The Centers for Medicare & Medicaid Services is proposing to cover transcatheter mitral valve repair procedures with the condition that the procedure is accompanied with the collection of data for research purposes to determine whether the evidence shows that TMVR is reasonable and necessary.
Heart teams and hospitals will be eligible for coverage. They must be participate in a prospective audited registry that will follow patients receiving the procedure under its Food and Drug Administration–approved indication for at least 1 year and track a number of outcomes, including 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. The registry "must be designed to permit identification and analysis of patient, practitioner and facility level variables that predict each of these outcomes," the agency said in the proposed coverage decision memo.
FDA approved the first transcatheter mitral valve repair (TMVR) device, Abbott Vascular’s MitraClip, in October 2013, following the agency’s Circulatory System Devices panel’s 5-3 vote in March 2013 that the device’s benefits outweighed its risks.
CMS is looking for information about outcomes and adverse events related to the procedure when conducted in a real-world setting, compared with those in pivotal clinical studies in general and within subpopulations; the long-term (at least 5 years) durability, outcomes, and adverse events, as well as demographic differences between registry patients and those enrolled in the clinical trials.
The agency also is proposing to cover TMVR for indications not expressly listed in the FDA approval when performed within an FDA-approved randomized clinical trial that evaluates a patient’s post TMVR quality of life and post-TMVR functional capacity at 1 year, compared with both outcomes prior to the procedure, as well as tracking outcomes similar to those for the registries covering the approved indication.
CMS opened the proposed TMVR coverage with evidence development proposal following a formal request from the Society of Thoracic Surgeons, the American College of Cardiology Foundation, the Society for Cardiovascular Angiography and Interventions and the American Association for Thoracic Surgery.
The agency is soliciting comments on the proposed coverage decision and will respond to those comments in its final decision memorandum. A deadline for comment submission was not listed in the proposal.