PET backers decry regulatory delays at Congressional caucus

May 18, 1994

Meeting may have alienated regulators A Congressional briefing held this month gave PET advocates achance to blow off steam accumulated while waiting years for Medicarereimbursement of the technology. The meeting provided PET proponentswith a

Meeting may have alienated regulators

A Congressional briefing held this month gave PET advocates achance to blow off steam accumulated while waiting years for Medicarereimbursement of the technology. The meeting provided PET proponentswith a forum to vent their frustrations, but some observers saythe caucus may have burned the federal regulators whose goodwillis needed to break PET's impasse.

PET's travails are an excellent example of a bureaucratic catch-22at its most extreme. The technology has run afoul of a warrenof federal agencies with overlapping jurisdictions and what someobservers say are hidden agendas.

PET's odyssey began six years ago, when the Institute for ClinicalPET (ICP), an Arlington, VA-based advocacy group, submitted anapplication to the Health Care Financing Administration for Medicarereimbursement of PET.

HCFA officials, however, have said that the agency can't acton the application until its Office of Health Care TechnologyAssessment completes a review of PET. The OHTA report cannot becompleted until the Food and Drug Administration approves a newdrug application (NDA) for fluorine-18 fluorodeoxyglucose (FDG),the positron-emitting tracer used in eight of 10 clinical PETprocedures (SCAN 7/1/92).

Some observers believe PET was the first medical imaging victimof two new developments within the federal government's regulationof medical drugs and devices: HCFA's effort to slow the spreadof expensive new medical technologies and the FDA's desire toexpand its regulatory authority over PET radiopharmaceuticals,which currently are governed by state laws of medicine.

PET's situation was discussed at a Congressional briefing heldMay 2 by the House of Representatives' medical technology caucus,a bipartisan group of 22 Congressional representatives that reviewshow new medical technologies are introduced into clinical practice.The meeting was intended to give Congressional staffers more informationabout the problems PET has encountered in earning Medicare reimbursement.No Congressional representatives attended the meeting.

The briefing generally was amicable, according to Dr. PeterKirchner, president of the ICP and director of nuclear medicineat the University of Iowa in Iowa City. Members of the ICP, theSociety of Nuclear Medicine and the American College of NuclearPhysicians made presentations at the meeting. Representativesfrom HCFA, FDA and OHTA attended but did not give presentations.

The medical community's strategy at the briefing was to callattention to the delay in PET Medicare coverage and make a casefor Medicare reimbursement independent of the FDA's review ofFDG, according to Kirchner.

"What we tried to present is that, in spite of the factthat there is genuine interest in solving these problems on thepart of agency staffers, there seems to be an administrative deadlock,"Kirchner said. "What we had hoped was that the Congressionalbriefing would focus attention on the administrative complexitiesand interactions that somehow prevented the initiation of Medicarecoverage."

The meeting may have been counterproductive, however. No federalregulator enjoys being called on the carpet at Capitol Hill toexplain his or her actions. In addition, some Washington observersbelieve that the ICP was misleading in the way it promoted thebriefing to members of the PET community.

The ICP intended the briefing to be as positive and constructiveas possible, Kirchner said.

"Our position was definitely intended to be constructive,not confrontational," he said. "I hope it was perceivedthat way."

PET proponents left the caucus with no indication when PETwould wake up from its regulatory nightmare. Some relief couldcome from the FDA, ironically, which appears to be close to approvingthe NDA filed for FDG.

Downstate Clinical PET Center at Methodist Medical Center ofIllinois in Peoria filed the NDA in September 1992. The centermade revisions to the NDA in January 1993 and resubmitted theapplication.

The FDA this month was reviewing the application's packageinsert language and appears to be nearing a decision on the radiopharmaceutical,according to Daniel Bingham, a radiochemist at the center. Thecenter expects FDA approval between July and December.

Even if the Peoria NDA gets FDA approval, there are still questionsas to whether the FDA will require every PET center to submitan NDA for its own formulation of FDG. In any event, the PET communitywould like to see the issue of PET Medicare coverage separatedfrom FDA actions. There are indications that HCFA is moving inthat direction.

"HCFA officials are willing to review the possibilitythat there could be some definition of coverage without waitingfor FDA approval," Kirchner said. "It indicates theinterest and willingness of HCFA administrators to deal with whatis a difficult problem for them: a technology that doesn't quiteconform to what they've dealt with in the past."