IB 

Union Calendar No. 571 

116TH CONGRESS 

2D SESSION H. R. 2113 

[Report No. 116–688, Part I] 

To amend titles XI and XVIII of the Social Security Act to provide for 

drug manufacturer price transparency, to require certain manufacturers 

to report on product samples provided to certain health care providers, 

and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

APRIL 8, 2019 

Mr. NEAL (for himself and Mr. BRADY) introduced the following bill; which 

was referred to the Committee on Ways and Means, and in addition to 

the Committee on Energy and Commerce, for a period to be subsequently 

determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned 

DECEMBER 24, 2020 

Additional sponsors: Mr. VAN DREW, Ms. FINKENAUER, Ms. HOULAHAN, Mr. 

RASKIN, Mr. MCADAMS, Ms. UNDERWOOD, Ms. SLOTKIN, Mr. LIPINSKI, 

Ms. LOFGREN, and Mr. AMODEI

DECEMBER 24, 2020 

Reported from the Committee on Ways and Means with an amendment 

[Strike out all after the enacting clause and insert the part printed in italic] 

DECEMBER 24, 2020 

Committee on Energy and Commerce discharged; committed to the Committee 

of the Whole House on the State of the Union and ordered to be printed 

[For text of introduced bill, see copy of bill as introduced on April 8, 2019] 


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A BILL 

To amend titles XI and XVIII of the Social Security Act 

to provide for drug manufacturer price transparency, 

to require certain manufacturers to report on product 

samples provided to certain health care providers, and 

for other purposes. 


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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 ‘‘Prescription Drug Sun5 shine, Transparency, Accountability and Reporting Act’’ or 

6 the ‘‘Prescription Drug STAR Act’’. 

7 SEC. 2. DRUG MANUFACTURER PRICE TRANSPARENCY. 

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

9 (42 U.S.C. 1301 et seq.) is amended by inserting after sec10 tion 1128K the following new section: 

11 ‘‘SEC. 1128L. DRUG MANUFACTURER PRICE TRANSPARENCY. 

12 ‘‘(a) IN GENERAL.—With respect to each year, begin13 ning with 2021, the Secretary shall, at least once during 

14 such year, determine if there is a triggered SPIKE increase 

15 (in accordance with subsection (b)) with respect to an ap16 plicable drug (as defined in subsection (f)(1)). If the Sec17 retary determines, with respect to a year, there is such an 

18 increase with respect to an applicable drug, the manufac19 turer of the applicable drug shall submit to the Secretary 

20 the justification described in subsection (c), subject to sub21 section (b)(4), for each such triggered SPIKE increase in 

22 accordance with the timing described in subsection (d)). 

23 ‘‘(b) TRIGGERED SPIKE INCREASE.— 

24 ‘‘(1) IN GENERAL.—A triggered SPIKE increase 

25 occurs, with respect an applicable drug and year (beVerDate Sep 11 2014 18:10 Dec 26, 2020 Jkt 019200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6203 E:\BILLS\H2113.RH H2113

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1 ginning with 2021 and referred to in this paragraph 

2 as the ‘applicable year’), in any of the following cases: 

3 ‘‘(A) If there is at least a 10 percent (or 

4 $10,000) cumulative increase with respect to the 

5 wholesale acquisition cost (or alternative cost 

6 measure specified by the Secretary under para7 graph (3)) of such drug during a calendar-year 

8 period beginning and ending within the lookback 

9 period that is the 5-year period preceding such 

10 applicable year. 

11 ‘‘(B) If there is at least a 25 percent (or 

12 $25,000) cumulative increase with respect to the 

13 wholesale acquisition cost (or such alternative 

14 cost measure) of such drug during any three-cal15 endar-year period beginning and ending within 

16 such lookback period. 

17 ‘‘(C) In the case of such a drug that is first 

18 covered under title XVIII with respect to such 

19 applicable year, if the estimated cost or spending 

20 under such title per individual or per user of 

21 such drug (as estimated by the Secretary) for 

22 such applicable year (or per course of treatment 

23 in such applicable year, as defined by the Sec24 retary) is at least $26,000. 


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1 ‘‘(2) INDEXING DOLLAR AMOUNTS.—The dollar 

2 amounts applied under paragraph (1) for 2022 and 

3 each subsequent year shall be the dollar amounts spec4 ified in such paragraph for the previous year in5 creased by the annual percentage increase in the con6 sumer price index (all items; U.S. city average) as of 

7 September of such previous year. If any amount es8 tablished under paragraph (1), after application of 

9 this paragraph, for a year is not a multiple of $10, 

10 it shall be rounded to the nearest multiple of $10. 

