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Medicare's volume requirements for reimbursement of transcatheter aortic valve replacement (TAVR) were finalized in an , announced Friday.

Institutional and operator criteria were unchanged from when they were first proposed in March following a Centers for Medicare & Medicaid Services (CMS) panel's recommendations last July.

For example, centers wishing to start new TAVR programs must have performed 50 or more open heart surgeries the prior year and 20 aortic valve-related procedures in the prior 2 years.

Maintaining a program requires at least 50 transcatheter or surgical aortic valve replacements per year (including 20 TAVRs), or 100 of these procedures every 2 years (including 40 TAVRs).

Programs both new and old will have to perform 300 percutaneous coronary interventions per year.

"Today's decision to update and streamline the TAVR coverage parameters demonstrates CMS' ongoing commitment to our beneficiaries," said CMS Administrator Seema Verma in a press release. "The decision ensures improved access to care for beneficiaries while supporting the continued evolution of this important technology in light of emerging evidence."

CMS is encouraging development of TAVR-specific outcome measures so that procedural volume will no longer have to be used as a surrogate for TAVR quality, the press release added.

TAVR stayed under Coverage with Evidence Development, which mandates registry participation, as there are four questions about TAVR that still need to be addressed in the eyes of CMS:

1. How do real-world outcomes and adverse events compare to the pivotal clinical studies?
2. What is the long term durability of the device?
3. What are the long term outcomes and adverse events?
4. What morbidity and procedure-related factors contribute to outcomes?

"We are encouraged that CMS is open to moving toward a quality measure focused on patient outcomes, not procedural volume, in evaluating hospitals eligible to provide TAVR in the U.S.," said Edwards Lifesciences, manufacturer of the Sapien line of TAVR valves, in a statement. Edwards said it believes such a move "could reasonably coincide in the future with discontinuation of Coverage with Evidence Development."

Earlier this year, two major trials were released supporting TAVR in low-risk patients. FDA's verdict on an indication for the low-risk population could come by the end of 2019.

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