1. 1 (8/8/06) NOPR National Oncologic PET Registry

2. 2 (8/8/06) PET Reimbursement Complex, slowly evolving process Dependent on FDA approval of PET drugs –Facilitated by FDAMA (1997) Reimbursable clinical indications –Determined by technology assessment panels of third-party payers –Process dominated by Centers for Medicare and Medicaid Services (CMS)

3. 3 (8/8/06) Medicare Coverage of PET Centers for Medicare and Medicaid Services (CMS) –Formerly Healthcare Financing Administration (HCFA) Standard for reimbursement is “reasonable and necessary” In 1990s, CMS adopted a new evidence-based approach for making coverage determinations –Requires peer-reviewed scientific evidence to document that new technology leads to changes in patient management and improved health outcomes

4. 4 (8/8/06) Medicare Coverage of PET CMS elected not to consider oncologic indications for PET broadly Rather evaluated the evidence on a cancer- specific and indication-specific basis Problematic because the specific evidence typically has not been very robust “Catch 22”

5. 5 (8/8/06) Medicare Coverage of PET: Recent History 2000Further expanded coverage for six prevalent cancers after new request for broad coverage and public meeting (PET must either resolve inconclusive results of standard test or replace standard test) 2002Individual requests - several other cancers Suspected Alzheimer’s disease vs. frontotemporal dementia 2004Proposed mechanism for expanded coverage

6. 6 (8/8/06) Medicare Reimbursement for Oncologic PET (2005) Diagnosis, staging, and restaging of: Non-small cell lung cancerLymphoma Esophageal cancerMalignant melanoma Colorectal cancer Head and neck cancer Staging, restaging, and Rx monitoring of breast cancer Detection of TG+/RAI– thyroid cancer Staging of cervical cancer (– CT/MRI outside pelvis) All other cancers/indicationsAll other cancers/indications –National registry

7. 7 (8/8/06) What is the NOPR? In 2000, the Centers for Medicare and Medicaid Services (CMS) expanded its coverage of positron emission tomography (PET) with F-18 fluorodeoxyglucose (FDG) to a wide variety of indications for several common cancers - but not all cancers. In November 2004, CMS proposed expanding PET coverage to most other cancers, if providers collect relevant data in a CMS-approved clinical registry. CMS Initiative –Coverage with Evidence Development (CED)

8. 8 (8/8/06) NOPR Is a CMS-approved –“Coverage with Evidence Development” Program Developed for the November 2004 expansion by CMS –All other cancers and indications except: Breast cancer diagnosis and axillary staging Melanoma regional nodal staging All PET facilities can participate (for a fee) Requires timely Pre-PET and Post-PET information All data will be submitted to CMS for payment processing Cases with patient and physician consent will be used by the NOPR to assess change in intended management

9. 9 (8/8/06) NOPR National Oncologic PET Registry Sponsored by Managed by Advisor Endorsed by

10. 10 (8/8/06) Objectives & Goals Objectives –Assess the effect of PET on referring physicians’ plans of intended patient management across a wide spectrum of cancer indications for PET that are currently not covered by the Medicare program, and in relation to cancer-type, indication, performance status, physician’s role in management, and type of PET. Goal –Acquire data that can be used to evaluate PET in a manner that does not interfere with patient clinical care and minimizes the burden to the patient, PET center, and referring physician.

11. 11 (8/8/06) Who owns the NOPR data? The Academy of Molecular Imaging, as an agent of CMS, will maintain ownership of the data collected by American College of Radiology (ACR) for the NOPR. The data will reside in an electronic database at ACR. Who has access to NOPR data? The members of the NOPR Working Group, NOPR project staff at ACR and the Center for Statistical Sciences at Brown University, and staff of CMS. CMS receives data from NOPR for all patients for payment determination. NOPR uses data for research only where consent obtained.

12. 12 (8/8/06) Data Analysis and Expected Results Data analyzed by cancer type and indication (reason for PET). For the most frequent cancer indications, interim analysis will be performed at N=200 to refine sample size estimates. If the frequency of change in intended management for a particular cancer indication is sufficient to suggest benefit, data (along with summary of published literature) will be provided to CMS with request for coverage. Eventual goal is to achieve broad coverage through analysis of data across all cancers and indications.

