The Centers for Medicare & Medicaid Services (CMS) today proposed that coverage for transcatheter aortic valve replacement (TAVR) be approved under coverage with evidence development (CED) for certain conditions.
Based on this determination, TAVR is covered for the treatment of severe symptomatic aortic valve stenosis only, when all of the following conditions 1-5 are met.
- 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.
- Two cardiac surgeons have, according to the pivotal PMA trial’s protocol, evaluated the patient’s suitability for open valve replacement surgery.
- The procedure is furnished in a facility that meets the following institutional requirements.
- For centers without previous PMA trial TAVR experience, the surgical program requirements are at least 50 total aortic valve replacement (AVR) procedures per year, including at least 10 patients with STS (Society of Thoracic Surgeons) Score of at least 6, and at least two institutionally based cardiac surgeons. For centers without previous PMA trial TAVR experience, the interventional program requirements are at least 400 caths/150 PCIs per year, and at least 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 include participation in ongoing TAVR programs, either randomized controlled trials or post-approval study; experience with at least 30 TAVR procedures and at least 20 per year; and TAVR program requirements of:
- At least 20 procedures per year OR at least 40 procedures every two years;
- 30-day all-cause mortality rate less than 15 percent;
- 30-day neurologic event rate of less than 15 percent;
- At least 90 percent institutional follow-up of patients; and
- At least 60 percent one-year survival for non-operable 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:
- The surgeon requirements are board certified in cardiovascular surgery; and professional experience with at least 100 AVR/career including 10 high-risk patients; OR at least a 25 AVR percent per year or 50 AVRs in two years; AND at least 20 in the last year prior to TAVR.
- The interventionalist requirements are that operators must be board certified 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 five 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 agency laid out other stipulations in the complete proposed determination . CMS is requesting public comments on this proposed determination, expressing specific interest in public comments on the use of CED in this decision. After considering the public comments, the agency will make a final determination and issue a final decision memorandum.