PET registry study authors ask Medicare to expand coverage

April 11, 2008

Physician authors of a study summarizing 12 months of positive results from the National Oncologic PET Registry have asked the Centers for Medicare and Medicaid Services to grant routine Medicare payment for numerous PET procedures tracked by the registry.

Physician authors of a study summarizing 12 months of positive results from the National Oncologic PET Registry have asked the Centers for Medicare and Medicaid Services to grant routine Medicare payment for numerous PET procedures tracked by the registry.

The formal request, dated March 25, came a day after the results of the NOPR study were published in the Journal of Clinical Oncology (Epub ahead of print Mar. 24). It asks CMS to grant routine coverage for FDG-PET evaluations for the diagnosis, staging, restaging, and evaluation of suspected recurrence of brain, cervical, ovarian, pancreatic, small cell lung, and testicular cancers.

The signatories of the Medicare coverage request were NOPR chair Dr. Bruce E. Hillner, cochairs Dr. Edward Coleman and Dr. Anthony F. Shields, and NOPR working group chair Dr. Barry A. Siegel.

The rationale for the requested change in coverage was based on a referring physician survey evaluating the influence of FDG-PET imaging on clinical decision making. The NOPR collected complete data in its first year of operation, beginning in May 2006, from 34,358 PET studies. As described in the JCO article, the study found that PET led to changes in treatment strategy in 36.5% of cases.

"We certainly think a study that shows that management changes more than a third of the time supports a request for coverage for these cancers," Coleman said in an interview before the request was submitted.

Shields noted that the finding confirmed numerous smaller studies that had preceded it.

"They all pretty much came to the same conclusion: that PET for staging or restaging will change the treatment plan from 30% to 40% of the time," he said in an interview.

The request does not include provisions to reimburse FDG-PET for monitoring the response of these cancers to therapy.

"We just thought the data pertaining to therapeutic effect were different enough from the other applications to deserve their own evaluation. Monitoring hasn't really been covered before except in breast imaging," Coleman said.

Whether CMS will consider the evidence strong enough to close the registry was still an open question, according to Shields, a professor of medicine and oncology at Wayne State University in Detroit.

"The trial does not complete the registry's work," he said. "The registry will remain open until CMS decides that it has enough information to close it."

The registry is sponsored by the Academy of Molecular Imaging and is administered by the American College of Radiology and the American College of Radiology Imaging Network. It was implemented in mid-2006 after CMS ruled that not enough clinical evidence had at that time been published to support the expansion of Medicare payments to numerous cancer-related applications. The registry was part of a compromise between CMS and AMI to permit payment while studying the effect of the new indications on clinical management.

A positive decision by CMS on the current reimbursement request would make it easier for oncologists to know when Medicare coverage is applicable, according to Shields.

"It has always been difficult. If somebody has colon cancer, I can get a PET scan for staging or restaging. But if they've got small-bowel cancer, I can't," he said. "This may help relieve that problem."

Interested parties have until May 10 to file comments with CMS about the petition.

For more information from the Diagnostic Imaging Archives:

PET affects treatment in over a third of cancer cases

NOPR paperwork bedevils payment for PET applications

Launch of registry aims to advance PET reimbursement