Surgeons Insist TAVI Reimbursement Rollout Won't Be Repeat of Carotid-Stenting Debacle

Reed Miller

January 30, 2012

January 30, 2012 (Ft Lauderdale, Florida) — Surgeons meeting in Ft Lauderdale insist that they will not make the mistakes made with Medicare coverage of carotid stenting when seeking national coverage for transcatheter aortic-valve implantation (TAVI) [1].

Even before the Food and Drug Administration approved the first TAVI system for the US market, the Centers for Medicare & Medicaid Services (CMS) opened a "national coverage analysis" for TAVI at the request of the American College of Cardiology (ACC) and the Society for Thoracic Surgeons (STS). The agency is currently collecting the second round of comments on the proposed coverage policy. It is planning to issue a new policy by the end of June.

The close collaboration of the STS, ACC, and CMS on this coverage policy contrasts to the discord that led to the current Medicare coverage policy on carotid stenting, which doesn't appear to satisfy surgeons, neurologists, or interventionalists. Medicare coverage of carotid stenting is "a fiasco because the interventionalists and surgeons were fighting about it," STS president Dr Michael Mack (Baylor Health Care System, TX) told heartwire . "I think everyone has learned their lesson from that."

During a presentation here at the Society of Thoracic Surgeons (STS) 2012 Annual Meeting, STS first vice president Dr Jeffrey Rich (Mid-Atlantic Cardiothoracic Surgeons, Norfolk, VA) said the national coverage policy for carotid stenting has been "written and rewritten nine times. It was the worst way--the worst example--of what not to do with a [national coverage determination], because all of the stakeholders were submitting requests for coverage without getting together or collaborating." Rich is also the former director of the CMS and a current member of CMS's Medicare Evidence Development & Coverage Advisory Committee.

"But [transcatheter aortic-valve replacement's] TAVR's [coverage process] has gone perfectly," Rich said. "It's very patient-centric, provider-driven, and industry-protective."

Mack also told heartwire that the national coverage decision for TAVI will be written in such a way that the CMS will not have to reopen the decision every time the FDA approves a new TAVI device or new TAVI indication.

Rational Dispersion

"I think everybody wants to not reproduce what happened in carotid stenting," Mack said at the STS meeting. He cited a recent study of Medicare data on carotid-stenting procedures, reported by heartwire , showing that the 30-day mortality was higher with carotid stent procedures performed by less experienced operators.

Mack cited the editorial that accompanied that study in the Journal of the American Medical Association by Dr Ethan A Halm (University of Texas Southwestern Medical Center, Dallas). Halm argued carotid stenting is being attempted by too many inexperienced or unqualified operators. Mack said "Everyone that has been involved in this rollout of TAVR is doing everything they can to make sure that the same editorial isn't written about TAVR five years from now." Instead, the STS is teaming up with other professional societies to ensure that the rollout of TAVI follows a pattern of "rational dispersion, which meant it just isn't going to be approved for everybody at every place for every disease at any time," Mack said.

The societies have agreed that TAVI should be limited to centers that have a multidisciplinary heart team--including an interventionalist, surgeon, anesthesiologist, echocardiographers, and general cardiologist--that has enough experience and performs a high enough annual volume of these procedures to maintain TAVI skills. "The whole concept here is that this is not just a procedure but a program, very similar to the transplant-care–center concept, in which there are appropriate [pre- and post-] procedural teams for access, selection, [and follow-up care]."

In collaboration with the STS and ACC, the Society for Cardiovascular Angiography and Intervention (SCAI) is leading the development of a document that will lay out credentialing criteria that centers will have to meet to be eligible for Medicare reimbursement of TAVI procedures. This will be "the starting point for institutions to deliver this new therapy," Mack said. Dr Fred Edwards (University of Florida, Jacksonville) and Dr John Carroll (University of Colorado, Denver) are leading the writing group with input from representatives of the CMS, FDA, Edwards Lifesciences, and Duke Clinical Research Institute, Mack said.

The STS and ACC are also partnering on the national Transcatheter Valve Therapy (TVT) Registry. The registry, developed in collaboration with the FDA, CMS, SCAI, and the American Association for Thoracic Surgery, will be linked to the Social Security Death Master File and CMS databases to track long-term outcomes. The societies have asked the CMS to make participation in the TVT registry a requirement to receive reimbursement for a TAVI procedure.

The same societies have also developed a "huge, robust" consensus document on all aspects of TAVI and aortic disease.

"Decisions are going to be made with us or without us, so that's why the societies have been involved in creating the guidance on these decisions," Mack said. "We're now part of the process along with all of the stakeholders. If we do this in a responsible manner, our opportunity to be part of the solution will continue and increase."

Mack has a nonremunerative position of interest on the executive committee of the PARTNER trial for Edwards Lifesciences. Rich is a consultant for Catapult Consultants.

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