Clinical Trials: Budget Development with Billing Analysis and Negotiations

1. Clinical Trials: Budget Development with Billing Analysis and Negotiations Ellen Datena RN, BSN Director of Clinical Research Billing Analysis University of Maryland Baltimore

2. Billing Analysis and Budget development How are they connected? How are patient care costs incorporated in budgets? How does federal funding differ from industry funded budgets?

3. Costs involved in Clinical Trials Patient care costs; �potential� billable clinical activity Study team effort Institutional indirects The investigational item (e.g., drug, device) Fees: CCT fee (contract execution) Research data storage fee IRB fees (initial and annual review) Investigational Pharmacy fees

4. Costs involved in Clinical Trials Subject reimbursement Pass through charges; items to be invoiced Subject injury responsibility Supplies

5. Grants often non-specific with the direct patient care costs Grants appear to place more focus on Effort Grant funding is often inadequate in covering the cost of performing and executing the clinical trial �Grant� funding

6. �Grant� funding Grants generally appear to have this misconception that most/all potentially billable clinical activity can be billed to subject�s insurance Grants are generally non-negotiable Remember that Federal agencies don�t always talk to one another especially when it comes to who is paying for what (e.g., Medicare, NIH)

7. Industry/Sponsor funding Sponsors usually have a line item specific budget Sponsors often work through CROs Sponsor budgets are generally negotiable

11. Along comes Research Billing Compliance Research billing compliance applies to all clinical trials that involve clinical care activity, regardless of funding Education of Faculty, Research Administrators, Principal Investigators, and Research Staff is imperative to having a successful program Compliance is here to stay

12. Research Billing Analysis and Compliance Identification of clinical research items or services that can or cannot be billed to third-party payers Assurances that processes are in place to bill third-party payers only for items or services that research billing rules allow Harmonization of relevant portions of study documents in accordance with research billing rules

13. Why is this important? OIG work plans usually include clinical research billing as a top priority in compliance initiatives OIG FY2010 federal budget requests over $2 billion for fraud and abuse; depending on �whistleblowers� Medicare �double billing� has been the subject of numerous OIG/DOJ investigations/settlements From both a research and business perspective, it�s important to determine conventional care versus �research only� items and services

14. What tools do we use? Medicare Clinical Trial Policy, NCD 310.10 Medicare is considered the �Gold Standard� by which many commercial payers base their coverage decisions, including coverage for clinical research services Several States have passed legislation requiring commercial payers to follow the Medicare rules Institutions are expected to follow the Medicare CTP and develop internal structures to address the coverage issues

15. Medicare(CMS) Medicare is a Federal program that is administered regionally through private companies that have contracts with CMS. These Local Medicare Contractors often have a broad range with their decision making, and The Local Medicare Contractors don�t always agree across regions

16. Medicare Clinical Trial Policy �Medicare covers the routine costs of qualifying clinical trials, as well as reasonable and necessary items and services used to diagnose and treat complications arising from participation in all clinical trials. All other Medicare rules apply.� �Routine costs of a clinical trial include all items and services that are otherwise generally available to Medicare beneficiaries that are provided in either the experimental or the control arms of a clinical trial� with specific exceptions.

17. What are routine costs? Conventional care-items or services that are otherwise generally available to Medicare beneficiaries(covered benefits) Services to detect, prevent or treat complications arising from the provision of an investigational drug Items or services required for the administration of the investigational item or service

18. What are not routine costs? The investigational item or service- unless the investigational item or service would be covered outside a clinical trial Items or services solely for research purposes (e.g., a confirmatory MRI) Items or services solely to determine trial eligibility Items or services paid for by the sponsor Items or services promised free in the informed consent

19. What are not routine costs? Those lacking a Medicare benefit Those which are statutorily excluded Those that fall under a national non-coverage policy Items and services other than those for the diagnosis and prevention of complications in a non-qualifying trial

20. Billing Analysis at UMB All clinical trials involving human subjects with potentially billable items and services regardless of funding source are submitted to CCT(Center for Clinical Trials) for review. A billing analysis is done for reasons of compliance as well as budget purposes Clinical trial budgets are based on true costs of the study We are not suppose to make money off of clinical trials COI issues, false claims and anti-kickback statute

