The CMS is considering easing coverage restrictions on a heart valve surgical procedure after clinicians claimed the policy prevents patients from receiving a potentially lifesaving operation.
The agency issued a national coverage analysis on Wednesday to ask the public whether they should change how they cover transcatheter aortic valve replacements (TAVR).
Under the CMS' current policy, hospitals have to show they perform a certain amount of other cardiac procedures each year before they can be reimbursed for TAVR surgeries.
TAVR is for people with symptomatic aortic stenosis, a narrowing of the main heart valve that impedes blood flow from the heart. As many as 1.5 million in the U.S. live with the disease. TAVR is considered a less-invasive alternative to standard valve replacement surgery because it is done via small openings in the chest rather than open-heart surgery.
Hospitals must perform at least 50 aortic valve replacements in the previous year and perform no less than 1,000 catheterizations per year to qualify for TAVR coverage. The CMS put the precautions in place when it started covering TAVRs in 2012 because the procedure was new and the agency wanted the most experienced surgeons to perform the operation.
The move could be good news for hospitals, which charge $35,000 on average to perform the operation, according to researchers. Hospital stays post-surgery can last at least five days, bringing the total average hospital costs to around $60,000 per patient, according to a 2016 study that appeared in the Journal of the American College of Cardiology.
"It is time to reconsider the TAVR national coverage determination. TAVR is no longer a new, experimental and risky procedure," Dr. Peter Pelikan, medical director of the cardiac catheterization laboratory at Providence St. John's Health Center in Santa Monica, Calif., said in a request posted on the CMS' website. "The current limitations listed in the national coverage decision limit the ability of lower volume medical centers and hospitals from providing this key service to Medicare beneficiaries, even if they are high-quality hospitals."
The public will have 30 days to weigh in on the volume restrictions. The comment period ends July 27.
The agency is also hosting a public meeting on July 25 to further explore the need for the volume requirements. The CMS will make a final decision on removing the coverage requirements by June 2019.
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