Medicare Boosts Coverage for FDG-PET Scans in Cancer

Roxanne Nelson

June 13, 2013

The US Centers for Medicare and Medicaid Services (CMS) is ending its requirement for coverage with evidence development for fluorodeoxyglucose positron emission tomography (FDG-PET) in oncology.

In their final decision memo on PET scanning for solid tumors, the agency removed the requirement for prospective data collection by the National Oncologic PET Registry (NOPR), and will now cover 3 scans after the completion of initial therapy. Coverage of any additional FDG-PET scans used to guide subsequent management will be determined by local Medicare contractors.

In addition, the CMS recognizes prostate cancer as a clinical indication for FDG-PET scans.

However, the use of PET scanning in some cases of prostate cancer is controversial. Its use in early-stage disease has been identified as "a cancer practice that must stop," as previously reported by Medscape Medical News. According to an American Society of Clinical Oncology report, patients with early-stage prostate cancer, who have a low risk for metastasis, do not need advanced imaging technologies — such as PET, CT, and radionuclide bones scans — to determine whether the cancer has spread (J Clin Oncol. 2012;30:1715-1724).

That report notes that "these tests are often used in staging evaluation of low-risk cancers, despite a lack of evidence suggesting that they detect metastatic disease or survival.... Unnecessary imaging can lead to harm through unnecessary invasive procedures, overtreatment, and misdiagnosis."

Coverage for 3 Scans

The decision that 3 scans will be covered after the completion of initial therapy was applauded by PET advocates, including the Society of Nuclear Medicine and Molecular Imaging and the Medical Imaging & Technology Alliance (MITA).

"MITA has long supported Medicare coverage decisions that facilitate access to PET imaging, which has revolutionized the diagnosis, treatment, and monitoring of a wide range of diseases," said MITA executive director Gail Rodriguez. "This final decision on FDG-PET for solid tumors is a step in the right direction in ensuring access to critical imaging procedures for patients with cancer."

Short History of Coverage

In 2006, before the CMS made any coverage decisions, they proposed establishing NOPR to collect data on FDG-PET. For the next 3 years, NOPR collected data from approximately 133,000 PET scans conducted in almost 2000 different locations.

In 2009, CMS decided to expand coverage for PET scanning for Medicare beneficiaries diagnosed with cancer. The ruling provided reimbursement for PET scans used in the initial evaluation of patients with most types of solid tumors and allowed for PET in subsequent evaluations for an expanded number of cancer types, as previously reported by Medscape Medical News.

In March 2013, CMS proposed removing its longstanding coverage with evidence development requirement and providing coverage for only 1 post-treatment FDG-PET scan, except in the case of prostate cancer.

At that time, the CMS stated that "FDG-PET for subsequent anti-tumor treatment strategy for beneficiaries with cancers of the prostate is not reasonable and necessary."

Most Opposed Limitations

An analysis of the 201 comments that were filed on the proposed coverage decision, conducted by Avalere Health, found that the vast majority of commenters (97%) explicitly opposed the proposal to limit national coverage of FDG-PET to just 1 scan. They urged the CMS to reconsider its decision and broaden coverage of FDG-PET.

Conversely, America's Health Insurance Plans expressed their support of increased coverage restrictions for scanning, stating that there is inadequate evidence to justify coverage of any post-treatment scans.

Avalere Health noted that 170 of the comments came from individual providers and, of those who disagreed with the CMS proposal, 44 commenters stated that subsequent scans should not be evaluated by local Medicare Administrative Contractors because of increased administrative burden.

A joint proposal — issued by the American College of Radiology, the American College of Nuclear Medicine, the American Society of Neuroradiology, the Society of Nuclear Medicine and Molecular Imaging, and the World Molecular Imaging Society — also strongly opposed the limitation of coverage to a single scan. "We recognize and endorse the concerns of CMS regarding the potential for overuse of FDG-PET for surveillance purposes," they wrote. "However, the 1 scan limitation will have significant adverse effects for beneficiaries and treating physicians alike."

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