13. 13 (8/8/06) Institutional Review Board (IRB) Approval & Subject Informed Consent Is this research? Yes, but only for the NOPR. Individual PET facilities and referring physicians are not engaged in research. Is IRB approval needed? Yes. ACR IRB has approved the NOPR. Individual PET facilities and referring physicians do not need to obtain IRB approval to participate. –All data will be sent to CMS. CMS is not engaged in research. –Patients and referring physicians will be given an IRB-approved information sheet and asked for oral consent to have their data included in NOPR research. –Only cases where both patient and physician give consent will be included in the NOPR research dataset.

14. 14 (8/8/06) HIPAA Requirements HIPAA requirements met through execution of a Business Associates Agreement with the American College of Radiology as an agent for the Academy of Molecular Imaging and CMS.

15. 15 (8/8/06) Participation Requirements - PET Facilities Any PET facility that is approved to bill CMS for either technical or global charges can participate in the NOPR. Facilities are not required to have or obtain ACR or ICANL accreditation. Participation Requirements - Patients Medicare beneficiaries, including those with Medicare HMO coverage, who are referred for FDG-PET for essentially all oncologic indications that are not currently reimbursable under Medicare. The Indications table lists the cancers and indications that are and are not eligible for the Registry. Verbal consent is necessary for inclusion in the NOPR research dataset; however, no consent is necessary to submit data to NOPR that will be sent to CMS payment determination.

16. 16 (8/8/06) PET Facility Responsibilities Collect and enter all required data through the NOPR Web site. –Patient must be registered within 14 days of the PET scan date –Give patient the Patient Information Sheet –Pre-PET Form must be entered by midnight of the PET scan date –PET Completion Form must be entered within 14 days of case registration –The PET Report & Post-PET forms must be entered within 30 days of scan PET facility is eligible to bill CMS when all required data are received at NOPR Operations Office. Referring Physician Responsibilities Complete Pre-PET Form (5 questions) and return it to PET Facility prior to PET scan. Complete Post-PET Form (4 - 7 questions) and return it to PET Facility within 30 days of PET scan. Pre- and Post-PET forms can be returned to the PET facility via FAX, mail, or hand delivery.

17. 17 (8/8/06) Cancers & Indications Eligible for Entry in the NOPR continued on next slide

18. 18 (8/8/06) Cancers & Indications Eligible for Entry in the NOPR continued

19. 19 (8/8/06) Facility and Patient Registration Register via the NOPR Web site www.cancerPETregistry.org –Complete Facility Registration Form PET facility information including Medicare Provider Number PET facility administrator (the individual responsible for managing registry activities at the facility) Participating interpreting physician(s) Equipment details Submit Executed Business Associates Agreement (BAA) $50 Facility Application Fee $50 Processing Fee for Each Patient –Advance payment held in escrow account

20. 20 (8/8/06) PET Facility Registration www.cancerPETregistry.org

21. 21 (8/8/06) 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

22. 22 (8/8/06) Pre-PET Form – 5 Questions Reason for the PET Scan Cancer Site/Type Summary of Disease Stage –NED, Localized, Regional, Metastatic, Unknown Performance Status –Asymptomatic, Symptomatic, Bedridden Intended Patient Management Plan

23. 23 (8/8/06) Pre-PET Form: Specific Reason For PET Diagnosis: To determine if a suspicious lesion is cancer Diagnosis –Unknown primary tumor: To detect a primary tumor site in a patient with a confirmed or strongly suspected metastatic lesion –Paraneoplastic: 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 chemotherapy, radiotherapy, or combined modality therapy Restaging after completion of therapy Suspected recurrence of a previously treated cancer 1.Check the single best match for the reason for the PET.

24. 24 (8/8/06) Pre-PET Form: Intended Patient Management Plan Observation (with close follow-up) Additional imaging (CT, MRI) or other non-invasive diagnostic tests Tissue biopsy (surgical, percutaneous, or endoscopic). Treatment (if treatment is selected, then also complete the following) Treatment Goal: (check one)  Curative  Palliative Type(s): (check all that apply) –  Surgical  Chemotherapy (including biologic modifiers) –  Radiation  Other  Supportive care 5.If PET were not available, your current management strategy would be (select one)?

