CMS Initiates National Coverage Analysis of TAVR

September 29, 2011—The US Centers for Medicare & Medicaid Services (CMS) has initiated a National Coverage Analysis (NCA) of transcatheter aortic valve replacement (TAVR). CMS stated that it received a formal national coverage determination (NCD) request from the Society of Thoracic Surgeons (STS) and the American College of Cardiology (ACC). 

According to CMS, STS and ACC advised the agency that clinical trial data shows that the most successful patient outcomes occur when the following criteria are met: the procedure is performed in a specialized heart center and managed using a multidisciplinary team in which each member has appropriate training and credentials (requirements are currently under development for this); the procedure is performed in a modified conventional cardiac laboratory or hybrid operating room that contains the specialized equipment necessary for the procedure; and the multidisciplinary team uses a planned approach to co-manage decision making as well as technical insertion of the device.

The STS-ACC request also identified the importance of long-term outcome analysis and ongoing analysis of data through continuous review of the data and refinement of recommendations. To accomplish this, they recommended that CMS require reporting of TAVR procedures in an STS-ACC transcatheter valvular therapy registry as one of several conditions of coverage.

STS and ACC issued an expert consensus document on TAVR in June 2011, which was reported in Cardiac Interventions Today. ACC President David R. Holmes Jr, MD, and STS President Michael J. Mack, MD, published the document in the Journal of the American College of Cardiology (2011;58:445–455) and in The Annals of Thoracic Surgery (2011;92:380–389).

CMS advised that it is aware of the high stroke and death rates associated with TAVR (6.7% and 5%, respectively, at 30 days; 10.6% and 30.7%, respectively, at 1 year), as demonstrated through the PARTNER trial. Sponsored by Edwards Lifesciences (Irvine, CA), the PARTNER trial is the pivotal clinical study of the Edwards Sapien transcatheter aortic valve in high-risk surgical patients (cohort A) and high-risk inoperable patients (cohort B) with severe aortic stenosis.

Martin Leon published results from the PARTNER trial's cohort B (comparing TAVR to standard medical therapy in patients unsuitable for surgery) on October 21, 2010, in The New England Journal of Medicine (2010;363:1597–1607). On June 9, 2011, Craig R. Smith, MD, et al published the results from the PARTNER trial's cohort A (comparing TAVR to surgery in high-risk patients) in The New England Journal of Medicine (364:2187–2198).

CMS stated that it is also concerned that these adverse events may be more frequent when TAVR is furnished in settings where the physician and/or the facility have limited experience or procedure volume to establish and maintain adequate expertise.

During the NCA, CMS will review evidence pertaining to the health outcomes attributable to the use of TAVR, including evidence on the experience and qualifications of physicians and facilities that affect these outcomes. Of particular interest to CMS is the conditions under which TAVR may be reasonable and necessary under Sections 1862(a)(1)(A) and 1862(a)(1)(E) of Title XVIII of the Social Security Act. 

CMS noted that within the United States, TAVR has historically been performed only by physician investigators in centers of excellence within clinical trials, not by other practitioners or in facilities with limited experience with TAVR. This limited experience in the United States raises the question of generalizability of the existing evidence base to more real-world settings, concluded CMS.

There are currently two TAVR devices available in Europe and seeking approval in the United States. 

The Edwards Sapien transcatheter heart valve is commercially available in Europe, where it received CE Mark approval in late 2007. In the United States, an advisory panel of the US Food and Drug Administration (FDA) voted on July 20, 2011, to recommend approval of the Edwards Sapien valve for the treatment of certain inoperable patients. The company is now awaiting further FDA action and approval for marketing in the United States. 

Medtronic, Inc. (Minneapolis, MN) received CE Mark approval for its CoreValve transcatheter aortic valve system in 2007. On October 15, 2010, the FDA granted conditional approval for the company's investigational device exemption application and pivotal clinical trial protocol to begin evaluating the CoreValve system for TAVR.

Edwards Lifesciences stated that it was aware for some time that CMS was considering initiating an NCA and believes that a well-written NCD that ensures adequate patient access to this therapy would be positive for patients and physicians. The company noted that the NCD draft is just entering the public comment period and the company expects it to evolve as the societies, regulators, and other stakeholders provide their input on the important details.