Molecular Imaging News
September 9, 2005
National Oncologic PET Registry Expected to Open in Fall
The National PET Data Registry is expected to begin accepting case studies this fall pending approval of the registry forms and procedures by the Centers for Medicare & Medicaid Services (CMS). Acceptance of cases by the registry will open the door to Medicare reimbursement for PET studies for a wide variety of oncologic imaging studies while the registry collects data on the cost effectiveness of PET for each indication.
The registry was approved in January when CMS announced that it would expand reimbursement for PET imaging studies to include all cancers and previously noncovered indications, except breast cancer diagnosis and regional lymph node staging, provided that patients either be enrolled in a high quality clinical trial or in an ?FDG PET clinical study that is designed to collect additional information ? to assist in patient management.? Requirements include that the study address specific hypotheses, collect appropriate data elements, utilize qualified providers to perform the scans and interpret the results, report data on patients not enrolled in other qualified clinical trials, and follow federal laws and patient confidentiality regulations.
The National PET Data Registry was developed to implement the clinical study requirement. It will allow CMS to evaluate the effectiveness of PET as a tool for the diagnosis, staging, and monitoring of therapy in the previously noncovered indications. Previously covered indications and the newly covered cervical cancer indication will not submit data to the registry. The registry is administered by the American College of Radiology Information Network (ACRIN).
An application fee of $50 per PET location and a per case fee of $50 will cover registry costs. (Mobile PET providers will be required to submit an application for each site of service.) The statisticians and professional database designers at ACRIN worked with CMS, professional societies including SNM, and clinicians to develop the database protocol. Gary Dillehay, MD, chair of the SNM Coding and Reimbursement Committee, was SNM's representative to the ACRIN team. As a clinician, he provided input on the clinical relevance of the data that will be collected and the appropriate level of clinical information that practitioners will be asked to provide.
Participating physicians will send a pre-PET Case Report Form (CRF) to the referring physician if the PET study is covered by participation in the PET registry. This form must be returned to the PET facility, which in turn will forward the form to ACRIN. This data on the form must be entered by 12 midnight on the day of the PET scan to qualify for reimbursement, Dillehay said. The form will include information about why the PET scan is being performed: diagnosis, staging, suspected recurrence, or therapy monitoring. In addition, the referring physician will note if the patient has a known cancer, if they know the stage, and the planned therapy if PET were not available. After the scan is completed, the formal report of the PET study is sent to ACRIN. ACRIN will then email the PET facility and the referring physician noting that they have received the report and requesting the post-PET CRF. This form asks how the PET scan confirmed the diagnosis or changed the management of the case. This must be returned to ACRIN within 30 days or payment will be denied. The referring physician or site will then be notified that the requirements have been met so that they can submit the bill to Medicare.
No time frame has been specified for the clinical study, but the number of indications that can be submitted to the registry will naturally decline as coverage determinations are issued by CMS based on the data the registry accumulates. For common cancers, a year?s worth of data may be sufficient, Dillehay said. The study will continue to register cases for less common cancers for much longer.
In the decision summary CMS stated: We are particularly interested in seeing evidence that would permit us to make a coverage or non-coverage decision, i.e., to move an FDG PET indication from coverage under a clinical trial or study to coverage or non-coverage based on definitive evidence of benefit, no benefit, or harm.? We strongly encourage oncology imaging communities to develop evidence-based clinical practice guidelines for the use of PET and other cancer imaging modalities in diagnosing, staging, restaging, and monitoring of cancer patients.