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 provi-
sions 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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Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Prescription Drug Sun-
shine, Transparency, Accountability and Reporting Act’’ or 
the ‘‘Prescription Drug STAR Act’’. 
SEC. 2. DRUG MANUFACTURER PRICE TRANSPARENCY. 
(a) IN GENERAL.—Title XI of the Social Security Act 
(42 U.S.C. 1301 et seq.) is amended by inserting after sec-
tion 1128K the following new section: 
‘‘SEC. 1128L. DRUG MANUFACTURER PRICE TRANSPARENCY. 
‘‘(a) IN GENERAL.—With respect to each year, begin-
ning with 2021, the Secretary shall, at least once during 
such year, determine if there is a triggered SPIKE increase 
(in accordance with subsection (b)) with respect to an ap-
plicable drug (as defined in subsection (f)(1)). If the Sec-
retary determines, with respect to a year, there is such an 
increase with respect to an applicable drug, the manufac-
turer of the applicable drug shall submit to the Secretary 
the justification described in subsection (c), subject to sub-
section (b)(4), for each such triggered SPIKE increase in 
accordance with the timing described in subsection (d)). 
‘‘(b) TRIGGERED SPIKE INCREASE.— 
‘‘(1) IN GENERAL.—A triggered SPIKE increase 
occurs, with respect an applicable drug and year (be-
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ginning with 2021 and referred to in this paragraph 
as the ‘applicable year’), in any of the following cases: 
‘‘(A) If there is at least a 10 percent (or 
$10,000) cumulative increase with respect to the 
wholesale acquisition cost (or alternative cost 
measure specified by the Secretary under para-
graph (3)) of such drug during a calendar-year 
period beginning and ending within the lookback 
period that is the 5-year period preceding such 
applicable year. 
‘‘(B) If there is at least a 25 percent (or 
$25,000) cumulative increase with respect to the 
wholesale acquisition cost (or such alternative 
cost measure) of such drug during any three-cal-
endar-year period beginning and ending within 
such lookback period. 
‘‘(C) In the case of such a drug that is first 
covered under title XVIII with respect to such 
applicable year, if the estimated cost or spending 
under such title per individual or per user of 
such drug (as estimated by the Secretary) for 
such applicable year (or per course of treatment 
in such applicable year, as defined by the Sec-
retary) is at least $26,000. 
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‘‘(2) INDEXING DOLLAR AMOUNTS.—The dollar 
amounts applied under paragraph (1) for 2022 and 
each subsequent year shall be the dollar amounts spec-
ified in such paragraph for the previous year in-
creased by the annual percentage increase in the con-
sumer price index (all items; U.S. city average) as of 
September of such previous year. If any amount es-
tablished under paragraph (1), after application of 
this paragraph, for a year is not a multiple of $10, 
it shall be rounded to the nearest multiple of $10. 
‘‘(3) ALTERNATIVE
TO
WAC.—The Secretary 
may, for purposes of making determinations under 
paragraph (1), in addition to using the wholesale ac-
quisition cost for an applicable drug, use alternative 
cost measures of such drug, or use such alternative 
cost measure if the wholesale acquisition cost is not 
available. 
‘‘(4) EXCEPTION.—A justification under sub-
section (c) shall not be required for a triggered 
SPIKE increase described in paragraph (1) of an ap-
plicable drug of a manufacturer if— 
‘‘(A) there is any portion of the lookback pe-
riod described in the respective subparagraph of 
such paragraph for such increase that is in-
cluded within the lookback period for another 
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Internet website of the Department of Health and 
Human Services— 
‘‘(A) 
alternative 
percentages, 
dollar 
amounts, and lookback periods that, if applied 
under paragraph (1), would be projected to in-
crease the number of applicable drugs for which 
a triggered SPIKE increase would occur for such 
year; and 
‘‘(B) the number of applicable drugs for 
which a triggered SPIKE increase would occur 
for such year if such an alternative percentage, 
dollar amount, or period were applied for such 
year. 
‘‘(c) JUSTIFICATION DESCRIBED.— 
‘‘(1) IN GENERAL.—The justification described in 
this subsection, with respect to a triggered SPIKE in-
crease described in subsection (b)(1) of an applicable 
drug of a manufacturer, is— 
‘‘(A) all of the information described in 
paragraph (2); 
‘‘(B) all of the information and supporting 
documentation described in paragraph (3), as 
applicable to the increase and drug; and 
‘‘(C) a certification described in paragraph 
(4). 
