(Medicare National Coverage Determinations Manual)

B. Nationally Covered Indications  The Centers for Medicare & Medicaid Services (CMS) covers TEER of the mitral valve under Coverage with Evidence Development (CED) with the following conditions:   A. For the treatment of symptomatic moderate -to-severe or severe functional mitral regurgitation (MR) when the patient remains symptomatic despite stable doses of maximally tolerated guideline -directed medical therapy (GDMT) plus cardiac resynchronization therapy, if appropriate, or for the treatment of significant symptomatic degenerative MR 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 mitr al valve TEER system that has received FDA premarket approval (PMA).   2. The patient (preoperatively and postoperatively) is under the care of a heart team: a cohesive, multidisciplinary, team of medical professionals.  The heart team concept embodies collabo ration and dedication across medical specialties to offer optimal patient- centered care. The heart team must include the following members with experience and training as specified:   a. Cardiac surgeon  i. With  20 mitral valve surgeries per year or  40 over tw o years, 50% of which are mitral valve repairs; and,  ii. Who is board eligible or certified in cardiothoracic surgery or similar foreign equivalent.  b. Interventional cardiologist  i. With professional experience of  50 career structural heart disease procedures; or   30 left -sided structural procedures per year; and,  ii. With participation in  20 career trans -septal interventions including 10 as primary or co- primary operator; and, iii. Who is board eligible or certified in interventional cardiology or similar foreign equivalent. c. Interventional echocardiographer (cardiologist or anesthesiologist)  i. With professional experience of  10 trans -septal guidance procedures and  30 structural heart procedures; and, ii. Who is board eligible or certified in transesophageal echocardiography with advanced training as required for privileging by the hospital where the TEER is performed.  d. Heart failure cardiologist experienced in treating patients with advanced heart failure (only required for functional MR patients); and,  e. Provide rs from other physician groups as well as advanced patient practitioners, nurses, research personnel, and administrators.  3. Each patients suitability for surgical mitral valve repair, TEER, or palliative therapy must be evaluated, documented, and made avai lable to other heart team members.  Additionally, for patients with functional MR, the heart team heart failure cardiologist must document that the patient has persistent symptoms despite maximally tolerated GDMT and cardiac resynchronization therapy, if appropriate, as described below:   a. For patients with functional MR: the heart team interventional cardiologist and heart team heart failure cardiologist independently evaluate the patient using information in the medical record and a face -to-face examination .  To decrease patient burden, the heart team heart failure cardiologist may meet this requirement through a review of the patients records and images if the patient has an established relationship with a cardiologist experienced in treating patients with  advanced heart failure.   b. For patients with degenerative MR: the heart team interventional cardiologist and heart team cardiac surgeon must independently evaluate the patient using information in the medical record and a face -to-face examination.  4. An inter ventional cardiologist or cardiac surgeon from the heart team must perform the mitral valve TEER and an interventional echocardiographer from the heart team must perform transesophageal echocardiography during the procedure.  The interventional echocardiographer may not also furnish anesthesiology during the same procedure. The interventional cardiologist and cardiac surgeon may jointly participate in the intra -operative technical aspects of TEER as appropriate. All physicians who participate in the procedure must have device -specific training as required by the manufacturer.   5. Mitral valve TEERs must be furnished in a hospital with appropriate infrastructure and experience 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 procedures;  c. Hospital volume requirements below must be met and maintained:  i.  20 mitral valve surgical procedures for severe MR per year or  40 over two years, of which at least 10 (or 20 over two years) must be mitral valve repairs; and,  ii.  2 physicians with cardiac surgery privileges experienced in valvular surgery; and,  iii.  1 physician with interventional cardiology privileges; and,  iv.  300 percutaneous coronary interventions (PCIs) per year.   6. The heart team and hospital are participating in a prospective, national, audited registry that: 1) comprehensively enrolls TEER patients; 2) accepts all manufactured devices; 3) follows the patient for at least one year; and, 4) complies with relevant reg ulations 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 a nd analysis of patient, practitioner, and facility level variables that predict each of these outcomes:   a. Stroke;  b. All-cause mortality;  c. Repeat TEER or other mitral procedures;  d. Transient Ischemic Attacks (TIAs);  e. Major vascular events;  f. Renal complications; g. Functional capacity; and  h. Quality of Life (QoL).   7. The registry shall collect all data necessary and have a written executable analysis plan in place to address the following questions. Specifically, for the CED question d, this must be addressed through a comp osite metric. For the below CED questions (a -e), the results must be reported publicly as described in CED criterion k.   a. When TEER procedures are performed outside a controlled clinical study, how do outcomes and adverse events compare to the pivotal clini cal studies?  b. How do outcomes and adverse events in subpopulations compare to patients in the pivotal clinical studies?  c. What is the long- term ( 5 year) durability of the device?  d. What are the long -term ( 5 year) outcomes and adverse events?  e. How do the demographics of registry patients compare to the pivotal studies?   Consistent with section 1142 of 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. Mitral valve TEERs are covered for uses that are not expressly listed as an FDA -approved indication when performed within a clinical study that fulfills all of the following:   1. An interventional cardiologist or cardiac surgeon must perform the mitral valve TEER and an interventional echocardiographer must perform transesophageal echocardiography during the procedure. The interventional echocardiographer may not also furnish anesthesiology during the same procedure.  