I 

116TH CONGRESS 

1ST SESSION H. R. 2113 

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 

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. 

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 

5 Sunshine, Transparency, Accountability and Reporting 

6 Act’’ or the ‘‘Prescription Drug STAR Act’’. 


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1 SEC. 2. DRUG MANUFACTURER PRICE TRANSPARENCY. 

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

3 (42 U.S.C. 1301 et seq.) is amended by inserting after 

4 section 1128K the following new section: 

5 ‘‘SEC. 1128L. DRUG MANUFACTURER PRICE TRANS6 PARENCY. 

7 ‘‘(a) IN GENERAL.—With respect to each year, begin8 ning with 2021, the Secretary shall, at least once during 

9 such year, determine if there is a triggered SPIKE in10 crease (in accordance with subsection (b)) with respect to 

11 an applicable drug (as defined in subsection (f)(1)). If the 

12 Secretary determines, with respect to a year, there is such 

13 an increase with respect to an applicable drug, the manu14 facturer of the applicable drug shall submit to the Sec15 retary the justification described in subsection (c), subject 

16 to subsection (b)(4), for each such triggered SPIKE in17 crease in accordance with the timing described in sub18 section (d). 

19 ‘‘(b) TRIGGERED SPIKE INCREASE.— 

20 ‘‘(1) IN GENERAL.—A triggered SPIKE in21 crease occurs, with respect an applicable drug and 

22 year (beginning with 2021 and referred to in this 

23 paragraph as the ‘applicable year’), in any of the fol24 lowing cases: 

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

26 $10,000) cumulative increase with respect to 


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1 the wholesale acquisition cost (or alternative 

2 cost measure specified by the Secretary under 

3 paragraph (3)) of such drug during a calendar4 year period beginning and ending within the 

5 lookback period that is the 5-year period pre6 ceding such applicable year. 

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

8 $25,000) cumulative increase with respect to 

9 the wholesale acquisition cost (or such alter10 native cost measure) of such drug during any 

11 three-calendar-year period beginning and end12 ing within such lookback period. 

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

14 first covered under title XVIII with respect to 

15 such applicable year, if the estimated cost or 

16 spending under such title per individual or per 

17 user of such drug (as estimated by the Sec18 retary) for such applicable year (or per course 

19 of treatment in such applicable year, as defined 

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

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

22 amounts applied under paragraph (1) for 2022 and 

23 each subsequent year shall be the dollar amounts 

24 specified in such paragraph for the previous year in25 creased by the annual percentage increase in the 


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1 consumer price index (all items; U.S. city average) 

2 as of September of such previous year. If any 

3 amount established under paragraph (1), after appli4 cation of this paragraph, for a year is not a multiple 

5 of $10, it shall be rounded to the nearest multiple 

6 of $10. 

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

8 may, for purposes of making determinations under 

9 paragraph (1), in addition to using the wholesale ac10 quisition cost for an applicable drug, use alternative 

11 cost measures of such drug, or use such alternative 

12 cost measure if the wholesale acquisition cost is not 

13 available. 

14 ‘‘(4) EXCEPTION.—A justification under sub15 section (c) shall not be required for a triggered 

16 SPIKE increase described in paragraph (1) of an 

17 applicable drug of a manufacturer if— 

18 ‘‘(A) there is any portion of the lookback 

19 period described in the respective subparagraph 

20 of such paragraph for such increase that is in21 cluded within the lookback period for another 

22 triggered SPIKE increase (or combination of 

23 such increases) for which a justification is made 

24 under this section for such drug by such manu25 facturer; or 


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1 ‘‘(B) such increase is less than the whole2 sale acquisition cost (or alternative cost meas3 ure specified by the Secretary under paragraph 

4 (3)) of such drug during the calendar-year pe5 riod described in paragraph (1)(A) or the three6 calendar-year period described in paragraph 

7 (1)(B), as applicable, for such increase, in8 creased by the percentage increase in the con9 sumer price index for all urban consumers (all 

10 items; United States city average) for the 12- 

11 month period ending six months prior to the 

12 calendar-year period so described and for the 

13 36-month period ending six months prior to the 

14 three-calendar-year period so described, respec15 tively. 

16 ‘‘(5) UNIT DETERMINATION.—For purposes of 

17 determining the wholesale acquisition cost in car18 rying out this section, the Secretary shall determine 

19 a unit (such as a unit size) to apply. 

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

21 to 2021, the Secretary shall publicly post on the 

22 Internet website of the Department of Health and 

23 Human Services— 

24 ‘‘(A) alternative percentages, dollar 

25 amounts, and lookback periods that, if applied 


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1 under paragraph (1), would be projected to in2 crease the number of applicable drugs for which 

3 a triggered SPIKE increase would occur for 

4 such year; and 

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

6 which a triggered SPIKE increase would occur 

7 for such year of such an alternative percentage, 

8 dollar amount, or period were applied for such 

9 year. 

