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Sodium Fluoride (NaF-18) PET Bone Imaging

National Oncologic PET Registry. Sodium Fluoride (NaF-18) PET Bone Imaging . Outline. Background – NaF-18 NCD (CMS manual 220.6.19) Differences FDG 2009 Registry vs NaF-18 Registry Billing Educational Information and Announcements Questions. 2 February 1, 2011.

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Sodium Fluoride (NaF-18) PET Bone Imaging

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  1. National Oncologic PET Registry Sodium Fluoride (NaF-18)PET Bone Imaging

  2. Outline • Background – NaF-18 NCD (CMS manual 220.6.19) • Differences • FDG 2009 Registry vs NaF-18 Registry • Billing • Educational Information and Announcements • Questions 2February 1, 2011

  3. NCA Tracking SheetPositron Emission Tomography (NaF-18) to Identify Bone Metastasis of Cancer (CAG-00065R) • Multi-society discussions with CMS-CAG (February 2009) • CMS internally generated request to open a formal reconsideration for NaF-18 PET (June 4, 2009) • Proposed Decision (November 30, 2009) • Final Decision (February 26, 2010) • NOPR begins development of a registry CMS National Coverage Decision (NCD) Reference: https://www.cms.gov/mcd/viewtrackingsheet.asp?from2=viewtrackingsheet.asp&id=233& 3February 1, 2011

  4. NOPR (NaF-PET)Registry for PET with F-18 Sodium Fluoride to Identify Bone Metastasis • The National Oncologic PET Registry (NOPR) has implemented a registry for NaF-PET similar to that now in place for FDG-PET • Launch date Monday February 7, 2011 4February 1, 2011

  5. NOPR: A Nationwide Collaborative Program Advisor Sponsored by Managed by Endorsed by • Chair, Bruce Hillner, MD, Virginia Commonwealth University • Co-chair, Barry A. Siegel, MD, Washington University • R. Edward Coleman, MD, Duke University • Anthony Shields, MD, PhD Wayne State University • Statistician: Fenghi Duan, PhD, Brown University • Epidemiologist: Ilana Gareen, PhD, Brown University 5February 1, 2011

  6. NOPR (NaF-PET) • NOPR is a CMS-approved “Coverage with Evidence Development” (CED) Program • Now expanded to include NaF-PET • All Medicare-eligible PET facilities can participate (for a fee) • Requires timely Pre-PET, PET evaluation, and Post-PET data • All data submitted to CMS • Cases with patient and both referring and interpreting physician consent will be used by the NOPR to assess impact of PET (change in intended management) 6February 1, 2011

  7. CMS questions to be answered with CED registry: Does use of NaF-PET in Medicare beneficiaries inform treating physicians to guide antitumor strategies that lead to:  • A change in patient management to more appropriate palliative care; or • A change in patient management to more appropriate curative care; or • Improved quality of life; or • Improved survival? 7February 1, 2011

  8. NOPR (NaF-PET): Primary Objective • To assess the effect of NaF-PET on referring physicians’ plans of intended management of patients with known or suspected bone metastases 8February 1, 2011

  9. NOPR (NaF-PET): Goals • Provide access to bone PET for patients with cancer • Minimize the burden to patients, PET centers, and referring physicians • Generate evidence of reasonable quality to assist CMS in deciding whether to expand coverage of PET 9February 1, 2011

  10. Participation Requirements/Responsibilities - PET Facilities • Any PET facility approved to bill CMS for either technical or global charges can participate in the NOPR. Facilities already registered to participate in NOPR 2009 do not need to re-register to participate in NOPR (NaF-PET). • Willingness to take on the burden and additional cost of collecting data and sending to NOPR. New for NOPR (NaF-PET) is an interpreting physician scan assessment form with consent submission. Participation Requirements - Patients • Medicare beneficiaries, including those with Medicare HMO coverage, who are referred for NaF-PET to evaluate for osseous metastasis are eligible. • Oral consent is necessary for inclusion in the NOPR research dataset.No consent necessary to submit data to NOPR that must be sent to CMS. 10February 1, 2011

  11. Referring Physician Responsibilities • Complete Pre-PET Form and send to PET Facility before scan. • Complete Post-PET Form and send to PET Facility within 30 days of PET scan. • Post-PET form consent is necessary for inclusion in the NOPR research dataset. • No Medicare payment to referring physicians for completing the Pre- and Post-PET Forms. Interpreting Physician Responsibilities • Complete Scan Assessment Form after NaF-PET scan. • Consent is necessary for inclusion in the NOPR research dataset. 11February 1, 2011

  12. NOPR Web Site • Information for • PET Facilities • Referring Physicians • Patients • Blank Forms • Register PET Facilities • Register Patients • PET Facility Tools • Case Status Reports • Account Balance • Fund Account by Credit Card http://www.cancerPETregistry.org 12February 1, 2011

