- Four medical societies have come out against revisions in CMS' proposed national coverage determination for transcatheter aortic valve replacement that could change requirements for initiating and maintaining a reimbursed program, arguing the potential easing of standards for starting a program will not produce the best outcomes for patients.
- In joint comments submitted to the agency, the groups raised concerns that the proposal would lead to a "proliferation" of low-volume programs at risk for suboptimal outcomes. They urged the agency to increase volume threshold requirements.
- The four groups that filed a combined comment are the Society of Thoracic Surgeons, American College of Cardiology, American Association for Thoracic Surgery, and the Society for Cardiovascular Angiography and Interventions.
CMS' draft policy on TAVR coverage, meant to replace the current NCD put into place in 2012, retains volume-based restrictions on which hospitals can get reimbursed for TAVR but revises other criteria that hospitals must meet.
With the overall success of TAVR and rapid growth of the market, some physicians had advocated a loosening of volume-based restrictions to allow more lower-volume facilities to perform the minimally invasive procedure. Following a July 2018 MEDCAC meeting on the subject, TAVR device maker Medtronic said more evidence was needed before abandoning the volume-based approach.
In its draft policy, CMS has proposed changes to how a hospital qualifies for coverage and retains it. To initiate coverage, a hospital would have to perform 50 open heart procedures of any type in the preceding year and 20 aortic valve related procedures in the preceding two years. To maintain coverage, a site would have to perform 50 TAVR procedures each year. The comment period closed April 25.
In their response to the CMS draft policy, the medical societies argue the volume threshold should be set at a minimum of 50 TAVRs annually, in line with current literature showing improved outcomes at that level.
"We are extremely concerned that the proposed volume requirements will translate into a proliferation of low volume TAVR programs at increased risk for having suboptimal outcomes," the groups wrote.
The groups point out that registry data recently published in the New England Journal of Medicine support requiring that each center perform at least 50 TAVRs annually. The article, they note, shows that even after excluding the first 12 months of a center's TAVR procedures, mortality at 30 days was higher and more variable at hospitals with low procedural volume than at hospitals with high procedural volume.
On a second issue, the societies support revising the two-surgeon pre-procedure consultation requirement to a heart team consultative requirement that includes one surgeon and one interventional cardiologist.
Boston Scientific, in comments filed separately, lent its support to CMS' proposed volume requirements, saying the revisions would facilitate patient access while maintaining quality in care delivery. The company last week became only the third manufacturer to gain FDA approval for a TAVR system called the Lotus Edge.
Abbott, which hopes to introduce its Portico device in the U.S. TAVR market in the first half of next year, also submitted a comment, saying it is in favor of CMS' move toward more simplified and less restrictive requirements for establishing and maintaining TAVR programs.
Doctors from Dartmouth-Hitchcock Medical Center, Yale University School of Medicine, University of Washington Medical Center and Columbia University Irving Medical Center focused on the importance of maintaining a heart team approach for decision making about options available to patients with severe aortic stenosis. In their submission, the academic clinicians supported a consultation plan requiring both an interventional cardiologist and a cardiac surgeon.