THE BRODY SCHOOL OF MEDICINE

NEW EMPLOYEE ORIENTATION

COMMITMENT TO COMPLIANCE: INTRODUCTION TO THE BSOM

COMPLIANCE PROGRAM

Joan A. Kavuru, JD, RN

Director of Compliance, BSOM

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.

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

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 (43388) Coding Analyst: A. Michele Lang (43101) Program Assistant: Debra Duncan (45200)

Compliance Committee Members include various representatives from BSOM and the University

Individual Employees at BSOM Most important resource Have a duty to report issues of concern; no retaliation if reports are made in good

faith

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

Areas of Focus: Billing and Reimbursement 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

Areas of Focus: Federal Anti-Kickback Statute

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.

Areas of Focus: Federal Anti-Kickback Statute

Federal Anti-kickback: Regulatory Safe Harbors Not a “per se” violation of law to be “outside” of a safe

harbor Most important consideration is “fair market value” Affects many physician contractual relationships Leases with referral sources (space or equipment),

employment and recruitment agreements, “joint ventures,”

Areas of Focus: Federal Anti-Kickback Statute

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.

Areas of Focus: Stark Law 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

Areas of Focus: Stark Law

Governs most financial relationships between physicians and referral sources (even members of same group practice)

Space and equipment leases, any type of ownership or compensation relationship, employment arrangements, independent contractor arrangements

Examples of requirements: Written agreements Term of one year Compensation “set in advance” Compensation cannot vary with volume or value of referrals Fair market value for services/equipment

Rapid City Regional Hospital $6.5 million settlement: Provided below-market lease of space to physician group.

Areas of Focus: Research Compliance Human Subject Protections Governed by HHS and FDA rules/Good

Clinical Practices Proper informed consent, must follow

protocol, financial disclosures, adverse event/other types of disclosure requirements

Patient safety top priority

Areas of Focus: Research ComplianceSeveral High Profile Cases Involving Breakdown of

Human Subject Protections Jesse Gelsinger

18 year old died in clinical trial at Univ. of Penn involving gene replacement therapy

Investigation revealed that PI had a financial interest in the sponsor of the trial which was not adequately disclosed to family

Certain safety data was not adequately disclosed to family Shutdown all gene therapy research at U Penn and at

several other institutions for a certain time period

Areas of Focus: Research Compliance Clinical Trial Billing

Cannot bill third party payor for items or services being provided “free” in trial or being paid for by the sponsor

As Principal Investigator, must be sure to notify institution’s finance department of billing status

Medicare now pays for “routine costs” for patients involved in clinical trials, provided that services associated with those costs are not promised “free” or being paid for by the sponsor

Areas of Focus: Research Compliance Time and Effort Reporting Requirements

Research involving federal funding: Must accurately account for time spent on research project

Cannot overstate time spent on federally funded projects 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

Areas of Focus: Conflicts of Interest Most institutions have policies requiring disclosure of

significant financial interests in outside entities Financial relationships with pharmaceutical companies,

medical device manufacturers, hedge funds, among others represent potential issues

Must adequately disclose relationships so patients and institution have full knowledge of potential conflicts

Need to manage potential conflicts to avoid impairment of medical decision making and undue influence of outside entities on your practice

Remain grounded: If it’s too good to be true it probably is (also, would you want the relationship disclosed on the front page of the local newspaper)

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

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.

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. In general, 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. Exception: Qui tam relators cannot share in proceeds

when recovery is against a state institution (e.g., a state university like ECU).

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.

Office of Compliance at BSOM Serves as a resource to all faculty and staff Contact information:

744-5200 kavuruj@ecu.edu