10 ‘‘(c) JUSTIFICATION DESCRIBED.— 

11 ‘‘(1) IN GENERAL.—The justification described 

12 in this subsection, with respect to a triggered 

13 SPIKE increase described in subsection (b)(1) of an 

14 applicable drug of a manufacturer, is— 

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

16 paragraph (2); 

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

18 documentation described in paragraph (3), as 

19 applicable to the increase and drug; and 

20 ‘‘(C) a certification described in paragraph 

21 (4). 

22 ‘‘(2) REQUIRED INFORMATION.—For purposes 

23 of paragraph (1), the information described in this 

24 paragraph is the following: 


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1 ‘‘(A) The individual factors that have con2 tributed to the increase in the wholesale acqui3 sition cost. 

4 ‘‘(B) An explanation of the role of each 

5 factor in contributing to such increase. 

6 ‘‘(3) INFORMATION AS APPLICABLE.—For pur7 poses of paragraph (1), the information and sup8 porting documentation described in this paragraph is 

9 the following, as applicable to the increase of the 

10 drug: 

11 ‘‘(A) Total expenditures of the manufac12 turer on— 

13 ‘‘(i) materials and manufacturing for 

14 such drug; 

15 ‘‘(ii) acquiring patents and licensing 

16 for each drug of the manufacturer; and 

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

18 drug from another company, if applicable. 

19 ‘‘(B) The percentage of total expenditures 

20 of the manufacturer on research and develop21 ment for such drug that was derived from Fed22 eral funds. 

23 ‘‘(C) The total expenditures of the manu24 facturer on research and development for such 

25 drug. 


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1 ‘‘(D) The total revenue and net profit gen2 erated from the applicable drug for each cal3 endar year since drug approval. 

4 ‘‘(E) The total costs associated with mar5 keting and advertising for the applicable drug. 

6 ‘‘(F) Additional information specific to the 

7 manufacturer of the applicable drug, such as— 

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

9 the manufacturer for the period of such in10 crease, as determined by the Secretary; 

11 ‘‘(ii) metrics used to determine execu12 tive compensation; 

13 ‘‘(iii) total expenditures on— 

14 ‘‘(I) drug research and develop15 ment; or 

16 ‘‘(II) clinical trials on drugs that 

17 failed to receive approval by the Food 

18 and Drug Administration; and 

19 ‘‘(iv) any additional information re20 lated to drug pricing decisions of the man21 ufacturer. 

22 ‘‘(G) Any other relevant information and 

23 supporting documentation necessary to justify 

24 the triggering SPIKE increase. 


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1 ‘‘(H) Any other relevant information and 

2 supporting documentation, as specified by the 

3 Secretary. 

4 ‘‘(4) CERTIFICATION.—For purposes of para5 graph (1), the certification described in this para6 graph is a certification, that all such information 

7 and documentation is accurate and complete, by one 

8 of the following: 

9 ‘‘(A) The chief executive officer of the 

10 manufacturer. 

11 ‘‘(B) The chief financial officer of the 

12 manufacturer. 

13 ‘‘(C) An individual who has delegated au14 thority to sign for, and who reports directly to, 

15 such chief executive officer or chief financial of16 ficer. 

17 ‘‘(d) TIMING.— 

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

19 after the date on which the Secretary makes the de20 termination that there is a triggering SPIKE in21 crease with respect to an applicable drug, the Sec22 retary shall notify the manufacturer of the applica23 ble drug of such determination. 

24 ‘‘(2) SUBMISSION OF JUSTIFICATION.—Not 

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1 facturer receives a notification under paragraph (1), 

2 subject to subsection (b)(4), the manufacturer shall 

3 submit to the Secretary the justification required 

4 under subsection (a), including a summary of such 

5 justification, in a form and manner specified by the 

6 Secretary. In specifying such form, with respect to 

7 the summary required under the previous sentence, 

8 the Secretary shall provide that such summary shall 

9 be in an easily understandable format, as specified 

10 by the Secretary, and shall permit the manufacturer 

11 to exclude proprietary information from such sum12 mary. 

13 ‘‘(3) POSTING ON INTERNET WEBSITE.—Not 

14 later than 30 days after receiving the complete jus15 tification under paragraph (2), the Secretary shall 

16 post on the Internet website of the Centers for Medi17 care & Medicaid Services the summary included for 

18 such justification. 

19 ‘‘(e) PENALTIES.— 

20 ‘‘(1) FAILURE TO SUBMIT TIMELY JUSTIFICA21 TION.—If the Secretary determines that a manufac22 turer has failed to submit a justification as required 

23 under this section, including in accordance with the 

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1 tary penalty in an amount of $10,000 for each day 

2 the manufacturer has failed to submit such justifica3 tion as so required. 