21. Billing Analysis at UMB The research administrator or research coordinator submits the study via the service request form This request form identifies the study, the PI, study coordinator, funding source, contacts, as well as additional demographics A Clinical Analyst is assigned to the study; he/she immediately sends out a request to the study team asking them to send all pertinent documents ( protocol, CTA, Informed Consent, FDA letters)

22. Billing Analysis at UMB Review all documents thoroughly The Medicare CTP, NCD 310.10 is our �bible� Determination made as to whether it is a Medicare qualifying trial Complete a billing grid listing all visits, items and services required for execution of the protocol Working closely with the PI and the study coordinator The grid basically identifies those items that are non-billable(NB) and those that are possibly billable(M)

23. Billing Analysis at UMB If billable(M) then we identify a justification (e.g., CMS NCD, LCD, reasonable and necessary) If non-billable (NB) we also provide rationale(e.g., Sponsor paying, informed consent states it is being provided free of charge, non-covered Medicare service All items and services that are non-billable become the responsibility of the sponsor, federal funding, foundation, department, and/or even the participant

25. Budget Development at UMB We have identified the items and services that sponsor is responsible for through the billing grid Internal Budget document initiated if a negotiable budget vs. grants( generally non-negotiable) The budgets are based on true costs of the trial We are working closely with the PI, study coordinator and research administrator in determining their budget needs in covering the cost of the trial

26. Budget Development at UMB We ask the PI and study coordinator to determine startup hours for those involved in getting the trial up and running We ask the research team to identify all members involved in the performance of the trial Research team determines the hours spent from when participant is consented until the participant has completed the study for each study team member These hours get entered on the internal budget document which then combined with salaries for each research team member calculates total effort for start-up and total effort for �per subject costs�

28. Budget Development at UMB List all items and services that are sponsor�s responsibility (billing analysis grid) on internal budget document Obtain pricing for facility charges (UMMC) and professional fee charges(UPI) from appropriate parties List frequency of each item Incorporate Institution�s indirect cost List in separate section all invoiceable items with the indirects included Include Pharmacy dispensing fee

29. Budget Development at UMB Other Costs considered: Pharmacy setup fees, pharmacy maintenance fees Storage of research records fee CCT fee-covers cost involved with contract execution Advertising Review of outside adverse events and submission to IRB IRB fees- initial as well as annual review Departmental fees; Institution Indirect costs Unscheduled visit costs Screen failure costs

30. Budget Development at UMB Compare our internal budget estimate to the funding provided by sponsor Is there a shortfall? Is funding excessive? Anti Kickback Law Federal False Claims Act.

31. Budget Negotiations at UMB Edit the sponsor�s line item budget Replace their funding for the appropriate items with our actual cost for the item If a per visit budget vs. a line item budget, adjust each visit incorporating cost of items involved with each visit and effort time Include all fees Include all invoiceable charges

33. Budget Negotiations at UMB We always obtain PIs approval of budget prior to beginning negotiations Submit revised sponsor budget to CRO/ Sponsor Negotiate, negotiate, negotiate Often difficult Be prepared to step away Performing a billing analysis and requesting actual costs aids in the negotiation process

34. Additional Information Non-negotiable budgets we do a cost estimate only-identify those items that cannot be billed to insurance The budget is part of the final executed contract, therefore working closely with the Contracts group is important The research team gets a copy of the signed internal budget as well as the billing grid to assist them in distributing the research funds properly and invoicing when applicable The internal budget document assists with specifics as to which specific items need to be invoiced

35. Finalizing Once contract is fully executed the signed internal budget is sent to study team along with the billing analysis The billing analysis and just the portion of the internal budget which identifies specific items costs go to UMMC (hospital/facility) and to UPI ( professional practice office) Our website has a one time on-line education module for the PIs, study coordinators, and research administrators to complete when submitting to us

36. Research Administrator Responsibility Research Administrator often involved at our site with budget development Important for you to know and understand the process The internal budget documents important for routing The internal budget specifies which charges need to be invoiced; which charges need to go to the research account