REVISION OF DEFINITION OF MEDICALLY ACCEPTED INDICATION FOR DRUGS.

SEC. 182. REVISION OF DEFINITION OF MEDICALLY ACCEPTED INDICATION FOR DRUGS.(a) Revision of Definition for Part D Drugs.—(1) In general.—Section 1860D–2(e)(1) of the Social Security Act (42 U.S.C. 1395w–102(e)(1)) is amended, in the matter following subparagraph (B)—(A) by striking “(as defined in section 1927(k)(6))” and inserting “(as defined in paragraph (4))”; and(B) by adding at the end the following new paragraph:“(4) Medically accepted indication defined.—“(A) In general.—For 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), except that in applying such section—“(I) ‘prescription drug plan or MA–PD plan’ shall be substituted for ‘carrier’ each place it appears; and“(II) subject to subparagraph (B), the compendia 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.—On and after January 1, 2010, subparagraph (A)(i)(II) shall not apply unless the compendia described in section 1927(g)(1)(B)(i)(III) meets the requirement 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) Effective date.—The amendments made by this subsection 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 transparent process for evaluating therapies and for identifying potential conflicts of interests.”.