Advertisement

June 27, 2019

SCAI Supports CMS Decision Memo on Procedural Requirements for TAVR

June 27, 2019—The Society for Cardiovascular Angiography and Interventions (SCAI) released a statement regarding the Centers for Medicare & Medicaid Services (CMS) finalized Decision Memo on Transcatheter Aortic Valve Replacement (TAVR) released on June 21.

The CMS decision updates 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. 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.

The society noted that patient access to TAVR will be expanded while patient safety and quality requirements are maintained. Essentially, the NCD lowers the volume requirements for establishing new TAVR centers and maintains the standards for hospitals with existing programs. SCAI has advocated on behalf of its members and patients to revise the Medicare coverage policy.

SCAI, as well as the American Association for Thoracic Surgery, American College of Cardiology (ACC), and the Society of Thoracic Surgeons (STS), presented the clinical and scientific evidence to the CMS coverage team that pertain to procedural volume requirements for surgical aortic valve replacement (SAVR), TAVR, percutaneous coronary intervention (PCI), and other relevant structural heart disease procedures as they relate to TAVR programs.

As summarized by SCAI, highlights of particular interest include:

  • A change in the previous requirement for two cardiothoracic surgeons to evaluate the patient before TAVR. Now one cardiothoracic surgeon and one interventional cardiologist will be required to independently evaluate the patient for TAVR.
  • Establishment of TAVR-specific quality measures and continuing evidence development utilizing data from the STS/ACC TVT Registry.
  • 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 aortic valve-related procedures in the 2 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 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 previous year or perform at least 100 or more aortic valve replacements (TAVR or SAVR) every 2 years, including 40 TAVR procedures in the previous 2 years.

SCAI President Ehtisham Mahmud, MD, commented in the statement, “This decision marks an important step for the growing number of TAVR programs. It strikes an evidence-based balance between expanding the number of TAVR centers across the United States 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.”

Dr. Mahmud concluded, “We believe CMS landed on a fair balance between access and quality in the final policy with regard to physician and hospital experience requirements. 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.”

Advertisement


July 8, 2019

Two-Year Data Presented From LATERAL Study of Medtronic's HeartWare HVAD

June 26, 2019

DEBUT Trial Supports DCB-Only PCI in High-Bleeding-Risk Patients