ST. PAUL
Hospitals across the country have been cranking out news releases this week about patients who are among the first to receive a new MRI-safe pacemaker from Medtronic.
But Medicare patients with the devices might get stuck with the bill should they need an MRI, doctors say.
The Centers for Medicare and Medicaid Services on Thursday issued a memorandum saying Medicare still won't pay for MRIs in patients who have pacemakers -- including those with devices deemed MRI-safe.
In the memorandum, CMS officials said the health insurance program will start paying for scans in pacemaker patients who participate in certain clinical trials. But government reviewers didn't have time to pass judgment on the new Medtronic product, which is called Revo and was approved by U.S. Food and Drug Administration earlier this month.
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For years, Medicare has had a policy denying payment for MRI exams in pacemaker patients due to safety concerns about how the technologies interact. The memo issued this week came in response to a doctor's request for Medicare to reconsider the policy.
"FDA approved the first pacemaker for use during certain MRI exams on Feb. 8," the CMS officials wrote. "This approval ... was too late for CMS to adequately review the evidence to address coverage for MRI for patients that may obtain this device."
On Friday, Medtronic submitted a formal request for Medicare to reconsider the policy once again, said Bob Thompson, the company's senior director
for reimbursement, economics and health policy. CMS must rule on the request within nine months, although Thompson hopes an answer will come sooner.
"We've asked that they consider granting payment for MRIs for people with pacemakers that have been developed specifically for use in the MRI environment and labeled as such by the FDA," Thompson said.
MRI is a test that uses a powerful magnetic field and computer to produce detailed pictures inside the body to diagnose ailments. The cost of a test depends on the body part being scanned; in 2009, Medicare paid about $500 for an MRI of the lower back.
Some commercial insurers on Friday said they likely would pay for MRI tests on patients with the new heart device.
"We would not deny payment for an MRI done on a patient with an MRI-safe pacemaker," said Dr. Patrick Courneya, a medical director for Bloomington-based HealthPartners.
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Greg Bury, a spokesman for Minnetonka-based Medica, said: "We think the MRI-safe pacemakers are a good thing."
Medtronic estimates that some 200,000 pacemaker patients in the U.S. must go without MRI scans each year because of potential problems between the devices and the scanners. Analysts believe the MRI-safe device -- the first such product approved for use in the U.S. -- will help Medtronic gain customers in the $4 billion pacemaker market.
Pacemakers with advanced features often sell for close to $6,500, analysts say. Adding MRI-safe technology to the devices could add between 5 percent and 10 percent to the price tag.
Distributed by McClatchy-Tribune Information Services.
