[Congressional Record Volume 168, Number 133 (Saturday, August 6, 2022)]
[Senate]
[Pages S4350-S4360]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

  SA 5479. Mr. CRAPO (for himself, Mr. Marshall, Mr. Daines, Mr. 
Tillis, Mr. Burr, and Mr. Risch) submitted an amendment intended to be 
proposed to amendment SA 5194 proposed by Mr. Schumer to the bill H.R. 
5376, to provide for reconciliation pursuant to title II of S. Con. 
Res. 14; which was ordered to lie on the table; as follows:

        Strike parts 1 through 4 of subtitle B of title I and 
     insert the following:

                PART 1--MEDICARE AND MEDICAID PROVISIONS

                 Subpart A--Medicare Part B Provisions

     SEC. 11001. IMPROVEMENTS TO MEDICARE SITE-OF-SERVICE 
                   TRANSPARENCY.

       Section 1834(t) of the Social Security Act (42 U.S.C. 
     1395m(t)) is amended--
       (1) in paragraph (1)--
       (A) in the heading, by striking ``In general'' and 
     inserting ``Site payment'';
       (B) in the matter preceding subparagraph (A)--
       (i) by striking ``or to'' and inserting ``, to'';
       (ii) by inserting ``, or to a physician for services 
     furnished in a physician's office'' after ``surgical center 
     under this title''; and
       (iii) by inserting ``(or 2023 with respect to a physician 
     for services furnished in a physician's office)'' after 
     ``2018''; and
       (C) in subparagraph (A)--
       (i) by striking ``and the'' and inserting ``, the''; and
       (ii) by inserting ``, and the physician fee schedule under 
     section 1848 (with respect to the practice expense component 
     of such payment amount)'' after ``such section'';
       (2) by redesignating paragraphs (2) through (4) as 
     paragraphs (3) through (5), respectively; and
       (3) by inserting after paragraph (1) the following new 
     paragraph:
       ``(2) Physician payment.--Beginning in 2023, the Secretary 
     shall expand the information included on the internet website 
     described in paragraph (1) to include--
       ``(A) the amount paid to a physician under section 1848 for 
     an item or service for the settings described in paragraph 
     (1); and
       ``(B) the estimated amount of beneficiary liability 
     applicable to the item or service.''.

     SEC. 11002. PROVIDING FOR VARIATION IN PAYMENT FOR CERTAIN 
                   DRUGS COVERED UNDER PART B OF THE MEDICARE 
                   PROGRAM.

       (a) In General.--Section 1847A(b) of the Social Security 
     Act (42 U.S.C. 1395w-3a(b)) is amended--
       (1) in paragraph (1)--
       (A) in subparagraph (A), by inserting after ``or 106 
     percent'' the following: ``(or, for a multiple source drug 
     (other than autologous cellular immunotherapy) furnished on 
     or after January 1, 2023, the applicable percent specified in 
     paragraph (9)(A) for the drug and quarter involved)''; and
       (B) in subparagraph (B) of paragraph (1), by inserting 
     after ``106 percent'' the following: ``(or, for a single 
     source drug or biological (other than autologous cellular 
     immunotherapy) furnished on or after January 1, 2023, the 
     applicable percent specified in paragraph (9)(A) for the drug 
     or biological and quarter involved)''; and
  

       (2) by adding at the end the following new paragraph:
       ``(9) Application of variable percentages based on 
     percentile ranking of per beneficiary allowed charges.--
       ``(A) Applicable percent to be applied.--
       ``(i) In general.--Subject to clause (ii), with respect to 
     a drug or biological furnished in a calendar quarter 
     beginning on or after January 1, 2023, if the Secretary 
     determines that the percentile rank of a drug or biological 
     under subparagraph (B)(i)(III), with respect to per 
     beneficiary allowed charges for all such drugs or 
     biologicals, is--

       ``(I) at least equal to the 85th percentile, the applicable 
     percent for the drug for such quarter under this subparagraph 
     is 104 percent;
       ``(II) at least equal to the 70th percentile, but less than 
     the 85th percentile, such applicable percent is 106 percent;
       ``(III) at least equal to the 50th percentile, but less 
     than the 70th percentile, such applicable percent is 108 
     percent; or
       ``(IV) less than the 50th percentile, such applicable 
     percent is 110 percent.

       ``(ii) Cases where data not sufficiently available to 
     compute per beneficiary allowed charges.--Subject to clause 
     (iii), in the case of a drug or biological furnished for 
     which the amount of payment is determined under subparagraph 
     (A) or (B) of paragraph (1) and not under subsection (c)(4), 
     for calendar quarters during a period in which data are not 
     sufficiently available to compute a per beneficiary allowed 
     charges for the drug or biological, the applicable percent is 
     106 percent.
       ``(B) Determination of percentile rank of per beneficiary 
     allowed charges of drugs.--
       ``(i) In general.--With respect to a calendar quarter 
     beginning on or after January 1, 2023, for drugs and 
     biologicals for which the amount of payment is determined 
     under subparagraph (A) or (B) of paragraph (1), except for 
     drugs or biologicals for which data are not sufficiently 
     available, the Secretary shall--

       ``(I) compute the per beneficiary allowed charges (as 
     defined in subparagraph (C)) for each such drug or 
     biological;
       ``(II) adjust such per beneficiary allowed charges for the 
     quarter, to the extent provided under subparagraph (D); and
       ``(III) arrange such adjusted per beneficiary allowed 
     charges for all such drugs or biologicals from high to low 
     and rank such drugs or biologicals by percentile of such per 
     beneficiary allowed charges.

       ``(ii) Frequency.--The Secretary shall make the 
     computations under clause (i)(I) every 6 months (or, if 
     necessary, as determined by the Secretary, every 9 or 12 
     months) and such computations shall apply

[[Page S4351]]

     to succeeding calendar quarters until a new computation has 
     been made.
       ``(iii) Applicable data period.--For purposes of this 
     paragraph, the term `applicable data period' means the most 
     recent period for which the data necessary for making the 
     computations under clause (i) are available, as determined by 
     the Secretary.
       ``(C) Per beneficiary allowed charges defined.--In this 
     paragraph, the term `per beneficiary allowed charges' means, 
     with respect to a drug or biological for which the amount of 
     payment is determined under subparagraph (A) or (B) of 
     paragraph (1)--
       ``(i) the allowed charges for the drug or biological for 
     which payment is so made for the applicable data period, as 
     estimated by the Secretary; divided by
       ``(ii) the number of individuals for whom any payment for 
     the drug or biological was made under paragraph (1) for the 
     applicable data period, as estimated by the Secretary.
       ``(D) Adjustment to reflect changes in average sales 
     price.--In applying this paragraph for a particular calendar 
     quarter, the Secretary shall adjust the per beneficiary 
     allowed charges for a drug or biological by multiplying such 
     per beneficiary allowed charges under subparagraph (C) for 
     the applicable data period by the ratio of--
       ``(i) the average sales price for the drug or biological 
     for the most recent calendar quarter used under subsection 
     (c)(5)(B); to
       ``(ii) the average sales price for the drug or biological 
     for the calendar quarter (or the weighted average for the 
     quarters involved) included in the applicable data period.''.
       (b) Application of Judicial Review Provisions.--Section 
     1847A(i) of the Social Security Act (42 U.S.C. 1395w-3a(i)) 
     is amended--
       (1) by striking ``and'' at the end of paragraph (4);
       (2) by striking the period at the end of paragraph (5) and 
     inserting ``; and''; and
       (3) by adding at the end the following new paragraph:
       ``(6) the determination of per beneficiary allowed charges 
     of drugs or biologicals and ranking of such charges under 
     subsection (b)(9).''.

     SEC. 11003. ESTABLISHMENT OF MAXIMUM ADD-ON PAYMENT FOR DRUGS 
                   AND BIOLOGICALS.

       (a) In General.--Section 1847A of the Social Security Act 
     (42 U.S.C. 1395w-3a), as amended by section 11002, is 
     amended--
       (1) in subsection (b)--
       (A) in paragraph (1), in the matter preceding subparagraph 
     (A), by striking ``paragraph (7)'' and inserting ``paragraphs 
     (7) and (10)''; and
       (B) by adding at the end the following new paragraph:
       ``(10) Maximum add-on payment amount.--
       ``(A) In general.--In determining the payment amount under 
     the provisions of subparagraph (A), (B), or (C) of paragraph 
     (1) of this subsection, subsection (c)(4)(A)(ii), or 
     subsection (d)(3)(C) for a drug or biological furnished on or 
     after January 1, 2023, if the applicable add-on payment (as 
     defined in subparagraph (B)) for each drug or biological on a 
     claim for a date of service exceeds the maximum add-on 
     payment amount specified under subparagraph (C) for the drug 
     or biological, then the payment amount otherwise determined 
     for the drug or biological under those provisions, as 
     applicable, shall be reduced by the amount of such excess.
       ``(B) Applicable add-on payment defined.--In this 
     paragraph, the term `applicable add-on payment' means the 
     following amounts, determined without regard to the 
     application of subparagraph (A):
       ``(i) In the case of a multiple source drug, an amount 
     equal to the difference between--

       ``(I) the amount that would otherwise be applied under 
     paragraph (1)(A); and
       ``(II) the amount that would be applied under such 
     paragraph if `100 percent' were substituted for the 
     applicable percent (as defined in paragraph (9)) for such 
     drug.

       ``(ii) In the case of a single source drug or biological, 
     an amount equal to the difference between--

       ``(I) the amount that would otherwise be applied under 
     paragraph (1)(B); and
       ``(II) the amount that would be applied under such 
     paragraph if `100 percent' were substituted for the 
     applicable percent (as defined in paragraph (9)) for such 
     drug or biological.

       ``(iii) In the case of a biosimilar biological product, the 
     amount otherwise determined under paragraph (8)(B).
       ``(iv) In the case of a drug or biological during the 
     initial period described in subsection (c)(4)(A), an amount 
     equal to the difference between--

       ``(I) the amount that would otherwise be applied under 
     subsection (c)(4)(A)(ii); and
       ``(II) the amount that would be applied under such 
     subsection if `100 percent' were substituted, as applicable, 
     for--

       ``(aa) `103 percent' in subclause (I) of such subsection; 
     or
       ``(bb) any percent in excess of 100 percent applied under 
     subclause (II) of such subsection.
       ``(v) In the case of a drug or biological to which 
     subsection (d)(3)(C) applies, an amount equal to the 
     difference between--

       ``(I) the amount that would otherwise be applied under such 
     subsection; and
       ``(II) the amount that would be applied under such 
     subsection if `100 percent' were substituted, as applicable, 
     for--

       ``(aa) any percent in excess of 100 percent applied under 
     clause (i) of such subsection; or
       ``(bb) `103 percent' in clause (ii) of such subsection.
       ``(C) Maximum add-on payment amount specified.--For 
     purposes of subparagraph (A), the maximum add-on payment 
     amount specified in this subparagraph is--
       ``(i) with respect to a drug or biological (other than 
     autologous or allogeneric cellular immunotherapy)--

       ``(I) for each of 2023 through 2030, $1,000; and
       ``(II) for a subsequent year, the amount specified in this 
     subparagraph for the preceding year increased by the 
     percentage increase in the consumer price index for all urban 
     consumers (all items; United States city average) for the 12-
     month period ending with June of the previous year; or

       ``(ii) with respect to a drug or biological consisting of 
     autologous or allogeneric cellular immunotherapy--

       ``(I) for each of 2023 through 2030, $2,000; and
       ``(II) for a subsequent year, the amount specified in this 
     subparagraph for the preceding year increased by the 
     percentage increase in the consumer price index for all urban 
     consumers (all items; United States city average) for the 12-
     month period ending with June of the previous year.

