Pathways’ Pick of the Week: Medicare and Mitral Valves

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In this week’s top news pick from MedTech Strategist Market Pathways: Medicare is reconsidering its coverage policy for mitral valve repair devices in a way that could streamline future market growth.

[For a complete roundup of medtech policy happenings that should be on your radar this week, check out August 20 ‘Pathways’ Picks’ in MTS Market Pathways.]

The Centers for Medicare and Medicaid Services has emphasized removing burdens to support medtech innovation in several recent policy announcements and it carried that theme through in its August 14 decision to open up a national coverage reconsideration for transcatheter mitral valve repair (TMVR). The reconsideration could, in the short term, be a big boon for Abbott Laboratories and its MitraClip TMVR device, and, in the longer term, it could help more quickly expand the nascent mitral valve device market more broadly. Following a request from cardiac surgery and interventional cardiology clinical societies, CMS opened the analysis to consider expanding its current policy, which is limited to TMVR for degenerative/primary mitral regurgitation, to include any device with FDA-approved functional/secondary MR indications. That would track with Abbott’s March FDA expanded approval of MitraClip, which could double or even trouble the market for the device if reimbursement fits into place.

CMS also seems to be considering going beyond the societies’ request—asking for input on whether it should remove the current coverage requirement that coverage be granted for non-FDA-approved TMVR indications only in the context of randomized controlled trials “to reduce burden and encourage innovation in this space.” The comment stands out because sparking technology innovation has not historically been a primary factor cited by CMS in making Medicare decisions.

CMS is further considering taking the word “repair” out of the coverage policy title and changing it to the more general “transcatheter mitral valve intervention.” That might afford a more streamlined coverage pathway for mitral valve replacement technologies, in development by multiple companies, once they pass the FDA threshold.

Initial public comments on the coverage analysis are due September 13, with a proposed policy anticipated by February 14, 2020.

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Articles from David Filmore:

Regulatory & Reimbursement

Pathways Document Depot: August 2020

A sortable and searchable inventory of global medtech regulatory and policy official documents issued in August 2020, including rules, guidance documents, memos, white papers, and more from national authorities, non-governmental groups, and global organizations. Updated August 13.

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