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‘‘(2) REQUIRED INFORMATION.—For purposes of 
paragraph (1), the information described in this 
paragraph is the following: 
‘‘(A) The individual factors that have con-
tributed to the increase in the wholesale acquisi-
tion cost. 
‘‘(B) An explanation of the role of each fac-
tor in contributing to such increase. 
‘‘(3) INFORMATION
AS
APPLICABLE.—For pur-
poses of paragraph (1), the information and sup-
porting documentation described in this paragraph is 
the following, as applicable to the increase of the 
drug: 
‘‘(A) Total expenditures of the manufacturer 
on— 
‘‘(i) materials and manufacturing for 
such drug; 
‘‘(ii) acquiring patents and licensing 
for each drug of the manufacturer; and 
‘‘(iii) costs to purchase or acquire the 
drug from another company, if applicable. 
‘‘(B) The percentage of total expenditures of 
the manufacturer on research and development 
for such drug that was derived from Federal 
funds. 
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‘‘(C) The total expenditures of the manufac-
turer on research and development for such drug. 
‘‘(D) The total revenue and net profit gen-
erated from the applicable drug for each calendar 
year since drug approval. 
‘‘(E) The total costs associated with mar-
keting and advertising for the applicable drug. 
‘‘(F) Additional information specific to the 
manufacturer of the applicable drug, such as— 
‘‘(i) the total revenue and net profit of 
the manufacturer for the period of such in-
crease, as determined by the Secretary; 
‘‘(ii) metrics used to determine execu-
tive compensation; 
‘‘(iii) total expenditures on— 
‘‘(I) drug research and develop-
ment; or 
‘‘(II) clinical trials on drugs that 
failed to receive approval by the Food 
and Drug Administration; and 
‘‘(iv) any additional information re-
lated to drug pricing decisions of the manu-
facturer. 
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‘‘(G) Any other relevant information and 
supporting documentation necessary to justify 
the triggering SPIKE increase. 
‘‘(H) Any other relevant information and 
supporting documentation, as specified by the 
Secretary. 
‘‘(4) CERTIFICATION.—For purposes of para-
graph (1), the certification described in this para-
graph is a certification, that all such information and 
documentation is accurate and complete, by one of the 
following: 
‘‘(A) The chief executive officer of the manu-
facturer. 
‘‘(B) The chief financial officer of the man-
ufacturer. 
‘‘(C) An individual who has delegated au-
thority to sign for, and who reports directly to, 
such chief executive officer or chief financial offi-
cer. 
‘‘(d) TIMING.— 
‘‘(1) NOTIFICATION.—Not later than 60 days 
after the date on which the Secretary makes the deter-
mination that there is a triggering SPIKE increase 
with respect to an applicable drug, the Secretary shall 
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notify the manufacturer of the applicable drug of such 
determination. 
‘‘(2) SUBMISSION OF JUSTIFICATION.—Not later 
than 90 days after the date on which a manufacturer 
receives a notification under paragraph (1), subject to 
subsection (b)(4), the manufacturer shall submit to 
the Secretary the justification required under sub-
section (a), including a summary of such justifica-
tion, in a form and manner specified by the Sec-
retary. In specifying such form, with respect to the 
summary required under the previous sentence, the 
Secretary shall provide that such summary shall be in 
an easily understandable format, as specified by the 
Secretary, and shall permit the manufacturer to ex-
clude proprietary information from such summary. 
‘‘(3) POSTING ON INTERNET WEBSITE.—Not later 
than 30 days after receiving the complete justification 
under paragraph (2), the Secretary shall post on the 
Internet website of the Centers for Medicare & Med-
icaid Services the summary included for such jus-
tification. 
‘‘(e) PENALTIES.— 
‘‘(1) FAILURE
TO
SUBMIT
TIMELY
JUSTIFICA-
TION.—If the Secretary determines that a manufac-
turer has failed to submit a justification as required 
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under this section, including in accordance with the 
timing and form required, with respect to an applica-
ble drug, the Secretary shall apply a civil monetary 
penalty in an amount of $10,000 for each day the 
manufacturer has failed to submit such justification 
as so required. 
