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The rules say that plans must pay for a medical service or item if regular Medicare would pay for it in this case. You can find this rule at 42 Code of Federal Regulations (CFR) Section 422.101.
The rules state that TAVR is covered for the treatment of symptomatic aortic valve stenosis when furnished according to a Food and Drug Administration (FDA)-approved indication and when all of the following conditions are met:
1. The procedure is furnished with a complete aortic valve and implantation system that has received FDA premarket approval (PMA) for that system's FDA approved indication.
2. The patient (preoperatively and postoperatively) is under the care of a heart team: a cohesive, multi-disciplinary, team of medical professionals. The heart team concept embodies collaboration and dedication across medical specialties to offer optimal patient-centered care. The heart team includes the following:
a. Cardiac surgeon and an interventional cardiologist experienced in the care and treatment of aortic stenosis who have:
i. independently examined the patient face-to-face, evaluated the patient's suitability for surgical aortic valve replacement (SAVR), TAVR or medical or palliative therapy;
ii. documented and made available to the other heart team members the rationale for their clinical judgment.
b. Providers from other physician groups as well as advanced patient practitioners, nurses, research personnel and administrators.
3. The heart team's interventional cardiologist(s) and cardiac surgeon(s) must jointly participate in the intra-operative technical aspects of TAVR.
4. TAVR must be furnished in a hospital with the appropriate infrastructure that includes but is not limited to:
a. On-site heart valve surgery and interventional cardiology programs,
b. Post-procedure intensive care facility with personnel experienced in managing patients who have undergone open-heart valve procedures,
c. Appropriate volume requirements per the applicable qualifications below:
There are two sets of qualifications; the first set outlined below is for hospital programs and heart teams without previous TAVR experience and the second set is for those with TAVR experience.
Qualifications to begin a TAVR program for hospitals without TAVR experience:
The hospital program must have the following:
a. &#8805; 50 open heart surgeries in the previous year prior to TAVR program initiation, and;
b. &#8805; 20 aortic valve related procedures in the 2 years prior to TAVR program initiation, and;
c. &#8805; 2 physicians with cardiac surgery privileges, and;
d. &#8805; 1 physician with interventional cardiology privileges, and;
e. &#8805; 300 percutaneous coronary interventions (PCIs) per year.
Qualifications to begin a TAVR program for heart teams without TAVR experience:
The heart team must include:
a. Cardiovascular surgeon with:
i. &#8805; 100 career open heart surgeries of which &#8805; 25 are aortic valve related; and,
b. Interventional cardiologist with:
i. Professional experience of &#8805; 100 career structural heart disease procedures; or, &#8805; 30 left-sided structural procedures per year; and,
ii. Device-specific training as required by the manufacturer.
Qualifications for hospital programs with TAVR experience:
The hospital program must maintain the following:
a. &#8805; 50 AVRs (TAVR or SAVR) per year including &#8805; 20 TAVR procedures in the prior year ; or,
b. &#8805; 100 AVRs (TAVR or SAVR) every 2 years, including &#8805; 40 TAVR procedures in the prior 2 years; and,
c. &#8805; 2 physicians with cardiac surgery privileges; and,
d. &#8805; 1 physician with interventional cardiology privileges, and
e. &#8805; 300 percutaneous coronary interventions (PCIs) per year; and,
The heart team and hospital are participating in a prospective, national, audited registry that: 1) consecutively enrolls TAVR patients; 2) accepts all manufactured devices; 3) follows the patient for at least one year; and, 4) complies with relevant regulations relating to protecting human research subjects, including 45 CFR Part 46 and 21 CFR Parts 50 & 56.
TAVR is not covered for patients in whom existing co-morbidities would preclude the expected benefit from correction of the aortic stenosis. You can find this in the National Coverage Determination (NCD): Transcatheter Aortic Valve Replacement (TAVR) (20.32).
If you want to read these Medicare rules, you can go to this website www.medicareappeal.com.
The Plan contract says that the Plan covers items and services in accordance with Medicare rules