II 

117TH CONGRESS 

1ST SESSION S. 2164 

To provide for certain reforms with respect to the Medicare program under 

title XVIII of the Social Security Act, and for other purposes. 

IN THE SENATE OF THE UNITED STATES 

JUNE 22, 2021 

Mr. CRAPO (for himself, Mr. BURR, Mr. SCOTT of South Carolina, Mr. 

DAINES, Mr. RISCH, Ms. ERNST, Mr. MARSHALL, and Mr. TILLIS) introduced the following bill; which was read twice and referred to the Committee on Finance 

A BILL 

To provide for certain reforms with respect to the Medicare 

program under title XVIII of the Social Security Act, 

and for other purposes. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Lower Costs, More 

5 Cures Act of 2021’’. 

6 SEC. 2. TABLE OF CONTENTS. 

7 The table of contents for this Act is as follows: 

Sec. 1. Short title. 

Sec. 2. Table of contents. 


pamtmann on DSKBC07HB2PROD with BILLS
2 

•S 2164 IS

TITLE I—MEDICARE AND MEDICAID PROVISIONS 

Subtitle A—Medicare Part B Provisions 

Sec. 101. Improvements to Medicare site-of-service transparency. 

Sec. 102. Requiring manufacturers of certain single-dose container or single-use 

package drugs payable under part B of the Medicare program 

to provide refunds with respect to discarded amounts of such 

drugs. 

Sec. 103. Providing for variation in payment for certain drugs covered under 

part B of the Medicare program. 

Sec. 104. Establishment of maximum add-on payment for drugs and 

biologicals. 

Sec. 105. Treatment of drug administration services furnished by certain excepted off-campus outpatient departments of a provider. 

Sec. 106. Payment for biosimilar biological products during initial period. 

Sec. 107. Credit under the Medicare Merit-Based Incentive Payment System 

for completion of a clinical medical education program on biosimilar biological products. 

Sec. 108. GAO study and report on average sales price. 

Subtitle B—Medicare Part D Provisions 

Sec. 111. Medicare part D benefit redesign. 

Sec. 112. Allowing the offering of additional prescription drug plans under 

Medicare part D. 

Sec. 113. Allowing certain enrollees of prescription drug plans and MA–PD 

plans under the Medicare program to spread out cost-sharing 

under certain circumstances. 

Sec. 114. Continuation of Part D Senior Savings Model. 

Sec. 115. Requiring prescription drug plans and MA–PD plans to report potential fraud, waste, and abuse to the Secretary of HHS. 

Sec. 116. Establishment of pharmacy quality measures under Medicare part D. 

Subtitle C—Medicaid Provisions 

Sec. 121. Price reporting clarifications for gene therapy outcomes-based agreements. 

Sec. 122. Anti-kickback statute and physician self-referral safe harbors. 

Sec. 123. GAO study and report on use of outcomes-based agreements. 

TITLE II—DRUG PRICE TRANSPARENCY PROVISIONS 

Sec. 201. Reporting on explanation for drug price increases. 

Sec. 202. Public disclosure of drug discounts. 

Sec. 203. Making prescription drug marketing sample information reported by 

manufacturers available to certain individuals and entities. 

Sec. 204. Sense of the Senate regarding the need to expand commercially available drug pricing comparison platforms. 

TITLE III—REVENUE PROVISION 

Sec. 301. Inclusion of insulin and other treatments for chronic conditions as 

preventive care. 

TITLE IV—MISCELLANEOUS PROVISIONS 


pamtmann on DSKBC07HB2PROD with BILLS
3 

•S 2164 IS

Sec. 401. Improving coordination between the Food and Drug Administration 

and the Centers for Medicare & Medicaid Services. 

Sec. 402. Patient consultation in Medicare national and local coverage determinations in order to mitigate barriers to inclusion of such perspectives. 

Sec. 403. MedPAC report on shifting coverage of certain Medicare part B 

drugs to Medicare part D. 

Sec. 404. Authority to require that direct-to-consumer advertisements for prescription drugs and biological products include truthful and 

non-misleading pricing information. 

Sec. 405. Chief Pharmaceutical Negotiator at the Office of the United States 

Trade Representative. 

1 TITLE I—MEDICARE AND 

2 MEDICAID PROVISIONS 

3 Subtitle A—Medicare Part B 

4 Provisions 

5 SEC. 101. IMPROVEMENTS TO MEDICARE SITE-OF-SERVICE 

6 TRANSPARENCY. 

7 Section 1834(t) of the Social Security Act (42 U.S.C. 

8 1395m(t)) is amended— 

9 (1) in paragraph (1)— 

10 (A) in the heading, by striking ‘‘IN GEN11 ERAL’’ and inserting ‘‘SITE PAYMENT’’; 

12 (B) in the matter preceding subparagraph 

13 (A)— 

14 (i) by striking ‘‘or to’’ and inserting ‘‘, 

15 to’’; 

16 (ii) by inserting ‘‘, or to a physician 

17 for services furnished in a physician’s of18 fice’’ after ‘‘surgical center under this 

19 title’’; and 


pamtmann on DSKBC07HB2PROD with BILLS
4 

•S 2164 IS

1 (iii) by inserting ‘‘(or 2022 with re2 spect to a physician for services furnished 

3 in a physician’s office)’’ after ‘‘2018’’; and 

4 (C) in subparagraph (A)— 

5 (i) by striking ‘‘and the’’ and insert6 ing ‘‘, the’’; and 

7 (ii) by inserting ‘‘, and the physician 

8 fee schedule under section 1848 (with re9 spect to the practice expense component of 

10 such payment amount)’’ after ‘‘such sec11 tion’’; 

12 (2) by redesignating paragraphs (2) through 

13 (4) as paragraphs (3) through (5), respectively; and 

14 (3) by inserting after paragraph (1) the fol15 lowing new paragraph: 

16 ‘‘(2) PHYSICIAN PAYMENT.—Beginning in 

17 2022, the Secretary shall expand the information in18 cluded on the internet website described in para19 graph (1) to include— 

20 ‘‘(A) the amount paid to a physician under 

21 section 1848 for an item or service for the set22 tings described in paragraph (1); and 

23 ‘‘(B) the estimated amount of beneficiary 

24 liability applicable to the item or service.’’. 


pamtmann on DSKBC07HB2PROD with BILLS
5 

•S 2164 IS

1 SEC. 102. REQUIRING MANUFACTURERS OF CERTAIN SIN2 GLE-DOSE CONTAINER OR SINGLE-USE PACK3 AGE DRUGS PAYABLE UNDER PART B OF THE 

4 MEDICARE PROGRAM TO PROVIDE REFUNDS 

5 WITH RESPECT TO DISCARDED AMOUNTS OF 

6 SUCH DRUGS. 

7 Section 1847A of the Social Security Act (42 U.S.C. 

8 1395–3a) is amended— 

9 (1) by redesignating subsection (h) as sub10 section (i); and 

11 (2) by inserting after subsection (g) the fol12 lowing new subsection: 

13 ‘‘(h) REFUND FOR CERTAIN DISCARDED SINGLE14 DOSE CONTAINER OR SINGLE-USE PACKAGE DRUGS.— 

15 ‘‘(1) SECRETARIAL PROVISION OF INFORMA16 TION.— 

17 ‘‘(A) IN GENERAL.—For each calendar 

18 quarter beginning on or after July 1, 2022, the 

19 Secretary shall, with respect to a refundable 

20 single-dose container or single-use package drug 

21 (as defined in paragraph (8)), report to each 

22 manufacturer (as defined in subsection 

23 (c)(6)(A)) of such refundable single-dose con24 tainer or single-use package drug the following 

25 for the calendar quarter: 


pamtmann on DSKBC07HB2PROD with BILLS
6 

•S 2164 IS

1 ‘‘(i) Subject to subparagraph (C), in2 formation on the total number of units of 

3 the billing and payment code of such drug, 

4 if any, that were discarded during such 

5 quarter, as determined using a mechanism 

6 such as the JW modifier used as of the 

7 date of enactment of this subsection (or 

8 any such successor modifier that includes 

9 such data as determined appropriate by 

10 the Secretary). 

11 ‘‘(ii) The refund amount that the 

12 manufacturer is liable for pursuant to 

13 paragraph (3). 

14 ‘‘(B) DETERMINATION OF DISCARDED

15 AMOUNTS.—For purposes of subparagraph 

16 (A)(i), with respect to a refundable single-dose 

17 container or single-use package drug furnished 

18 during a quarter, the amount of such drug that 

19 was discarded shall be determined based on the 

20 amount of such drug that was unused and dis21 carded for each drug on the date of service. 

22 ‘‘(C) EXCLUSION OF UNITS OF PACKAGED

23 DRUGS.—The total number of units of the bill24 ing and payment code of a refundable single25 dose container or single-use package drug of a 


pamtmann on DSKBC07HB2PROD with BILLS
7 

•S 2164 IS

1 manufacturer furnished during a calendar quar2 ter for purposes of subparagraph (A)(i), and 

3 the determination of the estimated total allowed 

4 charges for the drug in the quarter for purposes 

5 of paragraph (3)(A)(ii), shall not include such 

6 units that are packaged into the payment 

7 amount for an item or service and are not sepa8 rately payable. 

9 ‘‘(2) MANUFACTURER REQUIREMENT.—For 

10 each calendar quarter beginning on or after July 1, 

11 2022, the manufacturer of a refundable single-dose 

12 container or single-use package drug shall, for such 

13 drug, provide to the Secretary a refund that is equal 

14 to the amount specified in paragraph (3) for such 

15 drug for such quarter. 

16 ‘‘(3) REFUND AMOUNT.— 

17 ‘‘(A) IN GENERAL.—The amount of the re18 fund specified in this paragraph is, with respect 

19 to a refundable single-dose container or single20 use package drug of a manufacturer assigned to 

21 a billing and payment code for a calendar quar22 ter beginning on or after July 1, 2022, an 

23 amount equal to the estimated amount (if any) 

24 by which— 

25 ‘‘(i) the product of— 


pamtmann on DSKBC07HB2PROD with BILLS
8 

•S 2164 IS

1 ‘‘(I) the total number of units of 

2 the billing and payment code for such 

3 drug that were discarded during such 

4 quarter (as determined under para5 graph (1)); and 

6 ‘‘(II)(aa) in the case of a refund7 able single-dose container or single8 use package drug that is a single 

9 source drug or biological, the amount 

10 determined for such drug under sub11 section (b)(4); or 

12 ‘‘(bb) in the case of a refundable 

13 single-dose container or single-use 

14 package drug that is a biosimilar bio15 logical product, the average sales price 

16 determined under subsection 

17 (b)(8)(A); exceeds 

18 ‘‘(ii) an amount equal to the applica19 ble percentage (as defined in subparagraph 

20 (B)) of the estimated total allowed charges 

21 for such drug during the quarter. 

22 ‘‘(B) APPLICABLE PERCENTAGE DE23 FINED.— 


pamtmann on DSKBC07HB2PROD with BILLS
9 

•S 2164 IS

1 ‘‘(i) IN GENERAL.—For purposes of 

2 subparagraph (A)(ii), the term ‘applicable 

3 percentage’ means— 

4 ‘‘(I) subject to subclause (II), 10 

5 percent; and 

6 ‘‘(II) if applicable, in the case of 

7 a refundable single-dose container or 

8 single-use package drug described in 

9 clause (ii), a percentage specified by 

10 the Secretary pursuant to such clause. 

11 ‘‘(ii) TREATMENT OF DRUGS THAT

12 HAVE UNIQUE CIRCUMSTANCES.—In the 

13 case of a refundable single-dose container 

14 or single-use package drug that has unique 

15 circumstances involving similar loss of 

16 product as that described in paragraph 

17 (8)(B), the Secretary, through notice and 

18 comment rulemaking, may increase the ap19 plicable percentage otherwise applicable 

20 under clause (i)(I) as determined appro21 priate by the Secretary. 

22 ‘‘(4) FREQUENCY.—Amounts required to be re23 funded pursuant to paragraph (2) shall be paid in 

24 regular intervals (as determined appropriate by the 

25 Secretary). 


pamtmann on DSKBC07HB2PROD with BILLS
10 

•S 2164 IS

1 ‘‘(5) REFUND DEPOSITS.—Amounts paid as re2 funds pursuant to paragraph (2) shall be deposited 

3 into the Federal Supplementary Medical Insurance 

4 Trust Fund established under section 1841. 

5 ‘‘(6) ENFORCEMENT.— 

6 ‘‘(A) AUDITS.— 

7 ‘‘(i) MANUFACTURER AUDITS.—Each 

8 manufacturer of a refundable single-dose 

9 container or single-use package drug that 

10 is required to provide a refund under this 

11 subsection shall be subject to periodic 

12 audit with respect to such drug and such 

13 refunds by the Secretary. 

14 ‘‘(ii) PROVIDER AUDITS.—The Sec15 retary shall conduct periodic audits of 

16 claims submitted under this part with re17 spect to refundable single-dose container or 

18 single-use package drugs in accordance 

19 with the authority under section 1833(e) to 

20 ensure compliance with the requirements 

21 applicable under this subsection. 

22 ‘‘(B) CIVIL MONEY PENALTY.— 

23 ‘‘(i) IN GENERAL.—The Secretary 

24 shall impose a civil money penalty on a 

25 manufacturer of a refundable single-dose 


pamtmann on DSKBC07HB2PROD with BILLS
11 

•S 2164 IS

1 container or single-use package drug who 

2 has failed to comply with the requirement 

3 under paragraph (2) for such drug for a 

4 calendar quarter in an amount equal to the 

5 sum of— 

6 ‘‘(I) the amount that the manu7 facturer would have paid under such 

8 paragraph with respect to such drug 

9 for such quarter; and 

10 ‘‘(II) 25 percent of such amount. 

11 ‘‘(ii) APPLICATION.—The provisions 

12 of section 1128A (other than subsections 

13 (a) and (b)) shall apply to a civil money 

14 penalty under this subparagraph in the 

15 same manner as such provisions apply to a 

16 penalty or proceeding under section 

17 1128A(a). 

18 ‘‘(7) IMPLEMENTATION.—The Secretary shall 

19 implement this subsection through notice and com20 ment rulemaking. 

21 ‘‘(8) DEFINITION OF REFUNDABLE SINGLE22 DOSE CONTAINER OR SINGLE-USE PACKAGE DRUG.— 

23 ‘‘(A) IN GENERAL.—Except as provided in 

24 subparagraph (B), in this subsection, the term 

25 ‘refundable single-dose container or single-use 


pamtmann on DSKBC07HB2PROD with BILLS
12 

•S 2164 IS

1 package drug’ means a single source drug or bi2 ological (as defined in section 1847A(c)(6)(D)) 

3 or a biosimilar biological product (as defined in 

4 section 1847A(c)(6)(H)) for which payment is 

5 established under this part and that is fur6 nished from a single-dose container or single7 use package. 

8 ‘‘(B) EXCLUSIONS.—The term ‘refundable 

9 single-dose container or single-use package 

10 drug’ does not include— 

11 ‘‘(i) a drug or biological that is either 

12 a radiopharmaceutical or an imaging 

13 agent; 

14 ‘‘(ii) a drug or biological for which 

15 dosage and administration instructions ap16 proved by the Commissioner of Food and 

17 Drugs require filtration during the drug 

18 preparation process, prior to dilution and 

19 administration, and require that any un20 used portion of such drug after the filtra21 tion process be discarded after the comple22 tion of such filtration process; or 

23 ‘‘(iii) a drug or biological approved by 

24 the Food and Drug Administration on or 

25 after the date of enactment of this subVerDate Sep 11 2014 16:42 Jun 25, 2021 Jkt 019200 PO 00000 Frm 00012 Fmt 6652 Sfmt 6201 E:\BILLS\S2164.IS S2164

pamtmann on DSKBC07HB2PROD with BILLS
13 

•S 2164 IS

1 section and with respect to which payment 

2 has been made under this part for less 

3 than 18 months.’’. 

4 SEC. 103. PROVIDING FOR VARIATION IN PAYMENT FOR 

5 CERTAIN DRUGS COVERED UNDER PART B 

6 OF THE MEDICARE PROGRAM. 

7 (a) IN GENERAL.—Section 1847A(b) of the Social 

8 Security Act (42 U.S.C. 1395w–3a(b)) is amended— 

9 (1) in paragraph (1)— 

10 (A) in subparagraph (A), by inserting after 

11 ‘‘or 106 percent’’ the following: ‘‘(or, for a mul12 tiple source drug (other than autologous cellular 

13 immunotherapy) furnished on or after January 

14 1, 2022, the applicable percent specified in 

15 paragraph (9)(A) for the drug and quarter in16 volved)’’; and 

17 (B) in subparagraph (B) of paragraph (1), 

18 by inserting after ‘‘106 percent’’ the following: 

19 ‘‘(or, for a single source drug or biological 

20 (other than autologous cellular immunotherapy) 

21 furnished on or after January 1, 2022, the ap22 plicable percent specified in paragraph (9)(A) 

23 for the drug or biological and quarter in24 volved)’’; and 


pamtmann on DSKBC07HB2PROD with BILLS
14 

•S 2164 IS

1 (2) by adding at the end the following new 

2 paragraph: 

3 ‘‘(9) APPLICATION OF VARIABLE PERCENTAGES

4 BASED ON PERCENTILE RANKING OF PER BENE5 FICIARY ALLOWED CHARGES.— 

6 ‘‘(A) APPLICABLE PERCENT TO BE AP7 PLIED.— 

8 ‘‘(i) IN GENERAL.—Subject to clause 

9 (ii), with respect to a drug or biological 

10 furnished in a calendar quarter beginning 

11 on or after January 1, 2022, if the Sec12 retary determines that the percentile rank 

13 of a drug or biological under subparagraph 

14 (B)(i)(III), with respect to per beneficiary 

15 allowed charges for all such drugs or 

16 biologicals, is— 

17 ‘‘(I) at least equal to the 85th 

18 percentile, the applicable percent for 

19 the drug for such quarter under this 

20 subparagraph is 104 percent; 

21 ‘‘(II) at least equal to the 70th 

22 percentile, but less than the 85th per23 centile, such applicable percent is 106 

24 percent; 


pamtmann on DSKBC07HB2PROD with BILLS
15 

•S 2164 IS

1 ‘‘(III) at least equal to the 50th 

2 percentile, but less than the 70th per3 centile, such applicable percent is 108 

4 percent; or 

5 ‘‘(IV) less than the 50th per6 centile, such applicable percent is 110 

7 percent. 

