Attempt to broaden PET Medicare payments receives cool reception from HCFA officials

Sen. Stevens may step in again if reimbursement does not materialize

It may take some effort for the nuclear medicine community to increase the number of PET applications eligible for Medicare reimbursement. At a town hall meeting in Baltimore last month, officials from the Health Care Financing Administration appeared less than enthusiastic at the prospect of broadening federal payments for the modality. If they don't receive more PET coverage soon, PET proponents may once again resort to legislative means.

The meeting was held on Jan. 21 and 22 and is part of a new administrative procedure HCFA has developed to determine reimbursement policies for new technologies. Under the system, HCFA conducts public meetings to hear arguments for and against reimbursement, and then the agency's Bureau of Clinical Standards and Quality renders a decision. The new process replaces the agency's technical advisory committees, which previously investigated reimbursement options.

Medicare pays for only two PET applications: rubidium-82 imaging for cardiac applications and imaging of lung cancer. The latter indication includes both PET and coincidence detection techniques.

HCFA approved lung cancer payments last year in a move seen as a major victory for the modality (SCAN 1/14/98). But the agency did so reluctantly and after years of prodding from PET proponents, in particular Sen. Ted Stevens (R-AK), chairman of the Senate Appropriations Committee. Reimbursement was granted after Stevens and Secretary of Health and Human Services Donna Shalala reached an agreement in which HCFA said it would pay for lung cancer indications and investigate additional payments.

Last month's meeting seems to indicate that securing additional indications for PET may not be a walk in the park. Some of the 160 PET proponents in attendance at the meeting believe that HCFA staffers are still reluctant to expand Medicare payments and are holding PET to an unrealistic standard in proving its clinical utility and effectiveness.

The PET community presented a number of speakers testifying to the modality's utility, including practitioners, vendors, and patients who had undergone PET scans. Speakers also presented studies comparing the utility of PET imaging to other imaging modalities. The problem was that HCFA officials expressed the sentiment that the best way to determine the appropriateness of reimbursement for a technology is through double-blind clinical trials, and no such trials have yet been conducted on PET.

PET advocates believe that rigorous double-blind trials are more appropriate for drug applications than imaging devices. Double-blind trials using control groups are useful in drug trials to determine whether a drug is effective or not. But in medical imaging, a modality's effectiveness can be assessed by simply performing a study with another modality, according to Ruth Tesar, president of the Institute for Clinical PET and general manager of P.E.T.Net Pharmaceutical Services in Sacramento, CA.

"In diagnostic imaging, you have the perfect experiment in a patient. You can do a PET scan and a CT scan of the same patient," Tesar said. "You don't need these two control groups to determine whether the modality is working or not."

By the end of the meeting, HFCA officials had begun to recognize the shortcomings of the control-group model and perceive that medical imaging might require a different methodology. But whether they apply this new understanding to approving additional reimbursement is still a major question.

The PET community now awaits a thumbs-up or thumbs-down decision from HCFA on expanded reimbursement. Five new applications are being considered: colorectal cancer, melanoma, brain tumors, lymphoma, and head and neck cancer. The agency could approve all five, a mix of the five, or decline to act on any of them. HCFA has not indicated how long it might take to act.

If a positive result is not forthcoming, the agency could face additional pressure from legislators such as Sen. Stevens. Representatives from the senator's office were in attendance at the town hall meeting and also took a dim view of HCFA's position on rigorous clinical studies.

"HCFA can't get away from the notion that they need randomized clinical trials," said Liz Connell, a legislative assistant to Stevens. "This approach doesn't make a whole lot of sense. They are using it as a barrier to broader coverage."

Connell also said that Stevens is seriously considering filing legislation if he does not see positive results on PET reimbursement. Although HCFA staffers typically chafe at the injection of political considerations into reimbursement decisions, it could be the only way to bring about expanded PET coverage.

Meanwhile, PET sites have experienced difficulty securing Medicare payments for lung cancer imaging, which was approved over a year ago. Many PET centers that have submitted claims to Medicare have found themselves ensnared in red tape.

One site on the West Coast that submitted a claim received $1980 for the technical component of the exam, but only $60 for the professional component. The site also received a letter from the Medicare third-party carrier requesting proof from the center that the PET camera they were using had been approved by the Food and Drug Administration. Such requests are never made of other imaging modalities, according to Connell.

"I remember when Sen. Stevens negotiated the agreement with Secretary Shalala in November 1997 on the diagnosis and staging of lung cancer. The HHS staff told me with great jubilation that this agreement meant they would start cutting checks right away," Connell said. "I don't know whether it is just total incompetence on the part of Medicare carriers or something else, but this has not worked out the way we envisioned it."

The ICP's Tesar said that even with the difficulties in securing lung cancer payments, interest in PET is on the upswing.

"I am hopeful for these other indications," she said. "It would be very difficult for them to turn their backs on the data that was presented."