Reimbursement In Brief

In a Feb. 2 draft coverage decision, CMS proposes covering transcatheter aortic valve replacement (TAVR) procedures only within the coverage-with-evidence-development (CED) program and only under specific conditions. For example, TAVR should be used to treat severe symptomatic aortic valve stenosis when all these conditions are met: the procedure is for an FDA-approved indication using a complete valve and implantation system that has earned FDA pre-market approval; the patient has been evaluated for open valve replacement by two cardiac surgeons; the procedure is performed in a facility that meets all CMS requirements for TAVR; the facility collects data for a prospective national study; performing physicians meet strict qualifications and experience criteria; and the patient enrolls in a five-year, outcomes-based national registry. Stricter CED participation requirements are proposed for off-label TAVR procedures. TAVR would be explicitly non-covered in certain patients, such as those with mixed aortic valve disease or isolated aortic regurgitation. Comments are due March 3, and CMS expects to issue a final national coverage decision by May 2. (See Also see "Transcatheter Valve Stakeholders Weigh Merits Of Local Vs. National Coverage" - Medtech Insight, 7 November, 2011..) FDA granted a PMA for the first U.S. transcatheter aortic heart valve, Edward Lifesciences’ Sapien, last November. (See Also see "Edwards Wins Approval For Sapien Just In Time For TCT" - Medtech Insight, 7 November, 2011..)

CMS proposes expanding coverage for extracorporeal photopheresis (ECP) to treat lung allograft patients with progressive bronchiolitis obliterans syndrome (BOS), but...