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NOPR Objective
The goal of the National Oncologic PET Registry is to assess the effect
of positron emission tomography with F-18 fluorodeoxyglucose (PET) 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
tool on the NOPR Web site, www.CancerPETregistry.org. The facility will
complete the Facility Pre-Registration and Registration Forms online
through the PET Facility Registration link.
After completing the Registration process the facility must send an executed
ACR HIPAA Business Associates Agreement (BAA) to NOPR
Headquarters at 1818 Market Street, Philadelphia, PA 19103. The ACR HIPAA BAA is available on the NOPR Web site under
Sample Forms. 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, P.O. Box 2348,
Merrifield, VA 22116-2348. 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 is e-mailed a Pre-PET Form and a fax cover sheet for delivery of the Pre-PET Form to the referring physician (if this form has not alredy been submitted with the referral). The Pre-PET Form must be completed and returned 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 orally 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.
- Once the PET scan has been performed, the PET facility prepares and sends a report to the referring physician as usual, 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.
- After the PET scan report is received, the database sends the PET facility the case-specific Post-PET Form and a fax cover sheet for delivery of the Post-PET From 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 physicians when both have consented to have the data included. The Post-PET form must be completed 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.
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