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Medicare reimbursement for transcatheter mitral valve repair (TMVR) was extended to include secondary (functional) mitral regurgitation resulting from heart failure, according to a (NCD).

The Centers for Medicare & Medicaid Services (CMS) renamed the TMVR NCD to cover "mitral valve Transcatheter Edge-to-Edge Repair" for people with secondary mitral regurgitation who remain symptomatic despite guideline-directed medical therapy.

Notably, registry participation continues to be required as part of the Coverage with Evidence Development (CED) policy.

This comes in response to considerable backlash on a draft proposal to remove the CED requirement in the new NCD. Public commenters also disagreed with the proposed plan to establish coverage for primary (degenerative) mitral regurgitation at the discretion of Medicare Administrative Contractors.

With the final NCD, CMS covers mitral valve transcatheter edge-to-edge repair for primary and secondary mitral regurgitation.

Notably, the NCD had been expected in the fall of 2020.

"CMS acknowledges the delayed publication of this final NCD. CMS always aims to expeditiously complete rigorous national coverage analyses (NCAs) within statutory timeframes. 2020 was particularly challenging due to the COVID public health emergency," NCD writers said.

The CMS decision to cover more people with mitral regurgitation comes after the FDA green lit an expanded indication for the MitraClip device to treat people with secondary mitral regurgitation in March 2019. Months later, CMS announced it was starting to consider an NCD expansion for TMVR.

MitraClip remains the only TMVR device on the market and was originally approved by the FDA in late 2013 for severe, symptomatic primary mitral regurgitation. Operators perform edge-to-edge repair by using the device to clip together the leaflets of the mitral valve.

Use of TMVR in people with secondary mitral regurgitation has not been without controversy.

In 2018, the COAPT and MITRA-FR trials showed conflicting results regarding the efficacy of the MitraClip in these patients: COAPT associated the device with a significant reduction in heart failure hospitalizations at 24 months, whereas MITRA-FR found no benefit in terms of mortality and heart failure hospitalization rates at 12 months.

Subsequent analyses suggested that these benefits of the device may come with time, unlike the quality of life improvements that have been reported as early as 1 month after MitraClip placement.

Some researchers have also argued that certain secondary mitral regurgitation patients may be better candidates for TMVR than others.

"Secondary mitral regurgitation generally impacts older individuals suffering from heart failure who rely on Medicare for their healthcare coverage," said Neil Moat, MD, chief medical officer of Abbott's structural heart business, in an Abbott statement.

"CMS' decision to expand coverage for MitraClip marks a pivotal moment for people seeking a minimally invasive option that reduces mitral regurgitation and significantly improves their quality of life and chances of survival," Moat added.

The updated NCD stipulates institutional and operator volume requirements for transcatheter edge-to-edge repair of the mitral valve.

However, because of decreased volumes during COVID-19, CMS decided in early September listed for TMVR (along with percutaneous left atrial appendage closure, transcatheter aortic valve replacement, and ventricular assist device placement) for the duration of the public health emergency.

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