1. Division of Health Sciences Office of Institutional Integrity
Protecting Yourself and Your Practice

2. What is healthcare compliance?
Wide range of activities to help
prevent, detect, and avoid fraud and abuse.
Follow institutional policy, state and federal laws & regulations
Monitor practice ethics and patient rights legislation
Effective training, communication, monitoring, enforcement and response

3. Who Implements the Compliance Program?
Office of Institutional Integrity
Chief Institutional Integrity Officer- Kenneth DeVille, PhD, JD
Executive Assistant- Lauren Lumley
Interim Associate Director & Healthcare Regulatory Specialist- Michelle C. Evans, MPA
Billing Compliance Manager- Brandy Styron, RHIA, CCS-P
Billing Compliance Reviewers- Michele Lang, Kenya Dudley, Ashley Ross, and Anita Mangalore
Administrative Support Associate- Pam Martin
Director of Immigration Services- Brian Meyerhoeffer, JD
Compliance Committees (BSOM, CAHS, SoDM, CoN)
Most important resource: Individual Employees!

4. Top Compliance Risk Areas
Documentation and Billing Integrity
Fraud and Abuse Laws
HIPAA Privacy

5. Documentation and Billing
Accurate Coding and Billing are Critical
Fraudulent Billings Result in Stiff Penalties
Billing and Reimbursement Reviews
Billing for services not performed (or underperformed)
Ordering/billing for medically unnecessary
services
Double billing, Upcoding/Downcoding
If it’s not documented, it will not be
reimbursed

6. Documentation and Billing
Teaching Physician Documentation Rules
Generally need evidence of physician presence during key portion
of medical management with resident.
Electronic Medical Record Issues
Sharing of passwords prohibited
Cutting and pasting is not recommended
Easy for internal reviewers and external auditors to track.
Assuming notes (History and Physical, progress notes, office visit, consults) instead of adding an addendum. (i.e. when adding a teaching statement, do not click “make me the author”)

7. Navigating Fraud and abuse laws Fundamental points
Laws are very broad
Laws are complex and not intuitive
Laws apply to a wide variety of common financial relationships that are not obvious kickbacks or fraud
Penalties are serious
Enforcement is rising because of financial benefit to government.
Mistakes are not fraud, BUT lack of system to control mistakes or insufficient response to mistakes MAY BE
Defense is very expensive, even if successful.

8. Federal False Claims Act 31 U.S.C. §§ 3729-33
False Claims Act (FCA) prohibits anyone from “knowingly” submitting a false or fraudulent claim for payment to the government.
“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.

9. Federal False Claims Act
False Claims “can” result from actions such as:
Billing for services not rendered
“Upcoding”
“Double-billing”
Lack of medical necessity
Pattern of insufficient documentation
Violation of billing rules
False certification

10. Federal False Claims Act 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.

11. Federal False Claims Act
Civil Penalties:
Triple damages and penalties of $5,500 to $11,000 per false claim for submission or causing submission of false claim.
Criminal Penalties:
Felony conviction: 5-20 years in jail
Misdemeanor conviction: 1 year in jail

12. Federal Anti-Kickback Statute (42 USC § 1320a-7b(b))
Prohibits offering, paying, soliciting or receiving anything of value to induce or reward referrals or generate Federal health care program business

13. Federal Anti-Kickback Statute
Statute makes it a crime (felony) to:
Knowingly and willfully
Solicit, offer, receive, or pay
Any remuneration (cash or in kind)
With intent to induce
Referrals of an individual for
The furnishing of a service or item or procedure
For which a federal healthcare program will pay.
Any items or services. Intent must be proven (knowing and willful), Voluntary safe harbors, ALL federal health care programs
strict reading of AK statute would eliminate many relationships
DHHS has created “safe harbors”—list of arrangements which will not be violations of AK
Conduct outside of safe harbor has to be analyzed to see if if there was an intent to influence billing for government services

14. Federal Anti-kickback Statute
Examples of Kick-backs:
Money, discounts, gifts, and credits
Criminal and civil liability for failure to comply
Criminal fines up to $25,000 and up to 5 yrs prison term per violation
Civil money penalties of $50,000 per violation
Up to 3 times the amount of kickback
Exclusion from federal health care programs
*Possible violation of the False Claims Act
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, and joint ventures, for example, may implicate the Federal Anti-kickback Statute.

15. Federal Prohibition on Physician Self-Referral Stark Law (42 USC § 1395NN)
Prohibits a physician from referring Medicare patients for designated health services to an entity with which the physician (or immediate family member) has a financial relationship, unless an exception applies
Prohibits the designated health services entity from submitting claims to Medicare for those services resulting from a prohibited referral
Items: Designated health services
No intent standard for overpayment (strict liability)
Intent required for civil monetary penalties for knowing violations
Mandatory exceptions
Medicare / Medicaid Federal heatlh care programs.

16. Physician Self-Referral Stark Law
Only certain “designated health services” subject to Stark Law
Stark Safe Harbor/Exceptions
Civil liability for failure to comply
Overpayment/refund obligation
False Claims Act liability
Civil monetary penalties and program exclusion for knowing violations
Potential $15,000 CMP for each service
Civil assessment of up to three times the amount claimed

17. Hipaa privacy rule 45 CFR part 160 Subparts A & E of parts 164
Use and Disclosure of Protected Health Information (PHI)
Patient Rights regarding PHI
University Privacy Officer responsible for implementation and day-to-day administration
All privacy complaints should be directed to the
University Privacy Officer

18. Office of Institutional Integrity 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

19. Reporting Incidents of Potential Non-compliance to the Office of Institutional Integrity
Encouraged to use supervisors, administrators as the first line of reporting of any known incidents of noncompliance
Compliance Hotline
Available 24 hours a day, 7 days a week
Can be anonymous
Toll free
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
Physicians and staff have a professional duty to report potential problems.

20. Division of Health Sciences Office of Institutional Integrity
Contact Information: