THE BRODY SCHOOL OF MEDICINE NEW EMPLOYEE ORIENTATION COMMITMENT TO COMPLIANCE: INTRODUCTION TO THE BSOM COMPLIANCE PRO

1. THE BRODY SCHOOL OF MEDICINENEW EMPLOYEE ORIENTATIONCOMMITMENT TO COMPLIANCE: INTRODUCTIONTO THE BSOM COMPLIANCE PROGRAM Joan A. Kavuru, JD, RN Director of Compliance, BSOM

2. What is the BSOM compliance program? • A program designed to promote institutional and individual compliance with applicable laws, regulations, and University policies. • Controls that are established to prevent, detect, and resolve illegal, unethical or other actions that are not in compliance with University policy.

3. Why have a compliance program? • Imperative to prevent, detect, and correct potential violations of law, regulations, and policies of ECU • Support the integrity of the School’s mission: Patient care, education, and research • Institutional reputation • Ability to preserve resources to further mission • Industry standard • Evolution of compliance program development in health care • Federal Sentencing Guidelines and OIG guidance

4. Who implements the compliance program? • Office of Compliance at BSOM • Director of Compliance, Joan A. Kavuru, JD, RN • Billing Compliance Manager, Charlotte Price, RHIA, CCS-P, CPC • Coding Analyst: A. Michele Lang • Program Assistant: Debra Duncan • Compliance Committee • Chairperson, Nicholas Benson, M.D., M.B.A., Senior Associate Dean for Operations • Members include various representatives from BSOM, the University, and PCMH • Individual Employees at BSOM • Most important resource

5. Code of Conduct • Standards for conduct at BSOM • Must read and sign attestation for Code of Conduct • Individual commitment to understanding and following the rules and ethical standards • Condition of employment

6. Areas of Focus • Billing and Reimbursement for Patient Care Services • Highly regulated by Medicare and Medicaid • Commercial payor requirements • ECU Billing and Documentation Standards • Provider billing monitoring • Education • New employee education • Ongoing education for providers • Ensure highest integrity in our billing practices

7. Areas of Focus • Federal Anti-kickback Statute • Forbids any knowing and willful conduct involving the solicitation, receipt, offer or payment of any kind of remuneration in return for referring an individual or for recommending or arranging the purchase, lease or ordering of an item or service that may be paid for under a federal health care program. • Criminal and civil liability for failure to comply.

8. Areas of Focus • Federal Anti-kickback Statute • Tenet Healthcare $900 million settlement: Part of settlement resulted from hidden kickbacks in physician relocation agreements. • Serono $567 million settlement: Serono admitted to providing physicians all-expense paid trips to France to attend conference if wrote 30 new prescriptions for a certain drug. • Fresenius Medical Care $385 million settlement: Involved kickbacks to medical directors.

9. Areas of Focus • Federal Prohibition on Physician Self-Referral (Stark Law) • Prohibits referrals between a physician and an entity with which that physician has a financial interest • Only certain “designated health services” subject to the Stark Law • Civil liability for failure to comply • Stark Safe Harbor Regulations • Rapid City Regional Hospital $6.5 million settlement: Provided below-market lease of space to physician group.

10. Areas of Focus • Research Compliance • Human Subject Protections • Clinical Trial Billing Compliance • Rush University Medical Center self-disclosed clinical trial billing problems resulting in $1 million settlement with OIG; inadvertently billed Medicare for services provided during cancer therapy research studies that were not reimbursable by Medicare • Must not bill Medicare for study services/supplies already paid for by study sponsor

11. Areas of Focus • Research Compliance (cont’d) • Time and Effort Reporting • University of Alabama $3.39 million settlement: Inflated percentage of work effort researchers devoted to projects to more quickly access grant money; also siphoned off money to cover budget shortfalls in other areas and pay people who did not work on projects.

12. Areas of Focus • HIPAA Privacy and Security Rules • University Privacy Officer responsible for implementation and day to day administration • All privacy complaints should be directed to the University Interim Privacy Officer • Office of Compliance provides oversight

13. Areas of Focus • Conflict of Interest Disclosures • Annual Conflict of Interest Disclosure Forms • Ongoing duty to report changes • Notice of Intent to Engage in Outside Activities for Pay • Proper disclosure maintains integrity of patient care and research

14. False Claims Act • False Claims Act (FCA) prohibits anyone from “knowingly” submitting a false or fraudulent claim for payment • “Knowingly” means (i) actual knowledge; (ii) acts in deliberate ignorance of the truth or falsity of the information; or (iii) acts in reckless disregard of the truth or falsity of the information. • No proof of specific intent to defraud is required; liability is proven by evidence of deliberate ignorance or reckless disregard of truth of the claim

15. False Claims Act • Damages: Triple damages and penalties of $5,500 to $11,000 per false claim for submission or causing submission of false claim. • False claims can result from actions such as billing for services not rendered, upcoding and bundling, kickbacks, lack of medical necessity, false certification.

16. Qui Tam Actions • The FCA allows a private person (a “qui tam relator”) to bring a civil action in the name of the United States. • Qui tam relators share in any money recovered (including settlements). • If government joins in action, relator is entitled to 15% to 25% of proceeds depending on relator’s contribution to case. • If government does not join in action, court may award relator not less than 25% and not more than 30% of proceeds.

17. Reporting Incidents of Noncompliance • Encouraged to use supervisors, administrators as the first line of reporting of any known incidents of noncompliance. • BSOM Compliance Hotline • Available 24 hours a day, 7 days a week • Can be anonymous • Toll free 1-866-515-4587 • No retaliation for good faith reporting of incidents of noncompliance. • All good faith reports will be fully investigated. • Confidentiality maintained to the fullest extent possible.

18. Office of Compliance at BSOM • Serves as a resource to all faculty and staff • Contact information: • 744-5200 • kavuruj@ecu.edu