FAQs Minimize
What is the NOPR?
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 (PET) with F-18 fluorodeoxyglucose (FDG) to include cancers and indications that were not eligible for Medicare reimbursement. With the advent of NOPR, Medicare reimbursement for these PET studies could be obtained if the patient’s referring physician and the provider submit data to a clinical registry to assess the impact of FDG-PET on cancer patient management. The NOPR has implemented this registry for CMS. In addition, in 2011, the NOPR implemented another component of the registry to assess the impact of PET with sodium fluoride F-18 (NaF-PET), used to identify bone metastasis, on cancer patient management. The NOPR is sponsored by the World Molecular Imaging Society (WMIS) and managed by the American College of Radiology (ACR) through the American College of Radiology Imaging Network (ACRIN)

Has the NOPR Been Approved by the Medical Community?
The NOPR received input from, and is endorsed by, the American College of Radiology (ACR), the American Society of Clinical Oncology (ASCO), and the Society for Nuclear Medicine (SNM). The NOPR worked with the Centers for Medicare & Medicaid Services (CMS) to develop this registry. 

When Did the NOPR Open?
The NOPR began accepting facility registrations in late November 2005 but patient registration did not begin until May 8, 2006. Revised data collection procedures for FDG-PET were implemented on April 3, 2009 in conjunction with an expansion in Medicare coverage for FDG-PET. The registry closed for data collection for FDG-PET on June 11, 2013 in conjunction with a further expansion in Medicare coverage for FDG-PET. Data collection for NaF-PET began on January 31February 7, 2011 and is continuing to the present time. 

What PET Facilities Can Join the Registry?
Any PET facility that is approved to bill CMS for either technical or global charges for PET or PET/CT can apply to participate in the NOPR. Sites are not required to have ACR or ICANL accreditation to participate. 

Does my Site Need IRB Approval to Participate in the NOPR?
The only entity engaged in research is the registry itself (i.e., NOPR); the NOPR uses the data it is collecting for research purposes when both the patient and the referring physician (and also the interpreting in the case of NaF-PET) 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 results) is required by CMS for payment for PET studies for all Medicare-insured patients undergoing PET scans included in the registry. Additionally, CMS is not conducting research. The subjects of the NOPR research, patients, referring physicians and interpreting 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, referring physicians and interpreting radiologists when all 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 the NOPR Operations Manual to assist in this process. The Office of Human Research Protections (OHRP) has reviewed the NOPR procedures for protection of human research subjects and found them to be in compliance with the applicable DHHS regulations. Any individual IRBs with questions can contact OHRP. 

Can a PET Facility Make Changes to the Posted NOPR Business Associates Agreement (BAA)?
No. Each participating PET facility must execute a HIPAA Business Associates Agreement (BAA). The current NOPR BAA has been modified to incorporate the requirements of the HITECH Act. To facilitate your registration, the BAA posted on the NOPR Website must be executed. We understand that you may wish to use your own BAA. However, because of the number of facilities participating in the NOPR, it is not practical for the NOPR to provide legal review for different agreements to ensure compliance with HIPAA requirements. We believe the BAA on the NOPR Web site meets the requirements of both the HIPAA Privacy and Security rules, as well as the HITECH Act. 

What Patients are Eligible for the NOPR? 
Medicare beneficiaries, including those with conventional Medicare coverage and those with Medicare HMO coverage, who are referred for NaF-PET for evaluation of proven or strongly suspected bone metastases are eligible to participate in the NOPR. 

Patients with insurance coverage other than Medicare, including Medicaid, are not eligible to participate in the NOPR. Patients with managed Medicare health plans, such as Medicare Advantage, are eligible for the NOPR (but see additional FAQs below regarding Medicare Advantage plans). 

