(Updated with statement from the ACC and STS)
On Thursday the Centers for Medicare & Medicaid Services (CMS) released a memo containing details of its proposed Medicare coverage for TAVR (transcatheter aortic valve replacement). The memo is a response to a formal request for national coverage determination (NCD) from the Society of Thoracic Surgeons (STS) and the American College of Cardiology (ACC). The memo will be open for public comment until March 3, after which a final determination will be made.
In the memo CMS proposes coverage for TAVR only if 5 conditions are met, including
- The use of an FDA approved device for an FDA approved indication,
- Evaluation of the patient by 2 cardiac surgeons,
- Performance of the procedure at an institution with sufficient surgical and interventional cardiology experience and expertise, including participation in a prospective national TAVR study and a commitment to the Heart Team concept,
- Performance by physicians with sufficient experience and expertise,
- The patient must be enrolled in, and the physician must participate in a national TAVR registry that will track outcomes for at least five years after the procedure.
CMS also said it would provide coverage for patients enrolled in clinical trials that meet a long list of criteria. CMS recommended that coverage be denied for indications other than those specifically mentioned in the memo.
Update– On Friday, the STS and ACC released a statement (see below) expressing support for the CMS proposal.
“This is tremendous news for Medicare beneficiaries. ACC is pleased that CMS is proposing a national coverage policy that balances the critical need to provide access to this important, innovative service with the need to ensure that care is provided in qualified facilities by highly skilled heart care teams and the need to collect data on experience with the device and procedure in the real world. We are especially pleased to that CMS has proposed to provide a smooth path to Medicare coverage as the technology continues to evolve and improve,” said ACC President David R. Holmes, Jr., in the press release.
Here is the press release from the ACC and STS:
STS and ACC Support National Coverage Analysis for Transcatheter Aortic Valve Replacement
Cardiothoracic surgeons and cardiologists jointly support the coverage of this new heart therapy for U.S. patients
CHICAGO, IL, Feb. 3, 2012 – Today, The Society of Thoracic Surgeons (STS) and the American College of Cardiology (ACC), released a joint statement in support of the Centers for Medicare and Medicaid Service’s (CMS) release of a proposed National Coverage Determination (NCD) for transcatheter aortic valve replacement therapy (TAVR). A 30-day public comment period is now open and a final NCD for TAVR is expected to be released later this year.
“The Society of Thoracic Surgeons is pleased CMS has released a comprehensive approach to TAVR coverage. As surgeons, we support coverage efforts that seek to optimize patient safety and value physician collaboration. This coverage analysis achieves these goals through the use of specialized centers with multidisciplinary heart teams and registry enrollment,” commented STS President Jeffrey B. Rich, MD.
Released by CMS, the proposed NCD states that coverage for TAVR be approved under Coverage with Evidence Development and that TAVR should only be covered for the treatment of severe symptomatic aortic stenosis when all six of the following conditions are met:
- TAVR should performed for an FDA approved indication, with a complete valve and implantation system that has received FDA premarket approval for this indication;
- Two cardiac surgeons have evaluated the patient’s suitability for open valve replacement surgery;
- TAVR should only be done by a Heart Team that includes joint pre-op decision making and intra-op co-management of the technical aspects of the TAVR procedure;
- TAVR is performed in a facility that meets surgical or interventional program volume requirements and is committed to the Heart Team concept;
- TAVR should performed by physicians who meet strict surgeon or interventionalist requirements, including board certification/eligibility; and
- The TAVR patient and the treating physician team are enrolled in a prospective national registry to track outcomes.
“This is tremendous news for Medicare beneficiaries. ACC is pleased that CMS is proposing a national coverage policy that balances the critical need to provide access to this important, innovative service with the need to ensure that care is provided in qualified facilities by highly skilled heart care teams and the need to collect data on experience with the device and procedure in the real world. We are especially pleased to that CMS has proposed to provide a smooth path to Medicare coverage as the technology continues to evolve and improve,” said ACC President David R. Holmes, Jr., MD, FACC.”
In December 2011, STS and ACC launched the STS/ACC TVT Registry, the first-of-its-kind benchmarking tool to track outcomes of TAVR. Built to deliver insight into clinical practice patterns, the STS/ACC TVT Registry provides a data repository that captures and reports patient demographics, procedure details, and facility and physician information.
Backed by the registry expertise of the STS National Database and the ACC’s National Cardiovascular Data Registry (NCDR), the TVT Registry serves as the main repository for all clinical data related to TAVR and is positioned to incorporate additional catheter-based procedures that have yet to come to market in the United States.
The proposed NCD also included conditions for the national non-coverage of TAVR. Specific non-coverage events are: mixed aortic valve disease; isolated aortic regurgitation; untreated clinically significant coronary artery disease requiring revascularization; hypertrophic cardiomyopathy with or without obstruction; echocardiographic evidence of intracardiac mass, thrombus or vegetation; significant aortic disease; and iliofemoral vessel characteristics that would preclude safe placement of an introducer sheath. Please see the proposed National Coverage Determination for additional details on non-coverage of TAVR.
NCDs are policies issued by CMS under Section 1869(f) of the Social Security Act to determine whether or not a particular item or service should be covered nationally by Medicare. The NCD grants, limits, or excludes Medicare coverage. NCDs are binding on all Medicare carriers, fiscal intermediaries, quality improvement organizations, health maintenance organizations, competitive medical plans, and health care prepayment plans.