11 ‘‘(3) ALTERNATIVE TO WAC.—The Secretary 

12 may, for purposes of making determinations under 

13 paragraph (1), in addition to using the wholesale ac14 quisition cost for an applicable drug, use alternative 

15 cost measures of such drug, or use such alternative 

16 cost measure if the wholesale acquisition cost is not 

17 available. 

18 ‘‘(4) EXCEPTION.—A justification under sub19 section (c) shall not be required for a triggered 

20 SPIKE increase described in paragraph (1) of an ap21 plicable drug of a manufacturer if— 

22 ‘‘(A) there is any portion of the lookback pe23 riod described in the respective subparagraph of 

24 such paragraph for such increase that is in25 cluded within the lookback period for another 


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1 triggered SPIKE increase (or combination of 

2 such increases) for which a justification is made 

3 under this section for such drug by such manu4 facturer; or 

5 ‘‘(B) such increase is less than the wholesale 

6 acquisition cost (or alternative cost measure 

7 specified by the Secretary under paragraph (3)) 

8 of such drug during the calendar-year period de9 scribed in paragraph (1)(A) or the three-cal10 endar-year period described in paragraph 

11 (1)(B), as applicable, for such increase, increased 

12 by the percentage increase in the consumer price 

13 index for all urban consumers (all items; United 

14 States city average) for the 12-month period end15 ing six months prior to the calendar-year period 

16 so described and for the 36-month period ending 

17 six months prior to the three-calendar-year pe18 riod so described, respectively. 

19 ‘‘(5) UNIT DETERMINATION.—For purposes of de20 termining the wholesale acquisition cost in carrying 

21 out this section, the Secretary shall determine a unit 

22 (such as a unit size) to apply. 

23 ‘‘(6) PUBLIC POSTING.—Beginning with respect 

24 to 2021, the Secretary shall publicly post on the 


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1 Internet website of the Department of Health and 

2 Human Services— 

3 ‘‘(A) alternative percentages, dollar 

4 amounts, and lookback periods that, if applied 

5 under paragraph (1), would be projected to in6 crease the number of applicable drugs for which 

7 a triggered SPIKE increase would occur for such 

8 year; and 

9 ‘‘(B) the number of applicable drugs for 

10 which a triggered SPIKE increase would occur 

11 for such year if such an alternative percentage, 

12 dollar amount, or period were applied for such 

13 year. 

14 ‘‘(c) JUSTIFICATION DESCRIBED.— 

15 ‘‘(1) IN GENERAL.—The justification described in 

16 this subsection, with respect to a triggered SPIKE in17 crease described in subsection (b)(1) of an applicable 

18 drug of a manufacturer, is— 

19 ‘‘(A) all of the information described in 

20 paragraph (2); 

21 ‘‘(B) all of the information and supporting 

22 documentation described in paragraph (3), as 

23 applicable to the increase and drug; and 

24 ‘‘(C) a certification described in paragraph 

25 (4). 


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1 ‘‘(2) REQUIRED INFORMATION.—For purposes of 

2 paragraph (1), the information described in this 

3 paragraph is the following: 

4 ‘‘(A) The individual factors that have con5 tributed to the increase in the wholesale acquisi6 tion cost. 

7 ‘‘(B) An explanation of the role of each fac8 tor in contributing to such increase. 

9 ‘‘(3) INFORMATION AS APPLICABLE.—For pur10 poses of paragraph (1), the information and sup11 porting documentation described in this paragraph is 

12 the following, as applicable to the increase of the 

13 drug: 

14 ‘‘(A) Total expenditures of the manufacturer 

15 on— 

16 ‘‘(i) materials and manufacturing for 

17 such drug; 

18 ‘‘(ii) acquiring patents and licensing 

19 for each drug of the manufacturer; and 

20 ‘‘(iii) costs to purchase or acquire the 

21 drug from another company, if applicable. 

22 ‘‘(B) The percentage of total expenditures of 

23 the manufacturer on research and development 

24 for such drug that was derived from Federal 

25 funds. 


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1 ‘‘(C) The total expenditures of the manufac2 turer on research and development for such drug. 

3 ‘‘(D) The total revenue and net profit gen4 erated from the applicable drug for each calendar 

5 year since drug approval. 