  13. PET interpreted, reported, and interpreting physician assessment submitted NOPR (NaF-PET) Workflow Ongoingpatientmanagement Referring MD requests PET PET done Ask patient for consent Pre-PET Form Post-PET Form sent, including question for referring MD consent Post-PET Form completed. Claim submitted 13February 1, 2011

  14. 14February 1, 2011

  15. Pre-PET Form for NaF-PET • Reason for NaF-PET Scan (more granular than for FDG-PET) • Symptoms, Signs, Other Findings Prompting PET (NEW) • Cancer Site/Type/Tissue Diagnosis • Summary of Disease Stage • NED, Localized, Regional, Metastatic, Unknown • Intended Patient Management Plan • Details/Type Intended Treatment (expanded cf. FDG-PET) • Additional Questions for Treatment Monitoring • Physician Attestation of Data Accuracy 15February 1, 2011

  16. Specific Reason for NaF-PET Study • Diagnosisof suspected osseous metastatic disease in a patient without a pathologically proven diagnosis of cancer • Initial staging of newly diagnosed cancer • Suspected new osseous metastasis as a site of recurrence or progression • Suspectedprogression of known osseous metastasis • Monitoring Treatment ResponseDuring: (1) systemic therapy (including chemotherapy, biologic modifiers, hormonal therapy, and immunotherapy); (2) radiation therapy; or (3) both (additional questions) 16February 1, 2011

  17. Symptoms, Signs, Other Findings Prompting NaF-PET • None Or select all of the following that apply • Skeletal pain • New focal neurologic signs or symptoms • Other imaging findings suggesting osseous metastatic disease • Hypercalcemia • Elevated or increasing tumor marker(s) • Evidence of new metastases in non-osseous sites • Evidence of progression of known metastatic disease in non-osseous sites 17February 1, 2011

  18. Cancer Type Check the onepathologically proven or strongly suspected cancer type that most closely relates to the specific reason for PET study • Lung • Female breast • Prostate • Metastatic cancer of unknown primary origin • If other, describe cancer type and give 3 digit ICD-9 code See guidance on Pre-PET form about completion of suspected cancer type when NaF-PET is requested for “Diagnosis of suspected osseous metastatic disease in a patient without a pathologically proven diagnosis of cancer”. 18February 1, 2011

  19. Tissue Diagnosis Has this cancer diagnosis been pathologically proven? • Yes • No Unknown primary: dominant site of pathologically proven or strongly suspected metastatic disease • Liver • Bone/bone marrow • Lymph node(s) • Lung • Brain • Other 19February 1, 2011

  20. Working Stage Your working summary stage for the patient before the PET scan is: • No evidence of disease / In remission • Localized only • Regional by direct extension, lymph node involvement or both • Metastatic (distant) with a single suspected site • Metastatic (distant) with multiple suspected sites • Unknown or uncertain 20February 1, 2011

  21. Management Plan If the F-18 fluoride PET bone scan were not available, which ONE of the following would be the next step in your current management strategy?[Must assume that neither an F-18 fluoride PET bone scan nor a conventional bone scan would be available as the next step.] • Observation(with close follow-up) • Additional Imaging (CT, MRI, FDG-PET) [Do not check this option if you would order a conventional bone scan] • Tissue Biopsy (surgical, percutaneous, or endoscopic). • Supportive care only (e.g., pain management, hospice care) • Treatment for the cancer 21February 1, 2011

  22. If Treatment, Provide Details as Follows: Treatment Goal: (check one) • Curative • Palliative Treatment will be directed to: (check all that apply) • Primary tumor and/or loco-regional disease • Non-osseous distant metastatic disease • Osseous distant metastatic disease 22February 1, 2011

  23. Treatment Type (check all that apply) • Surgery • Radiation • Chemotherapy (including biologic modifiers) • Hormonal therapy • Bisphosphonate therapy • Immunotherapy (e.g., sipuleucel T (Provenge®) for prostate cancer) • Radiopharmaceutical therapy (Sr-89, Sm-153, etc.) • Other (specify type) 23February 1, 2011

  24. Additional Questions if Treatment MonitoringDefinition of Treatment Monitoring Treatment monitoring refers to use of PET to monitor tumor response to treatment during the planned course of therapy (i.e., when a change in therapy is anticipated). As an example, F-18 fluoride PET performed under NOPR may be covered for monitoring after 2 or 3 of a planned 6 cycles of chemotherapy in a patient considered not to be responding as expected. 24February 1, 2011

