I 
116TH CONGRESS 
1ST SESSION H. R. 4619 
To amend title XVIII of the Social Security Act to require drug manufactur-
ers to pay a Medicare part D rebate for certain drugs if the price 
of such drugs increases faster than inflation. 
IN THE HOUSE OF REPRESENTATIVES 
OCTOBER 8, 2019 
Ms. SCHAKOWSKY (for herself, Mr. HIGGINS of New York, and Ms. WILD) in-
troduced the following bill; which was referred to the Committee on En-
ergy and Commerce, and in addition to the Committee on Ways and 
Means, for a period to be subsequently determined by the Speaker, in 
each case for consideration of such provisions as fall within the jurisdic-
tion of the committee concerned 
A BILL 
To amend title XVIII of the Social Security Act to require 
drug manufacturers to pay a Medicare part D rebate 
for certain drugs if the price of such drugs increases 
faster than inflation. 
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 ‘‘Pharmaceutical Re-
bates for Excessive Pricing Above Inflation Act’’ or the 
‘‘Pharmaceutical REPAI Act’’. 
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SEC. 2. MEDICARE PART D PRESCRIPTION DRUG INFLA-
TION REBATE BY MANUFACTURERS. 
Part D of title XVIII of the Social Security Act is 
amended by inserting after section 1860D–14A (42 
U.S.C. 1395w–114a) the following new section: 
‘‘SEC. 1860D–14B. MANUFACTURER REBATE FOR CERTAIN 
DRUGS WITH PRICES INCREASING FASTER 
THAN INFLATION. 
‘‘(a) IN GENERAL.—Subject to the provisions of this 
section, in order for coverage to be available under this 
part for a part D rebatable drug of a manufacturer dis-
pensed during an applicable year, the manufacturer must 
have entered into and have in effect an agreement de-
scribed in subsection (b). For purposes of this section the 
term ‘applicable year’ means a year beginning with 2022. 
‘‘(b) AGREEMENTS.— 
‘‘(1) TERMS OF AGREEMENT.—An agreement 
described in this subsection, with respect to a manu-
facturer of a part D rebatable drug, is an agreement 
under which the following applies: 
‘‘(A) SECRETARIAL PROVISION OF INFOR-
MATION.—Not later than 9 months after the 
end of each applicable year with respect to 
which the agreement is in effect, the Secretary, 
for the part D rebatable drug of the manufac-
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turer, reports to the manufacturer the following 
for such year: 
‘‘(i) Information on the total units (as 
defined in subsection (g)(2)) dispensed for 
each dosage form and strength with re-
spect to such part D rebatable drug and 
year. 
‘‘(ii) Information on the amount (if 
any) of the excess average manufacturer 
price increase described in subsection 
(c)(1)(B) for each dosage form and 
strength with respect to such drug and 
year. 
‘‘(iii) The rebate amount specified 
under subsection (c) for each dosage form 
and strength with respect to such drug and 
year. 
‘‘(B) MANUFACTURER
REQUIREMENTS.— 
For each applicable year with respect to which 
the agreement is in effect, the manufacturer of 
the part D rebatable drug, for each dosage 
form and strength with respect to such drug, 
not later than 30 days after the date of receipt 
from the Secretary of the information described 
in subparagraph (A) for such year, provides to 
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the Secretary a rebate that is equal to the 
amount specified in subsection (c) for such dos-
age form and strength with respect to such 
drug for such year. 
‘‘(2) LENGTH OF AGREEMENT.— 
‘‘(A) IN GENERAL.—An agreement under 
this section, with respect to a part D rebatable 
drug, shall be effective for an initial period of 
not less than one year and shall be automati-
cally renewed for a period of not less than one 
year unless terminated under subparagraph 
(B). 
‘‘(B) TERMINATION.— 
‘‘(i) BY SECRETARY.—The Secretary 
may provide for termination of an agree-
ment under this section for violation of the 
requirements of the agreement or other 
good cause shown. Such termination shall 
not be effective earlier than 60 days after 
the date of notice of such termination. The 
Secretary shall provide, upon request, a 
manufacturer with a hearing concerning 
such a termination, but such hearing shall 
not delay the effective date of the termi-
nation. 
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‘‘(ii) BY A MANUFACTURER.—A man-
ufacturer may terminate an agreement 
under this section for any reason. Any 
such termination shall not be effective 
until the year beginning at least 60 days 
after the date the manufacturer provides 
notice to the Secretary. 
‘‘(C) EFFECTIVENESS OF TERMINATION.— 
Any termination under this paragraph shall not 
affect rebates due under the agreement under 
this section before the effective date of its ter-
mination. 
‘‘(D) DELAY
BEFORE
REENTRY.—In the 
case of any agreement under this section with 
a manufacturer which is terminated in a plan 
year, another such agreement with the manu-
facturer (or a successor manufacturer) may not 
be entered into before the subsequent plan year, 
unless the Secretary finds good cause for an 
earlier reinstatement of such an agreement. 