8 ‘‘(ii) CASES WHERE DATA NOT SUFFI9 CIENTLY AVAILABLE TO COMPUTE PER

10 BENEFICIARY ALLOWED CHARGES.—Sub11 ject to clause (iii), in the case of a drug or 

12 biological furnished for which the amount 

13 of payment is determined under subpara14 graph (A) or (B) of paragraph (1) and not 

15 under subsection (c)(4), for calendar quar16 ters during a period in which data are not 

17 sufficiently available to compute a per ben18 eficiary allowed charges for the drug or bi19 ological, the applicable percent is 106 per20 cent. 

21 ‘‘(B) DETERMINATION OF PERCENTILE

22 RANK OF PER BENEFICIARY ALLOWED CHARGES

23 OF DRUGS.— 

24 ‘‘(i) IN GENERAL.—With respect to a 

25 calendar quarter beginning on or after 


pamtmann on DSKBC07HB2PROD with BILLS
16 

•S 2164 IS

1 January 1, 2022, for drugs and biologicals 

2 for which the amount of payment is deter3 mined under subparagraph (A) or (B) of 

4 paragraph (1), except for drugs or 

5 biologicals for which data are not suffi6 ciently available, the Secretary shall— 

7 ‘‘(I) compute the per beneficiary 

8 allowed charges (as defined in sub9 paragraph (C)) for each such drug or 

10 biological; 

11 ‘‘(II) adjust such per beneficiary 

12 allowed charges for the quarter, to the 

13 extent provided under subparagraph 

14 (D); and 

15 ‘‘(III) arrange such adjusted per 

16 beneficiary allowed charges for all 

17 such drugs or biologicals from high to 

18 low and rank such drugs or biologicals 

19 by percentile of such per beneficiary 

20 allowed charges. 

21 ‘‘(ii) FREQUENCY.—The Secretary 

22 shall make the computations under clause 

23 (i)(I) every 6 months (or, if necessary, as 

24 determined by the Secretary, every 9 or 12 

25 months) and such computations shall apply 


pamtmann on DSKBC07HB2PROD with BILLS
17 

•S 2164 IS

1 to succeeding calendar quarters until a 

2 new computation has been made. 

3 ‘‘(iii) APPLICABLE DATA PERIOD.— 

4 For purposes of this paragraph, the term 

5 ‘applicable data period’ means the most re6 cent period for which the data necessary 

7 for making the computations under clause 

8 (i) are available, as determined by the Sec9 retary. 

10 ‘‘(C) PER BENEFICIARY ALLOWED

11 CHARGES DEFINED.—In this paragraph, the 

12 term ‘per beneficiary allowed charges’ means, 

13 with respect to a drug or biological for which 

14 the amount of payment is determined under 

15 subparagraph (A) or (B) of paragraph (1)— 

16 ‘‘(i) the allowed charges for the drug 

17 or biological for which payment is so made 

18 for the applicable data period, as estimated 

19 by the Secretary; divided by 

20 ‘‘(ii) the number of individuals for 

21 whom any payment for the drug or biologi22 cal was made under paragraph (1) for the 

23 applicable data period, as estimated by the 

24 Secretary. 


pamtmann on DSKBC07HB2PROD with BILLS
18 

•S 2164 IS

1 ‘‘(D) ADJUSTMENT TO REFLECT CHANGES

2 IN AVERAGE SALES PRICE.—In applying this 

3 paragraph for a particular calendar quarter, the 

4 Secretary shall adjust the per beneficiary al5 lowed charges for a drug or biological by multi6 plying such per beneficiary allowed charges 

7 under subparagraph (C) for the applicable data 

8 period by the ratio of— 

9 ‘‘(i) the average sales price for the 

10 drug or biological for the most recent cal11 endar quarter used under subsection 

12 (c)(5)(B); to 

13 ‘‘(ii) the average sales price for the 

14 drug or biological for the calendar quarter 

15 (or the weighted average for the quarters 

16 involved) included in the applicable data 

17 period.’’. 

18 (b) APPLICATION OF JUDICIAL REVIEW PROVI19 SIONS.—Section 1847A(i) of the Social Security Act (42 

20 U.S.C. 1395w–3a(i)), as redesignated by section 102, is 

21 amended— 

22 (1) by striking ‘‘and’’ at the end of paragraph 

23 (4); 

24 (2) by striking the period at the end of para25 graph (5) and inserting ‘‘; and’’; and 


pamtmann on DSKBC07HB2PROD with BILLS
19 

•S 2164 IS

1 (3) by adding at the end the following new 

2 paragraph: 

3 ‘‘(6) the determination of per beneficiary al4 lowed charges of drugs or biologicals and ranking of 

5 such charges under subsection (b)(9).’’. 

6 SEC. 104. ESTABLISHMENT OF MAXIMUM ADD-ON PAYMENT 

7 FOR DRUGS AND BIOLOGICALS. 

8 (a) IN GENERAL.—Section 1847A of the Social Secu9 rity Act (42 U.S.C. 1395w–3a), as amended by section 

10 103, is amended— 

11 (1) in subsection (b)— 

12 (A) in paragraph (1), in the matter pre13 ceding subparagraph (A), by striking ‘‘para14 graph (7)’’ and inserting ‘‘paragraphs (7) and 

15 (10)’’; and 

16 (B) by adding at the end the following new 

17 paragraph: 

18 ‘‘(10) MAXIMUM ADD-ON PAYMENT AMOUNT.— 

19 ‘‘(A) IN GENERAL.—In determining the 

20 payment amount under the provisions of sub21 paragraph (A), (B), or (C) of paragraph (1) of 

22 this subsection, subsection (c)(4)(A)(ii), or sub23 section (d)(3)(C) for a drug or biological fur24 nished on or after January 1, 2022, if the ap25 plicable add-on payment (as defined in subparaVerDate Sep 11 2014 16:42 Jun 25, 2021 Jkt 019200 PO 00000 Frm 00019 Fmt 6652 Sfmt 6201 E:\BILLS\S2164.IS S2164

pamtmann on DSKBC07HB2PROD with BILLS
20 

•S 2164 IS

1 graph (B)) for each drug or biological on a 

2 claim for a date of service exceeds the max3 imum add-on payment amount specified under 

4 subparagraph (C) for the drug or biological, 

5 then the payment amount otherwise determined 

6 for the drug or biological under those provi7 sions, as applicable, shall be reduced by the 

8 amount of such excess. 

9 ‘‘(B) APPLICABLE ADD-ON PAYMENT DE10 FINED.—In this paragraph, the term ‘applicable 

11 add-on payment’ means the following amounts, 

12 determined without regard to the application of 

13 subparagraph (A): 

14 ‘‘(i) In the case of a multiple source 

15 drug, an amount equal to the difference 

16 between— 

17 ‘‘(I) the amount that would oth18 erwise be applied under paragraph 

19 (1)(A); and 

20 ‘‘(II) the amount that would be 

21 applied under such paragraph if ‘100 

22 percent’ were substituted for the ap23 plicable percent (as defined in para24 graph (9)) for such drug. 


pamtmann on DSKBC07HB2PROD with BILLS
21 

•S 2164 IS

1 ‘‘(ii) In the case of a single source 

2 drug or biological, an amount equal to the 

3 difference between— 

4 ‘‘(I) the amount that would oth5 erwise be applied under paragraph 

6 (1)(B); and 

7 ‘‘(II) the amount that would be 

8 applied under such paragraph if ‘100 

9 percent’ were substituted for the ap10 plicable percent (as defined in para11 graph (9)) for such drug or biological. 

12 ‘‘(iii) In the case of a biosimilar bio13 logical product, the amount otherwise de14 termined under paragraph (8)(B). 

15 ‘‘(iv) In the case of a drug or biologi16 cal during the initial period described in 

17 subsection (c)(4)(A), an amount equal to 

18 the difference between— 

19 ‘‘(I) the amount that would oth20 erwise be applied under subsection 

21 (c)(4)(A)(ii); and 

22 ‘‘(II) the amount that would be 

23 applied under such subsection if ‘100 

24 percent’ were substituted, as applica25 ble, for— 


pamtmann on DSKBC07HB2PROD with BILLS
22 

•S 2164 IS

1 ‘‘(aa) ‘103 percent’ in sub2 clause (I) of such subsection; or 

3 ‘‘(bb) any percent in excess 

4 of 100 percent applied under 

5 subclause (II) of such subsection. 

6 ‘‘(v) In the case of a drug or biologi7 cal to which subsection (d)(3)(C) applies, 

8 an amount equal to the difference be9 tween— 

10 ‘‘(I) the amount that would oth11 erwise be applied under such sub12 section; and 

13 ‘‘(II) the amount that would be 

14 applied under such subsection if ‘100 

15 percent’ were substituted, as applica16 ble, for— 

17 ‘‘(aa) any percent in excess 

18 of 100 percent applied under 

19 clause (i) of such subsection; or 

20 ‘‘(bb) ‘103 percent’ in clause 

21 (ii) of such subsection. 

22 ‘‘(C) MAXIMUM ADD-ON PAYMENT AMOUNT

23 SPECIFIED.—For purposes of subparagraph 

24 (A), the maximum add-on payment amount 

25 specified in this subparagraph is— 


pamtmann on DSKBC07HB2PROD with BILLS
23 

•S 2164 IS

1 ‘‘(i) with respect to a drug or biologi2 cal (other than autologous or allogeneric 

3 cellular immunotherapy)— 

4 ‘‘(I) for each of 2022 through 

5 2029, $1,000; and 

6 ‘‘(II) for a subsequent year, the 

7 amount specified in this subparagraph 

8 for the preceding year increased by 

9 the percentage increase in the con10 sumer price index for all urban con11 sumers (all items; United States city 

12 average) for the 12-month period end13 ing with June of the previous year; or 

14 ‘‘(ii) with respect to a drug or biologi15 cal consisting of autologous or allogeneric 

16 cellular immunotherapy— 

17 ‘‘(I) for each of 2022 through 

18 2029, $2,000; and 

19 ‘‘(II) for a subsequent year, the 

20 amount specified in this subparagraph 

21 for the preceding year increased by 

22 the percentage increase in the con23 sumer price index for all urban con24 sumers (all items; United States city 


pamtmann on DSKBC07HB2PROD with BILLS
24 

•S 2164 IS

1 average) for the 12-month period end2 ing with June of the previous year. 

3 Any amount determined under this subpara4 graph that is not a multiple of $10 shall be 

5 rounded to the nearest multiple of $10.’’; and 

6 (2) in subsection (c)(4)(A)(ii), by striking ‘‘in 

7 the case’’ and inserting ‘‘subject to subsection 

8 (b)(10), in the case’’. 

9 (b) CONFORMING AMENDMENTS RELATING TO SEPA10 RATELY PAYABLE DRUGS.— 

11 (1) OPPS.—Section 1833(t)(14) of the Social 

12 Security Act (42 U.S.C. 1395l(t)(14)) is amended— 

13 (A) in subparagraph (A)(iii)(II), by insert14 ing ‘‘, subject to subparagraph (I)’’ after ‘‘are 

15 not available’’; and 

16 (B) by adding at the end the following new 

17 subparagraph: 

18 ‘‘(I) APPLICATION OF MAXIMUM ADD-ON

19 PAYMENT FOR SEPARATELY PAYABLE DRUGS

20 AND BIOLOGICALS.—In establishing the amount 

21 of payment under subparagraph (A) for a speci22 fied covered outpatient drug that is furnished 

23 as part of a covered OPD service (or group of 

24 services) on or after January 1, 2022, if such 

25 payment is determined based on the average 


pamtmann on DSKBC07HB2PROD with BILLS
25 

•S 2164 IS

1 price for the year established under section 

2 1847A pursuant to clause (iii)(II) of such sub3 paragraph, the provisions of subsection (b)(10) 

4 of section 1847A shall apply to the amount of 

5 payment so established in the same manner as 

6 such provisions apply to the amount of payment 

7 under section 1847A.’’. 

8 (2) ASC.—Section 1833(i)(2)(D) of the Social 

9 Security Act (42 U.S.C. 1395l(i)(2)(D)) is amend10 ed— 

11 (A) by moving clause (v) 6 ems to the left; 

12 (B) by redesignating clause (vi) as clause 

13 (vii); and 

14 (C) by inserting after clause (v) the fol15 lowing new clause: 

16 ‘‘(vi) If there is a separate payment 

17 under the system described in clause (i) for 

18 a drug or biological furnished on or after 

19 January 1, 2022, the provisions of sub20 section (t)(14)(I) shall apply to the estab21 lishment of the amount of payment for the 

22 drug or biological under such system in the 

23 same manner in which such provisions 

24 apply to the establishment of the amount 

25 of payment under subsection (t)(14)(A).’’. 


pamtmann on DSKBC07HB2PROD with BILLS
26 

•S 2164 IS

1 SEC. 105. TREATMENT OF DRUG ADMINISTRATION SERV2 ICES FURNISHED BY CERTAIN EXCEPTED 

3 OFF-CAMPUS OUTPATIENT DEPARTMENTS OF 

4 A PROVIDER. 

5 Section 1833(t)(16) of the Social Security Act (42 

6 U.S.C. 1395l(t)(16)) is amended by adding at the end the 

7 following new subparagraph: 

8 ‘‘(G) SPECIAL PAYMENT RULE FOR DRUG

9 ADMINISTRATION SERVICES FURNISHED BY AN

10 EXCEPTED DEPARTMENT OF A PROVIDER.— 

11 ‘‘(i) IN GENERAL.—In the case of a 

12 covered OPD service that is a drug admin13 istration service (as defined by the Sec14 retary) furnished by a department of a 

15 provider described in clause (ii) or (iv) of 

16 paragraph (21)(B), the payment amount 

17 for such service furnished on or after Jan18 uary 1, 2022, shall be the same payment 

19 amount (as determined in paragraph 

20 (21)(C)) that would apply if the drug ad21 ministration service was furnished by an 

22 off-campus outpatient department of a pro23 vider (as defined in paragraph (21)(B)). 

24 ‘‘(ii) APPLICATION WITHOUT REGARD

25 TO BUDGET NEUTRALITY.—The reductions 

26 made under this subparagraph— 


pamtmann on DSKBC07HB2PROD with BILLS
27 

•S 2164 IS

1 ‘‘(I) shall not be considered an 

2 adjustment under paragraph (2)(E); 

3 and 

4 ‘‘(II) shall not be implemented in 

5 a budget neutral manner.’’. 

6 SEC. 106. PAYMENT FOR BIOSIMILAR BIOLOGICAL PROD7 UCTS DURING INITIAL PERIOD. 

8 Section 1847A(c)(4) of the Social Security Act (42 

9 U.S.C. 1395w–3a(c)(4)) is amended— 

10 (1) in each of subparagraphs (A) and (B), by 

11 redesignating clauses (i) and (ii) as subclauses (I) 

12 and (II), respectively, and moving such subclauses 2 

13 ems to the right; 

14 (2) by redesignating subparagraphs (A) and 

15 (B) as clauses (i) and (ii) and moving such clauses 

16 2 ems to the right; 

17 (3) by striking ‘‘UNAVAILABLE.—In the case’’ 

18 and inserting ‘‘UNAVAILABLE.— 

19 ‘‘(A) IN GENERAL.—Subject to subpara20 graph (B), in the case’’; and 

21 (4) by adding at the end the following new sub22 paragraph: 

23 ‘‘(B) LIMITATION ON PAYMENT AMOUNT

24 FOR BIOSIMILAR BIOLOGICAL PRODUCTS DUR25 ING INITIAL PERIOD.—In the case of a bioVerDate Sep 11 2014 16:42 Jun 25, 2021 Jkt 019200 PO 00000 Frm 00027 Fmt 6652 Sfmt 6201 E:\BILLS\S2164.IS S2164

pamtmann on DSKBC07HB2PROD with BILLS
28 

•S 2164 IS

1 similar biological product furnished on or after 

2 January 1, 2022, in lieu of applying subpara3 graph (A) during the initial period described in 

4 such subparagraph with respect to the bio5 similar biological product, the amount payable 

6 under this section for the biosimilar biological 

7 product is the lesser of the following: 

8 ‘‘(i) The amount determined under 

9 clause (ii) of such subparagraph for the 

10 biosimilar biological product. 

11 ‘‘(ii) The amount determined under 

12 subsection (b)(1)(B) for the reference bio13 logical product.’’. 

