CMS on June 21 issued its finalized national coverage determination (NCD) for transcatheter aortic valve replacement (TAVR)—one that reportedly offers greater flexibility for hospitals and providers.
According to the final coverage policy, CMS will continue to cover TAVR under coverage with evidence development (CED) if the procedure is furnished in line with an FDA-approved indication. The agency has, however, updated the coverage criteria for hospitals and physicians who want to begin or maintain a TAVR program, requiring existing programs to perform at least 50 AVRs (TAVR or surgical AVR) and 300 percutaneous coronary interventions (PCIs) per year to retain their status.
When CMS first published a draft of the NCD on March 26, the document was met with some skepticism from the public. Physicians, caregivers and administrators logged 177 comments, some negative—“I am just so disappointed that everything is seeming still volume-based for doctors and hospitals,” one heart patient wrote—and others voicing support for the updated TAVR thresholds.
Some commenters worried that if hospitals are concerned with keeping up their TAVR program approval numbers, they’ll perform the procedure even when it isn’t the optimal choice.
Not much has changed since March, and in a statement the agency said their decision “reflects the current evidence base and strikes an appropriate balance between ensuring that hospitals have the experience and capabilities to handle complex heart disease cases while limiting the burden and barriers that excessive requirements create for hospitals and patients.”
Even CMS’ earliest draft of the NCD was more flexible than recommendations from four professional cardiology societies, all of whom agreed a threshold of 50 TAVRs and 30 SAVRs per year might be a more appropriate gauge of a program’s efficacy.
The new NCD requires that TAVR patients be under the care of a comprehensive heart team, including a cardiac surgeon and an interventional cardiologist experienced in the care and treatment of aortic stenosis. These two physicians are required to jointly participate in the intraoperative technical aspects of TAVR, which must be performed in a hospital with onsite heart valve surgery and interventional cardiology programs, a post-procedure intensive care facility and appropriate volume accommodations.
To quality for coverage, hospitals that don’t have previous TAVR experience must perform at least 50 open heart surgeries in the year prior to initiating a TAVR program; perform 20 aortic valve-related procedures in the two years prior to initiation; employ at least two physicians with cardiac surgery privileges and one physician with interventional cardiology privileges; and perform at least 300 PCIs per year.
Any hospitals and heart teams involved in CMS-covered TAVR programs will be enrolled in a prospective national registry that follows TAVR patients for at least one year and tracks outcomes ranging from transient ischemic attacks to quality of life.
“Today’s decision to update and streamline the TAVR coverage parameters demonstrates CMS’ ongoing commitment to our beneficiaries,” CMS Administrator Seema Verma said in a statement, noting the agency’s modifications are “generally consistent” with a 2018 consensus statement authored by major cardiology societies. “The decision ensures improved access to care for beneficiaries while supporting the continued evolution of this important technology in light of emerging evidence.”
Not everyone was pleased with the final NCD, though. In a statement issued June 24, Alliance for Aging Research CEO Susan Peschin, MHS, said older Medicare patients with aortic stenosis have been “stuck in the midst of a professional sea change” in heart valve disease treatment. She said CMS’ decision comes at a time when the FDA is likely to expand TAVR approval to low-risk patients, which would increase demand for the treatment, lengthen already lengthy waiting lists and increase patients’ risk of death while they wait for TAVR.
“When CMS makes decisions about how procedures and services are covered, there are almost always winners and losers,” Peschin said. “CMS’ final decision on TAVR coverage not only continues unequal treatment access, particularly for older rural and minority patients, but potentially restricts it even further by escalating some of the requirements. Medicare is supposed to put value over volume and patients over paperwork, but this decision fails to meet those goals.”
The full NCD can be found here.