I 
112TH CONGRESS 
2D SESSION 
H. R. 6611 
To amend title XVIII of the Social Security Act to promote public notification 
and provide incentives to reduce drug shortages, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
NOVEMBER 29, 2012 
Mr. CASSIDY (for himself, Mr. ROONEY, Mr. ROGERS of Michigan, Mr. HAR-
RIS, and Mr. BENISHEK) introduced the following bill; which was referred 
to the Committee on Energy and Commerce, and in addition to the Com-
mittee 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 jurisdiction of the committee concerned 
A BILL 
To amend title XVIII of the Social Security Act to promote 
public notification and provide incentives to reduce drug 
shortages, and for other purposes. 
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 ‘‘Patient Access to 
Drugs in Shortage Act of 2012’’. 
SEC. 2. MARKET STABILITY INCENTIVES. 
(a) MEDICARE.— 
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(1) IN GENERAL.—Section 1847A(b) of the So-
cial Security Act (42 U.S.C. 1395w–3a(b)) is 
amended— 
(A) in paragraph (1), in the matter pre-
ceding subparagraph (A), by striking ‘‘para-
graph (7)’’ and inserting ‘‘paragraphs (7) and 
(9)’’; and 
(B) by adding at the end the following new 
paragraph: 
‘‘(9) STERILE INJECTABLE PRODUCTS WITH 3 
OR FEWER ACTIVE MANUFACTURERS.— 
‘‘(A) IN GENERAL.—The payment amount 
for a drug described in subparagraph (B) that 
is furnished on or after July 1, 2013, and be-
fore January 1, 2020, shall be equal to— 
‘‘(i) in the case of a drug described in 
subparagraph (B)(i), the volume-weighted 
wholesale 
acquisition 
cost 
determined 
under subparagraph (C) for the drug; and 
‘‘(ii) in the case of a drug described in 
subparagraph (B)(ii), the wholesale acqui-
sition cost (as defined in subsection (c)) of 
the drug. 
‘‘(B) DRUG DESCRIBED.— 
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‘‘(i) IN GENERAL.—A drug described 
in this subparagraph is a sterile injectable 
drug product that is manufactured by 3 or 
fewer active manufacturers (as determined 
by the Secretary) and is— 
‘‘(I) a multiple source drug (as 
described in subsection (c)(6)(C)) for 
which there is no period of exclusivity 
in effect or available under section 
505(j), 505A, or 527 of the Federal 
Food, Drug, and Cosmetic Act; or 
‘‘(II) a single source drug (as de-
scribed in subsection (c)(6)(D)(ii)) for 
which there is no period of exclusivity 
in effect or available under section 
505(c), 505A, or 527 of the Federal 
Food, Drug, and Cosmetic Act. 
‘‘(ii) STERILE INJECTABLE DRUG DE-
FINED.—In this paragraph, the term ‘ster-
ile injectable drug’ means a drug approved 
by the Food & Drug Administration that is 
injected into the body. 
‘‘(C) USE
OF
VOLUME-WEIGHTED
AVER-
AGE WHOLESALE ACQUISITION COSTS FOR MUL-
TIPLE
SOURCE
DRUGS.—The volume-weighted 
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average wholesale acquisition costs under this 
paragraph shall be determined under this sub-
paragraph in the same manner as the volume- 
weighted average of the average sales prices is 
determined under paragraph (6) except that, 
for purposes of this paragraph, any reference in 
such paragraph (6) to the average sale prices 
for a drug is deemed a reference to wholesale 
acquisition cost (as defined in subsection 
(c)(6)(B)) for the drug.’’. 
(2) HOPD PROSPECTIVE PAYMENT SYSTEM.— 
Section 1833(t)(14) of the Social Security Act (42 
U.S.C. 1395l(t)(14)) is amended— 
(A) in subparagraph (A)(iii), in the matter 
preceding subclause (I), by striking ‘‘subpara-
graph (E)’’ and inserting ‘‘subparagraphs (E) 
and (I)’’; and 
(B) by adding at the end the following new 
subparagraph: 
‘‘(I) 
STERILE
INJECTABLE
PRODUCTS 
WITH 3 OR FEWER ACTIVE MANUFACTURERS.— 
The amount of payment for a drug described in 
section 1847A(b)(9)(B) that is furnished on or 
after July 1, 2013, and before January 1, 
2020, shall be equal to— 
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‘‘(i) in the case of a drug described in 
clause (i) of such section, the volume- 
weighted 
wholesale 
acquisition 
costs 
amount 
determined 
under 
section 
1847A(b)(9)(C) for the drug; and 
‘‘(ii) in the case of a drug described in 
clause (ii) of section 1847A(b)(9)(B), the 
wholesale acquisition cost (as defined in 
section 1847A(c)) of the drug.’’. 
