These devices are for patients for whom it is too risky to undergo mitral valve surgery. Mitral regurgitation is the most common type of heart valve insufficiency in the U.S., according to the CMS. It cited a study that estimates as many as 5 million people could suffer from the ailment by 2030, double the number of those who had the condition in 2000.
The proposed national coverage decision came with some apparent trepidation from the CMS. “We believe that there is promising but inconclusive evidence whether TMVR improves health outcomes for a defined subset of the Medicare population,” it said in a memo.
The trade group America's Health Insurance Plans also expressed unease about the idea during a public comment period initiated last year on whether the CMS should begin reviewing the device for coverage.
It had several concerns, the first being that there is only one Food and Drug Administration-approved TMV device, Abbott's MitraClip. Second, the clinical trial for that device was relatively small. Lastly, it noted that even though 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.
“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 insurance trade group said.
Other comments received by the CMS were generally supportive of the federal agency evaluating the device for coverage.
CMS' proposed approval does come with certain conditions, including mandatory FDA approval for the device, and requirements that a cardiac surgeon experienced in mitral-valve surgery and a cardiologist experienced in mitral-valve disease must independently determine that traditional surgery for a beneficiary would be too risky. In addition, the procedure must be performed in a hospital that has an on-site heart-valve surgery program and a cardiac catheterization lab.
The CMS also suggests the creation of a registry that would track long-term, or greater than five years, durability, outcomes and adverse events related to 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,” Chuck Simonton, chief medical officer for Abbott Vascular, said in a statement.
Comments on the proposed coverage decision are due June 14. The CMS expects to make a final decision by August 13.
Follow Virgil Dickson on Twitter: @MHvdickson
