NaF-18 PET Registry Overview

Overview of the National Oncologic PET Registry (NOPR) for Sodium Fluoride (NaF-18) PET Imaging

Background

• The National Oncologic PET Registry focuses on Sodium Fluoride (NaF-18) PET imaging for bone metastasis detection.

• The registry was initiated following the National Coverage Decision (NCD) from CMS under manual section 220.6.19.

Documentation Structure

• The presentation outlines the key areas:

  • Background: Discussing NaF-18 NCD (CMS manual 220.6.19)

  • Differences: Comparing FDG 2009 Registry vs NaF-18 Registry

  • Billing: Information related to billing processes.

  • Educational Information and Announcements: Updates on educational resources and announcements.

  • Questions: Addressing audience inquiries.

NCA Tracking Sheet

• Integrated discussions with CMS-CAG as of February 2009.

• CMS's request for reconsideration of NaF-18 PET was made on June 4, 2009.

• Sequence of decisions was recorded:

  • Proposed Decision issued on November 30, 2009

  • Final Decision concluded on February 26, 2010

• From this decision, the NOPR initiated the development of a registry for NaF-PET.

Registry Implementation

• Launch date for the NaF-PET registry was set for February 7, 2011, mirroring the operational framework of the FDG-PET registry.

NOPR Management and Structure

• NOPR, a national collaborative program, is sponsored and managed by key industry leaders:

  • Chair: Bruce Hillner, MD (Virginia Commonwealth University)

  • Co-chair: Barry A. Siegel, MD (Washington University)

  • Board Members: Include R. Edward Coleman, MD; Anthony Shields, MD, PhD; and statisticians from Brown University.

Coverage with Evidence Development (CED)

• NOPR is recognized as a CMS-approved CED program:

  • Inclusive of NaF-PET

  • Ensures all Medicare-eligible PET facilities can enroll (with fees).

  • Mandates the submission of timely pre-PET, PET evaluation, and post-PET data to CMS.

• Research findings will contribute to understanding the impact of PET imaging on treatment decisions.

Research Questions for CED Registry

• The central questions for CMS involve whether NaF-PET leads to better patient management outcomes:

  • Does it inform appropriate palliative care?

  • Does it lead to more appropriate curative measures?

  • What is its impact on quality of life and survival rates?

Primary Objectives of the NOPR (NaF-PET)

• Evaluate the effects of NaF-PET on referring physicians' intended management plans for patients known or suspected of having bone metastases.

• Additional goals include:

  • Ensuring access to bone PET for cancer patients.

  • Decreasing workload on PET centers and referring physicians.

  • Producing quality evidence to support potential CMS coverage expansion for PET.

Participation Requirements and Responsibilities

PET Facilities

• Facilities eligible to bill CMS can join NOPR-HF-PET without re-registration if they previously participated in NOPR 2009.

• Facilities must assume the responsibility and costs associated with data collection and forwarding to NOPR.

• Required new elements include a physician scan assessment form with patient consent.

Patient Eligibility

• Medicare beneficiaries including those under HMO coverage referred for NaF-PET for osseous metastasis evaluation can participate.

• Oral consent is necessary for inclusion in the NOPR dataset.

Referring Physician Duties

• Complete and submit the Pre-PET Form to the PET facility before scanning.

• Submit a Post-PET Form within 30 days post-scan.

• Consent is also required for research dataset inclusion, but Medicare will not compensate for form completions.

Interpreting Physician Duties

• Must complete a Scan Assessment Form post-NaF-PET scan.

• Obtain consent for research dataset inclusion.

NOPR Website Features

• Information available for PET facilities, physicians, and patients.

• Blank forms for registration and tools such as case status reports are available.

NOPR Workflow

• Steps include:

  • Referral for a NaF-PET scan followed by satisfactory form completions by both referring and interpreting physicians.

  • Claims submission post-workflow completion.

Pre-PET Form Specifics

• Essential components of the Pre-PET Form include detailed symptoms, signs, cancer diagnosis, disease stage (e.g., metastatic), intended management plan, and treatment specifics.

Treatment Monitoring Definition

• Treatment monitoring via PET serves to gauge tumor response during therapy.

• Coverage may include assessments after a specified number of chemotherapy cycles.

Additional Questions for Treatment Monitoring

• Includes assessments of therapy response and future management strategies without additional testing.

Submission Guidelines for Forms

Scan Assessment Form

• Comprises overall NaF-PET study assessments compared to prior imaging studies.

• Data must be submitted within 30 days alongside the PET report.

Post-PET Forms

• Should reflect reasons for scans and management intent updates.

Educational Materials

• NOPR supports access to valuable training resources and webinars for physicians involved in NaF-PET studies.

• Key educational links include SNM Practice Guidelines and archived continuing education events.

Medicare Billing Clarifications

Claims Coding for NaF-PET

• Understand approved codes and modifiers for billing under CED such as HCPCS codes A9580, O, and others.

Alternate Payment Structures

• Details related to payment for Medicare Advantage beneficiaries under the NOPR framework are discussed, ensuring coverage under clinical trial cost reimbursement.

Claims Submission Guidelines

• Documentation and coding for NaF-PET services must be meticulously adhered to ensure compliance with CMS mandates.

Conclusion

• The NOPR registry aims to enhance the understanding and application of NaF-PET in clinical settings.

• Date of Documentation: February 1, 2011

• Source: CANCER PETREGISTRY.ORG