No Double Dipping And We re Not Talking About the Crudit s

1. No Double Dipping(And We�re Not Talking About the Crudit�s) NCURA�s 49th Annual Meeting Washington D.C. November 7, 2007

2. 2 Moderator

3. 3 Agenda Review Key Statutes and Applicability in Research Context Coverage Analyses � Protection or Increased Risk? Overview of Current Medicare Coverage Roles and Responsibilities � IRB, PIs, Providers and Sponsors / Implementation Concerns � Case Studies and Practical Solutions Case Study #1: Medical College of Wisconsin, Froedtert Memorial Lutheran Hospital, and Children�s Hospital of Wisconsin Case Study #2: Rush University and Rush University Medical Center Case Study #3: Massachusetts General Hospital and Partners Healthcare, Inc. Key Takeaways

4. 4

5. 5 Civil False Claims Imposes liability against a person or entity who: Knowingly (can be demonstrated by �reckless disregard� or �deliberate ignorance�) Submits a false claim for payment, or Uses a false record or statement to get a claim paid or approved, or Causes a third party to do either of the above Civil Monetary Penalties (�CMPs�): $5,000-$11,000 per false claim submitted plus up to 3x the damages sustained by government

6. 6 Criminal False Claims Imposes liability against a person or entity who: Knowingly and willfully makes or causes to be made a false statement or misrepresentation on any claim, or having knowledge of an event affecting the initial or continued right to any such payment conceals or fails to disclose such event with intent to fraudulently secure such overpayment Penalties: 5 yrs imprisonment and/or $25,000 fine

7. 7 Applicability in Research Billing Frequency of services required by protocol, including �confirmatory� items / services Items / services unnecessarily repeated to fit the protocol�s screening or other windows Primarily research-oriented procedures Double-dipping / per capita payments in excess of fair market value (�FMV�) Nonbillable investigational item / service itself regardless of whether sponsor is providing at no charge Inappropriate use of research billing codes

8. 8 Common Myth Medicare rules should be applied for all payers Medicaid: Many states do not cover any services rendered as part of a clinical trial (e.g., Arizona) Non-coverage in others is broadly defined (e.g., Illinois) Although some do determine coverage based on Medicare and commercial payers (e.g., Wisconsin) Commercial payers: FCAs do apply State laws mandating coverage in cancer trials

9. 9 Deficit Reduction Act (DRA) Established the Medicaid Integrity Program (MIP) Improved Federal Financial Participation (FFP) for states with FCAs that comply with federal standards States that comply will receive an extra 10% in their share of recoveries Increased pressure on states to pass compliant FCAs Providers receiving $5M or more in Medicaid payments must have training and written policies re: fraud and abuse and the Federal and applicable state FCAs Includes employers, vendors and agents of the provider

10. 10 HIPAA � Not Just the Privacy Rule Added four new health care related crimes Health care fraud Theft or embezzlement in connection with health care fraud False statements relating to health care matters Obstruction of criminal investigation of health care offense Expanded definition of �health benefit plan� to include commercial payers

11. 11 JAZZ Pharmaceuticals 07/13/2007 �Criminal misbranding scheme induced physicians� to write prescriptions for Xyrem that were not reimbursable by private health insurers or public insurance programs� Criminal restitution of $12.2M to insurers and $5M criminal fine Penalties under Civil FCA of $3.75M Medical spokesperson for the company not only suggested off-label uses were customary and safe, but also advised how to �conceal� off-label uses �in order to ensure reimbursement��

12. 12

13. 13 Protection Protects against charges of false claims Shows �careful consideration� as opposed to �reckless disregard� or �deliberate ignorance� Serves as a guide for billing offices and other operating areas Assists the Institutional Review Board (�IRB�) Basis for �effective� auditing and monitoring programs in both billing and human subjects protection compliance

14. 14 Increased Risk Could lead to allegations of false claims if: Done incorrectly Based primarily on classification by the PI Classification of �routine� services not supported as �generally accepted in the medical community� Implemented incorrectly Supporting systems not in place and operational

15. 15

16. 16 Medicare Current Coverage Since 1995, Medicare will consider covering certain devices (and associated procedures) categorized as nonexperimental / investigational by FDA (Category B) Beginning 1/06, Medicare may cover Category A devices in clinical trials involving life-threatening situations Effective 9/00, Medicare covers �routine� costs incurred in �qualifying� clinical trials and costs to treat complications associated with participation in all trials �All other rules apply� Since then, some commercial payers have followed suit, (e.g. Aetna)

17. 17 Medicare Key Statutes / Regulations Social Security Act 42 U.S.C. �1395y(a)(1)(A) Excludes coverage for any item or service which is not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member Medicare Carriers Manual �2049.4 ��Services �related to� noncovered services (e.g., cosmetic surgery, noncovered organ transplantation, noncovered artificial organ implants, etc), including services related to follow up care and complications of noncovered services which require treatment during a hospital stay in which the noncovered service was performed are not covered services�

