I 
110TH CONGRESS 
1ST SESSION H. R. 1218 
To amend part D of title XVIII of the Social Security Act to authorize 
the Secretary of Health and Human Services to negotiate for lower 
prices for Medicare prescription drugs and to eliminate the gap in cov-
erage of Medicare prescription drug benefits, to authorize the Secretary 
of Health and Human Services to promulgate regulations for the re-
importation of prescription drugs, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
FEBRUARY 27, 2007 
Mr. WU introduced the following bill; which was referred to the Committee 
on Energy 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 juris-
diction of the committee concerned 
A BILL 
To amend part D of title XVIII of the Social Security 
Act to authorize the Secretary of Health and Human 
Services to negotiate for lower prices for Medicare pre-
scription drugs and to eliminate the gap in coverage 
of Medicare prescription drug benefits, to authorize the 
Secretary of Health and Human Services to promulgate 
regulations for the reimportation of prescription drugs, 
and for other purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
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SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Medicare Prescription 
Drug Improvement Act’’. 
TITLE 
I—IMPROVEMENT 
OF 
MEDICARE 
PRESCRIPTION 
DRUG BENEFITS 
SEC. 101. PERMITTING THE NEGOTIATION OF FAIR PRICES 
FOR MEDICARE PRESCRIPTION DRUGS ON 
BEHALF OF MEDICARE BENEFICIARIES. 
Section 1860D–11 of the Social Security Act (42 
U.S.C. 1395w–111) is amended by striking subsection (i) 
(relating to noninterference) and inserting the following: 
‘‘(i) AUTHORITY TO NEGOTIATE PRICES WITH MAN-
UFACTURERS.—In order to ensure that beneficiaries en-
rolled under prescription drug plans, MA–PD plans, and 
qualified retiree prescription drug plans pay the lowest 
possible price, the Secretary shall have authority similar 
to that of the Secretary of Veterans Affairs, Secretary of 
Defense, and the heads of other Federal agencies and de-
partments that purchase prescription drugs in bulk to ne-
gotiate contracts with manufacturers of covered part D 
drugs, consistent with the requirements and in further-
ance of the goals of providing quality care and containing 
costs under this part.’’. 
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SEC. 102. ELIMINATION OF GAP IN COVERAGE OF PRE-
SCRIPTION DRUG BENEFITS. 
(a) IN GENERAL.—Paragraph (3) of section 1860D– 
2(b) of the Social Security Act (42 U.S.C. 1395w–102(b)) 
is repealed. 
(b) 
CONFORMING
AMENDMENTS.—(1) 
Section 
1860D–2 of such Act (42 U.S.C. 1395w–102) is amend-
ed— 
(A) in subsection (a)(2)(A)(i)(I), by strik-
ing ‘‘, or an increase in the initial coverage 
limit with respect to covered part D drugs’’; 
(B) in subsection (b)(2)(A), by striking 
‘‘and up to the initial coverage limit under 
paragraph (3)’’; 
(C) in subsection (b)(4)(C)(i)— 
(i) by striking the comma after ‘‘para-
graph (1)’’ and inserting ‘‘and’’; and 
(ii) by striking ‘‘, and for amounts for 
which benefits are not provided because of 
the application of the initial coverage limit 
described in paragraph (3)’’; 
(D) in subsection (c)(1), by striking sub-
paragraph (C); and 
(E) in subsection (d)(1)(A), by striking ‘‘or 
an initial coverage limit (described in subsection 
(b)(3))’’. 
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(2) Section 1860D–4(a)(4)(B) of such Act (42 
U.S.C. 1395w–104(a)(4)(B)) is amended to read as 
follows: 
‘‘(B) when prescription drug benefits are 
provided under this part, a notice of the bene-
fits in relation to the annual out-of-pocket 
threshold for the current year.’’. 
(3)(A) Section 1860D–14(a) of such Act (42 
U.S.C. 1395w–114(a)) is amended— 
(i) in paragraph (1), by striking subpara-
graph (C) and redesignating subparagraphs (D) 
and (E) as subparagraphs (C) and (D), respec-
tively; 
(ii) in paragraph (2), by striking subpara-
graph (C) and redesignating subparagraphs (D) 
and (E) as subparagraphs (C) and (D), respec-
tively; and 
(iii) in paragraph (4)(A) in the matter pre-
ceding clause (i), by striking ‘‘paragraph 
(1)(D)(ii)’’ 
and 
inserting 
‘‘paragraph 
(1)(C)(ii)’’. 
