CMS’s Proposal to Severely Limit FDG-PET Use for Patients with Cancer Elicits Concern

Rosemary Frei, MSc

May 2013, Vol 4, No 4 - Health Policy

US oncologists and radiologists are waiting to see whether the Centers for Medicare & Medicaid Services (CMS) will reconsider its proposal to limit the use of and reimbursement for fluorodeoxy­glucose-positron emission tomography (FDG-PET) scan after initial anti­cancer therapy to 1 scan in patients with solid tumors (with the exception of patients with prostate cancer, who will not be reimbursed for any FDG-PET scans).

On March 14, 2013, officials at CMS proposed ending the requirement enacted in 2006 that FDG-PET scans of less common solid tumors should be included in the National Oncologic PET Registry (NOPR). This is in line with what NOPR had asked for in a September 2012 letter to CMS, citing the accrual of sufficient evidence of FDG-PET’s efficacy.

However, CMS also suggested in March that reimbursement should be granted only for a single posttreatment FDG-PET scan, to determine whether the initial therapy was effective. It would then be up to regional Medicare administrative contractors to determine whether subsequent scans should be covered.

Officials at NOPR responded in mid-April with a detailed and strongly worded letter showing that posttreatment FDG-PET can significantly change patient management. They stated that “the imposition of a one-size-fits-all national limit of one scan for subsequent patient management has no clinical or scien­tific basis” ( CMS will issue its final decision by June 14, 2013.

“Our bottom line is that we really support the notion that PET shouldn’t be used for surveillance, and neither should other forms of advanced imaging, because studies do not support it,” Barry A. Siegel, MD, coauthor of the letter to CMS and Co-Chair of NOPR, Chief of the Division of Nuclear Medicine, Washington University School of Medicine, St Louis, MO, told Value-Based Cancer Care. “There are better ways to accommodate the complexity of modern oncologic practice and the need for PET to evaluate what’s going on at particular times during patients’ treatment, while still avoiding healthy people who come back for a PET scan every 6 months ‘just because.’”

However, Dr Siegel and his colleagues at NOPR believe that it would be preferable for CMS to make clear to physicians that surveillance scanning is not appropriate for low-risk patients, while allowing the unrestricted national coverage of FDG-PET, with Medicare administrative contractors setting reasonable frequency limits as necessary.

“I have no problem with insurance companies imposing limits beyond which a peer-to-peer consultation is required, as long as it’s understood that the number of PET scans that is appropriate varies for different cancers and different stages of treatment,” said Dr Siegel.

A similar stance has been taken by the heads of the Society of Nuclear Medicine and Molecular Imaging, the World Molecular Imaging Society, the American College of Radiology, the American Society of Neuroradiology, and the American College of Nuclear Medicine. In a letter submitted to CMS in April 2013, they stated, “The Joint Societies would be pleased to collaborate with CMS to develop protocols that can be implemented to accomplish this end” of ensuring that only nonsurveillance FDG-PET scans are reimbursed.

FDG-PET Coverage in Oncology
Since 2009, CMS has allowed more than 1 FDG-PET scan during and after treatment for 10 common cancer types—breast, cervical, colo­­rectal, esophageal, head and neck, non–small-cell lung, non–small-cell ovarian, lymphoma, melanoma, and myeloma. Coverage for all other cancers was allowed if data were collected
for NOPR.

The average payment for an FDG-PET scan, including the technical and professional portions, is approximately $1200.

To demonstrate that more than 1 scan can be beneficial, Dr Siegel, together with NOPR Chair Bruce E. Hillner, MD, Professor and Eminent Scholar, Department of Internal Med­­icine, and Massey Cancer Center Research Member, Virginia Common­wealth University School of Medicine, Richmond, VA, and Co-Chair Anthony F. Shields, MD, PhD, Professor of Medicine and Oncology, Wayne State University School of Medicine, Karmanos Cancer Institute, Detroit, MI, analyzed 2006-2011 data from patients in NOPR.

Drs Siegel, Hillner, and Shields found that more than 30% of patients with 1 to 3 scans for restaging or detection of suspected cancer recurrence had a change in management, along with 28.7% of the few hundred patients with 4 scans. Furthermore, among patients with up to 4 scans for treatment monitoring, approximately 30% had switched or added a medication as a result, and another 14% to 16.9% had their treatment stopped.

The team also pointed out that imposing a 1 posttreatment scan limit could lead to a flood of requests to Medicare administrative contractors from physicians who are appealing rejected claims.

“The data…strongly indicate that additional scans are being ordered by physicians not for routine surveillance purposes, but to actively manage clinical problems in their patients,” the trio concluded. “We encourage CMS to recognize the medical reality that cancer patients have improved outcomes as a result of better and more tailored medications, targeted radiotherapeutic and surgical techniques, in conjunction with treatment monitoring strategies.”