6 ‘‘(E) The total costs associated with mar7 keting and advertising for the applicable drug. 

8 ‘‘(F) Additional information specific to the 

9 manufacturer of the applicable drug, such as— 

10 ‘‘(i) the total revenue and net profit of 

11 the manufacturer for the period of such in12 crease, as determined by the Secretary; 

13 ‘‘(ii) metrics used to determine execu14 tive compensation; 

15 ‘‘(iii) total expenditures on— 

16 ‘‘(I) drug research and develop17 ment; or 

18 ‘‘(II) clinical trials on drugs that 

19 failed to receive approval by the Food 

20 and Drug Administration; and 

21 ‘‘(iv) any additional information re22 lated to drug pricing decisions of the manu23 facturer. 


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1 ‘‘(G) Any other relevant information and 

2 supporting documentation necessary to justify 

3 the triggering SPIKE increase. 

4 ‘‘(H) Any other relevant information and 

5 supporting documentation, as specified by the 

6 Secretary. 

7 ‘‘(4) CERTIFICATION.—For purposes of para8 graph (1), the certification described in this para9 graph is a certification, that all such information and 

10 documentation is accurate and complete, by one of the 

11 following: 

12 ‘‘(A) The chief executive officer of the manu13 facturer. 

14 ‘‘(B) The chief financial officer of the man15 ufacturer. 

16 ‘‘(C) An individual who has delegated au17 thority to sign for, and who reports directly to, 

18 such chief executive officer or chief financial offi19 cer. 

20 ‘‘(d) TIMING.— 

21 ‘‘(1) NOTIFICATION.—Not later than 60 days 

22 after the date on which the Secretary makes the deter23 mination that there is a triggering SPIKE increase 

24 with respect to an applicable drug, the Secretary shall 


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1 notify the manufacturer of the applicable drug of such 

2 determination. 

3 ‘‘(2) SUBMISSION OF JUSTIFICATION.—Not later 

4 than 90 days after the date on which a manufacturer 

5 receives a notification under paragraph (1), subject to 

6 subsection (b)(4), the manufacturer shall submit to 

7 the Secretary the justification required under sub8 section (a), including a summary of such justifica9 tion, in a form and manner specified by the Sec10 retary. In specifying such form, with respect to the 

11 summary required under the previous sentence, the 

12 Secretary shall provide that such summary shall be in 

13 an easily understandable format, as specified by the 

14 Secretary, and shall permit the manufacturer to ex15 clude proprietary information from such summary. 

16 ‘‘(3) POSTING ON INTERNET WEBSITE.—Not later 

17 than 30 days after receiving the complete justification 

18 under paragraph (2), the Secretary shall post on the 

19 Internet website of the Centers for Medicare & Med20 icaid Services the summary included for such jus21 tification. 

22 ‘‘(e) PENALTIES.— 

23 ‘‘(1) FAILURE TO SUBMIT TIMELY JUSTIFICA24 TION.—If the Secretary determines that a manufac25 turer has failed to submit a justification as required 


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1 under this section, including in accordance with the 

2 timing and form required, with respect to an applica3 ble drug, the Secretary shall apply a civil monetary 

4 penalty in an amount of $10,000 for each day the 

5 manufacturer has failed to submit such justification 

6 as so required. 

7 ‘‘(2) FALSE INFORMATION.—Any manufacturer 

8 that submits a justification under this section that 

9 knowingly provides false information in such jus10 tification is subject to a civil monetary penalty in an 

11 amount not to exceed $100,000 for each item of false 

12 information. 

13 ‘‘(3) APPLICATION OF PROCEDURES.—The provi14 sions of section 1128A (other than subsections (a) and 

15 (b)) shall apply to a civil monetary penalty under 

16 this subsection in the same manner as such provisions 

17 apply to a penalty or proceeding under section 

18 1128A(a). Civil monetary penalties imposed under 

19 this subsection are in addition to other penalties as 

20 may be prescribed by law. 

21 ‘‘(f) DEFINITIONS.—In this section: 

22 ‘‘(1) APPLICABLE DRUG.— 

23 ‘‘(A) IN GENERAL.—Subject to subpara24 graph (B), the term ‘applicable drug’ means, 

25 with respect to a lookback period described in 


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1 subsection (b)(1), a covered outpatient drug (as 

2 defined in paragraph (2) of section 1927(k), 

3 without application of paragraph (3) of such sec4 tion) that is covered under title XVIII and is not 

5 a low cost drug. 