     Any amount determined under this subparagraph that is not a 
     multiple of $10 shall be rounded to the nearest multiple of 
     $10.''; and
       (2) in subsection (c)(4)(A)(ii), by striking ``in the 
     case'' and inserting ``subject to subsection (b)(10), in the 
     case''.
       (b) Conforming Amendments Relating to Separately Payable 
     Drugs.--
       (1) OPPS.--Section 1833(t)(14) of the Social Security Act 
     (42 U.S.C. 1395l(t)(14)) is amended--
       (A) in subparagraph (A)(iii)(II), by inserting ``, subject 
     to subparagraph (I)'' after ``are not available''; and
       (B) by adding at the end the following new subparagraph:
       ``(I) Application of maximum add-on payment for separately 
     payable drugs and biologicals.--In establishing the amount of 
     payment under subparagraph (A) for a specified covered 
     outpatient drug that is furnished as part of a covered OPD 
     service (or group of services) on or after January 1, 2023, 
     if such payment is determined based on the average price for 
     the year established under section 1847A pursuant to clause 
     (iii)(II) of such subparagraph, the provisions of subsection 
     (b)(10) of section 1847A shall apply to the amount of payment 
     so established in the same manner as such provisions apply to 
     the amount of payment under section 1847A.''.
       (2) ASC.--Section 1833(i)(2)(D) of the Social Security Act 
     (42 U.S.C. 1395l(i)(2)(D)) is amended--
       (A) by moving clause (v) 6 ems to the left;
       (B) by redesignating clause (vi) as clause (vii); and
       (C) by inserting after clause (v) the following new clause:
       ``(vi) If there is a separate payment under the system 
     described in clause (i) for a drug or biological furnished on 
     or after January 1, 2023, the provisions of subsection 
     (t)(14)(I) shall apply to the establishment of the amount of 
     payment for the drug or biological under such system in the 
     same manner in which such provisions apply to the 
     establishment of the amount of payment under subsection 
     (t)(14)(A).''.

     SEC. 11004. TREATMENT OF DRUG ADMINISTRATION SERVICES 
                   FURNISHED BY CERTAIN EXCEPTED OFF-CAMPUS 
                   OUTPATIENT DEPARTMENTS OF A PROVIDER.

       Section 1833(t)(16) of the Social Security Act (42 U.S.C. 
     1395l(t)(16)) is amended by adding at the end the following 
     new subparagraph:
       ``(G) Special payment rule for drug administration services 
     furnished by an excepted department of a provider.--
       ``(i) In general.--In the case of a covered OPD service 
     that is a drug administration service (as defined by the 
     Secretary) furnished by a department of a provider described 
     in clause (ii) or (iv) of paragraph (21)(B), the payment 
     amount for such service furnished on or after January 1, 
     2023, shall be the same payment amount (as determined in 
     paragraph (21)(C)) that would apply if the drug 
     administration service was furnished by an off-campus 
     outpatient department of a provider (as defined in paragraph 
     (21)(B)).
       ``(ii) Application without regard to budget neutrality.--
     The reductions made under this subparagraph--

       ``(I) shall not be considered an adjustment under paragraph 
     (2)(E); and
       ``(II) shall not be implemented in a budget neutral 
     manner.''.

     SEC. 11005. CREDIT UNDER THE MEDICARE MERIT-BASED INCENTIVE 
                   PAYMENT SYSTEM FOR COMPLETION OF A CLINICAL 
                   MEDICAL EDUCATION PROGRAM ON BIOSIMILAR 
                   BIOLOGICAL PRODUCTS.

       Section 1848(q)(5)(C) of the Social Security Act (42 U.S.C. 
     1395w-4(q)(5)(C)) is amended by adding at the end the 
     following new clause:
       ``(iv) Clinical medical education program on biosimilar 
     biological products.--Completion of a clinical medical 
     education program developed or improved under section 352A(b) 
     of the Public Health Service Act by a MIPS eligible 
     professional during a performance period shall earn such 
     eligible professional one-half of the highest potential score 
     for the performance category described in paragraph 
     (2)(A)(iii) for such performance period. A MIPS eligible 
     professional may only count the completion of such a program 
     for purposes of such category one time during the eligible 
     professional's lifetime.''.

[[Page S4352]]

  


     SEC. 11006. GAO STUDY AND REPORT ON AVERAGE SALES PRICE.

       (a) Study.--
       (1) In general.--The Comptroller General of the United 
     States (in this section referred to as the ``Comptroller 
     General'') shall conduct a study on spending for applicable 
     drugs under part B of title XVIII of the Social Security Act.
       (2) Applicable drugs defined.--In this section, the term 
     ``applicable drugs'' means drugs and biologicals--
       (A) for which reimbursement under such part B is based on 
     the average sales price of the drug or biological; and
       (B) that account for the largest percentage of total 
     spending on drugs and biologicals under such part B (as 
     determined by the Comptroller General, but in no case less 
     than 25 drugs or biologicals).
       (3) Requirements.--The study under paragraph (1) shall 
     include an analysis of the following:
       (A) The extent to which each applicable drug is paid for--
       (i) under such part B for Medicare beneficiaries; or
       (ii) by private payers in the commercial market.
       (B) Any change in Medicare spending or Medicare beneficiary 
     cost-sharing that would occur if the average sales price of 
     an applicable drug was based solely on payments by private 
     payers in the commercial market.
       (C) The extent to which drug manufacturers provide rebates, 
     discounts, or other price concessions to private payers in 
     the commercial market for applicable drugs, which the 
     manufacturer includes in its average sales price calculation, 
     for--
       (i) formulary placement;
       (ii) utilization management considerations; or
       (iii) other purposes.
       (D) Barriers to drug manufacturers providing such price 
     concessions for applicable drugs.
       (E) Other areas determined appropriate by the Comptroller 
     General.
       (b) Report.--Not later than 2 years after the date of the 
     enactment of this Act, the Comptroller General shall submit 
     to Congress a report on the study conducted under subsection 
     (a), together with recommendations for such legislation and 
     administrative action as the Secretary determines 
     appropriate.

                 Subpart B--Medicare Part D Provisions

     SEC. 11011. MEDICARE PART D BENEFIT REDESIGN.

       (a) Benefit Structure Redesign.--Section 1860D-2(b) of the 
     Social Security Act (42 U.S.C. 1395w-102(b)) is amended--
       (1) in paragraph (2)--
       (A) in subparagraph (A)--
       (i) in the matter preceding clause (i), by inserting ``for 
     a year preceding 2023 and for costs above the annual 
     deductible specified in paragraph (1) and up to the annual 
     out-of-pocket threshold specified in paragraph (4)(B) for 
     2023 and each subsequent year'' after ``paragraph (3)'';
       (ii) in clause (i), by inserting after ``25 percent'' the 
     following: ``(or, for 2023 and each subsequent year, 15 
     percent)''; and
       (iii) in clause (ii), by inserting ``(or, for 2023 and each 
     subsequent year, 15 percent)'' after ``25 percent'';
       (B) in subparagraph (C)--
       (i) in clause (i), in the matter preceding subclause (I), 
     by inserting ``for a year preceding 2023,'' after ``paragraph 
     (4),''; and
       (ii) in clause (ii)(III), by striking ``and each subsequent 
     year'' and inserting ``2021, and 2022''; and
       (C) in subparagraph (D)--
       (i) in clause (i)--

       (I) in the matter preceding subclause (I), by inserting 
     ``for a year preceding 2023,'' after ``paragraph (4),''; and
       (II) in subclause (I)(bb), by striking ``a year after 
     2018'' and inserting ``each of years 2018 through 2022''; and

       (ii) in clause (ii)(V), by striking ``2019 and each 
     subsequent year'' and inserting ``each of years 2019 through 
     2022'';
       (2) in paragraph (3)(A)--
       (A) in the matter preceding clause (i), by inserting ``for 
     a year preceding 2023,'' after ``and (4),''; and
       (B) in clause (ii), by striking ``for a subsequent year'' 
     and inserting ``for each of years 2007 through 2022''; and
       (3) in paragraph (4)--
       (A) in subparagraph (A)--
       (i) in clause (i)--

       (I) by redesignating subclauses (I) and (II) as items (aa) 
     and (bb), respectively, and indenting appropriately;
       (II) in the matter preceding item (aa), as redesignated by 
     subclause (I), by striking ``is equal to the greater of--'' 
     and inserting ``is equal to--
       ``(I) for a year preceding 2023, the greater of--'';
       (III) by striking the period at the end of item (bb), as 
     redesignated by subclause (I), and inserting ``; and''; and
       (IV) by adding at the end the following:
       ``(II) for 2023 and each succeeding year, $0.''; and

       (ii) in clause (ii)--

       (I) by striking ``clause (i)(I)'' and inserting ``clause 
     (i)(I)(aa)''; and
       (II) by adding at the end the following new sentence: ``The 
     Secretary shall continue to calculate the dollar amounts 
     specified in clause (i)(I)(aa), including with the adjustment 
     under this clause, after 2022 for purposes of section 1860D-
     14(a)(1)(D)(iii).'';

       (B) in subparagraph (B)--
       (i) in clause (i)--

       (I) in subclause (V), by striking ``or'' at the end;
       (II) in subclause (VI)--

       (aa) by striking ``for a subsequent year'' and inserting 
     ``for 2021 and 2022''; and
       (bb) by striking the period at the end and inserting a 
     semicolon; and

       (III) by adding at the end the following new subclauses:
       ``(VII) for 2023, is equal to $3,100; or
       ``(VIII) for a subsequent year, is equal to the amount 
     specified in this subparagraph for the previous year, 
     increased by the annual percentage increase described in 
     paragraph (6) for the year involved.''; and

       (ii) in clause (ii), by striking ``clause (i)(II)'' and 
     inserting ``clause (i)'';
       (C) in subparagraph (C)(i), by striking ``and for amounts'' 
     and inserting ``and for a year preceding 2023 for amounts''; 
     and
       (D) in subparagraph (E), by striking ``In applying'' and 
     inserting ``For each of 2011 through 2022, in applying''.
       (b) Decreasing Reinsurance Payment Amount.--Section 1860D-
     15(b)(1) of the Social Security Act (42 U.S.C. 1395w-
     115(b)(1)) is amended--
       (1) by striking ``equal to 80 percent'' and inserting 
     ``equal to--
       ``(A) for a year preceding 2023, 80 percent'';
       (2) in subparagraph (A), as added by paragraph (1), by 
     striking the period at the end and inserting ``; and''; and
       (3) by adding at the end the following new subparagraph:
       ``(B) for 2023 and each subsequent year, the sum of--
       ``(i) an amount equal to 20 percent of the allowable 
     reinsurance costs (as specified in paragraph (2)) 
     attributable to that portion of gross covered prescription 
     drug costs as specified in paragraph (3) incurred in the 
     coverage year after such individual has incurred costs that 
     exceed the annual out-of-pocket threshold specified in 
     section 1860D-2(b)(4)(B) with respect to applicable drugs (as 
     defined in section 1860D-14B(g)(2)); and
       ``(ii) an amount equal to 30 percent of the allowable 
     reinsurance costs (as specified in paragraph (2)) 
     attributable to that portion of gross covered prescription 
     drug costs as specified in paragraph (3) incurred in the 
     coverage year after such individual has incurred costs that 
     exceed the annual out-of-pocket threshold specified in 
     section 1860D-2(b)(4)(B) with respect to covered part D drugs 
     that are not applicable drugs (as so defined).''.
       (c) Manufacturer Discount Program.--
       (1) In general.--Part D of title XVIII of the Social 
     Security Act is amended by inserting after section 1860D-14A 
     (42 U.S.C. 1495w-114) the following new section:

     ``SEC. 1860D-14B. MANUFACTURER DISCOUNT PROGRAM.

       ``(a) Establishment.--The Secretary shall establish a 
     manufacturer discount program (in this section referred to as 
     the `program'). Under the program, the Secretary shall enter 
     into agreements described in subsection (b) with 
     manufacturers and provide for the performance of the duties 
     described in subsection (c). The Secretary shall establish a 
     model agreement for use under the program by not later than 
     January 1, 2024, in consultation with manufacturers, and 
     allow for comment on such model agreement.
       ``(b) Terms of Agreement.--
       ``(1) In general.--
       ``(A) Agreement.--An agreement under this section shall 
     require the manufacturer to provide applicable beneficiaries 
     access to discounted prices for applicable drugs of the 
     manufacturer that are dispensed on or after January 1, 2023.
  

