Panel pans FDG-PET for new Medicare oncology coverage

A Centers for Medicare and Medicaid Services advisory panel has found that most available clinical data for nine conditionally approved cancer indications of FDG-PET, evaluated by the National Oncologic PET Registry (NOPR) and a separate Canadian study, are too ambivalent to support Medicare coverage.

The 9-member Medicare Evidence Development and Coverage Advisory Committee (MedCAC) heard testimony from the Evidence-Based Practice Center in Edmonton and the NOPR last month in Woodland, Maryland. Members of the American Society for Therapeutic Radiology and Oncology, Academy of Molecular Imaging (AMI), American College of Radiology (ACR), and SNM, as well as patient advocates, also testified.

MedCAC did not recommend for or against Medicare reimbursement for the procedures or formally consider the future role of the NOPR, which was established to examine the effect of FDG-PET on clinical management of the nine conditionally approved indications. The committee’s assessment will be forwarded to CMS for further review.

In postmeeting interviews, imaging proponents questioned the committee’s narrow view of results. The discussion and voting did not take into account the nuances of the data, said Richard Wahl, MD, director of nuclear medicine and PET at Johns Hopkins University Medical Center.

The MedCAC session was convened to respond to a March 25 application to grant routine payment for PET to diagnose, stage, and restage soft-tissue sarcomas and brain, cervical, ovarian, pancreatic, small-cell lung, and testicular cancers.

The March application also asked Medicare to reimburse providers for PET prescribed to evaluate suspected recurrence of these conditions.

The rationale for expanded coverage was based on a referring physician survey evaluating the influence of FDG-PET imaging on clinical decision making. Under the supervision of the ACR Imaging Network (ACRIN), the NOPR collected complete data in its first year of operation, beginning in May 2006, from more than 34,000 PET studies.

An analysis of that experience, published in the Journal of Clinical Oncology (March 24, 2008), found that PET led to a major change in intended management in 30.3% to 39.7% of cases, depending on the indication. Data from the NOPR also showed that referring physicians were three times more likely to shift from nontreatment to treatment after PET imaging than vice versa (28.3% vs 8.2%). PET was associated more frequently with upstaging than downstaging.

The MedCAC panel discussed scientific data from the NOPR and Canadian studies. Seven members cast generally negative votes regarding the clinical value of FDG-PET for indications evaluated by the registry. Deliberations explored whether enough positive evidence had been gathered to improve physician decision making or patient outcomes for PET applications to diagnose, stage, restage, or monitor small-cell lung cancer and cancers of the bladder, brain, cervix, kidney, ovaries, pancreas, prostate gland, and testes.

Panel members were equivocal in votes concerning whether PET data could be applied broadly to other cancers, nonresearch PET facilities, and the general Medicare population. Their highest ratings were assigned to the restaging and monitoring of cancers of the cervix, kidney, and ovaries. FDG-PET for the diagnosis of cervical, prostate, and testicular cancer generally received low ratings.

Panelists raised questions about the statistical significance of the Edmonton group’s data. The quality of evidence was deemed poor to moderate.

The NOPR was organized in 2005 as a negotiated compromise between the AMI and CMS.

At the time, the AMI supported payment for more cancer-related PET indications beyond the nine other procedures then approved for Medicare payment. CMS responded with a ruling that called for Coverage with Evidence Development. Conditional payment was granted, but CMS required more research through the NOPR to determine PET’s effect on referring physician decision making. The registry did not study the clinical efficacy of the procedures.

This article is adapted from ONI’s sister publication Diagnostic Imaging Online (August 20, 2008).