The National Oncology PET Registry (NOPR)

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NOPR Objective
The goal of the National Oncologic PET Registry is to assess the effect of positron emission tomography (PET) with F-18 fluorodeoxyglucose (FDG) on referring physicians’ plans of intended patient management for those cancers and indications not currently eligible for reimbursement from the Centers for Medicare and Medicaid Services (CMS). Data will be collected from the referring physician before and after the FDG-PET study. If complete and timely data are reported to the NOPR within 30 days of the PET scan, the PET facility and interpreting physician (nuclear physician/radiologist) will be eligible for reimbursement by CMS.

Facility Registration
Any PET facility that is approved to bill CMS for either technical or global charges can apply to participate in the NOPR. Sites are not required to have ACR or ICANL accreditation to participate. Mobile PET providers will be required to submit an application for each location of service. Interested facilities will register via the Facility Registration Form tool on the NOPR Web site, www.CancerPETregistry.org. The facility will complete the Facility Registration Form online and submit an executed HIPAA Business Associates Agreement (BAA) to NOPR Headquarters. A standard HIPAA BAA is available on the NOPR web site, www.cancerPETregistry.org. Facilities will be charged a $50 facility registration fee and $50 for each patient entered on the Registry. Facilities will fund an escrow account with the NOPR and new patient registrations will be deducted from this account. Registration and escrow fees may be paid by credit card or check. Checks should be made payable to the ACR-NOPR and mailed to the American College of Radiology, 1818 Market Street, Ste. 1600, Philadelphia, PA 19103. The facility ID# must be written on the check. PET facilities can check on their escrow balance and other account information on the NOPR Web site.

Patient Eligibility
Medicare beneficiaries who are referred for PET for essentially all oncologic indications that are not currently reimbursable under Medicare (see Indications table for specific exclusions) are eligible to participate in the NOPR. The patient's referring physician must agree to complete Pre- and Post-PET data collection forms that include several questions regarding the patient's planned management.

Data Collection Process
The PET facility is responsible for entering all study data into the Registry database at www.CancerPETregistry.org as follows:

A referring physician contacts the facility requesting a PET study for an indication covered only by participation in the NOPR.
The PET facility obtains basic demographic information from the referring physician and then submits this information to NOPR via a Web form, at which time a Registry case number is assigned.
Once a Registry case number is created, the PET facility administrator is e-mailed the Pre-PET Form that must be completed and signed by the referring physician for entry into the NOPR database by midnight of the day of the PET scan.
Once the PET scan has been performed, the PET facility enters the study completion form within 14 days of the case registration date.
After the interpreting radiologist prepares the report, the PET facility prepares and sends the report to the referring physician as usual, and submits the report text electronically to the NOPR database.
The NOPR database sends a patient specific post-PET form to the PET facility for completion by the referring physician. The post-PET form must be completed and signed by the referring physician, and entered into the NOPR database within 30 days of the PET scan.
The NOPR database will notify 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 the case status of their patients at any time using the PET Facility Reporting Tools available on the NOPR Web site.

How to Obtain Medicare Reimbursement The NOPR database will notify the PET facility when all case data have been entered. After it receives this notification and not before, the PET facility (and the interpreting physician, if technical and professional component billing are performed separately) can bill CMS for the study. Billing should be performed using the appropriate CPT code for (1) tumor PET imaging (78811, 78812, or 78813); (2) tumor PET/CT imaging (78814, 78815, or 78816); or (3) for brain imaging (78608) when a dedicated brain PET study was done for brain tumor evaluation. For specific details regarding how to bill studies performed as part of the registry, providers should refer to current official Medicare claims and coverage instructions:

We caution PET facilities, especially those with automated billing systems, to set up in advance, internal mechanisms to hold these claims until all of the required case data for the NOPR have been entered and this has been acknowledged by the NOPR database. Each PET facility can check on the status of its patients at any time via the reporting tools available on the NOPR Web site.

IRB Approval Requirements for PET Facilities
The only entity engaged in research is the registry itself (i.e., NOPR); the NOPR intends to use the data it is collecting for research purposes when both the patient and the referring physician have consented to the use of the information for this purpose. The ACR IRB has granted approval for the NOPR to engage in research using these data (see Appendix IV of the Operations Manual for more details).

Individual PET facilities and referring physicians and their staff are not engaged in research and therefore are not required to have IRB approval for their participation in the activities of the NOPR. Submission of the information for the registry (pre-PET and post-PET case report forms and the PET scan report) is required by CMS for payment for PET studies for all Medicare-insured patients with cancer indications included in the registry. Additionally, CMS is not conducting research. The subjects of the NOPR research, patients and referring physicians, can consent (or not) to allow their data to be used for purposes of the research being conducted at NOPR. The dataset used by NOPR investigators for research will contain only the data of patients and physicians when both have consented to have the data included.

Any participating PET facility may nevertheless elect to have its local IRB review its participation in the NOPR. Some IRBs require, as a matter of institutional policy, that they review all research conducted in the institution, even if only to determine that the facility is not engaged in the research. Materials are provided in Appendix IV to assist in this process. The Office of Human Research Protections (OHRP) has reviewed the NOPR procedures for protection of human research subjects and finds them to be in compliance with the applicable DHHS regulations. Any individual IRBs with questions can contact OHRP.

1818 Market Street, Suite 1600, Philadelphia, PA 19103. | 215.717.0859 | pet_registry@phila.acr.org