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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 say that A. Treatment of significant symptomatic degenerative MR when furnished according to an FDA-approved indication and when all of the following conditions are met:1. The procedure is furnished with a complete TMVR system that has received FDA premarket approval (PMA) for that system's FDA-approved indication.2. Both a cardiothoracic surgeon experienced in mitral valve surgery and a cardiologist experienced in mitral valve disease have independently examined the patient face-to-face and evaluated the patient's suitability for mitral valve surgery and determination of prohibitive risk; and both surgeons have documented the rationale for their clinical judgment and the rationale is available to the heart team.3. The patient (pre-operatively and post-operatively) 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.TMVR must be furnished in a hospital with the appropriate infrastructure that includes but is not limited to:a. On-site active valvular heart disease surgical program with equal to 2 hospital-based cardiothoracic surgeons experienced in valvular surgery;b. Cardiac catheterization lab or hybrid operating room/catheterization lab equipped with a fixed radiographic imaging system with flat-panel fluoroscopy, offering catheterization laboratory-quality imaging,c. Non-invasive imaging expertise including transthoracic/transesophageal/3D echocardiography, vascular studies, and cardiac CT studies;d. Sufficient space, in a sterile environment, to accommodate necessary equipment for cases with and without complications;e. Post-procedure intensive care facility with personnel experienced in managing patients who have undergone open-heart valve procedures;f. Adequate outpatient clinical care facilitiesg. Appropriate volume requirements per the applicable qualifications below.There are institutional and operator requirements for performing TMVR. The hospital must have the following:a. A surgical program that performs equal to25 total mitral valve surgical procedures for severe MR per year of which at least 10 must be mitral valve repairs;b. An interventional cardiology program that performs equal to1000 catheterizations per year, including equal to400 percutaneous coronary interventions (PCIs) per year, with acceptable outcomes for conventional procedures compared to National Cardiovascular Data Registry (NCDR) benchmarks;c.The heart team must include:1. An interventional cardiologist(s) who:performs equal to 50 structural procedures per year including atrial septal defects (ASD), patent foramen ovale (PFO) and trans-septal punctures; and,must receive prior suitable training on the devices to be used; and,must be board-certified in interventional cardiology or board-certified/eligible in pediatric cardiology or similar boards from outside the United States;2. Additional members of the heart team, including: cardiac echocardiographers, other cardiac imaging specialists, heart valve and heart failure specialists, electrophysiologists, cardiac anesthesiologists, intensivists, nurses, nurse practitioners, physician assistants, data/research coordinators, and a dedicated administrator;
d. All cases must be submitted to a single national database;e. Ongoing continuing medical education (or the nursing/technologist equivalent) of 10 hours per year of relevant material;f. The cardiothoracic surgeon(s) must be board-certified in thoracic surgery or similar foreign equivalent.4. The heart team's interventional cardiologist or a cardiothoracic surgeon must perform the TMVR. Interventional cardiologist(s) and cardiothoracic surgeon(s) may jointly participate in the intra-operative technical aspects of TMVR as appropriate.5. The heart team and hospital are participating in a prospective, national, audited registry that: 1) consecutively enrolls TMVR 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 Code of Federal Regulations (CFR) Part 46 and 21 CFR Parts 50 & 56. The following outcomes must be tracked by the registry; and the registry must be designed to permit identification and analysis of patient-, practitioner-, and facility-level variables that predict each of these outcomes:i. All-cause mortality;ii. Stroke;iii. Repeat mitral valve surgery or other mitral procedures;iv. Worsening MR;v. Transient ischemic events (TIAs);vi. Major vascular events;vii. Renal complications;viii. Functional capacity;ix. Quality of Life (QoL).The registry should collect all data necessary and have a written executable analysis plan in place to address the following questions (to appropriately address some questions, Medicare claims or other outside data may be necessary):When performed outside a controlled clinical study, how do outcomes and adverse events compare to the pivotal clinical studies How do outcomes and adverse events in subpopulations compare to patients in the pivotal clinical studies What is the long-term (equal to 5 year) durability of the device What are the long-term (equal to5 year) outcomes and adverse events How do the demographics of registry patients compare to the pivotal studies Consistent with section 1142 of the Social Security Act (the Act), the Agency for Healthcare Research and Quality (AHRQ) supports clinical research studies that CMS determines meet the above-listed standards and address the above-listed research questions.B. TMVR for MR uses that are not expressly listed as an FDA-approved indication when performed within an FDA-approved randomized controlled trial that fulfills all of the following:1. TMVR must be performed by an interventional cardiologist or a cardiac surgeon. Interventional cardiologist(s) and cardiothoracic surgeon(s) may jointly participate in the intra-operative technical aspects of TMVR as appropriate.2. As a fully-described, written part of its protocol, the clinical research trial must critically evaluate the following questions at 12 months or longer follow-up:What is the rate of all-cause mortality in the group randomized to TMVR compared to the patients randomized to control (surgical repair, optimal medical therapy, or other specified control group)
What is the rate of re-operations (open surgical or transcatheter) of the mitral valve in the group randomized to TMVR compared to the patients randomized to control (surgical repair or other specified control group)?.What is the rate of severe MR in the group randomized to TMVR compared to the patients randomized to control (surgical repair or other specified control group)3. The randomized controlled trial must address all of the following questions at one year post-procedure:What is the incidence of stroke What is the incidence of TIAsWhat is the incidence of major vascular events?What is the incidence of renal complications?What is the incidence of worsening MR What is the patient's post-TMVR QoL What is the patient's post-TMVR functional capacity You can find this information in Medicare's National Coverage Determination (NCD) for Transcatheter Mitral Valve Repair (TMVR) (20.33).If you want to read these Medicare rules, you can go to this website www.medicareappeal.com