[Congressional Bills 111th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5732 Introduced in House (IH)]

111th CONGRESS
  2d Session
                                H. R. 5732

 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.


_______________________________________________________________________


                    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.

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

SECTION 1. SHORT TITLE.

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

SEC. 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.
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