‘‘(2) FALSE INFORMATION.—Any manufacturer 
that submits a justification under this section that 
knowingly provides false information in such jus-
tification is subject to a civil monetary penalty in an 
amount not to exceed $100,000 for each item of false 
information. 
‘‘(3) APPLICATION OF PROCEDURES.—The provi-
sions of section 1128A (other than subsections (a) and 
(b)) shall apply to a civil monetary penalty under 
this subsection in the same manner as such provisions 
apply to a penalty or proceeding under section 
1128A(a). Civil monetary penalties imposed under 
this subsection are in addition to other penalties as 
may be prescribed by law. 
‘‘(f) DEFINITIONS.—In this section: 
‘‘(1) APPLICABLE DRUG.— 
‘‘(A) IN
GENERAL.—Subject to subpara-
graph (B), the term ‘applicable drug’ means, 
with respect to a lookback period described in 
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subsection (b)(1), a covered outpatient drug (as 
defined in paragraph (2) of section 1927(k), 
without application of paragraph (3) of such sec-
tion) that is covered under title XVIII and is not 
a low cost drug. 
‘‘(B) EXCLUSION OF LOW COST DRUGS.— 
For purposes of subparagraph (A), not later than 
January 1, 2021, the Secretary shall specify a 
threshold (such as a cost or spending threshold) 
for identifying (and shall identify) low cost 
drugs to be excluded from the definition of the 
term ‘applicable drug’, such as a drug that has 
a wholesale acquisition cost of less than $10 per 
unit or less than $100 in average estimated ex-
penditures under title XVIII per individual per 
year or per user of such drug per year. For pur-
poses of this section, a drug shall not be consid-
ered specified as a low cost drug for a lookback 
period described in subsection (b)(1) with respect 
to a year unless such drug is identified as being 
below the specified threshold for the entirety of 
the lookback period. 
‘‘(2) MANUFACTURER.—The term ‘manufacturer’ 
has the meaning given that term in section 
1847A(c)(6)(A). 
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‘‘(3) WHOLESALE ACQUISITION COST.—The term 
‘wholesale acquisition cost’ has the meaning given 
that term in section 1847A(c)(6)(B).’’. 
(b) REPORTING TO THE SECRETARY OF THE TREAS-
URY.— 
(1) IN GENERAL.—Subpart A of part III of sub-
chapter A of chapter 61 of the Internal Revenue Code 
of 1986 is amended by inserting after section 6039J 
the following new section: 
‘‘SEC. 6039K. DRUG PRICE SPIKE INCREASE REPORTING. 
‘‘Each manufacturer (within the meaning of section 
1128L of the Social Security Act) shall file a return (at 
such time and in such form and manner as the Secretary 
may provide) showing for such year with respect to which 
such section applies all information and supporting docu-
mentation and the certification included within a justifica-
tion reported by the manufacturer under subsection (c)(1) 
of such section.’’. 
(2) CLERICAL AMENDMENT.—The table of sec-
tions for subpart A of part III of subchapter A of 
chapter 61 of such Code is amended by inserting after 
the item relating to section 6039J the following new 
item: 
‘‘Sec. 6039K. Drug price SPIKE increase reporting.’’. 
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SEC. 3. REQUIREMENT FOR MANUFACTURERS OF CERTAIN 
DRUGS, DEVICES, BIOLOGICALS, AND MED-
ICAL SUPPLIES TO REPORT ON PRODUCT 
SAMPLES PROVIDED TO CERTAIN HEALTH 
CARE PROVIDERS. 
(a) IN GENERAL.—Section 1128G(a) of the Social Se-
curity Act (42 U.S.C. 1320a–7h(a)) is amended by adding 
at the end the following new paragraph: 
‘‘(3) CERTAIN PRODUCT SAMPLES.— 
‘‘(A) IN GENERAL.—In addition to the re-
quirements under paragraphs (1)(A) and (2), on 
the 90th day of each calendar year (beginning 
with 2023), any applicable manufacturer that 
provides a payment or other transfer of value 
that is a product sample described in subpara-
graph (B) to any covered recipient (or to an en-
tity or individual at the request of, or designated 
on behalf of, such a covered recipient) shall sub-
mit to the Secretary, in such electronic form as 
the Secretary shall require, the following infor-
mation (aggregated per each drug, device, bio-
logical, or medical supply, as applicable) with 
respect to the preceding calendar year: 
‘‘(i) The total quantity of all such pay-
ments or other transfers of value provided to 
all covered recipients. 
