Report from AMI: Terms of CMS-mandated PET tumor registry become clear

Requirements for a Medicare-mandated PET tumor registry that will track how FDG-PET imaging influences patient management were announced Sunday at the opening session of the Academy of Molecular Imaging annual meeting in Orlando.

The Centers for Medicare and Medicaid Services asked for an outcomes study measuring the clinical impact of FDG-PET in November 2004 when it approved payment for FDG-PET imaging for the evaluation of most types of cancer.

Although the diagnosis of early breast cancer was excluded from coverage, reimbursement was granted for FDG-PET imaging associated with all other cancers not previously qualifying for Medicare payment, according to Dr. Bruce Hillner, associate chair of internal medicine at Virginia Commonwealth University.

In addition to billing for diagnosis and staging, physicians can for the first time charge Medicare for procedures that monitor the progress of therapy, he said.

CMS will begin paying for the additional FDG-PET applications when the registry is implemented. The reimbursement rates will be the same as for other FDG-PET procedures. The Medicare technical fee for hospital-based PET imaging of cancer is $1150 for PET and will be $1250 for PET/CT when that rate becomes effective on April 4, according to Sue Halliday, a PET practice consultant in Ovilla, TX. Providers are reimbursed $11.11 for FDG, and physicians reading the studies are paid from $80 to $100 per procedure.

Based on new CPT codes, regional Medicare carriers are receiving the rates paid to nonhospital providers for cancer-related PET, Halliday said. They range from about $1700 for PET to about $3000 for PET/CT. Some carriers are paying for FDG separately, while others are folding it into the technical component. The in-hospital professional fee schedule also applies to outpatient PET and PET/CT interpretation.

The target date to implement the registry is July 1, 2005, according to Hillner. He anticipated no change in Medicare reimbursement for previously approved PET procedures despite Medicare adoption of CPT codes this year for those procedures.

Hillner was recruited as an architect of the registry when his critique of PET research was published in the Journal of Clinical Oncology at the same time CMS linked the creation of the registry with its plan for greatly expanded coverage. The American College of Radiology Imaging Network was contracted to manage the project. ACRIN created the study design with help from the American College of Radiology, American College of Clinical Oncology, and AMI.

Referring physicians will be surveyed twice for each procedure they prescribe from the new set of FDG-PET applications, Hillner said. A pretest survey will track the management strategies referring physicians say they would have used if PET were not available when they ordered the procedure. Two weeks after the receipt of results, referrers will be queried on how FDG-PET findings affected decision-making concerning patient management. The registry will profile equipment inventories and utilization. Imaging services will also be required to file their radiologists' reports with the registry to aid its evaluation.

To encourage compliance, CMS linked reimbursement to participation in the registry. It will deny payment when referring physicians do not file a pretest survey with the registry before midnight on the day the procedure was performed, according to Hillner.

They must also file a postprocedural survey tracking their follow-up impressions two weeks later. The questionnaires will be either faxed or transmitted as e-mail messages to ACRIN. An elaborate communications system will keep all parties informed about reporting status, he said.

PET imaging services will pay a $50 application fee to join the registry. They will then pay ACRIN a $50 processing fee for each procedure, Hillner said.

Individual responses from referring physicians will be kept confidential. ACRIN will aggregate the results after two years of data collection. Its analysis will be reported as a peer-reviewed article, he said.

The registry was created as a remedy to a dearth of outcomes data to establish the validity of FDG-PET for staging cancers and guiding case management, Hillner said.

After emphasizing his work as a healthcare epidemiologist, Hillner said it was unfortunate that technical exhibitors at the AMI coverage depend entirely on anecdotal arguments to sell their wares.

"The era of anecdotal medicine is gone," he said.

All clinical sides take hard look at PET and PET/CT