Research Compliance Training

Please note, policy titles marked with a "new" graphic have been recently added; those marked with a "revised" graphic were recently updated. Please be sure to review the changes applicable to your role in research.

In April 2004, St. Luke's Medical Center entered into an agreement with the U.S. Office of Inspector General and the U.S. Department of Justice to settle a case involving Medicare and Medicaid claims related to investigational cardiac procedures and devices. The agreement requires that St. Luke's:

• Distribute research related policies and procedures to all those involved in the use of investigational cardiac devices or investigational cardiac patient care, as well as billing for those services.
• Provide training to all those associated with both the delivery of and billing for investigational cardiac devices and patient care.

In order to meet these obligations, please review all elements listed below.

I. Introductory/Overview Presentation
Please launch this narrated PowerPoint presentation for important background information and an overview of the mandatory training and informational elements. This is a copy of the presentation materials delivered at the Steimke Auditorium in St. Luke's Medical Center during June, 2004.

II. Governing Federal Law
Federal law dictates and governs the Centers for Medicare and Medicaid (CMS) billing rules and regulations. It is from this federal law and the associated CMS billing regulations that internal Aurora Policies or Procedures have been developed. All Aurora policies and procedures are listed below at III.

Please click here to view the actual governing law: 42 C.F.R 405.201-.215

III. Aurora Research Related Policies & Procedures (updated Jan. 2007)
In order to carry out federal law, and follow all applicable CMS billing regulations, Aurora has developed a myriad of internal policies and procedures to guide our associated activities in the arena of clinical research; both the patient/subject care and the associated billing for that care. To assist you in identifying policies or procedures that are applicable to your work area, the documents have been largely categorized by function, and within each function is a topical description of the policy or procedure. If your particular job function is not listed, please identify a category topically that describes your need. For example, if you are a clinician who will work with an investigational device, see the header "The Investigational Device or Drug".

Compliance Program Overview

• Aurora's Code of Excellence Compliance Program Description
• Research Compliance Program Overview
• Research Compliance Program Policy
• Research Billing Compliance Policy
• Compliance Helpline Call Response Procedure

Billing Coverage Analysis Process

• Coverage Analysis CRC Coversheet
• Coverage Analysis Process
• Coverage Analysis Decision Tree
• Device Coverage Analysis Checklist
• Drug/Biologic Coverage Analysis Checklist

Study Budgeting Process

• Research Study Budgeting Process
• Budget Template
• Subject/Participant Visit Matrix Template
• Approval for Discount from Usual & Customary Charges Form

The Research Contracting Process

• The Research Contracting Process
• IRB Fee Policy
• IRB New Submission Checklist
• Initial Review-Criteria for IRB Approval
• Continuing Review Criteria for IRB Renewal

Clinical Research Coordinator

• Clinical Trials Office; Standard Operating Procedures
• Medicare Prior Notification of a Device Trial
• Medicare Prior Notification Letter Template
• Patient ID & Notification Process
• Patient ID & Notification Form

Access to Aurora's IRB Standard Operating Procedures

Please click here to access all Aurora IRB Standard Operating Procedures. (Several, but not all IRB SOPs are accessible on this research compliance site.) Access to all IRB SOPs requires a password from the IRB. Please click on "For Investigators" in the left navigation area of the IRB site. Then call (414) 219-7744 or email the IRB for your password to access these procedures.

Patient Identification & Records
(Patient Access, Medical Records, Coding & the IRB)

• Patient Access/Registration Process for Research Patients
• Medical Record Documentation for Research Patients

Billing Process

• Establishing a New Study Billing File
• Checklist to set-up new Study Billing File
• Identifying & Flagging Research Visits in the Billing System
• Preparing a Patient Study Visit/Service for Claim Submission
• Research Claim Submission
• IRB Study Submission Checklist to the CBO
• IRB Notice to CBO of New Study
• IRB Notice to CBO of Continuing Review
• Medicare Prior Notification of a Device Trial
• If a billing discrepancy exists... follow this process
• Other Important Billing Issues Not Elsewhere Addressed

The Investigational Device or Drug
(Acquiring, Handling, Controlling, Storing, Charging and Accounting for)

• Investigational Device or Drug Acquisition
• Control of & Accounting for Device/Drug
• Documentation of Device/Drug Use (Medical Record)
• Charging for Investigational Device/Drug

Other/Miscellaneous

• Humanitarian Use Device Prior Approval Procedure
• Emergency Use of a Study Article Billing Procedure
• Glossary

Quality Review

• Quality Improvement Plan for Research
• Monitoring & Review of Protocols and Associated Billing
• Research Billing Audit Methodology
• Research Billing Audit Checklist
• Regulatory Documents Audit form
• Subject Data Audit form
• CRF Template Audit form
• General Audit Questionnaire form
• IRB File Audit form

IV. MANDATORY web-based training lessons
Mandatory web-based training lessons have been stratified to meet the needs of individual functions within the realm of investigational devices or procedures. Please click on the link below. You will be routed to a log-in screen. Once logged in, the system will identify you as a unique participant and direct you to the lessons required for your role in the research process. Participation along with lesson completion is tracked by the system and reported back for compliance purposes. All lessons must be completed no later than 30-days following hire/transfer for all individuals coming into cardiac research at St. Luke's Medical Center after 7/23/2004.

Please enter here for you mandatory web-based lessons. You will be asked to enter your Aurora employee number. For non-Aurora employed individuals, please use your full name: first name last name, without spaces, title or punctuation (ex. sallyjohnson). If you need further instructions, please click here for a copy. Print these instructions and refer to them in the future for sign-on assistance.

If you have difficulty logging in, please contact Aurora's Help Desk at (414) 647-3520 OR (800) 889-9677.

Note the following as you take your online lessons:

1. The number of lessons assigned varies depending upon the role you play in conducting research at St. Luke's or Aurora.
2. The amount of time required to complete all lessons varies by: number of lessons assigned, time of day you access the site, the speed of your internet connection, and your own comfort level. In total, expect to spend between 2 and 6 hours in total for all lessons. Please plan accordingly to meet the 30 days from hire deadline.
3. 100% accuracy is required for each test to demonstrate competency. If you do not achieve 100%, you need to retake the test until you achieve a 100% score.

V. Research Compliance Contact Information
For additional information on this Settlement, your individual obligations, or for any research compliance concerns, please contact Gail Buenger, J.D. or at (414) 649-5599.

You may also report compliance issues anonymously to the Corporate Compliance Hotline which is a line that rings only to voicemail. You can dial the hotline 24-hours a day, 7 days a week. The number is (888) 847-6331.

To contact any member of the Research Compliance Committee or to view the Compliance Committee scheduled meetings, please review these documents:

• Research Compliance Committee Members
• Research Compliance Committee Meeting Schedule