May 1, 2012—The Centers for Medicare & Medicaid Services (CMS) announced that the agency will cover transcatheter aortic valve replacement (TAVR) for Medicare patients under certain conditions. CMS had issued the proposed decision memo for public comments on February 2, 2012.
“We are pleased with this decision and the increased access to treatment options it will provide,” stated CMS Acting Administrator Marilyn Tavenner. “This decision is particularly important as it highlights cooperative efforts among CMS, the US Food and Drug Administration (FDA), the Agency for Healthcare Research and Quality, medical specialty societies, and the medical device industry.”
According to CMS, this final national coverage decision is one of the first coverage decisions completed under a mutual memorandum of understanding between CMS and the FDA, a joint effort aimed at getting sometimes lifesaving, new technology to patients sooner. The agency stated that because this technology is still relatively new, it is important that these procedures are performed by highly trained professionals in optimally equipped facilities. Therefore, this decision uses Coverage with Evidence Development as a condition of coverage, which will require certain provider, facility, and data collection criteria to be met. Such requirements are important to ensure that beneficiaries receive the safest and most appropriate care, advised CMS.
In its decision memorandum, CMS noted that the FDA approved the first TAVR device for marketing in the United States in November 2011. The Edwards Sapien transcatheter heart valve (Edwards Lifesciences, Irvine, CA) was approved “for transfemoral delivery in patients with severe symptomatic native aortic valve stenosis who have been determined by a cardiac surgeon to be inoperable for open aortic valve replacement and in whom existing comorbidities would not preclude the expected benefit from correction of the aortic stenosis,” as previously reported in Cardiac Interventions Today.
CMS also noted that the FDA approval recommended specific training and experience for practitioners who use the device, as well as continued clinical study and data submission to the Society of Thoracic Surgery–American College of Cardiology’s Transcatheter Valve Therapy Registry. Details of the registry were announced in December 2011.
On June 13, the FDA’s Circulatory System Devices Panel of the Medical Devices Advisory Committee will hold a public meeting to discuss, make recommendations, and vote on information related to Edwards’ premarket approval application for the Sapien device for the treatment of patients with severe, symptomatic aortic stenosis who are at high risk for surgery.
The Edwards Sapien device has been commercially available in Europe, where it received CE Mark approval in late 2007. Medtronic, Inc. (Minneapolis, MN) also received CE Mark approval for its CoreValve transcatheter aortic valve system in 2007. Medtronic is currently conducting a pivotal trial in the United States that will be used to support FDA approval of the CoreValve system.
The full National Coverage Analysis is available on the CMS Web site.
Details of the conditions for coverage are fully outlined in the decision memo. In brief, TAVR is covered for the treatment of symptomatic aortic valve stenosis when furnished according to an FDA-approved indication and when all of the conditions outlined in Part A of the decision are met. TAVR is covered for uses that are not expressly listed as an FDA-approved indication when performed within a clinical study that fulfills all of the conditions outlined in Part B of the decision. TAVR is not covered for patients in whom existing comorbidities would preclude the expected benefit from correction of the aortic stenosis.
In Part A, the conditions outlined for TAVR coverage include:
• The procedure is furnished with a complete aortic valve and implantation system that has received FDA premarket approval for that system’s FDA approved indication.
• Two cardiac surgeons have independently examined the patient face-to-face and evaluated the patient’s suitability for open AVR surgery, and both surgeons have documented the rationale for their clinical judgment and the rationale is available to the heart team.
• The patient (preoperatively and postoperatively) is under the care of a heart team: a cohesive, multidisciplinary team of medical professionals. The heart team concept embodies collaboration and dedication across medical specialties to offer optimal patient-centered care. This section also details the hospital infrastructure that must be in place for a TAVR program, as well as the conditions that need to be met for starting a TAVR program.
• The heart team’s interventional cardiologist(s) and cardiac surgeon(s) must jointly participate in the intraoperative technical aspects of TAVR.
• The heart team and hospital are participating in a prospective, national, audited registry that: consecutively enrolls TAVR patients, accepts all manufactured devices, follows the patient for at least 1 year, and complies with relevant regulations relating to protecting human research subjects.
• The registry must be designed to track and permit identification and analysis of patient, practitioner, and facility-level variables that predict each of these outcomes: stroke, all-cause mortality, transient ischemic attacks, major vascular events, acute kidney injury, repeat aortic valve procedures, and quality of life.
In the final decision memo’s Section B regarding CMS coverage of TAVR procedures conducted in clinical studies, a notable change from February’s proposed decision memo is that the final memo has dropped the requirement that said that the study must be designed to test superiority (not noninferiority). In the final decision memo, CMS permits noninferiority study designs to qualify for coverage of TAVR.
According to CMS, during the public response period, 23 commenters disagreed with the requirement that unlabeled uses of TAVR covered in clinical studies must have superiority designs, asserting that that the superiority requirement is unnecessarily restrictive and will inhibit the medical device industry from introducing next-generation devices.
In the final decision, CMS stated that superiority trial designs provide important advantages that are not completely addressed by noninferiority design, but that the agency recognizes that noninferiority trials have a place in the conduct of medical device regulatory trials and that a broad noncoverage of noninferiority trials may have unintended consequences for certain important studies.
CMS concluded that, when feasible, superiority study designs should be used to investigate nonapproved, off-indication, and off-label uses; and where a noninferiority or equivalence study design is utilized, trial sponsors should comply with the most recently published CONSORT (Consolidated Standards of Reporting Trials) checklist of items for reporting noninferiority or equivalence trials, which are further specified in the memorandum.
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