       ``(B) Provision of discounted prices at the point-of-
     sale.--The discounted prices described in subparagraph (A) 
     shall be provided to the applicable beneficiary at the 
     pharmacy or by the mail order service at the point-of-sale of 
     an applicable drug.
       ``(2) Provision of appropriate data.--Each manufacturer 
     with an agreement in effect under this section shall collect 
     and have available appropriate data, as determined by the 
     Secretary, to ensure that it can demonstrate to the Secretary 
     compliance with the requirements under the program.
       ``(3) Compliance with requirements for administration of 
     program.--Each manufacturer with an agreement in effect under 
     this section shall comply with requirements imposed by the 
     Secretary or a third party with a contract under subsection 
     (d)(3), as applicable, for purposes of administering the 
     program, including any determination under subparagraph (A) 
     of subsection (c)(1) or procedures established under such 
     subsection (c)(1).
       ``(4) Length of agreement.--
       ``(A) In general.--An agreement under this section shall be 
     effective for an initial period of not less than 12 months 
     and shall be automatically renewed for a period of not less 
     than 1 year unless terminated under subparagraph (B).
       ``(B) Termination.--
       ``(i) By the secretary.--The Secretary may provide for 
     termination of an agreement under this section for a knowing 
     and willful violation of the requirements of the agreement or 
     other good cause shown. Such termination shall not be 
     effective earlier than 30 days after the date of notice to 
     the manufacturer of such termination. The Secretary shall 
     provide, upon request, a manufacturer with a hearing 
     concerning such a termination, and such hearing shall take 
     place prior to the effective date of the termination with 
     sufficient time for such effective date

[[Page S4353]]

     to be repealed if the Secretary determines appropriate.
       ``(ii) By a manufacturer.--A manufacturer may terminate an 
     agreement under this section for any reason. Any such 
     termination shall be effective, with respect to a plan year--

       ``(I) if the termination occurs before January 30 of a plan 
     year, as of the day after the end of the plan year; and
       ``(II) if the termination occurs on or after January 30 of 
     a plan year, as of the day after the end of the succeeding 
     plan year.

       ``(iii) Effectiveness of termination.--Any termination 
     under this subparagraph shall not affect discounts for 
     applicable drugs of the manufacturer that are due under the 
     agreement before the effective date of its termination.
       ``(iv) Notice to third party.--The Secretary shall provide 
     notice of such termination to a third party with a contract 
     under subsection (d)(3) within not less than 30 days before 
     the effective date of such termination.
       ``(5) Effective date of agreement.--An agreement under this 
     section shall take effect on a date determined appropriate by 
     the Secretary, which may be at the start of a calendar 
     quarter.
       ``(c) Duties Described.--The duties described in this 
     subsection are the following:
       ``(1) Administration of program.--Administering the 
     program, including--
       ``(A) the determination of the amount of the discounted 
     price of an applicable drug of a manufacturer;
       ``(B) the establishment of procedures under which 
     discounted prices are provided to applicable beneficiaries at 
     pharmacies or by mail order service at the point-of-sale of 
     an applicable drug;
       ``(C) the establishment of procedures to ensure that, not 
     later than the applicable number of calendar days after the 
     dispensing of an applicable drug by a pharmacy or mail order 
     service, the pharmacy or mail order service is reimbursed for 
     an amount equal to the difference between--
       ``(i) the negotiated price of the applicable drug; and
       ``(ii) the discounted price of the applicable drug;
       ``(D) the establishment of procedures to ensure that the 
     discounted price for an applicable drug under this section is 
     applied before any coverage or financial assistance under 
     other health benefit plans or programs that provide coverage 
     or financial assistance for the purchase or provision of 
     prescription drug coverage on behalf of applicable 
     beneficiaries as the Secretary may specify; and
       ``(E) providing a reasonable dispute resolution mechanism 
     to resolve disagreements between manufacturers, applicable 
     beneficiaries, and the third party with a contract under 
     subsection (d)(3).
       ``(2) Monitoring compliance.--
       ``(A) In general.--The Secretary shall monitor compliance 
     by a manufacturer with the terms of an agreement under this 
     section.
       ``(B) Notification.--If a third party with a contract under 
     subsection (d)(3) determines that the manufacturer is not in 
     compliance with such agreement, the third party shall notify 
     the Secretary of such noncompliance for appropriate 
     enforcement under subsection (e).
       ``(3) Collection of data from prescription drug plans and 
     ma-pd plans.--The Secretary may collect appropriate data from 
     prescription drug plans and MA-PD plans in a timeframe that 
     allows for discounted prices to be provided for applicable 
     drugs under this section.
       ``(d) Administration.--
       ``(1) In general.--Subject to paragraph (2), the Secretary 
     shall provide for the implementation of this section, 
     including the performance of the duties described in 
     subsection (c).
       ``(2) Limitation.--In providing for the implementation of 
     this section, the Secretary shall not receive or distribute 
     any funds of a manufacturer under the program.
       ``(3) Contract with third parties.--The Secretary shall 
     enter into a contract with one or more third parties to 
     administer the requirements established by the Secretary in 
     order to carry out this section. At a minimum, the contract 
     with a third party under the preceding sentence shall require 
     that the third party--
       ``(A) receive and transmit information between the 
     Secretary, manufacturers, and other individuals or entities 
     the Secretary determines appropriate;
       ``(B) receive, distribute, or facilitate the distribution 
     of funds of manufacturers to appropriate individuals or 
     entities in order to meet the obligations of manufacturers 
     under agreements under this section;
       ``(C) provide adequate and timely information to 
     manufacturers, consistent with the agreement with the 
     manufacturer under this section, as necessary for the 
     manufacturer to fulfill its obligations under this section; 
     and
       ``(D) permit manufacturers to conduct periodic audits, 
     directly or through contracts, of the data and information 
     used by the third party to determine discounts for applicable 
     drugs of the manufacturer under the program.
       ``(4) Performance requirements.--The Secretary shall 
     establish performance requirements for a third party with a 
     contract under paragraph (3) and safeguards to protect the 
     independence and integrity of the activities carried out by 
     the third party under the program under this section.
       ``(5) Administration.--Chapter 35 of title 44, United 
     States Code, shall not apply to the program under this 
     section.
       ``(e) Enforcement.--
       ``(1) Audits.--Each manufacturer with an agreement in 
     effect under this section shall be subject to periodic audit 
     by the Secretary.
       ``(2) Civil money penalty.--
       ``(A) In general.--The Secretary shall impose a civil money 
     penalty on a manufacturer that fails to provide applicable 
     beneficiaries discounts for applicable drugs of the 
     manufacturer in accordance with such agreement for each such 
     failure in an amount the Secretary determines is commensurate 
     with the sum of--
       ``(i) the amount that the manufacturer would have paid with 
     respect to such discounts under the agreement, which will 
     then be used to pay the discounts which the manufacturer had 
     failed to provide; and
       ``(ii) 25 percent of such amount.
       ``(B) Application.--The provisions of section 1128A (other 
     than subsections (a) and (b)) shall apply to a civil money 
     penalty under this paragraph in the same manner as such 
     provisions apply to a penalty or proceeding under section 
     1128A(a).
       ``(f) Clarification Regarding Availability of Other Covered 
     Part D Drugs.--Nothing in this section shall prevent an 
     applicable beneficiary from purchasing a covered part D drug 
     that is not on the formulary of the prescription drug plan or 
     MA-PD plan that the applicable beneficiary is enrolled in.
       ``(g) Definitions.--In this section:
       ``(1) Applicable beneficiary.--The term `applicable 
     beneficiary' means an individual who, on the date of 
     dispensing a covered part D drug--
       ``(A) is enrolled in a prescription drug plan or an MA-PD 
     plan;
       ``(B) is not enrolled in a qualified retiree prescription 
     drug plan; and
       ``(C) has incurred costs for covered part D drugs in the 
     year that are equal to or exceed the annual deductible 
     specified in section 1860D-2(b)(1) for such year.
       ``(2) Applicable drug.--The term `applicable drug' means, 
     with respect to an applicable beneficiary, a covered part D 
     drug--
       ``(A) approved under a new drug application under section 
     505(c) of the Federal Food, Drug, and Cosmetic Act or, in the 
     case of a biologic product, licensed under section 351 of the 
     Public Health Service Act (including a product licensed under 
     subsection (k) of such section); and
       ``(B)(i) if the PDP sponsor of the prescription drug plan 
     or the MA organization offering the MA-PD plan uses a 
     formulary, which is on the formulary of the prescription drug 
     plan or MA-PD plan that the applicable beneficiary is 
     enrolled in;
       ``(ii) if the PDP sponsor of the prescription drug plan or 
     the MA organization offering the MA-PD plan does not use a 
     formulary, for which benefits are available under the 
     prescription drug plan or MA-PD plan that the applicable 
     beneficiary is enrolled in; or
       ``(iii) is provided through an exception or appeal.
       ``(3) Applicable number of calendar days.--The term 
     `applicable number of calendar days' means--
       ``(A) with respect to claims for reimbursement submitted 
     electronically, 14 days; and
       ``(B) with respect to claims for reimbursement submitted 
     otherwise, 30 days.
       ``(4) Discounted price.--
       ``(A) In general.--The term `discounted price' means, with 
     respect to an applicable drug of a manufacturer furnished 
     during a year to an applicable beneficiary, 90 percent of the 
     negotiated price of such drug.
       ``(B) Clarification.--Nothing in this section shall be 
     construed as affecting the responsibility of an applicable 
     beneficiary for payment of a dispensing fee for an applicable 
     drug.
       ``(C) Special case for claims spanning deductible.--In the 
     case where the entire amount of the negotiated price of an 
     individual claim for an applicable drug with respect to an 
     applicable beneficiary does not fall at or above the annual 
     deductible specified in section 1860D-2(b)(1) for the year, 
     the manufacturer of the applicable drug shall provide the 
     discounted price under this section on only the portion of 
     the negotiated price of the applicable drug that falls at or 
     above such annual deductible.
       ``(5) Manufacturer.--The term `manufacturer' means any 
     entity which is engaged in the production, preparation, 
     propagation, compounding, conversion, or processing of 
     prescription drug products, either directly or indirectly by 
     extraction from substances of natural origin, or 
     independently by means of chemical synthesis, or by a 
     combination of extraction and chemical synthesis. Such term 
     does not include a wholesale distributor of drugs or a retail 
     pharmacy licensed under State law.
       ``(6) Negotiated price.--The term `negotiated price' has 
     the meaning given such term in section 1860D-2(d)(1)(B), 
     except that such negotiated price shall not include any 
     dispensing fee for an applicable drug.
       ``(7) Qualified retiree prescription drug plan.--The term 
     `qualified retiree prescription drug plan' has the meaning 
     given such term in section 11860D-22(a)(2).''.
       (2) Sunset of medicare coverage gap discount program.--
     Section 1860D-14A of the Social Security Act (42 U.S.C. 1395-
     114a) is amended--
       (A) in subsection (a), in the first sentence, by striking 
     ``The Secretary'' and inserting ``Subject to subsection (h), 
     the Secretary''; and
       (B) by adding at the end the following new subsection:
       ``(h) Sunset of Program.--

[[Page S4354]]

       ``(1) In general.--The program shall not apply to 
     applicable drugs dispensed on or after January 1, 2023, and, 
     subject to paragraph (2), agreements under this section shall 
     be terminated as of such date.
       ``(2) Continued application for applicable drugs dispensed 
     prior to sunset.--The provisions of this section (including 
     all responsibilities and duties) shall continue to apply 
     after January 1, 2023, with respect to applicable drugs 
     dispensed prior to such date.''.
       (3) Inclusion of actuarial value of manufacturer discounts 
     in bids.--Section 1860D-11 of the Social Security Act (42 
     U.S.C. 1395w-111) is amended--
       (A) in subsection (b)(2)(C)(iii)--
       (i) by striking ``assumptions regarding the reinsurance'' 
     and inserting ``assumptions regarding--

       ``(I) the reinsurance''; and

       (ii) by adding at the end the following:

       ``(II) for 2023 and each subsequent year, the manufacturer 
     discounts provided under section 1860D- 14B subtracted from 
     the actuarial value to produce such bid; and''; and

