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March 31, 2019

CMS Proposes Updates to Coverage Policy for TAVR

April 1, 2019—The Centers for Medicare & Medicaid Services (CMS) proposed to update its national coverage policy for transcatheter aortic valve replacement (TAVR). CMS advised that the decision was made in response to a formal request and is consistent with recommendations from a meeting of the Medicare Evidence Development & Coverage Advisory Committee on July 25, 2018.

According to CMS, the current national coverage determination, which became effective May 1, 2012, established CMS coverage for TAVR under Coverage with Evidence Development (CED). Since 2012, TAVR programs have been established in > 500 hospitals across the country.

With the coverage proposal, 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.

CMS also seeks to gather more information about metrics other than volume that could be used to assess quality and safety. Specifically, the agency is 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 is seeking comments on the proposed national coverage determination. All public comments may be submitted via the CMS website here. A final decision will be issued no later than 60 days after the conclusion of the 30-day public comment period. The proposed decision can be accessed on the CMS website here.

CMS stated that 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 who undergo the procedure.

CMS Administrator, Seema Verma, commented in the announcement, “CMS must continually refine our policies and requirements in light of emerging evidence. 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.”

CMS advised that the agency met with numerous stakeholders in developing the proposed decision, including medical professional societies that continue to recommend requirements for providers to perform a certain volume of procedures.

As outlined in the announcement, the proposed decision includes the requirements for providers to perform a certain volume of procedures. These requirements were developed because of the link between 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, the American Association for Thoracic Surgery, the Society for Cardiovascular Angiography and Interventions, and the Society of Thoracic Surgeons, noted CMS.

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April 1, 2019

SCAI Publishes Recommendations for Use of PFO Closure Technologies

April 1, 2019

SCAI Publishes Recommendations for Use of PFO Closure Technologies