  25. Additional Pre-PET Treatment Monitoring Questions What is your impression (before PET) of your patient’s response to currently ongoing therapy? (check one) • Probable complete response • Possible partial response, but uncertain about degree of response • Suspect no response (stable disease) • Suspect progressive disease If you were to continue your patient’s management without doing any other testing first (e.g., PET, CT, MRI, biopsy), what would be your treatment plan today? (check one) • Continue and complete currently ongoing therapy • Modify dose or schedule of currently ongoing therapy • Switch to another therapy or add another mode of therapy • Stop therapy and switch to supportive care 25February 1, 2011

  26. Pre-PET Form: Last Step PHYSICIAN ATTESTATION OF DATA ACCURACY By signing below I verify that, to the best of my knowledge, the information on this form is accurate. Physician Signature: Date: Printed Name: 26February 1, 2011

  27. Interpreting Physician Scan Assessment Form • Overall assessment of the NaF-PET study using a categorical scale • Asks whether NaF-PET was compared with prior study (conventional bone scintigraphy or NaF-PET), and whether there was a change in the scan appearance • Consent to use the data for NOPR research • Submitted within 30 days of PET (but optimally along with the PET report) 27February 1, 2011

  28. NaF-PET Report Submission • Only free text submission permitted(no pdf or jpg uploads as for FDG-PET) • Document patient consent 28February 1, 2011

  29. Post-PET Forms for NaF-PET • Tailored to reason for scan • Repeat intended management question (except where NaF-PET being done to diagnosis metastasis in patients without known cancer) • Consent to use the data for NOPR research • Must be submitted within 30 days of PET 29February 1, 2011

  30. Welcome Page for NOPR (NaF-PET) New PET interpreting Physician Scan Assessment Form – Submit with PET report. 30February 1, 2011

  31. CMS Transmittal Claims Processing & Billing • November 19, 2010 Transmittal 2096 CR 7125 • Billing Clarification for Positron Emission Tomography (Sodium Fluoride-18) (NaF-18) PET for Identifying Bone Metastasis of Cancer in Context of a Clinical Trial • http://www.cms.gov/transmittals/downloads/R2096CP.pdf 31February 1, 2011

  32. Coding NaF-PET Bone Imaging Under CED Transmittal 2096, Change Request 7125 (November 19, 2010) Choose the most appropriate code for study performed (78811-78816) • Apply all appropriate Oncology PET modifier(s) • PI or PS, Q0, KX and V70.7 (condition code 30) • HCPCS code A9580 F-18 Sodium Fluoride, per study dose • What will you be paid? • The same rate as you get for all other NOPR PET cases for the setting in which you perform the study 32February 1, 2011

  33. Identifier for CMS PET Claims: HCPCS Modifier 33February 1, 2011

  34. Identifier for CMS PET Claims: CPT Modifier 34February 1, 2011

  35. Identifier for CMS PET Claims 35February 1, 2011

  36. Medicare CED-Covered PET Radiopharmaceutical 36February 1, 2011

  37. CMS PET Claims: HCPCS Modifier for NaF-PET 37February 1, 2011

  38. Medicare Advantage Plans – NOPR 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 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 intermediaries and carriers who will make payments on behalf of MA organizations 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 (Rev. 89; Issued: 11-02-07; Effective/Implementation: 11-02-07). http://www.cms.gov/Transmittals/2010Trans/itemdetail.asp?filterType=dual,%20keyword&filterValue=R1937& filterByDID=0&sortByDID=2&sortOrder=descending&itemID=CMS1234255&intNumPerPage=10 38February 1, 2011

  39. NOPR (NaF-PET): Educational Materials The Society of Nuclear Medicine has made a recent educational webinar entitled “F-18 Sodium Fluoride PET Imaging” available. • NOPR investigators believe this educational program is of interest to physicians who plan to interpret NaF-PET studies, as well as to referring physicians and technical staff. • The webinar can be accessed free of charge at http://webinars.snm.org/?meeting=8022110. • Individuals who prefer to obtain continuing education credit for this webinar (for a fee) can access it via www.snm.org/onlinelectures, and follow the instructions at that site. 39February 1, 2011

  40. NOPR (NaF-PET): Educational Materials • The NOPR investigators and staff encourage technical and professional staff at PET facilities to review the recently published “SNM Practice Guideline for Sodium 18F-Fluoride PET/CT Bone Scans 1.1” accessible at http://interactive.snm.org/docs/Practice%20Guideline%20NaF%20PET%20V1.1.pdf. 40February 1, 2011

  41. Continuing Education ArticleJ Nucl Med 2008;49:68-78 41February 1, 2011

  42. NOPR Educational Materials 42February 1, 2011

  43. QUESTIONS? Type in your question in the on-line screen box located on the right side of the screen If you have questions after the seminar, contact pet_registry@phila.acr.org 43February 1, 2011

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