       (B) in subsection (c)(1)(C)--
       (i) by striking ``an actuarial valuation of the 
     reinsurance'' and inserting ``an actuarial valuation of--
       ``(i) the reinsurance'';
       (ii) in clause (i), as added by clause (i) of this 
     subparagraph, by adding ``and'' at the end; and
       (iii) by adding at the end the following:
       ``(ii) for 2023 and each subsequent year, the manufacturer 
     discounts provided under section 1860D-14B;''.
       (4) Clarification regarding exclusion of manufacturer 
     discounts from troop.--Section 1860D-2(b)(4) of the Social 
     Security Act (42 U.S.C. 1395w-102(b)(4)) is amended--
       (A) in subparagraph (C), by inserting ``and subject to 
     subparagraph (F)'' after ``subparagraph (E)''; and
       (B) by adding at the end the following new subparagraph:
       ``(F) Clarification regarding exclusion of manufacturer 
     discounts.--In applying subparagraph (A), incurred costs 
     shall not include any manufacturer discounts provided under 
     section 1860D-14B.''.
       (d) Determination of Allowable Reinsurance Costs.--Section 
     1860D-15(b) of the Social Security Act (42 U.S.C. 1395w-
     115(b)) is amended--
       (1) in paragraph (2)--
       (A) by striking ``Costs.--For purposes'' and inserting 
     ``Costs.--
       ``(A) In general.--Subject to subparagraph (B), for 
     purposes''; and
       (B) by adding at the end the following new subparagraph:
       ``(B) Inclusion of manufacturer discounts on applicable 
     drugs.--For purposes of applying subparagraph (A), the term 
     `allowable reinsurance costs' shall include the portion of 
     the negotiated price (as defined in section 1860D-14B(g)(6)) 
     of an applicable drug (as defined in section 1860D-14(g)(2)) 
     that was paid by a manufacturer under the manufacturer 
     discount program under section 1860D-14B.''; and
       (2) in paragraph (3)--
       (A) in the first sentence, by striking ``For purposes'' and 
     inserting ``Subject to paragraph (2)(B), for purposes''; and
       (B) in the second sentence, by inserting ``or, in the case 
     of an applicable drug, by a manufacturer'' after ``by the 
     individual or under the plan''.
       (e) Updating Risk Adjustment Methodologies To Account for 
     Part D Modernization Redesign.--Section 1860D-15(c) of the 
     Social Security Act (42 U.S.C. 1395w-115(c)) is amended by 
     adding at the end the following new paragraph:
       ``(3) Updating risk adjustment methodologies to account for 
     part d modernization redesign.--The Secretary shall update 
     the risk adjustment model used to adjust bid amounts pursuant 
     to this subsection as appropriate to take into account 
     changes in benefits under this part pursuant to the 
     amendments made by section 121 of the Lower Costs, More Cures 
     Act of 2019.''.
       (f) Conditions for Coverage of Drugs Under This Part.--
     Section 1860D-43 of the Social Security Act (42 U.S.C. 1395w-
     153) is amended--
       (1) in subsection (a)--
       (A) in paragraph (2), by striking ``and'' at the end;
       (B) in paragraph (3), by striking the period at the end and 
     inserting a semicolon; and
       (C) by adding at the end the following new paragraphs:
       ``(4) participate in the manufacturer discount program 
     under section 1860D-14B;
       ``(5) have entered into and have in effect an agreement 
     described in subsection (b) of such section 1860D-14B with 
     the Secretary; and
       ``(6) have entered into and have in effect, under terms and 
     conditions specified by the Secretary, a contract with a 
     third party that the Secretary has entered into a contract 
     with under subsection (d)(3) of such section 1860D-14B.'';
       (2) by striking subsection (b) and inserting the following:
       ``(b) Effective Date.--Paragraphs (1) through (3) of 
     subsection (a) shall apply to covered part D drugs dispensed 
     under this part on or after January 1, 2011, and before 
     January 1, 2023, and paragraphs (4) through (6) of such 
     subsection shall apply to covered part D drugs dispensed on 
     or after January 1, 2023.''; and
       (3) in subsection (c), by striking paragraph (2) and 
     inserting the following:
       ``(2) the Secretary determines that in the period beginning 
     on January 1, 2011, and ending on December 31, 2011 (with 
     respect to paragraphs (1) through (3) of subsection (a)), or 
     the period beginning on January 1, 2023, and ending December 
     31, 2023 (with respect to paragraphs (4) through (6) of such 
     subsection), there were extenuating circumstances.''.
       (g) Conforming Amendments.--
       (1) Section 1860D-2 of the Social Security Act (42 U.S.C. 
     1395w-102) is amended--
       (A) in subsection (a)(2)(A)(i)(I), by striking ``, or an 
     increase in the initial'' and inserting ``or for a year 
     preceding 2023 an increase in the initial'';
       (B) in subsection (c)(1)(C)--
       (i) in the subparagraph heading, by striking ``at initial 
     coverage limit''; and
       (ii) by inserting ``for a year preceding 2023 or the annual 
     out-of-pocket threshold specified in subsection (b)(4)(B) for 
     the year for 2023 and each subsequent year'' after 
     ``subsection (b)(3) for the year'' each place it appears; and
       (C) in subsection (d)(1)(A), by striking ``or an initial'' 
     and inserting ``or for a year preceding 2023, an initial''.
       (2) Section 1860D-4(a)(4)(B)(i) of the Social Security Act 
     (42 U.S.C. 1395w-104(a)(4)(B)(i)) is amended by striking 
     ``the initial'' and inserting ``for a year preceding 2023, 
     the initial''.
       (3) Section 1860D-14(a) of the Social Security Act (42 
     U.S.C. 1395w-114(a)) is amended--
       (A) in paragraph (1)--
       (i) in subparagraph (C), by striking ``The continuation'' 
     and inserting ``For a year preceding 2023, the 
     continuation'';
       (ii) in subparagraph (D)(iii), by striking ``1860D-
     2(b)(4)(A)(i)(I)'' and inserting ``1860D-
     2(b)(4)(A)(i)(I)(aa)''; and
       (iii) in subparagraph (E), by striking ``The elimination'' 
     and inserting ``For a year preceding 2023, the elimination''; 
     and
       (B) in paragraph (2)--
       (i) in subparagraph (C), by striking ``The continuation'' 
     and inserting ``For a year preceding 2023, the 
     continuation''; and
       (ii) in subparagraph (E)--

       (I) by inserting ``for a year preceding 2023,'' after 
     ``subsection (c)''; and
       (II) by striking ``1860D- 2(b)(4)(A)(i)(I)'' and inserting 
     ``1860D-2(b)(4)(A)(i)(I)(aa)''.

       (4) Section 1860D-21(d)(7) of the Social Security Act (42 
     U.S.C. 1395w-131(d)(7)) is amended by striking ``section 
     1860D-2(b)(4)(B)(i)'' and inserting ``section 1860D-
     2(b)(4)(C)(i)''.
       (5) Section 1860D-22(a)(2)(A) of the Social Security Act 
     (42 U.S.C. 1395w-132(a)(2)(A)) is amended--
       (A) by striking ``the value of any discount'' and inserting 
     the following: ``the value of--
       ``(i) for years prior to 2023, any discount'';
       (B) in clause (i), as inserted by subparagraph (A) of this 
     paragraph, by striking the period at the end and inserting 
     ``; and''; and
       (C) by adding at the end the following new clause:
       ``(ii) for 2023 and each subsequent year, any discount 
     provided pursuant to section 1860D-14B.''.
       (6) Section 1860D-41(a)(6) of the Social Security Act (42 
     U.S.C. 1395w-151(a)(6)) is amended--
       (A) by inserting ``for a year before 2023'' after ``1860D-
     2(b)(3)''; and
       (B) by inserting ``for such year'' before the period.
       (h) Effective Date.--The amendments made by this section 
     shall apply to plan year 2023 and subsequent plan years.

     SEC. 11012. ALLOWING THE OFFERING OF ADDITIONAL PRESCRIPTION 
                   DRUG PLANS UNDER MEDICARE PART D.

       (a) Rescinding and Issuance of New Guidance.--Not later 
     than one year after the date of the enactment of this Act, 
     the Secretary of Health and Human Services (in this section 
     referred to as the ``Secretary'') shall--
       (1) rescind sections of any sub-regulatory guidance that 
     limit the number of prescription drug plans in each PDP 
     region that may be offered by a PDP sponsor under part D of 
     title XVIII of the Social Security Act (42 U.S.C. 1395w-101 
     et seq.); and
       (2) issue new guidance specifying that a PDP sponsor may 
     offer up to 4 (or a greater number if determined appropriate 
     by the Secretary) prescription drug plans in each PDP region, 
     except in cases where the PDP sponsor may offer up to 2 
     additional plans in a PDP region pursuant to section 1860D-
     11(d)(4) of the Social Security Act (42 U.S.C. 1395w-
     111(d)(4)), as added by subsection (b).
       (b) Offering of Additional Plans.--Section 1860D-11(d) of 
     the Social Security Act (42 U.S.C. 1395w-111(d)) is amended 
     by adding at the end the following new paragraph:
       ``(4) Offering of additional plans.--
       ``(A) In general.--For plan year 2023 and each subsequent 
     plan year, a PDP sponsor may offer up to 2 additional 
     prescription drug plans in a PDP region (in addition to any 
     limit established by the Secretary under this part) provided 
     that the PDP sponsor complies with subparagraph (B) with 
     respect to at least one such prescription drug plan.
       ``(B) Requirements.--In order to be eligible to offer up to 
     2 additional plans in a PDP region pursuant to subparagraph 
     (A), a PDP sponsor must ensure that, with respect to at least 
     one such prescription drug plan, the sponsor or any entity 
     that provides pharmacy benefits management services under a 
     contract with any such sponsor or plan does not receive 
     direct or indirect remuneration, as defined in section 
     423.308 of title 42, Code

[[Page S4355]]

     of Federal Regulations (or any successor regulation), unless 
     at least 25 percent of the aggregate reductions in price or 
     other remuneration received by the PDP sponsor or entity from 
     drug manufacturers with respect to the plan and plan year--
       ``(i) are reflected at the point-of-sale to the enrollee; 
     or
       ``(ii) are used to reduce total beneficiary cost-sharing 
     estimated by the PDP sponsor for prescription drug coverage 
     under the plan in the annual bid submitted by the PDP sponsor 
     under section 1860D-11(b).
       ``(C) Definition of reductions in price.--For purposes of 
     subparagraph (B), the term `reductions in price' refers only 
     to collectible amounts, as determined by the Secretary, which 
     excludes amounts which after adjudication and reconciliation 
     with pharmacies and manufacturers are duplicate in nature, 
     contrary to other contractual clauses, or otherwise 
     ineligible (such as due to beneficiary disenrollment or 
     coordination of benefits).''.
       (c) Rule of Construction.--Nothing in the provisions of, or 
     amendments made by, this section shall be construed as 
     limiting the ability of the Secretary to increase any limit 
     otherwise applicable on the number of prescription drug plans 
     that a PDP sponsor may offer, at the discretion of the PDP 
     sponsor, in a PDP region under part D of title XVIII of the 
     Social Security Act (42 U.S.C. 1395w-101 et seq.).

     SEC. 11013. ALLOWING CERTAIN ENROLLEES OF PRESCRIPTION DRUG 
                   PLANS AND MA-PD PLANS UNDER THE MEDICARE 
                   PROGRAM TO SPREAD OUT COST-SHARING UNDER 
                   CERTAIN CIRCUMSTANCES.

