Full article reprinted from "The Gray Sheet" - July 6, 2009
Use of magnetic resonance imaging to assess heart valve disease in Medicare patients may be an easier proposition for physicians if a June 30 CMS coverage 1 proposal is adopted. Find out more...
Full article reprinted from "The Gray Sheet" - July 6, 2009
Use of magnetic resonance imaging to assess heart valve disease in Medicare patients may be an easier proposition for physicians if a June 30 CMS coverage 1 proposal is adopted.
The Medicare agency said in the proposal it would remove the phrase "blood flow measurements" from the list of MRI indications that are nationally non-covered.
The decision responds to a December request by four medical specialty societies representing radiologists and cardiologists. They argue that the non-coverage policy for MRI blood flow measurement does not reflect current clinical realities and puts doctors in a difficult position (2 'The Gray Sheet' Jan. 26, 2009).
In the interval since the non-coverage policy was established in the 1980s, "a lot of research has been done demonstrating that [MRI] flow measurements are accurate and valuable," said Pamela Woodard, president of the North American Society for Cardiovascular Imaging. NASCI was one of the groups requesting the coverage change, and Woodard also is co-head of cardiac MRI and CT at the Washington University School of Medicine.
MRI blood flow and velocity outcomes are an important tool in assessing patients with heart valve disease for potential valve repair or replacement, the proponent groups say.
But the non-coverage policy forces doctors to choose between not being reimbursed for performing and coding a complete MRI examination, performing a complete examination but down-coding to exclude flow/velocity measures from the reimbursement request (which opens the practitioner up to Medicare fraud allegations) or performing an incomplete examination and referring the patient for additional studies to get the needed information, the societies explained in a letter to CMS.
"If you can provide the physician with this information through an MRI that they are obtaining anyway, it [will be] a lot more convenient and expedient for the patient and, in many cases, less invasive," Woodard explained in an interview.
CMS says it agrees that available evidence does not warrant blanket non-coverage.
Since there was no request for a national coverage determination, however, the best a finalized policy will do is allow local Medicare contractors to make independent determinations about covering the diagnostic procedure for their regions.
Pacemaker MRI Non-Coverage Likely To Remain
Also as part of the June 30 CMS proposal, the agency declined to remove its prohibition on covering MRIs in patients with pacemakers.
MRIs have long been contraindicated for pacemaker and implantable defibrillator patients because of the potential for electromagnetic interference to cause patient injury or device malfunction.
But Medtronic decided to take advantage of the ongoing MRI coverage determination process relating to blood flow measurements to request more flexibility to employ the imaging tool in Medicare beneficiaries with pacemakers.
In February, the company sent a letter to CMS requesting that pacemakers be removed from the non-covered language when devices are used that have been "designed, tested and FDA labeled, for use in the MRI environment."
Medtronic markets its EnRhythm MRI SureScan as an MRI-compatible pacemaker in Europe and is pursuing FDA approval in the U.S., where it would be the first pacemaker labeled for MRI safety, according to the company (3 'The Gray Sheet' May 25, 2009).
CMS says it would agree to look at the data once the device is on the market, but until then, there is nothing for the agency to assess.
Comments on the proposals are due July 30. A final decision is expected by September.
- David Filmore
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