[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4769 Introduced in House (IH)]
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116th CONGRESS
1st Session
H. R. 4769
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.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
October 21, 2019
Ms. Schakowsky 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 part D of title XVIII of the Social Security Act to deliver a
meaningful benefit and lower prescription drug prices under 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 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, 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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