I 113th CONGRESS 1st Session H. R. 1239 IN THE HOUSE OF REPRESENTATIVES March 18, 2013 Mr. Cassidy (for himself and Ms. Matsui ) 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 part D of title XVIII of the Social Security Act to count the negotiated price of drugs provided free or at nominal charge under compassionate treatment programs towards incurred out-of-pocket costs.

1. Short title This Act may be cited as the Accessing Medicare Therapies Act of 2013 . 2. Counting the negotiated price of drugs provided free or at nominal charge under compassionate treatment programs towards incurred out-of-pocket costs (a) In general Section 1860D–2(b)(4) of the Social Security Act ( 42 U.S.C. 1395w–102(b)(4) ) is amended— (1) in subparagraph (C), by striking subparagraph (E) and inserting subparagraphs (E) and (F) ; and (2) by adding at the end the following new subparagraph: (F) Inclusion of negotiated price of drugs provided under compassionate treatment programs (i) In general In applying subparagraph (A) with respect to an individual enrolled in a prescription drug plan, incurred costs shall include the negotiated price described in clause (ii) of a covered part D drug if— (I) the drug is classified, for purposes of applying tiered copayments consistent with section 1860D–2(b)(2)(B), in the highest copayment tier (such as a tier 4 for specialty brand-name drugs); (II) the drug is furnished to the individual free or at nominal charge under a compassionate treatment program (as defined in clause (iii)); and (III) the drug, if furnished other than through such program, is covered under the formulary of the plan or is available through exception or appeal. (ii) Negotiated price The negotiated price described in this clause, for a covered part D drug which is dispensed to an enrollee— (I) by a pharmacy, is the negotiated price at such pharmacy; or (II) other than by a pharmacy, is the average negotiated price for the drug in the prescription drug plan in the zip code of the enrollee as of the date the drug is dispensed. (iii) Compassionate treatment program defined In this subparagraph, the term compassionate treatment program means, with respect to covered part D drugs, a program that— (I) is administered by an entity described in section 501(c)(3) of the Internal Revenue Code of 1986 that is exempt from tax under section 501(a) of such Code; (II) takes title to the drugs and distributes the drugs to eligible part D individuals free or at nominal charge on the basis of the entity’s assessment of financial need of such individuals; (III) does not distribute the drugs to an individual unless the individual’s household income (as determined under section 36B of the Internal Revenue Code of 1986) is less than the maximum income level for the taxpayer in the household to be eligible for a refundable credit under such section; and (IV) meets such additional requirements as the Inspector General of the Department of Health and Human Services establishes, consistent with guidance and advisory opinions issued under section 1128D, to prevent fraud or abuse in the application of this subparagraph. . (b) Effective date The amendments made by subsection (a) shall apply to drugs furnished in plan years beginning on or after January 1, 2014.