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

5 that submits a justification under this section that 

6 knowingly provides false information in such jus7 tification is subject to a civil monetary penalty in an 

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

9 false information. 

10 ‘‘(3) APPLICATION OF PROCEDURES.—The pro11 visions of section 1128A (other than subsections (a) 

12 and (b)) shall apply to a civil monetary penalty 

13 under this subsection in the same manner as such 

14 provisions apply to a penalty or proceeding under 

15 section 1128A(a). Civil monetary penalties imposed 

16 under this subsection are in addition to other pen17 alties as may be prescribed by law. 

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

19 ‘‘(1) APPLICABLE DRUG.— 

20 ‘‘(A) IN GENERAL.—Subject to subpara21 graph (B), the term ‘applicable drug’ means, 

22 with respect to a lookback period described in 

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

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

25 without application of paragraph (3) of such 


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1 section) that is covered under title XVIII and 

2 is not a low cost drug. 

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

4 For purposes of subparagraph (A), not later 

5 than January 1, 2021, the Secretary shall 

6 specify a threshold (such as a cost or spending 

7 threshold) for identifying (and shall identify) 

8 low cost drugs to be excluded from the defini9 tion of the term ‘applicable drug’, such as a 

10 drug that has a wholesale acquisition cost of 

11 less than $10 per unit or less than $100 in av12 erage estimated expenditures under title XVIII 

13 per individual per year or per user of such drug 

14 per year. For purposes of this section, a drug 

15 shall not be considered specified as a low cost 

16 drug for a lookback period described in sub17 section (b)(1) with respect to a year unless such 

18 drug is identified as being below the specified 

19 threshold for the entirety of the lookback pe20 riod. 

21 ‘‘(2) MANUFACTURER.—The term ‘manufac22 turer’ has the meaning given that term in section 

23 1847A(c)(6)(A). 


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

2 term ‘wholesale acquisition cost’ has the meaning 

3 given 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 

7 subchapter A of chapter 61 of the Internal Revenue 

8 Code of 1986 is amended by inserting after section 

9 6039J 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 (as 

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

14 may provide) showing for each 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 

22 after the item relating to section 6039J the fol23 lowing new 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 

7 Security Act (42 U.S.C. 1320a–7h(a)) is amended by add8 ing 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), 

12 on the 90th day of each calendar year (begin13 ning with 2023), any applicable manufacturer 

14 that provides a payment or other transfer of 

15 value that is a product sample described in sub16 paragraph (B) to any covered recipient (or to 

17 an entity or individual at the request of, or des18 ignated on behalf of, such a covered recipient) 

19 shall submit to the Secretary, in such electronic 

20 form as the Secretary shall require, the fol21 lowing information (aggregated per each drug, 

22 device, biological, or medical supply, as applica23 ble) with respect to the preceding calendar year: 

24 ‘‘(i) The total quantity of all such 

25 payments or other transfers of value pro26 vided to all covered recipients. 


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

3 to 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 sam10 ple described in this subparagraph is a product 

11 sample that is not intended to be sold and is in12 tended for patient use.’’. 

13 (b) PUBLIC AVAILABILITY OF INFORMATION.—Sec14 tion 1128G(c)(1)(C)(ii) of the Social Security Act (42 

15 U.S.C. 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 manufac3 turer, the total amount of all payments or 

4 other transfers of value described in such 

5 paragraph provided to all covered recipi6 ents, the total value of all such payments 

7 or other transfers of value provided to all 

8 covered recipients, and the name of the 

9 covered drug, device, biological, or medical 

10 supply, as applicable;’’. 

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 

19 subchapter A of chapter 61 of the Internal Revenue 

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

21 amended by inserting after section 6039K the fol22 lowing new section: 


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1 ‘‘SEC. 6039L. PRODUCT SAMPLES OF APPLICABLE MANU2 FACTURERS. 

3 ‘‘Each applicable manufacturer (within the meaning 

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

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

6 as the Secretary may provide) showing for each year to 

7 which 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, 

16 is further amended by inserting after the item relat17 ing 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 

24 inpatient 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 

6 of 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 

13 use 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 

18 inpatient hospital setting, including the analyses described 

19 in 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 

22 $3,000,000 from the Federal Hospital Insurance Trust 

23 Fund under section 1817 of the Social Security Act (42 

24 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 per6 mitted under subsection (e))’’ after ‘‘disclosed by the 

7 Secretary’’; 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 

15 such rebates, discounts, and price concessions that 

16 are passed through to plan sponsors, beginning Jan17 uary 1, 2020, the Secretary shall make available on 

18 the Internet website of the Department of Health 

19 and Human Services the information with respect to 

20 the second preceding calendar year provided to the 

21 Secretary on generic dispensing rates (as described 

22 in paragraph (1) of subsection (b)) and information 

23 provided to the Secretary under paragraphs (2) and 

24 (3) of such subsection that, as determined by the 

25 Secretary, 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 conces8 sions, with respect to an individual drug or an 

9 individual 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 

15 ensure confidentiality of proprietary informa16 tion or other information that is prevented to 

17 be disclosed under subparagraph (A).’’. 

