CMS has updated its national coverage determination (NCD) for transcatheter mitral valve repair (TMVR), finalizing a policy shift first proposed to healthcare providers and industry representatives back in June 2020.
One key update is that the procedure will now be known as transcatheter edge-to-edge repair (TEER), a change that CMS has said provides a more accurate definition.
More importantly, the new policy means that coverage for TEER—again, formally known as TMVR—has been expanded so that patients with functional/secondary mitral regurgitation (MR) are included. When patients with functional MR still show symptoms despite guideline-directed medical therapy, they will now be eligible for TEER.
The NCD does still requires TEER sites to submit data to a national registry that tracks patient outcomes such as stroke and all-cause mortality. The original proposal indicated such data collection would no longer be required, numerous cardiovascular societies pushed back and urged CMS to reconsider. The American College of Cardiology (ACC), Society of Thoracic Surgeons, American Association for Thoracic Surgery and Society for Cardiovascular Angiography and Interventions all shared their concerns in a letter.
CMS also decided not to separate degenerative MR from this NCD, another potential change that had been included in the initial proposal. The ACC and the other societies had also expressed concern over that change, noting that it could put some patients with functional MR at risk.
The ACC shared its thoughts on the finalized NCD, praising the efforts of its own representatives and the other societies that helped share concerns with CMS. Read the full text of that article here.
Abbott, the company behind MitraClip, shared its own statement on this change, noting that it was “critically important” for patients with functional MR to be covered.
“Secondary MR generally impacts older individuals suffering from heart failure who rely on Medicare for their healthcare coverage,” Neil Moat, MD, chief medical officer of Abbott's structural heart business, said in the statement. “CMS' decision to expand coverage for MitraClip marks a pivotal moment for people seeking a minimally invasive option that reduces mitral regurgitation and significantly improves their quality of life and chances of survival.”
“We've worked tirelessly, for nearly two decades, to make MitraClip's leading technology available to patients suffering from mitral regurgitation, and CMS' expanded coverage allows our safe, effective and potentially life-saving treatment option to be available to the many more people who could benefit from our minimally invasive therapy,” added Michael Dale, senior vice president of Abbott's structural heart business.
The Alliance for Aging Research also shared a statement, noting that its members were “pleased” with the final NCD.
“The expansion of coverage to patients with functional MR will improve outcomes and provide a needed treatment option for this severely ill population,” according to the statement. “We applaud CMS for the steps it has taken to advance innovation for Medicare patients, and we thank the agency for adopting recommendations from advocacy organizations representing patients and family caregivers.”
Michael has more than 16 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.