Case Study: University of Washington s Clinical Research Billing Audit Program 7 th Annual Conference for Effective Compliance Systems in Higher Education Richard A. Meeks, CCEP
Agenda Background Probe Audit Research Billing Audit Program Proposal Research Billing Audit Program Program Results 2
Background
4
Research at Seattle Cancer Care Alliance About 600 studies About 600 study staff Over $1 billion in research $250,000 in Clinical Trials Research 5
Medicare regulatory landscape National Coverage Decision (NCD) September 2000 Coverage for Medicare beneficiaries on clinical trials costs beyond usual or conventional care 2005 Rush settles with Federal Government for $1 million. 6
Medicare regulatory landscape Medicare Clinical Trials Policy (CTP) October 2007 Affirmed original NCD w/modifications and provided clarification on existing requirements Expanded coverage for studies that are deemed qualified Required identification of all study services that are billed, even usual care Issued new billing codes, January 2008 7
Timeline 2002 Task Force on Billing Compliance in Clinical Trials formed (reported 2003) 2003 Transitional Task Force formed to develop an implementation plan (report 2004) 2005 Clinical Research Budget & Billing Office (CRBB) established, issued policy on Clinical Research Billing which established consistent study budget planning, review and data collection across School of Medicine (SOM) 2006 Probe audit started 8
Timeline 2007 Probe audit report issued 2007 Audit program established 2007 Process improvement project implemented to separate study charges from patient charges 2008 Next phase of improvements to implement Medicare s Clinical Trials Policy rolled out 9
Key terminology Routine costs Usual care care provided absent study Expanded care administration of the investigational care item, treating complications, monitoring Investigation care item or service under investigation Research costs Items or services provided solely to satisfy data collection and analysis needs Deemed qualified studies Studies sponsored by NIH or other federal agencies (CDC, AHRQ, CMS, DoD, Veterans Affairs) Industry-sponsored drug and device trials 10
Clinical Research Billing Risks Compliance Risks Billing non-covered research services to patient/medicare Double billing research services by accepting sponsor funding and billing patient/medicare Other Risks Not billing for all services provided Not including proper coding on routine costs billed to Medicare in conjunction with a clinical trial 11
Probe Audit
Probe Audit Objectives Policy Compliance Billing Compliance in Clinical Research Policy - April 25, 2005 Consistency in payment terms Research study s: informed consent, protocol, contract, budget, & billing grid Billing performed in accordance with the proposed billing grid Clear documentation of completed coverage analysis 13
Probe Audit Scope Facility and professional charges Studies at HMC, SCCA, UWMC Studies had enrolled subjects after 10/1/05 5 studies per entity 3-5 patients per study All billing activity reviewed from 10/1/05 to 9/30/06 14
Probe Audit Methodology Studies randomly selected from databases maintained by HSD, OSP, and GCA UWMC & HMC - only one study per department within SOM Included federally & industry funded studies Each study had unique PI Studies included both facility and professional charges where possible 15
Sample Size 16 studies reviewed 68 patients were enrolled in 13 studies 30 patient accounts were audited 16
Probe Audit Report 15 of 16 studies in compliance with policy One study did not register study subjects All 16 studies had consistent payment terms between informed consent, protocol, contract, budget, and billing grid. 3 of 13 studies billed for clinical services in accordance with the proposed billing grid 3 of 13 studies had clear documentation of coverage analysis 17
General Probe Audit Findings 8 studies submitted research charges improperly 14 of 30 patient accounts audited needed to be adjusted Total adjusted charges $12,727.16 Improper charges were remediated 18
General Probe Audit Findings (cont.) UWMC had two studies in which clinical services were provided, but no billing was found Data collection and retrieval was challenging Multiple resources had to be used to conduct audit (PFS, Medical Records, CDS, Ancillary Services) UWMC unable to obtain patient-specific charges for several ancillary department charges 19
