1. 1 February 1, 2011 Sodium Fluoride (NaF-18) PET Bone Imaging National Oncologic PET Registry

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 2 February 1, 2011

3. NCA Tracking Sheet Positron 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& 3 February 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 4 February 1, 2011

5. NOPR: A Nationwide Collaborative Program Sponsored by Managed by Advisor 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 5 February 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) 6 February 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? 7 February 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 8 February 1, 2011

9. 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 9 February 1, 2011 NOPR (NaF-PET): Goals

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. 10 February 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. 11 February 1, 2011 Interpreting Physician Responsibilities Complete Scan Assessment Form after NaF-PET scan. Consent is necessary for inclusion in the NOPR research dataset.

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 12 February 1, 2011 http://www.cancerPETregistry.org

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

14. 14 February 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 15 February 1, 2011

16. Specific Reason for NaF-PET Study  Diagnosis of 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  Suspected progression of known osseous metastasis  Monitoring Treatment Response During: (1) systemic therapy (including chemotherapy, biologic modifiers, hormonal therapy, and immunotherapy); (2) radiation therapy; or (3) both (additional questions) 16 February 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 17 February 1, 2011

18. Cancer Type Check the one pathologically 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 18 February 1, 2011 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”.

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 19 February 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 20 February 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 21 February 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 22 February 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) 23 February 1, 2011

24. Additional Questions if Treatment Monitoring Definition 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. 24 February 1, 2011

25. Additional Pre-PET Treatment Monitoring Questions 25 February 1, 2011 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

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: 26 February 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) 27 February 1, 2011

28. NaF-PET Report Submission Only free text submission permitted (no pdf or jpg uploads as for FDG-PET) Document patient consent 28 February 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 29 February 1, 2011

30. Welcome Page for NOPR (NaF-PET) New PET interpreting Physician Scan Assessment Form – Submit with PET report. 30 February 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 31 February 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 32 February 1, 2011

33. PET Oncology Modifiers HCPCS Modifier Descriptor Effective October 30, 2009 on Claims With DOS April 3, 2009 for covered FDG-PET Oncologic- Related Claims PI (eye) Positron emission tomography (PET) or PET/computed tomography initial treatment strategy of tumors that are biopsy proven or suspected of being cancerous based on other diagnostic testing PET tumor initial treatment strategy “Diagnosis” or “initial staging” PS Positron emission tomography (PET) or PET/computed tomography (CT) to inform the subsequent treatment strategy of cancerous tumors when the beneficiary's treating physician determines that the PET study is needed to inform subsequent anti-tumor strategy. PET tumor subsequent treatment strategy “Restaging” or “monitoring” Identifier for CMS PET Claims: HCPCS Modifier 33 February 1, 2011

34. CED (PET NOPR) Identifying Modifier CPT ModifierDescriptionComments Q0 (Zero) Investigational clinical service provided in a clinical research study that is in an approved clinical research study QR was deleted effective Dec 31, 2007; Q0 (zero) is used for DOS effective January 1, 2008 to present to identify a claims covered under CED/ NOPR PET study. Use with Medicare Physician Fee Schedule (MPFS)-1500 Claim Form IDE# not required for NOPR claims Identifier for CMS PET Claims: CPT Modifier 34 February 1, 2011

35. CED (PET NOPR) Identifying Modifier ICD 9 CMDescriptionComments V70.7 Exam of Participants in Clinical Trials Enter NOPR Identifier in FL 68 Placed in the second diagnosis position with no period Condition Code 30 Qualifying Clinical Trials Non-research services provided to all patients, including managed care enrollees enrolled in a Qualified Clinical Trial. Form Locator 24-30: Use with Hospital Outpatient Prospective Payment System (HOPPS) UB-04 1450 Claim Form Identifier for CMS PET Claims 35 February 1, 2011

36. Medicare CED-Covered PET Radiopharmaceutical HCPCS Level II Trade / Common Name Description A9580 NaF Sodium Fluoride Sodium fluoride F-18, diagnostic, per study dose, up to 40 millicuries 36 February 1, 2011

37. PET Oncology NaF Bone Scan Modifiers HCPCS Modifier DescriptorCMS Transmittal KX Requirements specified in the medical policy have been met Use for professional services modifier -26 to identify CED covered NaF-18 services for metastatic cancer to bone Used to allow professional-only claims with a -26 modifier e to be identified and paid. Global or TC claims have NaF code (A9580) on the claim to identify it separately from FDG code (A9552). KX is not necessary on NaF claims billed for global or technical services, nor is it necessary for Hospitals, as those claims are technical. CMS PET Claims: HCPCS Modifier for NaF-PET 37 February 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 38 February 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. 39 February 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 18 F-Fluoride PET/CT Bone Scans 1.1” accessible at http://interactive.snm.org/docs/Practice%20Guid eline%20NaF%20PET%20V1.1.pdf. 40 February 1, 2011

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

42. NOPR Educational Materials 42 February 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 43 February 1, 2011