CMS Releases Proposed Updates for Coverage of Transcatheter MV Repair

After some delay, the Centers for Medicare & Medicaid Services (CMS) released yesterday its proposed changes to the national coverage determination (NCD) for catheter-based mitral valve repair, which would expand coverage to include treatment of patients with functional mitral regurgitation (MR). The prior NCD, issued in 2014, provided coverage for degenerative MR only.

Of note, CMS chose to replace the term transcatheter mitral valve repair (TMVR) with mitral valve transcatheter edge-to-edge repair (TEER) “to more precisely define the treatment addressed in this proposed NCD.” The MitraClip (Abbott) remains the only TEER device approved by the US Food and Drug Administration.

CMS will be accepting comments on the proposed NCD through July 30 and is due to make a final determination on September 28, 2020.

CMS reviewed evidence from the COAPT and MITRA-FR trials, observational studies, and meta-analyses. They found the COAPT results particularly compelling, suggesting that TEER improves symptoms, quality of life, and survival in select patients with secondary MR.

Under the proposal, TEER will be covered when used for patients with moderate-to-severe or severe functional MR who remain symptomatic despite guideline-directed medical therapy, and who meet the following requirements (consistent with COAPT inclusion criteria):

• Ischemic or nonischemic cardiomyopathy
• LVEF 20% to 50%
• NYHA functional class II, III, or IVa (ambulatory)
• LV end-diastolic dimension ≤ 70 mm

In addition, the patient must be under the care of a local heart team that has decided that mitral valve surgery is not an option.

TEER will not be covered in certain patients consistent with the COAPT exclusion criteria, including those with coexisting aortic or tricuspid disease requiring surgery or transcatheter intervention and those “in whom existing comorbidities would preclude the expected benefit from correction of the mitral valve.”

Multisociety Involvement

The proposed NCD also lays out requirements for new and existing TEER programs, including various procedural volume mandates, with CMS noting that it was guided by recommendations from a consensus document released at the end of 2019 by the American Association for Thoracic Surgery (AATS), the American College of Cardiology (ACC), the Society for Cardiovascular Angiography and Interventions (SCAI), and the Society of Thoracic Surgeons (STS); it was also endorsed by the Heart Failure Society of America (HFSA). CMS sought to “align as much as possible valve program requirements for programs performing both TEER and TAVR so as to minimize burden on facilities in meeting procedural volume requirements set forth across different policies.”

Regarding TEER for degenerative MR, which has been reimbursed with a coverage with evidence development (CED) requirement since August 2014, CMS proposes that coverage determinations will be made by Medicare administrative contractors (MACs) “due to the very low number of procedures, < 1% of the Medicare population undergo TEER of the mitral valve for degenerative MR, and the published procedural volume recommendations from the professional societies . . . . The MACs are structured to be able to take into account local patient, physician, and institutional factors, which are especially important when overall prevalence is very low.”

CMS opened a review of the TMVR NCD in August 2019 based on a request by the STS, ACC, AATS, and SCAI, as the societies wished to harmonize reimbursement criteria and FDA-approved indications for MitraClip, which were expanded to include functional MR in March 2019. The subsequent public comment period drew 26 comments, which CMS says all supported expansion of coverage of TEER for functional MR.

Public Feedback

In a statement, Susan Peschin, president and CEO of the Alliance for Aging Research, said the nonprofit organization “is encouraged” by the draft NCD, “and—except for some conditions of coverage that should be modified—believes this is a significant step forward for Medicare patients with mitral valve disease.”

She expressed concern about the proposed minimum surgical procedure volumes for TEER programs, however. “While thoracic specialty societies may favor volume requirements, these restrictions do not help patients with advanced heart failure in need of mitral valve repair,” she wrote. “The standard of care for such patients is guideline-directed medical therapy, not surgery. These patients are frequently too sick to tolerate surgery, let alone invasive open-heart surgery, which has not demonstrated a clinical benefit in such patients, making medical therapy alone (until the recent introduction of TEER) their only option.”

Peschin also took issue with the draft NCD recommending “separate new and established program requirements, which will create new, unnecessary hurdles for smaller and rural hospitals that likely cannot meet the volume requirements” and with the requirement of “separate face-to-face patient examinations by a cardiac surgeon and interventional cardiologist, creating an additional barrier for patients in obtaining TEER.”

For its part as maker of the only FDA-approved TEER device, Abbott said in a statement that it is pleased with the proposed decision to expand coverage to include functional MR, adding, “We look forward to CMS’ final decision in the weeks ahead.”