The interventional cardiologist and cardia c surgeon may jointly participate in the intra -operative technical aspects of TEER as appropriate. All physicians who participate in the procedure must have device specific training as required by the manufacturer.   2. As a fully -described, written part of it s protocol, the clinical research trial must critically evaluate the following questions at 12 months or longer follow -up:  a. What is the rate of all -cause mortality in the intervention group?  b. What is the rate of re -operations (open surgical or transcatheter ) of the mitral valve in the intervention group?  c. What is the rate of moderate- to-severe or severe MR in the intervention groups?   3. As a fully -described, written part of its protocol, the clinical research study must critically evaluate not only each patient s quality of life pre - and post -TEER (minimum 1 year), but must also address at least one of the following questions:   a. What is the incidence of stroke?  b. What is the incidence of TIAs?  c. What is the incidence of major vascular events?  d. What is the incidence of  renal complications?  e. What is the incidence of worsening MR?  f. What is the change in quality of life after TEER?  g. What is the change in the patients functional capacity after TEER?   4. The clinical study must adhere to the following standards of scientific inte grity and relevance to the Medicare population:   a. The principal purpose of the study is to test whether the item or service meaningfully improves health outcomes of affected beneficiaries who are represented by the enrolled subjects.  b. The rationale for the study is well supported by available scientific and medical evidence.  c. The study results are not anticipated to unjustifiably duplicate existing knowledge.  d. The study design is methodologically appropriate and the anticipated number of enrolled subjects is sufficient to answer the research question(s) being asked in the National Coverage Determination (NCD).  e. The study is sponsored by an organization or individual capable of completing it successfully.  f. The research study is in compliance with all applicabl e Federal regulations concerning the protection of human subjects found in the Code of Federal Regulations (CFR) at 45 CFR Part 46. If a study is regulated by the Food and Drug Administration (FDA), it is also in compliance with 21 CFR Parts 50 and 56. In addition, to further enhance the protection of human subjects in studies conducted under CED, the study must provide and obtain meaningful informed consent from patients regarding the risks associated with the study items and /or services, and the use and eventual disposition of the collected data.  g. All aspects of the research study are conducted according to appropriate standards of scientific integrity. h. The study has a written protocol that clearly demonstrates adherence to the standards listed here as Med icare requirements.  i. The study is not designed to exclusively test toxicity or disease pathophysiology in healthy individuals. Such studies may meet this requirement only if the disease or condition being studied is life threatening as defined in 21 CFR 312.81(a) and the patient has no other viable treatment options.  j. The clinical research studies and registries are registered on the www.ClinicalTrials.gov website by the principal sponsor/investigator prior to the enrollment of the first study subject. Regis tries are also registered in the Agency for Healthcare Quality (AHRQ) Registry of Patient Registries (RoPR).  k. The research study protocol specifies the method and timing of public release of all prespecified outcomes to be measured including release of outcomes if outcomes are negative or study is terminated early. The results must be made public within 12 months of the studys primary completion date, which is the date the final subject had final data collection for the primary endpoint, even if the trial does not achieve its primary aim. The results must include number started/completed, summary results for primary and secondary outcome measures, statistical analyses, and adverse events. Final results must be reported in a publicly accessibly manner; either  in a peer -reviewed scientific journal (in print or on- line), in an on-line publicly accessible registry dedicated to the dissemination of clinical trial information such as ClinicalTrials.gov, or in journals willing to publish in abbreviated format (e.g., for studies with negative or incomplete results).  l. The study protocol must explicitly discuss beneficiary subpopulations affected by the item or service under investigation, particularly traditionally underrepresented groups in clinical studies, how the inclusion and exclusion criteria effect enrollment of these populations, and a plan for the retention and reporting of said populations on the trial. If the inclusion and exclusion criteria are expected to have a negative effect on the recruitment or retenti on of underrepresented populations, the protocol must discuss why these criteria are necessary.  m. The study protocol explicitly discusses how the results are or are not expected to be generalizable to affected beneficiary subpopulations. Separate discussions  in the protocol may be necessary for populations eligible for Medicare due to age, disability or Medicaid eligibility.   Consistent with section 1142 of the Act, the Agency for Healthcare Research and Quality (AHRQ) supports clinical research studies that meet the above -listed standards and address the above -listed research questions.   The principal investigator must submit the complete study protocol, identify the relevant CMS research question(s) that will be addressed, and cite the location of the detail ed analysis plan for those questions in the protocol, plus provide a statement addressing how the study satisfies each of the standards of scientific integrity (a. through m. listed above), as well as the investigator's contact information, to the address below. The information will be reviewed, and approved studies will be identified on the CMS Website.  Director, Coverage and Analysis Group  Re: TEER CED  Centers for Medicare & Medicaid Services (CMS)  7500 Security Blvd., Mail Stop S3- 02-01 Baltimore, MD 21 244-1850  Email address for protocol submissions: clinicalstudynotification@cms.hhs.gov Email subject line: "CED TEER [name of sponsor/primary investigator]"   C. Nationally Non- Covered Indications   TEER of the mitral valve is not covered under the following circumstances: