I 
109TH CONGRESS 
2D SESSION 
H. R. 6123 
To include costs incurred by the Indian Health Service, a federally qualified 
health center, an AIDS drug assistance program, certain hospitals, or 
a pharmaceutical manufacturer patient assistance program in providing 
prescription drugs toward the annual out of pocket threshold under 
part D of title XVIII of the Social Security Act and to provide a 
safe harbor for assistance provided under a pharmaceutical manufacturer 
patient assistance program. 
IN THE HOUSE OF REPRESENTATIVES 
SEPTEMBER 20, 2006 
Mr. HOLT 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 include costs incurred by the Indian Health Service, a 
federally qualified health center, an AIDS drug assist-
ance program, certain hospitals, or a pharmaceutical 
manufacturer patient assistance program in providing 
prescription drugs toward the annual out of pocket 
threshold under part D of title XVIII of the Social 
Security Act and to provide a safe harbor for assistance 
provided under a pharmaceutical manufacturer patient 
assistance program. 
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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 ‘‘Helping Fill the Medi-
care Rx Gap Act of 2006’’. 
SEC. 2. INCLUDING COSTS INCURRED BY THE INDIAN 
HEALTH SERVICE, A FEDERALLY QUALIFIED 
HEALTH CENTER, AN AIDS DRUG ASSISTANCE 
PROGRAM, CERTAIN HOSPITALS, OR A PHAR-
MACEUTICAL MANUFACTURER PATIENT AS-
SISTANCE PROGRAM IN PROVIDING PRE-
SCRIPTION DRUGS TOWARD THE ANNUAL 
OUT OF POCKET THRESHOLD UNDER PART D. 
(a) IN GENERAL.—Section 1860D–2(b)(4)(C) of the 
Social Security Act (42 U.S.C. 1395w–102(b)(4)(C)) is 
amended— 
(1) in clause (i), by striking ‘‘and’’ at the end; 
(2) in clause (ii)— 
(A) by striking ‘‘such costs shall be treated 
as incurred only if’’ and inserting ‘‘subject to 
clause (iii), such costs shall be treated as in-
curred if’’; 
(B) by striking ‘‘, under section 1860D– 
14, or under a State Pharmaceutical Assistance 
Program’’; and 
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(C) by striking the period at the end and 
inserting ‘‘; and’’; and 
(3) by inserting after clause (ii) the following 
new clause: 
‘‘(iii) such costs shall be treated as in-
curred and shall not be considered to be 
reimbursed under clause (ii) if such costs 
are borne or paid— 
‘‘(I) under section 1860D–14; 
‘‘(II) under a State Pharma-
ceutical Assistance Program; 
‘‘(III) by the Indian Health Serv-
ice, an Indian tribe or tribal organiza-
tion, or an urban Indian organization 
(as defined in section 4 of the Indian 
Health Care Improvement Act); 
‘‘(IV) by a federally qualified 
health center (as defined in section 
1861(aa)(4)); 
‘‘(V) under an AIDS Drug As-
sistance Program under part B of 
title XXVI of the Public Health Serv-
ice Act; 
‘‘(VI) by a subsection (d) hos-
pital 
(as 
defined 
in 
section 
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1886(d)(1)(B)) that meets the re-
quirements of clauses (i) and (ii) of 
section 340B(a)(4)(L) of the Public 
Health Service Act; or 
‘‘(VII) by a pharmaceutical man-
ufacturer patient assistance program, 
either directly or through the distribu-
tion or donation of covered part D 
drugs, which shall be valued at the 
negotiated price of such covered part 
D drug under the enrollee’s prescrip-
tion drug plan or MA–PD plan as of 
the date that the drug was distributed 
or donated.’’. 
(b) EFFECTIVE DATE.—The amendments made by 
subsection (a) shall apply to costs incurred on or after 
January 1, 2006. 
SEC. 3. PROVIDING A SAFE HARBOR FOR PHARMA-
CEUTICAL MANUFACTURER PATIENT ASSIST-
ANCE PROGRAMS. 
(a) SAFE HARBOR.—Section 1128B(b)(3) of the So-
cial Security Act (42 U.S.C. 1320a–7b(b)(3)) is amend-
ed— 
(1) in subparagraph (G), by striking ‘‘and’’ at 
the end; 
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(2) in subparagraph (H), as added by section 
237(d) of the Medicare Prescription Drug, Improve-
ment, and Modernization Act of 2003 (Public Law 
108–173; 117 Stat. 2213)— 
(A) by moving such subparagraph 2 ems to 
the left; and 
(B) by striking the period at the end and 
inserting a semicolon; 
(3) by redesignating subparagraph (H), as 
added by section 431(a) of the Medicare Prescrip-
tion Drug, Improvement, and Modernization Act of 
2003 (Public Law 108–173; 117 Stat. 2287), as 
subparagraph (I); 
(4) in subparagraph (I), as so redesignated— 
(A) by moving such subparagraph 2 ems to 
the left; and 
(B) by striking the period at the end and 
inserting ‘‘; and’’; and 
(5) by adding at the end the following new sub-
paragraph: 
‘‘(J) any remuneration paid by a pharma-
ceutical manufacturer patient assistance program, 
either in cash or through the distribution or dona-
tion of covered Part D drugs (as defined in section 
1860D–2(e)), to an individual enrolled in a prescrip-
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tion drug plan under part D of title XVIII or in an 
MA–PD plan under part C of such title.’’. 
(b) EFFECTIVE DATE.—The amendments made by 
subsection (a) shall apply to remuneration paid on or after 
January 1, 2006. 
Æ 
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