June 24, 2019 — The Centers for Medicare and Medicaid Services (CMS) recently finalized its decision to update the national coverage policy for transcatheter aortic valve replacement (TAVR), streamlining key elements of the original national coverage determination that went into effect in 2012.
CMS will continue to cover TAVR — a procedure for a condition known as aortic stenosis in which the heart valve that propels blood from the heart to the rest of the body becomes narrowed — under coverage with evidence development (CED) when furnished according to a U.S. Food and Drug Administration (FDA)-approved indication. However, CMS is updating the coverage criteria for hospitals and physicians to begin or maintain a TAVR program. The decision provides greater flexibility for hospitals and providers to meet the requirements for performing TAVR.
“Today’s decision to update and streamline the TAVR coverage parameters demonstrates CMS’ ongoing commitment to our beneficiaries,” said CMS Administrator Seema Verma. “The modification to the TAVR hospital and physician requirements is generally consistent with the 2018 Consensus Statement from the American College of Cardiology, the American Association for Thoracic Surgery, the Society for Cardiovascular Angiography and Interventions and the Society of Thoracic Surgeons. The decision ensures improved access to care for beneficiaries while supporting the continued evolution of this important technology in light of emerging evidence.”
In developing its decision, CMS met with numerous stakeholders including medical professional societies, who recommended requirements for hospitals and physicians to perform a certain volume of heart procedures. The decision includes updated volume requirements for hospitals and physicians to begin and maintain TAVR programs.
CMS said the 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. CMS will continue to follow efforts by medical societies to develop TAVR-specific outcome measures, and the agency will encourage continued progress toward the establishment of such widely supported measures as potential replacements for procedural volume criteria.
The CMS decision was made in response to a formal request and is consistent with recommendations from a meeting of the MEDCAC (Medicare Evidence Development & Coverage Advisory Committee) on July 25, 2018. The MEDCAC provides CMS with an external review of medical literature, technology assessments, public testimony, and other data and information on the benefits, harms, and appropriateness of therapies under review.
For more information: www.cms.gov