CMS Issues Proposed Decision Memo for TAVR Coverage

February 2, 2012—The Centers for Medicare & Medicaid Services (CMS) issued a proposed decision memo (CAG-00430N) on transcatheter aortic valve replacement (TAVR).

CMS is requesting public comments on this proposed determination and is specifically interested in public comments on the use of Coverage With Evidence Development (CED) in this decision. After considering the public comments, the agency will make a final determination and issue a final decision memorandum.

CMS's proposed decision memo outlines in three sections the conditions and specifications that must be met for TAVR coverage to be approved under CED.

Section A
TAVR is covered for the treatment of severe symptomatic aortic valve stenosis only, when all of the following five conditions are met:

(1) The procedure is furnished for an FDA-approved indication, with a complete valve and implantation system that has received FDA premarket approval (PMA) for this indication.

(2) Two cardiac surgeons have, according to the pivotal PMA trial's protocol, evaluated the patient's suitability for open valve replacement surgery.

(3) The procedure is furnished in a facility that meets the following institutional requirements:

• For centers without previous PMA clinical trial TAVR experience, the surgical program requirements are: (1) ≥ 50 total aortic valve replacement (AVR) procedures per year, including ≥ 10 patients with Society of Thoracic Surgeons score ≥ 6; and (2) ≥ 2 institutionally based cardiac surgeons. The interventional program requirements are (1) ≥ 400 catheterizations/150 percutaneous coronary interventions per year; and (2) ≥ 15 left-sided structural (endovascular aneurysm repair, thoracic endovascular aortic repair, etc.) interventions per year.
• For centers with previous PMA clinical trial TAVR experience, the requirements are participation in ongoing TAVR programs—either randomized controlled trials or a postapproval study—and experience with ≥ 30 TAVR procedures overall and ≥ 20 per year. TAVR program requirements are (1) ≥ 20 procedures per year or ≥ 40 procedures per 2 years; (2) 30-day all-cause mortality ≤ 15%; (3) 30-day neurologic events ≤ 15%; (4) ≥ 90% institutional follow-up of patients; and (5) ≥ 60% 1-year survival for nonoperable patients.
• For all centers, with or without previous PMA clinical trial TAVR experience, the requirements are: participation in a prospective national TAVR study for ongoing enrollment and follow up of all TAVR patients; and commitment to the “Heart Team” concept.

(4) The procedure is performed by physicians with the following qualifications and experience:

Surgeons are required to be board certified/eligible in cardiovascular surgery and have professional experience with ≥ 100 AVRs per career including 10 high-risk patients; or ≥ 25 AVRs per year or 50 AVRs in 2 years and ≥ 20 AVRs in the last year before TAVR. Requirements for nonsurgeon interventionists are that operators must be board certified/eligible in interventional cardiology and have professional experience with 50 structural heart disease procedures.

(5) The patient is enrolled in and the treating physician team is participating in a prospective national registry that consecutively enrolls TAVR patients and tracks at least the following outcomes at the patient data level for a period of at least 5 years from the time of the TAVR procedure: major stroke, all-cause mortality, minor stroke/transient ischemic attack, major vascular events, acute kidney injury, repeat aortic valve procedures, and quality-of-life measures.

The registry must be designed to permit identification and analysis of patient, practitioner, and facility factors that predict patient risk for these outcomes. The patient must have given informed consent after being informed of the reported risks of TAVR and reasonable alternative management strategies.

Section B
CMS proposes coverage (except as specified under section A or section C) for all unlabeled uses of TAVR only if it is performed in clinical studies that have a
superiority (not noninferiority) TAVR study design and
in which TAVR is performed by a multidisciplinary heart team that includes cardiologist(s) and cardiac surgeon(s) jointly participating in intraoperative technical aspects of TAVR. Additionally, the clinical study must adhere to 13 standards of scientific integrity and relevance to the Medicare population that are detailed in the proposed memo.

Section C
CMS proposes national noncoverage of TAVR for all indications other than those noted above and further specifies noncoverage of TAVR in patients with the following conditions: mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation > 3+);
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, including abdominal aortic or thoracic aneurysm defined as maximal luminal diameter ≥ 5 cm; marked tortuosity (hyperacute bend), aortic arch atheroma (especially if > 5 mm, protruding, or ulcerated) or narrowing (especially with calcification and surface irregularities) of the abdominal or thoracic aorta, severe “unfolding,” and tortuosity of the thoracic aorta, unless the patient qualifies for a transapical or other aortic or subclavian approaches; and iliofemoral vessel characteristics that would preclude safe placement of an introducer sheath such as severe obstructive calcification, severe tortuosity or small vessel size (applicable for transfemoral patients only), unless the patient qualifies for a transapical or other aortic approach.