The National Oncologic PET Registry

Study Overview
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Brief Summary
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The Centers for Medicare & Medicaid Services (CMS), as the Federal agency that administers the Medicare program, only pays for positron emission tomography (PET) scans in patients with cancer for certain reasons and for certain types of cancer. This study was developed to help CMS determine if they should pay for PET scans for additional reasons and additional types of cancer. In order to collect the information needed to decide which other types of cancer should be covered by Medicare, CMS will provide payment for the otherwise non-covered PET scans of patients who are properly registered with the National Oncologic PET Registry (NOPR). This information will then be analyzed to determine the effect PET scans had on the way physicians planned to treat their patients.

Detailed Description
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The National Oncologic PET Registry (NOPR) was developed in response to the Centers for Medicare & Medicaid Services (CMS) proposal to expand coverage for positron emission tomography with F-18 fluorodeoxyglucose (FDG-PET) to include cancers and indications not presently eligible for Medicare reimbursement. Under this coverage with evidence development (CED) program, Medicare reimbursement for these cancers can be obtained if the patient's referring physician and the provider submit data to a clinical registry to assess the impact of PET on cancer patient management. The NOPR implemented this registry for CMS. The NOPR is sponsored by the World Molecular Imaging Society (formerly the Academy of Molecular Imaging), and managed by the American College of Radiology through the American College of Radiology Imaging Network. The original goal of the National Oncologic PET Registry was to assess the effect of positron emission tomography with F-18 fluorodeoxyglucose (FDG-PET) on referring physicians' plans of intended patient management for those cancers and indications not currently eligible for reimbursement from CMS. Data were collected from the referring physician before and after the 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) are eligible for reimbursement by CMS. Based in part on data obtained from the NOPR, CMS expanded coverage for FDG-PET in patients with cancer on April 3, 2009 and further expanded coverage on June 11, 2013. Specifically, on June 11, 2013, CMS issued a final decision memorandum ending the prospective data collection requirements under CED for all oncologic indications for FDG-PET. Overall accrual to the FDG-PET registry was nearly 288,000 scans. On February 26, 2010, CMS announced its decision to cover the use NaF-18 PET to identify bone metastasis. Under this new policy, the use of NaF-18 PET would be covered only under an approved (CED) program. The NOPR obtained CMS approval to develop a registry for NaF-18 as an amendment to the then-existing NOPR for FDG-PET. The NaF-18 PET registry component of NOPR was activated for accrual on February 7, 2011. Estimated total accrual to the NaF-PET registry is 45,000 cases. As with the registry for FDG-PET, the goal of the NaF-18 PET registry component is to assess the impact of this imaging examination on referring physicians' plans of intended management of patients with known or suspected osseous metastatic disease. Data are collected from the referring physician before and after the PET study, as well as 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) are eligible for reimbursement by CMS.

Official Title
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The National Oncologic PET Registry

Conditions
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Cancer

Intervention / Treatment
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* Other: PET scanning in cancer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All Medicare beneficiaries who are referred for NaF-18 PET to identify bone metastasis are eligible to be included in the NOPR. Exclusion Criteria: NaF-18 PET for other (non-oncologic) indications. NaF-18 PET performed as part of a clinical trial approved by CMS.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| FDG-PET<br>F-18 fluorodeoxyglucose (FDG-PET) | Other: PET scanning in cancer<br>* Collection of institutional practice PET imaging data<br>* Other names: NOPR;|
| NaF-18 PET<br>F-18 sodum-fluoride (NaF-18 PET) | Other: PET scanning in cancer<br>* Collection of institutional practice PET imaging data<br>* Other names: NOPR;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the effect of PET on referring physicians' plans of intended patient management of patients with cancer types eligible for inclusion in the National Oncologic PET Registry. |  | PET Scans as ordered by treating physician per CMS frequency guidelines | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Patients with proven or suspected cancer referred for NaF-18 PET to identify bone metastasis