The National Oncologic PET Registry: Background and Operational Overview Barry A. Siegel, M.D. Mallinckrodt Institute

1. The National Oncologic PET Registry: Background and Operational OverviewBarry A. Siegel, M.D.Mallinckrodt Institute of Radiology St. Louis, MO

2. Medicare Coverage for Oncologic PET • CMS coverage decisions from 1998 to 2004 were cancer- and indication-specific (unwieldy approach) • Diagnosis, staging, and restaging of: Non-small cell lung cancer Lymphoma Esophageal cancer Malignant melanoma Colorectal cancer Head and neck cancer • Staging, restaging, and Rx monitoring of breast cancer • Detection of thyroid cancer • Staging of cervical cancer • Mechanism announced in November 2004 to cover all other cancers and indications–National Registry

3. NOPR: A Nationwide Collaborative Program Advisor • 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:Dawei Liu, PhD, FenghaiDuan, PhD, Brown University • Epidemiologist:IlanaGareen, PhD, Brown University Sponsored by Managed by Endorsed by

4. The National Oncologic PET Registry (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

5. Objectives • Assess the effect of PET on referring physicians’ plans of intended patient management • across a wide spectrum of cancer indications for PET not currently covered by the Medicare program, and • in relation to cancer-type, indication, performance status, physician’s role in management, and type of PET.

6. Goal • Provide access to the service (PET) • Minimize the burden to patients, PET facilities, and referring physicians • Generate evidence of reasonable quality to assist CMS in deciding whether to expand coverage of PET • Registry to be financially self-supporting • How is the NOPR funded? • Start-up funding provided by AMI • NOPR is expected to be self-sufficient by collection of registration fees from participating PET facilities • $50 per facility • $50 per patient

7. 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 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.

8. Participation Requirements/Responsibilities - PET Facilities • Any PET facility approved to bill CMS for either technical or global charges can participate in the NOPR. • Willingness to take on the burden and additional cost of collecting data and sending to NOPR (including NOPR fees) Participation Requirements – Patients • Medicare beneficiaries, including those with Medicare HMO coverage, who are referred for FDG-PET for essentially all oncologic indications not currently reimbursable under Medicare. • Oral consent is necessary for inclusion in the NOPR research dataset; however, no consent is necessary to submit data to NOPR that must be sent to CMS.

9. 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. • No Medicare payment to referring physicians for completing the Pre- and Post-PET Forms. • Referring MD cooperation essential to the success of this CED program

10. NOPR Workflow PET interpreted & reported 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

11. 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

12. Pre-PET Form: Intended Patient Management If PET were not available, your current management strategy would be (select one)?

13. Pre-PET Form: Specific Reason For PET Check the single best match for the reason for the PET scan. • Diagnosis • To determine if a suspicious lesion is cancer • Unknown primary tumor: To detect primary tumor site in patient with confirmed /strongly suspected metastatic disease • To detect primary site in patient with presumed paraneoplastic syndrome • Known Cancer • Initial staging of histologically confirmed, newly diagnosed cancer • Restaging after completion of therapy • Suspected recurrence of a previously treated cancer • Monitoring treatment response during chemotherapy, radiotherapy, or combined modality therapy • 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

14. Post-PET Form – 4 to 7 Questions • Questions customized by specific indication for PET • Yes or no answer for majority • Two questions repeated from the Pre-PET Form • Intended Patient Management Plan • Planned Cancer Care Provider • Referring physician consent

15. NOPR Web Site • Information for • PET Facilities • Referring Physicians • Patients • Blank Forms • Register PET Facilities • Register Patients • Data Entry • PET Facility Tools • Case Status Reports • Account Balance • Fund Account by Credit Card March 2006

16. Pre-PET Web Form 2. 42 Primary and Metastatic Sites Listed

17. Pre-PET Web Form continued

18. Issues Prior to Launch • Determination made that NOPR data collection was exempt from “Common Rule” requirements for research. • 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. • Paperwork Reduction Act requirements met. • CMS completing the final regulatory & contractual requirements. • Launch expected early 2006

19. NOPR Status (as of February 2006) • Operational details (“protocol”) finalized – Late 2005Took nearly a full year to develop • Web-based data entry/database operational – Feb 2006 • Over 500 PET facilities pre-registered to participate • CMS announces approval of the registry – Feb 14, 2006 • Go-live date set – Mar 6, 2006

20. Issues Prior to Launch: Determining Need for Institutional Review Board (IRB) Approval and Patient Informed Consent (as of 2/27/06) • Is this research? Yes • Is IRB approval needed? No • CMS has designated participation in the registry as “coverage with evidence development”. • Participation is required for Medicare reimbursement. • Thus, exempt from IRB approval under 45 CFR 46.101(b)(5) for all 45 CFR part 46 requirements. • Is IRB exemption required? Yes • Each PET facility must request exemption from its own IRB (or otherwise make determination of exempt status of registry). • Is a research informed consent required? No

21. Solution: Institutional Review Board (IRB) Approval and 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 consent to have their data included for NOPR research.

22. Startup Problems • Not all carriers prepared to accept NOPR claims on June 19, 2006 (as required by CMS) • Various billing issues (frequency limitations, non-cancer ICD-9 codes) • Confusion about data entry deadlines • Inclusion of covered cancers/indications under NOPR • Only cases where both patient and physician give consent will be included in the NOPR research dataset.

23. Startup Problems • Some problems with completion of case report forms by referring physicians/staff members (e.g., logically inconsistent responses to related questions) • Confusion about the meaning of “Diagnosis” • Payments to referring physicians for form completion • Charging of NOPR fee to patients

24. Major Problem with the NOPR Paradigm • Only possible to collect limited data and difficult to control data quality • Consequence of the self-funded model with non-engaged participants (You get what you pay for!) • Tradeoff between data quantity/quality and access

25. Major Problem with the NOPR Paradigm: Possible solutions • Collecting more detailed clinical data and information about actual outcomes will require funding of participating sites/referring MDs • Collecting better quality data will require more education of participants • Certification before participation • Require referring MDs to enter data on-line with logic checks and “wizards” to help guide responses • Audits/scrubbing of incoming data • These steps will surely increase cost, limit access, and require IRB approval

26. NOPR Status as of April 3 2009 (date of new NCD) • Opened for patient accrual on May 8, 2006 • 1,891 PET facilities nationwide participating(over 90% of all sites) • 132,946 patients - data entry completed • Approximately 92% of patients and 96% of referring physicians gave consenting for research use of data • CMS expenditure of ~$125 million to provide NOPR PET scans