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

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

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!

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

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

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”)

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.

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.

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

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.

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

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

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

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.

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. http://blog.tcs-inc.us/the-medsafe-compliance-corner/bid/54023/The-Stark-Law

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

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

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

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 1-866-515-4587 E-mail dhscompliance@ecu.edu 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.

Division of Health Sciences Office of Institutional Integrity Contact Information: dhscompliance@ecu.edu 744-5200