18. 18 Medicare Key Statutes / Regulations Devices and Related Services 60 FR 48417 Excludes coverage for devices assigned Category A / Category B devices are potentially covered Coverage provided by local Medicare contractors Most fiscal intermediaries and carriers require providers obtain prior approval letters The majority only address the device and related procedure Payment is based on, and may not exceed, amount that would have been paid for an FDA-approved device serving the same or similar purpose Specifically, applies the �related to, not related to� rules

19. 19 NCD on Routine Costs in Clinical Trials Trial must meet three initial requirements: Subject or purpose must be the evaluation of an item or service that falls within a Medicare benefit category and is not statutorily excluded Must not be designed exclusively to test toxicity or disease pathophysiology � must have therapeutic intent Must enroll patients with diagnosed disease, but trials of diagnostic interventions may enroll healthy patients as controls Generally, items and services covered as routine costs under this NCD must be available to beneficiaries not participating in trials

20. 20 NCD on Routine Costs in Clinical Trials For noncovered items and services, including those statutorily excluded, only the treatment of complications and unrelated reasonable and necessary care is covered Items and services not covered by virtue of a national noncoverage decision that are the focus of a qualifying clinical trial are not covered, but the routine costs of the trial (as defined by Medicare) are covered

21. 21 NCD on Routine Costs in Clinical Trials Trial must also be a �qualifying� trial Federally-funded by NIH, CDC, AHRQ, CMS, DOD and VA Trials supported by cooperative groups or centers funded above agencies Conducted under an investigational new drug application (IND) reviewed by the FDA Exempt from FDA�s IND requirements under 21 CFR 312.2(b)(1)

22. 22 NCD on Routine Costs in Clinical Trials Routine costs do not include: Investigational items and services Items and services solely to satisfy data collection and analysis needs which are not used in the direct clinical management of the patient Items and services provided for free or paid for by the sponsor Routine costs include: Conventional care items and services typically provided absent a trial Administration of the investigational item, clinically appropriate monitoring of the effects or prevention of complications Items and services for the diagnosis or treatment of complications

23. 23

24. 24

25. 25 Medical College of Wisconsin Medical College (professional services) Froedtert Lutheran Memorial Hospital Children�s Hospital of Wisconsin Zablocki VA Medical Center Blood Research Institute (Bloodcenter of Wisconsin)

26. 26 Multiple Iterations IRBs Grants/contracts offices (pre-award) Research fund accounting offices (post-award) General Counsel offices Risk Management offices Facility pricing functions Facility billing offices

27. 27 Eye of the Needle Assemble all documents (grant/contract, protocol, consent document, etc.) in one place Construct �Schedule of Events� Research pricing plan What costs are covered by external support? What costs are assignable to subjects? What costs remain unreimbursable? Reconcile billing plan with consent document Issue approved billing plan as compliance guide Can all downstream billing offices adhere to billing plan?

28. 28

29. 29 Rush University Medical Center: Challenges Centralization of Research Office Coverage analysis Query departments on research billing processes. Determination of down stream concern Registration Development and implementation (test) Education, education, education, education Roll-Out Evaluation

30. 30 Centralization of Research Office Prior to 11/5/04, projects reviewed in isolation (study with ICF, budget and contract) Under one roof, bring together the following divisions: Human Subjects� Protections Sponsored Research Projects Clinical Trials Office Coverage Analysts Positive result, projects reviewed together and ascertain all documents match.

31. 31 Coverage Analysis Methodology brought to RUSH by McAllister Consulting. First department for studies to have a coverage analysis was DHO. All studies underwent coverage analysis (pre and post NCD). Effective 11/5/04 all studies submitted for IRB review had to have a coverage analysis. Outsourced process, and hired and trained staff during process: IRB reviewed coverage analysis with respect to subjects� financial liability All studies require coverage analysis before submission to IRB

32. 32 Coverage Analysis (cont) Issues Centralization of office with staff changes, new process and education all concurrently PI upset as a new process was put in place without prior notice (including requiring an itemized budget) Required numerous one-one departmental meetings Took TIME before becoming custom/culture and realization of the importance Now, an adopted custom, culture and requested to assist with budget development

33. 33 Query departments on research billing processes At same time as�. centralization of research office, new process and education Queried departments on billing processes, including OR Determination of down stream concerns Determination of scope of opportunities Determination of common thread for decentralized research (registration); also various un-intregated systems in place Meetings to review data, develop process, review forms and set �go live� date

34. 34 Development and implementation (test) At same time as�. centralization of research office, new process and education Stake holder working meeting (staff from various departments) Develop standardized method for registration of subjects on clinical trials. Share this information with all stake holders and users Develop standardized forms Develop Manual Identification of researchers and personnel involved with research

35. 35 Education, education, education, education At same time�centralization of office with staff changes, new process and education all concurrently Phase I Web based module on the National Coverage Determination (NCD)- annual requirement (available 5/1/06, by 5/31/06, 91% completion. Phase II Every department was provided information on the methodology developed for clinical trials billing in an hour session (24 sessions held in May 2006)

36. 36 Education, education, education, education Phase III (ongoing)- 18 sessions from (2/07-3/15/07) for the remainder who did not complete Phase II Monthly sessions currently held for new PI�s, study coordinators and research administrators.

