Clinical Research Billing & Compliance

1. Clinical Research Billing & Compliance September 2010

2. Executive Memorandum • President Clinton signed an executive memorandum on June 7, 2000 directing the Secretary of Health and Human Services to “explicitly authorize (Medicare) payment for routine patient care costs. . .and costs due to medical complications associated with participation in clinical trials”. Source: CMS Transmittal AB-00-89

3. Covered Routine Costs • All items and services that are otherwise generally available to Medicare beneficiaries, including: • Those provided absent a clinical trial (e.g., conventional care) • Those required solely for the provision of the investigational item or service (e.g., administration of a non-covered chemotherapeutic agent) • Those required for clinically appropriate monitoring of effects of investigational item or service, or prevention of complications • Those needed for reasonable and necessary care, for diagnosis or treatment of complications

4. What Happens When You Don’t Get It Right? • Northwestern University $5.5 million settlement • John Hopkins $2.6 million settlement • Hospital Settlement $5.4 million cardiac device settlement • TJU $2.6 million settlement • Univ of Louisville Mandated to review 1,151 open studies • Beth Israel Deaconess $920,000 settlement • Medical College of Georgia $6.1 million settlement • Univ of CA at San Diego $4.7 million settlement • Mayo $6.5 million • University of Alabama $3.4 million • Dr LaHaye $1.1 million settlement • Yale University 194,000 • Rush University More than $ 1 million * Exclusion from government contracting, subcontracting or involvement in procurement programs can also be imposed

5. Clinical Research Improvements • Instituted steeper clinical discounts for professional and hospital fees for clinical research • Reduced turnaround time on new applications to IRBMED and redesigned internal processes, enabling more timely launch of studies • Launched clinical research pricing tool to assist study teams in preparing study budgets • Offered training workshops for faculty on the nuts and bolts of billing calendars • Improved access to clinical research support services by moving MICHR, IRBMED, CRAO and CCC Clinical Trials Office to NCRC • Implemented lean initiative to remove bottlenecks and increase efficiency of billing calendar workflow • Partnered with Hospital to fund mechanism for payment for subject injury when not covered by sponsor (includes NIH) • Established CRAO as a module within eResearch • Concluded strategic assessment of clinical research enterprise. Plans now underway: • Virtual home for study coordinators to enhance their knowledge, ability, and impact • Clinical Research Support Unit to establish best practices, tools, and resources • Demonstration project with DRDA to reduce the contract and regulatory approval processes timelines • Signed contract with eThority to provide robust clinical trials software application

6. Clinical Research Improvement Patient Complaints 2007-2010 Note: data prior to 2007 was not being tracked with any regularity.

7. eThority How do we get there?

8. What is eThority? • Clinical trials software application for budgeting, billing calendar, enrollment, reporting, and analysis for all clinical trials activity • Easy-to-use, Citrix-based software for large, experienced investigative teams; individual junior investigators; and everyone in between • Vendor with successful track record of software implementations at UMHS

9. Why? • Enable researchers to create more timely and accurate budgets, improving negotiation with sponsors • Develop standard and consistent work to enable faster review and reduce administrative burden • Ensure appropriate billing for items and services, enhancing compliance • Provide researchers with single application in which to build budgets and billing calendars • Provide direct access to CPT and CDM codes and discounted pricing • Enable study budget and billing calendar to be automatically populated • Enable researchers to look at financial feasibility of protocol and understand changes required to improve financial performance • Provide improved reporting capabilities for better ongoing management of activity

10. When?

11. How? • Executive Sponsors: D Spahlinger, S Kunkel • Project Leads: S Silver, T Grieb • Steering Committee: S Silver, T Grieb, J Bell, M Ceo, B Davies, D Gipson, G Hiller, B Johnson, A Lok, T Marks, A Milliman, T Shanely, G Vuocolo-Branch • Development & Implementation: Members from MSA/FGP, CRAO, ProFee Billing, Internal Medicine, MSIS, MICHR, eThority • Several sub-teams focused on Clinical Systems, Calendar/Budget Design & Subject Enrollment, Education/Training, IT Implementation, CRB Database, Charge Master & Bundling, and Communications

