Edwards Accepts Most STS/ACC Recommended Restrictions for CMS Coverage of Sapien TAVR Device

November 2, 2011—Bloomberg.com reported online that Edwards Lifesciences (Irvine, CA) has accepted restrictions on its Sapien transcatheter heart valve for transcatheter aortic valve replacement (TAVR) as the company seeks to gain coverage approval for the device from the US Centers for Medicare & Medicaid (CMS). On November 2, the US Food and Drug Administration (FDA) granted approval for transfemoral delivery of the Edwards Sapien device to treat inoperable patients who have severe symptomatic aortic stenosis.

According to the Bloomberg report, Edwards backed most requirements sought by the Society of Thoracic Surgeons (STS) in Chicago and the American College of Cardiology (ACC) made in a formal national coverage determination (NCD) request on September 29, 2011. Cardiac Interventions Today news coverage of that request and CMS's subsequent initiation of a National Coverage Analysis are available online.

On October 27, Dirksen Lehman, Edwards' Vice President of Government Affairs and Reimbursement, submitted a letter with supplemental information to Louis Jacques, MD, the Director of the Coverage and Analysis Group at the CMS' Office of Clinical Standards and Quality. In the letter, available online, Mr. Lehman reiterated the company's belief in the immediate need and value of the Sapien valve and the strength of the clinical data from the PARTNER trial used to support Edwards' application for FDA approval and CMS coverage. The supplemental information included the company's review of the pertinent clinical evidence, a discussion of—and some proposed revisions to—the STS/ACC proposed coverage policy, and a comprehensive bibliography and description of the company's literature research methodology. Mr. Lehman reasserted the company's desire to continue to work closely with CMS throughout the NCA process and to provide more information if required. To read all public comments on the NCA submitted to CMS from September 28 to October 28, click here.

As summarized in the Bloomberg article, in its supplemental information, Edwards agreed with STS and ACC that United States health plans should pay only for FDA-approved uses in inoperable and high-risk patients at this time. Also, curbs would limit the device's use to hospitals with equipment necessary for the procedure and teams of doctors trained on the device. Hospital oversight boards would be required to approve doctors for the procedure and monitor the device's use in patients with a narrowing of their aortic valve.

The societies' proposals for the NCD included definitions of covered patient populations, facility requirements, provider training and credentialing, and data collection. In addressing these topics, Edwards generally supported the recommendations while challenging some specific strictures. In its conclusion to the supplemental information, Edwards stated that the societies' proposed restriction policy “provides a sound basis for CMS coverage policy.”

Edwards did counter CMS and STS/ACC concerns that adverse events may be more frequent when TAVR is performed by physicians with limited experience and/or in a facility with limited procedure volume. The company asserted that the literature and PARTNER experience have not demonstrated a correlation of volume and procedural success. Also, depending on the severity of the volume requirements, such policies could significantly limit the number of hospitals that could provide TAVR and restrict patient access to this important new therapy.