WASHINGTON - On June 24, 2019, the Centers for Medicare & Medicaid Services (CMS) finalized the Decision Memo for on Transcatheter Aortic Valve Replacement (TAVR), updating the May 2012 National Coverage Determination (NCD) for TAVR procedures which established specific requirements for coverage including procedural volume requirements hospitals must meet to begin and maintain TAVR programs. As a result, patient access to this life-saving technology will be expanded while patient safety and quality requirements are maintained.

The Society for Cardiovascular Angiography and Interventions (SCAI) has successfully advocated on behalf of its members and patients to revise the Medicare coverage policy.  The NCD, in essence, lowers the volume requirements for establishing new TAVR centers and maintains the standards for hospitals with existing programs.

Throughout the past year, SCAI alongside the American Association for Thoracic Surgery, American College of Cardiology, and the Society of Thoracic Surgeons engaged in numerous phone calls and face-to-face meetings with the CMS coverage team to educate them on the clinical and scientific evidence pertaining to procedural volume requirements for SAVR, TAVR, PCI and other relevant structural heart disease procedures as they relate to TAVR programs.   

“This decision marks an important step for the growing number of TAVR programs,” says SCAI President Ehtisham Mahmud, M.D., FSCAI.  “It strikes an evidence-based balance between expanding the number of TAVR Centers across the US while ensuring access to care for patients in rural or underserved communities. It also enables a more streamlined process for the work-up of patients prior to the TAVR procedure.”

The new national coverage policy will continue to cover TAVR procedures with further development of evidence for the procedure when performed according to an FDA-approved indication.

Specific highlights of the decision that may be of interest to SCAI members include:

• A change in the prior requirement for two CT surgeons to evaluate the patient prior to TAVR. Now one CT surgeon and one interventional cardiologist will be required to independently evaluate the patient for TAVR.

• Establishment of TAVR specific quality measures and continuing evidencedevelopment utilizing data from the STS/ACC TVT Registry^TM
• Lowering the minimum number of procedures for hospitals without TAVR experience. CMS will require TAVR programs to perform at least 50 open heart surgeries and 20 or more aortic valve-related procedures in the two years preceding TAVR program initiation. The hospital must also have at least two physicians with cardiac surgery privileges, one with interventional cardiology privileges, and perform at least 300 percutaneous coronary interventions (PCIs) per year.
• Maintaining the requirements for hospitals with TAVR experience.  They will need to perform at least 50 aortic valve replacements per year (TAVR or SAVR), including 20 or more TAVR procedures in the prior year or perform at least 100 or more aortic valve replacements (TAVR or SAVR) every two years, including 40 TAVR procedures in the prior two years.

“We believe CMS landed on a fair balance between access and quality in the final policy with regard to physician and hospital experience requirements,” says Mahmud. “SCAI will continue to focus on quality metrics, ongoing tracking of patient outcomes, research, and the best practices that play a vital role in ensuring the best care for our patients.”