I 111th CONGRESS 2d Session H. R. 5732 IN THE HOUSE OF REPRESENTATIVES July 14, 2010 Ms. Kilroy (for herself, Mr. Thornberry, and Mr. Burgess) 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 amend title XVIII of the Social Security Act to permit coverage of certain covered part D drugs for uses that are determined to be for medically accepted indications based upon clinical evidence in peer reviewed medical literature.

1.

Short title

This Act may be cited as the Part D Off-Label Prescription Parity Act.

2.

Revised definition of medically accepted indication for Medicare covered part D drugs

(a)

In general

Section 1860D–2(e)(4) of the Social Security Act (42 U.S.C. 1395w–102(e)(4)) is amended by adding at the end the following new subparagraph: (D)

Clarification

Notwithstanding subparagraph (A)(ii), none of the provisions of this subsection shall prevent a PDP sponsor offering a prescription drug plan or an MA organization offering an MA–PD plan from determining (whether through a determination, reconsideration of such a determination, or an appeal of such a determination under section 1852(g) or subsection (g) or (h) of section 1860D–4, as applicable) that a use of a covered part D drug is for a medically accepted indication for purposes of coverage of such drug under such plan if such determination is based upon guidance provided by the Secretary for determining accepted uses of covered part D drugs and on supportive clinical evidence in peer reviewed medical literature. . (b)

Effective date

The amendment made by this section shall apply to plan years beginning on or after January 1, 2011.