The Centers for Medicare and Medicaid Services has proposed letting local Medicare contractors cover new PET imaging agents for cancer. The new rules, if approved, could expand the availability of the radiopharmaceuticals for seniors while upending a nearly 12-year-old policy.

The proposal, released Dec. 13, applies to new, Food and Drug Administration-approved PET agents used in oncologic imaging. It excludes the four "workhorse" agents widely used in PET cancer and cardiac imaging and already subject to national coverage decisions: FDG, Rb-8, ammonia N-13 and NaF-18.

Typically Medicare Administrative Contractors make decisions on what procedures or products to pay for in their own regions in the absence of national coverage rules. However, since at least 2000, language in Medicare guidelines restricted coverage of PET imaging agents for MACs.
If the new proposal takes effect, it means it could allow MACs to OK coverage for C-11 choline, an agent approved by the FDA in September for testing recurrent prostate cancer. It would not apply, however, to Amyvid, an Eli Lilly drug approved in April to help identify patients with Alzheimer's. CMS said it was separately analyzing national coverage decisions on neurocognitive imaging, and had already opened an analysis for Amyvid and other beta-amyloid imaging drugs.

The request to eliminate the so-called national non-coverage decision for PET came from the Medical Imaging & Trade Alliance, a lobby for imaging OEMs, which welcomed the news of CMS' proposal.

"CMS' proposal will improve patient care and lead to cost-savings by improving efficiency in cancer care," Gail Rodriguez, MITA's executive director, said in a statement.

However, she said the group was "concerned" that the decision does not apply to novel PET agents used in cardiology and neurology.

CMS is now accepting public comments on the proposal.

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