ACRIN Partners with AMI to Implement National PET Data Registry


Significant expansion of Medicare coverage for positron emission tomography (PET) indications is on the horizon. The Centers for Medicaid and Medicare Services (CMS) announced in January that PET scans will be available for Medicare beneficiaries for indications currently not covered "when the patient and doctor participate in high-quality clinical studies or submit information to a PET database."

Members of the Academy of Molecular Imaging (AMI) have been working with CMS representatives in recent years to develop the PET database concept to ensure that sufficient data are available for making future PET coverage decisions. The project, said AMI President R. Edward Coleman, MD, "will provide valuable data on the accuracy of PET and its impact on physician management of patients."

The American College of Radiology Imaging Network's electronic data collection infrastructure for conducting medical imaging clinical trials makes it a logical partner to work on the development and maintenance of the National PET Data Registry.

"The ACRIN leadership looks forward to applying its resources to implement this innovative program," said ACRIN Network Chair Bruce J. Hillman, MD. "The more radiologists and physicians participate in the program, and the more data are submitted to the registry, the faster an indication could be approved for reimbursement."

Coincident with CMS' decision to move forward with the PET database project, research results on the effect PET imaging has on the management of cancer patients' care were published in the October 2004 issue of the Journal of Clinical Oncology. The study's author, Bruce Hillner, MD, a professor of medicine at Virginia Commonwealth University, was recruited as principal investigator of the project and key program architect. Hillner's research employed pre- and post-PET questionnaires to obtain information from clinicians, an approach that will be closely mirrored by the PET Data Registry.

The PET Data Registry team has met weekly since early February to develop draft case report forms (CRFs) for data collection and initial work processes in consultation with CMS. Team members widely disseminated the proposed project details to gain feedback from professional organizations and individuals.

"The many instructive comments we received helped the registry team to make the case report forms as concise and the data collection process as efficient as possible," noted Barry A. Siegel, MD, chair of ACRIN's Nuclear Medicine/PET/SPECT Committee and a member of the AMI Board of Directors. "Our goal has been to minimize the work required by busy clinicians and PET facility personnel and, at the same time, satisfy CMS requirements for obtaining data upon which future reimbursement decisions can be made."

CMS staff have approved both the final CRFs and the data collection process that were submitted for their review in late March. ACRIN has begun creating the Web-based CRFs and implementing the administrative processes for managing the project. Prior to the PET Data Registry's implementation, CMS must finalize details related to data confidentiality and ownership. CMS representatives expect a project start date of mid-summer 2005.

Updates on the status of the PET Data Registry will be available on the ACRIN Web site (www.acrin.org) and the AMI Web site (www.ami-imaging.org/index.htm).

How the National PET Data Registry will Work

Application Process

Any PET facility that is approved to bill Medicare for either technical or global charges can apply to participate in the PET Data Registry. Mobile PET providers will be required to submit an application for each location of service. An initial $50 application fee is required. In addition, a $50 fee, payable in advance, will be assessed for each case registered in the PET Data Registry. PET facilities will be encouraged to schedule monthly payments to ACRIN based on the number of scans anticipated to be eligible for the PET Data Registry.

Process for enrolling a case in the National PET Data Registry:

  1. A referring clinician contacts the facility requesting a PET study for an indication only covered by participation in the PET Data Registry.

  2. The PET facility obtains basic demographic information from the referring clinician and then provides this information to ACRIN via a Web form, at which time a Registry Study Number will be assigned.

  3. Once a Registry Study Number is created, the referring clinician receives a Case Report Form (CRF) from the PET facility to be completed and returned prior to the day of the PET scan.

    IMPORTANT: Pre-PET CRF data must be entered by midnight of the day of the PET scan for the study to qualify for reimbursement.

  4. Once the PET scan has been performed, the PET facility prepares and sends a report to the clinician as usual, enters the study completion date into a Web form, and delivers the text report electronically to ACRIN. (Note: the final step may not be implemented at the project's onset.)

  5. Approximately 5 days after the PET scan report is sent, the PET facility sends the clinician a postscan CRF for completion.

  6. ACRIN notifies the PET facility when all case data have been entered so that the facility can then bill CMS for the study. The PET facility can check on a specific patient's status at any time using the Registry Study Number or on the performance of a specific referring clinician.

The pre- and postcase report forms the referring clinician will complete include approximately 5 questions regarding a patient's planned management. As project principal investigator, Hillner points out, "the primary study endpoint, asked before and after the PET scan, is 'If PET was not available, what would be your current management strategy?'"