D-3 of the Social Security Act (42
U.S.C. 1395w-103) is amended by adding at the end the
following new subsection:
``(c) Provisions Only Applicable in 2006 Through 2020.--The
provisions of this section shall only apply with respect to
2006 through 2020.''.
(B) Section 1860D-11(g) of such Act (42 U.S.C. 1395w-
111(g)) is amended by adding at the end the following new
paragraph:
``(8) No authority for fallback plans after 2020.--A
fallback prescription drug plan shall not be available after
December 31, 2020.''.
(3) Section 1860D-13(c)(3) of the Social Security Act (42
U.S.C. 1395w-113(c)(3)) is amended--
(A) in the heading, by inserting ``and medicare operated
prescription drug plans'' after ``Fallback plans''; and
(B) by inserting ``or a Medicare operated prescription drug
plan'' after ``a fallback prescription drug plan''.
(4) Section 1860D-16(b)(1) of the Social Security Act (42
U.S.C. 1395w-116(b)(1)) is amended--
(A) in subparagraph (C), by striking ``and'' after the
semicolon at the end;
(B) in subparagraph (D), by striking the period at the end
and inserting ``; and''; and
(C) by adding at the end the following new subparagraph:
``(E) payments for expenses incurred with respect to the
operation of Medicare operated prescription drug plans under
section 1860D-11A.''.
(5) Section 1860D-41(a) of the Social Security Act (42
U.S.C. 1395w-151(a)) is amended by adding at the end the
following new paragraph:
``(19) Medicare operated prescription drug plan.--The term
`Medicare operated prescription drug plan' has the meaning
given such term in section 1860D-11A(d).''.
(c) Rule of Construction.--Nothing in this section shall be
interpreted to supersede any other negotiation authority
granted to the Secretary under Federal law with respect to
prescription drug prices.
SEC. 3. IMPROVED APPEALS PROCESS UNDER THE MEDICARE OPERATED
PRESCRIPTION DRUG PLAN.
Section 1860D-4(h) of the Social Security Act (42 U.S.C.
1305w-104(h)) is amended by adding at the end the following
new paragraph:
``(4) Appeals process for medicare operated prescription
drug plan.--
``(A) In general.--The Secretary shall develop a well-
defined process for appeals for denials of benefits under
this part under the Medicare operated prescription drug plan
(as defined in section 1860D-11A(d)). Such process shall be
efficient, impose minimal administrative burdens, and ensure
the timely procurement of medications. Medical necessity
shall be based on professional medical judgment, the medical
condition of the beneficiary, and other medical evidence.
``(B) Consultation in development of process.--In
developing the appeals process under subparagraph (A), the
Secretary shall consult with consumer and patient groups, as
well as other key stakeholders, to ensure the goals described
in subparagraph (A) are achieved.''.
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