Dive Brief:

• CMS announced final revisions Friday to its national coverage policy setting rules hospitals must meet to perform transcatheter aortic valve replacement procedures, easing volume requirements for hospitals and physicians to begin TAVR programs but upping the number of valve procedures necessary to maintain a program.
• Medtronic said it supports the decision and believes the new policy allows for appropriate patient access to TAVR, especially in rural communities, while maintaining rigorous requirements for providers of the therapy.
• Edwards Lifesciences said it was encouraged that CMS is open to moving toward quality measures focused on patient outcomes, not procedural volume, in evaluating hospitals eligible to provide TAVR.

Dive Insight:

The new criteria are expected to expand patient access to TAVR by lessening the requirements that hospitals and clinicians must meet to begin programs. Analysts at Jefferies estimate the update could add 200 U.S. TAVR sites to the current 600 facilities approved to perform the procedure, per a note to investors Sunday.

In addition to Medtronic and Edwards, Boston Scientific sells a TAVR device and Abbott is hoping to jump into the market next year.

To begin such a program, hospitals without TAVR experience must have performed at least 50 open heart surgeries in the previous year and 20 aortic valve related procedures in the preceding two years.

Hospitals with TAVR experience must maintain a volume of at least 50 aortic valve replacements, either TAVR or surgical, each year, including at least 20 TAVR procedures in the prior year, or at least 100 valve replacements every two years.

With the overall success of TAVR and rapid growth of the market, some physicians had advocated for a loosening of volume-based restrictions to allow more lower-volume facilities to perform the procedure.

But four medical societies — the Society of Thoracic Surgeons, American College of Cardiology, American Association for Thoracic Surgery, and the Society for Cardiovascular Angiography and Interventions — expressed concern that easing the standards for starting a program would not produce the best outcomes for patients.

CMS said the decision reflects the continued development of the therapy, a minimally invasive approach to treating aortic stenosis, a narrowing of the heart valve that propels blood from the heart to the rest of the body. The agency’s original national coverage determination went into effect in 2012.  

The agency said its new policy is consistent with recommendations from the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) meeting in July 2018 and aims to strike a balance between making sure that hospitals have the experience and capabilities to handle complex heart disease cases and “limiting the burden and barriers that excessive requirements create for hospitals and patients.”

CMS said it will continue to follow efforts by medical societies to develop TAVR-specific outcome measures, and it encourages progress toward the establishment of the measures as potential replacements for procedural volume criteria.

“The decision ensures improved access to care for beneficiaries while supporting the continued evolution of this important technology in light of emerging evidence,” CMS Administrator Seema Verma said in a press release.

The Jefferies analysts said the coverage update improves on the agency’s March proposal by specifying that both a surgeon and an interventional cardiologist need to assess patients for TAVR appropriateness, rather than a surgeon only as originally proposed.