After successful outreach from ACC Advocacy, including written comments and meetings with policymakers in response to its initial proposal, the Centers for Medicare and Medicaid Services (CMS) on Jan. 19 revised and finalized a national coverage determination (NCD) for transcatheter edge-to-edge-repair (TEER), a narrower definition of transcatheter mitral valve repair (TMVR). As expected, the new policy adds coverage for functional mitral regurgitation (MR) consistent with approved indications that were added by the U.S. Food and Drug Administration (FDA) in 2019.

CMS reconsidered removing coverage for degenerative MR from the NCD, and coverage for degenerative MR will remain under the umbrella of the new NCD rather than local Medicare Administrative Contractors (MACs). Both FMR and DMR will now be covered for indications that match FDA labeling. Linking this coverage back to FDA indications means future changes to FDA indications for TEER will not require another NCD reconsideration.

Reversing course from the proposed NCD, CMS reinstalled a requirement for TEER sites to participate in a "prospective, national, audited registry" that tracks stroke, all-cause mortality, quality of life, and other important outcomes under its Coverage with Evidence Development (CED) paradigm. In part because of these change, CMS will not implement COAPT trial exclusion criteria as rigid contraindications. Contraindications still exist "for patients in whom existing comorbidities would preclude the expected benefit from a mitral valve TEER" and "in patients with untreated severe aortic stenosis."

The NCD continues to rely on care by a comprehensive heart team and significantly aligns with facility and operator infrastructure and volume requirements from the 2019 AATS/ACC/SCAI/STS Expert Consensus Systems of Care Document for TMVR. The full text of final NCD memorandum is available here. The coverage parameters of the NCD are effective immediately. However, it takes CMS several months to create claims processing instructions that Medicare Administrative Contractors (MAC) use to update their software. Sites should contact their MACs directly if they encounter claims processing difficulties while the update process is pending.

Clinical Topics: Valvular Heart Disease, Mitral Regurgitation

Keywords: Centers for Medicare and Medicaid Services, U.S., Mitral Valve Insufficiency, Mitral Valve, United States Food and Drug Administration, Medicare, Aortic Valve Stenosis, Registries, Cardiology Magazine

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