Page:United States Statutes at Large Volume 114 Part 5.djvu/586

 114 STAT. 2763A-546 PUBLIC LAW 106-554—APPENDIX F " (7) ANNUAL REPORT ON NATIONAL COVERAGE DETERMINA- TIONS. — "(A) IN GENERAL. —Not later than December 1 of each year, beginning in 2001, the Secretary shall submit to Congress a report that sets forth a detailed compilation of the actual time periods that were necessary to complete and fully implement national coverage determinations that were made in the previous fiscal year for items, services, or medical devices not previously covered as a benefit under this title, including, with respect to each new item, service, or medical device, a statement of the time taken by the Secretary to make and implement the necessary coverage, coding, and payment determinations, including the time taken to complete each significant step in the process of making and implementing such determinations. " (B) PUBLICATION OF REPORTS ON THE INTERNET.— The Secretary shall publish each report submitted under clause (i) on the medicare Internet site of the Department of Health and Human Services. "(8) CONSTRUCTION. —Nothing in this subsection shall be construed as permitting administrative or judicial review pursuant to this section insofar as such review is explicitly prohibited or restricted under another provision of law.". (b) ESTABLISHMENT OF A PROCESS FOR COVERAGE DETERMINA- TIONS. —Section 1862(a) (42 U.S.C. 1395y(a)) is amended by adding at the end the following new sentence: "In making a nation^ coverage determination (as defined in paragraph (1)(B) of section 1869(f)) the Secretary shall ensure that the public is afforded notice and opportunity to comment prior to implementation by the Secretary of the determination; meetings of advisory committees established under section 1114(f) with respect to the determination are made on the record; in making the determination, the Secretary has considered applicable information (including clinical experience and medical, technical, and scientific evidence) with respect to the subject matter of the determination; and in the determination, provide a clear statement of the basis for the determination (including responses to comments received from the public), the assumptions underlying that basis, and make available to the public the data (other than proprietary data) considered in making the determination.". (c) IMPROVEMENTS TO THE MEDICARE ADVISORY COMMITTEE PROCESS. —Section 1114 (42 U.S.C. 1314) is amended by adding at the end the following new subsection: "(i)(l) Any advisory committee appointed under subsection (f) to advise the Secretary 6n matters relating to the interpretation, application, or implementation of section 1862(a)(1) shall assure the full participation of a nonvoting member in the deliberations of the advisory committee, and shall provide such nonvoting member access to all information and data made available to voting members of the advisory committee, other than information that— "(A) is exempt from disclosure pursuant to subsection (a) of section 552 of title 5, United States Code, by reason of subsection (b)(4) of such section (relating to trade secrets); or "(B) the Secretary determines would present a conflict of interest relating to such nonvoting member.

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