The clock is ticking. With its deadline looming, the Centers for Medicare & Medicaid Services (CMS) is exploring issues related to transcatheter aortic valve replacement (TAVR) as the agency completes its national coverage determination. The final decision, originally scheduled for June 26, may be released as early as May.
CMS was approached by the Society of Thoracic Surgeons (STS) and the American College of Cardiology (ACC), which argued that TAVR procedures should be performed in a specialized heart center by a multidisciplinary team. The groups recommended that the team be trained, credentialed and the facility include a modified conventional cardiac laboratory or hybrid operating room, among other requirements.
How CMS will reimburse for TAVR procedures remains one of many questions. There is only one valve approved by the FDA for use in the U.S., the Sapien valve sold by Edwards Lifesciences. Depending on the cost of the valve, hospitals may fare well with a valve priced at $15,000 but possibly record negative contribution margins with a valve set at a commercial value of around $32,000, according to one analysis.
In the meantime, TAVR and the Sapien valve continue to make headlines. At the ACC’s scientific session, results from the PARTNER A trial showed that at two years, outcomes for high-risk patient who underwent TAVR remained similar to those who underwent surgical aortic valve replacement. Based on PARTNER A data, Edward submitted a premarket approval application to the FDA for approval of the Sapien valve in the treatment of patients with severe, symptomatic aortic stenosis who are at high risk for surgery--but not inoperable, so these are lower risk patients. The FDA’s review is scheduled for June 13.
Be sure to check out our website for up-to-date news coverage of these topics as well as our magazine, which will feature valves and echocardiography in the June issue. For a free subscription, sign up here.
Editor, Cardiovascular Business