National Oncologic PET Registry (NOPR): Update
The long-awaited National Oncologic PET Registry (NOPR) remains on course for a planned launch in late 2005. The protocol has been finalized, programming of the web site to be used for data entry is progressing well, and final operational details are being worked out with the Centers for Medicare and Medicaid Services (CMS). Educational materials for PET facilities and referring physicians are being prepared.
The primary purpose of this update is to dispel a recently circulating rumor that participation in the registry was going to require that the PET facility be accredited by the American College of Radiology. This is NOT correct. Neither ACR nor ICANL accreditation is required for participation. All PET facilities that are approved providers for the Medicare program will be able to participate.
Please check the AMI web site periodically at http://www.ami-imaging.org for registry updates.
Academy of Molecular Imaging
Tel: 310-267-2614
The National Oncologic PET Registry (NOPR) was developed in response to the Centers for Medicare and Medicaid Services (CMS) proposal to expand coverage for FDG-PET to include cancers and indications not presently eligible for Medicare reimbursement. Medicare reimbursement for these cancers will be available 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 is implementing this registry for CMS. The NOPR is sponsored by the Academy of Molecular Imaging (AMI) and is managed by the American College of Radiology (ACR) through the American College of Radiology Imaging Network (ACRIN). The NOPR is endorsed by the American College of Radiology (ACR), the American Society for Clinical Oncology (ASCO), and the Society for Nuclear Medicine (SNM).
Any PET facility that is approved to bill CMS for either technical or global PET charges can apply to participate in the NOPR. Sites are not required to have ACR or ICANL accreditation to participate. When a registered PET facility enters a patient on the NOPR, the patient's referring physician will be asked to complete both pre- and post-PET data collection forms that ask several questions regarding the patient's planned management. The PET Facility will enter this information and a copy of the PET scan report into the NOPR database via a Web form. If the PET facility completes the data collection process in a timely fashion, the facility can bill for the Medicare procedure.
Below are several helpful links:
Starting December 5, 2005 visit the
NOPR Web site.
The American College of Radiology Information Network (ACRIN) website has posted some early details of the expected process.
How the National PET Data Registry will Work - The Application Process
The CMS Decision Memorandum
The objectives and goals of this data collection are as follows:
- Primary objective: To assess the effect of FDG PET on referring physicians’ plans of intended patient management across the spectrum of the expanded cancer indications for FDG-PET.
- Secondary objective: To assess the effect of FDG-PET on referring physician’ plans of intended management in relation to cancer-type, indication, performance status, physicians role in management, and type of PET.
- First goal: To acquire data that can be used to evaluate PET and PET/CT in a manner that does not interfere with the clinical care of the patient.
- Second goal: To minimize hassle to patients, PET centers and referring clinicians while acquiring the data.
Facility Registration
NOPR will launch PET facility registration on November 27, 2005 at the annual meeting of the Radiological Society of North America (RSNA) in Chicago. Physicians and administrators attending the conference can complete the pre-registration form at the ACR Booth (#3950 South Building, Hall A) and have the balance of the registration materials emailed to their facility's designated contact. Booth visitors also can sign up to receive PET Registry updates and preview the NOPR Web site. The NOPR Web site will be activated on December 5, 2005 and will provide access to facility registration forms, sample data collection forms, information for clinicians and more.
Patient Registration
Although the NOPR will begin the PET facility registration process at RSNA, PET centers cannot enter patients into the Registry until final approval is received from the Centers for Medicare and Medicaid Services (CMS). It is hoped that this approval will be awarded by the end of 2005.
What data can we expect to provide?
Details of the Registry are being finalized, and more information will be posted, as it is available.
The following information
is based on informal discussions with CMS and other sources we have consulted, but this information is not official or final. We
will post more information to this section, the Registry Forms section and the News section as it becomes available.
Below are examples of data that may be required before the PET scan concerning demographics:
- Specific reason for PET
- Cancer type and working stage
- Patient performance status
- Intended management
- Cancer care provider
Under "specific reason for PET", one of the following reasons would be selected:
- Diagnosis: To determine if a suspicious lesion is cancer
- Diagnosis: To detect an unknown primary tumor site in a patient with a confirmed metastatic lesion
- Diagnosis: To detect a primary tumor site in a patient with a presumed paraneoplastic syndrome
- Initial Staging of histologically confirmed, newly diagnosed cancer
- Monitoring treatment response during chemoRx, radiation therapy or combined modality therapy
- Restaging after completion of therapy
- Suspected recurrence of a previously treated cancer
Below are questions concerning the primary study endpoint on planned management of the patients may be asked and answered both before and after the study:
- If PET were not available, what would your current management strategy be? (Check one)
- Observation (with close follow-up)
- Additional imaging (CT, MRI) or other non-invasive diagnostic tests
- Tissue biopsy (surgical, percutaneous, or endoscopic)
- What treatment and type? (Check all that apply)
- Surgical
- Chemotherapy
- Radiation
- Other
- Supportive care only
- What is the treatment goal?
