The National Oncologic PET Registry



Status:Recruiting
Conditions:Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any
Updated:4/21/2016
Start Date:May 2006
End Date:December 2016
Contact:Bruce Hillner, MD
Email:Hillner@vcu.edu
Phone:804-828-5129

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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.

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.

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.
We found this trial at
1
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Philadelphia, Pennsylvania 19103
Phone: 215-717-0859
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