[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]




          STATEMENTS ON INTRODUCED BILLS AND JOINT RESOLUTIONS

      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,

[[Page S5925]]

     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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