6 ‘‘(B) EXCLUSION OF LOW COST DRUGS.— 

7 For purposes of subparagraph (A), not later than 

8 January 1, 2021, the Secretary shall specify a 

9 threshold (such as a cost or spending threshold) 

10 for identifying (and shall identify) low cost 

11 drugs to be excluded from the definition of the 

12 term ‘applicable drug’, such as a drug that has 

13 a wholesale acquisition cost of less than $10 per 

14 unit or less than $100 in average estimated ex15 penditures under title XVIII per individual per 

16 year or per user of such drug per year. For pur17 poses of this section, a drug shall not be consid18 ered specified as a low cost drug for a lookback 

19 period described in subsection (b)(1) with respect 

20 to a year unless such drug is identified as being 

21 below the specified threshold for the entirety of 

22 the lookback period. 

23 ‘‘(2) MANUFACTURER.—The term ‘manufacturer’ 

24 has the meaning given that term in section 

25 1847A(c)(6)(A). 


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1 ‘‘(3) WHOLESALE ACQUISITION COST.—The term 

2 ‘wholesale acquisition cost’ has the meaning given 

3 that term in section 1847A(c)(6)(B).’’. 

4 (b) REPORTING TO THE SECRETARY OF THE TREAS5 URY.— 

6 (1) IN GENERAL.—Subpart A of part III of sub7 chapter A of chapter 61 of the Internal Revenue Code 

8 of 1986 is amended by inserting after section 6039J 

9 the following new section: 

10 ‘‘SEC. 6039K. DRUG PRICE SPIKE INCREASE REPORTING. 

11 ‘‘Each manufacturer (within the meaning of section 

12 1128L of the Social Security Act) shall file a return (at 

13 such time and in such form and manner as the Secretary 

14 may provide) showing for such year with respect to which 

15 such section applies all information and supporting docu16 mentation and the certification included within a justifica17 tion reported by the manufacturer under subsection (c)(1) 

18 of such section.’’. 

19 (2) CLERICAL AMENDMENT.—The table of sec20 tions for subpart A of part III of subchapter A of 

21 chapter 61 of such Code is amended by inserting after 

22 the item relating to section 6039J the following new 

23 item: 

‘‘Sec. 6039K. Drug price SPIKE increase reporting.’’. 


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1 SEC. 3. REQUIREMENT FOR MANUFACTURERS OF CERTAIN 

2 DRUGS, DEVICES, BIOLOGICALS, AND MED3 ICAL SUPPLIES TO REPORT ON PRODUCT 

4 SAMPLES PROVIDED TO CERTAIN HEALTH 

5 CARE PROVIDERS. 

6 (a) IN GENERAL.—Section 1128G(a) of the Social Se7 curity Act (42 U.S.C. 1320a–7h(a)) is amended by adding 

8 at the end the following new paragraph: 

9 ‘‘(3) CERTAIN PRODUCT SAMPLES.— 

10 ‘‘(A) IN GENERAL.—In addition to the re11 quirements under paragraphs (1)(A) and (2), on 

12 the 90th day of each calendar year (beginning 

13 with 2023), any applicable manufacturer that 

14 provides a payment or other transfer of value 

15 that is a product sample described in subpara16 graph (B) to any covered recipient (or to an en17 tity or individual at the request of, or designated 

18 on behalf of, such a covered recipient) shall sub19 mit to the Secretary, in such electronic form as 

20 the Secretary shall require, the following infor21 mation (aggregated per each drug, device, bio22 logical, or medical supply, as applicable) with 

23 respect to the preceding calendar year: 

24 ‘‘(i) The total quantity of all such pay25 ments or other transfers of value provided to 

26 all covered recipients. 


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1 ‘‘(ii) The total value of all such pay2 ments or other transfers of value provided to 

3 all covered recipients. 

4 ‘‘(iii) If applicable, information de5 scribed in clauses (vii) and (viii) of para6 graph (1)(A) with respect to such a pay7 ment or other transfer of value. 

8 ‘‘(B) PRODUCT SAMPLE DESCRIBED.—For 

9 purposes of subparagraph (A), a product sample 

10 described in this subparagraph is a product sam11 ple that is not intended to be sold and is in12 tended for patient use.’’. 

13 (b) PUBLIC AVAILABILITY OF INFORMATION.—Section 

14 1128G(c)(1)(C)(ii) of the Social Security Act (42 U.S.C. 

