There are some confusing reports out there that appear to suggest that Medicare will now pay for MRI scans for patients with MRI-safe implanted pacemakers.
Uh, not yet. Although the chances for this seem to have just improved. Earlier this week, the Centers for Medicare and Medicaid (CMS) put out a memo, also known as the Proposed Decision Memorandum, that said: “We propose to change the language in … the NCD Manual to remove the contraindication for Medicare coverage of MRI in beneficiaries with implanted [pacemakers] when the [pacemakers] are used according to the FDA-approved labeling for use in an MRI environment.” A final decision on Medicare coverage will follow after a 30-day comment period.
On Feb. 8, Fridley-based Medtronic announced that its Revo MRI SureScan became the first FDA-approved MRI-safe pacemaker. But CMS announced later that month that the federal government would only reimburse MRI procedures for patients with implanted permanent pacemakers when they are enrolled in a clinical trial.
Medtronic immediately sent CMS a letter asking for reconsideration. Their argument was that the Revo SureScan pacemaker is specifically approved by the FDA to be used under MRI environments. CMS had until Sept. 3 to respond to the letter. But in this week’s memo, it said that there is adequate evidence “to conclude that magnetic resonance imaging (MRI) improves health outcomes for Medicare beneficiaries with implanted permanent pacemakers (PMs) when the PMs are used according to the FDA-approved labeling for use in an MRI environment.”
A Medtronic spokeswoman responded with cautious optimism.
“Medtronic is pleased that Medicare has expedited review of our request,” said Wendy Dougherty in an email. “The Proposed Decision Memorandum (PDR) is a positive step for pacemaker patients who may someday need access to an MRI scan. We look forward to the final Medicare coverage decision on this issue.”
That Medicare will cover the procedure is almost a foregone conclusion, unless some adverse event were to occur between now and May 25, the end of the comment period, said Barb Peterson, a reimbursement expert and president and CEO of Minnetonka, Minnesota-based Emerson Consultants.
“It’s obviously good news for Medtronic,” Peterson said, because reimbursement from Medicare helps in the adoption of new technology.
Medtronic has high hopes for the Revo SureScan and leads the competition in getting an MRI-safe pacemaker approved for sale in the United States. In his final earnings call as CEO of Medtronic hosted after the FDA approved the device (but before CMS decided that Medicare would only cover MRI-safe pacemakers for patients in a clinical trial), Bill Hawkins said:
“We believe this product will help to draw share and alleviate pricing pressure [on pacemakers]. So I’m fairly bullish that this is going to be a real big opportunity for us.”