It's only December 18, but the nuclear medicine community has already received a new PET for Christmas. On Friday the U.S. Health Care Financing Agency (HCFA) announced new or expanded Medicare coverage of PET imaging for six types of cancer, including lung, colorectal, lymphoma, melanoma, head and neck, and esophageal -- as well as a few neurological and cardiac applications.
The new rules also give doctors more leeway in determining when the use of PET might improve patient care decisions.
In addition to broader cancer coverage, PET is now approved for presurgical evaluation of patients with refractory seizures, and for evaluating myocardial viability when SPECT imaging is inconclusive.
But Santa's bag was decidedly mixed. Even though nuclear medicine doctors have been good all year -- producing encouraging studies on the use of PET in breast cancer, ovarian cancer, prostate cancer, and Alzheimer's disease -- HCFA was not persuaded to add these applications, citing insuffiencies in published data. Instead the agency referred them to an advisory committee, and interested parties were invited to reapply for approval. Neurooncology applications were also ignored.
"As far as it goes, we're pleased that they extended the coverage," said William Uffelman, public affairs director for the Reston, VA-based Society of Nuclear Medicine. "Ideally we would have liked to have the broad coverage that was applied for, as opposed to having to keep going back."
Then there's the problem of which scanners can be used. The new regulations cover only dedicated PET cameras, leaving the status of various hybrid and fusion systems very much in doubt.
"Whether [HCFA] will go back and approve the others retroactively is an open question," Uffelman said.
Even though the approval wasn't everything proponents wanted, it marked a significant recognition of PET's ability to examine the biological origins of disease in a cost-effective manner. In announcing the new coverage, the agency said that PET can often pinpoint the source of cancers, as well as heart and neurological disease, in a single scan, eliminating the need for redundant diagnostic tests and surgical procedures. And it can be more accurate in its ability to pinpoint disease than CT or MRI exams that look for structural abnormalities, HCFA said.
In a significant departure from the limited indications that were covered in the past, Friday's decision gives doctors broad leverage to use PET in the diagnosis, staging, and restaging of cancer. PET will now be covered "if its use could be considered reasonable and necessary," or "if its use could potentially replace one or more imaging studies," according to the agency.
For example, if the stage of a cancer remains in doubt after completion of a standard diagnostic workup, PET is approved for restaging in disease recurrence, or following completion of therapy.
"It's going to make it easier for physicians to monitor therapy with restaging exams, particularly when conventional imaging is equivocal or indeterminate," said Dr. Marc Seltzer, a nuclear medicine specialist from the Ahmanson Biological Imaging Clinic at the University of California, Los Angeles. "You can't use it during therapy, but once you've completed therapy and your standard workup is still unclear as to what stage the cancer is, then a PET scan would be covered to stage that patient."
Even for applications that were covered previously, the rules give doctors more leeway in charting a course of treatment. Under the old guidelines, for example, PET could be used for lung cancer screening only when solitary pulmonary nodules (SPN) were reported.
"For lung cancer you had to show the CT scan," Seltzer said. "But some [reports] are vague about SPN, they'll say maybe there's an infiltrate, or depending on the size of the lesion they may not classify it as an SPN. But now it seems it will be at the discretion of the physician to decide. You don't have to provide as narrow a definition of why the scan was ordered."
The same is true for colorectal scans, where PET was previously covered only in the presence of rising CEA levels. Now, if recurrence is suspected, PET will be covered regardless of the tumor marker's status, he said.
Seltzer said that while the decision to exclude Alzheimer's disease was especially disappointing, the new rules would have a positive effect overall.
"I think this is great news for patients, and will result in better patient management," he said.
By Eric Barnes
AuntMinnie.com staff writer
December 18, 2000
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