(b) MEDICAID.— 
(1) IN GENERAL.—Section 1927(a) of the So-
cial Security Act (42 U.S.C. 1396r–8(a)) is amended 
by adding at the end the following new paragraph: 
‘‘(8) STERILE INJECTABLE PRODUCTS WITH 3 
OR FEWER ACTIVE MANUFACTURERS.— 
‘‘(A) IN GENERAL.—Paragraph (1) of this 
subsection and section 1903(i)(10)(A) shall not 
apply to a drug that is described in section 
1847A(b)(9)(C), that is furnished on or after 
July 1, 2013, and before January 1, 2020, and 
for which payment may be made under part B 
of title XVIII. 
‘‘(B) GUIDANCE.—Not later than July 1, 
2013, the Secretary shall publish guidance on 
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the exclusion of certain sterile injectable prod-
ucts under subparagraph (A).’’. 
(2) 
CONFORMING
AMENDMENT.—Section 
1903(i)(10)(A) of the Social Security Act (42 U.S.C. 
1396b(i)(10)(A)) is amended by striking ‘‘unless sec-
tion 1927(a)(3) applies’’ and inserting ‘‘unless para-
graph (3) or (9) of section 1927(a) applies’’. 
(c) 340B PROGRAM.— 
(1) IN GENERAL.—Section 340B of the Public 
Health Service Act (42 U.S.C. 256b) is amended by 
inserting after subsection (e) the following: 
‘‘(f) EXCLUSION OF CERTAIN STERILE INJECTABLE 
PRODUCTS.— 
‘‘(1) IN GENERAL.—For purposes of this sec-
tion (including with respect to the prohibition de-
scribed in subsection (a)(5)(L)(iii)), the term ‘cov-
ered outpatient drug’ shall not include a drug that 
is described in section 1847A(b)(9)(C) of the Social 
Security Act, that is furnished on or after July 1, 
2013, and before January 1, 2020, and for which 
payment may be made under part B of title XVIII 
of such Act. 
‘‘(2) GUIDANCE.—Not later than July 1, 2013, 
the Secretary shall publish guidance on the exclusion 
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of certain sterile injectable products under para-
graph (1).’’. 
(d) STUDY AND REPORT.— 
(1) IN GENERAL.—The Secretary of Health and 
Human Services shall contract with an independent 
entity to study the effects of the amendments made 
by this section on patient access to sterile injectable 
products. 
(2) REPORT.—As a condition of the contract 
described under paragraph (1), the independent enti-
ty shall agree to submit to Congress and such Sec-
retary, not later than 3 years after the date of en-
actment of this Act, a report that describes the re-
sults of the study conducted under paragraph (1). 
SEC. 3. EXCLUSION OF BRANDED PRESCRIPTION DRUGS 
FROM ANNUAL FEE DURING PERIODS OF 
SHORTAGE. 
(a) IN GENERAL.—Subsection (e) of section 9008 of 
the Patient Protection and Affordable Care Act is amend-
ed by redesignating paragraph (4) as paragraph (5) and 
by inserting after paragraph (3) the following new para-
graph: 
‘‘(4) EXCLUSION
DURING
SHORTAGE.—The 
term ‘branded prescription drug sales’ shall not in-
clude sales of any branded prescription drug that— 
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‘‘(A) is on the drug shortage list main-
tained under section 506E of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 356e), and 
‘‘(B)(i) is the listed drug (as defined in 
section 505(j)(2)(A)(i) of the Federal Food, 
Drug, 
and 
Cosmetic 
Act 
(21 
U.S.C. 
355(j)(2)(A)(i)) for a drug for which the ap-
proval of an application under section 505(j) of 
such Act (21 U.S.C. 355(j)) is in effect, or 
‘‘(ii) is the reference product (as defined in 
section 351(i) of the Public Health Service Act 
(42 U.S.C. 262(i)) for a biological product for 
which the approval of an application under sec-
tion 351(k) of such Act (42 U.S.C. 262(j)) is 
in effect.’’. 
(b) EFFECTIVE DATE.—The amendment made by 
subsection (a) shall apply to sales after the date of the 
enactment of this Act. 
Æ 
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