CMS Restricts TAVI Coverage to Experienced Operators

Reed Miller

May 01, 2012

May 1, 2012 (Silver Spring, Maryland) — The Centers for Medicare & Medicaid Services (CMS) will restrict Medicare coverage of transcatheter aortic-valve implants (TAVI) to centers with experienced surgeons and interventionalists that participate in a national registry, the agency announced late in the day today, with the release of its final decision memo for transcatheter aortic-valve replacement [1].

The decision mostly affirms the draft decision the agency released in February. The CMS policy was created with input from industry, the FDA, and professional societies and incorporates the recommendations of the multisociety US expert-consensus document that was released earlier this year. "Everybody is generally pretty happy with it. The CMS listened and worked hard to incorporate everybody's comments and suggestions, and I really haven't heard any dissatisfaction with the final product," surgeon Dr Michael Mack (Medical City Dallas Hospital, TX) told heartwire. Mack was investigator in the pivotal PARTNER trial, the most important evidence on TAVI cited in the CMS's coverage decision.

Of note, Medicare will not cover TAVI patients whose comorbidities would preclude the expected benefit from correction of the aortic stenosis. 

The coverage policy emphasizes the importance of the "heart-team" approach, in which surgeons and interventionalists collaborate on valve repair decisions.

Controlled Rollout

The policy also sets thresholds for the physicians' experience and annual volume. Centers without previous experience with TAVI will not be reimbursed for these procedures unless they can document at least 50 previous aortic-valve repairs, including at least 10 in high-risk patients, plus at least 1000 catheter procedures, including at least 400 PCIs, per year. These kinds of requirements are not common in Medicare coverage policies but are not unprecedented. Similar rules govern which hospitals can implant ventricular assist devices, for example, Mack pointed out. About 400 US centers are expected to qualify to perform TAVI under these rules, Mack said.

The heart team at new TAVI centers must include a surgeon who has done at least 100 career aortic-valve repairs, including at least 10 in high-risk patients, and at least 25 aortic-valve repairs in the past year or at least 50 in the past two years and 20 in the past year. New TAVI programs seeking Medicare reimbursement must have a total of at least two physicians with cardiac surgery privileges.

The heart team must also include an interventional cardiologist with professional experience with 100 structural heart disease procedures lifetime or 30 left-sided structural procedures per year, of which 60% should be balloon aortic valvuloplasties (BAV). Additional members of the heart team, including echocardiographers, imaging specialists, heart-failure specialists, anesthesiologists, intensivists, nurses, and social workers, should undergo device-specific training.

The requirements for centers with TAVI experience are similar.

Mack explained that in addition to the volume and data-collection requirements, the coverage policy will also require hospitals performing TAVI to meet certain outcomes goals as specified in the credentialing criteria created by the American College of Cardiology (ACC), the Society for Cardiovascular Angiography and Intervention (SCAI), and the Society for Thoracic Surgeons (STS). "These are not superstrict outcomes by any means, at least for inoperable patients," Mack said. But those criteria will evolve if and when the FDA-approved indications for TAVI expand to lower-risk patients.

The criteria for surgery-ineligible patients (PARTNER cohort B) are referenced in the coverage policy document, but not in the conditions of coverage themselves, so that new criteria for surgery-eligible patients and perhaps future TAVI technologies can be added to the credentialing criteria without compelling the CMS to go through the arduous process of reopening this national coverage policy. "If you put that outcomes criteria in the [national coverage policy itself], it's basically carved in stone, and then to write new criteria, you'd have to write a new [national coverage determination] NCD, and everyone's intent here was to get rid of that lag period of rewriting the NCD," Mack explained.

Postmarket Data Collection Focuses on Key Questions

The coverage policy also insists that the heart team and hospital participate in a prospective, national, audited registry that consecutively enrolls patients, accepts devices from all manufacturers, and follows the patient for at least one year, tracking stroke, all-cause mortality, transient ischemic attack, major vascular events, acute kidney injury, repeat aortic-valve procedures, and quality of life.

The center must collect enough data to help answer the following questions.

  • How do the outcomes and adverse events of TAVI procedures performed in the real world compare with the pivotal clinical studies?

  • How do the demographics of registry patients compare with the pivotal studies?

  • How do outcomes and adverse events in various subpopulations compare with patients in the pivotal clinical studies? 

  • What is the long-term durability of the device and what are the long-term outcomes and adverse events (beyond five years)?

The policy states that the CMS will also cover TAVI procedures within clinical trials meeting certain qualifications that address the above questions.

At a "town-hall" meeting at the American Association of Thoracic Surgery (AATS) 2012 Annual Meeting, the director of the CMS coverage and analysis group, Dr Louis Jacques, explained that everyone involved is trying to avoid a repeat of the struggles with the carotid-stenting coverage policy. "But it occurred to me that we don't want a repeat of [the experience with] implantable cardioverter defibrillators, either. We don't want to have data collection going on forever and ever without anyone actually calling the question. Because at some point, you'll have enough data to get whatever precision you need to answer the questions that a registry can answer, and if there remain outstanding questions, more data won't help you," Jacques said.

Triumph of Collaboration

At the AATS meeting, outgoing president of the ACC Dr David Holmes (Mayo Clinic, Rochester, MN) said, "The process has been unbelievably exciting for the [ACC] to be involved so closely with [the FDA and CMS]. It's been a wonderful journey for us, and we hope it's the first of many such journeys." Dr Alan Schwartz (New York Presbyterian Hospital, NY) added, "Had it not gone by this sort of collaborative process, it doesn't take a lot of imagination to see how difficult the introduction of this technology would be."

Also at the AATS meeting, Dr Bram Zuckerman, head of the division of cardiovascular devices at the FDA's Center for Devices and Radiological Health, said, "We can do things more efficiently and better if we get all of the relevant stakeholders to the plate early and try to see where the common interests are. This NCD is an excellent example of this paradigm being set into motion. It's easy to talk about things, but it's another thing to walk the walk, and a central reason that this paradigm has been successful is the role that the professional societies have played."

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