PET Medicare decision doesn’t go far enough, medical device makers say

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The Center for Medicare & Medicaid Services announced a shift in their decision regarding reimbursement for positron emission tomography scanning that will open the door for states to make their own coverage decisions for PET.

Lobbying group Medical Imaging & Technology Alliance supported the move, but chided the agency for failing to make the decision universal. CMS applied the shift specifically to oncologic tracers, despite MITA’s request.

"MITA is concerned that CMS stopped short of our complete request, which called for local coverage of all PET tracers that are newly approved by the FDA, not just oncologic tracers," MITA executive director Gail Rodriguez said in prepared remarks. "We are disappointed that these applications were not included in the decision memorandum and believe that the consideration of coverage for PET tracers should be no different than for other items and services."

MITA remains hopeful that CMS will "continue to evaluate the preponderance of evidence that guides physician utilization of PET tracers in specialties outside of oncology in order to avoid lengthy, bureaucratic reviews of items and services that are rapidly becoming the standard of care."

PET imaging is used to scan tissue in treatment and analysis of cancer, ischemic heart disease and certain neurological disorders, according to the CMS note. The technology is generally not reimbursed, with the exception of some radioactive tracers.

MITA in July 2011 submitted a formal request to CMS to remove the non-coverage decision for PET radio-pharmaceuticals, allowing local Medicare providers to determine their own coverage policies for the scanning technology.

Ultimately CMS decided that "for labeled uses of FDA approved radio-pharmaceuticals approved after September 1, 2012, Medicare coverage for diagnostic PET imaging for oncologic uses may be considered at the discretion of local contractors for uses that are not determined by NCD."

"We are encouraged that CMS has taken an important first step in covering PET procedures, but disappointed that broader PET coverage decisions for cardiac and neurological applications were not included in this final decision," MITA’s Rodriguez said. "We are disappointed that these applications were not included in the decision memorandum and believe that the consideration of coverage for PET tracers should be no different than for other items and services."

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