Page:United States Statutes at Large Volume 122.djvu/2606

 12 2 STA T . 2 583PUBLIC LA W 11 0– 2 7 5 —J UL Y 15, 2008 sup p ortC o ng r e ss a s set out i nt h eir authori z ing stat - utes )f or the purposes of c on d ucting Congressiona l o v ersight ,m onitoring, ma k ing recommendations, and anal y sis of the program under this title .’ ’. SEC.182 . R E VI SI ON O FD EFINI T ION OF M EDIC AL L Y ACCE P TED INDICA - TION FOR DR UG S. ( a) REVIS I ON O FD EFINI T ION FO RPA RTDDR UG S. — ( 1 ) I N GENERA L .— S ection 1 860 D –2 (e)(1) of the Social Secu- rity A ct( 4 2 U .S.C. 1 395w –102(e)(1)) is amended, in the matter following su b paragraph ( B )— (A) by striking ‘ ‘(as defined in section 192 7 (k)(6))’’ and inserting ‘‘(as defined in paragraph (4))’’ and (B) by adding at the end the following new paragraph

‘‘(4) M E D I C ALL Y ACCE P TED INDICATION DEFINED.— ‘‘(A) IN GENERAL.— F or purposes of paragraph (1), the term ‘medically accepted indication’ has the meaning given that term— ‘‘(i) in the case of a covered part D drug used in an anticancer chemotherapeutic regimen, in section 1861(t)(2)(B), e x cept that in applying such section— ‘‘(I) ‘prescription drug plan or MA–PD plan’ shall be substituted for ‘carrier’ each place it appears; and ‘‘(II) sub j ect to subparagraph (B), the com- pendia described in section 1927(g)(1)(B)(i)(III) shall be included in the list of compendia described in clause (ii)(I) section 1861(t)(2)(B); and ‘‘(ii) in the case of any other covered part D drug, in section 1927(k)(6). ‘‘(B) CONFLICT OF INTEREST.— O n and after J anuary 1, 2010, subparagraph (A)(i)(II) shall not apply unless the compendia described in section 1927(g)(1)(B)(i)(III) meets the re q uirement in the third sentence of section 1861(t)(2)(B). ‘‘(C) UPDATE.—For purposes of applying subparagraph (A)(ii), the Secretary shall revise the list of compendia described in section 1927(g)(1)(B)(i) as is appropriate for identifying medically accepted indications for drugs. Any such revision shall be done in a manner consistent with the process for revising compendia under section 1861(t)(2)(B).’’. (2) E FFECTIVE DATE.— T he amendments made by this sub- section shall apply to plan years beginning on or after January 1, 2009. (b) CONFLICTS OF INTEREST.—Section 1861(t)(2)(B) of the Social Security Act (42 U.S.C. 1395x(t)(2)(B)) is amended by adding at the end the following new sentence: ‘‘On and after January 1, 2010, no compendia may be included on the list of compendia under this subparagraph unless the compendia has a publicly trans- parent process for evaluating therapies and for identifying potential conflicts of interests.’’. SEC. 18 3 . CONTRACT W IT H A CONSENSUS- B ASED ENTITY REGARDING PERFORMANCE MEASUREMENT. (a) CONTRACT.— Ef f ectiv e da te .42USC1395w– 1 0 2 no te. Effective date.

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