I 

110TH CONGRESS 

1ST SESSION H. R. 2058 

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 

APRIL 26, 2007 

Mr. HOLT (for himself, Mr. FERGUSON, Mr. FRELINGHUYSEN, Mr. GRIJALVA, 

Mr. BOSWELL, Mr. MCNULTY, Ms. NORTON, Mr. CUMMINGS, Ms. WOOLSEY, Mr. JOHNSON of Georgia, Mr. ELLISON, Ms. HIRONO, Mr. CONYERS, Ms. CORRINE BROWN of Florida, Ms. JACKSON-LEE of Texas, Mr. 

COHEN, and Mr. WYNN) 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 jurisdiction of the committee concerned 

A BILL 

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 


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provided under a pharmaceutical manufacturer patient 

assistance program. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Helping Fill the Medi5 care Rx Gap Act of 2007’’. 

6 SEC. 2. INCLUDING COSTS INCURRED BY THE INDIAN 

7 HEALTH SERVICE, A FEDERALLY QUALIFIED 

8 HEALTH CENTER, AN AIDS DRUG ASSISTANCE 

9 PROGRAM, CERTAIN HOSPITALS, OR A PHAR10 MACEUTICAL MANUFACTURER PATIENT AS11 SISTANCE PROGRAM IN PROVIDING PRE12 SCRIPTION DRUGS TOWARD THE ANNUAL 

13 OUT OF POCKET THRESHOLD UNDER PART D. 

14 (a) IN GENERAL.—Section 1860D–2(b)(4)(C) of the 

15 Social Security Act (42 U.S.C. 1395w–102(b)(4)(C)) is 

16 amended— 

17 (1) in clause (i), by striking ‘‘and’’ at the end; 

18 (2) in clause (ii)— 

19 (A) by striking ‘‘such costs shall be treated 

20 as incurred only if’’ and inserting ‘‘subject to 

21 clause (iii), such costs shall be treated as in22 curred if’’; 


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1 (B) by striking ‘‘, under section 1860D– 

2 14, or under a State Pharmaceutical Assistance 

3 Program’’; and 

4 (C) by striking the period at the end and 

5 inserting ‘‘; and’’; and 

6 (3) by inserting after clause (ii) the following 

7 new clause: 

8 ‘‘(iii) such costs shall be treated as in9 curred and shall not be considered to be 

10 reimbursed under clause (ii) if such costs 

11 are borne or paid— 

12 ‘‘(I) under section 1860D–14; 

13 ‘‘(II) under a State Pharma14 ceutical Assistance Program; 

15 ‘‘(III) by the Indian Health Serv16 ice, an Indian tribe or tribal organiza17 tion, or an urban Indian organization 

18 (as defined in section 4 of the Indian 

19 Health Care Improvement Act); 

20 ‘‘(IV) by a federally qualified 

21 health center (as defined in section 

22 1861(aa)(4)); 

23 ‘‘(V) under an AIDS Drug As24 sistance Program under part B of 


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1 title XXVI of the Public Health Serv2 ice Act; 

3 ‘‘(VI) by a subsection (d) hos4 pital (as defined in section 

5 1886(d)(1)(B)) that meets the re6 quirements of clauses (i) and (ii) of 

7 section 340B(a)(4)(L) of the Public 

8 Health Service Act; or 

9 ‘‘(VII) by a pharmaceutical man10 ufacturer patient assistance program, 

11 either directly or through the distribu12 tion or donation of covered part D 

13 drugs, which shall be valued at the 

14 negotiated price of such covered part 

15 D drug under the enrollee’s prescrip16 tion drug plan or MA–PD plan as of 

17 the date that the drug was distributed 

18 or donated.’’. 

19 (b) EFFECTIVE DATE.—The amendments made by 

20 subsection (a) shall apply to costs incurred on or after 

21 January 1, 2007. 


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1 SEC. 3. PROVIDING A SAFE HARBOR FOR PHARMA2 CEUTICAL MANUFACTURER PATIENT ASSIST3 ANCE PROGRAMS. 

4 (a) SAFE HARBOR.—Section 1128B(b)(3) of the So5 cial Security Act (42 U.S.C. 1320a–7b(b)(3)) is amend6 ed— 

7 (1) in subparagraph (G), by striking ‘‘and’’ at 

8 the end; 

9 (2) in subparagraph (H), as added by section 

10 237(d) of the Medicare Prescription Drug, Improve11 ment, and Modernization Act of 2003 (Public Law 

12 108–173; 117 Stat. 2213)— 

13 (A) by moving such subparagraph 2 ems to 

14 the left; and 

15 (B) by striking the period at the end and 

16 inserting a semicolon; 

17 (3) by redesignating subparagraph (H), as 

18 added by section 431(a) of the Medicare Prescrip19 tion Drug, Improvement, and Modernization Act of 

20 2003 (Public Law 108–173; 117 Stat. 2287), as 

21 subparagraph (I); 

22 (4) in subparagraph (I), as so redesignated— 

23 (A) by moving such subparagraph 2 ems to 

24 the left; and 

25 (B) by striking the period at the end and 

26 inserting ‘‘; and’’; and 


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1 (5) by adding at the end the following new sub2 paragraph: 

3 ‘‘(J) any remuneration paid by a pharma4 ceutical manufacturer patient assistance program, 

5 either in cash or through the distribution or dona6 tion of covered Part D drugs (as defined in section 

7 1860D–2(e)), to an individual enrolled in a prescrip8 tion drug plan under part D of title XVIII or in an 

9 MA–PD plan under part C of such title.’’. 

10 (b) EFFECTIVE DATE.—The amendments made by 

11 subsection (a) shall apply to remuneration paid on or after 

12 January 1, 2007. 

Æ 


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