37. 37 Roll-0ut and Evaluation At same time as�. centralization of research office, new process and education Rollout occurred concurrently Focus on research billing Compliance ascertained by audits

38. 38 Rush University Medical Center: Lessons Learned Not a good idea for variety of changes to occur simultaneously Essential for Senior Leadership support Need to take a step back and celebrate successes rather than focus on outstanding issues Need to take a step back�for clarity Communication is essential People are frustrated and it is very stressful Timelines not always met Research will slow down Team work Constant Education

39. 39

40. 40 Massachusetts General Hospital: Challenges Decentralization of Research Entity vs. Corporate Responsibility/Who�s in Charge? Where to Start?? Education and Training Coverage Analysis: the missing step The Future: Education and Training (round two) Audit, Feedback, and Evaluation System Enhancements

41. 41 Decentralization of Research Research traditionally set-up in silos: Grants & Contracts, Research Finance, Research Management, Research Administration, PIs Poor integration with Patient Accounts, Billing Compliance, Operations Administration, etc. Decision-making process and authority related to clinical services often poorly defined Accountability Oversight Clinical research billing often an afterthought in system and process design Resources may not be deployed appropriately

42. 42 Entity vs. Corporate Responsibility/Who�s in Charge? MGH is one of the member hospitals of Partners Healthcare, Inc. Corporate office responsible for many of the individual functions related to Research (grants management, contracting, billing) Unique systems and processes at each of the entities (billing system, patient registration, discounting research charges, training, etc.) Broad acknowledgement across departments and hospitals that pieces of the process needed attention, but unclear who had the authority to authorize changes Clinical Research created entity level Steering Committee with corporate representation and input

43. 43 Where to Start? Coverage Analysis without an implementation/ operations strategy increases risk Chicken and the Egg: Need to understand and fix downstream revenue cycle process related to clinical research billing before you can effectively implement proactive coverage analysis prior to completing budgets, enrolling patients, etc. Difficult to effectively bill trials without coverage analysis Had to rely on PI judgment as interim step Gap analysis performed to fully understand current state and develop implementation plan Focus on incremental improvement to gain momentum

44. 44 Education and Training Just do it! Started training what we did know while we gained knowledge and experience Broad audience Administrative Directors, VPs Research Coordinators Departmental research staff PI education through more indirect means Make materials available online Policies and Procedures, including flowcharts General contact people to triage questions Continually update and refresh materials, wider audiences

45. 45 Coverage Analysis Coverage analysis was traditionally a decentralized function performed by Research Coordinator and PI In order to ensure consistent and quality output, function was centralized for all trials in the budgeting group, renamed Clinical Research Financial Services Still short of centralized Clinical Trials Office Training of key personnel performed by outside consulting firm Key to success is understanding how to operationalize coverage analysis so it translates smoothly to the grant and insurance billing Still a work in progress, more to come�

46. 46 The Future Implementation Plan delineating local vs. corporate tasks, as well as quick hits Oversight of progress by MGH Clinical Research Steering Committee Hiring Research Compliance personnel and building more robust monitoring and education process Evaluating system enhancements to integrate information into one system, including patient tracking, and sponsor invoicing Eventually moving all hospitals to one system with robust Clinical Trials module (under design) Continuing to integrate Research into everyday department administration

47. 47 MGH: Lessons Learned Involve and leverage senior leadership, especially those without �Research� in their title Fully integrate clinical research into operational workflow, discussions, and line management Don�t jump to a solution, take the time to develop a well-thought out plan or framework that will address multiple issues Make it as easy as possible for people to do the right thing Listen to stakeholders

48. 48 MGH: Lessons Learned (cont.) Establish and maintain oversight of the process until changes are fully integrated Steering Committee or Role tasked with oversight Monitor and audit periodically following implementation Educate and train, educate and train some more Why it�s important How to do it right Have a contact people can go to with any question or concern

49. 49

50. 50 Key Themes Centralized vs. Decentralized functions within your organization�what makes sense? Involve and leverage senior management Diagnose the Problem: spend time understanding current process and clarifying gaps; use gaps to define action plan Policies & Procedures Training and Education Integration Points Audit and Feedback Pick a starting point for intervention Less important where you start as long as you begin and have a plan

51. 51 Key Themes (cont.) Define and understand key stakeholder needs Customer-service oriented approach Timeliness Compliance Financial protection for hospital Know your information systems and their limitations Billing/Accounts Receivable Award Management Infrastructure (Pre and Post) Educate and Communicate, you can never do either too much Continually evaluate process and provide feedback