Probe Audit Comments & Recommendations Audit Comments Front End & Downstream Processes (Billing and Data Retrieval Issues) - 5 Staff not following procedures or unknown procedures - 5 Billing rules not understood 2 Process Recommendations - 2 20
Identified Next Steps Track management responses to the audit findings Research Billing Audit Program Proposal Hospital Research Services Process Improvement Project Created a Clinical Research Billing Remediation policy 21
Research Billing Auditing Program Proposal
Research Billing Audit Program Proposal 7FTEs for Compliance Internal Audit Consulting 23
Approved 3 FTEs in Compliance $300K budget 24
Research Billing Audit Program
Scope Ensure that researchers are complying with UW Medicine Policies Billing Compliance in Clinical Research Ensure that subject s research related clinical services are billed appropriately and according to applicable regulations 26
Elements of the audits Policy Compliance s Billing Compliance in Clinical Research Consistency in payment terms Research study s consent, contract, & budget Determine whether billing is in accordance with billing plan Review 20% of total study subjects or five subjects, whichever is greater Review billing data from the previous year 27
Auditing One Research Study per PI (Based on Risk to the Organization) Studies with a large volume of clinical services in the budget A previous history of compliance concerns Studies expected to have high enrollment No research coordinator or few study personnel associated with study Studies begun prior to April 2005 Implantable device studies 28
Department/Division Selection The order in which Departments/Divisions were audited was based on the total award amounts and subjects enrolled 29
Consultations for study selection Department/Division Leadership Chair/Chief Director/Administrator Research Billing Audit Work Group 30
Department/Division Meeting 1. Clinical Research Billing Audit team meets with Department/Division leadership 2. Audit plan is shared 3. AAA Database (database of all clinical trials) reviewed for possible studies 4. Communication template provided to Chair/Chief to communicate to the PIs who will be audited 31
Study Audit Process Communicate/meet with PI and study staff Obtain pertinent study documentation Protocol Consent Billing grid Contract Budget Billing data Subject inventory Audit performed 32
Study Audit Process (cont.) Draft report reviewed with PI and study staff Final report provided to Research Coordinator, PI, Entity Compliance Officer, Department/Division Leadership, Ancillary Departments Department is provided summary of all study findings from their department 33
Additional Auditing Studies that have an audit finding error rate greater than 10% of billing transactions (line items) undergo a 100% audit of all study subjects patient accounts. (Only the last year of billing data is audited) 34
Audit Results Analyzed to Determine: The need for repayments, adjustments, disclosures, policy modifications, procedural changes and/or training Information that will help refine operational processes s comprehensive long-range plan for auditing clinical research billing activities 35
Where we started Medicine Allergy & Infectious Diseases Psychiatry and Behavioral Sciences Medicine Gastroenterology Medicine Metabolism, Endocrinology, & Nutrition Radiology Neurology Medicine Oncology (in process) 36
Program Results
General Observations Studies are not being closed with CRBB Study subjects are not in the CRBB subject inventory Billing plans are not updated when protocols or billing codes change 38
Program Reporting Quarterly - Board Compliance Committee Monthly - Clinical Trials Budgeting and Billing Oversight Committee Monthly Research Billing Audit Work Group Biweekly Clinical Trials Biweekly Group 39
Program Status Contacted 97 PIs Completed 60 study audits Completed 5 Department/Division Reports Completed 2 Department Memos 40
Overall Audit Results Reviewed 2,370 lines of service <1% error rate of patient accounts being billed incorrectly Identified $16,000 of lost revenue through incorrect coding Identified $57,000 of unbilled research services 41
Next Steps Review auditing process to gain efficiencies Facility Billing System replacement Modifier Review 42
Templates Research Billing Audit Summary Research Billing Audit Monthly Status Report Research Billing Audit Report Division-Department Summary Report Model 43
Questions Richard Meeks Compliance meeksr@u.washington.edu 206-543-0300