Sec. 5. Report on coding, coverage, and payment processes under Medicare for new medical products
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Not later than 12 months after the date of enactment of this Act, the Secretary of Health and Human Services shall publish a report on the internet website of the Department of Health and Human Services regarding processes under the Medicare program under title XVIII of the Social Security Act ( 42 U.S.C. 1395 et seq.) with respect to the coding, coverage, and payment of medical products described in subsection (b). Such report shall include the following: A description of challenges in the coding, coverage, and payment processes under the Medicare program for medical products described in such subsection.
Recommendations to— incorporate patient experience data (such as the impact of a disease or condition on the lives of patients and patient treatment preferences) into the coverage and payment processes within the Centers for Medicare & Medicaid Services; decrease the length of time to make national and local coverage determinations under the Medicare program (as those terms are defined in subparagraph
(A)and (B), respectively, of section 1862(l)(6) of the Social Security Act ( 42 U.S.C. 1395y(l)(6) )); streamline the coverage process under the Medicare program and incorporate input from relevant stakeholders into such coverage determinations; and identify potential mechanisms to incorporate novel payment designs similar to those in development in commercial insurance plans and State plans under title XIX of the Social Security Act ( 42 U.S.C. 1396r et seq.) into the Medicare program. For purposes of subsection (a), a medical product described in this subsection is a medical product, including a drug, biological (including gene and cell therapy and gene editing), or medical device, that has been designated as a breakthrough therapy under section 506(a) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 356(a) ), a breakthrough device under section 515B of such Act ( 21 U.S.C. 360e–3 ), or a regenerative advanced therapy under section 506(g) of such Act ( 21 U.S.C. 356(g) ).
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- 21 USC 360e–3
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Sec. 5
Report on coding, coverage, and payment processes under Medicare for new medical products
Cite21 USC 360e–3
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