15 1320a–7h(c)(1)(C)(ii)) is amended— 

16 (1) by striking ‘‘(ii) contains’’ and inserting 

17 ‘‘(ii)(I) with respect to information that is not infor18 mation submitted under paragraph (3) of subsection 

19 (a), contains’’; 

20 (2) by striking ‘‘, as applicable;’’ and inserting 

21 ‘‘, as applicable; and’’; and 

22 (3) by adding at the end the following new sub23 clause: 

24 ‘‘(II) with respect to information sub25 mitted under paragraph (3) of subsection 


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1 (a), contains information that is presented 

2 by the name of the applicable manufacturer, 

3 the total amount of all payments or other 

4 transfers of value described in such para5 graph provided to all covered recipients, the 

6 total value of all such payments or other 

7 transfers of value provided to all covered re8 cipients, and the name of the covered drug, 

9 device, biological, or medical supply, as ap10 plicable;’’. 

11 (c) CONFORMING AMENDMENT.—Section 

12 1128G(e)(10)(B)(ii) of the Social Security Act (42 U.S.C. 

13 1320a–7h(e)(10)(B)(ii)) is amended by striking ‘‘Product 

14 samples’’ and inserting ‘‘Except for purposes of paragraph 

15 (3) of subsection (a), product samples’’. 

16 (d) REPORTING TO THE SECRETARY OF THE TREAS17 URY.— 

18 (1) IN GENERAL.—Subpart A of part III of sub19 chapter A of chapter 61 of the Internal Revenue Code 

20 of 1986, as amended by section 2, is further amended 

21 by inserting after section 6039K the following new 

22 section: 


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1 ‘‘SEC. 6039L. PRODUCT SAMPLES OF APPLICABLE MANUFAC2 TURERS. 

3 ‘‘Each applicable manufacturer (within the meaning 

4 of section 1128G(a)(3) of the Social Security Act) shall file 

5 a return (at such time and in such form and manner as 

6 the Secretary may provide) showing for such year to which 

7 such section applies— 

8 ‘‘(1) the amount described in section 

9 1128G(a)(3)(A)(ii) of such Act with respect to such 

10 year, and 

11 ‘‘(2) the portion of such amount for which a de12 duction was claimed under section 162.’’. 

13 (2) CLERICAL AMENDMENT.—The table of sec14 tions for subpart A of part III of subchapter A of 

15 chapter 61 of such Code, as amended by section 2, is 

16 further amended by inserting after the item relating 

17 to section 6039K the following new item: 

‘‘Sec. 6039L. Product samples of applicable manufacturers.’’. 

18 SEC. 4. ANALYSIS AND REPORT ON INPATIENT HOSPITAL 

19 DRUG COSTS. 

20 (a) ANALYSIS.—The Secretary of Health and Human 

21 Services shall conduct an analysis that, to the extent prac22 ticable— 

23 (1) focuses on drugs that are furnished in the in24 patient setting; 


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1 (2) includes data on inpatient hospital drug 

2 costs, Medicare spending, volume, and spending per 

3 admission; 

4 (3) considers trends in inpatient hospital drug 

5 costs, such as trends by hospital size, classification of 

6 urban or rural, whether the hospital is a teaching 

7 hospital, or other categorization; and 

8 (4) examines the impact of drug shortages on 

9 services that are furnished in an inpatient hospital 

10 setting. 

11 In conducting such analysis, the Secretary may conduct 

12 hospital surveys, use data from hospital cost reports, or use 

13 other data as determined by the Secretary. 

14 (b) REPORT.—Not later than January 1, 2021, the 

15 Secretary shall submit to the Committee on Ways and 

16 Means of the House of Representatives and the Finance 

17 Committee of the Senate a report on drug costs in the inpa18 tient hospital setting, including the analyses described in 

19 paragraphs (1) through (4) of subsection (a). 

20 (c) FUNDING.—For purposes of carrying out this sec21 tion, there shall be transferred to the Secretary $3,000,000 

22 from the Federal Hospital Insurance Trust Fund under sec23 tion 1817 of the Social Security Act (42 U.S.C. 1395i). 


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1 SEC. 5. PUBLIC DISCLOSURE OF DRUG DISCOUNTS. 

