Sec. 3. Coverage determinations for novel medical products
288 words·~1 min read·
/bill/116/s/2326/is/section-3A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
Section 1862(l) of the Social Security Act ( 42 U.S.C. 1395y(l) ) is amended by adding at the end the following new paragraph: The Secretary shall facilitate an efficient coverage pathway to expedite a national coverage decision for coverage with evidence development process under this title for novel medical products described in subparagraph (D). The Secretary shall review such novel medical products for the coverage process on an expedited basis, beginning as soon as the Secretary assigns a HCPCS code to the product under clause (iii)(V)(aa) of section 1174(b)(2)(B).
Such coverage pathway shall include, with respect to such novel medical products, if the Secretary determines coverage with evidence development is appropriate, issuance of a national coverage determination of coverage with evidence development for a period up to, but not to exceed, 4 years from the date of such determination. Not later than 4 years after issuing such national coverage determination, the Secretary shall submit to Congress and to the manufacturer of the novel medical product a report providing options for alternative payment models under this title for the novel medical product or class of such products, which may include the utilization of existing models in the commercial health insurance market.
Such report shall include any recommendations for legislation and administrative action as the Secretary determines appropriate to facilitate such payment arrangements. For purposes of this paragraph, a novel medical product described in this subparagraph is a novel medical product, as defined in clause
(iv)of section 1174(b)(2)(B), that is assigned a HCPCS code pursuant to the expedited coding process under clause
(iii)of such section. Nothing in this paragraph shall prevent the Secretary from issuing a noncoverage or a national coverage determination for a novel medical product. .
Connectionstraces to 1
Traces to 1 document
Citation graph
cites case law
Sec. 3
Coverage determinations for novel medical products
Cites 1Cited by 0 across 0 sources