What are the PET Facility's Responsibilities?
Below is a brief summary of the data collection procedure.
  • When a request is sent to the PET facility for a PET scan for which inclusion in the NOPR is required, the facility contacts the referring physician and obtains confirmation that the physician will submit the pre- and post-PET data requirements.
  • The facility registers the patient in the NOPR via a Web form, at which time a Registry case number is assigned.
  • The NOPR e-mail's confirmation to the PET facility.
  • If the PET facility indicated on the Case Registration Form that the Pre-PET form was not yet submitted, the database will e-mail a copy of the pre-PET form and a fax cover sheet for the PET facility to send to the referring physician.
  • The referring physician must complete and return the Pre-PET Form to the PET facility and the PET facility must enter the Pre-PET Form into the NOPR database by midnight of the day of the PET scan.
  • At some time before the PET study, or when the patient arrives for the PET scan, the PET facility will provide the patient with the ACR IRB-approved standard NOPR Patient Information Sheet that is posted on the NOPR Web site. The patient will be able to contact the NOPR directly for more information, if necessary. The patient will indicate his or her consent verbally to staff at the PET facility, either on the day of the PET study or within two working days after the PET study is completed. Written consent is not required. The PET facility will note in the database, on the PET Report Form, if the patient gave or withheld consent for use of his or her data in future NOPR research.
  • After the PET scan is performed, the PET facility sends the PET report to the physician, enters the study completion date into a Web form, and submits the report text electronically to the NOPR database. Note that the PET scan must be completed and the PET Scan Completion Form must be entered into the database within 14 days of case registration or the case will be marked as ineligible. For NaF-PET, the interpreting physician also is required to complete a PET Scan Assessment Form that must be entered into the NOPR database within 30 days of the PET scan. This form will also include an ACR IRB-approved Interpreting Physician Information Sheet. The interpreting physician will indicate on the PET Scan Assessment Form whether consent for use of the response data in future NOPR research has been given or withheld.
  • After the PET Report Submission Form is received, the database will send the PET facility a patient-specific Post-PET Form for delivery to the referring physician. This form will also include an ACR IRB-approved Referring Physician Information Sheet. The physician will indicate on the Post-PET Form whether consent for use of the response data in future NOPR research has been given or withheld. All data will be sent to CMS, but the dataset used by NOPR investigators for research will contain only the data of patients and referring and interpreting physicians when all have consented to have the data included. This form must be completed, returned to the PET facility, and entered into the NOPR database within 30 days of the PET scan.
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 for NaF-PET 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 studies performed as part of the registry, providers should refer to current official Medicare claims and coverage instructions:
The Medicare Claims Processing Manual for PET (Transmittal 527)

The National Coverage Determinations Manual containing the PET NCD (Section 220.6) pages 22 – 49 

Billing Clarification for Positron Emission Tomography (Sodium Fluoride -18) (NaF-18) PET for Identify Bone Metastasis of Cancer in Context of a Clinical Trial 

MLN Matters Number MM7125
For information on the mandatory reporting of an eight-digit clinical trial number on claims (currently in use for all CED programs: https://clinicaltrials.gov/)see: 

The clinical trial number for the NOPR is 00868582

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. 

Will Managed Medicare Plans Such as Medicare Advantage Reimburse for Patients Entered in the Registry?
Medicare Advantage (MA) beneficiaries are eligible to be included in the registry. The MA plan will make payments for MA enrollees. NOPR claims should be billed to the MA plan. This policy is explained in more detail in Publication 100-16Chapter 4: Managed Care Manual 10.7.3 – Benefits and Beneficiary Protections – Payment for Clinical Studies Approved Under Coverage with Evidence 

Are Medicare Advantage Beneficiaries Who Participate in the NOPR Liable for Deductible or Co-Payment?
Beneficiaries enrolled in Medicare Advantage (MA) plans are responsible for for cost-share applicable to their MA plan., meaning that the deductible is NOT waived. The beneficiaries in MA plans are liable for coinsurance amounts under MA plan rules. 

The PET provider should bill the MA enrollee for any cost-sharing. This includes both co-payments and deductibles.. 

Is Pre-Authorization Still Needed for Patients in Managed Medicare Plans?
Publication 100-3 Section 310.1 of the NCD Manual: Routine Costs in a Clinical Trial states that Medicare Advantage (MA) plans cannot require prior authorization or approval for enrollees participating in clinical trials or for coverage with evidence development in CMS-approved trials. . However PET facilities should pre-certify or send notification to the MA plan. The MA plans may direct patients to their preferred providers assuming the MA plan preferred providers are participating in the NOPR NaF-PET registry. 