18 SEC. 6. REQUIRING CERTAIN MANUFACTURERS TO REPORT 

19 DRUG PRICING INFORMATION WITH RE20 SPECT TO DRUGS UNDER THE MEDICARE 

21 PROGRAM. 

22 (a) IN GENERAL.—Section 1847A of the Social Secu23 rity Act (42 U.S.C. 1395w–3a) is amended— 

24 (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 pe3 riod 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 ‘‘deter7 mined by’’; and 

8 (C) in paragraph (6)(A), in the matter 

9 preceding 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 

14 inserting 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 man21 ufacturer of a drug or biological described in 

22 subparagraph (C), (E), or (G) of section 

23 1842(o)(1) or in clause (ii) or (iii) of section 

24 1881(b)(14)(B) that does not have a rebate 

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1 endar quarters beginning on or after January 

2 1, 2020, such manufacturer shall report to the 

3 Secretary the information described in sub4 section (b)(3)(A)(iii) of such section 1927 with 

5 respect to such drug or biological in a time and 

6 manner 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 

10 and Human Services. 

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

12 survey wholesalers and manufacturers that di13 rectly distribute drugs described in subpara14 graph (A), when necessary, to verify manufac15 turer prices and manufacturer’s average sales 

16 prices (including wholesale acquisition cost) if 

17 required to make payment reported under sub18 paragraph (A). The Secretary may impose a 

19 civil monetary penalty in an amount not to ex20 ceed $100,000 on a wholesaler, manufacturer, 

21 or direct seller, if the wholesaler, manufacturer, 

22 or direct seller of such a drug refuses a request 

23 for information about charges or prices by the 

24 Secretary in connection with a survey under 

25 this subparagraph or knowingly provides false 


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1 information. The provisions of section 1128A 

2 (other than subsections (a) (with respect to 

3 amounts of penalties or additional assessments) 

4 and (b)) shall apply to a civil money penalty 

5 under this subparagraph in the same manner as 

6 such provisions apply to a penalty or proceeding 

7 under section 1128A(a). 

8 ‘‘(D) CONFIDENTIALITY.—Notwithstand9 ing any other provision of law, information dis10 closed by manufacturers or wholesalers under 

11 this paragraph (other than the wholesale acqui12 sition cost for purposes of carrying out this sec13 tion) is confidential and shall not be disclosed 

14 by the Secretary in a form which discloses the 

15 identity of a specific manufacturer or whole16 saler or prices charged for drugs by such manu17 facturer or wholesaler, except— 

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

19 necessary to carry out this section (includ20 ing the determination and implementation 

21 of the payment amount), or to carry out 

22 section 1847B; 

23 ‘‘(ii) to permit the Comptroller Gen24 eral to review the information provided; 

25 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) 

16 the 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, 

23 the Secretary shall apply a civil money penalty 

24 in an amount of $10,000 for each day the manVerDate Sep 11 2014 00:43 Apr 09, 2019 Jkt 089200 PO 00000 Frm 00024 Fmt 6652 Sfmt 6201 E:\BILLS\H2113.IH H2113

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25 

•HR 2113 IH

1 ufacturer has failed to report such information 

2 and such amount shall be paid to the Treasury. 

3 ‘‘(C) FALSE INFORMATION.—Any manu4 facturer required to submit information under 

5 subsection (f)(2) that knowingly provides false 

6 information is subject to a civil money penalty 

7 in an amount not to exceed $100,000 for each 

8 item of false information. Such civil money pen9 alties are in addition to other penalties as may 

10 be prescribed by law.’’; and 

11 (2) in subsection (c)(6)(A), by striking the pe12 riod at the end and inserting ‘‘, except that, for pur13 poses of subsection (f)(2), the Secretary may, if the 

14 Secretary determines appropriate, exclude repack15 agers of a drug or biological from such term.’’. 

16 (c) REPORT.—Not later than January 1, 2021, the 

17 Inspector General of the Department of Health and 

18 Human Services shall assess and submit to Congress a 

19 report on the accuracy of average sales price information 

20 submitted by manufacturers under section 1847A of the 

21 Social Security Act (42 U.S.C. 1395w–3a). Such report 

22 shall include any recommendations on how to improve the 

23 accuracy of such information. 

Æ 


pamtmann on DSKBFK8HB2PROD with BILLS