Medicare Compliance & Reimbursement

With twists and turns aplenty, the Centers for Medicare & Medicaid Services (CMS) has finally issued a notice on how it plans to offer access to emerging technologies and devices, cover the innovations, and protect beneficiaries.

First: In September 2021, CMS repealed the ‘‘Medicare Program; Medicare Coverage of Innovative Technology (MCIT) and Definition of ‘Reasonable and Necessary’” final rule because the agency found the research lacking and wanted more study and regulation over Food and Drug Administration (FDA)-designated breakthrough devices (see Medicare Compliance & Reimbursement, Vol. 47, No. 20).

Next: In November 2022, CMS released four guidelines for use in future rulemaking, ensuring more safety for beneficiaries, support for manufacturers and clinicians, and better coordination with the FDA on regulatory reform (see Medicare Compliance & Reimbursement, Vol. 48, No. 21).

Now: On June 27, CMS published a notice in the Federal Register, which lays out the agency’s transitional coverage for emerging technologies (TCET) through the national coverage determination (NCD) process. Harnessing feedback the agency garnered from the MCIT rule, “the TCET pathway aims to coordinate benefit category determination, coding, and payment reviews and to allow any evidence gaps to be addressed through fit-for-purpose studies,” CMS says in the notice.

Resource: Find the notice and submit comments through Aug. 28 at www.federalregister.gov/documents/2023/06/27/2023-13544/medicare-program-transitional-coverage-for-emerging-technologies.