12 2 STA T . 2 58 2 PUBLIC LA W 11 0– 2 7 5 —J UL Y 15 , 2008 ‘ ‘ (i)IDENTIF I CA TI O NOFD RUGS IN CERTAIN CAT - EGORIES AND C L ASSES .—Beg i n ning w i thpla n y ea r201 0 , the S e c retary s hall i d enti f y, as appr o priate, cat- egories and classes of dr u gs for which b oth of the following criteria are m et
‘‘(I) R estricted access to drugs in the category or class would ha v ema j or or life threatening clin- ical conse q uences for individuals who have a dis- ease or disorder treated by the drugs in such cat- egory or class. ‘‘(II) T here is significant clinical need for such individuals to have access to multiple drugs within a category or class due to unique chemical actions and pharmacological effects of the drugs within the category or class, such as drugs used in the treatment of cancer. ‘‘(ii) F OR M ULAR Y RE Q UIREMENTS.—Subject to clause (iii), PD P sponsors offering prescription drug plans shall be required to include all covered part D drugs in the categories and classes identified by the Secretary under clause (i). ‘‘(iii) EX CE P TIONS.—The Secretary may establish e x ceptions that permits a PDP sponsor of a prescription drug plan to exclude from its formulary a particular covered part D drug in a category or class that is otherwise required to be included in the formulary under clause (ii) (or to otherwise limit access to such a drug, including through prior authori z ation or utiliza- tion management). A ny exceptions established under the preceding sentence shall be provided under a process that— ‘‘(I) ensures that any exception to such require- ment is based upon scientific evidence and medical standards of practice (and, in the case of antiretroviral medications, is consistent with the Department of H ealth and Human Services G uide- lines for the U se of Antiretroviral Agents in HI V - 1-Infected Adults and Adolescents)
and ‘‘(II) includes a public notice and comment period. ’ ’. Subti t leF—O t h e rP r ov i s io n s SEC.18 1. U SE OFPARTD DATA. Section 1 86 0D – 12(b)( 3 )(D) of the Social Security Act ( 4 2 U.S. C . 13 95 w–112(b)(3)(D)) is amended by adding at the end the following sentence: ‘‘ N otwithstanding any other provision of law, information provided to the Secretary under the application of section 185 7 (e)(1) to contracts under this section under the preceding sentence— ‘‘(i) may be used for the purposes of carrying out this part, improving public health through research on the utilization, safety, effectiveness, quality, and efficiency of health care services (as the Secretary determines appropriate); and ‘‘(ii) shall be made available to Congressional sup- port agencies (in accordance with their obligations to Ef f ectiv e da te .
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