14 SEC. 107. CREDIT UNDER THE MEDICARE MERIT-BASED IN15 CENTIVE PAYMENT SYSTEM FOR COMPLE16 TION OF A CLINICAL MEDICAL EDUCATION 

17 PROGRAM ON BIOSIMILAR BIOLOGICAL 

18 PRODUCTS. 

19 Section 1848(q)(5)(C) of the Social Security Act (42 

20 U.S.C. 1395w–4(q)(5)(C)) is amended by adding at the 

21 end the following new clause: 

22 ‘‘(iv) CLINICAL MEDICAL EDUCATION

23 PROGRAM ON BIOSIMILAR BIOLOGICAL

24 PRODUCTS.—Completion of a clinical med25 ical education program developed or imVerDate Sep 11 2014 16:42 Jun 25, 2021 Jkt 019200 PO 00000 Frm 00028 Fmt 6652 Sfmt 6201 E:\BILLS\S2164.IS S2164

pamtmann on DSKBC07HB2PROD with BILLS
29 

•S 2164 IS

1 proved under section 352A(b) of the Public 

2 Health Service Act by a MIPS eligible pro3 fessional during a performance period shall 

4 earn such eligible professional one-half of 

5 the highest potential score for the perform6 ance category described in paragraph 

7 (2)(A)(iii) for such performance period. A 

8 MIPS eligible professional may only count 

9 the completion of such a program for pur10 poses of such category one time during the 

11 eligible professional’s lifetime.’’. 

12 SEC. 108. GAO STUDY AND REPORT ON AVERAGE SALES 

13 PRICE. 

14 (a) STUDY.— 

15 (1) IN GENERAL.—The Comptroller General of 

16 the United States (in this section referred to as the 

17 ‘‘Comptroller General’’) shall conduct a study on 

18 spending for applicable drugs under part B of title 

19 XVIII of the Social Security Act. 

20 (2) APPLICABLE DRUGS DEFINED.—In this sec21 tion, the term ‘‘applicable drugs’’ means drugs and 

22 biologicals— 

23 (A) for which reimbursement under such 

24 part B is based on the average sales price of 

25 the drug or biological; and 


pamtmann on DSKBC07HB2PROD with BILLS
30 

•S 2164 IS

1 (B) that account for the largest percentage 

2 of total spending on drugs and biologicals under 

3 such part B (as determined by the Comptroller 

4 General, but in no case less than 25 drugs or 

5 biologicals). 

6 (3) REQUIREMENTS.—The study under para7 graph (1) shall include an analysis of the following: 

8 (A) The extent to which each applicable 

9 drug is paid for— 

10 (i) under such part B for Medicare 

11 beneficiaries; or 

12 (ii) by private payers in the commer13 cial market. 

14 (B) Any change in Medicare spending or 

15 Medicare beneficiary cost-sharing that would 

16 occur if the average sales price of an applicable 

17 drug was based solely on payments by private 

18 payers in the commercial market. 

19 (C) The extent to which drug manufactur20 ers provide rebates, discounts, or other price 

21 concessions to private payers in the commercial 

22 market for applicable drugs, which the manu23 facturer includes in its average sales price cal24 culation, for— 

25 (i) formulary placement; 


pamtmann on DSKBC07HB2PROD with BILLS
31 

•S 2164 IS

1 (ii) utilization management consider2 ations; or 

3 (iii) other purposes. 

4 (D) Barriers to drug manufacturers pro5 viding such price concessions for applicable 

6 drugs. 

7 (E) Other areas determined appropriate by 

8 the Comptroller General. 

9 (b) REPORT.—Not later than 2 years after the date 

10 of the enactment of this Act, the Comptroller General shall 

11 submit to Congress a report on the study conducted under 

12 subsection (a), together with recommendations for such 

13 legislation and administrative action as the Secretary de14 termines appropriate. 

15 Subtitle B—Medicare Part D 

16 Provisions 

17 SEC. 111. MEDICARE PART D BENEFIT REDESIGN. 

18 (a) BENEFIT STRUCTURE REDESIGN.—Section 

19 1860D–2(b) of the Social Security Act (42 U.S.C. 1395w– 

20 102(b)) is amended— 

21 (1) in paragraph (2)— 

22 (A) in subparagraph (A)— 

23 (i) in the matter preceding clause (i), 

24 by inserting ‘‘for a year preceding 2022 

25 and for costs above the annual deductible 


pamtmann on DSKBC07HB2PROD with BILLS
32 

•S 2164 IS

1 specified in paragraph (1) and up to the 

2 annual out-of-pocket threshold specified in 

3 paragraph (4)(B) for 2022 and each subse4 quent year’’ after ‘‘paragraph (3)’’; 

5 (ii) in clause (i), by inserting after 

6 ‘‘25 percent’’ the following: ‘‘(or, for 2022 

7 and each subsequent year, 15 percent)’’; 

8 and 

9 (iii) in clause (ii), by inserting ‘‘(or, 

10 for 2022 and each subsequent year, 15 

11 percent)’’ after ‘‘25 percent’’; 

12 (B) in subparagraph (C)— 

13 (i) in clause (i), in the matter pre14 ceding subclause (I), by inserting ‘‘for a 

15 year preceding 2022,’’ after ‘‘paragraph 

16 (4),’’; and 

17 (ii) in clause (ii)(III), by striking 

18 ‘‘and each subsequent year’’ and inserting 

19 ‘‘and 2021’’; and 

20 (C) in subparagraph (D)— 

21 (i) in clause (i)— 

22 (I) in the matter preceding sub23 clause (I), by inserting ‘‘for a year 

24 preceding 2022,’’ after ‘‘paragraph 

25 (4),’’; and 


pamtmann on DSKBC07HB2PROD with BILLS
33 

•S 2164 IS

1 (II) in subclause (I)(bb), by 

2 striking ‘‘a year after 2018’’ and in3 serting ‘‘each of years 2018 through 

4 2021’’; and 

5 (ii) in clause (ii)(V), by striking 

6 ‘‘2019 and each subsequent year’’ and in7 serting ‘‘each of years 2019 through 

8 2021’’; 

9 (2) in paragraph (3)(A)— 

10 (A) in the matter preceding clause (i), by 

11 inserting ‘‘for a year preceding 2022,’’ after 

12 ‘‘and (4),’’; and 

13 (B) in clause (ii), by striking ‘‘for a subse14 quent year’’ and inserting ‘‘for each of years 

15 2007 through 2021’’; and 

16 (3) in paragraph (4)— 

17 (A) in subparagraph (A)— 

18 (i) in clause (i)— 

19 (I) by redesignating subclauses 

20 (I) and (II) as items (aa) and (bb), 

21 respectively, and indenting appro22 priately; 

23 (II) in the matter preceding item 

24 (aa), as redesignated by subclause (I), 


pamtmann on DSKBC07HB2PROD with BILLS
34 

•S 2164 IS

1 by striking ‘‘is equal to the greater 

2 of—’’ and inserting ‘‘is equal to— 

3 ‘‘(I) for a year preceding 2022, 

4 the greater of—’’; 

5 (III) by striking the period at the 

6 end of item (bb), as redesignated by 

7 subclause (I), and inserting ‘‘; and’’; 

8 and 

9 (IV) by adding at the end the fol10 lowing: 

11 ‘‘(II) for 2022 and each suc12 ceeding year, $0.’’; and 

13 (ii) in clause (ii)— 

14 (I) by striking ‘‘clause (i)(I)’’ and 

15 inserting ‘‘clause (i)(I)(aa)’’; and 

16 (II) by adding at the end the fol17 lowing new sentence: ‘‘The Secretary 

18 shall continue to calculate the dollar 

19 amounts specified in clause (i)(I)(aa), 

20 including with the adjustment under 

21 this clause, after 2021 for purposes of 

22 section 1860D–14(a)(1)(D)(iii).’’; 

23 (B) in subparagraph (B)— 

24 (i) in clause (i)— 


pamtmann on DSKBC07HB2PROD with BILLS
35 

•S 2164 IS

1 (I) in subclause (V), by striking 

2 ‘‘or’’ at the end; 

3 (II) in subclause (VI)— 

4 (aa) by striking ‘‘for a sub5 sequent year’’ and inserting ‘‘for 

6 2021’’; and 

7 (bb) by striking the period 

8 at the end and inserting a semi9 colon; and 

10 (III) by adding at the end the 

11 following new subclauses: 

12 ‘‘(VII) for 2022, is equal to 

13 $3,100; or 

14 ‘‘(VIII) for a subsequent year, is 

15 equal to the amount specified in this 

16 subparagraph for the previous year, 

17 increased by the annual percentage in18 crease described in paragraph (6) for 

19 the year involved.’’; and 

20 (ii) in clause (ii), by striking ‘‘clause 

21 (i)(II)’’ and inserting ‘‘clause (i)’’; 

22 (C) in subparagraph (C)(i), by striking 

23 ‘‘and for amounts’’ and inserting ‘‘and for a 

24 year preceding 2022 for amounts’’; and 


pamtmann on DSKBC07HB2PROD with BILLS
36 

•S 2164 IS

1 (D) in subparagraph (E), by striking ‘‘In 

2 applying’’ and inserting ‘‘For each of 2011 

3 through 2021, in applying’’. 

4 (b) DECREASING REINSURANCE PAYMENT

5 AMOUNT.—Section 1860D–15(b)(1) of the Social Security 

6 Act (42 U.S.C. 1395w–115(b)(1)) is amended— 

7 (1) by striking ‘‘equal to 80 percent’’ and in8 serting ‘‘equal to— 

9 ‘‘(A) for a year preceding 2022, 80 per10 cent’’; 

11 (2) in subparagraph (A), as added by para12 graph (1), by striking the period at the end and in13 serting ‘‘; and’’; and 

14 (3) by adding at the end the following new sub15 paragraph: 

16 ‘‘(B) for 2022 and each subsequent year, 

17 the sum of— 

18 ‘‘(i) an amount equal to 20 percent of 

19 the allowable reinsurance costs (as speci20 fied in paragraph (2)) attributable to that 

21 portion of gross covered prescription drug 

22 costs as specified in paragraph (3) in23 curred in the coverage year after such indi24 vidual has incurred costs that exceed the 

25 annual out-of-pocket threshold specified in 


pamtmann on DSKBC07HB2PROD with BILLS
37 

•S 2164 IS

1 section 1860D–2(b)(4)(B) with respect to 

2 applicable drugs (as defined in section 

3 1860D–14B(g)(2)); and 

4 ‘‘(ii) an amount equal to 30 percent of 

5 the allowable reinsurance costs (as speci6 fied in paragraph (2)) attributable to that 

7 portion of gross covered prescription drug 

8 costs as specified in paragraph (3) in9 curred in the coverage year after such indi10 vidual has incurred costs that exceed the 

11 annual out-of-pocket threshold specified in 

12 section 1860D–2(b)(4)(B) with respect to 

13 covered part D drugs that are not applica14 ble drugs (as so defined).’’. 

15 (c) MANUFACTURER DISCOUNT PROGRAM.— 

16 (1) IN GENERAL.—Part D of title XVIII of the 

17 Social Security Act is amended by inserting after 

18 section 1860D–14A (42 U.S.C. 1495w–114) the fol19 lowing new section: 

20 ‘‘SEC. 1860D–14B. MANUFACTURER DISCOUNT PROGRAM. 

21 ‘‘(a) ESTABLISHMENT.—The Secretary shall estab22 lish a manufacturer discount program (in this section re23 ferred to as the ‘program’). Under the program, the Sec24 retary shall enter into agreements described in subsection 

25 (b) with manufacturers and provide for the performance 


pamtmann on DSKBC07HB2PROD with BILLS
38 

•S 2164 IS

1 of the duties described in subsection (c). The Secretary 

2 shall establish a model agreement for use under the pro3 gram by not later than January 1, 2023, in consultation 

4 with manufacturers, and allow for comment on such model 

5 agreement. 

6 ‘‘(b) TERMS OF AGREEMENT.— 

7 ‘‘(1) IN GENERAL.— 

8 ‘‘(A) AGREEMENT.—An agreement under 

9 this section shall require the manufacturer to 

10 provide applicable beneficiaries access to dis11 counted prices for applicable drugs of the man12 ufacturer that are dispensed on or after Janu13 ary 1, 2022. 

14 ‘‘(B) PROVISION OF DISCOUNTED PRICES

15 AT THE POINT-OF-SALE.—The discounted prices 

16 described in subparagraph (A) shall be provided 

17 to the applicable beneficiary at the pharmacy or 

18 by the mail order service at the point-of-sale of 

19 an applicable drug. 

20 ‘‘(2) PROVISION OF APPROPRIATE DATA.—Each 

21 manufacturer with an agreement in effect under this 

22 section shall collect and have available appropriate 

23 data, as determined by the Secretary, to ensure that 

24 it can demonstrate to the Secretary compliance with 

25 the requirements under the program. 


pamtmann on DSKBC07HB2PROD with BILLS
39 

•S 2164 IS

1 ‘‘(3) COMPLIANCE WITH REQUIREMENTS FOR

2 ADMINISTRATION OF PROGRAM.—Each manufac3 turer with an agreement in effect under this section 

4 shall comply with requirements imposed by the Sec5 retary or a third party with a contract under sub6 section (d)(3), as applicable, for purposes of admin7 istering the program, including any determination 

8 under subparagraph (A) of subsection (c)(1) or pro9 cedures established under such subsection (c)(1). 

10 ‘‘(4) LENGTH OF AGREEMENT.— 

11 ‘‘(A) IN GENERAL.—An agreement under 

12 this section shall be effective for an initial pe13 riod of not less than 12 months and shall be 

14 automatically renewed for a period of not less 

15 than 1 year unless terminated under subpara16 graph (B). 

17 ‘‘(B) TERMINATION.— 

18 ‘‘(i) BY THE SECRETARY.—The Sec19 retary may provide for termination of an 

20 agreement under this section for a knowing 

21 and willful violation of the requirements of 

22 the agreement or other good cause shown. 

23 Such termination shall not be effective ear24 lier than 30 days after the date of notice 

25 to the manufacturer of such termination. 


pamtmann on DSKBC07HB2PROD with BILLS
40 

•S 2164 IS

1 The Secretary shall provide, upon request, 

2 a manufacturer with a hearing concerning 

3 such a termination, and such hearing shall 

4 take place prior to the effective date of the 

5 termination with sufficient time for such 

6 effective date to be repealed if the Sec7 retary determines appropriate. 

8 ‘‘(ii) BY A MANUFACTURER.—A man9 ufacturer may terminate an agreement 

10 under this section for any reason. Any 

11 such termination shall be effective, with re12 spect to a plan year— 

13 ‘‘(I) if the termination occurs be14 fore January 30 of a plan year, as of 

15 the day after the end of the plan year; 

16 and 

17 ‘‘(II) if the termination occurs on 

18 or after January 30 of a plan year, as 

19 of the day after the end of the suc20 ceeding plan year. 

21 ‘‘(iii) EFFECTIVENESS OF TERMI22 NATION.—Any termination under this sub23 paragraph shall not affect discounts for 

24 applicable drugs of the manufacturer that 


pamtmann on DSKBC07HB2PROD with BILLS
41 

•S 2164 IS

1 are due under the agreement before the ef2 fective date of its termination. 

3 ‘‘(iv) NOTICE TO THIRD PARTY.—The 

4 Secretary shall provide notice of such ter5 mination to a third party with a contract 

6 under subsection (d)(3) within not less 

7 than 30 days before the effective date of 

8 such termination. 

9 ‘‘(5) EFFECTIVE DATE OF AGREEMENT.—An 

10 agreement under this section shall take effect on a 

11 date determined appropriate by the Secretary, which 

12 may be at the start of a calendar quarter. 

13 ‘‘(c) DUTIES DESCRIBED.—The duties described in 

14 this subsection are the following: 

15 ‘‘(1) ADMINISTRATION OF PROGRAM.—Admin16 istering the program, including— 

17 ‘‘(A) the determination of the amount of 

18 the discounted price of an applicable drug of a 

19 manufacturer; 

20 ‘‘(B) the establishment of procedures 

21 under which discounted prices are provided to 

22 applicable beneficiaries at pharmacies or by 

23 mail order service at the point-of-sale of an ap24 plicable drug; 


pamtmann on DSKBC07HB2PROD with BILLS
42 

•S 2164 IS

1 ‘‘(C) the establishment of procedures to 

2 ensure that, not later than the applicable num3 ber of calendar days after the dispensing of an 

4 applicable drug by a pharmacy or mail order 

5 service, the pharmacy or mail order service is 

6 reimbursed for an amount equal to the dif7 ference between— 

8 ‘‘(i) the negotiated price of the appli9 cable drug; and 

10 ‘‘(ii) the discounted price of the appli11 cable drug; 

12 ‘‘(D) the establishment of procedures to 

13 ensure that the discounted price for an applica14 ble drug under this section is applied before any 

15 coverage or financial assistance under other 

16 health benefit plans or programs that provide 

17 coverage or financial assistance for the pur18 chase or provision of prescription drug coverage 

19 on behalf of applicable beneficiaries as the Sec20 retary may specify; and 

21 ‘‘(E) providing a reasonable dispute resolu22 tion mechanism to resolve disagreements be23 tween manufacturers, applicable beneficiaries, 

24 and the third party with a contract under sub25 section (d)(3). 


pamtmann on DSKBC07HB2PROD with BILLS
43 

•S 2164 IS

1 ‘‘(2) MONITORING COMPLIANCE.— 

2 ‘‘(A) IN GENERAL.—The Secretary shall 

3 monitor compliance by a manufacturer with the 

4 terms of an agreement under this section. 

5 ‘‘(B) NOTIFICATION.—If a third party 

6 with a contract under subsection (d)(3) deter7 mines that the manufacturer is not in compli8 ance with such agreement, the third party shall 

9 notify the Secretary of such noncompliance for 

10 appropriate enforcement under subsection (e). 

11 ‘‘(3) COLLECTION OF DATA FROM PRESCRIP12 TION DRUG PLANS AND MA–PD PLANS.—The Sec13 retary may collect appropriate data from prescrip14 tion drug plans and MA–PD plans in a timeframe 

15 that allows for discounted prices to be provided for 

16 applicable drugs under this section. 