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‘‘(ii) The total value of all such pay-
ments or other transfers of value provided to 
all covered recipients. 
‘‘(iii) If applicable, information de-
scribed in clauses (vii) and (viii) of para-
graph (1)(A) with respect to such a pay-
ment or other transfer of value. 
‘‘(B) PRODUCT
SAMPLE
DESCRIBED.—For 
purposes of subparagraph (A), a product sample 
described in this subparagraph is a product sam-
ple that is not intended to be sold and is in-
tended for patient use.’’. 
(b) PUBLIC AVAILABILITY OF INFORMATION.—Section 
1128G(c)(1)(C)(ii) of the Social Security Act (42 U.S.C. 
1320a–7h(c)(1)(C)(ii)) is amended— 
(1) by striking ‘‘(ii) contains’’ and inserting 
‘‘(ii)(I) with respect to information that is not infor-
mation submitted under paragraph (3) of subsection 
(a), contains’’; 
(2) by striking ‘‘, as applicable;’’ and inserting 
‘‘, as applicable; and’’; and 
(3) by adding at the end the following new sub-
clause: 
‘‘(II) with respect to information sub-
mitted under paragraph (3) of subsection 
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(a), contains information that is presented 
by the name of the applicable manufacturer, 
the total amount of all payments or other 
transfers of value described in such para-
graph provided to all covered recipients, the 
total value of all such payments or other 
transfers of value provided to all covered re-
cipients, and the name of the covered drug, 
device, biological, or medical supply, as ap-
plicable;’’. 
(c) 
CONFORMING
AMENDMENT.—Section 
1128G(e)(10)(B)(ii) of the Social Security Act (42 U.S.C. 
1320a–7h(e)(10)(B)(ii)) is amended by striking ‘‘Product 
samples’’ and inserting ‘‘Except for purposes of paragraph 
(3) of subsection (a), product samples’’. 
(d) REPORTING TO THE SECRETARY OF THE TREAS-
URY.— 
(1) IN GENERAL.—Subpart A of part III of sub-
chapter A of chapter 61 of the Internal Revenue Code 
of 1986, as amended by section 2, is further amended 
by inserting after section 6039K the following new 
section: 
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‘‘SEC. 6039L. PRODUCT SAMPLES OF APPLICABLE MANUFAC-
TURERS. 
‘‘Each applicable manufacturer (within the meaning 
of section 1128G(a)(3) of the Social Security Act) shall file 
a return (at such time and in such form and manner as 
the Secretary may provide) showing for such year to which 
such section applies— 
‘‘(1) 
the 
amount 
described 
in 
section 
1128G(a)(3)(A)(ii) of such Act with respect to such 
year, and 
‘‘(2) the portion of such amount for which a de-
duction was claimed under section 162.’’. 
(2) CLERICAL AMENDMENT.—The table of sec-
tions for subpart A of part III of subchapter A of 
chapter 61 of such Code, as amended by section 2, is 
further amended by inserting after the item relating 
to section 6039K the following new item: 
‘‘Sec. 6039L. Product samples of applicable manufacturers.’’. 
SEC. 4. ANALYSIS AND REPORT ON INPATIENT HOSPITAL 
DRUG COSTS. 
(a) ANALYSIS.—The Secretary of Health and Human 
Services shall conduct an analysis that, to the extent prac-
ticable— 
(1) focuses on drugs that are furnished in the in-
patient setting; 
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(2) includes data on inpatient hospital drug 
costs, Medicare spending, volume, and spending per 
admission; 
(3) considers trends in inpatient hospital drug 
costs, such as trends by hospital size, classification of 
urban or rural, whether the hospital is a teaching 
hospital, or other categorization; and 
(4) examines the impact of drug shortages on 
services that are furnished in an inpatient hospital 
setting. 
In conducting such analysis, the Secretary may conduct 
hospital surveys, use data from hospital cost reports, or use 
other data as determined by the Secretary. 
