II 

109TH CONGRESS 

2D SESSION S. 3650 

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 SENATE OF THE UNITED STATES 

JULY 12, 2006 

Mr. BINGAMAN (for himself, Mr. LAUTENBERG, Mr. MENENDEZ, Mr. DORGAN, Mr. KENNEDY, Ms. STABENOW, Mr. DAYTON, Mr. JOHNSON, Mrs. 

CLINTON, and Mr. AKAKA) introduced the following bill; which was read 

twice and referred to the Committee on Finance 

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 

provided under a pharmaceutical manufacturer patient 

assistance program. 


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•S 3650 IS

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 2006’’. 

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’’; 

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

24 14, or under a State Pharmaceutical Assistance 

25 Program’’; and 


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

2 inserting ‘‘; and’’; and 

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

4 new clause: 

5 ‘‘(iii) such costs shall be treated as in6 curred and shall not be considered to be 

7 reimbursed under clause (ii) if such costs 

8 are borne or paid— 

9 ‘‘(I) under section 1860D–14; 

10 ‘‘(II) under a State Pharma11 ceutical Assistance Program; 

12 ‘‘(III) by the Indian Health Serv13 ice, an Indian tribe or tribal organiza14 tion, or an urban Indian organization 

15 (as defined in section 4 of the Indian 

16 Health Care Improvement Act); 

17 ‘‘(IV) by a federally qualified 

18 health center (as defined in section 

19 1861(aa)(4)); 

20 ‘‘(V) under an AIDS Drug As21 sistance Program under part B of 

22 title XXVI of the Public Health Serv23 ice Act; 

24 ‘‘(VI) by a subsection (d) hos25 pital (as defined in section 


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1 1886(d)(1)(B)) that meets the re2 quirements of clauses (i) and (ii) of 

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

4 Health Service Act; or 

5 ‘‘(VII) by a pharmaceutical man6 ufacturer patient assistance program, 

7 either directly or through the distribu8 tion or donation of covered part D 

9 drugs, which shall be valued at the 

10 negotiated price of such covered part 

11 D drug under the enrollee’s prescrip12 tion drug plan or MA–PD plan as of 

13 the date that the drug was distributed 

14 or donated.’’. 

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

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

17 January 1, 2006. 

18 SEC. 3. PROVIDING A SAFE HARBOR FOR PHARMA19 CEUTICAL MANUFACTURER PATIENT ASSIST20 ANCE PROGRAMS. 

21 (a) SAFE HARBOR.—Section 1128B(b)(3) of the So22 cial Security Act (42 U.S.C. 1320a–7b(b)(3)) is amend23 ed— 

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

25 the end; 


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

2 237(d) of the Medicare Prescription Drug, Improve3 ment, and Modernization Act of 2003 (Public Law 

4 108–173; 117 Stat. 2213)— 

5 (A) by moving such subparagraph 2 ems to 

6 the left; and 

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

8 inserting a semicolon; 

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

10 added by section 431(a) of the Medicare Prescrip11 tion Drug, Improvement, and Modernization Act of 

12 2003 (Public Law 108–173; 117 Stat. 2287), as 

13 subparagraph (I); 

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

15 (A) by moving such subparagraph 2 ems to 

16 the left; and 

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

18 inserting ‘‘; and’’; and 

19 (5) by adding at the end the following new sub20 paragraph: 

21 ‘‘(J) any remuneration paid by a pharma22 ceutical manufacturer patient assistance program, 

23 either in cash or through the distribution or dona24 tion of covered Part D drugs (as defined in section 

25 1860D–2(e)), to an individual enrolled in a prescripVerDate Aug 31 2005 18:16 Jul 15, 2006 Jkt 049200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S3650.IS S3650

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1 tion drug plan under part D of title XVIII or in an 

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

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

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

5 January 1, 2006. 

Æ 


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