       (a) Standard Prescription Drug Coverage.--Section 1860D-
     2(b)(2) of the Social Security Act (42 U.S.C. 1395w-
     102(b)(2)), as amended by section 11011, is amended--
       (1) in subparagraph (A), by striking ``Subject to 
     subparagraphs (C) and (D)'' and inserting ``Subject to 
     subparagraphs (C), (D), and (E)''; and
       (2) by adding at the end the following new subparagraph:
       ``(E) Enrollee option regarding spreading cost-sharing.--
       ``(i) In general.--The Secretary shall establish by 
     regulation a process under which, with respect to plan year 
     2023 and subsequent plan years, a prescription drug plan or 
     an MA-PD plan shall, in the case of a part D eligible 
     individual enrolled with such plan for such plan year with 
     respect to whom the plan projects that the dispensing of a 
     covered part D drug to such individual will result in the 
     individual incurring costs within a 30-day period that are 
     equal to a significant percentage (as specified by the 
     Secretary pursuant to such regulation) of the annual out-of-
     pocket threshold specified in paragraph (4)(B) for such plan 
     year, provide such individual with the option to make the 
     coinsurance payment required under subparagraph (A) for such 
     costs in the form of equal monthly installments over the 
     remainder of such plan year.
       ``(ii) Significant percentage limitations.--In specifying a 
     significant percentage pursuant to the regulation established 
     by the Secretary under clause (i), the Secretary shall not 
     specify a percentage that is less than 30 percent or greater 
     than 100 percent.''.
       (b) Alternative Prescription Drug Coverage.--Section 1860D-
     2(c) of the Social Security Act (42 U.S.C. 1395w-102(c)) is 
     amended by adding at the end the following new paragraph:
       ``(4) Same enrollee option regarding spreading cost-
     sharing.--For plan year 2023 and subsequent plan years, the 
     coverage provides the enrollee option regarding spreading 
     cost-sharing described in and required under subsection 
     (b)(2)(E).''.

     SEC. 11014. CONTINUATION OF PART D SENIOR SAVINGS MODEL.

       Section 1115A of the Social Security Act (42 U.S.C. 1315a) 
     is amended by adding at the end the following new subsection:
       ``(h) Part D Senior Savings Model.--Notwithstanding any 
     other provision of law, the Secretary shall provide for the 
     continued implementation on a permanent basis of the Part D 
     Senior Savings Model under this section, under the same 
     parameters under which such model was implemented for plan 
     year 2021.''.

     SEC. 11015. REQUIRING PRESCRIPTION DRUG PLANS AND MA-PD PLANS 
                   TO REPORT POTENTIAL FRAUD, WASTE, AND ABUSE TO 
                   THE SECRETARY OF HHS.

       Section 1860D-4 of the Social Security Act (42 U.S.C. 
     1395w-104) is amended by adding at the end the following new 
     subsection:
       ``(p) Reporting Potential Fraud, Waste, and Abuse.--
     Beginning January 1, 2023, the PDP sponsor of a prescription 
     drug plan shall report to the Secretary, as specified by the 
     Secretary--
       ``(1) any substantiated or suspicious activities (as 
     defined by the Secretary) with respect to the program under 
     this part as it relates to fraud, waste, and abuse; and
       ``(2) any steps made by the PDP sponsor after identifying 
     such activities to take corrective actions.''.

     SEC. 11016. ESTABLISHMENT OF PHARMACY QUALITY MEASURES UNDER 
                   MEDICARE PART D.

       Section 1860D-4(c) of the Social Security Act (42 U.S.C. 
     1395w-104(c)) is amended by adding at the end the following 
     new paragraph:
       ``(8) Application of pharmacy quality measures.--
  

       ``(A) In general.--A PDP sponsor that implements incentive 
     payments to a pharmacy or price concessions paid by a 
     pharmacy based on quality measures shall use measures 
     established or approved by the Secretary under subparagraph 
     (B) with respect to payment for covered part D drugs 
     dispensed by such pharmacy.
       ``(B) Standard pharmacy quality measures.--The Secretary 
     shall establish or approve standard quality measures from a 
     consensus and evidence-based organization for payments 
     described in subparagraph (A). Such measures shall focus on 
     patient health outcomes and be based on proven criteria 
     measuring pharmacy performance.
       ``(C) Effective date.--The requirement under subparagraph 
     (A) shall take effect for plan years beginning on or after 
     January 1, 2024, or such earlier date specified by the 
     Secretary if the Secretary determines there are sufficient 
     measures established or approved under subparagraph (B) to 
     meet the requirement under subparagraph (A).''.

                     Subpart C--Medicaid Provisions

     SEC. 11021. PRICE REPORTING CLARIFICATIONS FOR GENE THERAPY 
                   OUTCOMES-BASED AGREEMENTS.

       (a) Quarterly Price Reporting Obligation.--Section 
     1927(b)(3) of the Social Security Act (42 U.S.C. 1396r-
     8(b)(3)) is amended by adding at the end the following new 
     subparagraph:
       ``(E) Outcomes-based agreements.--
       ``(i) In general.--Beginning January 1, 2023, in the case 
     of a covered outpatient drug that is a single course 
     transformative therapy (as defined in subsection (k)(12)) and 
     is sold under an outcomes-based agreement (as defined in 
     subsection (k)(13)) during a rebate period, the manufacturer 
     of such drug shall report (in addition to any other 
     information required under this paragraph) the pricing 
     structure for such drug based on pre-defined outcomes or 
     measures specified in such outcomes-based agreement.
       ``(ii) Access to outcomes-based agreements for state 
     plans.--As a condition of excluding a refund, rebate, 
     reimbursement, free item, withholding, or repayment made 
     under an outcomes-based agreement with respect to a covered 
     outpatient drug from the best price or average manufacturer 
     price of the drug for a rebate period (as described in 
     subsection (c)(1)(C)(i)(VII) or (k)(1)(B)(i)(VI), as 
     applicable), the manufacturer shall--

       ``(I) make available to each State plan the opportunity to 
     enter into an outcomes-based agreement for such drug and 
     rebate period; and
       ``(II) certify to the Secretary that the manufacturer has 
     made such opportunity so available to each State plan.

       ``(iii) Rules of construction.--Nothing in this 
     subparagraph shall be construed as--

       ``(I) requiring a manufacturer to execute an outcomes-based 
     agreement with a State for a covered outpatient drug that is 
     a single course transformative therapy (as defined in 
     subsection (k)(12)); ;
       ``(II) precluding the execution of a rebate agreement under 
     this section for such a drug; or
       ``(III) limiting States' ability to join together for a 
     multi-State contract with a single manufacturer to establish 
     an outcomes-based agreement for such a drug.''.

       (b) Definition of Best Price.--Section 1927(c)(1)(C) of the 
     Social Security Act (42 U.S.C. 1396-8(c)(1)(C)) is amended--
       (1) in clause (i)--
       (A) in subclause (V), by striking ``and'';
       (B) in subclause (VI), by striking the period at the end 
     and inserting ``; and''; and
       (C) by adding at the end the following new subclause:

       ``(VII) subject to subsection (b)(3)(E)(ii), with respect 
     to a covered outpatient drug that is a single course 
     transformative therapy (as defined in subsection (k)(12)) and 
     is sold under an outcomes-based agreement (as defined in 
     subsection (k)(13)) during the rebate period, any prices 
     resulting from--

       ``(aa) a refund, rebate, reimbursement, or free goods from 
     the manufacturer or third party on behalf of the 
     manufacturer; or
       ``(bb) the withholding or reduction of a payment to the 
     manufacturer or third party on behalf of the manufacturer,

     that is triggered by a patient who fails to achieve outcomes 
     or measures defined under the terms of such outcomes-based 
     agreement during the period for which such agreement is 
     effective.''; and

       (2) in clause (ii)
       (A) in subclause (I), by striking the semicolon at the end 
     and inserting ``, except any price adjustment described in 
     clause (i)(VII);'';
       (B) in subclause (III), by striking ``and'';
       (C) in subclause (IV)--
       (i) by moving the left margin of such subclause 2 ems to 
     the right; and
       (ii) by striking the period at the end and inserting ``; 
     and''; and
       (D) by adding at the end the following new subclause:

       ``(V) in the case of a covered outpatient drug that is a 
     single course transformative therapy (as defined in 
     subsection (k)(12)) and is sold under an outcomes-based 
     agreement (as defined in subsection (k)(13)) that provides 
     that payment for such drug is made in installments over the 
     course of such agreement, shall be determined as if the 
     aggregate price per the terms of the agreement was paid in 
     full in the first installment during the rebate period.''.

       (c) Definition of Average Manufacturer Price.--Section 
     1927(k)(1) of the Social Security Act (42 U.S.C. 1396r-
     8(k)(1)) is amended--

[[Page S4356]]

       (1) in subparagraph (B)(i)--
       (A) in subclause (IV), by striking at the end ``and'';
       (B) in subclause (V), by striking the period at the end and 
     inserting ``; and''; and
       (C) by adding at the end the following new subclause:

       ``(VI) subject to subsection (b)(3)(E)(ii), with respect to 
     a covered outpatient drug that is a single course 
     transformative therapy (as defined in paragraph (12)) and is 
     sold under an outcomes-based agreement (as defined in 
     paragraph (13)) during the rebate period--

       ``(aa) a refund, rebate, reimbursement, or free goods from 
     the manufacturer or third party on behalf of the 
     manufacturer; or
       ``(bb) the withholding or reduction of a payment to the 
     manufacturer or third party on behalf of the manufacturer,

     that is triggered by a patient who fails to achieve outcomes 
     or measures defined under the terms of such outcomes-based 
     agreement during the period for which such agreement is 
     effective.''; and

       (2) by adding at the end the following new subparagraph:
       ``(D) Special rule for certain outcomes-based agreements.--
     For the purpose of subparagraph (A), in determining the 
     average price paid to the manufacturer for a covered 
     outpatient drug that is a single course transformative 
     therapy (as defined in paragraph (12)) and is sold under an 
     outcomes-based agreement (as defined in paragraph (13)) that 
     provides that payment for such drug is made in installments 
     over the course of such agreement, such price shall be 
     determined as if the aggregate price per the terms of the 
     agreement was paid in full in the first installment during 
     the rebate period.''.
       (d) Other Definitions.--Section 1927(k) of the Social 
     Security Act (42 U.S.C. 1396r-8(k)) is amended by adding at 
     the end the following paragraphs:
       ``(12) Single course transformative therapy.--The term 
     `single course transformative therapy' means a treatment that 
     consists of the administration of a covered outpatient drug 
     that--
       ``(A) is a form of gene therapy, as defined by the 
     Commissioner of Food and Drugs, that is--
       ``(i) designated under section 526 of the Federal Food, 
     Drug, and Cosmetics Act; and
       ``(ii) licensed under subsection (a) or (k) of section 351 
     of the Public Health Service Act for a serious or life-
     threatening rare disease or condition;
       ``(B) if administered in accordance with the `Indications 
     and Usage' section of its label, is expected to result in--
       ``(i) the cure of such disease or condition;
       ``(ii) a reduction in the symptoms of such disease or 
     condition to the extent that it is expected to--

       ``(I) extend life expectancy for those individuals with 
     such disease or condition;
       ``(II) prevent, eliminate, or halt progression of 
     comorbidities related to such disease or condition in such 
     individuals; or
       ``(III) allow such individuals to achieve or maintain 
     maximum functional capacity in performing daily activities; 
     or

       ``(iii) prevention or elimination of episodes, illnesses, 
     injuries, or disabilities related to such disease or 
     condition; and
       ``(C) is expected to achieve a result described in 
     subparagraph (B), which may be achieved over an extended 
     period of time, following a single prescribed course of 
     treatment.
       ``(13) Outcomes-based agreement.--The term `outcomes-based 
     agreement' means a written contract between a manufacturer 
     and purchaser in which the aggregate price over the course of 
     the contract of the covered outpatient drug is based on the 
     achievement of pre-defined outcomes or measures and adjusted 
     accordingly.''.
       (e) Effective Date.--The amendments made by this section 
     shall take effect on January 1, 2023.

     SEC. 11022. ANTI-KICKBACK STATUTE AND PHYSICIAN SELF-REFERRAL 
                   SAFE HARBORS.