(b) REPORT.—Not later than January 1, 2021, the 
Secretary shall submit to the Committee on Ways and 
Means of the House of Representatives and the Finance 
Committee of the Senate a report on drug costs in the inpa-
tient hospital setting, including the analyses described in 
paragraphs (1) through (4) of subsection (a). 
(c) FUNDING.—For purposes of carrying out this sec-
tion, there shall be transferred to the Secretary $3,000,000 
from the Federal Hospital Insurance Trust Fund under sec-
tion 1817 of the Social Security Act (42 U.S.C. 1395i). 
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SEC. 5. PUBLIC DISCLOSURE OF DRUG DISCOUNTS. 
Section 1150A of the Social Security Act (42 U.S.C. 
1320b–23) is amended— 
(1) in subsection (c), in the matter preceding 
paragraph (1), by inserting ‘‘(other than as permitted 
under subsection (e))’’ after ‘‘disclosed by the Sec-
retary’’; and 
(2) by adding at the end the following new sub-
section: 
‘‘(e) PUBLIC AVAILABILITY
OF CERTAIN INFORMA-
TION.— 
‘‘(1) IN GENERAL.—In order to allow the com-
parison of PBMs’ ability to negotiate rebates, dis-
counts, and price concessions and the amount of such 
rebates, discounts, and price concessions that are 
passed through to plan sponsors, beginning January 
1, 2020, the Secretary shall make available on the 
Internet website of the Department of Health and 
Human Services the information with respect to the 
second preceding calendar year provided to the Sec-
retary on generic dispensing rates (as described in 
paragraph (1) of subsection (b) and information pro-
vided to the Secretary under paragraphs (2) and (3) 
of such subsection that, as determined by the Sec-
retary, is with respect to each PBM. 
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‘‘(2) AVAILABILITY OF DATA.—In carrying out 
paragraph (1), the Secretary shall ensure the fol-
lowing: 
‘‘(A) CONFIDENTIALITY.—The information 
described in such paragraph is displayed in a 
manner that prevents the disclosure of informa-
tion on rebates, discounts, and price concessions, 
with respect to an individual drug or an indi-
vidual plan. 
‘‘(B) CLASS
OF
DRUG.—The information 
described in such paragraph is made available 
by class of drug, using an existing classification 
system, but only if the class contains such num-
ber of drugs, as specified by the Secretary, to en-
sure confidentiality of proprietary information 
or other information that is prevented to be dis-
closed under subparagraph (A).’’. 
SEC. 6. REQUIRING CERTAIN MANUFACTURERS TO REPORT 
DRUG PRICING INFORMATION WITH RESPECT 
TO DRUGS UNDER THE MEDICARE PROGRAM. 
(a) IN GENERAL.—Section 1847A of the Social Secu-
rity Act (42 U.S.C. 1395w–3a) is amended— 
(1) in subsection (b)— 
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(A) in paragraph (2)(A), by inserting ‘‘or 
subsection (f)(2), as applicable’’ before the period 
at the end; 
(B) in paragraph (3), in the matter pre-
ceding subparagraph (A), by inserting ‘‘or sub-
section (f)(2), as applicable,’’ before ‘‘determined 
by’’; and 
(C) in paragraph (6)(A), in the matter pre-
ceding clause (i), by inserting ‘‘or subsection 
(f)(2), as applicable,’’ before ‘‘determined by’’; 
and 
(2) in subsection (f)— 
(A) by striking ‘‘For requirements’’ and in-
serting the following: 
‘‘(1) IN GENERAL.—For requirements’’; and 
(B) by adding at the end the following new 
paragraph: 
‘‘(2) MANUFACTURERS
WITHOUT
A
REBATE 
AGREEMENT UNDER TITLE XIX.— 
‘‘(A) IN GENERAL.—In the case of a manu-
facturer of a drug or biological described in sub-
paragraph (C), (E), or (G) of section 1842(o)(1) 
or 
in 
clause 
(ii) 
or 
(iii) 
of 
section 
1881(b)(14)(B) that does not have a rebate agree-
ment in effect under section 1927, for calendar 
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quarters beginning on or after January 1, 2020, 
such manufacturer shall report to the Secretary 
the 
information 
described 
in 
subsection 
(b)(3)(A)(iii) of such section 1927 with respect to 
such drug or biological in a time and manner 
specified by the Secretary. 
