Medical societies take a stand as CMS nears final decision on TAVR proposal
The U.S. Centers for Medicare and Medicaid Services (CMS) has proposed significant changes to current transcatheter aortic valve replacement (TAVR) policies, and a final decision is expected soon. If finalized, these changes would transform patient care in numerous ways. TAVR would be covered in all asymptomatic patients, for example, and coverage with evidence development (CED) requirements would no longer be required when performing TAVR on symptomatic patients.
In the meantime, three of the country’s leading cardiovascular health societies have joined forces to share their own perspective on the CMS proposal. The American College of Cardiology (ACC) and Society for Cardiovascular Angiography and Interventions (SCAI) and Society of Thoracic Surgeons (STS) sent CMS a letter highlighting the importance of the current national coverage determination (NCD). The groups also outlined multiple recommendations they believe are critical to ensure patients continue to receive the high-quality care they deserve.
“As CMS considers updates to this policy, we believe it is important to build upon this successful foundation while maintaining the safeguards that have supported high-quality patient care and evidence generation,” the groups wrote. “We strongly support modernizing the NCD and offer the following recommendations to help ensure the policy continues to promote high-quality, evidence-based and patient-centered care.”
5 recommendations as CMS considers sweeping TAVR changes
1. Preserve the multidisciplinary heart team model. The CMS proposal appears to de-emphasize existing requirements that say an interventional cardiologist and cardiac surgeon should work together to determine if TAVR is the best path forward for each individual patient. CMS should clarify that both interventional cardiologists are vital to this process, according to the three groups, to ensure these decisions are never made by a cardiologist or surgeon alone.
2. Maintain a targeted CED pathway for patient populations where evidence gaps remains. The TAVR NCD has always required facilities performing TAVR to follow certain CED rules that require patient data to be collected through clinical trials or registries. This new proposal from CMS does away with those requirements for symptomatic TAVR patients, but the three medical societies believes this takes things too far. Instead, the groups recommend keeping the CED requirements when symptomatic patients are being treated if, for example, those individuals present with bicuspid aortic valve anatomy or are set to be treated with a newly approved transcatheter heart valve.
“CMS should also consider whether additional evidence development requirements are appropriate for newly established TAVR programs that have not previously performed TAVR procedures,” the groups wrote.
3. Keep it mandatory to participate in a national audited registry. Like the previous recommendation, this step would help ensure TAVR programs are contributing data that can be evaluated in the future while also benefiting from long-term data that already exist. Experts see these registries as one of the best ways to ensure programs are providing high-quality care.
4. Preserve nationally standardized approaches to quality measurement, benchmarking and continuous quality improvement through registry participation and externally benchmarked performance assessment. The three groups believes CMS should be clear about the importance of external benchmarking. By comparing their program’s data to other programs, cardiologists and other clinicians can clearly see how they compare and, for instance, what areas may require additional work.
5. Adopt operator requirements that value institutional performance and quality metrics over “rigid operator volume thresholds.” CMS proposed changes to the operator requirements in an attempt to expand TAVR access to more patients. However, the three groups did note that less experienced operators are regularly linked to worse outcomes. This does not necessarily mean these clinicians should not be able to perform TAVR, but the societies provide an example in their letter of how to expand access without forgetting the importance of experience and multidisciplinary care.
“We remain committed to working with CMS to develop a final NCD that reflects both the strength of the evidence base and the expert consensus of the clinical community,” the groups wrote.
The letter to CMS was signed by ACC President Roxana Mehran, MD, SCAI President J. Dawn Abbott, MD, and STS President Vinay Badhwar, MD.
Click here to read a PDF of the complete letter, which includes more detail.
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.