CMS Releases Proposed Coverage Decision for Transcatheter Mitral Valve Repair

The Centers for Medicare and Medicaid Services (CMS) announced May 15, 2014, its proposed coverage decision for transcatheter mitral valve replacement. This information has been eagerly awaited since the October 2013 approval by the US Food and Drug Administration (FDA) of the catheter-delivered MitraClip device (Abbott Vascular; Santa Clara, CA) for treatment of patients with significant symptomatic degenerative mitral regurgitation at prohibitive risk for surgery.

CMS proposed that transcatheter mitral valve replacement be covered so long as it is planned for an FDA-approved indication using an FDA-approved device. Additionally, a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in mitral valve disease must have independently examined the patient and determined that he or she is at prohibitive risk for surgery. The patient must also be under the care of a multidisciplinary heart team and treated at a hospital with the “appropriate infrastructure” including:

• Onsite heart valve surgery program
• Cardiac cath lab or hybrid OR with cath lab-quality imaging
• Noninvasive imaging with expertise in transthoracic and transesophageal echocardiography
• At least 25 total mitral valve procedures in the previous year of which at least 10 must be mitral valve repairs
• ICU with personnel experienced in managing patients who have undergone open heart valve procedures
• At least 1,000 catheterizations per year including at least 400 PCIs
• Interventionalist with at least 50 structural procedures per year including atrial septal defects, PFOs, and transseptal punctures

Additionally, the proposal states that the interventional cardiologist and cardiac surgeon “must jointly participate in the intraoperative technical aspects” of the procedure. The heart team and hospital must also participate in a national registry that follows patients for at least 1 year.

Transcatheter mitral valve repair will further be covered for nonapproved indications when performed within an FDA-approved clinical trial.

Two Operators Unnecessary

In a telephone interview with TCTMD, Ted Feldman, MD, of Evanston Hospital (Evanston, IL), said the language of the proposal came verbatim from a multi-society document. However, he pointed to one discrepancy—the CMS proposal states that the procedure should be done by at least 2 co-operators, while the “multi-society document recognizes that the MitraClip procedure has been a single-operator procedure pretty much all along and recommended flexible language suggesting that a single [operator] or co-operators would be fine for this procedure.”

At its inception, TAVR was “a very precipitous procedure and the ‘two heads are better than one’ idea was very real,” Dr. Feldman explained. But implanting “the MitraClip is one of the least eventful catheter procedures we’ve ever done. The patients are remarkably stable throughout,” he said.

The mechanics of the device can be easily managed by a single operator, he added, “so to mandate that a second operator stand around for a couple of hours is just a drain on resources.” Additionally, it does not matter whether the primary operator is a surgeon or an interventional cardiologist as long as the physician is qualified, Dr. Feldman clarified.

Future DRG Decision Will Affect Reimbursement

A “great strength” of the TAVR coverage decision, he reported, is that coverage was originally proposed to be amended as the evidence developed. The fact that CMS followed the same practice with transcatheter mitral valve repair will enable the community to “accumulate experience in the TVT registry and with ongoing trials, [and] we should see expansion of coverage…. I think [that is] a great thing.”

The proposal will now enter a 30 day comment period before it becomes finalized. However, a decision still remains to be made regarding diagnosis-related group (DRG) allocation for the procedure. Dr. Feldman said transcatheter mitral valve replacement was reimbursed at a level similar to PCI or valvuloplasty in previous trials, but “the reality of the procedure in terms of resource utilization is that it’s much more like surgery because it requires general anesthesia, transesophageal echo during the procedure, [and] time in a recovery room.

“I don’t know that we can expect it to be similar to mitral valve repair surgically, in the way that TAVR has the same DRG as surgical AVR, but that would be the ideal. It is a mitral repair and it’s very resource intensive,” he commented.

Dr. Feldman concluded, “This is a therapy that really has an important clinical benefit for patients [who] don’t have other options. I’m really pleased that we are finally bringing it into practice in the [United States], and at the same time hopeful that we’ll be able to bring it beyond the very narrow indication that we currently have.”

In a press statement, Chuck Simonton of Abbott Vascular, noted, “Continued collaboration will also be important to establish appropriate physician and hospital reimbursement so that Medicare beneficiaries have access to this breakthrough medical innovation.”

 

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Source:
Centers for Medicare and Medicaid Services. Proposed decision memo for transcatheter mitral valve (TMV) procedures (CAG-00438N). http://www.cms.gov/medicare-coverage-database/details/nca-proposed-decision-memo.aspx?NCAId=273. Published May 15, 2014. Accessed May 16, 2014.

 

 

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