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: 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:

Under "specific reason for PET", one of the following reasons would be selected: 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: 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.