PET scores big win with CMS coverage for 11 cancers

Image Source: Siemens Healthcare

The Centers for Medicare & Medicaid Services issued its long-awaited decision late yesterday for a national coverage determination (NCD) to expand coverage for all nine oncologic conditions under consideration, along with two additional cancers—ovarian and myeloma—to allow initial PET diagnostic testing for Medicare beneficiaries.

The agency has decided to adopt a coverage framework that replaces the four-part diagnosis, staging, restaging and monitoring response to treatment categories with a two-part framework that differentiates FDG-PET imaging used to inform the initial antitumor treatment strategy from other uses related to guiding subsequent antitumor treatment strategies after the completion of initial treatment.

This decision was based, in large part, on compelling clinical evidence of the effectiveness of PET for cancer management and treatment contained in the National Oncologic PET Registry (NOPR), a comprehensive study released in May 2008 in the Journal of Clinical Oncology that showed a striking consistency of the impact of PET on referring physicians’ intended management plans in more than one in three patients. This prompted the registry to formally ask CMS to reconsider a national coverage determination (NCD) on oncologic use of PET. NOPR was established in 2006 to track the utility of PET in patients with cancer. The May 2008 study includes data from more than 41,000 patients. NOPR is sponsored by the Academy of Molecular Imaging (AMI) and managed by the American College of Radiology (ACR) and ACR Imaging Network (ACRIN). The registry received input from—and is endorsed by—ACR, the American Society for Clinical Oncology (ASCO) and SNM.

Previously, PET scans for many cancers were reimbursed only if the PET facility submitted data to the NOPR. Now, all Medicare beneficiaries with certain cancers will be covered by Medicare for at least one PET scan. The nine currently covered cancers have all been expanded to cover the subsequent treatment strategy, in addition to initial diagnosis. For all other cancers, PET coverage for subsequent treatment strategy evaluation requires participation in an approved Coverage with Evidence Development (CED) program, such as a modified NOPR.

CMS has determined that “the evidence is adequate to determine that the results of FDG-PET imaging are useful in determining the appropriate initial treatment strategy for beneficiaries with suspected solid tumors and myeloma and improve health outcomes and thus are reasonable and necessary.” Therefore, CMS will cover only one FDG-PET study for beneficiaries who have solid tumors that are biopsy proven or strongly suspected based on other diagnostic testing.

However, CMS has determined that the available evidence is sufficient to determine that FDG-PET imaging for subsequent anti-tumor treatment strategy for tumor types other than breast, colorectal, esophagus, head and neck (non-CNS/thyroid), lymphoma, melanoma, non-small cell lung, and thyroid may be covered as research through coverage with evidence development (CED).

“This is a major victory for patients,” said Robert W. Atcher, Ph.D., M.B.A., president of SNM and University of New Mexico/Los Alamos National Laboratory professor of pharmacy. “CMS’ decision to cover PET scans for cancer demonstrates the intrinsic medical value of PET and important role of these scans in diagnosing, staging, restaging and monitoring treatment for many cancers.”

SNM applauded the CMS decision, saying it will save patients thousands of dollars who would otherwise have to pay out-of-pocket for their PET scans. Additionally, this decision increases the likelihood that private insurers will eventually follow CMS’ lead.

“For years, physicians and researchers around the world have known that PET is an invaluable diagnostic tool for guiding management of patients with a wide range of cancers,” said Barry Siegel, M.D., co-chair of the NOPR Working Group and chief of the nuclear medicine at the Mallinckrodt Institute of Radiology, St. Louis, Mo. “The evidence contained in the NOPR study proves the effectiveness of PET as an essential part of a cancer patient’s treatment planning.”

For the agency full decision, please visit their website.

To help PET providers better understand the repercussions of the new CMS policy and navigate the new NOPR system effectively, SNM will host a live audio conference, Monday, April 27, 1 p.m. to 2:30 p.m. EDT. For more information or to register for the audio conference, visit www.snm.org/PETChanges.