Anticipate that there will be 5-6 questions total after the scan has been performed. Three to four questions are
customized by PET indication, mostly requiring Yes/No answers, and two questions that are common to both the Pre-PET
Form and the Post-PET Form concerning intended management and cancer care provider information.
Getting Paid
After the pre-scan data has been submitted; the registered facility performs, reviews and reports the scan; then the post-scan data is submitted and if the data is collectled in a timely fashion the facility can bill Medicare for the procedure.
Covered Indications
NOPR expands coverage to most cancers not presently covered by Medicare, except for those that are nationally non-covered. Below is a table that outlines which studies are presently covered by Medicare, which studies are non-covered by Medicare, and which will be covered under National Oncologic PET Registry.
Coverage
of FDG PET for Cancer Indications
Effective
January 28, 2005
|
Indication
|
Covered1
|
Nationally
Non-covered 2
|
Covered By
NOPR 3
|
|
Brain
|
|
|
X
|
|
Breast
Diagnosis
Initial staging of axillary nodes
Staging of distant metastasis
Restaging, monitoring 4
|
X
X
|
X
X
|
|
|
Cervical
Staging as adjunct to conventional imaging
Other staging
Diagnosis, restaging, monitoring 4
|
X
|
|
X
X
|
|
Colorectal
Diagnosis, staging, restaging
Monitoring 4
|
X
|
|
X
|
|
Esophagus
Diagnosis, staging, restaging
Monitoring 4
|
X
|
|
X
|
|
Head
and Neck (non-CNS/thyroid)
Diagnosis, staging, restaging
Monitoring 4
|
X
|
|
X
|
|
Lymphoma
Diagnosis, staging, restaging
Monitoring 4
|
X
|
|
X
|
|
Melanoma
Diagnosis, staging, restaging
Monitoring 4
|
X
|
|
X
|
|
Non
small cell lung cancer
Diagnosis, staging, restaging
Monitoring 4
|
X
|
|
X
|
|
Ovarian
|
|
|
X
|
|
Pancreatic
|
|
|
X
|
|
Small
cell lung
|
|
|
X
|
|
Soft
tissue sarcoma
|
|
|
X
|
|
Solitary
pulmonary nodule (characterization)
|
X
|
|
|
|
Thyroid
Staging of follicular cell tumors
Restaging of medullary cell tumors
Diagnosis, other staging & restaging
Monitoring 4
|
X
|
|
X
X
X
|
|
Testicular
|
|
|
X
|
|
All
other cancers not listed herein
(all
indications)
|
|
|
X
|
1 Covered nationally based on
evidence of benefit. Refer to National Coverage Determination Manual Section 220.6 in its entirety for
specific coverage language and limitations for each indication. http://www.cms.hhs.gov/manuals/103_cov_determ/ncd103c1_Part4.pdf
2 Non-covered nationally based on
evidence of harm or no benefit.
3Covered only in specific settings discussed above if certain patients' safeguards are provided. Otherwise, non-covered nationally based on lack of evidence sufficient to establish either benefit or harm or no prior decision addressing this cancer. Medicare will notify providers and beneficiaries where these services can be accessed, as they become available, via the following:
4
Monitoring = monitoring response to treatment when a change in therapy is
anticipated.
This article may be helpful in understanding more about the Registry:
Clinical Decisions Associated With Positron Emission Tomography in a Prospective Cohort of Patients With Suspected or
Known Cancer at One Unites States Center
Bruce E. Hillner, Renuka Tunuguntla, and Melvin Fratkin
Journal of Clinical Oncology 22:4147-4156 (2004)
Disclaimer
This information provided by PETNET Solutions is based on published guidelines and on our experience, and is provided for
general information only, as a service and at no charge to our customers. It is based on information found in published
CMS National Coverage documents, but is not all-inclusive. We believe that the information set forth herein is generally
accurate; however, we cannot provide assurance that it is complete, accurate or current. Always check with your local
insurance carriers, as coverage may vary by region. The referring physician is responsible for pre-authorization and
providing proof of medical necessity for any PET scan. PETNET Solutions and its representatives hereby expressly disclaim any
and all liability for claims, including bodily injury or death, arising from any reliance on the information set forth herein.