What Financial Administrators Must Know About Clinical Research at MSU

Transcription

1 What Financial Administrators Must Know About Clinical Research at MSU Philip Reed, Interim Director CTSI & Director of BRIC, Clinical & Translational Sciences Institute Ann Smith, Operations Administrative Manager, Clinical & Translational Sciences Institute 1

2 Vice President for Research & Graduate Studies Clinical & Translational Sciences Institute (CTSI) Biomedical Research Informatics Core (BRIC) Develop New Opportunities With Research Partners Office of Clinical Research (OCR) BRIC s Research Portfolio: CDC, DOD, NIH, Trinity Health Data Mgt. & Informatics Support of Funded MSU- PI Projects Budget Review, Development & Negotiation Services Clinical Trials: Find Trials for Departments CTSI-Based Trials Support Dept.- Based Trials Investigator Support in New Grant Application Development PI & Staff Training in Study Execution & Compliance Research Facilitation & Interdepartment al Liaison 2 Personnel & Lab Support Services

3 3 Clinical Research Interface Touch Points

4 What is Clinical Research? Human Research Clinical Research Clinical Trials Investigator Initiated Industry Sponsored 4

5 Clinical Research is a Business Clinical Research is a BUSINESS and must be run accordingly! A Business best achieves goals by starting with a STRATEGIC PLAN 5

6 Clinical Research Strategic Planning Why are you in the business of clinical research? What is your market? What are your research fixed operating costs, and how will you fund them through clinical research? How will you attract and retain high-quality staff? 6

7 Use of Business Tools Operational Budgets Project Budget Templates Breakeven Analysis Protocol Feasibility Clinical Research Management Systems 7

8 Presents a Win/Win/Win Opportunity Generates revenues to support equipment, personnel and other resources Provides access to state-of-the-art therapies, devices and techniques 8

9 The Challenge: Clash of Cultures Industry s Culture Profit-oriented Protection of proprietary data Swift moving Results oriented 9

10 The Challenge: Clash of Cultures University s Culture Non-profit Values dissemination of ideas Values deliberation and consensus Primary responsibility is to the public 10

11 The Business of a Research Study A Clinical Research Study is Type of Virtual Company It has Similarities with a Movie Production Company 11

12 What and Who are Involved? Principal Investigators Other Compliance staff (IRB, Human Subjects Liaisons The Process Sub- Investigators 12 Administration (Contracts, Budget & Billing) Study Staff (Coordinators, Nurses, Data Managers) Ancillary Services

13 Protocol Feasibility Overview Know your subject base and have recruitment plans Be aware of project logistics and available resources Be aware of financial obligations of the study Is the research important to the Department/College? Beware of over-enthusiastic PIs 13

14 Who Processes Agreements at MSU All Industrial Sponsored Clinical Trials & Research Agreements are handled by MSU Business Connect, Randy Sheets All Federally Sponsored or Non-Profits Clinical Trials & Research Agreements are handled by the Office of Sponsored Programs, Fred Salas Appropriate application of the clinical trial F&A cost rate 26% of direct costs for Industrial Sponsored Trials 53.5% for federally sponsored investigator-initiated research Other rates 14

15 Issues in the Business of Clinical Research FDA reports nearly 4,000 active investigational new drug applications in clinical trials at any one time Only 14% of studies are completed on time 81% of studies are delayed six months or more Pharmaceutical Companies under intense competitive pressures R&D budgets increased by 14% to 16%/ year; but study budgets have remained flat In 1994, 76% of clinical research was conducted in the academic setting; in % is done in universities 15

16 The Challenge: It Takes To Long Time from Confidential Disclosure Agreement (CDA) to First Patient Enrolled Industry Goal 90 days Universities 180 days MSU 270 days 16 CDA 1 st Patient Enrolled

17 Simultaneous Institutional Evaluation (Pre-Award) Department / College Approvals Submit for Review by CTSI Contract Rev by Appropriate Office Submit IRB Application Additional Required Reviews? Obtain All Needed Institutional Reviews &/or Approvals, CGA Account Setup, & Notify All Parties 17

18 18 Budget Preparation and Negotiation

19 Budget Objectives Analyze the Protocol and determine the study services Identify costs for services Create overall study budget Upfront/Start Up Costs Per Subject Costs Fixed Costs Produce Study Billing Grid Negotiate Budget and Payment Terms (Contract) 19

20 Typical Budget Components Study Effort/Personnel Costs Upfront/Start Up Costs IRB fees Per subject (variable) costs pharmacy, imaging, labs, regulatory prep and amendment fees, Safety report review fees, supplies, record archiving Ongoing Administration Expenses Facilities and Administrative Costs (F&A) assessed on all items except IRB fees 20

21 Tips on what to look for when Analyzing the Protocol for Study Costs Identify each event to occur at each study visit Do not rely solely on the schedule of events Include costs for ancillary services required by the protocol Include hidden and personnel costs Identify open enrollment period for inflation factor 21

22 Cost Sources Start-up admin fee - PI Protocol Review - IRB Preparation - Budget Preparation - Study Coordinator - Administrative Staff - Investigator and site initiation meeting IRB Submission Research Pharmacy (set-up and close out) Telephone, Fax, Office Supplies Records Archiving Equipment Training Study management and maintenance- - Monitoring visits, data queries - Sponsor contact (teleconferences, meetings, s) - Financial management - Supply and Pharmacy drug/device management -Reporting - Regulatory submissions (revisions, renewals, SAE reporting) Study close out - Data queries - Drug / device return - Financial reconciliations 22