17 ‘‘(d) ADMINISTRATION.— 

18 ‘‘(1) IN GENERAL.—Subject to paragraph (2), 

19 the Secretary shall provide for the implementation of 

20 this section, including the performance of the duties 

21 described in subsection (c). 

22 ‘‘(2) LIMITATION.—In providing for the imple23 mentation of this section, the Secretary shall not re24 ceive or distribute any funds of a manufacturer 

25 under the program. 


pamtmann on DSKBC07HB2PROD with BILLS
44 

•S 2164 IS

1 ‘‘(3) CONTRACT WITH THIRD PARTIES.—The 

2 Secretary shall enter into a contract with one or 

3 more third parties to administer the requirements 

4 established by the Secretary in order to carry out 

5 this section. At a minimum, the contract with a 

6 third party under the preceding sentence shall re7 quire that the third party— 

8 ‘‘(A) receive and transmit information be9 tween the Secretary, manufacturers, and other 

10 individuals or entities the Secretary determines 

11 appropriate; 

12 ‘‘(B) receive, distribute, or facilitate the 

13 distribution of funds of manufacturers to ap14 propriate individuals or entities in order to 

15 meet the obligations of manufacturers under 

16 agreements under this section; 

17 ‘‘(C) provide adequate and timely informa18 tion to manufacturers, consistent with the 

19 agreement with the manufacturer under this 

20 section, as necessary for the manufacturer to 

21 fulfill its obligations under this section; and 

22 ‘‘(D) permit manufacturers to conduct 

23 periodic audits, directly or through contracts, of 

24 the data and information used by the third 


pamtmann on DSKBC07HB2PROD with BILLS
45 

•S 2164 IS

1 party to determine discounts for applicable 

2 drugs of the manufacturer under the program. 

3 ‘‘(4) PERFORMANCE REQUIREMENTS.—The 

4 Secretary shall establish performance requirements 

5 for a third party with a contract under paragraph 

6 (3) and safeguards to protect the independence and 

7 integrity of the activities carried out by the third 

8 party under the program under this section. 

9 ‘‘(5) ADMINISTRATION.—Chapter 35 of title 44, 

10 United States Code, shall not apply to the program 

11 under this section. 

12 ‘‘(e) ENFORCEMENT.— 

13 ‘‘(1) AUDITS.—Each manufacturer with an 

14 agreement in effect under this section shall be sub15 ject to periodic audit by the Secretary. 

16 ‘‘(2) CIVIL MONEY PENALTY.— 

17 ‘‘(A) IN GENERAL.—The Secretary shall 

18 impose a civil money penalty on a manufacturer 

19 that fails to provide applicable beneficiaries dis20 counts for applicable drugs of the manufacturer 

21 in accordance with such agreement for each 

22 such failure in an amount the Secretary deter23 mines is commensurate with the sum of— 

24 ‘‘(i) the amount that the manufac25 turer would have paid with respect to such 


pamtmann on DSKBC07HB2PROD with BILLS
46 

•S 2164 IS

1 discounts under the agreement, which will 

2 then be used to pay the discounts which 

3 the manufacturer had failed to provide; 

4 and 

5 ‘‘(ii) 25 percent of such amount. 

6 ‘‘(B) APPLICATION.—The provisions of 

7 section 1128A (other than subsections (a) and 

8 (b)) shall apply to a civil money penalty under 

9 this paragraph in the same manner as such 

10 provisions apply to a penalty or proceeding 

11 under section 1128A(a). 

12 ‘‘(f) CLARIFICATION REGARDING AVAILABILITY OF

13 OTHER COVERED PART D DRUGS.—Nothing in this sec14 tion shall prevent an applicable beneficiary from pur15 chasing a covered part D drug that is not on the formulary 

16 of the prescription drug plan or MA–PD plan that the 

17 applicable beneficiary is enrolled in. 

18 ‘‘(g) DEFINITIONS.—In this section: 

19 ‘‘(1) APPLICABLE BENEFICIARY.—The term 

20 ‘applicable beneficiary’ means an individual who, on 

21 the date of dispensing a covered part D drug— 

22 ‘‘(A) is enrolled in a prescription drug plan 

23 or an MA–PD plan; 

24 ‘‘(B) is not enrolled in a qualified retiree 

25 prescription drug plan; and 


pamtmann on DSKBC07HB2PROD with BILLS
47 

•S 2164 IS

1 ‘‘(C) has incurred costs for covered part D 

2 drugs in the year that are equal to or exceed 

3 the annual deductible specified in section 

4 1860D–2(b)(1) for such year. 

5 ‘‘(2) APPLICABLE DRUG.—The term ‘applicable 

6 drug’ means, with respect to an applicable bene7 ficiary, a covered part D drug— 

8 ‘‘(A) approved under a new drug applica9 tion under section 505(c) of the Federal Food, 

10 Drug, and Cosmetic Act or, in the case of a bio11 logic product, licensed under section 351 of the 

12 Public Health Service Act (including a product 

13 licensed under subsection (k) of such section); 

14 and 

15 ‘‘(B)(i) if the PDP sponsor of the prescrip16 tion drug plan or the MA organization offering 

17 the MA–PD plan uses a formulary, which is on 

18 the formulary of the prescription drug plan or 

19 MA–PD plan that the applicable beneficiary is 

20 enrolled in; 

21 ‘‘(ii) if the PDP sponsor of the prescrip22 tion drug plan or the MA organization offering 

23 the MA–PD plan does not use a formulary, for 

24 which benefits are available under the prescripVerDate Sep 11 2014 16:42 Jun 25, 2021 Jkt 019200 PO 00000 Frm 00047 Fmt 6652 Sfmt 6201 E:\BILLS\S2164.IS S2164

pamtmann on DSKBC07HB2PROD with BILLS
48 

•S 2164 IS

1 tion drug plan or MA–PD plan that the appli2 cable beneficiary is enrolled in; or 

3 ‘‘(iii) is provided through an exception or 

4 appeal. 

5 ‘‘(3) APPLICABLE NUMBER OF CALENDAR

6 DAYS.—The term ‘applicable number of calendar 

7 days’ means— 

8 ‘‘(A) with respect to claims for reimburse9 ment submitted electronically, 14 days; and 

10 ‘‘(B) with respect to claims for reimburse11 ment submitted otherwise, 30 days. 

12 ‘‘(4) DISCOUNTED PRICE.— 

13 ‘‘(A) IN GENERAL.—The term ‘discounted 

14 price’ means, with respect to an applicable drug 

15 of a manufacturer furnished during a year to 

16 an applicable beneficiary, 90 percent of the ne17 gotiated price of such drug. 

18 ‘‘(B) CLARIFICATION.—Nothing in this 

19 section shall be construed as affecting the re20 sponsibility of an applicable beneficiary for pay21 ment of a dispensing fee for an applicable drug. 

22 ‘‘(C) SPECIAL CASE FOR CLAIMS SPANNING

23 DEDUCTIBLE.—In the case where the entire 

24 amount of the negotiated price of an individual 

25 claim for an applicable drug with respect to an 


pamtmann on DSKBC07HB2PROD with BILLS
49 

•S 2164 IS

1 applicable beneficiary does not fall at or above 

2 the annual deductible specified in section 

3 1860D–2(b)(1) for the year, the manufacturer 

4 of the applicable drug shall provide the dis5 counted price under this section on only the 

6 portion of the negotiated price of the applicable 

7 drug that falls at or above such annual deduct8 ible. 

9 ‘‘(5) MANUFACTURER.—The term ‘manufac10 turer’ means any entity which is engaged in the pro11 duction, preparation, propagation, compounding, 

12 conversion, or processing of prescription drug prod13 ucts, either directly or indirectly by extraction from 

14 substances of natural origin, or independently by 

15 means of chemical synthesis, or by a combination of 

16 extraction and chemical synthesis. Such term does 

17 not include a wholesale distributor of drugs or a re18 tail pharmacy licensed under State law. 

19 ‘‘(6) NEGOTIATED PRICE.—The term ‘nego20 tiated price’ has the meaning given such term in sec21 tion 1860D–2(d)(1)(B), except that such negotiated 

22 price shall not include any dispensing fee for an ap23 plicable drug. 

24 ‘‘(7) QUALIFIED RETIREE PRESCRIPTION DRUG

25 PLAN.—The term ‘qualified retiree prescription drug 


pamtmann on DSKBC07HB2PROD with BILLS
50 

•S 2164 IS

1 plan’ has the meaning given such term in section 

2 11860D–22(a)(2).’’. 

3 (2) SUNSET OF MEDICARE COVERAGE GAP DIS4 COUNT PROGRAM.—Section 1860D–14A of the So5 cial Security Act (42 U.S.C. 1395–114a) is amend6 ed— 

7 (A) in subsection (a), in the first sentence, 

8 by striking ‘‘The Secretary’’ and inserting 

9 ‘‘Subject to subsection (h), the Secretary’’; and 

10 (B) by adding at the end the following new 

11 subsection: 

12 ‘‘(h) SUNSET OF PROGRAM.— 

13 ‘‘(1) IN GENERAL.—The program shall not 

14 apply to applicable drugs dispensed on or after Jan15 uary 1, 2022, and, subject to paragraph (2), agree16 ments under this section shall be terminated as of 

17 such date. 

18 ‘‘(2) CONTINUED APPLICATION FOR APPLICA19 BLE DRUGS DISPENSED PRIOR TO SUNSET.—The 

20 provisions of this section (including all responsibil21 ities and duties) shall continue to apply after Janu22 ary 1, 2022, with respect to applicable drugs dis23 pensed prior to such date.’’. 

24 (3) INCLUSION OF ACTUARIAL VALUE OF MANU25 FACTURER DISCOUNTS IN BIDS.—Section 1860D–11 


pamtmann on DSKBC07HB2PROD with BILLS
51 

•S 2164 IS

1 of the Social Security Act (42 U.S.C. 1395w–111) 

2 is amended— 

3 (A) in subsection (b)(2)(C)(iii)— 

4 (i) by striking ‘‘assumptions regarding 

5 the reinsurance’’ and inserting ‘‘assump6 tions regarding— 

7 ‘‘(I) the reinsurance’’; and 

8 (ii) by adding at the end the fol9 lowing: 

10 ‘‘(II) for 2022 and each subse11 quent year, the manufacturer dis12 counts provided under section 1860D– 

13 14B subtracted from the actuarial 

14 value to produce such bid; and’’; and 

15 (B) in subsection (c)(1)(C)— 

16 (i) by striking ‘‘an actuarial valuation 

17 of the reinsurance’’ and inserting ‘‘an ac18 tuarial valuation of— 

19 ‘‘(i) the reinsurance’’; 

20 (ii) in clause (i), as added by clause 

21 (i) of this subparagraph, by adding ‘‘and’’ 

22 at the end; and 

23 (iii) by adding at the end the fol24 lowing: 


pamtmann on DSKBC07HB2PROD with BILLS
52 

•S 2164 IS

1 ‘‘(ii) for 2022 and each subsequent 

2 year, the manufacturer discounts provided 

3 under section 1860D–14B;’’. 

4 (4) CLARIFICATION REGARDING EXCLUSION OF

5 MANUFACTURER DISCOUNTS FROM TROOP.—Section 

6 1860D–2(b)(4) of the Social Security Act (42 

7 U.S.C. 1395w–102(b)(4)) is amended— 

8 (A) in subparagraph (C), by inserting ‘‘and 

9 subject to subparagraph (F)’’ after ‘‘subpara10 graph (E)’’; and 

11 (B) by adding at the end the following new 

12 subparagraph: 

13 ‘‘(F) CLARIFICATION REGARDING EXCLU14 SION OF MANUFACTURER DISCOUNTS.—In ap15 plying subparagraph (A), incurred costs shall 

16 not include any manufacturer discounts pro17 vided under section 1860D–14B.’’. 

18 (d) DETERMINATION OF ALLOWABLE REINSURANCE

19 COSTS.—Section 1860D–15(b) of the Social Security Act 

20 (42 U.S.C. 1395w–115(b)) is amended— 

21 (1) in paragraph (2)— 

22 (A) by striking ‘‘COSTS.—For purposes’’ 

23 and inserting ‘‘COSTS.— 

24 ‘‘(A) IN GENERAL.—Subject to subpara25 graph (B), for purposes’’; and 


pamtmann on DSKBC07HB2PROD with BILLS
53 

•S 2164 IS

1 (B) by adding at the end the following new 

2 subparagraph: 

3 ‘‘(B) INCLUSION OF MANUFACTURER DIS4 COUNTS ON APPLICABLE DRUGS.—For purposes 

5 of applying subparagraph (A), the term ‘allow6 able reinsurance costs’ shall include the portion 

7 of the negotiated price (as defined in section 

8 1860D–14B(g)(6)) of an applicable drug (as 

9 defined in section 1860D–14(g)(2)) that was 

10 paid by a manufacturer under the manufacturer 

11 discount program under section 1860D–14B.’’; 

12 and 

13 (2) in paragraph (3)— 

14 (A) in the first sentence, by striking ‘‘For 

15 purposes’’ and inserting ‘‘Subject to paragraph 

16 (2)(B), for purposes’’; and 

17 (B) in the second sentence, by inserting 

18 ‘‘or, in the case of an applicable drug, by a 

19 manufacturer’’ after ‘‘by the individual or 

20 under the plan’’. 

21 (e) UPDATING RISK ADJUSTMENT METHODOLOGIES

22 TO ACCOUNT FOR PART D MODERNIZATION REDE23 SIGN.—Section 1860D–15(c) of the Social Security Act 

24 (42 U.S.C. 1395w–115(c)) is amended by adding at the 

25 end the following new paragraph: 


pamtmann on DSKBC07HB2PROD with BILLS
54 

•S 2164 IS

1 ‘‘(3) UPDATING RISK ADJUSTMENT METH2 ODOLOGIES TO ACCOUNT FOR PART D MODERNIZA3 TION REDESIGN.—The Secretary shall update the 

4 risk adjustment model used to adjust bid amounts 

5 pursuant to this subsection as appropriate to take 

6 into account changes in benefits under this part pur7 suant to the amendments made by section 121 of 

8 the Lower Costs, More Cures Act of 2019.’’. 

9 (f) CONDITIONS FOR COVERAGE OF DRUGS UNDER

10 THIS PART.—Section 1860D–43 of the Social Security 

11 Act (42 U.S.C. 1395w–153) is amended— 

12 (1) in subsection (a)— 

13 (A) in paragraph (2), by striking ‘‘and’’ at 

14 the end; 

15 (B) in paragraph (3), by striking the pe16 riod at the end and inserting a semicolon; and 

17 (C) by adding at the end the following new 

18 paragraphs: 

19 ‘‘(4) participate in the manufacturer discount 

20 program under section 1860D–14B; 

21 ‘‘(5) have entered into and have in effect an 

22 agreement described in subsection (b) of such sec23 tion 1860D–14B with the Secretary; and 

24 ‘‘(6) have entered into and have in effect, under 

25 terms and conditions specified by the Secretary, a 


pamtmann on DSKBC07HB2PROD with BILLS
55 

•S 2164 IS

1 contract with a third party that the Secretary has 

2 entered into a contract with under subsection (d)(3) 

3 of such section 1860D–14B.’’; 

4 (2) by striking subsection (b) and inserting the 

5 following: 

6 ‘‘(b) EFFECTIVE DATE.—Paragraphs (1) through (3) 

7 of subsection (a) shall apply to covered part D drugs dis8 pensed under this part on or after January 1, 2011, and 

9 before January 1, 2022, and paragraphs (4) through (6) 

10 of such subsection shall apply to covered part D drugs 

11 dispensed on or after January 1, 2022.’’; and 

12 (3) in subsection (c), by striking paragraph (2) 

13 and inserting the following: 

14 ‘‘(2) the Secretary determines that in the period 

15 beginning on January 1, 2011, and ending on De16 cember 31, 2011 (with respect to paragraphs (1) 

17 through (3) of subsection (a)), or the period begin18 ning on January 1, 2022, and ending December 31, 

19 2022 (with respect to paragraphs (4) through (6) of 

20 such subsection), there were extenuating cir21 cumstances.’’. 

22 (g) CONFORMING AMENDMENTS.— 

23 (1) Section 1860D–2 of the Social Security Act 

24 (42 U.S.C. 1395w–102) is amended— 


pamtmann on DSKBC07HB2PROD with BILLS
56 

•S 2164 IS

1 (A) in subsection (a)(2)(A)(i)(I), by strik2 ing ‘‘, or an increase in the initial’’ and insert3 ing ‘‘or for a year preceding 2022 an increase 

4 in the initial’’; 

5 (B) in subsection (c)(1)(C)— 

6 (i) in the subparagraph heading, by 

7 striking ‘‘AT INITIAL COVERAGE LIMIT’’; 

8 and 

9 (ii) by inserting ‘‘for a year preceding 

10 2022 or the annual out-of-pocket threshold 

11 specified in subsection (b)(4)(B) for the 

12 year for 2022 and each subsequent year’’ 

13 after ‘‘subsection (b)(3) for the year’’ each 

14 place it appears; and 

15 (C) in subsection (d)(1)(A), by striking ‘‘or 

16 an initial’’ and inserting ‘‘or for a year pre17 ceding 2022, an initial’’. 

18 (2) Section 1860D–4(a)(4)(B)(i) of the Social 

19 Security Act (42 U.S.C. 1395w–104(a)(4)(B)(i)) is 

20 amended by striking ‘‘the initial’’ and inserting ‘‘for 

21 a year preceding 2022, the initial’’. 