‘‘(3) INFORMATION.—For purposes of carrying 
out this section, the Secretary shall use information 
submitted 
by 
manufacturers 
under 
section 
1927(b)(3). 
‘‘(c) REBATE AMOUNT.— 
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sion’ means, with respect to a part D reba-
table drug, a new formulation of the drug 
(as determined by the Secretary), such as 
an extended release formulation, but does 
not include an abuse-deterrent formulation 
of the drug (as determined by the Sec-
retary), regardless of whether such abuse- 
deterrent formulation is an extended re-
lease formulation. 
‘‘(d) REBATE DEPOSITS.—Amounts paid as rebates 
under subsection (c) shall be deposited into the Medicare 
Prescription Drug Account in the Federal Supplementary 
Medical Insurance Trust Fund established under section 
1841. 
‘‘(e) CIVIL MONEY PENALTY.—In the case of a man-
ufacturer of a part D rebatable drug with an agreement 
in effect under this section who has failed to comply with 
the terms of the agreement under subsection (b)(1)(B) 
with respect to such drug for an applicable year, the Sec-
retary may impose a civil money penalty on such manufac-
turer in an amount equal to 125 percent of the amount 
specified in subsection (c) for such drug for such year. 
The provisions of section 1128A (other than subsections 
(a) (with respect to amounts of penalties or additional as-
sessments) and (b)) shall apply to a civil money penalty 
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under this subsection in the same manner as such provi-
sions apply to a penalty or proceeding under section 
1128A(a). 
‘‘(f) JUDICIAL REVIEW.—There shall be no judicial 
review of the following: 
‘‘(1) The determination of units under this sec-
tion. 
‘‘(2) The determination of whether a drug is a 
part D rebatable drug under this section. 
‘‘(3) The calculation of the rebate amount 
under this section. 
‘‘(g) DEFINITIONS.—In this section: 
‘‘(1) PART D REBATABLE DRUG DEFINED.— 
‘‘(A) IN
GENERAL.—The term ‘part D 
rebatable drug’ means a drug or biological that 
would (without application of this section) be a 
covered part D drug, except such term shall, 
with respect to an applicable year, not include 
such a drug or biological if the average total 
cost under a prescription drug plan under this 
part or MA–PD plan under part C for such 
year per individual who uses such a drug or bi-
ological, as determined by the Secretary, are 
less than, subject to subparagraph (B), $100, 
as determined by the Secretary using the most 
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recent data available or, if data is not available, 
as estimated by the Secretary. 
‘‘(B) INCREASE.—The dollar amount ap-
plied under subparagraph (A)— 
‘‘(i) for 2023, shall be the dollar 
amount specified under such subparagraph 
for 2022, increased by the percentage in-
crease in the consumer price index for all 
urban consumers (United States city aver-
age) as of January of 2022; and 
‘‘(ii) for a subsequent year, shall be 
the dollar amount specified in this sub-
paragraph (or subparagraph (A)) for the 
previous year, increased by the percentage 
increase in the consumer price index for all 
urban consumers (United States city aver-
age) as of January of the previous year. 
Any dollar amount specified under this sub-
paragraph that is not a multiple of $10 shall be 
rounded to the nearest multiple of $10. 
‘‘(2) UNIT DEFINED.—The term ‘unit’ means, 
with respect to a part D rebatable drug, the lowest 
identifiable quantity (such as a capsule or tablet, 
milligram of molecules, or grams) of the part D 
rebatable drug that is dispensed to individuals en-
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rolled under a prescription drug plan under this part 
or an MA–PD plan under part C. 
‘‘(3) PAYMENT AMOUNT BENCHMARK YEAR.— 
The term ‘payment amount benchmark year’ means 
the year beginning January 1, 2016. 
‘‘(4) BENCHMARK
PERIOD
CPI–U.—The term 
‘benchmark period CPI–U’ means the consumer 
price index for all urban consumers (United States 
city average) for January 2016. 
‘‘(5) REBATE PERIOD CPI–U.—The term ‘rebate 
period CPI–U’ means, with respect to an applicable 
year, the consumer price index for all urban con-
sumers (United States city average) for January of 
such year. 
‘‘(6) AVERAGE
MANUFACTURER
PRICE.—The 
term ‘average manufacturer price’ has the meaning, 
with respect to a part D rebatable drug of a manu-
facturer for an applicable year, given such term in 
section 1927(k)(1), with respect to a covered out-
patient drug of a manufacturer for a rebate period 
under section 1927. For purposes of applying the 
previous sentence, with respect to a part D rebatable 
drug of a manufacturer and an applicable year, the 
Secretary shall use the information with respect to 
the average manufacturer price for such drug re-
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ported 
by 
the 
manufacturer 
under 
section 
1927(b)(3) with respect to each of the quarters in 
the applicable year and calculate an annual average 
manufacturer price for such applicable year as the 
average of such average manufacturer prices for 
each such quarter, weighted by units of such drug 
sold or dispensed with respect to such applicable 
year.’’. 
Æ 
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