CMS Issues Proposed Decision Memo for Coverage of Transcatheter Mitral Valve Repair

May 15, 2014—The US Centers for Medicare & Medicaid Services (CMS) has issued a proposed decision memorandum for coverage of transcatheter mitral valve repair (TMVR). CMS is seeking comments on this proposed decision and will respond to public comments in a final decision memorandum.

CMS proposes to cover TMVR under Coverage with Evidence Development with three major conditions and related criteria.

A. TMVR is covered for the treatment of significant symptomatic mitral regurgitation 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 transcatheter mitral valve repair system that has received FDA premarket approval for that system’s FDA-approved indication.

2.        Both a cardiac 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, both physicians have documented the rationale for their clinical judgment, and the rationale is available to the heart team.

3.        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 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, standards outlined in the proposed decision memo. The qualification requirements for hospital surgical programs wishing to perform TMVR procedures are also outlined in the decision memo.

4.        The heart team’s interventional cardiologist(s) and cardiac surgeon(s) must jointly participate in the intraoperative technical aspects of TMVR.

5.        The heart team and hospital are participating in a prospective, national, audited registry that (a) consecutively enrolls TMVR patients; (b) accepts all manufactured devices; (c) follows the patient for at least 1 year; and (d) complies with relevant regulations relating to protecting human research subjects. 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: quality of life, functional capacity, stroke, all-cause mortality, transient ischemic events, major vascular events, renal complications, repeat mitral valve surgery or other mitral procedures, and worsening mitral regurgitation.

6.        The registry should collect all data necessary and have a written executable analysis plan in place to address the questions outlined in the CMS proposed decision memo.

B. TMVR is covered for uses that are not expressly listed as an FDA-approved indication when performed within a FDA-approved randomized clinical trial that fulfills the following criteria: (1) the heart team’s interventional cardiologist(s) and cardiac surgeon(s) must jointly participate in the intraoperative technical aspects of TMVR, and (2) as a fully described, written part of its protocol, the clinical research study must critically evaluate a series of questions, which are listed in the proposed decision memo.

C.   All CMS-approved clinical studies and registries must adhere to the standards of scientific integrity and relevance to the Medicare population outlined in the proposed decision memo. The study’s 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 detailed analysis plan for those questions in the protocol, plus provide a statement addressing how the study satisfies each of the standards of scientific integrity, as well as the investigator’s contact information. The information will be reviewed, and approved studies will be identified on the CMS website.