22 (3) Section 1860D–14(a) of the Social Security 

23 Act (42 U.S.C. 1395w–114(a)) is amended— 

24 (A) in paragraph (1)— 


pamtmann on DSKBC07HB2PROD with BILLS
57 

•S 2164 IS

1 (i) in subparagraph (C), by striking 

2 ‘‘The continuation’’ and inserting ‘‘For a 

3 year preceding 2022, the continuation’’; 

4 (ii) in subparagraph (D)(iii), by strik5 ing ‘‘1860D–2(b)(4)(A)(i)(I)’’ and insert6 ing ‘‘1860D–2(b)(4)(A)(i)(I)(aa)’’; and 

7 (iii) in subparagraph (E), by striking 

8 ‘‘The elimination’’ and inserting ‘‘For a 

9 year preceding 2022, the elimination’’; and 

10 (B) in paragraph (2)— 

11 (i) in subparagraph (C), by striking 

12 ‘‘The continuation’’ and inserting ‘‘For a 

13 year preceding 2022, the continuation’’; 

14 and 

15 (ii) in subparagraph (E)— 

16 (I) by inserting ‘‘for a year pre17 ceding 2022,’’ after ‘‘subsection (c)’’; 

18 and 

19 (II) by striking ‘‘1860D– 

20 2(b)(4)(A)(i)(I)’’ and inserting 

21 ‘‘1860D–2(b)(4)(A)(i)(I)(aa)’’. 

22 (4) Section 1860D–21(d)(7) of the Social Secu23 rity Act (42 U.S.C. 1395w–131(d)(7)) is amended 

24 by striking ‘‘section 1860D–2(b)(4)(B)(i)’’ and in25 serting ‘‘section 1860D–2(b)(4)(C)(i)’’. 


pamtmann on DSKBC07HB2PROD with BILLS
58 

•S 2164 IS

1 (5) Section 1860D–22(a)(2)(A) of the Social 

2 Security Act (42 U.S.C. 1395w–132(a)(2)(A)) is 

3 amended— 

4 (A) by striking ‘‘the value of any discount’’ 

5 and inserting the following: ‘‘the value of— 

6 ‘‘(i) for years prior to 2022, any dis7 count’’; 

8 (B) in clause (i), as inserted by subpara9 graph (A) of this paragraph, by striking the pe10 riod at the end and inserting ‘‘; and’’; and 

11 (C) by adding at the end the following new 

12 clause: 

13 ‘‘(ii) for 2022 and each subsequent 

14 year, any discount provided pursuant to 

15 section 1860D–14B.’’. 

16 (6) Section 1860D–41(a)(6) of the Social Secu17 rity Act (42 U.S.C. 1395w–151(a)(6)) is amended— 

18 (A) by inserting ‘‘for a year before 2022’’ 

19 after ‘‘1860D–2(b)(3)’’; and 

20 (B) by inserting ‘‘for such year’’ before the 

21 period. 

22 (h) EFFECTIVE DATE.—The amendments made by 

23 this section shall apply to plan year 2022 and subsequent 

24 plan years. 


pamtmann on DSKBC07HB2PROD with BILLS
59 

•S 2164 IS

1 SEC. 112. ALLOWING THE OFFERING OF ADDITIONAL PRE2 SCRIPTION DRUG PLANS UNDER MEDICARE 

3 PART D. 

4 (a) RESCINDING AND ISSUANCE OF NEW GUID5 ANCE.—Not later than one year after the date of the en6 actment of this Act, the Secretary of Health and Human 

7 Services (in this section referred to as the ‘‘Secretary’’) 

8 shall— 

9 (1) rescind sections of any sub-regulatory guid10 ance that limit the number of prescription drug 

11 plans in each PDP region that may be offered by a 

12 PDP sponsor under part D of title XVIII of the So13 cial Security Act (42 U.S.C. 1395w–101 et seq.); 

14 and 

15 (2) issue new guidance specifying that a PDP 

16 sponsor may offer up to 4 (or a greater number if 

17 determined appropriate by the Secretary) prescrip18 tion drug plans in each PDP region, except in cases 

19 where the PDP sponsor may offer up to 2 additional 

20 plans in a PDP region pursuant to section 1860D– 

21 11(d)(4) of the Social Security Act (42 U.S.C. 

22 1395w–111(d)(4)), as added by subsection (b). 

23 (b) OFFERING OF ADDITIONAL PLANS.—Section 

24 1860D–11(d) of the Social Security Act (42 U.S.C. 

25 1395w–111(d)) is amended by adding at the end the fol26 lowing new paragraph: 


pamtmann on DSKBC07HB2PROD with BILLS
60 

•S 2164 IS

1 ‘‘(4) OFFERING OF ADDITIONAL PLANS.— 

2 ‘‘(A) IN GENERAL.—For plan year 2022 

3 and each subsequent plan year, a PDP sponsor 

4 may offer up to 2 additional prescription drug 

5 plans in a PDP region (in addition to any limit 

6 established by the Secretary under this part) 

7 provided that the PDP sponsor complies with 

8 subparagraph (B) with respect to at least one 

9 such prescription drug plan. 

10 ‘‘(B) REQUIREMENTS.—In order to be eli11 gible to offer up to 2 additional plans in a PDP 

12 region pursuant to subparagraph (A), a PDP 

13 sponsor must ensure that, with respect to at 

14 least one such prescription drug plan, the spon15 sor or any entity that provides pharmacy bene16 fits management services under a contract with 

17 any such sponsor or plan does not receive direct 

18 or indirect remuneration, as defined in section 

19 423.308 of title 42, Code of Federal Regula20 tions (or any successor regulation), unless at 

21 least 25 percent of the aggregate reductions in 

22 price or other remuneration received by the 

23 PDP sponsor or entity from drug manufactur24 ers with respect to the plan and plan year— 


pamtmann on DSKBC07HB2PROD with BILLS
61 

•S 2164 IS

1 ‘‘(i) are reflected at the point-of-sale 

2 to the enrollee; or 

3 ‘‘(ii) are used to reduce total bene4 ficiary cost-sharing estimated by the PDP 

5 sponsor for prescription drug coverage 

6 under the plan in the annual bid submitted 

7 by the PDP sponsor under section 1860D– 

8 11(b). 

9 ‘‘(C) DEFINITION OF REDUCTIONS IN

10 PRICE.—For purposes of subparagraph (B), the 

11 term ‘reductions in price’ refers only to collect12 ible amounts, as determined by the Secretary, 

13 which excludes amounts which after adjudica14 tion and reconciliation with pharmacies and 

15 manufacturers are duplicate in nature, contrary 

16 to other contractual clauses, or otherwise ineli17 gible (such as due to beneficiary disenrollment 

18 or coordination of benefits).’’. 

19 (c) RULE OF CONSTRUCTION.—Nothing in the provi20 sions of, or amendments made by, this section shall be 

21 construed as limiting the ability of the Secretary to in22 crease any limit otherwise applicable on the number of 

23 prescription drug plans that a PDP sponsor may offer, 

24 at the discretion of the PDP sponsor, in a PDP region 


pamtmann on DSKBC07HB2PROD with BILLS
62 

•S 2164 IS

1 under part D of title XVIII of the Social Security Act (42 

2 U.S.C. 1395w–101 et seq.). 

3 SEC. 113. ALLOWING CERTAIN ENROLLEES OF PRESCRIP4 TION DRUG PLANS AND MA–PD PLANS UNDER 

5 THE MEDICARE PROGRAM TO SPREAD OUT 

6 COST-SHARING UNDER CERTAIN CIR7 CUMSTANCES. 

8 (a) STANDARD PRESCRIPTION DRUG COVERAGE.— 

9 Section 1860D–2(b)(2) of the Social Security Act (42 

10 U.S.C. 1395w–102(b)(2)), as amended by section 111, is 

11 amended— 

12 (1) in subparagraph (A), by striking ‘‘Subject 

13 to subparagraphs (C) and (D)’’ and inserting ‘‘Sub14 ject to subparagraphs (C), (D), and (E)’’; and 

15 (2) by adding at the end the following new sub16 paragraph: 

17 ‘‘(E) ENROLLEE OPTION REGARDING

18 SPREADING COST-SHARING.— 

19 ‘‘(i) IN GENERAL.—The Secretary 

20 shall establish by regulation a process 

21 under which, with respect to plan year 

22 2022 and subsequent plan years, a pre23 scription drug plan or an MA–PD plan 

24 shall, in the case of a part D eligible indi25 vidual enrolled with such plan for such 


pamtmann on DSKBC07HB2PROD with BILLS
63 

•S 2164 IS

1 plan year with respect to whom the plan 

2 projects that the dispensing of a covered 

3 part D drug to such individual will result 

4 in the individual incurring costs within a 

5 30-day period that are equal to a signifi6 cant percentage (as specified by the Sec7 retary pursuant to such regulation) of the 

8 annual out-of-pocket threshold specified in 

9 paragraph (4)(B) for such plan year, pro10 vide such individual with the option to 

11 make the coinsurance payment required 

12 under subparagraph (A) for such costs in 

13 the form of equal monthly installments 

14 over the remainder of such plan year. 

15 ‘‘(ii) SIGNIFICANT PERCENTAGE LIMI16 TATIONS.—In specifying a significant per17 centage pursuant to the regulation estab18 lished by the Secretary under clause (i), 

19 the Secretary shall not specify a percent20 age that is less than 30 percent or greater 

21 than 100 percent.’’. 

22 (b) ALTERNATIVE PRESCRIPTION DRUG COV23 ERAGE.—Section 1860D–2(c) of the Social Security Act 

24 (42 U.S.C. 1395w–102(c)) is amended by adding at the 

25 end the following new paragraph: 


pamtmann on DSKBC07HB2PROD with BILLS
64 

•S 2164 IS

1 ‘‘(4) SAME ENROLLEE OPTION REGARDING

2 SPREADING COST-SHARING.—For plan year 2022 

3 and subsequent plan years, the coverage provides the 

4 enrollee option regarding spreading cost-sharing de5 scribed in and required under subsection 

6 (b)(2)(E).’’. 

7 SEC. 114. CONTINUATION OF PART D SENIOR SAVINGS 

8 MODEL. 

9 Section 1115A of the Social Security Act (42 U.S.C. 

10 1315a) is amended by adding at the end the following new 

11 subsection: 

12 ‘‘(h) PART D SENIOR SAVINGS MODEL.—Notwith13 standing any other provision of law, the Secretary shall 

14 provide for the continued implementation on a permanent 

15 basis of the Part D Senior Savings Model under this sec16 tion, under the same parameters under which such model 

17 was implemented for plan year 2021.’’. 

18 SEC. 115. REQUIRING PRESCRIPTION DRUG PLANS AND 

19 MA–PD PLANS TO REPORT POTENTIAL 

20 FRAUD, WASTE, AND ABUSE TO THE SEC21 RETARY OF HHS. 

22 Section 1860D–4 of the Social Security Act (42 

23 U.S.C. 1395w–104) is amended by adding at the end the 

24 following new subsection: 


pamtmann on DSKBC07HB2PROD with BILLS
65 

•S 2164 IS

1 ‘‘(p) REPORTING POTENTIAL FRAUD, WASTE, AND

2 ABUSE.—Beginning January 1, 2022, the PDP sponsor 

3 of a prescription drug plan shall report to the Secretary, 

4 as specified by the Secretary— 

5 ‘‘(1) any substantiated or suspicious activities 

6 (as defined by the Secretary) with respect to the 

7 program under this part as it relates to fraud, 

8 waste, and abuse; and 

9 ‘‘(2) any steps made by the PDP sponsor after 

10 identifying such activities to take corrective ac11 tions.’’. 

12 SEC. 116. ESTABLISHMENT OF PHARMACY QUALITY MEAS13 URES UNDER MEDICARE PART D. 

14 Section 1860D–4(c) of the Social Security Act (42 

15 U.S.C. 1395w–104(c)) is amended by adding at the end 

16 the following new paragraph: 

17 ‘‘(8) APPLICATION OF PHARMACY QUALITY

18 MEASURES.— 

19 ‘‘(A) IN GENERAL.—A PDP sponsor that 

20 implements incentive payments to a pharmacy 

21 or price concessions paid by a pharmacy based 

22 on quality measures shall use measures estab23 lished or approved by the Secretary under sub24 paragraph (B) with respect to payment for cov25 ered part D drugs dispensed by such pharmacy. 


pamtmann on DSKBC07HB2PROD with BILLS
66 

•S 2164 IS

1 ‘‘(B) STANDARD PHARMACY QUALITY

2 MEASURES.—The Secretary shall establish or 

3 approve standard quality measures from a con4 sensus and evidence-based organization for pay5 ments described in subparagraph (A). Such 

6 measures shall focus on patient health outcomes 

7 and be based on proven criteria measuring 

8 pharmacy performance. 

9 ‘‘(C) EFFECTIVE DATE.—The requirement 

10 under subparagraph (A) shall take effect for 

11 plan years beginning on or after January 1, 

12 2023, or such earlier date specified by the Sec13 retary if the Secretary determines there are suf14 ficient measures established or approved under 

15 subparagraph (B) to meet the requirement 

16 under subparagraph (A).’’. 

17 Subtitle C—Medicaid Provisions 

18 SEC. 121. PRICE REPORTING CLARIFICATIONS FOR GENE 

19 THERAPY OUTCOMES-BASED AGREEMENTS. 

20 (a) QUARTERLY PRICE REPORTING OBLIGATION.— 

21 Section 1927(b)(3) of the Social Security Act (42 U.S.C. 

22 1396r–8(b)(3)) is amended by adding at the end the fol23 lowing new subparagraph: 

24 ‘‘(E) OUTCOMES-BASED AGREEMENTS.— 


pamtmann on DSKBC07HB2PROD with BILLS
67 

•S 2164 IS

1 ‘‘(i) IN GENERAL.—Beginning Janu2 ary 1, 2022, in the case of a covered out3 patient drug that is a single course trans4 formative therapy (as defined in subsection 

5 (k)(12)) and is sold under an outcomes6 based agreement (as defined in subsection 

7 (k)(13)) during a rebate period, the manu8 facturer of such drug shall report (in addi9 tion to any other information required 

10 under this paragraph) the pricing struc11 ture for such drug based on pre-defined 

12 outcomes or measures specified in such 

13 outcomes-based agreement. 

14 ‘‘(ii) ACCESS TO OUTCOMES-BASED

15 AGREEMENTS FOR STATE PLANS.—As a 

16 condition of excluding a refund, rebate, re17 imbursement, free item, withholding, or re18 payment made under an outcomes-based 

19 agreement with respect to a covered out20 patient drug from the best price or average 

21 manufacturer price of the drug for a re22 bate period (as described in subsection 

23 (c)(1)(C)(i)(VII) or (k)(1)(B)(i)(VI), as 

24 applicable), the manufacturer shall— 


pamtmann on DSKBC07HB2PROD with BILLS
68 

•S 2164 IS

1 ‘‘(I) make available to each State 

2 plan the opportunity to enter into an 

3 outcomes-based agreement for such 

4 drug and rebate period; and 

5 ‘‘(II) certify to the Secretary that 

6 the manufacturer has made such op7 portunity so available to each State 

8 plan. 

9 ‘‘(iii) RULES OF CONSTRUCTION.— 

10 Nothing in this subparagraph shall be con11 strued as— 

12 ‘‘(I) requiring a manufacturer to 

13 execute an outcomes-based agreement 

14 with a State for a covered outpatient 

15 drug that is a single course trans16 formative therapy (as defined in sub17 section (k)(12)); ; 

18 ‘‘(II) precluding the execution of 

19 a rebate agreement under this section 

20 for such a drug; or 

21 ‘‘(III) limiting States’ ability to 

22 join together for a multi-State con23 tract with a single manufacturer to 

24 establish an outcomes-based agree25 ment for such a drug.’’. 


pamtmann on DSKBC07HB2PROD with BILLS
69 

•S 2164 IS

1 (b) DEFINITION OF BEST PRICE.—Section 

2 1927(c)(1)(C) of the Social Security Act (42 U.S.C. 

3 1396–8(c)(1)(C)) is amended— 

4 (1) in clause (i)— 

5 (A) in subclause (V), by striking ‘‘and’’; 

6 (B) in subclause (VI), by striking the pe7 riod at the end and inserting ‘‘; and’’; and 

8 (C) by adding at the end the following new 

9 subclause: 

10 ‘‘(VII) subject to subsection 

11 (b)(3)(E)(ii), with respect to a covered 

12 outpatient drug that is a single course 

13 transformative therapy (as defined in 

14 subsection (k)(12)) and is sold under 

15 an outcomes-based agreement (as de16 fined in subsection (k)(13)) during 

17 the rebate period, any prices resulting 

18 from— 

19 ‘‘(aa) a refund, rebate, reim20 bursement, or free goods from 

21 the manufacturer or third party 

22 on behalf of the manufacturer; or 

23 ‘‘(bb) the withholding or re24 duction of a payment to the manVerDate Sep 11 2014 16:42 Jun 25, 2021 Jkt 019200 PO 00000 Frm 00069 Fmt 6652 Sfmt 6201 E:\BILLS\S2164.IS S2164

pamtmann on DSKBC07HB2PROD with BILLS
70 

•S 2164 IS

1 ufacturer or third party on behalf 

2 of the manufacturer, 

3 that is triggered by a patient who 

4 fails to achieve outcomes or measures 

5 defined under the terms of such out6 comes-based agreement during the pe7 riod for which such agreement is ef8 fective.’’; and 

9 (2) in clause (ii)— 

10 (A) in subclause (I), by striking the semi11 colon at the end and inserting ‘‘, except any 

12 price adjustment described in clause (i)(VII);’’; 

13 (B) in subclause (III), by striking ‘‘and’’; 

14 (C) in subclause (IV)— 

15 (i) by moving the left margin of such 

16 subclause 2 ems to the right; and 

17 (ii) by striking the period at the end 

18 and inserting ‘‘; and’’; and 

19 (D) by adding at the end the following new 

20 subclause: 

21 ‘‘(V) in the case of a covered out22 patient drug that is a single course 

23 transformative therapy (as defined in 

24 subsection (k)(12)) and is sold under 

25 an outcomes-based agreement (as deVerDate Sep 11 2014 02:33 Jun 26, 2021 Jkt 019200 PO 00000 Frm 00070 Fmt 6652 Sfmt 6201 E:\BILLS\S2164.IS S2164

pamtmann on DSKBC07HB2PROD with BILLS
71 

•S 2164 IS

1 fined in subsection (k)(13)) that pro2 vides that payment for such drug is 

3 made in installments over the course 

4 of such agreement, shall be deter5 mined as if the aggregate price per 

6 the terms of the agreement was paid 

7 in full in the first installment during 

8 the rebate period.’’. 

9 (c) DEFINITION OF AVERAGE MANUFACTURER

10 PRICE.—Section 1927(k)(1) of the Social Security Act (42 

11 U.S.C. 1396r–8(k)(1)) is amended— 

12 (1) in subparagraph (B)(i)— 

13 (A) in subclause (IV), by striking at the 

14 end ‘‘and’’; 

15 (B) in subclause (V), by striking the period 

16 at the end and inserting ‘‘; and’’; and 

17 (C) by adding at the end the following new 

18 subclause: 

19 ‘‘(VI) subject to subsection 

20 (b)(3)(E)(ii), with respect to a covered 

21 outpatient drug that is a single course 

22 transformative therapy (as defined in 

23 paragraph (12)) and is sold under an 

24 outcomes-based agreement (as defined 


pamtmann on DSKBC07HB2PROD with BILLS
72 

•S 2164 IS

1 in paragraph (13)) during the rebate 

2 period— 

3 ‘‘(aa) a refund, rebate, reim4 bursement, or free goods from 

5 the manufacturer or third party 

6 on behalf of the manufacturer; or 

7 ‘‘(bb) the withholding or re8 duction of a payment to the man9 ufacturer or third party on behalf 

10 of the manufacturer, 

11 that is triggered by a patient who 

12 fails to achieve outcomes or measures 

13 defined under the terms of such out14 comes-based agreement during the pe15 riod for which such agreement is ef16 fective.’’; and 

17 (2) by adding at the end the following new sub18 paragraph: 

19 ‘‘(D) SPECIAL RULE FOR CERTAIN OUT20 COMES-BASED AGREEMENTS.—For the purpose 

21 of subparagraph (A), in determining the aver22 age price paid to the manufacturer for a cov23 ered outpatient drug that is a single course 

24 transformative therapy (as defined in para25 graph (12)) and is sold under an outcomesVerDate Sep 11 2014 02:33 Jun 26, 2021 Jkt 019200 PO 00000 Frm 00072 Fmt 6652 Sfmt 6201 E:\BILLS\S2164.IS S2164

pamtmann on DSKBC07HB2PROD with BILLS
73 

•S 2164 IS

1 based agreement (as defined in paragraph (13)) 

2 that provides that payment for such drug is 

3 made in installments over the course of such 

4 agreement, such price shall be determined as if 

5 the aggregate price per the terms of the agree6 ment was paid in full in the first installment 

7 during the rebate period.’’. 

8 (d) OTHER DEFINITIONS.—Section 1927(k) of the 

9 Social Security Act (42 U.S.C. 1396r–8(k)) is amended 

10 by adding at the end the following paragraphs: 

11 ‘‘(12) SINGLE COURSE TRANSFORMATIVE THER12 APY.—The term ‘single course transformative ther13 apy’ means a treatment that consists of the adminis14 tration of a covered outpatient drug that— 

15 ‘‘(A) is a form of gene therapy, as defined 

16 by the Commissioner of Food and Drugs, that 

17 is— 

18 ‘‘(i) designated under section 526 of 

19 the Federal Food, Drug, and Cosmetics 

20 Act; and 

21 ‘‘(ii) licensed under subsection (a) or 

22 (k) of section 351 of the Public Health 

23 Service Act for a serious or life-threatening 

24 rare disease or condition; 


pamtmann on DSKBC07HB2PROD with BILLS
74 

•S 2164 IS

1 ‘‘(B) if administered in accordance with 

2 the ‘Indications and Usage’ section of its label, 

3 is expected to result in— 

4 ‘‘(i) the cure of such disease or condi5 tion; 

6 ‘‘(ii) a reduction in the symptoms of 

7 such disease or condition to the extent that 

8 it is expected to— 

9 ‘‘(I) extend life expectancy for 

10 those individuals with such disease or 

11 condition; 

12 ‘‘(II) prevent, eliminate, or halt 

13 progression of comorbidities related to 

14 such disease or condition in such indi15 viduals; or 

16 ‘‘(III) allow such individuals to 

17 achieve or maintain maximum func18 tional capacity in performing daily ac19 tivities; or 

20 ‘‘(iii) prevention or elimination of epi21 sodes, illnesses, injuries, or disabilities re22 lated to such disease or condition; and 

23 ‘‘(C) is expected to achieve a result de24 scribed in subparagraph (B), which may be 


pamtmann on DSKBC07HB2PROD with BILLS
75 

•S 2164 IS

1 achieved over an extended period of time, fol2 lowing a single prescribed course of treatment. 

3 ‘‘(13) OUTCOMES-BASED AGREEMENT.—The 

4 term ‘outcomes-based agreement’ means a written 

5 contract between a manufacturer and purchaser in 

6 which the aggregate price over the course of the con7 tract of the covered outpatient drug is based on the 

8 achievement of pre-defined outcomes or measures 

9 and adjusted accordingly.’’. 

10 (e) EFFECTIVE DATE.—The amendments made by 

11 this section shall take effect on January 1, 2022. 

12 SEC. 122. ANTI-KICKBACK STATUTE AND PHYSICIAN SELF13 REFERRAL SAFE HARBORS. 

14 (a) EXCLUSION FROM ANTIKICKBACK PROHIBI15 TION.—Section 1128B(b)(3) of the Social Security Act 

16 (42 U.S.C. 1320a–7b(b)(3)) is amended— 

17 (1) in subclause (J)— 

18 (A) by moving the left margin of such sub19 paragraph 2 ems to the left; and 

20 (B) by striking ‘‘and’’ after the semicolon 

21 at the end; 

22 (2) in subclause (K)— 

23 (A) by moving the left margin of such sub24 paragraph 2 ems to the left; and 


pamtmann on DSKBC07HB2PROD with BILLS
76 

•S 2164 IS

1 (B) by striking the period at the end and 

2 inserting ‘‘; and’’; and 

3 (3) by adding at the end the following new sub4 paragraph: 

5 ‘‘(L) any remuneration provided by a manufac6 turer or third party on behalf of a manufacturer to 

7 a plan under an outcomes-based agreement (as de8 fined in section 1927(k)(13)) in the event a patient 

9 fails to achieve outcomes or measures defined in 

10 such agreement following the administration of a 

11 covered outpatient drug that is a single course 

12 transformative therapy (as defined in section 

13 1927(k)(12).’’. 

14 (b) EXCLUSION FROM PHYSICIAN SELF-REFERRAL

15 PROHIBITION.—Section 1877(h)(1)(C) of the Social Secu16 rity Act (42 U.S.C. 1395nn(h)(1)(C)) is amended by add17 ing at the end the following new clause: 

18 ‘‘(iv) Any amounts paid under an out19 comes-based agreement (as defined in section 

20 1927(k)(13)).’’. 

21 (c) EFFECTIVE DATE.—The amendments made by 

22 this section shall take effect on January 1, 2022. 


pamtmann on DSKBC07HB2PROD with BILLS
77 

•S 2164 IS

1 SEC. 123. GAO STUDY AND REPORT ON USE OF OUTCOMES2 BASED AGREEMENTS. 

3 (a) STUDY.—The Comptroller General of the United 

4 States shall conduct a study on the extent to which out5 comes-based agreements (as defined in section 

6 1927(k)(13) of the Social Security Act (42 U.S.C. 1396r– 

7 8(k)(13)) for rare disease gene therapies facilitate patient 

8 access to such therapies, improve patient outcomes, lower 

9 overall health system costs, and lower costs for patients 

10 in Federal health care programs. In conducting such 

11 study, the Comptroller General shall— 

12 (1) study the impact of this subtitle on– 

13 (A) mitigating socioeconomic disparities in 

14 accessing rare disease gene therapies through 

15 its requirement that State Medicaid programs 

16 have access to the same outcomes-based agree17 ment remedy terms that are available in the 

18 commercial market for the gene therapy; and 

19 (B) the Medicaid Drug Rebate Program, 

20 the 340B Drug Pricing Program, and the Medi21 care Part B program, including compliance with 

22 such programs; and 

23 (2) with respect to rare disease gene therapies 

24 sold under an outcomes-based agreement (as so de25 fined), conduct an audit of manufacturers offering 

26 State Medicaid programs the same remedy terms for 


pamtmann on DSKBC07HB2PROD with BILLS
78 

•S 2164 IS

1 non-responding patients as offered to commercial in2 surance plans during a particular rebate period, as 

3 described in subsections (c)(1)(C)(i)(VII) and 

4 (k)(1)(B)(i)(VI) of section 1927 of the Social Secu5 rity Act (42 U.S.C. 1396r–8), as added by this sub6 title. 

7 (b) REPORT.—Not later than June 30, 2027, the 

8 Comptroller General of the United States shall submit to 

9 Congress a report containing the results of the study con10 ducted under subsection (a). 

11 TITLE II—DRUG PRICE 

12 TRANSPARENCY PROVISIONS 

13 SEC. 201. REPORTING ON EXPLANATION FOR DRUG PRICE 

14 INCREASES. 

15 (a) IN GENERAL.—Title XI of the Social Security Act 

16 (42 U.S.C. 1301 et seq.) is amended by inserting after 

17 section 1128K the following new section: 

18 ‘‘SEC. 1128L. DRUG PRICE REPORTING. 

19 ‘‘(a) DEFINITIONS.—In this section: 

20 ‘‘(1) MANUFACTURER.—The term ‘manufac21 turer’ means the person— 

22 ‘‘(A) that holds the application for a drug 

23 approved under section 505 of the Federal 

24 Food, Drug, and Cosmetic Act or licensed 


pamtmann on DSKBC07HB2PROD with BILLS
79 

•S 2164 IS

1 under section 351 of the Public Health Service 

2 Act; or 

3 ‘‘(B) who is responsible for setting the 

4 wholesale acquisition cost for the drug. 

5 ‘‘(2) QUALIFYING DRUG.—The term ‘qualifying 

6 drug’ means any drug that is approved under sub7 section (c) or (j) of section 505 of the Federal Food, 

8 Drug, and Cosmetic Act or licensed under subsection 

9 (a) or (k) of section 351 of this Act— 

10 ‘‘(A) that has a wholesale acquisition cost 

11 of $100 or more, adjusted for inflation occur12 ring after the date of enactment of this section, 

13 for a month’s supply or a typical course of 

14 treatment that lasts less than a month, and 

15 is— 

16 ‘‘(i) subject to section 503(b)(1) of 

17 the Federal Food, Drug, and Cosmetic 

18 Act; 

19 ‘‘(ii) administered or otherwise dis20 pensed to treat a disease or condition af21 fecting more than 200,000 persons in the 

22 United States; and 

23 ‘‘(iii) not a vaccine; and 

24 ‘‘(B) for which, during the previous cal25 endar year, at least 1 dollar of the total amount 


pamtmann on DSKBC07HB2PROD with BILLS
80 

•S 2164 IS

1 of sales were for individuals enrolled under the 

2 Medicare program under title XVIII or under a 

3 State Medicaid plan under title XIX or under 

4 a waiver of such plan. 

5 ‘‘(3) WHOLESALE ACQUISITION COST.—The 

6 term ‘wholesale acquisition cost’ has the meaning 

7 given that term in section 1847A(c)(6)(B). 

8 ‘‘(b) REPORT.— 

9 ‘‘(1) REPORT REQUIRED.—The manufacturer of 

10 a qualifying drug shall submit a report to the Sec11 retary— 

12 ‘‘(A) for each increase in the price of a 

13 qualifying drug that results in an increase in 

14 the wholesale acquisition cost of that drug that 

15 is equal to— 

16 ‘‘(i) 10 percent or more within a sin17 gle calendar year beginning on or after 

18 January 1, 2021; or 

19 ‘‘(ii) 25 percent or more within three 

20 consecutive calendar years for which the 

21 first such calendar year begins on or after 

22 January 1, 2021; and 

23 ‘‘(B) in the case that the qualifying drug 

24 is first covered under title XVIII with respect 

25 to an applicable year, if the estimated cost or 


pamtmann on DSKBC07HB2PROD with BILLS
81 

•S 2164 IS

1 spending under such title per individual or per 

2 user of such drug (as estimated by the Sec3 retary) for such applicable year (or per course 

4 of treatment in such applicable year, as defined 

5 by the Secretary) is at least $26,000. 

6 ‘‘(2) REPORT DEADLINE.—Each report de7 scribed in paragraph (1) shall be submitted to the 

8 Secretary— 

9 ‘‘(A) in the case of a report with respect 

10 to an increase in the price of a qualifying drug 

11 that occurs during the period beginning on Jan12 uary 1, 2021, and ending on the day that is 60 

13 days after the date of enactment of this section, 

14 not later than 90 days after such date of enact15 ment; 

16 ‘‘(B) in the case of a report with respect 

17 to an increase in the price of a qualifying drug 

18 that occurs after the period described in sub19 paragraph (A), not later than 30 days prior to 

20 the planned effective date of such price increase 

21 for such qualifying drug; and 

22 ‘‘(C) in the case of a report with respect 

23 to a qualifying drug that meets the criteria de24 scribed in paragraph (1)(B), not later than 30 

25 days after such drug meets such criteria. 


pamtmann on DSKBC07HB2PROD with BILLS
82 

•S 2164 IS

1 ‘‘(c) CONTENTS.—A report under subsection (b), con2 sistent with the standard for disclosures described in sec3 tion 213.3(d) of title 12, Code of Federal Regulations (as 

4 in effect on the date of enactment of this section), shall, 

5 at a minimum, include— 

6 ‘‘(1) with respect to the qualifying drug— 

7 ‘‘(A) the percentage by which the manufac8 turer will raise the wholesale acquisition cost of 

9 the drug within the calendar year or three con10 secutive calendar years as described in sub11 section (b)(1)(A) or (b)(1)(B), if applicable, and 

12 the effective date of such price increase; 

13 ‘‘(B) an explanation for, and description 

14 of, each price increase for such drug that will 

15 occur during the calendar year period described 

16 in subsection (b)(1)(A) or the three consecutive 

17 calendar year period described in subsection 

18 (b)(1)(B), as applicable; 

19 ‘‘(C) if known and different from the man20 ufacturer of the qualifying drug, the identity 

21 of— 

22 ‘‘(i) the sponsor or sponsors of any in23 vestigational new drug applications under 

24 section 505(i) of the Federal Food, Drug, 

25 and Cosmetic Act for clinical investigations 


pamtmann on DSKBC07HB2PROD with BILLS
83 

•S 2164 IS

1 with respect to such drug, for which the 

2 full reports are submitted as part of the 

3 application— 

4 ‘‘(I) for approval of the drug 

5 under section 505 of such Act; or 

6 ‘‘(II) for licensure of the drug 

7 under section 351 of the Public 

8 Health Service Act; and 

9 ‘‘(ii) the sponsor of an application for 

10 the drug approved under such section 505 

11 of the Federal Food, Drug, and Cosmetic 

12 Act or licensed under section 351 of the 

13 Public Health Service Act; 

14 ‘‘(D) a description of the history of the 

15 manufacturer’s price increases for the drug 

16 since the approval of the application for the 

17 drug under section 505 of the Federal Food, 

18 Drug, and Cosmetic Act or the issuance of the 

19 license for the drug under section 351 of the 

20 Public Health Service Act, or since the manu21 facturer acquired such approved application or 

22 license, if applicable; 

23 ‘‘(E) the current wholesale acquisition cost 

24 of the drug; 


pamtmann on DSKBC07HB2PROD with BILLS
84 

•S 2164 IS

1 ‘‘(F) the total expenditures of the manu2 facturer on— 

3 ‘‘(i) materials and manufacturing for 

4 such drug; and 

5 ‘‘(ii) acquiring patents and licensing 

6 for such drug; 

7 ‘‘(G) the percentage of total expenditures 

8 of the manufacturer on research and develop9 ment for such drug that was derived from Fed10 eral funds; 

11 ‘‘(H) the total expenditures of the manu12 facturer on research and development for such 

13 drug that is necessary to demonstrate that it 

14 meets applicable statutory standards for ap15 proval under section 505 of the Federal Food, 

16 Drug, and Cosmetic Act or licensure under sec17 tion 351 of the Public Health Service Act, as 

18 applicable; 

19 ‘‘(I) the total expenditures of the manufac20 turer on pursuing new or expanded indications 

21 or dosage changes for such drug under section 

22 505 of the Federal Food, Drug, and Cosmetic 

23 Act or section 351 of the Public Health Service 

24 Act; 


pamtmann on DSKBC07HB2PROD with BILLS
85 

•S 2164 IS

1 ‘‘(J) the total expenditures of the manufac2 turer on carrying out postmarket requirements 

3 related to such drug, including under section 

4 505(o)(3) of the Federal Food, Drug, and Cos5 metic Act; 

6 ‘‘(K) the total revenue and the net profit 

7 generated from the qualifying drug for each cal8 endar year since the approval of the application 

9 for the drug under section 505 of the Federal 

10 Food, Drug, and Cosmetic Act or the issuance 

11 of the license for the drug under section 351 of 

12 the Public Health Service Act, or since the 

13 manufacturer acquired such approved applica14 tion or license; and 

15 ‘‘(L) the total costs associated with mar16 keting and advertising for the qualifying drug; 

17 ‘‘(2) with respect to the manufacturer— 

18 ‘‘(A) the total revenue and the net profit 

19 of the manufacturer for each of the 1-year pe20 riod described in subsection (b)(1)(A) or the 3- 

21 year period described in subsection (b)(1)(B), 

22 as applicable; 

23 ‘‘(B) all stock-based performance metrics 

24 used by the manufacturer to determine execu25 tive compensation for each of the 1-year period 


pamtmann on DSKBC07HB2PROD with BILLS
86 

•S 2164 IS

1 described in subsection (b)(1)(A) or the 3-year 

2 period described in subsection (b)(1)(B), as ap3 plicable; and 

4 ‘‘(C) any additional information the manu5 facturer chooses to provide related to drug pric6 ing decisions, such as total expenditures on— 

7 ‘‘(i) drug research and development; 

8 or 

9 ‘‘(ii) clinical trials, including on drugs 

10 that failed to receive approval by the Food 

11 and Drug Administration; and 

12 ‘‘(3) such other related information as the Sec13 retary considers appropriate and as specified by the 

14 Secretary through notice-and-comment rulemaking. 

15 ‘‘(d) INFORMATION PROVIDED.—The manufacturer 

16 of a qualifying drug that is required to submit a report 

17 under subsection (b), shall ensure that such report and 

18 any explanation for, and description of, each price increase 

19 described in subsection (c)(1)(B) shall be truthful, not 

20 misleading, and accurate. 