       (a) Exclusion From Antikickback Prohibition.--Section 
     1128B(b)(3) of the Social Security Act (42 U.S.C. 1320a-
     7b(b)(3)) is amended--
       (1) in subclause (J)--
       (A) by moving the left margin of such subparagraph 2 ems to 
     the left; and
       (B) by striking ``and'' after the semicolon at the end;
       (2) in subclause (K)--
       (A) by moving the left margin of such subparagraph 2 ems to 
     the left; and
  

       (B) by striking the period at the end and inserting ``; 
     and''; and
       (3) by adding at the end the following new subparagraph:
       ``(L) any remuneration provided by a manufacturer or third 
     party on behalf of a manufacturer to a plan under an 
     outcomes-based agreement (as defined in section 1927(k)(13)) 
     in the event a patient fails to achieve outcomes or measures 
     defined in such agreement following the administration of a 
     covered outpatient drug that is a single course 
     transformative therapy (as defined in section 1927(k)(12).''.
       (b) Exclusion From Physician Self-referral Prohibition.--
     Section 1877(h)(1)(C) of the Social Security Act (42 U.S.C. 
     1395nn(h)(1)(C)) is amended by adding at the end the 
     following new clause:
       ``(iv) Any amounts paid under an outcomes-based agreement 
     (as defined in section 1927(k)(13)).''.
       (c) Effective Date.--The amendments made by this section 
     shall take effect on January 1, 2023.

     SEC. 11023. GAO STUDY AND REPORT ON USE OF OUTCOMES-BASED 
                   AGREEMENTS.

       (a) Study.--The Comptroller General of the United States 
     shall conduct a study on the extent to which outcomes-based 
     agreements (as defined in section 1927(k)(13) of the Social 
     Security Act (42 U.S.C. 1396r-8(k)(13)) for rare disease gene 
     therapies facilitate patient access to such therapies, 
     improve patient outcomes, lower overall health system costs, 
     and lower costs for patients in Federal health care programs. 
     In conducting such study, the Comptroller General shall--
       (1) study the impact of this subpart on--
       (A) mitigating socioeconomic disparities in accessing rare 
     disease gene therapies through its requirement that State 
     Medicaid programs have access to the same outcomes-based 
     agreement remedy terms that are available in the commercial 
     market for the gene therapy; and
       (B) the Medicaid Drug Rebate Program, the 340B Drug Pricing 
     Program, and the Medicare Part B program, including 
     compliance with such programs; and
       (2) with respect to rare disease gene therapies sold under 
     an outcomes-based agreement (as so defined), conduct an audit 
     of manufacturers offering State Medicaid programs the same 
     remedy terms for non-responding patients as offered to 
     commercial insurance plans during a particular rebate period, 
     as described in subsections (c)(1)(C)(i)(VII) and 
     (k)(1)(B)(i)(VI) of section 1927 of the Social Security Act 
     (42 U.S.C. 1396r-8), as added by this subpart.
       (b) Report.--Not later than June 30, 2027, the Comptroller 
     General of the United States shall submit to Congress a 
     report containing the results of the study conducted under 
     subsection (a).

               PART 2--DRUG PRICE TRANSPARENCY PROVISIONS

     SEC. 11101. REPORTING ON EXPLANATION FOR DRUG PRICE 
                   INCREASES.

       (a) In General.--Title XI of the Social Security Act (42 
     U.S.C. 1301 et seq.) is amended by inserting after section 
     1128K the following new section:

     ``SEC. 1128L. DRUG PRICE REPORTING.

       ``(a) Definitions.--In this section:
       ``(1) Manufacturer.--The term `manufacturer' means the 
     person--
       ``(A) that holds the application for a drug approved under 
     section 505 of the Federal Food, Drug, and Cosmetic Act or 
     licensed under section 351 of the Public Health Service Act; 
     or
       ``(B) who is responsible for setting the wholesale 
     acquisition cost for the drug.
       ``(2) Qualifying drug.--The term `qualifying drug' means 
     any drug that is approved under subsection (c) or (j) of 
     section 505 of the Federal Food, Drug, and Cosmetic Act or 
     licensed under subsection (a) or (k) of section 351 of this 
     Act--
       ``(A) that has a wholesale acquisition cost of $100 or 
     more, adjusted for inflation occurring after the date of 
     enactment of this section, for a month's supply or a typical 
     course of treatment that lasts less than a month, and is--
       ``(i) subject to section 503(b)(1) of the Federal Food, 
     Drug, and Cosmetic Act;
       ``(ii) administered or otherwise dispensed to treat a 
     disease or condition affecting more than 200,000 persons in 
     the United States; and
       ``(iii) not a vaccine; and
       ``(B) for which, during the previous calendar year, at 
     least 1 dollar of the total amount of sales were for 
     individuals enrolled under the Medicare program under title 
     XVIII or under a State Medicaid plan under title XIX or under 
     a waiver of such plan.
       ``(3) Wholesale acquisition cost.--The term `wholesale 
     acquisition cost' has the meaning given that term in section 
     1847A(c)(6)(B).
       ``(b) Report.--
       ``(1) Report required.--The manufacturer of a qualifying 
     drug shall submit a report to the Secretary--
       ``(A) for each increase in the price of a qualifying drug 
     that results in an increase in the wholesale acquisition cost 
     of that drug that is equal to--
       ``(i) 10 percent or more within a single calendar year 
     beginning on or after January 1, 2022; or
       ``(ii) 25 percent or more within three consecutive calendar 
     years for which the first such calendar year begins on or 
     after January 1, 2022; and
       ``(B) in the case that the qualifying drug is first covered 
     under title XVIII with respect to an applicable year, if the 
     estimated cost or spending under such title per individual or 
     per user of such drug (as estimated by the Secretary) for 
     such applicable year (or per course of treatment in such 
     applicable year, as defined by the Secretary) is at least 
     $26,000.
       ``(2) Report deadline.--Each report described in paragraph 
     (1) shall be submitted to the Secretary--
       ``(A) in the case of a report with respect to an increase 
     in the price of a qualifying drug that occurs during the 
     period beginning on January 1, 2022, and ending on the day 
     that is 60 days after the date of enactment of this section, 
     not later than 90 days after such date of enactment;
       ``(B) in the case of a report with respect to an increase 
     in the price of a qualifying drug that occurs after the 
     period described in subparagraph (A), not later than 30 days 
     prior to the planned effective date of such price increase 
     for such qualifying drug; and

[[Page S4357]]

       ``(C) in the case of a report with respect to a qualifying 
     drug that meets the criteria described in paragraph (1)(B), 
     not later than 30 days after such drug meets such criteria.
       ``(c) Contents.--A report under subsection (b), consistent 
     with the standard for disclosures described in section 
     213.3(d) of title 12, Code of Federal Regulations (as in 
     effect on the date of enactment of this section), shall, at a 
     minimum, include--
       ``(1) with respect to the qualifying drug--
       ``(A) the percentage by which the manufacturer will raise 
     the wholesale acquisition cost of the drug within the 
     calendar year or three consecutive calendar years as 
     described in subsection (b)(1)(A) or (b)(1)(B), if 
     applicable, and the effective date of such price increase;
       ``(B) an explanation for, and description of, each price 
     increase for such drug that will occur during the calendar 
     year period described in subsection (b)(1)(A) or the three 
     consecutive calendar year period described in subsection 
     (b)(1)(B), as applicable;
       ``(C) if known and different from the manufacturer of the 
     qualifying drug, the identity of--
       ``(i) the sponsor or sponsors of any investigational new 
     drug applications under section 505(i) of the Federal Food, 
     Drug, and Cosmetic Act for clinical investigations with 
     respect to such drug, for which the full reports are 
     submitted as part of the application--

       ``(I) for approval of the drug under section 505 of such 
     Act; or
       ``(II) for licensure of the drug under section 351 of the 
     Public Health Service Act; and

       ``(ii) the sponsor of an application for the drug approved 
     under such section 505 of the Federal Food, Drug, and 
     Cosmetic Act or licensed under section 351 of the Public 
     Health Service Act;
       ``(D) a description of the history of the manufacturer's 
     price increases for the drug since the approval of the 
     application for the drug under section 505 of the Federal 
     Food, Drug, and Cosmetic Act or the issuance of the license 
     for the drug under section 351 of the Public Health Service 
     Act, or since the manufacturer acquired such approved 
     application or license, if applicable;
       ``(E) the current wholesale acquisition cost of the drug;
       ``(F) the total expenditures of the manufacturer on--
       ``(i) materials and manufacturing for such drug; and
       ``(ii) acquiring patents and licensing for such drug;
       ``(G) the percentage of total expenditures of the 
     manufacturer on research and development for such drug that 
     was derived from Federal funds;
       ``(H) the total expenditures of the manufacturer on 
     research and development for such drug that is necessary to 
     demonstrate that it meets applicable statutory standards for 
     approval under section 505 of the Federal Food, Drug, and 
     Cosmetic Act or licensure under section 351 of the Public 
     Health Service Act, as applicable;
       ``(I) the total expenditures of the manufacturer on 
     pursuing new or expanded indications or dosage changes for 
     such drug under section 505 of the Federal Food, Drug, and 
     Cosmetic Act or section 351 of the Public Health Service Act;
       ``(J) the total expenditures of the manufacturer on 
     carrying out postmarket requirements related to such drug, 
     including under section 505(o)(3) of the Federal Food, Drug, 
     and Cosmetic Act;
       ``(K) the total revenue and the net profit generated from 
     the qualifying drug for each calendar year since the approval 
     of the application for the drug under section 505 of the 
     Federal Food, Drug, and Cosmetic Act or the issuance of the 
     license for the drug under section 351 of the Public Health 
     Service Act, or since the manufacturer acquired such approved 
     application or license; and
       ``(L) the total costs associated with marketing and 
     advertising for the qualifying drug;
       ``(2) with respect to the manufacturer--
       ``(A) the total revenue and the net profit of the 
     manufacturer for each of the 1-year period described in 
     subsection (b)(1)(A) or the 3-year period described in 
     subsection (b)(1)(B), as applicable;
       ``(B) all stock-based performance metrics used by the 
     manufacturer to determine executive compensation for each of 
     the 1-year period described in subsection (b)(1)(A) or the 3-
     year period described in subsection (b)(1)(B), as applicable; 
     and
       ``(C) any additional information the manufacturer chooses 
     to provide related to drug pricing decisions, such as total 
     expenditures on--
       ``(i) drug research and development; or
       ``(ii) clinical trials, including on drugs that failed to 
     receive approval by the Food and Drug Administration; and
       ``(3) such other related information as the Secretary 
     considers appropriate and as specified by the Secretary 
     through notice-and-comment rulemaking.
       ``(d) Information Provided.--The manufacturer of a 
     qualifying drug that is required to submit a report under 
     subsection (b), shall ensure that such report and any 
     explanation for, and description of, each price increase 
     described in subsection (c)(1)(B) shall be truthful, not 
     misleading, and accurate.
       ``(e) Civil Monetary Penalty.--Any manufacturer of a 
     qualifying drug that fails to submit a report for the drug as 
     required by this section, following notification by the 
     Secretary to the manufacturer that the manufacturer is not in 
     compliance with this section, shall be subject to a civil 
     monetary penalty of $75,000 for each day on which the 
     violation continues.
       ``(f) False Information.--Any manufacturer that submits a 
     report for a drug as required by this section that knowingly 
     provides false information in such report is subject to a 
     civil monetary penalty in an amount not to exceed $75,000 for 
     each item of false information.
       ``(g) Public Posting.--
       ``(1) In general.--Subject to paragraph (3), the Secretary 
     shall post each report submitted under subsection (b) on the 
     public website of the Department of Health and Human Services 
     the day the price increase of a qualifying drug is scheduled 
     to go into effect.
       ``(2) Format.--In developing the format in which reports 
     will be publicly posted under paragraph (1), the Secretary 
     shall consult with stakeholders, including beneficiary 
     groups, and shall seek feedback from consumer advocates and 
     readability experts on the format and presentation of the 
     content of such reports to ensure that such reports are--
       ``(A) user-friendly to the public; and
       ``(B) written in plain language that consumers can readily 
     understand.
       ``(3) Protected information.--Nothing in this section shall 
     be construed to authorize the public disclosure of 
     information submitted by a manufacturer that is prohibited 
     from disclosure by applicable laws concerning the protection 
     of trade secrets, commercial information, and other 
     information covered under such laws.
       ``(h) Annual Report to Congress.--
       ``(1) In general.--Subject to paragraph (2), the Secretary 
     shall submit to Congress, and post on the public website of 
     the Department of Health and Human Services in a way that is 
     user-friendly to the public and written in plain language 
     that consumers can readily understand, an annual report--
       ``(A) summarizing the information reported pursuant to this 
     section;
       ``(B) including copies of the reports and supporting 
     detailed economic analyses submitted pursuant to this 
     section;
       ``(C) detailing the costs and expenditures incurred by the 
     Department of Health and Human Services in carrying out this 
     section; and
       ``(D) explaining how the Department of Health and Human 
     Services is improving consumer and provider information about 
     drug value and drug price transparency.
       ``(2) Protected information.--Nothing in this subsection 
     shall be construed to authorize the public disclosure of 
     information submitted by a manufacturer that is prohibited 
     from disclosure by applicable laws concerning the protection 
     of trade secrets, commercial information, and other 
     information covered under such laws.''.
       (b) Effective Date.--The amendment made by subsection (a) 
     shall take effect on the date of enactment of this Act.

