The CMS is proposing Medicare coverage for leadless pacemakers, but only those used in federally approved clinical studies.
Medtronic's Micra Transcatheter Pacing System is the only leadless device currently on the market. It was approved by the Food and Drug Administration in April, but the CMS feels additional studies are needed before it grants nonconditional reimbursement for the device.
The agency believes there's not sufficient evidence to determine long-term health outcomes or to identify who would be most likely to "experience overall benefit or harm from leadless pacemakers,” the agency said in its proposed coverage decision.
“Significant questions remain regarding the potential for deterioration in left ventricular function and other long term outcomes, as well as device longevity,” it said, adding that conditional coverage allows the CMS to study further evidence while letting patients benefit from innovative technology.
Medtronic has not disclosed the device's actual cost but it's been estimated to cost $10,000 compared with conventional pacemakers that average about $2,500.
Micra is the world's smallest pacemaker. The one-inch device is implanted directly onto the heart's right ventricle chamber and uses prongs that generate electrical impulses to regulate heartbeats in the same fashion as traditional pacemakers.
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.
A Medtronic spokeswoman said the company is reviewing the proposed coverage decision.
But providers were thrilled with the news. “There's often too much of a delay between FDA approval and Medicare coverage, often up to a year, which puts patients in a difficult position,” said Dr. Bradley Knight, medical director of the Center for Heart Rhythm Disorders at Northwestern Medicine's Bluhm Cardiovascular Institute at Northwestern Memorial Hospital.
Knight advised Medtronic during the FDA approval process for Micra.
He expects other devicemakers will also welcome the news since several Medtronic competitors are creating their own leadless pacemakers.
St. Jude Medical is believed to be the furthest along with its competing device known as Nanostim. The company experienced a setback last month when it told doctors to stop implanting the device due to reports of problems with electronic data reporting caused by a battery malfunction.
