Bill > S2326

This bill, the New Opportunities for Value that Extend Lives Act of 2019 (or the NOVEL Act of 2019), aims to expedite the coding and coverage of novel medical products under the Medicare program. Key provisions include: 1) Requiring the Secretary of Health and Human Services to make modifications to the Healthcare Common Procedure Coding System (HCPCS) code set at least once every quarter for novel medical products (defined as drugs, biological products, or medical devices that have not been assigned a HCPCS code and have received certain FDA designations). 2) Establishing a coverage pathway for novel medical products, including a process for the Secretary to make national coverage decisions with evidence development for up to 4 years, and requirements for the Secretary to report on alternative payment models for these products. 3) Directing the Secretary to convene a public meeting to discuss coordination between the FDA and CMS on the availability of novel medical products, and to update guidance on the Medicare coverage determination process for these products. 4) Requiring the Secretary to publish a report on challenges and recommendations for the coding, coverage, and payment processes under Medicare for breakthrough medical products.

Budget and Finance

https://www.congress.gov/bill/116th-congress/senate-bill/2326/all-info