CMS’ updated coverage policy for transcatheter aortic valve replacement gives hospitals more operational flexibility, but some cardiovascular leaders warn the financial incentives built into the change could weaken the heart team model and open the door to self-referral, according to Oct. 13 article in Medscape.
CMS issued the national coverage determination in September after a nine-month review that included the American College of Cardiology, the Society of Thoracic Surgeons, the American Association for Thoracic Surgery and other groups. The final policy lifts the coverage with evidence development requirement for TAVR in patients with severe symptomatic aortic stenosis and adds coverage, with evidence development, for patients with asymptomatic severe aortic stenosis.
Hospitals must still have on-site cardiac surgery capabilities and access to critical care resources, but the policy eliminates hospital-level volume thresholds. The most significant changes involve the heart team. A team with at least one cardiac surgeon and one interventional cardiologist must still review each patient’s chart, but a single in-person evaluation can now be done by either specialist, and either one can perform the procedure without the other. A second evaluation and second operator are covered if the heart team deems them appropriate.
Thoralf Sundt, MD, a past president of the American Association for Thoracic Surgery, director of the Cardiac Surgery Clinical Service for Somerville, Mass.-based Mass General Brigham and chief of the division of cardiac surgery at Massachusetts General Hospital in Boston, credited CMS with keeping the model largely intact.
“I think that they did a good job of maintaining, to the extent possible, the heart team approach,” he said in the article. “It’s not surprising to me that it’s gone to where it will permit a single operator. I don’t know that that’s bad, as long as the decision-making is joint decision-making.”
The open question is how hospitals and physicians put the policy into practice, and how payment shapes those choices.
“It’s inescapable that there will be concerns from the surgeons that everyone will have a TAVR, even people who ought to have a surgical valve,” Dr. Sundt said in the article. “Show me the incentives, I’ll show you the outcome. If the incentive is to perform the procedure yourself that you can bill for, then that’s the problem. And that’s human nature.”
Roxana Mehran, MD, president of the American College of Cardiology and director of the Women’s Heart and Vascular Center at Mount Sinai in New York City, spoke to the evolution of the policy since TAVR first came to market.
“It was the best thing that CMS did to basically marry the coverage to continuing to develop evidence, especially with new technology when TAVR first came out,” she said in the article. “But also, it is matured now enough that it is no longer necessary [for aortic stenosis].”
CMS did not fully adopt the professional societies’ recommendations on heart team requirements. Still, Dr. Mehran said the final policy “is easier operationally.”
Her concern centers on where the procedure is performed and who performs it. Dr. Mehran said aortic valve replacement in ambulatory surgical units “is not what should ever happen with this kind of a procedure.”
“The most important thing is that we have to, collectively as physicians and members of the heart team, make sure that the heart team doesn’t go away,” she said in the article. “There’s always going to be the cowboy interventional cardiologist or cowgirl interventional cardiologist who says, ‘I don’t really need a surgeon.’ But that is not the way forward. We need to have the heart team.”
Real-world evidence shows a low surgical conversion rate for TAVR, but Dr. Mehran said the risk does not disappear.
“With every scenario we will still have some disaster in the cath lab with a patient who is really complex,” she said.
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