23 The Budgeting Process Tools Available to Assist You Office of Clinical Research (OCR) Review Budgets, Clinical Trial Agreement (CTA) payment language Assist with analyzing MSU costs vs Sponsor payment Negotiate Clinical Trial/Research Budget Costs w/ Sponsors Clinical Research Management System Access currently Merge CRMS 23 Access to Study Staff for purchase on a percent FTE for investigators just getting started who do not have own staff

24 Billing Compliance & Medicare Coverage Analysis 24

25 Overview of Billing Rules Many rules govern the billing Process False Claim Act Erroneous Billing Stark I, II & III Anti-Kickback Act Medicare Rules Patient Protection and Affordable Care Act (PPACA) State Insurance Regulations Institution Policies 25

26 IMPORTANT: Pitfalls to Avoid Need to have a Medicare Coverage Analysis done to ensure no inadvertent double billings occur A variety of information must be coordinated across many MSU departments to manage research billing compliance Verify Cost are Covered Communication should be done as early in the process as possible to manage compliance risks Office of Clinical Research is available to help units with both of these processes 26 Adapted from materials presented by Meade & Roche LLP at HCCA Research Basic Compliance Academies, Aug 15-18, 2011, Las Vegas

27 Billing Grid Details each study visit activity and related charges Created as part of the budgeting process Billing Grid illustrates how procedures will be charged Standard Of Care (SOC)- Procedures/items are routine and are to be paid by patient s insurance or Third Party Payer Research-Related Procedures and Activities 27

28 Billing Grid Example 28 28

29 Clinical Research Billing Risks Double Billing billing for services that are already paid for by sponsor to a Third-Party Insurance Billing for services that in the informed consent indicated would be at no cost to the participant Billing for services that are research only Billing for services that are part of a non-qualifying clinical trial, Medicare is not willing to pay for all standard of care for all studies. 29 Adapted from materials presented by Meade & Roche LLP at HCCA Research Basic Compliance Academies, Aug 15-18, 2011, Las Vegas

30 Why Do We Care? ETHICAL, LEGAL & PR CONSIDERATIONS 30

31 Office of Inspector General - False Claims Kevin Cosens (Device salesman) Qui Tam Action Inappropriate billing of non-fda approved cardiac devices 31 Over 130 major academic medical centers and community hospitals named over 40 still being actively pursued 34 previous settlements recovering $45 million Larger Settlements: University of Washington $3.6 million University of California SD $4.7 million Allegheny General Hospital $3.2 million Catholic Healthcare West $10.8 million In addition, most of these hospitals are now operating under Cooperate Integrity Agreements

32 Other False Claims Settlements (Research-related) The Methodist Hospital (Houston) St. Luke s Episcopal Hospital (Houston) Deaconess Medical Center (Spokane) Legacy Good Samaritan Hospital (Portland) Orlando Regional Medical Center (Orlando) Scripps Health (La Jolla, San Diego) UPMC Health System (Pittsburgh) INTEGRIS Baptist Med Center (Oklahoma City) Hoag Hospital (Newport Beach) St. Joseph s Regional Medical Center (South Bend) Beth Israel Deaconess Medical Center LDS Hospital (Salt Lake City) Holy Cross Hospital (Ft. Lauderdale) Miami Heart Institute (Miami) $2.75 million $575,000 $775,000 $410,000 $390,000 $3.8 million $1.5 million $629,000 $305,000 $107,000 $3.2 million $850,000 $2.8 million $1.9 million 32

33 33 Financial Management

34 Pre-Award Financial Management Budget development & internal costing Subcontract budget development if needed Billing grid generation for proper billing (3 rd party for routine vs study funds for research-related charges) Post-Award Track sponsor payments; review for accuracy Invoicing sponsor for line items Payables to service providers per billing grid Labor distributions & effort reporting Study subject stipends and 1099 Subrecipient Monitoring Study closeout of finances 34

35 Automatic Payments (ACH/Check) Payments generated upon completion of study events Payments trigger by either data entry or monitoring visits Payment notification goes to departments for correct payment verification 35 CGA cash management group needs to be notified notification of ACH deposit and study title, account number, amount and type of payment (i.e. per subject payment, invoiceable, or start-up) Cover letter containing the information above to accompany check when dropped off at CGA

36 Invoicing Items that are not automatically paid Invoices are generated by site, needs close monitoring for payment by sponsor and to ensure credit to your account. Units need a system to track invoices & reconcile payments received 36

37 37 Be aware of partial payments Sponsor may only pay a portion of an invoice due to many items, which may include: -Payment withholds until end of study -Prorated payment due to study milestones -Case Report Form issues: incomplete, delayed, unverified - Not all study procedures may have been performed -Subject withdrawal

38 38 Accounts Payable Payments for ancillary services Either by subcontract or purchase order for external providers For internal providers, via EBS as internal bill to the res. account Examples of Subcontracts (are considered engaged in research) Sparrow Pharmacy Hospital Bed Fees Examples of Purchase Orders (services providers) Sparrow Laboratory testing, Research Pharmacy services, imaging services Internal Service Providers IRB Fees MSU Imaging Services Cardiology Services MSU Pharmacy

39 Subject Stipend Payments Stipend: Payment to subject for reimbursement of study-related effort and expense. Dispensation of stipends must be tracked Cash Management Checks Privacy Compliance Internal Control Mechanisms Sensitive data should not be listed in 39 the EBS system when paying participants

40 In Summary Proactive fiscal administration enhances billing compliance! Develop Billing Grid Track subject enrollment & visits Reconcile research services against billing grid 40

41 41 Questions?