12. Future State • Uniform budget/billing calendar development with single entry • User-obvious design with built-in wizards • Searchable pricing with smart charge master • Subject enrollment and reporting • Enhanced financial analysis and reporting capabilities • Improved billing compliance and reduced subject complaints

13. Thank you for your advice and guidance!Mat InnesBenjie JohnsonAndree JoyauxMelissa KarjalaJack KufahlSarah KyleKim LeppertAnna LokJill MalayangTom MarksJim MaszaticsBrett MillerAmy Milliman Shari Barnett Mary Hill Samya Nasr Rick Bluhm Glen Hiller Sandy O’Holleran Kerri Briesmiester Mei-Lan Huang Carolyn Pappas David Browning Rebecca Hughes Paulina Radenbaugh John Burnett Judy Rotthoff Maria Ceo Marifelice Roulo Karis Crawford Tom Shanley Sarah Faix Nan-Sheng Sheng Mary Greer Jane Sierra Jaimee Gauthier Sam Silver Steve Gendler Monica Stiddom Debbie Gipson Karen Strode David Golden Gina Vuocolo-Branch Teri Grieb Mariella Wells Cathy Handyside Peg White Jan Hewett Sandy Wilcock Diane Hilfinger

14. APPENDIX

15. CRAO Ancillary Committee Useful Tips • 5 core documents required at time of IRB application submission • Billing Calendar • Informed Consent • Protocol • Budget (internal/external) when applicable • Contract when applicable Note: Draft versions accepted and satisfactory for CRAO review

16. CRAO Ancillary Committee Useful Tips (cont’d) • All applicable documents are reviewed for harmony • Revisions are made to BC and inconsistencies are shared with study team • Budgets assist the CRAO review with the assignment of routine care vs. study • Assist in determining study is exempt from CRAO review and no BC is needed • If your study does not have a budget and/or contract, note in correspondence within eRRM , e.g., internally funded and/or NIH

17. Compliance Challenges • Recovery Audit Contractor (RAC) Program • Authorized by Congress to identify improper Medicare payments (overpayments and underpayments) • Office of Inspector General (OIG) • OIG duties carried out through nationwide network of audits, investigations, inspections and other mission-related functions performed by OIG components • OIG has an annual work plan and targets specific issues, etc.

18. Compliance Risks • CMS-False Claim Act (highlights) (a) Any person who… (1) knowingly presents, or causes to be presented, to an officer or employee of the United States Government or a member of the Armed Forces of the United States a false or fraudulent claim for payment or approval; (2) knowingly makes, uses, or causes to be made or used, a false record or statement to get a false or fraudulent claim paid or approved by the Government; (3) conspires to defraud the Government by getting a false or fraudulent claim paid or approved by the Government is liable to the United States Government for a civil penalty of not less than $5,000 and not more than $10,000, plus 3 times the amount of damages which the Government sustains because of the act of that person . . . . http://www.cms.gov/transmittals/downloads/R1723CP.pdf

19. Compliance Wake Up Call • Rush University Settlement • Allegations • Improperly billed Medicare for physician and hospital research services as routine care costs under NCD • Absence of “synchronization of the Medicare rules, the compensation arrangements with the sponsors, and the financial discussion in the informed consent” • Voluntary self-disclosure to DOJ • Refund Medicare overpayments plus 50% penalty ($1 million) • 3-year Certification of Compliance Agreement (CCA) • Require clinical trials to receive a coverage analysis

20. 2010 FGP Compliance Work Plan Very High Risk

21. Routine Costs Do NOT Include • Investigational item or service itself • Items & Services: • For which there is no Medicare benefit category or are statutorily excluded • Furnished solely to satisfy data collection and analysis not used in clinical management • Customarily provided by research sponsor • Provided solely to determine eligibility

22. Clinical Research Billing • Accurate billing of I/S for participants in clinical trials • Standard of Care I/S billed to 3rd party payers • Research I/S billed to trial sponsors • Billing Calendar (BC) also used to allocate appropriate modifier (Q0,Q1) to subject’s medical claim to reflect and investigational device or routine care services provided during approved clinical trial

23. Billing for Routine Clinical Research • Q0 – For investigational item or service provided during or as part of an approved clinical research study • Q1 – For routine item or service provided during or as part of an approved clinical research study Pub. 100-04, Transmitttal:1418, January 18, 2008, Change Request:5805 Effective Date January 1, 2008.