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

3 1320b–23) is amended— 

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

5 paragraph (1), by inserting ‘‘(other than as permitted 

6 under subsection (e))’’ after ‘‘disclosed by the Sec7 retary’’; and 

8 (2) by adding at the end the following new sub9 section: 

10 ‘‘(e) PUBLIC AVAILABILITY OF CERTAIN INFORMA11 TION.— 

12 ‘‘(1) IN GENERAL.—In order to allow the com13 parison of PBMs’ ability to negotiate rebates, dis14 counts, and price concessions and the amount of such 

15 rebates, discounts, and price concessions that are 

16 passed through to plan sponsors, beginning January 

17 1, 2020, the Secretary shall make available on the 

18 Internet website of the Department of Health and 

19 Human Services the information with respect to the 

20 second preceding calendar year provided to the Sec21 retary on generic dispensing rates (as described in 

22 paragraph (1) of subsection (b) and information pro23 vided to the Secretary under paragraphs (2) and (3) 

24 of such subsection that, as determined by the Sec25 retary, is with respect to each PBM. 


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

2 paragraph (1), the Secretary shall ensure the fol3 lowing: 

4 ‘‘(A) CONFIDENTIALITY.—The information 

5 described in such paragraph is displayed in a 

6 manner that prevents the disclosure of informa7 tion on rebates, discounts, and price concessions, 

8 with respect to an individual drug or an indi9 vidual plan. 

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

11 described in such paragraph is made available 

12 by class of drug, using an existing classification 

13 system, but only if the class contains such num14 ber of drugs, as specified by the Secretary, to en15 sure confidentiality of proprietary information 

16 or other information that is prevented to be dis17 closed under subparagraph (A).’’. 

18 SEC. 6. REQUIRING CERTAIN MANUFACTURERS TO REPORT 

19 DRUG PRICING INFORMATION WITH RESPECT 

20 TO DRUGS UNDER THE MEDICARE PROGRAM. 

21 (a) IN GENERAL.—Section 1847A of the Social Secu22 rity Act (42 U.S.C. 1395w–3a) is amended— 

23 (1) in subsection (b)— 


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1 (A) in paragraph (2)(A), by inserting ‘‘or 

2 subsection (f)(2), as applicable’’ before the period 

3 at the end; 

4 (B) in paragraph (3), in the matter pre5 ceding subparagraph (A), by inserting ‘‘or sub6 section (f)(2), as applicable,’’ before ‘‘determined 

7 by’’; and 

8 (C) in paragraph (6)(A), in the matter pre9 ceding clause (i), by inserting ‘‘or subsection 

10 (f)(2), as applicable,’’ before ‘‘determined by’’; 

11 and 

12 (2) in subsection (f)— 

13 (A) by striking ‘‘For requirements’’ and in14 serting the following: 

15 ‘‘(1) IN GENERAL.—For requirements’’; and 

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

17 paragraph: 

18 ‘‘(2) MANUFACTURERS WITHOUT A REBATE

19 AGREEMENT UNDER TITLE XIX.— 

20 ‘‘(A) IN GENERAL.—In the case of a manu21 facturer of a drug or biological described in sub22 paragraph (C), (E), or (G) of section 1842(o)(1) 

23 or in clause (ii) or (iii) of section 

24 1881(b)(14)(B) that does not have a rebate agree25 ment in effect under section 1927, for calendar 


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1 quarters beginning on or after January 1, 2020, 

2 such manufacturer shall report to the Secretary 

3 the information described in subsection 

4 (b)(3)(A)(iii) of such section 1927 with respect to 

5 such drug or biological in a time and manner 

6 specified by the Secretary. 

7 ‘‘(B) AUDIT.—Information reported under 

8 subparagraph (A) is subject to audit by the In9 spector General of the Department of Health and 

10 Human Services. 

11 ‘‘(C) VERIFICATION.—The Secretary may 

12 survey wholesalers and manufacturers that di13 rectly distribute drugs described in subparagraph 

14 (A), when necessary, to verify manufacturer 

15 prices and manufacturer’s average sales prices 

16 (including wholesale acquisition cost) if required 

17 to make payment reported under subparagraph 

18 (A). The Secretary may impose a civil monetary 

19 penalty in an amount not to exceed $100,000 on 

20 a wholesaler, manufacturer, or direct seller, if the 

21 wholesaler, manufacturer, or direct seller of such 

22 a drug refuses a request for information about 

23 charges or prices by the Secretary in connection 

24 with a survey under this subparagraph or know25 ingly provides false information. The provisions 


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1 of section 1128A (other than subsections (a) 

2 (with respect to amounts of penalties or addi3 tional assessments) and (b)) shall apply to a 

4 civil money penalty under this subparagraph in 

5 the same manner as such provisions apply to a 

6 penalty or proceeding under section 1128A(a). 

