Medicare today proposed to cover surgeries to fix or replace leaky heart valves called transcatheter mitral valve procedures, issuing a draft National Coverage Decision for the procedure.
The FDA granted pre-market approval for the MitraClip device in October 2013 for patients with significant, symptomatic, degenerative mitral valve regurgitation who can’t have surgery to repair the valve. The PMA decision followed an FDA advisory panel’s narrow recommendation in March 2013 that the federal watchdog agency approve the device.
"This national coverage proposal represents an important step in improving access to Abbott’s MitraClip device for very sick patients, who often have no other treatment options. We commend the extensive, collaborative efforts between CMS, FDA and medical societies in supporting this process so that patients can benefit from this innovative therapy that could significantly improve the quality of life for these people. Continued collaboration will also be important to establish appropriate physician and hospital reimbursement, so that Medicare beneficiaries have access to this breakthrough medical innovation," Abbott’s chief medical officer, Dr. Chuck Simonton, said in prepared remarks.
In public comments posted on the Medicare website, insurance lobby America’s Health Insurance Plans urged Medicare to require further studies of the MitraClip device and TMVR procedures in general.
"Although the 30-day mortality from the transcatheter procedure is lower than the predicted surgical mortality of an open procedure, it is equivalent to the 30-day mortality of patients who are managed with non-surgical interventions. Thus, to date there does not appear to be a definitive advantage to the transcatheter procedure, and there is much unknown regarding the durability of the procedure and whether individuals will later require an open procedure (as they age and possibly become more frail). The study is promising, but requires validation and further study," the association said. "Our members believe that additional outcomes data are warranted prior to coverage as an acceptable approach to this TMV procedure. If CMS decides to cover the procedure, it should be in the setting of a well-designed, qualified clinical trial, as defined in CMS’ Clinical Trial Policy."
That view is contradicted by the Society of Thoracic Surgeons, the American College of Cardiology, the Society for Cardiovascular Angiography and Interventions and the American Assn. for Thoracic Surgery, which all joined Abbott in requesting Medicare coverage for MitraClip.
Dr. Christina Vassileva, lead author of a study 47,279 Medicare mitral valve repair patients over 10 years, also backed a positive coverage decision for MitraClip but urged the development of strict patient selection guidelines.
"Because the MitraClip studies have uniformly defined procedural success with residual grade of mitral regurgitation of 2 or less (moderate mitral regurgitation), which in the surgical arena is defined as a surgical failure, I would urge the CMS authorities to institute their own guidelines and external audits in place to ensure that inappropriate up-creeping of patient risk does not occur as a result of device availability," Vassileva wrote. "In addition, my own research as well as that of others has documented substantial non-adherence to mitral valve guidelines with inappropriate delays in referral to surgery for patients with mitral valve disease, especially in the elderly. Before patients are called high risk or inoperable, we need to ensure that there are practices in place that implement appropriate referral as soon as patients meet guideline criteria, preferably on an elective basis and prior to the onset of heart failure. This would result in dramatic cost savings to CMS in preventing subsequent hospitalization. CMS determination of centers of excellence must take into account center compliance with mitral valve guidelines to ensure that patients are not inappropriately denied surgery until surgical risk has risen to meet device guidelines."