II 109th CONGRESS 2d Session S. 3650 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.

1.

Short title

This Act may be cited as the Helping Fill the Medicare Rx Gap Act of 2006.

2.

Including 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

(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 incurred if; (B)by striking , under section 1860D–14, or under a State Pharmaceutical Assistance Program; and (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 incurred 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 Pharmaceutical Assistance Program; (III)by the Indian Health Service, an Indian tribe or tribal organization, 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 Assistance Program under part B of title XXVI of the Public Health Service Act; (VI)by a subsection (d) hospital (as defined in section 1886(d)(1)(B)) that meets the requirements of clauses (i) and (ii) of section 340B(a)(4)(L) of the Public Health Service Act; or (VII)by a pharmaceutical manufacturer patient assistance program, either directly or through the distribution 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 prescription 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.

3.

Providing a safe harbor for pharmaceutical manufacturer patient assistance programs

(a)

Safe Harbor

Section 1128B(b)(3) of the Social Security Act (42 U.S.C. 1320a–7b(b)(3)) is amended— (1)in subparagraph (G), by striking and at the end; (2)in subparagraph (H), as added by section 237(d) of the Medicare Prescription Drug, Improvement, 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 Prescription 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 subparagraph: (J)any remuneration paid by a pharmaceutical manufacturer patient assistance program, either in cash or through the distribution or donation of covered Part D drugs (as defined in section 1860D–2(e)), to an individual enrolled in a prescription 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.