21 ‘‘(e) CIVIL MONETARY PENALTY.—Any manufac22 turer of a qualifying drug that fails to submit a report 

23 for the drug as required by this section, following notifica24 tion by the Secretary to the manufacturer that the manu25 facturer is not in compliance with this section, shall be 


pamtmann on DSKBC07HB2PROD with BILLS
87 

•S 2164 IS

1 subject to a civil monetary penalty of $75,000 for each 

2 day on which the violation continues. 

3 ‘‘(f) FALSE INFORMATION.—Any manufacturer that 

4 submits a report for a drug as required by this section 

5 that knowingly provides false information in such report 

6 is subject to a civil monetary penalty in an amount not 

7 to exceed $75,000 for each item of false information. 

8 ‘‘(g) PUBLIC POSTING.— 

9 ‘‘(1) IN GENERAL.—Subject to paragraph (3), 

10 the Secretary shall post each report submitted under 

11 subsection (b) on the public website of the Depart12 ment of Health and Human Services the day the 

13 price increase of a qualifying drug is scheduled to go 

14 into effect. 

15 ‘‘(2) FORMAT.—In developing the format in 

16 which reports will be publicly posted under para17 graph (1), the Secretary shall consult with stake18 holders, including beneficiary groups, and shall seek 

19 feedback from consumer advocates and readability 

20 experts on the format and presentation of the con21 tent of such reports to ensure that such reports 

22 are— 

23 ‘‘(A) user-friendly to the public; and 

24 ‘‘(B) written in plain language that con25 sumers can readily understand. 


pamtmann on DSKBC07HB2PROD with BILLS
88 

•S 2164 IS

1 ‘‘(3) PROTECTED INFORMATION.—Nothing in 

2 this section shall be construed to authorize the pub3 lic disclosure of information submitted by a manu4 facturer that is prohibited from disclosure by appli5 cable laws concerning the protection of trade secrets, 

6 commercial information, and other information cov7 ered under such laws. 

8 ‘‘(h) ANNUAL REPORT TO CONGRESS.— 

9 ‘‘(1) IN GENERAL.—Subject to paragraph (2), 

10 the Secretary shall submit to Congress, and post on 

11 the public website of the Department of Health and 

12 Human Services in a way that is user-friendly to the 

13 public and written in plain language that consumers 

14 can readily understand, an annual report— 

15 ‘‘(A) summarizing the information re16 ported pursuant to this section; 

17 ‘‘(B) including copies of the reports and 

18 supporting detailed economic analyses sub19 mitted pursuant to this section; 

20 ‘‘(C) detailing the costs and expenditures 

21 incurred by the Department of Health and 

22 Human Services in carrying out this section; 

23 and 

24 ‘‘(D) explaining how the Department of 

25 Health and Human Services is improving conVerDate Sep 11 2014 16:42 Jun 25, 2021 Jkt 019200 PO 00000 Frm 00088 Fmt 6652 Sfmt 6201 E:\BILLS\S2164.IS S2164

pamtmann on DSKBC07HB2PROD with BILLS
89 

•S 2164 IS

1 sumer and provider information about drug 

2 value and drug price transparency. 

3 ‘‘(2) PROTECTED INFORMATION.—Nothing in 

4 this subsection shall be construed to authorize the 

5 public disclosure of information submitted by a man6 ufacturer that is prohibited from disclosure by appli7 cable laws concerning the protection of trade secrets, 

8 commercial information, and other information cov9 ered under such laws.’’. 

10 (b) EFFECTIVE DATE.—The amendment made by 

11 subsection (a) shall take effect on the date of enactment 

12 of this Act. 

13 SEC. 202. PUBLIC DISCLOSURE OF DRUG DISCOUNTS. 

14 Section 1150A of the Social Security Act (42 U.S.C. 

15 1320b–23) is amended— 

16 (1) in subsection (c), in the matter preceding 

17 paragraph (1), by inserting ‘‘(other than as per18 mitted under subsection (e))’’ after ‘‘disclosed by the 

19 Secretary’’; and 

20 (2) by adding at the end the following new sub21 section: 

22 ‘‘(e) PUBLIC AVAILABILITY OF CERTAIN INFORMA23 TION.— 

24 ‘‘(1) IN GENERAL.—In order to allow the com25 parison of PBMs’ ability to negotiate rebates, disVerDate Sep 11 2014 16:42 Jun 25, 2021 Jkt 019200 PO 00000 Frm 00089 Fmt 6652 Sfmt 6201 E:\BILLS\S2164.IS S2164

pamtmann on DSKBC07HB2PROD with BILLS
90 

•S 2164 IS

1 counts, direct and indirect remuneration fees, ad2 ministrative fees, and price concessions and the 

3 amount of such rebates, discounts, direct and indi4 rect remuneration fees, administrative fees, and 

5 price concessions that are passed through to plan 

6 sponsors, beginning January 1, 2022, the Secretary 

7 shall make available on the internet website of the 

8 Department of Health and Human Services the in9 formation with respect to the second preceding cal10 endar year provided to the Secretary on generic dis11 pensing rates (as described in paragraph (1) of sub12 section (b)) and information provided to the Sec13 retary under paragraphs (2) and (3) of such sub14 section that, as determined by the Secretary, is with 

15 respect to each PBM. 

16 ‘‘(2) AVAILABILITY OF DATA.—In carrying out 

17 paragraph (1), the Secretary shall ensure the fol18 lowing: 

19 ‘‘(A) CONFIDENTIALITY.—The information 

20 described in such paragraph is displayed in a 

21 manner that prevents the disclosure of informa22 tion, with respect to an individual drug or an 

23 individual plan, on rebates, discounts, direct 

24 and indirect remuneration fees, administrative 

25 fees, and price concessions. 


pamtmann on DSKBC07HB2PROD with BILLS
91 

•S 2164 IS

1 ‘‘(B) CLASS OF DRUG.—The information 

2 described in such paragraph is made available 

3 by class of drug, using an existing classification 

4 system, but only if the class contains such num5 ber of drugs, as specified by the Secretary (but 

6 not fewer than three drugs), to ensure confiden7 tiality of proprietary information or other infor8 mation that is prevented to be disclosed under 

9 subparagraph (A).’’. 

10 SEC. 203. MAKING PRESCRIPTION DRUG MARKETING SAM11 PLE INFORMATION REPORTED BY MANUFAC12 TURERS AVAILABLE TO CERTAIN INDIVID13 UALS AND ENTITIES. 

14 (a) IN GENERAL.—Section 1128H of the Social Secu15 rity Act (42 U.S.C. 1320a–7i) is amended— 

16 (1) by redesignating subsection (b) as sub17 section (e); and 

18 (2) by inserting after subsection (a) the fol19 lowing new subsections: 

20 ‘‘(b) DATA SHARING AGREEMENTS.— 

21 ‘‘(1) IN GENERAL.—The Secretary shall enter 

22 into agreements with the specified data sharing indi23 viduals and entities described in paragraph (2) 

24 under which— 


pamtmann on DSKBC07HB2PROD with BILLS
92 

•S 2164 IS

1 ‘‘(A) upon request of such an individual or 

2 entity, as applicable, the Secretary makes avail3 able to such individual or entity the information 

4 submitted under subsection (a) by manufactur5 ers and authorized distributors of record; and 

6 ‘‘(B) such individual or entity agrees to 

7 not disclose publicly or to another individual or 

8 entity any information that identifies a par9 ticular practitioner or health care facility. 

10 ‘‘(2) SPECIFIED DATA SHARING INDIVIDUALS

11 AND ENTITIES.—For purposes of paragraph (1), the 

12 specified data sharing individuals and entities de13 scribed in this paragraph are the following: 

14 ‘‘(A) OVERSIGHT AGENCIES.—Health over15 sight agencies (as defined in section 164.501 of 

16 title 45, Code of Federal Regulations), includ17 ing the Centers for Medicare & Medicaid Serv18 ices, the Office of the Inspector General of the 

19 Department of Health and Human Services, the 

20 Government Accountability Office, the Congres21 sional Budget Office, the Medicare Payment 

22 Advisory Commission, and the Medicaid and 

23 CHIP Payment and Access Commission. 

24 ‘‘(B) RESEARCHERS.—Individuals who 

25 conduct scientific research (as defined in secVerDate Sep 11 2014 16:42 Jun 25, 2021 Jkt 019200 PO 00000 Frm 00092 Fmt 6652 Sfmt 6201 E:\BILLS\S2164.IS S2164

pamtmann on DSKBC07HB2PROD with BILLS
93 

•S 2164 IS

1 tion 164.501 of title 45, Code of Federal Regu2 lations) in relevant areas as determined by the 

3 Secretary. 

4 ‘‘(C) PAYERS.—Private and public health 

5 care payers, including group health plans, 

6 health insurance coverage offered by health in7 surance issuers, Federal health programs, and 

8 State health programs. 

9 ‘‘(3) EXEMPTION FROM FREEDOM OF INFORMA10 TION ACT.—Except as described in paragraph (1), 

11 the Secretary may not be compelled to disclose the 

12 information submitted under subsection (a) to any 

13 individual or entity. For purposes of section 552 of 

14 title 5, United States Code (commonly referred to as 

15 the Freedom of Information Act), this paragraph 

16 shall be considered a statute described in subsection 

17 (b)(3)(B) of such section. 

18 ‘‘(c) PENALTIES.— 

19 ‘‘(1) DATA SHARING AGREEMENTS.—Subject to 

20 paragraph (3), any specified data sharing individual 

21 or entity described in subsection (b)(2) that violates 

22 the terms of a data sharing agreement the individual 

23 or entity has with the Secretary under subsection 

24 (b)(1) shall be subject to a civil money penalty of 

25 not less than $1,000, but not more than $10,000, 


pamtmann on DSKBC07HB2PROD with BILLS
94 

•S 2164 IS

1 for each such violation. Such penalty shall be im2 posed and collected in the same manner as civil 

3 money penalties under subsection (a) of section 

4 1128A are imposed and collected under that section. 

5 ‘‘(2) FAILURE TO REPORT.—Subject to para6 graph (3), any manufacturer or authorized dis7 tributor of record of an applicable drug under sub8 section (a) that fails to submit information required 

9 under such subsection in a timely manner in accord10 ance with rules or regulations promulgated to carry 

11 out such subsection shall be subject to a civil money 

12 penalty of not less than $1,000, but not more than 

13 $10,000, for each such failure. Such penalty shall be 

14 imposed and collected in the same manner as civil 

15 money penalties under subsection (a) of section 

16 1128A are imposed and collected under that section. 

17 ‘‘(3) LIMITATION.—The total amount of civil 

18 money penalties imposed under paragraph (1) or (2) 

19 with respect to a year and an individual or entity de20 scribed in paragraph (1) or a manufacturer or dis21 tributor described in paragraph (2), respectively, 

22 shall not exceed $150,000. 

23 ‘‘(d) DRUG SAMPLE DISTRIBUTION INFORMATION.— 

24 ‘‘(1) IN GENERAL.—Not later than January 1 

25 of each year (beginning with 2022), the Secretary 


pamtmann on DSKBC07HB2PROD with BILLS
95 

•S 2164 IS

1 shall maintain a list containing information related 

2 to the distribution of samples of applicable drugs. 

3 Such list shall provide the following information with 

4 respect to the preceding year: 

5 ‘‘(A) The name of the manufacturer or au6 thorized distributor of record of an applicable 

7 drug for which samples were requested or dis8 tributed under this section. 

9 ‘‘(B) The quantity and class of drug sam10 ples requested. 

11 ‘‘(C) The quantity and class of drug sam12 ples distributed. 

13 ‘‘(2) PUBLIC AVAILABILITY.—The Secretary 

14 shall make the information in such list available to 

15 the public on the internet website of the Food and 

16 Drug Administration.’’. 

17 (b) FDA MAINTENANCE OF INFORMATION.—The 

18 Food and Drug Administration shall maintain information 

19 available to affected reporting companies to ensure their 

20 ability to fully comply with the requirements of section 

21 1128H of the Social Security Act. 

22 (c) PROHIBITION ON DISTRIBUTION OF SAMPLES OF

23 OPIOIDS.—Section 503(d) of the Federal Food, Drug, and 

24 Cosmetic Act (21 U.S.C. 353(d)) is amended— 


pamtmann on DSKBC07HB2PROD with BILLS
96 

•S 2164 IS

1 (1) by moving the margin of paragraph (4) 2 

2 ems to the left; and 

3 (2) by adding at the end the following: 

4 ‘‘(5) No person may distribute a drug sample of a 

5 drug that is— 

6 ‘‘(A) an applicable drug (as defined in section 

7 1128H(e) of the Social Security Act); 

8 ‘‘(B) a controlled substance (as defined in sec9 tion 102 of the Controlled Substances Act) for which 

10 the findings required under section 202(b)(2) of 

11 such Act have been made; and 

12 ‘‘(C) approved under section 505 for use in the 

13 management or treatment of pain (other than for 

14 the management or treatment of a substance use 

15 disorder).’’. 

16 (d) MEDPAC REPORT.—Not later than 3 years after 

17 the date of the enactment of this Act, the Medicare Pay18 ment Advisory Commission shall conduct a study on the 

19 impact of drug samples on provider prescribing practices 

20 and health care costs and may, as the Commission deems 

21 appropriate, make recommendations on such study. 

22 SEC. 204. SENSE OF THE SENATE REGARDING THE NEED TO 

23 EXPAND COMMERCIALLY AVAILABLE DRUG 

24 PRICING COMPARISON PLATFORMS. 

25 It is the sense of the Senate that— 


pamtmann on DSKBC07HB2PROD with BILLS
97 

•S 2164 IS

1 (1) commercially available drug pricing com2 parison platforms can, at no cost, help patients find 

3 the lowest price for their medications at their local 

4 pharmacy; 

5 (2) such platforms should be integrated, to the 

6 maximum extent possible, in the health care delivery 

7 ecosystem; and 

8 (3) pharmacy benefit managers should work to 

9 disclose generic and brand name drug prices to such 

10 platforms to ensure that— 

11 (A) patients can benefit from the lowest 

12 possible price available to them; and 

13 (B) overall drug prices can be reduced as 

14 more educated purchasing decisions are made 

15 based on price transparency. 

16 TITLE III—REVENUE PROVISION 

17 SEC. 301. INCLUSION OF INSULIN AND OTHER TREAT18 MENTS FOR CHRONIC CONDITIONS AS PRE19 VENTIVE CARE. 

20 (a) IN GENERAL.—Subparagraph (C) of section 

21 223(c)(2) of the Internal Revenue Code of 1986 is amend22 ed— 

23 (1) by striking ‘‘DEDUCTIBLE.—A plan’’ and 

24 inserting ‘‘DEDUCTIBLE.— 

25 ‘‘(i) IN GENERAL.—A plan’’, and 


pamtmann on DSKBC07HB2PROD with BILLS
98 

•S 2164 IS

1 (2) by adding at the end the following new 

2 clause: 

3 ‘‘(ii) SPECIAL RULE.—The term ‘pre4 ventive care’ includes such drugs (includ5 ing insulin), devices, supplies, and medical 

6 services or screenings prescribed for the 

7 prevention or avoidance of a disease or 

8 condition, or the regular treatment and 

9 maintenance of a chronic disease or condi10 tion, as are determined by the Secretary, 

11 in consultation with the Secretary of 

12 Health and Human Services, to be— 

13 ‘‘(I) low in cost, 

14 ‘‘(II) supported by medical evi15 dence to have a high cost efficiency in 

16 preventing exacerbation of a chronic 

17 condition or the development of a sec18 ondary condition, and 

19 ‘‘(III) likely (as documented by 

20 clinical evidence), when prescribed for 

21 a class of individuals, to prevent exac22 erbation of the chronic condition of 

23 such individuals or the development of 

24 a secondary condition requiring sig25 nificantly higher cost treatments.’’. 


pamtmann on DSKBC07HB2PROD with BILLS
99 

•S 2164 IS

1 (b) EFFECTIVE DATE.— 

2 (1) IN GENERAL.—The amendments made by 

3 this section shall apply to taxable years beginning 

4 after the date of the enactment of this Act. 

