Slightly over a year and a half since the opening of the National Oncologic PET Registry, the conclusion has become clear to participants and program managers: Coping with the paperwork involved is not always easy, but it is worthwhile. About 1600 PET facilities obtained Medicare cash for indications not eligible for reimbursement through standard channels. And more than 50,000 patients have benefited from imaging tests that they otherwise might never have undergone.
The NOPR was a compromise between the Centers for Medicare and Medicaid Services and PET advocates to provide coverage for FDG-PET for the diagnosis, staging, and management of cancers not currently covered by CMS. The registry was designed to gather enough data to prove FDG-PET's efficacy for these indications. The top cancer sites include prostate, ovaries/uterus, pancreas, kidney, bladder, lung, stomach, and bone marrow. Official patient registration began in May 2006, although preregistration of interested facilities had already started about six months earlier.
The registry has helped change outcomes for cancer patients whose referring physicians believe they can benefit from PET, said Dr. R. Edward Coleman, vice chair of radiology at Duke University and cochair of the NOPR working group.
"Previous studies have shown that PET and PET/CT result in changes in management in at least 30% of the patients studied. These patients would either not have had the studies performed or would have had to pay for them from their own resources," he said.
While the benefit of the registry may be obvious, the full force of its impact has been blunted somewhat by the bureaucratic maze of paperwork necessary to take part in the program. Users face a steep learning curve with the pre- and post-PET forms and additional resources to complete the paperwork were not always readily available.
"The paperwork is an issue, as paid secretarial staff must be assigned, and our departmental new hiring is restricted. This has impeded implementation somewhat," said Dr. Michael C. Roarke, director of nuclear radiology at the Mayo Clinic in Scottsdale, AZ. "The clinicians have been fairly good about completing the pre- and post-test questionnaires but sometimes have to be chased down to meet the deadlines."
Participating practitioners realize, however, that the paperwork is necessary to build the database that one day could answer questions regarding PET's efficacy. They also acknowledge that the data can be rewarding. Roarke's facility has seen a volume increase of about 15% to 20%, mostly in myeloma and gastrointestinal and genitourinary cancers.
The NOPR provides an avenue to assess PET's utility prospectively across a spectrum of diseases. Clinicians and imagers alike have an interest in knowing where PET works and where it doesn't to maximize the value of scarce U.S. healthcare dollars, Roarke said.
"We have recently added clinical staff experts in multiple myeloma who have been able to use PET/CT through the registry, and it is quite clear to all involved that PET is effective in assessing disease activity. For ovarian cancer, we have had similar results," he said.
PERILOUS MISTAKES
Referring physicians and facilities have to ensure that requested studies really are intended to aid in the patient's management and meet the general Medicare guidelines on PET's use. There is a concern some participants may not be paying close attention to the program's purpose.
The pre-PET forms include definitions and guidelines about when it's appropriate to perform PET studies. They also emphasize that the purpose of the registry is to capture information about patients who really need the imaging. Facilities should not do PET scans simply because they can and certainly not as a means to increase their revenue, especially if there is no clinical indication for the study, said Dr. Barry Siegel, director of nuclear medicine at the Mallinckrodt Institute of Radiology and cochair of the NOPR working group.
"We can help answer questions, and we do it all the time. I'm constantly responding to e-mails asking, 'Is this patient eligible?' 'How should I fill out this particular question based on the information I have available to me?' We want to make sure that the forms are being filled out either by the referring physician or by someone knowledgeable in the referring physician's office," he said.
One of the worries is that, either accidentally or deliberately, some PET facilities may fail to comply with Medicare procedures and could get in trouble. The worst-case scenario, however, involves unwarranted cases that could compromise the integrity of the registry data.
One example is prostate cancer. Although it is common in the Medicare age population and has been included in the registry's list of covered indications, most of the available evidence in the literature suggests that PET has a rather limited role in prostate cancer. FDG-PET probably has no utility in the diagnosis of localized disease. It has very limited accuracy for initial staging and has some use in detecting recurrent disease. Its true role seems to be the evaluation of treatment response, particularly when disease becomes hormone-refractory. NOPR researchers, however, have been observing a high number of PET scans done for initial staging and even for diagnosis of prostate cancer, Siegel said.
Any scientific study contains data that need to be cleaned up, and, given the nature and number of facilities involved, there is always room for confusion. Most participating PET facilities and referring physicians do not ordinarily take part in clinical trials. The NOPR working group recognizes that they will not have perfect data, Siegel said.
"Nonetheless, we hope that the data we are getting are truly representative of the value of PET in routine clinical practice," Siegel said. "This is not information gathered under very carefully controlled conditions in a few academic medical centers. This is information gathered right down there in the trenches."
Physicians want to provide their patients with the opportunity to have a PET study and patients want the best test available within their insurance plan.
"A lot of our physicians are happy with the registry because they can take care of certain patients who couldn't afford to pay cash for their PET scans," said Debbie Carrano, a patient service representative at Thunderbird MRI & PET Center in Glendale, AZ, who oversees NOPR patients. "It's been beneficial on both sides."
The program has allowed participating centers to provide proper patient management in specific situations, confirming or ruling out the need for surgery in several of these patients, said Dr. Annick D. Van den Abbeele, chief of radiology at the Dana-Farber Cancer Institute in Boston.
"Over the last year, we have entered more than 100 patients who would not have been able to get access to PET, and for many of these patients, the test had a significant impact on their management," she said.
The registry has provided the PET community with an opportunity to gain valuable clinical experience, Siegel said. He gave CMS credit for providing an innovative way to make PET accessible to patients and physicians in cases when the scientific evidence was promising but did not quite meet the government's standard for approval.
Mr. Abella is associate editor of Diagnostic Imaging.