25. 25 (8/8/06) Pre-PET Web Form 2. 42 Primary and Metastatic Sites Listed

26. 26 (8/8/06) Pre-PET Web Form continued

27. 27 (8/8/06) Post-PET Form – 4 to 7 Questions Questions Customized by Specific Reason for PET (Indication) 4 - 7 Questions per Indication Most Require a Yes or No Answer 2 Questions are Repeated from the Pre-PET Form –Intended Patient Management Plan –Planned Cancer Care Provider

28. 28 (8/8/06) Post-PET Web Form Suspected Cancer

29. 29 (8/8/06) Referring MD Requests PET Referring MD Requests PET Pre-PET Questionnaire Pre-PET Questionnaire PET Done PET Done PET Reviewed & Reported PET Reviewed & Reported Post-PET Questionnaire Sent Includes Question for Referring Physician Consent Post-PET Questionnaire Sent Includes Question for Referring Physician Consent Questionnaire Completed $$ Questionnaire Completed $$ Clinical Actions Ongoing Clinical Actions Ongoing NOPR Workflow Ask Patient For Consent Ask Patient For Consent

30. 30 (8/8/06) Timeline

31. 31 (8/8/06) Timeline Providers Bill Medicare Using Appropriate Claim Form & Codes Hospitals Use UB/1450 Claim Form Technical Only Non-Hospitals Use 1500 Claim Form Professional/Technical/Global No Waiting Period

32. 32 (8/8/06) FDG-PET Procedure and Supply Codes 2006 HCPCS Code Description 78811 Tumor imaging, positron emission tomography (PET); limited area (eg, chest, head/neck) 78812 Tumor imaging, positron emission tomography (PET); skull base to mid-thigh 78813 Tumor imaging, positron emission tomography (PET); whole body 78608 Brain imaging, positron emission tomography (PET); metabolic evaluation A9552 Fluorodeoxyglucose F-18 FDG, diagnostic, per study dose, up to 45 millicuries

33. 33 (8/8/06) FDG-PET/CT Procedure and Supply Codes 2006 HCPCS Code Description 78814 Tumor imaging, positron emission tomography (PET) with concurrently acquired computed tomography (CT) for attenuation correction and anatomical localization; limited area (eg, chest, head/neck) 78815 Tumor imaging, positron emission tomography (PET) with concurrently acquired computed tomography (CT) for attenuation correction and anatomical localization; skull base to mid-thigh 78816 Tumor imaging, positron emission tomography (PET) with concurrently acquired computed tomography (CT) for attenuation correction and anatomical localization; whole body A9552 Fluorodeoxyglucose F-18 FDG, diagnostic, per study dose, up to 45 millicuries

34. 34 (8/8/06) For Carriers on 1500 Claim Form Use Modifier 2006 HCPCS Modifier Description QR Item or service provided as routine care in a Medicare specified study or Medicare qualifying clinical trial Modifier Use by Providers to Identify NOPR Claims Use only with procedure, not necessary with the radiopharmaceutical billed on the same DOS as the procedure. CMS Transmittal 956, 5/19/06.

35. 35 (8/8/06) Hospitals ONLY on 1450 Claim Form (UB) 2006 Hospital Revenue/ICD 9 CM Codes Description 0343 Diagnostic Radiopharmaceutical 0404 PET Procedures V70.7 Examination of participants in clinical trial V70.7 Use in the Second Diagnosis Position FL 68 From Current CMS policy CR 3741

36. 36 (8/8/06) A 72-year-old woman with diffuse large cell non- Hodgkin's lymphoma is undergoing chemotherapy with R-CHOP. PET/CT (skull-base to proximal thigh) is requested after the second cycle of treatment for monitoring of therapy. 2006 Hospital Revenue Code 2006 HCPCS/ ICD 9 CM Codes Description 040478815 Tumor imaging, positron emission tomography (PET) with concurrently acquired computed tomography (CT) for attenuation correction and anatomical localization; skull base to mid-thigh 0343A9552 Fluorodeoxyglucose F-18 FDG, diagnostic, per study dose, up to 45 millicuries N/A202.80 Other Lymphomas (malignant): Not otherwise specified (NOS) Case 1

