Broader Medicare PET coverage promises to cut costs, streamline patient management

Nuclear physicians praised the Centers for Medicare and Medicaid Services' decision to expand Medicare coverage of PET scans in the initial treatment strategy of most solid cancers and myeloma. More than a third of Medicare patients will now be able to get PET scans without going through the National Oncologic PET Registry.

"The vast majority of Medicare patients will now have coverage outside of coverage with evidence development," said Dr. Barry Siegel, director of nuclear medicine at the Mallinckrodt Institute of Radiology and cochair of the NOPR Working Group, in an interview with Diagnostic Imaging. "They will have routine coverage, and that will relieve a substantial paperwork burden for many cases and their physicians."

According to the decision memo published April 3, CMS will replace four previous coverage categories, including diagnosis, staging, restaging, and monitoring response to treatment, with a two-part system. The new national coverage determination (NCD) will be used to differentiate FDG-PET scans done to plan initial tumor treatment strategy from further imaging needed to guide patient management after the completion of initial treatment.

CMS determined that available scientific evidence was strong enough to show that FDG-PET could guide the appropriate initial treatment strategy for patients with suspected solid tumors and myeloma and lead to improved health outcomes. The new NCD will cover one PET scan for patients with solid tumors that are biopsy-proven or strongly suspected based on other diagnostic exams. CMS will reimburse PET imaging done for the initial diagnosis and management of breast, cervical, colorectal, esophageal, head and neck, lymphoma, melanoma, non-small cell lung, and thyroid cancers.

CMS has added to the coverage list ovarian cancer and myeloma. In total, the new coverage policy for the initial diagnosis and subsequent treatment strategy includes 11 indications. PET coverage for all other cancers will still require participation in an approved coverage with evidence development program.

SNM, a professional society that advocates PET and other forms of molecular imaging, applauded the CMS decision and said it was based to a significant degree on compelling clinical evidence of the effectiveness of PET for cancer management and treatment provided by the NOPR. The new CMS decision will save patients thousands of dollars that would otherwise have to come out of their own pockets, according to SNM. The decision also increases the likelihood that private insurers will eventually follow CMS' lead.

"This is a major victory for patients," said SNM president Robert W. Atcher, Ph.D. "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."

About 40% of the Medicare patients who got PET scans under the initial NOPR will now be able to get them without going through the registry. But other patients will still need to go in the registry to have their PET scans covered, said NOPR cochair Dr. R. Edward Coleman, director of nuclear medicine at Duke University.

"We'll still be able to provide coverage but only under the registry for the subsequent treatment strategy patients," Coleman said.

The NOPR will continue to collect data, in collaboration with CMS and the Agency for Healthcare Quality and Research, to examine unanswered questions about the value of FDG-PET for monitoring patient responses to therapy. Claims data will be analyzed to provide additional evidence on treatment outcomes that could eventually result in across-the-board coverage, he said.

"We will be gathering that data over the next many months and analyzing that data and see if we can convince Medicare that for the subsequent treatment strategy PET scans do help those patients," Coleman said. "Hopefully, we can get coverage for those after completion of the study somewhere down the road."

One of the things that NOPR did not do and that was not part of the initial plan was to see how patient treatment actually changed. NOPR researchers analyzed data to see how physicians had planned to change treatment, but they did not actually verify that information, said NOPR cochair Dr. Anthony Shields. The plan for NOPR in the future is to incorporate such information into the analysis and determine if the treatment has actually changed.

"Previously published studies have indicated that, for the most part, when doctors said that they are going to change treatment based on a PET scan they actually did that, but we want to verify for the tumor types here that were not covered by this new decision from CMS," Shield said.

Registry collection of data should continue until all questions asked by policy makers are properly addressed, according to Dr. Mitchell Schnall, chair of the American College of Radiology Imaging Network.

"If there were still lingering questions about some of the indications and additional data were requested, then our plan would be to try to work with CMS to continue NOPR on those areas and try to answer the questions that they think need to be answered," he said.

Schnall credited the collaborative work between the Academy of Molecular Imaging and ACRIN through the NOPR for the coverage decisions. He also announced two ACRIN-led trials to pursue coverage for coronary CT angiography.

"We have had very strong solicitation of the NOPR. It has generated a lot of data, which are hard to obtain by any other means. We are hopeful that when any recommendations come based on those data that we are going to have some successes," Schnall said.

For more information from the Diagnostic Imaging and SearchMedica archives:

Medicare approves coverage of FDG-PET for 11 cancersProponents call proposed PET coverage ‘bittersweet'Medicare proposes expanded coverage for cancer-related FDG-PETPanel pans clinical trials justifying PET coverageImaging research efforts place focus on clinical effectiveness