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 pataortic valve repairient data level for a period of at least five years from the time of the TAVR procedure:
- At least 20 procedures per year OR at least 40 procedures every two years;
The interventionalist requirements are that operators must be board certified in interventional cardiology, and have professional experience with 50 structural heart disease procedures.
t. 401 383 5660
- 30-day neurologic event rate of less than 15 percent;
CMS recommends coverage for TAVR, with stipulations aortic valve repair,Based on this determination, TAVR is covered for the treatment of severe symptomatic aortic valve stenosis only, whenof the following conditions 1-5 are met.
- At least 90 percent institutional follow-up of patients; and
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.
TriMed Media Group
For centers without previous PMA trial TAVR experience, the surgical program requirements are at least 50 total aortic valve replacemenCMS recommends coverage for TAVR, with stipulations aortic valve repairt (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 60 percent one-year survival for non-operable patients.
- 30-day all-cause mortality rate less than 15 percent;
275 Promenade Street
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.
Two cardiac surgeons have, according to the pivotal PMA trials protocol, evaluated the patients suitability for open valve replacement surgery.
Suite 225
Providence, RI 02908
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.
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.
f. 401 383 3896
The agency laid out other stipulations in the complete. 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.
