The U.S. Centers for Medicare and Medicaid Services (CMS) posted the much-anticipated draft do-over of the mitral valve repair device coverage memo, and in the process renamed the policy the mitral valve transcatheter edge-to-edge repair (TEER) national coverage memo. The agency confirmed it is considering coverage of secondary mitral regurgitation, which would considerably boost the market for the affected devices, including the Mitraclip by Abbott Vascular Inc., of Redwood City, Calif.

CMS announced in August 2019 that it would revisit its coverage policy at the behest of several medical societies, which had pressed the agency to cover secondary (functional) regurgitation. As matters stand, CMS covers mitral valve repair devices for primary (degenerative) regurgitation, albeit only in the context of participation in a registry that takes all comers and all devices approved for the existing indication.

While the interests of medical societies cannot be discounted, the CMS also had to address the FDA’s March 14, 2019, approval of the expanded indication for the Mitraclip. Abbott was not without a substantial body of data to support the secondary regurgitation indication, unveiling those data at last year’s scientific sessions of the American College of Cardiology that included quality-of-life returns.

The CMS posted the draft revision late in the day June 30, after collecting a series of comments from stakeholders. Among those was Don May, executive vice president for payment policy at the Advanced Medical Technology Association. May said one of the association’s concerns regarding the first coverage memo was that the CMS had required randomized, controlled trials for use of transcatheter mitral valve repair (TMVR) devices outside of labeled indications.

More recently, Advamed’s concerns have revolved around the stipulation that only FDA-approved trials would be covered under the coverage with evidence development (CED) policy. That policy, May said, would exclude studies sponsored by physician- or medical society-sponsored studies, which could provide more insight into the sub-population benefits of TMVR. He said elimination of this exclusion would align the TMVR policy with the Medicare policy for transcatheter aortic valve replacement (TAVR) devices.

However, May also pointed to the question of nomenclature, stating that the title of the memo should be tweaked to be permissive of alternative technologies that will address both degenerative (primary) regurgitation along with secondary regurgitation.

Maria Stewart, vice president for market access at Marlborough, Mass.-based Boston Scientific Corp., seconded the notion that the coverage memo should steer toward a device-agnostic stance. Stewart said a coverage-to-label policy would permit novel technologies not considered in the first iteration of the NCD, suggesting the use of the terms “therapies” or “procedures” in lieu of “interventions.” Stewart also supported elimination of the RCT mandate for randomization in CED studies, echoing May’s remark that such a switch would “provide consistency” with the TAVR policy.

This latest draft of the NCD proposes that the patient be under the care of a team of health care professionals to include a cardiac surgeon along with an interventional cardiologist, which was the case with the original NCD. The institutional requirements are slightly tweaked from the existing policy, which requires that a surgical program for severe regurgitation have performed at least 25 total procedures in a year, 10 of which must be mitral valve repairs. The draft revision calls for at least 20 mitral interventions per year or at least 40 every two years along with the same numbers for mitral valve surgeries. The new draft said that Medicare administrative contractors (MACs) would have some discretion in providing coverage of degenerative MR, which an accompanying press release suggests is the mechanism by which the CED requirement is eliminated.

Stakeholders encouraged, but concerns remain

Sue Peschin, CEO of the Washington-based Alliance for Aging Research, told BioWorld, “overall, I would say the Alliance is encouraged” by the terms of the draft, which provides “a significant step forward for older adult patients.”

Peschin said the draft demonstrates that the agency is attuned to the concerns of patients and their families, adding that the proposed expansion of coverage reflects a willingness on the part of CMS to accept evidence from trials other than RCTs. One of the benefits of the terms of the draft is that patients in advanced stages of heart failure may enjoy substantially improved survival, and Peschin said the Alliance’s view is that CMS should cover mitral valve repair devices for the terms of any related FDA approvals.

On the other hand, Peschin said there is some concern about the fact that the draft is less than specific about the tools used in shared decision-making procedures. Shared decision making “sounds warm and fuzzy on its face,” she said, adding that if the decision-making tools “are not properly validated … they can have unintended effects on patient access.”

Peschin said the requirements for mitral valve surgeries are unnecessary as they do not reflect institutional experience with interventional approaches to the condition. The Alliance’s preference is that the agency avoid any effort to referee any disagreements between the medical societies about the respective roles of thoracic surgeons and interventional cardiologists, she said, adding that the predicament leaves patients stuck in a tug-of-war between medical societies. Beyond this, Peschin said there are studies of recent vintage in the medical literature that demonstrate no association between surgery vs. catheter-based mitral valve intervention, adding, “the ball is in the specialty societies’ court to prove otherwise.”

The Alliance is also unenthused about the requirement that the patient have a face-to-face encounter with both the surgeon and the interventionalist, for two reasons. One is that this requirement may force a very sick patient to make separate trips to a physician office, but Peschin said there is no justification for leaving the patient in the middle of a disagreement between the physicians. The coverage memo proposes a transcatheter approach as an alternative to medical management, and thus surgery is not directly addressed. Hence, the Alliance’s question is “why is this thoracic surgeon evaluating the patient?” she asked.

All the same, the Alliance sees much to celebrate, Peschin said. “Having worked on TAVR, we think CMS took some significant steps to advance innovation for patients,” she stated adding that while the organization is grateful to CMS for listening to its concerns, “we’re going to battle it out in the public comment period” regarding some of the sticking points.

Speaking for Edwards Lifesciences Corp., of Irvine, Calif., Sarah Huoh told BioWorld that the company "appreciates CMS’ commitment to ensuring patient access to new medical therapies through the current policy review.” Edwards is the sponsor of the Pascal device, another in the class of edge-to-edge devices, while the company’s Harpoon device approaches the problem by means of repair of mitral leaflet chords.

“We are encouraged there are elements within the draft NCD that will enable mitral valve disease patients to have improved access to therapy options,” Huoh said, noting that the suite of device options for mitral valve regurgitation “have continued to mature and expand over the last several years.” She said Edwards will review the draft NCD in more detail, and will provide input toward “a modernized version of the NCD which better reflects today’s landscape and emphasizes the need for patient access and high-quality patient outcomes.”

Added indication may triple market

In a June 30 analysis, Cowen Washington Research Group said the FDA approval of the Mitraclip for secondary regurgitation should blend with the proposed expansion of coverage to roughly triple the population eligible for catheter-based edge-to-edge mitral valve repair. Cowen said the current market stands at approximately 70,000 patients, and that the draft rewrite may add as many as another 140,000.

Cowen said Abbott’s lead in this space should afford it some insulation from the competition, including Edwards, adding that the upcoming fourth generation of the Mitraclip will add to the hurdles faced by competitors. Medtronic plc of Dublin, sponsor of the Intrepid device, declined to comment on the renaming of the coverage memo.

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