Sec. 4. Enhancing coordination with the Food and Drug Administration
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Not later than 12 months after the date of the enactment of this Act, the Secretary shall convene a public meeting for the purposes of discussing and providing input on improvements to coordination between the Food and Drug Administration and the Centers for Medicare & Medicaid Services in preparing for the availability of novel medical products (as defined in section 1174(b)(2)(B)(iv) of the Social Security Act, as added by section 2) on the market in the United States. The public meeting shall include— representatives of relevant Federal agencies, including representatives from each of the medical product centers within the Food and Drug Administration and representatives from the coding, coverage, and payment offices within the Centers for Medicare & Medicaid Services; stakeholders with expertise in the research and development of novel medical products, including manufacturers of such products; representatives of commercial health insurance payers; stakeholders with expertise in the administration and use of novel medical products, including physicians; and stakeholders representing patients and with expertise in the utilization of patient experience data in medical product development.
The public meeting shall include a discussion of— the status of the drug and medical device development pipeline related to the availability of novel medical products; the anticipated expertise necessary to review the safety and effectiveness of such products at the Food and Drug Administration and current gaps in such expertise, if any; the expertise necessary to make coding, coverage, and payment decisions with respect to such products within the Centers for Medicare & Medicaid Services, and current gaps in such expertise, if any; trends in the differences in the data necessary to determine the safety and effectiveness of a novel medical product and the data necessary to determine whether a novel medical product meets the reasonable and necessary requirements for coverage and payment under title XVIII of the Social Security Act pursuant to section 1862(a)(1)(A) of such Act ( 42 U.S.C. 1395y(a)(1)(A) ); the availability of information for sponsors of such novel medical products to meet each of those requirements; and the coordination of information related to significant clinical improvement over existing therapies for patients between the Food and Drug Administration and the Centers for Medicare & Medicaid Services with respect to novel medical products.
No information discussed as a part of the public meeting under this section shall be construed as authorizing the Secretary to disclose any information that is a trade secret or confidential information subject to section 552(b)(4) of title 5, United States Code. Not later than 18 months after the public meeting under subsection (a), the Secretary of Health and Human Services shall update the final guidance entitled National Coverage Determinations with Data Collection as a Condition of Coverage:
Coverage with Evidence Development to improve the availability and coordination of information as described in subparagraphs
(D)through
(F)subsection (a)(3), and clarify novel medical product clinical data requirements to meet reasonable and necessary requirements for coverage and payment under title XVIII of the Social Security Act. Not later than 12 months after issuing draft guidance under paragraph (1), the Secretary shall finalize the updated guidance.
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Sec. 4
Enhancing coordination with the Food and Drug Administration
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