I 

113TH CONGRESS 

1ST SESSION H. R. 1239 

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. 

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 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 ‘‘Accessing Medicare 

5 Therapies Act of 2013’’. 


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1 SEC. 2. COUNTING THE NEGOTIATED PRICE OF DRUGS 

2 PROVIDED FREE OR AT NOMINAL CHARGE 

3 UNDER COMPASSIONATE TREATMENT PRO4 GRAMS TOWARDS INCURRED OUT-OF-POCK5 ET COSTS. 

6 (a) IN GENERAL.—Section 1860D–2(b)(4) of the So7 cial Security Act (42 U.S.C. 1395w–102(b)(4)) is amend8 ed— 

9 (1) in subparagraph (C), by striking ‘‘subpara10 graph (E)’’ and inserting ‘‘subparagraphs (E) and 

11 (F)’’; and 

12 (2) by adding at the end the following new sub13 paragraph: 

14 ‘‘(F) INCLUSION OF NEGOTIATED PRICE

15 OF DRUGS PROVIDED UNDER COMPASSIONATE

16 TREATMENT PROGRAMS.— 

17 ‘‘(i) IN GENERAL.—In applying sub18 paragraph (A) with respect to an indi19 vidual enrolled in a prescription drug plan, 

20 incurred costs shall include the negotiated 

21 price described in clause (ii) of a covered 

22 part D drug if— 

23 ‘‘(I) the drug is classified, for 

24 purposes of applying tiered copay25 ments consistent with section 1860D– 

26 2(b)(2)(B), in the highest copayment 


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1 tier (such as a tier 4 for specialty 

2 brand-name drugs); 

3 ‘‘(II) the drug is furnished to the 

4 individual free or at nominal charge 

5 under a compassionate treatment pro6 gram (as defined in clause (iii)); and 

7 ‘‘(III) the drug, if furnished 

8 other than through such program, is 

9 covered under the formulary of the 

10 plan or is available through exception 

11 or appeal. 

12 ‘‘(ii) NEGOTIATED PRICE.—The nego13 tiated price described in this clause, for a 

14 covered part D drug which is dispensed to 

15 an enrollee— 

16 ‘‘(I) by a pharmacy, is the nego17 tiated price at such pharmacy; or 

18 ‘‘(II) other than by a pharmacy, 

19 is the average negotiated price for the 

20 drug in the prescription drug plan in 

21 the zip code of the enrollee as of the 

22 date the drug is dispensed. 

23 ‘‘(iii) COMPASSIONATE TREATMENT

24 PROGRAM DEFINED.—In this subpara25 graph, the term ‘compassionate treatment 


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1 program’ means, with respect to covered 

2 part D drugs, a program that— 

3 ‘‘(I) is administered by an entity 

4 described in section 501(c)(3) of the 

5 Internal Revenue Code of 1986 that is 

6 exempt from tax under section 501(a) 

7 of such Code; 

8 ‘‘(II) takes title to the drugs and 

9 distributes the drugs to eligible part 

10 D individuals free or at nominal 

11 charge on the basis of the entity’s as12 sessment of financial need of such in13 dividuals; 

14 ‘‘(III) does not distribute the 

15 drugs to an individual unless the indi16 vidual’s household income (as deter17 mined under section 36B of the Inter18 nal Revenue Code of 1986) is less 

19 than the maximum income level for 

20 the taxpayer in the household to be el21 igible for a refundable credit under 

22 such section; and 

23 ‘‘(IV) meets such additional re24 quirements as the Inspector General 

25 of the Department of Health and 


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1 Human Services establishes, con2 sistent with guidance and advisory 

3 opinions issued under section 1128D, 

4 to prevent fraud or abuse in the appli5 cation of this subparagraph.’’. 

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

7 subsection (a) shall apply to drugs furnished in plan years 

8 beginning on or after January 1, 2014. 

Æ 


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