To amend title XVIII of the Social Security Act to make improvements in the national coverage determination process to respond to changes in technology.

1. Adds SEC. __. IMPROVEMENTS IN NATIONAL COVERAGE DETERMINATION PROCESS TO RESPOND TO CHANGES IN TECHNOLOGY at the end of subtitle C of title IV

   Adds a section

   In S. 1 · Reported to Senate

   (ii) adverse events due to unintended prescription drug-to-drug interactions.

   Inserted: SEC. __. IMPROVEMENTS IN NATIONAL COVERAGE DETERMINATION PROCESS TO RESPOND TO CHANGES IN TECHNOLOGY.

   Inserted: (a) In General.--Section 1862 (42 U.S.C. 1395y) is amended--

   Inserted: (A) in the third sentence of subsection (a) by inserting "consistent with subsection (j)" after "the Secretary shall ensure"; and

   Inserted: (B) by adding at the end the following new subsection:

   Inserted: "(j) National Coverage Determination Process.--

   Inserted: "(1) Timeframe for decisions on requests for national coverage determinations.--In the case of a request for a national coverage determination that--

   Inserted: "(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; or

   Inserted: "(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.

   Inserted: "(2) Process for public comment in national coverage determinations.--At the end of the 6-month period (with respect to a request under paragraph (1)(A)) or 9-month period (with respect to a request under paragraph (1)(B)) that begins on the date a request for a national coverage determination is made, the Secretary shall--

   Inserted: "(A) make a draft of proposed decision on the request available to the public through the Medicare Internet site of the Department of Health and Human Services or other appropriate means;

   Inserted: "(B) provide a 30-day period for public comment on such draft;

   Inserted: "(C) make a final decision on the request within 60 days of the conclusion of the 30-day period referred to under subparagraph (B);

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   Inserted: "(D) include in such final decision summaries of the public comments received and responses thereto;

   Inserted: "(E) 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

   Inserted: "(F) in the case of a decision to grant the coverage determination, assign a temporary or permanent code and implement the coverage decision at the end of the 60-day period referred to in subparagraph (C).

   Inserted: "(3) National coverage determination defined.--For purposes of this subsection, the term 'national coverage determination' has the meaning given such term in section 1869(f)(1)(B).".

   Inserted: (b) Effective date.--The amendments made by this section shall apply to national coverage determinations as of January 1, 2004.

   Original wording

   At the end of subtitle C of title IV, add the following:

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As printed