In a final decision on coverage for leadless pacemakers, the CMS met physicians halfway, not giving them unconditional coverage, but certainly expanding what Medicare will pay for.
On Wednesday, the CMS said it would cover leadless pacemakers implanted during a long-term study. The agency last year said it would cover the devices only if they were used in federally approved clinical studies.
“We recognize that certain FDA-approved studies may not provide uniform access across the country,” the CMS said in the notice.
Physicians argued that there is more than enough evidence to support the safety and efficacy of the products, which are estimated to cost $10,000 compared with conventional pacemakers that average about $2,500.
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. Though complications of this implantation are uncommon, the electrodes can break, become dislodged or become infected, requiring subsequent procedures.
Physicians wrote comments to the CMS arguing that the cost of the safer leadless device could make it out of reach for some.
“Not allowing general use of this technology for qualified device implanters will significantly impede technology advancement,” Dr. Ryan Aleong, an assistant professor of medicine at the University of Colorado Hospital said in a comment to the CMS.
But officials at the CMS said there wasn't enough evidence to expand coverage.
Medtronic's Micra Transcatheter Pacing System is the only leadless device currently on the market. It's the world's smallest pacemaker. The 1-inch device is implanted directly onto the heart's right ventricle chamber and uses prongs to generate electrical impulses that regulate heartbeats like traditional pacemakers.
St. Jude Medical is the closest to competing with Medtronic. However, the company experienced a setback last year when it told doctors to stop implanting the Nanostim device because of problems with electronic data reporting caused by a battery malfunction.