The National Oncologic PET Registry (NOPR) will start accepting patient entries on May 8, 2006. The last step in the process for launching the NOPR occurred when The American College of Radiology (ACR) Institutional Review Board (IRB) reviewed and approved the a slightly modified project plan. On February 10, 2006 the Centers for Medicare and Medicaid Services (CMS) announced the agreement with the NOPR to collect data regarding PET scans, thereby allowing for expanded coverage of oncologic PET by Medicare ("coverage with evidence development"). Shortly following that announcement, it became apparent that some changes were necessary related to IRB review and approval, and subject consent.

The major change to the original project design is that the research in which the NOPR entity will be engaged is no longer considered exempt from IRB approval. However, PET centers and referring physicians are not considered to be engaged in the NOPR research and do not need separate IRB approval.

The new project design requires both the patient and the referring physician to indicate their willingness to participate in the research component of the NOPR, although written informed consent is not needed. Should either the patient or referring physician choose not to participate in the NOPR research, the information pertaining to that specific patient's PET scan will be excluded from the research database. Refusal of either the patient or referring physician to participate in the NOPR research will not effect CMS reimbursement for the PET scan. As originally planned, CMS reimbursement for PET scans covered by the NOPR is based upon receipt of the required information from the referring physician within the designated timeframe.

All project changes have been reviewed and approved by the ACR IRB. At this time, it is expected that all infrastructure and processes necessary for operation of the NOPR, in accordance with the new regulatory requirements, will be in place to support the NOPR activation on Monday, May 8.

The NOPR will host a live Web cast to address program details and answer questions. This free Web cast will be open to all interested persons and a notice of the program's date and time will be sent shortly.