37. 37 (8/8/06) A 67-year-old man has a history of glioblastoma multiforme of left parietal lobe treated with surgery, radiation therapy, and temazolamide. Follow-up MRI demonstrates a new 8 mm focus of contrast enhancement adjacent to the original tumor bed. Brain PET is requested for restaging, to distinguish recurrent tumor for radiation necrosis. 2006 Hospital Revenue Code 2006 HCPCS/ ICD 9 CM Codes Description 040478608Brain imaging, positron emission tomography (PET); metabolic evaluation 0343A9552 Fluorodeoxyglucose F-18 FDG, diagnostic, per study dose, up to 45 millicuries N/A191.3 Malignant neoplasm of brain, parietal lobe Case 2

38. 38 (8/8/06) A 68-year-old woman has newly diagnosed dermatomyositis and progressive weight loss. CT of the chest, abdomen, and pelvis demonstrated no evidence of malignancy. Whole-body PET/CT is requested to detect an occult malignancy as the cause of her paraneoplastic syndrome. 2006 Hospital Revenue Code 2006 HCPCS/ ICD 9 CM Codes Description 040478816 Tumor imaging, positron emission tomography (PET) with concurrently acquired computed tomography (CT) for attenuation correction and anatomical localization; whole body 0343A9552 Fluorodeoxyglucose F-18 FDG, diagnostic, per study dose, up to 45 millicuries N/A710.3 Dermatomyositis N/A783.21 Abnormal Loss of Weight Case 3

39. 39 (8/8/06) Advance Beneficiary Notice (ABN) A PET facility can ask registry patients to sign an ABN. This decision is left up to each PET facility. However, an ABN should not be necessary. If patient eligibility is carefully checked before the patient is entered into the registry and before the PET scan is performed and if the facility works closely with its referring physicians to ensure that the required paperwork is submitted in a timely fashion, there will be no need to obtain ABNs.

40. 40 (8/8/06) Medigap Insurance for Co-Payments Medigap insurance should cover the co-payment for a registry PET scan, as for any other Medicare covered service. Managed Medicare Plans – Medicare Advantage Managed Medicare plans such as Medicare Advantage should pay any claims that would be covered by Medicare. –Follow Pre-Authorization as required by the plan

41. 41 (8/8/06) Will non-Medicare insurers reimburse for patients entered in the Registry? No, there are no non-Medicare insurers who have elected to reimburse for patients entered in the registry. Patients with insurance coverage other than Medicare, including Medicaid, are not eligible to participate in the NOPR.

42. 42 (8/8/06) Does NOPR Apply to Inpatients? Yes. The technical charge for a PET study on a Medicare inpatient is not billed directly, but is considered to be covered by the Diagnostic Related Grouping (DRG) payment to the hospital for that patient. Inclusion of the patient in the NOPR is necessary, however, for professional component reimbursement for the PET study.

43. 43 (8/8/06) I have registered my facility with NOPR and have not sent any money. What do I need to do NOW to prepare for a smooth transition? Down Load IRB Materials & Operations Manual; implement the required procedures. Put systems in place to identify (up front) NOPR patients and put triggers into billing systems to hold claims (back end). If external MD reading, ensure the reader does the same. Meet/communicate with referring physicians regarding required forms/timelines and set up efficient processes prior to accepting patients. Decide how your facility will handle ABNs for NOPR patients. Watch for notice of registry activation and e-mails containing facility ID#, passwords and invoice. Print patient and physician consent information for appropriate distribution

44. 44 (8/8/06) NOPR Working Group Chair, Bruce Hillner, MD, Virginia Commonwealth University Co-chair, Barry A. Siegel, MD, Washington University R. Edward Coleman, MD, Duke University Anthony Shields, MD, Wayne State University Statistician: Dawei Liu, PhD, Brown University Epidemiologist: Ilana Gareen, PhD, Brown University NOPR Operations Office American College of Radiology 1818 Market Street, Suite 1600 Philadelphia, PA 19103 215-717-0859 800-227-5463 x 4859

45. 45 (8/8/06) Endorsing Organizations’ Educational Contacts Academy of Molecular Imaging –Sue Halliday, shalliday@eplushealthcare.com American College of Radiology –Joy Brown, jbrown@phila.acr.org American College of Radiology Imaging Network –Nancy Fredericks, nfredericks@phila.acr.org American Society of Clinical Oncology –Nancy Daly, dalyn@asco.org Society of Nuclear Medicine –Denise Merlino, denise@merlinohccc.com