(B) Section 1860D–14(c)(1) of such Act (42 
U.S.C. 1395w–114(c)(1)) is amended in the second 
sentence by striking ‘‘subsections (a)(1)(D) and 
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(a)(2)(E)’’ and inserting ‘‘subsections (a)(1)(C) and 
(a)(2)(D)’’. 
(C) Section 1860D–15(e)(1)(B) of such Act (42 
U.S.C. 1395w–115(e)(1)(B)) is amended by striking 
‘‘paragraphs (1)(D) and (2)(E)’’ and inserting 
‘‘paragraphs (1)(C) and (2)(D)’’. 
(4)(A) Section 1860D–41(a)(6) of such Act (42 
U.S.C. 1395w–151(a)(6)) is amended by striking 
paragraph (6) and redesignating paragraphs (7) 
through (18) as paragraphs (6) through (17), re-
spectively. 
(B) Section 1860D–1(a)(1)(A) of such Act (42 
U.S.C. 1395w–101(a)(1)(A)) is amended by striking 
‘‘1860D–41(a)(14)’’ 
and 
inserting 
‘‘1860D– 
41(a)(13)’’. 
(c) EFFECTIVE DATE.—The amendments made by 
this section shall apply to benefits for plan years beginning 
after the date of the enactment of this Act. 
TITLE II—IMPORTATION OF 
PRESCRIPTION DRUGS 
SEC. 201. SHORT TITLE. 
This title may be cited as the ‘‘Pharmaceutical Mar-
ket Access Act of 2007’’. 
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SEC. 202. IMPORTATION OF PRESCRIPTION DRUGS. 
(a) NULLIFICATION
OF
CERTAIN
AMENDMENTS 
MADE BY PUBLIC LAW 108–173.—The Federal Food, 
Drug, and Cosmetic Act is amended— 
(1) in section 804 (21 U.S.C. 384), by amend-
ing the section to read as if section 1121(a) of Pub-
lic Law 108–173 had not been enacted; 
(2) in section 301 (21 U.S.C. 331), by amend-
ing the section to read as if section 1121(b)(1) of 
Public Law 108–173 had not been enacted; and 
(3) in section 303 (21 U.S.C. 333), by amend-
ing the section to read as if section 1121(b)(2) of 
Public Law 108–173 had not been enacted. 
(b) IMPORTATION OF PRESCRIPTION DRUGS.—Sec-
tion 804 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 384), as amended by subsection (a)(1) of this 
section, is amended— 
(1) in subsection (a)— 
(A) by striking ‘‘The Secretary’’ and in-
serting ‘‘Not later than 180 days after the date 
of the enactment of the Pharmaceutical Market 
Access Act of 2007, the Secretary’’; and 
(B) by striking ‘‘pharmacists and whole-
salers’’ and inserting ‘‘pharmacists, wholesalers, 
and qualifying individuals’’; 
(2) in subsection (b)— 
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(A) by amending paragraph (1) to read as 
follows: 
‘‘(1) require that each covered product imported 
pursuant to such subsection complies with sections 
501, 502, and 505, and other applicable require-
ments of this Act; and’’; 
(B) in paragraph (2), by striking ‘‘, includ-
ing subsection (d); and’’ and inserting a period; 
and 
(C) by striking paragraph (3); 
(3) in subsection (c), by inserting ‘‘by phar-
macists and wholesalers (but not qualifying individ-
uals)’’ after ‘‘importation of covered products’’; 
(4) in subsection (d)— 
(A) by striking paragraphs (3) and (10); 
(B) in paragraph (5), by striking ‘‘, includ-
ing the professional license number of the im-
porter, if any’’; 
(C) in paragraph (6)— 
(i) in subparagraph (C), by inserting 
‘‘(if required under subsection (e))’’ before 
the period; 
(ii) in subparagraph (D), by inserting 
‘‘(if required under subsection (e))’’ before 
the period; and 
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