5 (2) TREASURY GUIDANCE IN EFFECT ON DATE

6 OF ENACTMENT.— 

7 (A) IN GENERAL.—No inference shall be 

8 drawn by reason of the amendments made by 

9 this Act with respect to the effectiveness of the 

10 provisions of Internal Revenue Service Notice 

11 2019-45 on the date of the enactment of this 

12 Act, and such notice shall continue to apply as 

13 in effect on July 17, 2019, unless amended by 

14 the Secretary of the Treasury (or the Sec15 retary’s delegate) pursuant to the amendments 

16 made by this Act or pursuant to subparagraph 

17 (B). 

18 (B) CONTINUED PUBLICATION AND UP19 DATE OF LIST.— 

20 (i) IN GENERAL.—The Secretary of 

21 the Treasury (or the Secretary’s delegate) 

22 may publish, and update from time to time 

23 as such Secretary (or delegate) deems ap24 propriate, a list of the drugs, devices, sup25 plies, and services identified under section 


pamtmann on DSKBC07HB2PROD with BILLS
100 

•S 2164 IS

1 223(c)(2)(C)(ii) of the Internal Revenue 

2 Code of 1986, in consultation with the Sec3 retary of Health and Human Services (or 

4 such Secretary’s delegate), as preventive 

5 care. 

6 (ii) INCLUSION OF CERTAIN DIABETIC

7 SUPPLIES.—As soon as practicable after 

8 the date of the enactment of this Act, the 

9 list in effect under Internal Revenue Serv10 ice Notice 2019-45 shall be amended to in11 clude insulin delivery devices and related 

12 supplies, and continuous glucose moni13 toring systems and related supplies. 

14 TITLE IV—MISCELLANEOUS 

15 PROVISIONS 

16 SEC. 401. IMPROVING COORDINATION BETWEEN THE FOOD 

17 AND DRUG ADMINISTRATION AND THE CEN18 TERS FOR MEDICARE & MEDICAID SERVICES. 

19 (a) IN GENERAL.— 

20 (1) PUBLIC MEETING.— 

21 (A) IN GENERAL.—Not later than 12 

22 months after the date of the enactment of this 

23 Act, the Secretary of Health and Human Serv24 ices (referred to in this section as the ‘‘Sec25 retary’’) shall convene a public meeting for the 


pamtmann on DSKBC07HB2PROD with BILLS
101 

•S 2164 IS

1 purposes of discussing and providing input on 

2 improvements to coordination between the Food 

3 and Drug Administration and the Centers for 

4 Medicare & Medicaid Services in preparing for 

5 the availability of novel medical products de6 scribed in subsection (c) on the market in the 

7 United States. 

8 (B) ATTENDEES.—The public meeting 

9 shall include— 

10 (i) representatives of relevant Federal 

11 agencies, including representatives from 

12 each of the medical product centers within 

13 the Food and Drug Administration and 

14 representatives from the coding, coverage, 

15 and payment offices within the Centers for 

16 Medicare & Medicaid Services; 

17 (ii) stakeholders with expertise in the 

18 research and development of novel medical 

19 products, including manufacturers of such 

20 products; 

21 (iii) representatives of commercial 

22 health insurance payers; 

23 (iv) stakeholders with expertise in the 

24 administration and use of novel medical 

25 products, including physicians; and 


pamtmann on DSKBC07HB2PROD with BILLS
102 

•S 2164 IS

1 (v) stakeholders representing patients 

2 and with expertise in the utilization of pa3 tient experience data in medical product 

4 development. 

5 (C) TOPICS.—The public meeting shall in6 clude a discussion of— 

7 (i) the status of the drug and medical 

8 device development pipeline related to the 

9 availability of novel medical products; 

10 (ii) the anticipated expertise necessary 

11 to review the safety and effectiveness of 

12 such products at the Food and Drug Ad13 ministration and current gaps in such ex14 pertise, if any; 

15 (iii) the expertise necessary to make 

16 coding, coverage, and payment decisions 

17 with respect to such products within the 

18 Centers for Medicare & Medicaid Services, 

19 and current gaps in such expertise, if any; 

20 (iv) trends in the differences in the 

21 data necessary to determine the safety and 

22 effectiveness of a novel medical product 

23 and the data necessary to determine 

24 whether a novel medical product meets the 

25 reasonable and necessary requirements for 


pamtmann on DSKBC07HB2PROD with BILLS
103 

•S 2164 IS

1 coverage and payment under title XVIII of 

2 the Social Security Act pursuant to section 

3 1862(a)(1)(A) of such Act (42 U.S.C. 

4 1395y(a)(1)(A)); 

5 (v) the availability of information for 

6 sponsors of such novel medical products to 

7 meet each of those requirements; and 

8 (vi) the coordination of information 

9 related to significant clinical improvement 

10 over existing therapies for patients between 

11 the Food and Drug Administration and the 

12 Centers for Medicare & Medicaid Services 

13 with respect to novel medical products. 

14 (D) TRADE SECRETS AND CONFIDENTIAL

15 INFORMATION.—No information discussed as a 

16 part of the public meeting under this paragraph 

17 shall be construed as authorizing the Secretary 

18 to disclose any information that is a trade se19 cret or confidential information subject to sec20 tion 552(b)(4) of title 5, United States Code. 

21 (2) IMPROVING TRANSPARENCY OF CRITERIA

22 FOR MEDICARE COVERAGE.— 

23 (A) DRAFT GUIDANCE.—Not later than 18 

24 months after the public meeting under para25 graph (1), the Secretary shall update the final 


pamtmann on DSKBC07HB2PROD with BILLS
104 

•S 2164 IS

1 guidance titled ‘‘National Coverage Determina2 tions with Data Collection as a Condition of 

3 Coverage: Coverage with Evidence Develop4 ment’’ to address any opportunities to improve 

5 the availability and coordination of information 

6 as described in clauses (iv) through (vi) of para7 graph (1)(C). 

8 (B) FINAL GUIDANCE.—Not later than 12 

9 months after issuing draft guidance under sub10 paragraph (A), the Secretary shall finalize the 

11 updated guidance to address any such opportu12 nities. 

13 (b) REPORT ON CODING, COVERAGE, AND PAYMENT

14 PROCESSES UNDER MEDICARE FOR NOVEL MEDICAL

15 PRODUCTS.—Not later than 12 months after the date of 

16 the enactment of this Act, the Secretary shall publish a 

17 report on the internet website of the Department of 

18 Health and Human Services regarding processes under 

19 the Medicare program under title XVIII of the Social Se20 curity Act (42 U.S.C. 1395 et seq.) with respect to the 

21 coding, coverage, and payment of novel medical products 

22 described in subsection (c). Such report shall include the 

23 following: 


pamtmann on DSKBC07HB2PROD with BILLS
105 

•S 2164 IS

1 (1) A description of challenges in the coding, 

2 coverage, and payment processes under the Medicare 

3 program for novel medical products. 

4 (2) Recommendations to— 

5 (A) incorporate patient experience data 

6 (such as the impact of a disease or condition on 

7 the lives of patients and patient treatment pref8 erences) into the coverage and payment proc9 esses within the Centers for Medicare & Med10 icaid Services; 

11 (B) decrease the length of time to make 

12 national and local coverage determinations 

13 under the Medicare program (as those terms 

14 are defined in subparagraph (A) and (B), re15 spectively, of section 1862(l)(6) of the Social 

16 Security Act (42 U.S.C. 1395y(l)(6))); 

17 (C) streamline the coverage process under 

18 the Medicare program and incorporate input 

19 from relevant stakeholders into such coverage 

20 determinations; and 

21 (D) identify potential mechanisms to incor22 porate novel payment designs similar to those 

23 in development in commercial insurance plans 

24 and State plans under title XIX of such Act 


pamtmann on DSKBC07HB2PROD with BILLS
106 

•S 2164 IS

1 (42 U.S.C. 1396 et seq.) into the Medicare pro2 gram. 

3 (c) NOVEL MEDICAL PRODUCTS DESCRIBED.—For 

4 purposes of this section, a novel medical product described 

5 in this subsection is a medical product, including a drug, 

6 biological (including gene and cell therapy), or medical de7 vice, that has been designated as a breakthrough therapy 

8 under section 506(a) of the Federal Food, Drug, and Cos9 metic Act (21 U.S.C. 356(a)), a breakthrough device 

10 under section 515B of such Act (21 U.S.C. 360e–3), or 

11 a regenerative advanced therapy under section 506(g) of 

12 such Act (21 U.S.C. 356(g)). 

13 SEC. 402. PATIENT CONSULTATION IN MEDICARE NA14 TIONAL AND LOCAL COVERAGE DETERMINA15 TIONS IN ORDER TO MITIGATE BARRIERS TO 

16 INCLUSION OF SUCH PERSPECTIVES. 

17 Section 1862(l) of the Social Security Act (42 U.S.C. 

18 1395y(l)) is amended by adding at the end the following 

19 new paragraph: 

20 ‘‘(7) PATIENT CONSULTATION IN NATIONAL

21 AND LOCAL COVERAGE DETERMINATIONS.—The Sec22 retary may consult with patients and organizations 

23 representing patients in making national and local 

24 coverage determinations.’’. 


pamtmann on DSKBC07HB2PROD with BILLS
107 

•S 2164 IS

1 SEC. 403. MEDPAC REPORT ON SHIFTING COVERAGE OF 

2 CERTAIN MEDICARE PART B DRUGS TO MEDI3 CARE PART D. 

4 (a) STUDY.—The Medicare Payment Advisory Com5 mission (in this section referred to as the ‘‘Commission’’) 

6 shall conduct a study on shifting coverage of certain drugs 

7 and biologicals for which payment is currently made under 

8 part B of title XVIII of the Social Security Act (42 U.S.C. 

9 1395j et seq.) to part D of such title (42 U.S.C. 1395w– 

10 21 et seq.). Such study shall include an analysis of— 

11 (1) differences in program structures and pay12 ment methods for drugs and biologicals covered 

13 under such parts B and D, including effects of such 

14 a shift on program spending, beneficiary cost-shar15 ing liability, and utilization management techniques 

16 for such drugs and biologicals; and 

17 (2) the feasibility and policy implications of 

18 shifting coverage of drugs and biologicals for which 

19 payment is currently made under such part B to 

20 such part D. 

21 (b) REPORT.— 

22 (1) IN GENERAL.—Not later than June 30, 

23 2023, the Commission shall submit to Congress a re24 port containing the results of the study conducted 

25 under subsection (a). 


pamtmann on DSKBC07HB2PROD with BILLS
108 

•S 2164 IS

1 (2) CONTENTS.—The report under paragraph 

2 (1) shall include information, and recommendations 

3 as the Commission deems appropriate, regarding— 

4 (A) formulary design under such part D; 

5 (B) the ability of the benefit structure 

6 under such part D to control total spending on 

7 drugs and biologicals for which payment is cur8 rently made under such part B; 

9 (C) changes to the bid process under such 

10 part D, if any, that may be necessary to inte11 grate coverage of such drugs and biologicals 

12 into such part D; 

13 (D) any other changes to the program that 

14 Congress should consider in determining wheth15 er to shift coverage of such drugs and 

16 biologicals from such part B to such part D; 

17 and 

18 (E) the feasibility and policy implications 

19 of creating a methodology to preserve the 

20 healthcare provider’s ability to take title of the 

21 drug, including a methodology under which— 

22 (i) prescription drug plans negotiate 

23 reimbursement rates and other arrange24 ments with drug manufacturers on behalf 

25 of a wholesaler; 


pamtmann on DSKBC07HB2PROD with BILLS
109 

•S 2164 IS

1 (ii) wholesalers purchase the drugs 

2 from the manufacturers at the negotiated 

3 rate and ship them through distributors to 

4 physicians to administer to patients; 

5 (iii) physicians and hospitals purchase 

6 the drug from the wholesaler via the dis7 tributor; 

8 (iv) after administering the drug, the 

9 physician submits a claim to the MAC for 

10 their drug administration fee; 

11 (v) to be reimbursed for the purchase 

12 of the drug from the distributor, the physi13 cian furnishes the claim for the drug itself 

14 to the wholesaler and the wholesaler would 

15 refund the cost of the drug to the physi16 cian; and 

17 (vi) the wholesaler passes this claim to 

18 the PDP to receive reimbursement. 

19 SEC. 404. AUTHORITY TO REQUIRE THAT DIRECT-TO-CON20 SUMER ADVERTISEMENTS FOR PRESCRIP21 TION DRUGS AND BIOLOGICAL PRODUCTS IN22 CLUDE TRUTHFUL AND NON-MISLEADING 

23 PRICING INFORMATION. 

24 Part A of title XI of the Social Security Act is 

25 amended by adding at the end the following new section: 


pamtmann on DSKBC07HB2PROD with BILLS
110 

•S 2164 IS

1 ‘‘SEC. 1150D. AUTHORITY TO REQUIRE THAT DIRECT-TO2 CONSUMER ADVERTISEMENTS FOR PRE3 SCRIPTION DRUGS AND BIOLOGICAL PROD4 UCTS INCLUDE TRUTHFUL AND NON-MIS5 LEADING PRICING INFORMATION. 

6 ‘‘(a) IN GENERAL.—The Secretary may require that 

7 each direct-to-consumer advertisement for a prescription 

8 drug or biological product for which payment is available 

9 under title XVIII or XIX includes an internet website ad10 dress that provides an appropriate disclosure of truthful 

11 and non-misleading pricing information with respect to the 

12 drug or product. 

13 ‘‘(b) DETERMINATION BY CMS.—The Secretary, act14 ing through the Administrator of the Centers for Medicare 

15 & Medicaid Services, shall determine the components of 

16 the requirement under subsection (a), such as the forms 

17 of advertising, the manner of disclosure, the price point 

18 listing, and the price information for disclosure.’’. 

19 SEC. 405. CHIEF PHARMACEUTICAL NEGOTIATOR AT THE 

20 OFFICE OF THE UNITED STATES TRADE REP21 RESENTATIVE. 

22 (a) IN GENERAL.—Section 141 of the Trade Act of 

23 1974 (19 U.S.C. 2171) is amended— 

24 (1) in subsection (b)(2)— 

25 (A) by striking ‘‘and one Chief Innovation 

26 and Intellectual Property Negotiator’’ and inVerDate Sep 11 2014 16:42 Jun 25, 2021 Jkt 019200 PO 00000 Frm 00110 Fmt 6652 Sfmt 6201 E:\BILLS\S2164.IS S2164

pamtmann on DSKBC07HB2PROD with BILLS
111 

•S 2164 IS

1 serting ‘‘one Chief Innovation and Intellectual 

2 Property Negotiator, and one Chief Pharma3 ceutical Negotiator’’; 

4 (B) by striking ‘‘or the Chief Innovation 

5 and Intellectual Property Negotiator’’ and in6 serting ‘‘the Chief Innovation and Intellectual 

7 Property Negotiator, or the Chief Pharma8 ceutical Negotiator’’; and 

9 (C) by striking ‘‘and the Chief Innovation 

10 and Intellectual Property Negotiator’’ and in11 serting ‘‘the Chief Innovation and Intellectual 

12 Property Negotiator, and the Chief Pharma13 ceutical Negotiator’’; and 

14 (2) in subsection (c), by adding at the end the 

15 following new paragraph: 

16 ‘‘(7) The principal function of the Chief Phar17 maceutical Negotiator shall be to conduct trade ne18 gotiations and to enforce trade agreements relating 

19 to United States pharmaceutical products and serv20 ices. The Chief Pharmaceutical Negotiator shall be 

21 a vigorous advocate on behalf of United States phar22 maceutical interests. The Chief Pharmaceutical Ne23 gotiator shall perform such other functions as the 

24 United States Trade Representative may direct.’’. 


pamtmann on DSKBC07HB2PROD with BILLS
112 

•S 2164 IS

1 (b) COMPENSATION.—Section 5314 of title 5, United 

2 States Code, is amended by striking ‘‘Chief Innovation 

3 and Intellectual Property Negotiator, Office of the United 

4 States Trade Representative.’’ and inserting the following: 

5 ‘‘Chief Innovation and Intellectual Property Ne6 gotiator, Office of the United States Trade Rep7 resentative. 

8 ‘‘Chief Pharmaceutical Negotiator, Office of the 

9 United States Trade Representative.’’. 

10 (c) REPORT REQUIRED.—Not later than the date 

11 that is one year after the appointment of the first Chief 

12 Pharmaceutical Negotiator pursuant to paragraph (2) of 

13 section 141(b) of the Trade Act of 1974, as amended by 

14 subsection (a), and annually thereafter, the United States 

15 Trade Representative shall submit to the Committee on 

16 Finance of the Senate and the Committee on Ways and 

17 Means of the House of Representatives a report describing 

18 in detail— 

19 (1) enforcement actions taken by the United 

20 States Trade Representative during the 1-year pe21 riod preceding the submission of the report to en22 sure the protection of United States pharmaceutical 

23 products and services; and 


pamtmann on DSKBC07HB2PROD with BILLS
113 

•S 2164 IS

1 (2) other actions taken by the United States 

2 Trade Representative to advance United States 

3 pharmaceutical products and services. 

Æ 


pamtmann on DSKBC07HB2PROD with BILLS