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CMS Finalizes Updates to Coverage Policy for Transcatheter Aortic Valve Replacement (TAVR)
Decision expands access to TAVR in Medicare by modernizing the requirements that providers must meet to perform the cardiac procedure under Coverage with Evidence Development (CED)
Today the Centers for Medicare & Medicaid Services (CMS) finalized its decision to update the national coverage policy for Transcatheter Aortic Valve Replacement (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. CMS' decision comes in response to the continued development of this therapy and streamlines key elements of the original national coverage determination, which went into effect in 2012.
CMS will continue to cover TAVR under coverage with evidence development (CED) when furnished according to an 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 today's 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. Today's decision includes updated volume requirements for hospitals and physicians to begin and maintain TAVR programs.
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.
Today's 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.
To read the decision, visit the CMS website at: https://www.cms.gov/medicare-coverage-database/details/nca-tracking-sheet.aspx?NCAId=293.
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