CMS Publishes Proposed TAVR Coverage Conditions
Mere months after US Food and Drug Administration (FDA) approval of the first device for transcatheter aortic valve replacement (TAVR), the Centers for Medicare and Medicaid Services (CMS) has issued a memo outlining its decision for potential coverage of the technology. The document, released on February 2, 2012, is open for public comment over the next 30 days.
Proposals Get Warm Reception
Both the American College of Cardiology (ACC) and the Society of Thoracic Surgeons (STS), which recently copublished an expert consensus document focusing on TAVR in the Journal of the American College of Cardiology along with several other professional societies, lauded the memo for its emphasis on interdisciplinary cooperation and patient outcomes. The 2 groups collaborated on a joint proposal to CMS that initiated the process toward coverage in September 2011.
In a prepared statement, ACC president David R. Holmes Jr, MD, of the Mayo Clinic (Rochester, MN), characterized the CMS memo as “tremendous news for Medicare beneficiaries.”
Dr. Holmes indicated that the “ACC is pleased that CMS is proposing a national coverage policy that balances the critical need to provide access to this important, innovative service with the need to ensure that care is provided in qualified facilities by highly skilled heart care teams and the need to collect data on experience with the device and procedure in the real world.”
The CMS document lists 5 conditions for coverage:
- TAVR should be performed for an FDA-approved indication, with a complete valve and implantation system that has received premarket approval for this indication
- Two cardiac surgeons should evaluate the patient’s suitability for open surgery
- TAVR should take place in a facility using a ‘heart team’ approach with adequate experience in both interventional and surgical procedures, varying according to whether the center has previously participated in a premarket approval clinical trial
- Procedure should be carried out by physicians who have specific qualifications and experience levels, which differ for surgeons and interventionalists
- Patient and treating physician team should be enrolled in a prospective national registry through 5-year follow-up
Recommendations Support Quality Control
In a telephone interview with TCTMD, Josep Rodés-Cabau, MD, of Laval University (Quebec City, Canada), stressed that while he could not speak to the intricacies of the CMS process, the memo seems reasonable in its requirements, which follow the FDA indications and the guidance of professional societies.
In particular, Dr. Rodés-Cabau said, the numbers for operator and site experience are not prohibitive. Centers that have previously participated in clinical trials of TAVR, for example, must perform at least 20 procedures per year, or approximately 2 per month. “[This] should really be the strict minimum” to maintain necessary skills, he noted.
One condition that caught Dr. Rodés-Cabau’s attention applies to centers without trial experience, whose interventional programs must perform at least 15 left-sided structural procedures per year to qualify for coverage. “It’s a bit curious,” he said, adding that many structural procedures including closure of atrial septal defect and left atrial appendage are instead performed through the venous side.
Importantly, the memo incorporates outcomes in its stipulations, Dr. Rodés-Cabau noted. Programs with previous trial experience must maintain 30-day all-cause mortality and neurologic event rates no higher than 15% and 1-year survival rates of at least 60%. “This is very interesting because it forces the heart teams to do the best for patient selection, to really try to avoid accepting patients that are too sick to receive intervention. It puts some pressure on centers to maintain acceptable results,” he said, noting that most already exceed these standards.
Dr. Rodés-Cabau concluded, “All of the recommendations will provide quality control and will allow the US [practitioners] to keep a good eye on this technology.”
Centers for Medicare and Medicaid Services and Food and Drug Administration. Proposed Decision Memo for Transcatheter Aortic Valve Replacement (TAVR) http://www.cms.gov/medicare-coverage-database/details/nca-proposed-decision-memo.aspx?NCAId=257&fromdb=true. Published February 2, 2012. Accessed February 3, 2012.
- Dr. Rodés-Cabau reports serving as a consultant for Edwards Lifesciences.