     SEC. 11102. PUBLIC DISCLOSURE OF DRUG DISCOUNTS.

       Section 1150A of the Social Security Act (42 U.S.C. 1320b-
     23) is amended--
       (1) in subsection (c), in the matter preceding paragraph 
     (1), by inserting ``(other than as permitted under subsection 
     (e))'' after ``disclosed by the Secretary''; and
       (2) by adding at the end the following new subsection:
       ``(e) Public Availability of Certain Information.--
       ``(1) In general.--In order to allow the comparison of 
     PBMs' ability to negotiate rebates, discounts, direct and 
     indirect remuneration fees, administrative fees, and price 
     concessions and the amount of such rebates, discounts, direct 
     and indirect remuneration fees, administrative fees, and 
     price concessions that are passed through to plan sponsors, 
     beginning January 1, 2023, the Secretary shall make available 
     on the internet website of the Department of Health and Human 
     Services the information with respect to the second preceding 
     calendar year provided to the Secretary on generic dispensing 
     rates (as described in paragraph (1) of subsection (b)) and 
     information provided to the Secretary under paragraphs (2) 
     and (3) of such subsection that, as determined by the 
     Secretary, is with respect to each PBM.
       ``(2) Availability of data.--In carrying out paragraph (1), 
     the Secretary shall ensure the following:
       ``(A) Confidentiality.--The information described in such 
     paragraph is displayed in a manner that prevents the 
     disclosure of information, with respect to an individual drug 
     or an individual plan, on rebates, discounts, direct and 
     indirect remuneration fees, administrative fees, and price 
     concessions.
       ``(B) Class of drug.--The information described in such 
     paragraph is made available by class of drug, using an 
     existing classification system, but only if the class 
     contains such number of drugs, as specified by the Secretary 
     (but not fewer than three drugs), to ensure confidentiality 
     of proprietary information or other information that is 
     prevented to be disclosed under subparagraph (A).''.

     SEC. 11102. MAKING PRESCRIPTION DRUG MARKETING SAMPLE 
                   INFORMATION REPORTED BY MANUFACTURERS AVAILABLE 
                   TO CERTAIN INDIVIDUALS AND ENTITIES.

       (a) In General.--Section 1128H of the Social Security Act 
     (42 U.S.C. 1320a-7i) is amended--
       (1) by redesignating subsection (b) as subsection (e); and
       (2) by inserting after subsection (a) the following new 
     subsections:

[[Page S4358]]

       ``(b) Data Sharing Agreements.--
       ``(1) In general.--The Secretary shall enter into 
     agreements with the specified data sharing individuals and 
     entities described in paragraph (2) under which--
       ``(A) upon request of such an individual or entity, as 
     applicable, the Secretary makes available to such individual 
     or entity the information submitted under subsection (a) by 
     manufacturers and authorized distributors of record; and
       ``(B) such individual or entity agrees to not disclose 
     publicly or to another individual or entity any information 
     that identifies a particular practitioner or health care 
     facility.
       ``(2) Specified data sharing individuals and entities.--For 
     purposes of paragraph (1), the specified data sharing 
     individuals and entities described in this paragraph are the 
     following:
       ``(A) Oversight agencies.--Health oversight agencies (as 
     defined in section 164.501 of title 45, Code of Federal 
     Regulations), including the Centers for Medicare & Medicaid 
     Services, the Office of the Inspector General of the 
     Department of Health and Human Services, the Government 
     Accountability Office, the Congressional Budget Office, the 
     Medicare Payment Advisory Commission, and the Medicaid and 
     CHIP Payment and Access Commission.
       ``(B) Researchers.--Individuals who conduct scientific 
     research (as defined in section 164.501 of title 45, Code of 
     Federal Regulations) in relevant areas as determined by the 
     Secretary.
       ``(C) Payers.--Private and public health care payers, 
     including group health plans, health insurance coverage 
     offered by health insurance issuers, Federal health programs, 
     and State health programs.
       ``(3) Exemption from freedom of information act.--Except as 
     described in paragraph (1), the Secretary may not be 
     compelled to disclose the information submitted under 
     subsection (a) to any individual or entity. For purposes of 
     section 552 of title 5, United States Code (commonly referred 
     to as the Freedom of Information Act), this paragraph shall 
     be considered a statute described in subsection (b)(3)(B) of 
     such section.
       ``(c) Penalties.--
       ``(1) Data sharing agreements.--Subject to paragraph (3), 
     any specified data sharing individual or entity described in 
     subsection (b)(2) that violates the terms of a data sharing 
     agreement the individual or entity has with the Secretary 
     under subsection (b)(1) shall be subject to a civil money 
     penalty of not less than $1,000, but not more than $10,000, 
     for each such violation. Such penalty shall be imposed and 
     collected in the same manner as civil money penalties under 
     subsection (a) of section 1128A are imposed and collected 
     under that section.
       ``(2) Failure to report.--Subject to paragraph (3), any 
     manufacturer or authorized distributor of record of an 
     applicable drug under subsection (a) that fails to submit 
     information required under such subsection in a timely manner 
     in accordance with rules or regulations promulgated to carry 
     out such subsection shall be subject to a civil money penalty 
     of not less than $1,000, but not more than $10,000, for each 
     such failure. Such penalty shall be imposed and collected in 
     the same manner as civil money penalties under subsection (a) 
     of section 1128A are imposed and collected under that 
     section.
       ``(3) Limitation.--The total amount of civil money 
     penalties imposed under paragraph (1) or (2) with respect to 
     a year and an individual or entity described in paragraph (1) 
     or a manufacturer or distributor described in paragraph (2), 
     respectively, shall not exceed $150,000.
       ``(d) Drug Sample Distribution Information.--
       ``(1) In general.--Not later than January 1 of each year 
     (beginning with 2023), the Secretary shall maintain a list 
     containing information related to the distribution of samples 
     of applicable drugs. Such list shall provide the following 
     information with respect to the preceding year:
       ``(A) The name of the manufacturer or authorized 
     distributor of record of an applicable drug for which samples 
     were requested or distributed under this section.
       ``(B) The quantity and class of drug samples requested.
       ``(C) The quantity and class of drug samples distributed.
       ``(2) Public availability.--The Secretary shall make the 
     information in such list available to the public on the 
     internet website of the Food and Drug Administration.''.
       (b) FDA Maintenance of Information.--The Food and Drug 
     Administration shall maintain information available to 
     affected reporting companies to ensure their ability to fully 
     comply with the requirements of section 1128H of the Social 
     Security Act.
       (c) Prohibition on Distribution of Samples of Opioids.--
     Section 503(d) of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 353(d)) is amended--
       (1) by moving the margin of paragraph (4) 2 ems to the 
     left; and
       (2) by adding at the end the following:
       ``(5) No person may distribute a drug sample of a drug that 
     is--
       ``(A) an applicable drug (as defined in section 1128H(e) of 
     the Social Security Act);
       ``(B) a controlled substance (as defined in section 102 of 
     the Controlled Substances Act) for which the findings 
     required under section 202(b)(2) of such Act have been made; 
     and
       ``(C) approved under section 505 for use in the management 
     or treatment of pain (other than for the management or 
     treatment of a substance use disorder).''.
       (d) MedPAC Report.--Not later than 3 years after the date 
     of the enactment of this Act, the Medicare Payment Advisory 
     Commission shall conduct a study on the impact of drug 
     samples on provider prescribing practices and health care 
     costs and may, as the Commission deems appropriate, make 
     recommendations on such study.

     SEC. 11104. SENSE OF THE SENATE REGARDING THE NEED TO EXPAND 
                   COMMERCIALLY AVAILABLE DRUG PRICING COMPARISON 
                   PLATFORMS.

       It is the sense of the Senate that--
       (1) commercially available drug pricing comparison 
     platforms can, at no cost, help patients find the lowest 
     price for their medications at their local pharmacy;
       (2) such platforms should be integrated, to the maximum 
     extent possible, in the health care delivery ecosystem; and
       (3) pharmacy benefit managers should work to disclose 
     generic and brand name drug prices to such platforms to 
     ensure that--
       (A) patients can benefit from the lowest possible price 
     available to them; and
       (B) overall drug prices can be reduced as more educated 
     purchasing decisions are made based on price transparency.

                       PART 3--REVENUE PROVISION

     SEC. 11201. INCLUSION OF INSULIN AND OTHER TREATMENTS FOR 
                   CHRONIC CONDITIONS AS PREVENTIVE CARE.

       (a) In General.--Subparagraph (C) of section 223(c)(2) of 
     the Internal Revenue Code of 1986 is amended--
       (1) by striking ``deductible.--A plan'' and inserting 
     ``deductible.--
       ``(i) In general.--A plan'', and
       (2) by adding at the end the following new clause:
       ``(ii) Special rule.--The term `preventive care' includes 
     such drugs (including insulin), devices, supplies, and 
     medical services or screenings prescribed for the prevention 
     or avoidance of a disease or condition, or the regular 
     treatment and maintenance of a chronic disease or condition, 
     as are determined by the Secretary, in consultation with the 
     Secretary of Health and Human Services, to be--

       ``(I) low in cost,
       ``(II) supported by medical evidence to have a high cost 
     efficiency in preventing exacerbation of a chronic condition 
     or the development of a secondary condition, and
       ``(III) likely (as documented by clinical evidence), when 
     prescribed for a class of individuals, to prevent 
     exacerbation of the chronic condition of such individuals or 
     the development of a secondary condition requiring 
     significantly higher cost treatments.''.

       (b) Effective Date.--
       (1) In general.--The amendments made by this section shall 
     apply to taxable years beginning after the date of the 
     enactment of this Act.
       (2) Treasury guidance in effect on date of enactment.--
       (A) In general.--No inference shall be drawn by reason of 
     the amendments made by this Act with respect to the 
     effectiveness of the provisions of Internal Revenue Service 
     Notice 2019-45 on the date of the enactment of this Act, and 
     such notice shall continue to apply as in effect on July 17, 
     2019, unless amended by the Secretary of the Treasury (or the 
     Secretary's delegate) pursuant to the amendments made by this 
     Act or pursuant to subparagraph (B).
       (B) Continued publication and update of list.--
       (i) In general.--The Secretary of the Treasury (or the 
     Secretary's delegate) may publish, and update from time to 
     time as such Secretary (or delegate) deems appropriate, a 
     list of the drugs, devices, supplies, and services identified 
     under section 223(c)(2)(C)(ii) of the Internal Revenue Code 
     of 1986, in consultation with the Secretary of Health and 
     Human Services (or such Secretary's delegate), as preventive 
     care.
       (ii) Inclusion of certain diabetic supplies.--As soon as 
     practicable after the date of the enactment of this Act, the 
     list in effect under Internal Revenue Service Notice 2019-45 
     shall be amended to include insulin delivery devices and 
     related supplies, and continuous glucose monitoring systems 
     and related supplies.

                        PART 4--OTHER PROVISIONS

     SEC. 11301. IMPROVING COORDINATION BETWEEN THE FOOD AND DRUG 
                   ADMINISTRATION AND THE CENTERS FOR MEDICARE & 
                   MEDICAID SERVICES.