‘‘(B) AUDIT.—Information reported under 
subparagraph (A) is subject to audit by the In-
spector General of the Department of Health and 
Human Services. 
‘‘(C) VERIFICATION.—The Secretary may 
survey wholesalers and manufacturers that di-
rectly distribute drugs described in subparagraph 
(A), when necessary, to verify manufacturer 
prices and manufacturer’s average sales prices 
(including wholesale acquisition cost) if required 
to make payment reported under subparagraph 
(A). The Secretary may impose a civil monetary 
penalty in an amount not to exceed $100,000 on 
a wholesaler, manufacturer, or direct seller, if the 
wholesaler, manufacturer, or direct seller of such 
a drug refuses a request for information about 
charges or prices by the Secretary in connection 
with a survey under this subparagraph or know-
ingly provides false information. The provisions 
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of section 1128A (other than subsections (a) 
(with respect to amounts of penalties or addi-
tional assessments) and (b)) shall apply to a 
civil money penalty under this subparagraph in 
the same manner as such provisions apply to a 
penalty or proceeding under section 1128A(a). 
‘‘(D) CONFIDENTIALITY.—Notwithstanding 
any other provision of law, information disclosed 
by manufacturers or wholesalers under this 
paragraph (other than the wholesale acquisition 
cost for purposes of carrying out this section) is 
confidential and shall not be disclosed by the 
Secretary in a form which discloses the identity 
of a specific manufacturer or wholesaler or prices 
charged for drugs by such manufacturer or 
wholesaler, except— 
‘‘(i) as the Secretary determines to be 
necessary to carry out this section (includ-
ing the determination and implementation 
of the payment amount), or to carry out 
section 1847B; 
‘‘(ii) to permit the Comptroller General 
to review the information provided; and 
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pbinns on DSKJLVW7X2PROD with BILLS
‘‘(iii) to permit the Director of the 
Congressional Budget Office to review the 
information provided.’’. 
(b) ENFORCEMENT.—Section 1847A such Act (42 
U.S.C. 1395w–3a) is further amended— 
(1) in subsection (d)(4)— 
(A) in subparagraph (A), by striking ‘‘IN 
GENERAL’’ and inserting ‘‘MISREPRESENTA-
TION’’; 
(B) in subparagraph (B), by striking ‘‘sub-
paragraph (B)’’ and inserting ‘‘subparagraph 
(A), (B), or (C)’’; 
(C) by redesignating subparagraph (B) as 
subparagraph (D); and 
(D) by inserting after subparagraph (A) the 
following new subparagraphs: 
‘‘(B) FAILURE TO PROVIDE TIMELY INFOR-
MATION.—If the Secretary determines that a 
manufacturer described in subsection (f)(2) has 
failed to report on information described in sec-
tion 1927(b)(3)(A)(iii) with respect to a drug or 
biological in accordance with such subsection, the 
Secretary shall apply a civil money penalty in 
an amount of $10,000 for each day the manufac-
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turer has failed to report such information and 
such amount shall be paid to the Treasury. 
‘‘(C) FALSE INFORMATION.—Any manufac-
turer required to submit information under sub-
section (f)(2) that knowingly provides false infor-
mation is subject to a civil money penalty in an 
amount not to exceed $100,000 for each item of 
false information. Such civil money penalties are 
in addition to other penalties as may be pre-
scribed by law.’’; and 
(2) in subsection (c)(6)(A), by striking the period 
at the end and inserting ‘‘, except that, for purposes 
of subsection (f)(2), the Secretary may, if the Sec-
retary determines appropriate, exclude repackagers of 
a drug or biological from such term.’’. 
(c) REPORT.—Not later than January 1, 2021, the In-
spector General of the Department of Health and Human 
Services shall assess and submit to Congress a report on 
the accuracy of average sales price information submitted 
by manufacturers under section 1847A of the Social Secu-
rity Act (42 U.S.C. 1395w–3a). Such report shall include 
any recommendations on how to improve the accuracy of 
such information. 
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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 Secu-
rity 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. 
DECEMBER 24, 2020 
Reported from the Committee on Ways and Means with 
an amendment 
DECEMBER 24, 2020 
Committee on Energy and Commerce discharged; com-
mitted to the Committee of the Whole House on the 
State of the Union and ordered to be printed 
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