Clinical Trial Billing Compliance at UAB

Transcription

1 Clinical Trial Billing Compliance at UAB Carolyn P. Whitmire, MBA, CHRC Director, Research Implementa?on Co- Administra?ve Director, Clinical Trials Office

2 UAB Infrastructure Campus and Health System are separate en??es Separate Health System billing offices and systems Hospital Healthquest Health Services Founda?on (HSF) - IDX Electronic medical record (EMR) - Cerner Clinical trial ac?va?on process occurs on campus side Campus, Health System and School of Medicine partner to fund a Clinical Trials Office concept Coordinated effort between VP for Research, School of Medicine and Health System to improve the clinical trial ac?va?on process and posi?on UAB to grow its clinical trial business

3 UAB and Clinical Trials Over 3,000 ac?ve IRB protocols 800 1,000 ac?ve clinical trials u?lize clinical services provided and billed by UAB Health System

4 History of UAB and Clinical Trial Billing Compliance Created Research Compliance Office in response to OIG subpoena for informa?on about clinical trials billing and effort repor?ng Created a paper- based clinical trial billing no?fica?on (CTBN) process to inform the Health System billing offices Implemented a robust clinical trial billing audi?ng plan and required training for effort repor?ng Implemented Coverage Analysis Process in 2005/2006 Harmoniza?on of billing grid, contract, budget and informed consent Implemented SiteMinder Clinical Trial Management System (CTMS) to automate the paper CTBN process Focused only on those research projects with services provided and billed by UAB Health System Research Compliance Office renamed University Compliance Office and scope of responsibili?es expanded in 2010

5 Clinical Protocol Ac;va;on Process UAB Clinical Protocol Ac?va?on Process Coverage Analysis should occur early in the ac?va?on process, preferably prior to: Submission to Office of Sponsored Programs Submission to Office of the Ins?tu?onal Review Board Ini?a?on of budget nego?a?ons Approved billing matrix is built into a CTMS to drive our billing compliance no?fica?ons

6 Current CTMS Process Overview

7 No;fica;ons from CTMS to Billing Offices Data Feed #1. SM budget must be finalized no less than 24 hours prior to the first subject enrolled date. The data feed is generated daily at 11pm and sent to Hospital and HSF to be worked the next business day. MSO creates occ/med dictionary entry for the study, and Hospital Lab initiates steps to create institutional lab account, if applicable. Hospital PFS takes no action in HQ at this point. Data Feed #2. Patient record created in SM and patient linked to study on the day consent is signed. The data feed is generated daily at 11pm and sent to Hospital and HSF to be worked the next business day. MSO creates a case for the patient in IDX. Hospital Lab/Hospital PFS does not take action on this data feed.. Data Feed #3. Research appointments should be added to the SM calendar no later than 5pm the day before the visit date. NOTE: There is an exception report here which includes visits scheduled in SM after the visit date. This data feed is generated daily at 11pm and sent to Hospital and HSF to be worked the next business day. MSO and Hospital PFS use this information to compare to accounts in HQ and appointments in IDX and where there is a match, the appointment/account is flagged to be billed after receipt of a CTBN. Data Feed #4. For visits where the appointment is in the SM calendar by 5pm the day before the visit date, the visit can be kept no later than 48 hours (excluding weekends) after the visit date. CTBN s are generated every 2 hours for SiteMInder visits that have been kept. This data is available to the Health System billing offices via an on- line database. For a visit where the criteria described for data feed #3 is not met, the visit must be kept on the day of the visit.

8 Clinical Trial Billing No;ce

9 Problems with Current Process Limited informa?on to assess the performance of our clinical trial book of business Unclear policies and expecta?ons for clinical trial budget development and financial management Financial losses due to under- es?ma?on of costs or over- es?ma?on of enrollment Duplica?on of effort by study teams leads to tardy CTBNs to billing offices Inefficient or unavailable tools for financial management of clinical trials Inefficient and manual processes

10 Changes on the Horizon Require a coverage analysis for all clinical trials Require an internal cost analysis (i.e. budget) for all clinical trials Must be approved by department or division Require the use of a CTMS to manage all aspects of a clinical trial Implement Cerner s PowerTrials product to support ordering of clinical services for research {this process facilitates billing compliance}

11 Future State with CTMS and PowerTrials (EMR)

12 Clinical Trial Budget and Billing Plan Downloadable version to excel to reflect costs versus charge by ac?vity and by visit

13 Research PowerPlan Segregates Research Only versus Rou;ne Care Research SOC Billing Charges appear on ins?tu?onal account; automa?cally discounted to the correct research rate Charges appear on pa?ent account with appropriate billing modifiers

14 PowerTrials Implementa;on Approach Begin with most frequently u?lized clinical services clinical lab and radiology Inpa?ent clinical trials to be addressed in subsequent phase Design process for protocol amendments and their impact on the clinical trial budget and research powerplan A CTBN (detailed account of visit ac?vity per pa?ent) will con?nue to exist in CTMS but use of this informa?on will transi?on to more of a monitoring/compliance tool versus a tool used in day- to- day billing ac?vi?es

15 Challenges Blinded studies Clinical services that should not be part of pa?ent s medical record Coordinated approach to pa?ent care clinical care and research care

16 Key Lessons Learned Execu?ve and School leadership and support is essen?al Require the use of a clinical trial management system (CTMS) to facilitate the overall management of a clinical trial Integrate CTMS with other systems to the extent possible Include study team members in the design of future state Develop clear policies and expecta?ons along with clearly defined roles/responsibili?es Design processes with input from subject maker experts and include built- in compliance checks Implement a robust monitoring plan for billing compliance

17 Ques;ons????? Contact informa;on: Tracy Popp Norton Healthcare Carolyn Whitmire The University of Alabama at Birmingham