Clinical PET gets shot in the arm as HCFA approves lung payments

Decision also applies to coincidence detection techniques

Positron imaging has entered the clinical mainstream. On Jan. 1, Medicare began reimbursing for the diagnosis and staging of lung cancer using positron imaging. And this may be only the beginning: Several other applications might be included in Medicare coverage over the next two years. In addition, the Clinton administration has agreed to a fast-track review of other positron applications, possibly within the next 18 to 24 months.

"This is a huge victory for PET and for the thousands of patients who will benefit from PET scan technology in the diagnosis and treatment of illness," said Sen. Ted Stevens (R-AK), chairman of the Senate Appropriations Committee.

The Health Care Financing Administration (HCFA), which runs the Medicare program, has promised to evaluate several other applications of positron imaging. Technology assessments to evaluate patients for brain cancer and myocardial viability will be conducted by either Blue Cross or the Agency for Health Care Policy and Research. These assessments could be completed before the end of 1998.

For purposes of reimbursement, no distinction is being made between exams done on dedicated PET scanners and those done on gamma cameras capable of coincidence detection. Virtually any type of positron imaging is now being covered, at least under the current lung cancer indications, according to Jennifer Keppler, executive director of the Institute for Clinical PET (ICP) in Foothill Ranch, CA.

"Everything is being covered, traditional PET as well as coincidence detection PET," Keppler said.

The reimbursement decision is unquestionably a major leap for providers of positron imaging. But there are serious concerns about HCFA's still-evolving policy and its long-term ramifications. HCFA officials have not yet set a reimbursement rate, which means practitioners are being asked to conduct exams and submit for Medicare reimbursement in the hopes that a reasonable fee will be assigned.

"It will take them one to three months to get the billing set up, so HCFA is going to work with ICP to contact all the people performing positron imaging studies starting this week and tell them to hold the bills," said Michael Phelps, chief of nuclear medicine at the University of California, Los Angeles.

But even when reimbursement is finalized, practitioners may still have to struggle to get paid. The third-party payors that contract with HCFA must still be brought on board.

"We'll have a substantial amount of work to do with the (insurance) intermediaries, because all of a sudden they will get a new page to their coverage manual that says they will cover this procedure, and they'll have to do it out of their current budget," Keppler said. "There's a substantial education process that will need to be done."

And the faith of providers in the federal government will be tested in other ways as well. At least until CPT codes are available to classify positron reimbursement submissions, the exams will be classified under HCFA's G code mechanism. G codes are designed to record the total cost of care-diagnosis and therapy-provided to a patient. HCFA used G codes some years ago in determining whether Medicare coverage would be extended to the use of rubidium for myocardial evaluation, according to Keppler.

"There are two reasons for HCFA to use a G code," she said. "One is if there is not a good CPT code for describing what needs to be done. The other is that it allows (HCFA) to collect data about whether the results were positive or negative, and they can get some basic outcomes data, if they choose to, down the road."

In this case, HCFA plans to use the data captured under the G code over the next 12 months to evaluate the cost-effectiveness and clinical benefit of positron imaging. Some radiologists are concerned that this sets a dangerous precedent.

"HCFA will review whether they are going to reimburse for PET at the end of the year using criteria that will evaluate the actual total cost of care for patients who have PET scans versus patients who don't have PET scans with comparable illnesses," said Dr. William Strauss, section chief of nuclear medicine and a professor of radiology at Stanford. "If the data don't pan out, (PET reimbursement) could be a flash in the pan. HCFA could withdraw the reimbursement for PET."

Shifting momentum.But Phelps is not concerned. Political momentum within government agencies and on Capitol Hill has shifted in favor of positron imaging, he believes. An agreement has been struck between Stevens and Secretary of Health and Human Services Donna Shalala to promote the development of positron imaging. Shalala rides herd over both HCFA and the Food and Drug Administration; Stevens' position as chair of the Senate Appropriations Committee makes him one of the most powerful people in the Senate.

"They will continue to watch over this and make sure it works not just for this year, but next year and the year after," Phelps said.

Stevens' support was instrumental not only in pushing the PET negotiations forward but in getting the FDA Modernization Act of 1997 through Congress. Language in the act, which takes effect in February, dramatically changes the rules regarding PET regulation, relieving the FDA for the next two years of its authority over PET radiopharmaceuticals (SCAN 12/17/97). The act opens the door for the manufacture of PET agents according to criteria established by the U.S. Pharmacopoeia. At the end of the two-year period, the FDA must have developed guidelines for regulating the manufacture of PET radiopharmaceuticals that recognize the unique characteristics of the drugs, or regulatory authority will not revert back to the agency.

The FDA has already complied with the congressional mandate. On Dec. 21 the agency revoked the use of two guidance documents affecting the regulation of PET radiopharmaceuticals, particularly the requirements for manufacture of the agents. The FDA still holds authority over the clearance of PET scanners and gamma cameras capable of positron imaging. But HCFA, with its authority to determine Medicare coverage, could be the major determinant of the modality's future success. Considering HCFA's plans to review the cost-effectiveness of positron imaging, some in the PET community would have preferred-at least initially-a HCFA policy covering only dedicated PET scanners.

"PET has shown a higher specificity and sensitivity than coincidence systems, and there is a higher probability, when averaged over time, that the cost savings will be significant," said Steve Prince, senior product manager for positron imaging marketing at the nuclear medicine group of Siemens Medical Systems in Hoffman Estates, IL.

Others in the industry applauded HCFA's decision. Among them was David Lowe, chairman of ADAC Laboratories.

"We believe HCFA's coverage decision will ensure the highest quality of healthcare to Medicare patients at the lowest possible cost," Lowe said.

ADAC, as one of the first nuclear medicine companies to embrace positron imaging on gamma cameras, has a lot to gain from the decision. The Milpitas, CA, company is aggressively promoting its Molecular Coincidence Detection technology, and the HCFA coverage policy should help. ADAC in June will also begin selling PET cameras manufactured by UGM Medical Systems under an agreement reached last month (SCAN 12/17/97).

But some PET proponents worry that making an economic case for positron imaging when using even the most advanced equipment will be tough, because there are so many variables that might affect clinical outcomes.

"It really depends on when the (positron scans) are performed in the course of the patient's care and the rationale for doing the tests," Stanford's Strauss said.

Mixing data from equipment with varying capabilities could make the case for positron imaging harder to prove. But UCLA's Phelps said that asking HCFA to differentiate between the capabilities of different scanners could have been more dangerous.

"To have HCFA come in and do something they have never done-to set device specifications-is not a good precedent, nor are they competent to do that," Phelps said. "If I said to HCFA, 'Determine the maximum count rate or the intrinsic resolution to draw the line (for coverage),' they wouldn't know what I was talking about."