Does the NOPR Apply to Hospitalized Medicare Inpatients?
Yes. Note that the technical charge for a PET study on a Medicare inpatient is not billed directly, but rather is considered to be covered by the Diagnostic Related Grouping (DRG) payment to the hospital for that patient. Inclusion of the patient in the NOPR is necessary, however, for professional component reimbursement for the PET study. 

Will a Medicare Patient's Medigap Insurance Cover the Cost of the Co-payment for a Registry PET Scan?
Yes, Medigap insurance should cover the co-payment, as for any other Medicare covered service,in patients with traditional Medicare coverage (Part A and Part B).

No, for patients in Medicare Advantage (MA) plans, as MA beneficiaries are liable for co-payment/co insurance, where Medigap insurance does not typically apply. 

Will Managed Medicare Plans Such as Medicare Advantage Reimburse for Patients Entered in the Registry?
Medicare Advantage (MA) beneficiaries are eligible to be included in the registry and CMS will make payments for MA enrollees on a fee-for-service basis for covered clinical trial costs. CMS determined that the policy of making payments on a fee-for-service basis for covered clinical trial items and services provided to MA enrollees is appropriate because the capitation rates do not account for costs of scans provided through NOPR as part of a Coverage with Evidence Development clinical study. Effective April 3, 2009, NOPR claims should be billed to the Medicare Administrative Contractors (MAC) instead of the MA plan; the MAC will make payments directly to providers of the PET scan, on a fee-for-service basis. This policy is explained in more detail in Publication 100-16, Chapter 8: Managed Care Manual 40.4.3 - Special Rules for the September 2000 NCD on Clinical Trials. 

Are Medicare Advantage Beneficiaries Who Participate in the NOPR Liable for Deductible or Co-Payment?
Beneficiaries enrolled in Medicare Advantage (MA) plans are not responsible for meeting either Part A or Part B deductibles, meaning that the deductible is waived. The beneficiaries in MA plans are liable for coinsurance amounts under MA plan rules. 

The PET provider should bill the MA enrollee for any cost-sharing. The enrollee should not be billed for any deductible. 

Is Pre-Authorization Still Needed for Patients in Managed Medicare Plans?
Publication 100-3 Section 310.1 of the NCD Manual: Routine Costs in a Clinical Trial states that Medicare Advantage (MA) plans cannot require prior authorization or approval for enrollees participating in clinical trials. However, providers can pre-certify to direct patients to their preferred providers assuming that the providers follow HMO guidelines. 

Will Non-Medicare Insurers Reimburse for Patients Entered in the Registry?
No, there are no non-Medicare insurers who have elected to reimburse for patients entered in the registry. Patients with Medicaid and other types of insurance coverage other than Medicare are not eligible to participate in the NOPR. Medicare or a managed Medicare plan must be the primary insurance for coverage under NOPR. 

Can the NOPR be Used for PET Studies Performed with Radiopharmaceuticals Other Than NaF ?
No, only oncologic PET studies performed with sodium fluroide F-18 (NaF) are eligible for inclusion in the registry. 

Can the NOPR be Used for NaF-PET Studies Performed for Indications Other Than Evaluation of Bone Metastases?
No, only NaF-PET studies obtained for evaluation of proven or strongly suspected bony metastatic disease are eligible for inclusion in the registry. Thus, for example, an NaF-PET study obtained to evaluate for fracture or other osteomyelitis is not eligible for inclusion in the registry. 

Who Has Access to NOPR Data?
The members of the NOPR working group, NOPR project staff at the American College of Radiology Imaging Network (ACRIN) and the Center for Statistical Sciences at Brown University, and staff of the Centers for Medicare and Medicaid Services (CMS). 

Who Owns the NOPR Data?
The World Molecular Imaging Society, as an Agent of the Centers for Medicare and Medicaid Services (CMS), will maintain ownership of the data collected by American College of Radiology (ACR) for the NOPR. The data will reside in an electronic database at the ACR. 

Why Can't We Attach Our PET Scan Report as a Word Document?
In an effort to minimize the spread of computer viruses and maximize their research value, the PET Report Submission Form for NaF-PET will accept only direct text entry of the report. PDF and JPEG files will not be accepted as uploaded attachments. Text from Microsoft Word documents, or any other type of text file, can be cut and pasted into the text field on the form.
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