In an effort to scale back use of high-priced imaging of questionable value in cancer treatment, Medicare has proposed ending reimbursement for post-treatment positron emission tomography scanning in prostate cancer patients and limiting its use to one scan for most other cancer indications.
Use of the technology, which involves injecting F-18 fluorodeoxyglucose (FDG) into the blood so the PET scan can identify regions of heightened metabolic activity, a sign of cancer metastasis, has grown sharply in recent years. The CMS, in giving preliminary approval to payments for the technology in 2005, required manufacturers and radiologists to establish a registry to monitor outcomes from its use.
The evidence garnered from that registry convinced the CMS that the scans provided no useful information for oncologists treating prostate cancer patients who had already completed their initial therapy, according to the March 13 proposed decision memo. “CMS believes at this point that the available evidence does not support the usefulness of FDG PET in beneficiaries who have completed initial treatment of prostate cancer,” the memo states.
The proposal drew fire from PET scan equipment manufacturers and the American College of Radiology, which represents physicians who administer and read the scans. “It's a disappointment when something is not covered,” said Gail Rodriguez, executive director of the Medical Imaging & Technology Alliance, which represents imaging manufacturers. She expressed concern that the CMS' recommendation will limit scans for patients who may require more than one study as part of their follow-up treatment.
Dr. Rathan Subramaniam, vice chair of the American College of Radiology's nuclear medicine commission, said FDG PET imaging is useful for patients with aggressive forms of prostate cancer, including those with castrate-resistant prostate cancer, but agreed it is not as useful for patients with nonaggressive forms of the disease.
“Lumping it together (and) saying it's not useful is not a good approach,” Subramaniam said. “It's a valuable test in patients with aggressive prostate cancer. It should be funded.”
The recommendations are part of a broader effort by the CMS to evaluate what medical technologies it will reimburse through its coverage with the evidence development (CED) program, established under former CMS director Mark McClellan during the George W. Bush administration. The CMS says the program helps “address coverage of items and services that were believed to be promising but whose ultimate impact on Medicare beneficiary health outcomes remained unconfirmed.”
As part of the CED program, the National Oncologic PET Registry was established in 2005. The registry, which collects data from clinicians about PET scans and is managed by the American College of Radiology, last year requested that the CMS end data-collection requirements for FDG PET imaging used with cancer patients.
The CMS agreed, also proposing to end data collection for FDG PET scans in the March memo. An agency spokesman declined to comment further, citing the proposal's comment period, which ends April 12.
Advanced imaging, which includes PET scans as well as computed tomography and magnetic resonance imaging, has often been cited as a major contributor to rising healthcare costs.
A study published in the Journal of the American Medical Association in 2010 found that the rate of increase in imaging costs for Medicare beneficiaries with cancer outpaced the rate of increase in total costs among the same patients from 1999 to 2006.
During the same time period, PET scans for prostate cancer patients reported the most significant annual increase in mean imaging procedure counts, compared with seven other imaging modalities such as CT scans and bone-density studies, even though the overall mean-imaging procedure counts for PET scans were far fewer than other modalities.
PET scans are usually more expensive than CT imaging, which is the most common follow-up treatment for patients with prostate cancer, said Dr. Kevin Schulman, associate director of Duke University's clinical research institute and a co-author of the 2010 study.
“Trying to make sure that technology is being used appropriately is a critical issue,” he said. “It's the cost and the impact on the (Medicare) program that is driving attention.”
The CMS' proposed decision would directly affect regional CMS contractors who may make differing determinations on whether to reimburse more than one post-treatment PET scan for cancer patients. In those cases, it could come back to a national coverage decision, Schulman said.
The CMS has “taken a look at PET scans almost continuously for the last decade,” Schulman said. “They are going to stay involved in advanced imaging for quite some time given the costs of imaging.”