Physicians want wider Medicare coverage for leadless pacemakers, arguing the current reimbursement proposal puts the device out of reach for too many patients.
Last month, the CMS proposed limited Medicare coverage for leadless pacemakers that are used in federally approved clinical studies.
The agency collected public comments on the decision through Dec. 14 and received around 50 comments, mostly from cardiologists. They called for the CMS to cover Food and Drug Administration-approved leadless pacemaker devices for all Medicare beneficiaries who meet FDA-approved indications.
Medtronic's Micra Transcatheter Pacing System is the only leadless device now on the market with FDA approval. It was approved for patients suffering from abnormal heart rhythms and is not intended for patients who have implanted devices that would interfere with the pacemaker, who are severely obese, or who have an intolerance to materials in the device or the blood thinner heparin. It is also contraindicated for patients with veins that may be too small for the device.
In its proposed coverage decision issued in November, the CMS said additional studies were needed to support further reimbursement for the device, concluding there's not enough evidence to determine long-term health outcomes or to identify who would be most likely to "experience overall benefit or harm.”
“Significant questions remain regarding the potential for deterioration in left ventricular function and other long-term outcomes, as well as device longevity,” the CMS said. Conditional coverage, the agency said, would allow it to review subsequent evidence while letting patients benefit from innovative technology.
Healthcare providers say the proposal would severely limit access to the Micra device and force patients who might benefit from the device to wait an extended period of time before they can get it.
“These devices should be approved immediately without waiting period,” Dr. Farhat Khairallah, a electrophysiologist at Tallahassee (Fla.) Memorial HealthCare, wrote in a comment letter. “They are a game changer and would improve patient outcomes.”
Dr. Ryan Aleong, an assistant professor of medicine at the University of Colorado Hospital, warned the CMS that limiting coverage to sites participating in clinical trials “would basically exclude many patients who would benefit from this technology in a large area of the United States.”
The American College of Cardiology suggested the CMS could offer broader coverage of the device while at the same time developing a data-collection mechanism, such as a registry, to monitor experiences with the product. We “recognize that significant questions regarding leadless pacemaker technology remain and strongly support collection of the necessary data to address critical clinical questions,” the cardiologists group said in a comment letter.
However, the CMS tends to be cautious in coverage decisions “until it is satisfied that the quantity and quality of data justify an additional treatment for a chronic condition,” said Robert Wanerman, an attorney at Epstein Becker Green and former assistant counsel at HHS.
And while it's not unusual for the CMS to change course because of input from the industry, “It would be more likely if there were strong opposition from the patient groups,” said Michael Gaba, an attorney with Holland & Knight in Washington.
Micra is touted by Medtronic as the world's smallest pacemaker. The one-inch device is attached to the heart's right ventricle chamber with tiny prongs that generate electrical impulses to regulate heartbeats. The company has not disclosed the device's actual cost, but it has been estimated to cost $10,000, compared with about $2,500 for a conventional pacemaker.
Conventional pacemakers require electrodes to be inserted through a large vein into chambers of the heart. The device is implanted just under the skin below the collarbone. Complications are uncommon, but additional procedures can be required if the electrodes break or become dislodged or infected.
Experts agreed with the CMS that more research is needed. Evidence shows that while the leadless pacemaker eliminates some of the key drawbacks of existing pacemakers, they also increase the likelihood of some complications and may introduce new ones, according to Dr. Jay Ronquillo, director of biomedical informatics at the National Center for Health Research, a no-for-profit think tank focused on health research.
“At this point, there is no reason for patients to feel cheated if Medicare doesn't cover the cost of leadless pacemakers, because leadless pacemakers may be no better, and possibly worse, than pacemakers with leads,” Ronquillo said.