March 27, 2019 — The Centers for Medicare and Medicaid Services (CMS) proposed to update its national coverage policy for transcatheter aortic valve replacement (TAVR). The current national coverage determination, effective May 1, 2012, established CMS coverage for TAVR under Coverage with Evidence Development (CED). Since the finalization of the 2012 national coverage determination, TAVR programs have been established in more than 500 hospitals across the country.
Under the coverage proposal announced this week, CMS would continue to cover TAVR under 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 proposed decision provides more flexibility in how providers can meet the requirements for performing TAVR, while continuing to ensure good health outcomes for patients receiving the procedure.
“CMS must continually refine our policies and requirements in light of emerging evidence,” said CMS Administrator Seema Verma. “Today’s decision updates the requirements for hospitals and physicians to perform TAVR to ensure these requirements are in line with the latest research on patient outcomes, in order to broaden access to care while safeguarding quality and safety for Medicare beneficiaries.”
In developing the proposed decision, CMS met with numerous stakeholders including medical professional societies who continue to recommend requirements for providers to perform a certain volume of heart procedures. The proposed decision includes requirements for providers to perform a certain volume of procedures, given the link between heart procedure volume and patient outcomes in the medical literature and the risks from receiving care in low-volume settings. However, the proposed decision provides more flexibility in how providers can meet these requirements to reflect the latest evidence on volume and outcomes. The proposal is generally consistent with the 2018 Consensus Statement from the American College of Cardiology (ACC), the American Association for Thoracic Surgery (AATS), the Society for Cardiovascular Angiography and Interventions (SCAI), and the Society of Thoracic Surgeons (STS).
In the proposed decision, CMS also seeks to gather more information about metrics other than volume that could be used to assess quality and safety. CMS is specifically proposing a question regarding the relationship between other metrics and patient health outcomes, which could inform a future change to replace the volume criteria with a different metric.
CMS said the decision was made in response to a formal request and is consistent with recommendations from a meeting of the MEDCAC (Medicare Evidence Development and 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.
CMS is seeking comments on the proposed National Coverage Determination. All public comments may be submitted at www.cms.gov/medicare-coverage-database/indexes/nca-open-for-public-comment-index.aspx. A final decision will be issued no later than 60 days after the conclusion of the 30-day public comment period.
To read the proposed decision, visit the CMS website at: https://www.cms.gov/medicare-coverage-database/details/nca-proposed-decision-memo.aspx?NCAId=293