CMS issues coverage proposal for transcatheter mitral valve repair

The CMS issued a decision memo proposing coverage for certain cases of transcatheter mitral valve repair for the treatment of symptomatic mitral regurgitation.

The proposal follows the FDA approval in October of the catheter-based MitraClip device (Abbott Vascular) for the treatment of patients with significant degenerative mitral regurgitation who are at prohibitive risk for mitral valve surgery.

In order for the procedure to be covered, the following conditions must be met, according to the CMS memo:

The procedure incorporates a complete, FDA-approved transcatheter mitral valve repair system, used for the system’s intended indication.
The patient receives independent examination both a cardiac surgeon and a cardiologist experienced with mitral valve disease, and each has determined the patient is eligible for surgery. Both physicians have also documented the rationale for their decision and made this documentation available to the team handling the patient. The surgeon and cardiologist must jointly participate in the intraoperative technical aspects of the procedure.
Both before and after the procedure, the patient receives care from a “cohesive, multidisciplinary team of medical professionals.” The facility at which the surgery will take place must have the appropriate infrastructure for the procedure, including an on-site surgery program, a properly equipped catheterization lab or operating room and non-invasive imaging capabilities, among other factors.
The hospital and the heart team must participate in a prospective, national audited registry of consecutively enrolled transcatheter mitral valve repair patients. This registry will include all manufactured devices and collect follow-up data on patients for at least 1 year. Evaluated outcomes will include quality of life, stroke, all-cause mortality, vascular and transient ischemic events, repeat procedures, worsening mitral regurgitation, renal complications and functional capacity.

According to the memo, transcatheter mitral valve repair will also be covered for certain indications not specifically approved by the FDA, under the following conditions:

Both the interventional cardiologist and cardiac surgeon serving on the heart team jointly participate in the intra-operative technical aspects of the procedure.
The written protocol must include critical evaluations of the patient’s post-procedure quality of life and functional capacity at 1 year compared with prior to the surgery.
At 1 year post-procedure, the incidence of stroke, all-cause mortality, transient ischemic attack, major vascular events, renal complications, subsequent mitral valve procedures and worsening mitral regurgitation must be addressed in clinical research.

“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,” Chuck Simonton, chief medical officer for Abbott Vascular, said in a company statement. “… Continued collaboration will also be important to establish appropriate physician and hospital reimbursement, so that Medicare beneficiaries have access to this breakthrough medical innovation.”