Regulatory issues hamper launch of new PET registry

Backers of a huge study examining the effect of PET on patient management face regulatory problems that threaten to delay a planned July 1 implementation of expanded Medicare Part B coverage of FDG-PET for cancer imaging.

The Centers for Medicare and Medicaid Services mandated the study in November when it approved Medicare Part B payment for PET imaging of most cancers not previously covered by the federal healthcare program. CMS contracted with the American College of Radiology Imaging Network (ACRIN) to manage a patient registry that will capture referring-physician survey data collected before and after patients are imaged.

Through pre- and post imaging questionnaires, researchers hope to measure how PET influences physician decision making concerning patient management. Medicare will deny payment for procedures when the referring physician fails to complete the required surveys.

The unique arrangement is part of a compromise worked out between the Academy of Molecular Imaging and CMS, according to AMI president Dr. R. Edward Coleman. The AMI has lobbied Medicare to expand the covered applications of PET to include most forms of cancer since the first indications for PET cancer imaging were approved in 2000. CMS resisted granting payment for more applications until PET supporters could demonstrate that the added costs would translate into better patient care.

A breakthrough came last October, when a prospective study examining how PET influences the clinical management of cancer at a single hospital appeared in the Journal of Clinical Oncology (2004, 22[20]: 4147-4157). The study by Dr. Bruce E. Hillner, associate chair of internal medicine at Virginia Commonwealth University, found that PET led to changes in intended management in 61% of patients. It also demonstrated to CMS and AMI officials that it was possible to design a trial that could gain almost universal support from referring physicians to sort out how PET imaging affects the attending physician's decision-making process. ACRIN recruited Hillner as chief architect of the tumor registry, and his experimental model was adopted as the basis for its massive clinical trial, said Dr. Bruce J. Hillman, ACRIN chair.

Unanticipated provisions of the National Paperwork Reduction Act are the most alarming of several problems that now threaten to delay the planned July implementation of Medicare's expanded payment policy, Hillner said. As of mid-April, NPRA regulators had yet to review crucial survey forms, and such reviews can take up to three months. Hillman was still waiting for CMS to exempt providers from institutional review board approval for human subject research. Patient privacy questions associated with the Health Insurance Portability and Accountability Act and issues relating to ownership of and public access to data compiled by the ACRIN registry also remained unresolved.

Diagnosis of early breast cancer was exempted from Medicare's new policy. The exemption will allow providers to bill Medicare for FDG-PET to monitor response to cancer therapies, said Susan Halliday, a PET practice consultant in Ovilla, TX.

Medicare reimbursement rates for the new indications 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, a rate that became effective in April. Providers will be paid $211 for FDG, and professional fees are $80 to $100 per procedure.

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

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. They must file a postprocedural survey tracking their follow-up impressions two weeks later. The questionnaires will be transmitted to ACRIN, and an elaborate communications system will keep all parties informed about reporting status.

Among other unresolved issues, planners have yet to decide how long the registry must operate before enough information is collected to perform analyses. According to Hillman, data analysis may begin for highly prevalent cancers as soon as six months after program initiation. For rarer cancers, two years of data collection may be necessary.