Information for PET Facilities Minimize
NOPR Objective
The initial goal of the National Oncologic PET Registry (NOPR) since it began operation in 2006 was 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 that were not eligible at that time for reimbursement under the Medicare program, based on the national PET coverage policy of the the Centers for Medicare & Medicaid Services (CMS). After the April 2009 expansion in CMS coverage for FDG-PET, the NOPR continued to collect similar data for many remaining cancer indications for FDG-PET (NOPR 2009).This data collection ended in June 2013, when CMS again revised its coverage policy for FDG-PET to allow for coverage of all cancer types and indications. 

Additionally, beginning in 2011, based on a February 2010 National Coverage Decision, the NOPR also is collecting data on referring physicians’ plans of intended patient management for Medicare patients undergoing PET with sodium fluoride-18 (NaF-PET) for evaluation of proven or strongly suspected bony metastatic disease [NOPR (NaF-PET)] 

Data are collected from the referring physician before and after the NaF-PET study, and from the interpreting physician. 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. 

Patient Eligibility
Medicare beneficiaries who are referred for NaF-PET for evaluation of bony metastatic disease 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. In addition, the interpreting physician must complete a scan assessment form. 

Data Collection Process
The PET facility is responsible for entering all study data into the Registry database at as follows:
  1. A referring physician contacts the facility requesting a NaF-PET study covered only by participation in the NOPR.
  2. 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.
  3. 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
  4. Once the PET scan has been performed, the PET facility enters the study completion form within 14 days of the case registration date.
  5. 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 interpreting physician also must complete an F-18 Fluoride PET Interpreting Physician Scan Assessment Form for entry into the database within 30 days after the PET scan
  6. 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.
  7. 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 
For NaF-PET studies, billing should be performed using the appropriate CPT code for (1) body PET imaging (78811, 78812, or 78813); or (2) body PET/CT imaging (78814, 78815, or 78816). For specific details regarding how to bill NaF-PET studies performed as part of the registry, providers should refer to current official Medicare claims and coverage instructions:
  1. CMS Coverage of NaF-18 PET to Identify Bone Metastasis

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 IRB with questions can contact OHRP.