       (a) In General.--
       (1) Public meeting.--
       (A) In general.--Not later than 12 months after the date of 
     the enactment of this Act, the Secretary of Health and Human 
     Services (referred to in this section as the ``Secretary'') 
     shall convene a public meeting for the purposes of discussing 
     and providing input on improvements to coordination between 
     the Food and Drug Administration and the Centers for Medicare 
     & Medicaid Services in preparing for the availability of 
     novel medical products described in subsection (c) on the 
     market in the United States.
       (B) Attendees.--The public meeting shall include--
       (i) representatives of relevant Federal agencies, including 
     representatives from each of the medical product centers 
     within the Food and Drug Administration and representatives 
     from the coding, coverage, and payment offices within the 
     Centers for Medicare & Medicaid Services;

[[Page S4359]]

       (ii) stakeholders with expertise in the research and 
     development of novel medical products, including 
     manufacturers of such products;
       (iii) representatives of commercial health insurance 
     payers;
       (iv) stakeholders with expertise in the administration and 
     use of novel medical products, including physicians; and
       (v) stakeholders representing patients and with expertise 
     in the utilization of patient experience data in medical 
     product development.
       (C) Topics.--The public meeting shall include a discussion 
     of--
       (i) the status of the drug and medical device development 
     pipeline related to the availability of novel medical 
     products;
       (ii) the anticipated expertise necessary to review the 
     safety and effectiveness of such products at the Food and 
     Drug Administration and current gaps in such expertise, if 
     any;
       (iii) the expertise necessary to make coding, coverage, and 
     payment decisions with respect to such products within the 
     Centers for Medicare & Medicaid Services, and current gaps in 
     such expertise, if any;
       (iv) trends in the differences in the data necessary to 
     determine the safety and effectiveness of a novel medical 
     product and the data necessary to determine whether a novel 
     medical product meets the reasonable and necessary 
     requirements for coverage and payment under title XVIII of 
     the Social Security Act pursuant to section 1862(a)(1)(A) of 
     such Act (42 U.S.C. 1395y(a)(1)(A));
       (v) the availability of information for sponsors of such 
     novel medical products to meet each of those requirements; 
     and
       (vi) the coordination of information related to significant 
     clinical improvement over existing therapies for patients 
     between the Food and Drug Administration and the Centers for 
     Medicare & Medicaid Services with respect to novel medical 
     products.
       (D) Trade secrets and confidential information.--No 
     information discussed as a part of the public meeting under 
     this paragraph shall be construed as authorizing the 
     Secretary to disclose any information that is a trade secret 
     or confidential information subject to section 552(b)(4) of 
     title 5, United States Code.
       (2) Improving transparency of criteria for medicare 
     coverage.--
       (A) Draft guidance.--Not later than 18 months after the 
     public meeting under paragraph (1), the Secretary shall 
     update the final guidance titled ``National Coverage 
     Determinations with Data Collection as a Condition of 
     Coverage: Coverage with Evidence Development'' to address any 
     opportunities to improve the availability and coordination of 
     information as described in clauses (iv) through (vi) of 
     paragraph (1)(C).
       (B) Final guidance.--Not later than 12 months after issuing 
     draft guidance under subparagraph (A), the Secretary shall 
     finalize the updated guidance to address any such 
     opportunities.
       (b) Report on Coding, Coverage, and Payment Processes Under 
     Medicare for Novel Medical Products.--Not later than 12 
     months after the date of the enactment of this Act, the 
     Secretary shall publish a report on the internet website of 
     the Department of Health and Human Services regarding 
     processes under the Medicare program under title XVIII of the 
     Social Security Act (42 U.S.C. 1395 et seq.) with respect to 
     the coding, coverage, and payment of novel medical products 
     described in subsection (c). Such report shall include the 
     following:
       (1) A description of challenges in the coding, coverage, 
     and payment processes under the Medicare program for novel 
     medical products.
       (2) Recommendations to--
       (A) incorporate patient experience data (such as the impact 
     of a disease or condition on the lives of patients and 
     patient treatment preferences) into the coverage and payment 
     processes within the Centers for Medicare & Medicaid 
     Services;
       (B) decrease the length of time to make national and local 
     coverage determinations under the Medicare program (as those 
     terms are defined in subparagraph (A) and (B), respectively, 
     of section 1862(l)(6) of the Social Security Act (42 U.S.C. 
     1395y(l)(6)));
       (C) streamline the coverage process under the Medicare 
     program and incorporate input from relevant stakeholders into 
     such coverage determinations; and
       (D) identify potential mechanisms to incorporate novel 
     payment designs similar to those in development in commercial 
     insurance plans and State plans under title XIX of such Act 
     (42 U.S.C. 1396 et seq.) into the Medicare program.
       (c) Novel Medical Products Described.--For purposes of this 
     section, a novel medical product described in this subsection 
     is a medical product, including a drug, biological (including 
     gene and cell therapy), or medical device, that has been 
     designated as a breakthrough therapy under section 506(a) of 
     the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356(a)), 
     a breakthrough device under section 515B of such Act (21 
     U.S.C. 360e-3), or a regenerative advanced therapy under 
     section 506(g) of such Act (21 U.S.C. 356(g)).

     SEC. 11302. PATIENT CONSULTATION IN MEDICARE NATIONAL AND 
                   LOCAL COVERAGE DETERMINATIONS IN ORDER TO 
                   MITIGATE BARRIERS TO INCLUSION OF SUCH 
                   PERSPECTIVES.

       Section 1862(l) of the Social Security Act (42 U.S.C. 
     1395y(l)) is amended by adding at the end the following new 
     paragraph:
       ``(7) Patient consultation in national and local coverage 
     determinations.--The Secretary may consult with patients and 
     organizations representing patients in making national and 
     local coverage determinations.''.

     SEC. 11303. MEDPAC REPORT ON SHIFTING COVERAGE OF CERTAIN 
                   MEDICARE PART B DRUGS TO MEDICARE PART D.

       (a) Study.--The Medicare Payment Advisory Commission (in 
     this section referred to as the ``Commission'') shall conduct 
     a study on shifting coverage of certain drugs and biologicals 
     for which payment is currently made under part B of title 
     XVIII of the Social Security Act (42 U.S.C. 1395j et seq.) to 
     part D of such title (42 U.S.C. 1395w-21 et seq.). Such study 
     shall include an analysis of--
       (1) differences in program structures and payment methods 
     for drugs and biologicals covered under such parts B and D, 
     including effects of such a shift on program spending, 
     beneficiary cost-sharing liability, and utilization 
     management techniques for such drugs and biologicals; and
       (2) the feasibility and policy implications of shifting 
     coverage of drugs and biologicals for which payment is 
     currently made under such part B to such part D.
       (b) Report.--
       (1) In general.--Not later than June 30, 2024, the 
     Commission shall submit to Congress a report containing the 
     results of the study conducted under subsection (a).
       (2) Contents.--The report under paragraph (1) shall include 
     information, and recommendations as the Commission deems 
     appropriate, regarding--
       (A) formulary design under such part D;
       (B) the ability of the benefit structure under such part D 
     to control total spending on drugs and biologicals for which 
     payment is currently made under such part B;
       (C) changes to the bid process under such part D, if any, 
     that may be necessary to integrate coverage of such drugs and 
     biologicals into such part D;
       (D) any other changes to the program that Congress should 
     consider in determining whether to shift coverage of such 
     drugs and biologicals from such part B to such part D; and
       (E) the feasibility and policy implications of creating a 
     methodology to preserve the healthcare provider's ability to 
     take title of the drug, including a methodology under which--
       (i) prescription drug plans negotiate reimbursement rates 
     and other arrangements with drug manufacturers on behalf of a 
     wholesaler;
       (ii) wholesalers purchase the drugs from the manufacturers 
     at the negotiated rate and ship them through distributors to 
     physicians to administer to patients;
       (iii) physicians and hospitals purchase the drug from the 
     wholesaler via the distributor;
       (iv) after administering the drug, the physician submits a 
     claim to the MAC for their drug administration fee;
       (v) to be reimbursed for the purchase of the drug from the 
     distributor, the physician furnishes the claim for the drug 
     itself to the wholesaler and the wholesaler would refund the 
     cost of the drug to the physician; and
       (vi) the wholesaler passes this claim to the PDP to receive 
     reimbursement.

     SEC. 11304. AUTHORITY TO REQUIRE THAT DIRECT-TO-CONSUMER 
                   ADVERTISEMENTS FOR PRESCRIPTION DRUGS AND 
                   BIOLOGICAL PRODUCTS INCLUDE TRUTHFUL AND NON-
                   MISLEADING PRICING INFORMATION.

       Part A of title XI of the Social Security Act is amended by 
     adding at the end the following new section:

     ``SEC. 1150D. AUTHORITY TO REQUIRE THAT DIRECT-TO-CONSUMER 
                   ADVERTISEMENTS FOR PRESCRIPTION DRUGS AND 
                   BIOLOGICAL PRODUCTS INCLUDE TRUTHFUL AND NON-
                   MISLEADING PRICING INFORMATION.

       ``(a) In General.--The Secretary may require that each 
     direct-to-consumer advertisement for a prescription drug or 
     biological product for which payment is available under title 
     XVIII or XIX includes an internet website address that 
     provides an appropriate disclosure of truthful and non-
     misleading pricing information with respect to the drug or 
     product.
       ``(b) Determination by CMS.--The Secretary, acting through 
     the Administrator of the Centers for Medicare & Medicaid 
     Services, shall determine the components of the requirement 
     under subsection (a), such as the forms of advertising, the 
     manner of disclosure, the price point listing, and the price 
     information for disclosure.''.

     SEC. 11305. CHIEF PHARMACEUTICAL NEGOTIATOR AT THE OFFICE OF 
                   THE UNITED STATES TRADE REPRESENTATIVE.

       (a) In General.--Section 141 of the Trade Act of 1974 (19 
     U.S.C. 2171) is amended--
       (1) in subsection (b)(2)--
       (A) by striking ``and one Chief Innovation and Intellectual 
     Property Negotiator'' and inserting ``one Chief Innovation 
     and Intellectual Property Negotiator, and one Chief 
     Pharmaceutical Negotiator'';
       (B) by striking ``or the Chief Innovation and Intellectual 
     Property Negotiator'' and inserting ``the Chief Innovation 
     and Intellectual Property Negotiator, or the Chief 
     Pharmaceutical Negotiator''; and
       (C) by striking ``and the Chief Innovation and Intellectual 
     Property Negotiator'' and inserting ``the Chief Innovation 
     and Intellectual Property Negotiator, and the Chief 
     Pharmaceutical Negotiator''; and
       (2) in subsection (c), by adding at the end the following 
     new paragraph:

[[Page S4360]]

       ``(7) The principal function of the Chief Pharmaceutical 
     Negotiator shall be to conduct trade negotiations and to 
     enforce trade agreements relating to United States 
     pharmaceutical products and services. The Chief 
     Pharmaceutical Negotiator shall be a vigorous advocate on 
     behalf of United States pharmaceutical interests. The Chief 
     Pharmaceutical Negotiator shall perform such other functions 
     as the United States Trade Representative may direct.''.
       (b) Compensation.--Section 5314 of title 5, United States 
     Code, is amended by striking ``Chief Innovation and 
     Intellectual Property Negotiator, Office of the United States 
     Trade Representative.'' and inserting the following:
       ``Chief Innovation and Intellectual Property Negotiator, 
     Office of the United States Trade Representative.
       ``Chief Pharmaceutical Negotiator, Office of the United 
     States Trade Representative.''.
       (c) Report Required.--Not later than the date that is one 
     year after the appointment of the first Chief Pharmaceutical 
     Negotiator pursuant to paragraph (2) of section 141(b) of the 
     Trade Act of 1974, as amended by subsection (a), and annually 
     thereafter, the United States Trade Representative shall 
     submit to the Committee on Finance of the Senate and the 
     Committee on Ways and Means of the House of Representatives a 
     report describing in detail--
       (1) enforcement actions taken by the United States Trade 
     Representative during the 1-year period preceding the 
     submission of the report to ensure the protection of United 
     States pharmaceutical products and services; and
       (2) other actions taken by the United States Trade 
     Representative to advance United States pharmaceutical 
     products and services.
  

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