7 ‘‘(D) CONFIDENTIALITY.—Notwithstanding 

8 any other provision of law, information disclosed 

9 by manufacturers or wholesalers under this 

10 paragraph (other than the wholesale acquisition 

11 cost for purposes of carrying out this section) is 

12 confidential and shall not be disclosed by the 

13 Secretary in a form which discloses the identity 

14 of a specific manufacturer or wholesaler or prices 

15 charged for drugs by such manufacturer or 

16 wholesaler, except— 

17 ‘‘(i) as the Secretary determines to be 

18 necessary to carry out this section (includ19 ing the determination and implementation 

20 of the payment amount), or to carry out 

21 section 1847B; 

22 ‘‘(ii) to permit the Comptroller General 

23 to review the information provided; and 


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1 ‘‘(iii) to permit the Director of the 

2 Congressional Budget Office to review the 

3 information provided.’’. 

4 (b) ENFORCEMENT.—Section 1847A such Act (42 

5 U.S.C. 1395w–3a) is further amended— 

6 (1) in subsection (d)(4)— 

7 (A) in subparagraph (A), by striking ‘‘IN

8 GENERAL’’ and inserting ‘‘MISREPRESENTA9 TION’’; 

10 (B) in subparagraph (B), by striking ‘‘sub11 paragraph (B)’’ and inserting ‘‘subparagraph 

12 (A), (B), or (C)’’; 

13 (C) by redesignating subparagraph (B) as 

14 subparagraph (D); and 

15 (D) by inserting after subparagraph (A) the 

16 following new subparagraphs: 

17 ‘‘(B) FAILURE TO PROVIDE TIMELY INFOR18 MATION.—If the Secretary determines that a 

19 manufacturer described in subsection (f)(2) has 

20 failed to report on information described in sec21 tion 1927(b)(3)(A)(iii) with respect to a drug or 

22 biological in accordance with such subsection, the 

23 Secretary shall apply a civil money penalty in 

24 an amount of $10,000 for each day the manufacVerDate Sep 11 2014 18:10 Dec 26, 2020 Jkt 019200 PO 00000 Frm 00025 Fmt 6652 Sfmt 6203 E:\BILLS\H2113.RH H2113

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26 

•HR 2113 RH

1 turer has failed to report such information and 

2 such amount shall be paid to the Treasury. 

3 ‘‘(C) FALSE INFORMATION.—Any manufac4 turer required to submit information under sub5 section (f)(2) that knowingly provides false infor6 mation is subject to a civil money penalty in an 

7 amount not to exceed $100,000 for each item of 

8 false information. Such civil money penalties are 

9 in addition to other penalties as may be pre10 scribed by law.’’; and 

11 (2) in subsection (c)(6)(A), by striking the period 

12 at the end and inserting ‘‘, except that, for purposes 

13 of subsection (f)(2), the Secretary may, if the Sec14 retary determines appropriate, exclude repackagers of 

15 a drug or biological from such term.’’. 

16 (c) REPORT.—Not later than January 1, 2021, the In17 spector General of the Department of Health and Human 

18 Services shall assess and submit to Congress a report on 

19 the accuracy of average sales price information submitted 

20 by manufacturers under section 1847A of the Social Secu21 rity Act (42 U.S.C. 1395w–3a). Such report shall include 

22 any recommendations on how to improve the accuracy of 

23 such information. 


pbinns on DSKJLVW7X2PROD with BILLS

pbinns on DSKJLVW7X2PROD with BILLS
Union Calendar No. 571 

116TH CONGRESS 

2D SESSION H. R. 2113 

[Report No. 116–688, Part I] 

A BILL 

To amend titles XI and XVIII of the Social Secuhealth care providers, and for other purposes. report on product samples provided to certain transparency, to require certain manufacturers to rity Act to provide for drug manufacturer price 

DECEMBER 24, 2020 

Reported from the Committee on Ways and Means with 

an amendment 

DECEMBER 24, 2020 

Committee on Energy and Commerce discharged; comState of the Union and ordered to be printed mitted to the Committee of the Whole House on the 


pbinns on DSKJLVW7X2PROD with BILLS