IMPROVEMENTS IN NATIONAL AND LOCAL COVERAGE DETERMINATION PROCESS TO RESPOND TO CHANGES IN TECHNOLOGY.

SEC. 731. IMPROVEMENTS IN NATIONAL AND LOCAL COVERAGE DETERMINATION PROCESS TO RESPOND TO CHANGES IN TECHNOLOGY.(a) National and Local Coverage Determination Process.—(1) In general.—Section 1862 (42 U.S.C. 1395y), as amended by sections 948 and 950, is amended—(A) in the third sentence of subsection (a), by inserting “consistent with subsection (l)” after “the Secretary shall ensure”; and(B) by adding at the end the following new subsection:“(l) National and Local Coverage Determination Process.—“(1) Factors and evidence used in making national coverage determinations.—The Secretary shall make available to the public the factors considered in making national coverage determinations of whether an item or service is reasonable and necessary. The Secretary shall develop guidance documents to carry out this paragraph in a manner similar to the development of guidance documents under section 701(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371(h)).“(2) Timeframe for decisions on requests for national coverage determinations.—In the case of a request for a national coverage determination that—“(A) does not require a technology assessment from an outside entity or deliberation from the Medicare Coverage Advisory Committee, the decision on the request shall be made not later than 6 months after the date of the request; or117 STAT. 2350“(B) requires such an assessment or deliberation and in which a clinical trial is not requested, the decision on the request shall be made not later than 9 months after the date of the request.“(3) Process for public comment in national coverage determinations.—“(A) Period for proposed decision.—Not later than the end of the 6-month period (or 9-month period for requests described in paragraph (2)(B)) that begins on the date a request for a national coverage determination is made, the Secretary shall make a draft of proposed decision on the request available to the public through the Internet website of the Centers for Medicare & Medicaid Services or other appropriate means.“(B) 30-day period for public comment.—Beginning on the date the Secretary makes a draft of the proposed decision available under subparagraph (A), the Secretary shall provide a 30-day period for public comment on such draft.“(C) 60-day period for final decision.—Not later than 60 days after the conclusion of the 30-day period referred to under subparagraph (B), the Secretary shall—“(i) make a final decision on the request; “(ii) include in such final decision summaries of the public comments received and responses to such comments; “(iii) make available to the public the clinical evidence and other data used in making such a decision when the decision differs from the recommendations of the Medicare Coverage Advisory Committee; and“(iv) in the case of a final decision under clause (i) to grant the request for the national coverage determination, the Secretary shall assign a temporary or permanent code (whether existing or unclassified) and implement the coding change.“(4) Consultation with outside experts in certain national coverage determinations.—With respect to a request for a national coverage determination for which there is not a review by the Medicare Coverage Advisory Committee, the Secretary shall consult with appropriate outside clinical experts.“(5) Local coverage determination process.—“(A) Plan to promote consistency of coverage determinations.—The Secretary shall develop a plan to evaluate new local coverage determinations to determine which determinations should be adopted nationally and to what extent greater consistency can be achieved among local coverage determinations.“(B) Consultation.—The Secretary shall require the fiscal intermediaries or carriers providing services within the same area to consult on all new local coverage determinations within the area.“(C) Dissemination of information.—The Secretary should serve as a center to disseminate information on local coverage determinations among fiscal intermediaries and carriers to reduce duplication of effort.117 STAT. 2351“(6) National and local coverage determination defined.—For purposes of this subsection—“(A) National coverage determination.—The term ‘national coverage determination’ means a determination by the Secretary with respect to whether or not a particular item or service is covered nationally under this title.“(B) Local coverage determination.—The term ‘local coverage determination’ has the meaning given that in section 1869(f)(2)(B).”.(2) Effective date.—The amendments made by paragraph (1) shall apply to national coverage determinations as of January 1, 2004, and section 1862(l)(5) of the Social Security Act, as added by such paragraph, shall apply to local coverage determinations made on or after July 1, 2004.(b) Medicare Coverage of Routine Costs Associated With Certain Clinical Trials of Category A Devices.—(1) In general.—Section 1862 (42 U.S.C. 1395y), as amended by subsection (a), is amended by adding at the end the following new subsection:“(m) Coverage of Routine Costs Associated With Certain Clinical Trials of Category A Devices.—“(1) In general.—In the case of an individual entitled to benefits under part A, or enrolled under part B, or both who participates in a category A clinical trial, the Secretary shall not exclude under subsection (a)(1) payment for coverage of routine costs of care (as defined by the Secretary) furnished to such individual in the trial.“(2) Category a clinical trial.—For purposes of paragraph (1), a ‘category A clinical trial’ means a trial of a medical device if—“(A) the trial is of an experimental/investigational (category A) medical device (as defined in regulations under section 405.201(b) of title 42, Code of Federal Regulations (as in effect as of September 1, 2003));“(B) the trial meets criteria established by the Secretary to ensure that the trial conforms to appropriate scientific and ethical standards; and“(C) in the case of a trial initiated before January 1, 2010, the device involved in the trial has been determined by the Secretary to be intended for use in the diagnosis, monitoring, or treatment of an immediately life-threatening disease or condition.”.(2) Effective date.—The amendment made by paragraph (1) shall apply to routine costs incurred on and after January 1, 2005, and, as of such date, section 411.15(o) of title 42, Code of Federal Regulations, is superseded to the extent inconsistent with section 1862(m) of the Social Security Act, as added by such paragraph.(3) Rule of construction.—Nothing in the amendment made by paragraph (1) shall be construed as applying to, or affecting, coverage or payment for a nonexperimental/investigational (category B) device.(c) Issuance of Temporary National Codes.—Not later than July 1, 2004, the Secretary shall implement revised procedures for the issuance of temporary national HCPCS codes under part B of title XVIII of the Social Security Act.117 STAT. 2352