Final CMS Decision on TAVR Reimbursement

Kerry Dooley Young

June 25, 2019

The Centers for Medicare & Medicaid Services (CMS) has finalized an update to a national coverage decision (NCD) for transcatheter aortic valve replacement (TAVR), first set in 2012.

The final decision is largely similar to the draft document released in March for public review, outlining volume requirements for qualifying personnel and TAVR programs.

In a statement released June 21, the agency notes that "CMS will continue to cover TAVR under coverage with evidence development when furnished according to an FDA-approved indication. However, CMS is updating the coverage criteria for hospitals and providers to meet the requirements for performing TAVR."

The decision, the statement adds, "provides greater flexibility for hospitals and providers to meet the requirements for performing TAVR."

"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," CMS Administrator Seema Verma said in the agency's statement. "The decision ensures improved access to care for beneficiaries while supporting the continued evolution of this important technology in light of emerging evidence."

The decision states that TAVR is covered for the treatment of symptomatic aortic valve stenosis "when furnished according to" an FDA-approved indication, and when all of certain conditions are met.

Among these is the condition that the valve and implantation system has received FDA premarket approval for that system's approved indication, and that the patient receive pre- and postoperative care from a heart team that is "a cohesive, multi-disciplinary team of healthcare professionals," the decision summary notes.

The team is to include a cardiac surgeon and interventional cardiologist experienced in the treatment of aortic stenosis who have independently examined the patient face-to-face and evaluated suitability for surgical aortic valve replacement (SAVR), TAVR, or medical or palliative therapy, and documented the rationale for their clinical judgment to other members of the team. They should jointly participate in the intraoperative technical aspects of the procedure, the summary notes.

Hospitals providing TAVR must have "appropriate infrastructure that includes but is not limited to" onsite valve surgery and interventional cardiology programs and a postprocedure intensive care facility with personnel experienced in valve procedures.

The document outlines volume requirements that are different for hospitals and heart teams with and without previous experience with TAVR.

To begin a TAVR program in hospitals without previous experience, the program must meet all of the following criteria:

  • at least 50 open heart surgeries in the year prior to TAVR program initiation

  • at least 20 aortic-valve-related procedures in the 2 years prior to TAVR program initiation

  • at least two physicians with cardiac surgery privileges

  • at least one physician with interventional cardiology privileges

  • at least 300 percutaneous coronary interventions (PCIs) per year.

The heart teams in these programs without TAVR experience must include a cardiovascular surgeon with at least 100 career open-heart surgeries, of which at least 25 are related to aortic valves, and an interventional cardiologist with at least 100 career structural heart disease procedures or at least 30 left-sided structural procedures per year, and device-specific training as required by the manufacturer.

Qualifications for hospital programs with TAVR experiences specify that the programs must meet the following criteria:

  • at least 50 AVRs (TAVR or SAVR) per year, including at least 20 TAVR procedures in the previous year, or at least 100 AVRs every 2 years, including at least 40 TAVR procedures in the previous 2 years

  • at least two physicians with cardiac surgery privileges

  • at least one physician with interventional cardiology privileges

  • at least 300 PCIs per year.

The heart team and hospital will also participate in a prospective national registry consecutively that enrolls TAVR patients, includes all devices, and follows patients at least a year. Outcomes tracked by the registry will include all-cause mortality, transient ischemic attack, major vascular events, acute kidney injury, repeat aortic valve procedures, new permanent pacemaker implantation, and quality-of-life measures.

TAVR is also covered, the summary notes, "for uses that are not expressly listed as an FDA-approved indication when performed within a clinical study" that meet specific criteria.

Interdisciplinary Approach

In a statement, Richard J. Kovacs, MD, president of the American College of Cardiology, said the group is "pleased" that the updated TAVR coverage criteria "emphasizes care by an interdisciplinary heart team for these complex patients" while continuing to mandate the collection of patient data.

The makers of TAVR devices also issued statements in support of the updated NCD.

The CMS "new coverage policy allows for appropriate patient access to TAVR — especially for patients in rural communities — while still maintaining rigorous requirements for centers and operators providing the therapy," Dublin-headquartered Medtronic Plc said.

In its statement, Edward Lifesciences Corp. said that "the modernized requirements and more streamlined patient evaluation process are meaningful enhancements that may help ensure equitable access for more patients."

"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 US, which Edwards believes could reasonably coincide in the future with discontinuation of Coverage with Evidence Development," the Irvine, California–based Edwards said.

Heart Valve Voice, a nonprofit group that lists from Edwards and Medtronic among its supporters, has been pressing for CMS to shift its approach for judging hospitals based on quality outcomes, arguing this could safely increase access to the treatment. Currently, of the more than 80,000 TAVR procedures conducted in the United States, 95% of patients have been white and 70% lived in higher-income zip codes, Lisa M. Tate, interim executive director for Heart Valve Voice, said in a statement.

"Seniors living in rural areas, African Americans, and Hispanics are particularly impacted by today's decision," Tate said. "The majority of hospitals that offer TAVR will continue to primarily be urban teaching hospitals."

Centers for Medicaid and Medicare Services: Decision Memo for Transcatheter Aortic Valve Replacement. June 21, 2019.


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