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Elizabeth Sullivan was featured in "Medicare Reimbursement for Beneficiaries with Permanent Pacemakers," published by RBMA

Medicare Reimbursement for Beneficiaries with Permanent Pacemakers

By: Elizabeth Sullivan

The Centers for Medicare & Medicaid Services (CMS) have proposed modifying the current National Coverage Determination Manual to cover reimbursement for MRIs performed on Medicare beneficiaries with permanent pacemakers.

In its Proposed Decision Memo for Magnetic Resonance Imaging (MRI) (CAG – 00399R3) (“Memorandum”), CMS issued the statement that “evidence is adequate to conclude that magnetic resonance imaging (MRI) improves health outcomes for Medicare beneficiaries with implanted permanent pacemakers when . . . used according to the FDA-approved labeling for use in an MRI environment.”

As a result of its determination, CMS suggested in the Memorandum that such MRI use is reasonable and necessary and proposed a change to the National Coverage Determination Manual to remove the current contraindication for Medicare coverage of MRIs performed on beneficiaries with permanent pacemakers if such use is in accordance with the FDA requirements.

The CMS proposal comes after a CMS determination on February 24, 2011 that provided for limited coverage for Medicare beneficiaries with permanent pacemakers enrolled in certain clinical studies. Following the February 24, 2011 determination, Medtronic, Inc., the maker of the Medtronic RevoMRI SureScan Pacing System pacemaker, requested that CMS reconsider its determination and completely remove the contraindication for Medicare beneficiaries with pacemaker devices approved by the FDA for use in the MRI environment. Ultimately, CMS did not agree to the breadth of Medtronic, Inc.’s proposed language, but did determine that coverage should be provided for MRIs performed on Medicare beneficiaries with pacemakers as long as such procedures were in accordance with FDA-approved labeling for use in an MRI environment. Until CMS’s February 24, 2011 determination, Medicare did not cover MRIs for Medicare beneficiaries with pacemakers.

While CMS concluded that there was sufficient evidence to cover MRIs in the scenario described above, the Memorandum makes clear that CMS did not issue a coverage determination for the performance MRIs that would be applicable to specific pacemakers, diseases or conditions.

Read the CMS Proposed Decision Memorandum at: http://www.cms.gov/medicare-coverage-database/details/nca-proposed-decision-memo.aspx?NCAId=252&fromdb=true.

Reprinted with permission from RBMA RadCast June 7, 2011 issue.

http://rbma.org/Products_and_Resources/Legal_Resources/RBMA_Monthly_Legal_Update_Digest_June_2011.aspx