This week is National "Corporate Compliance and Ethics Week." Your Billing Compliance Office will email information about compliance this week. We will also send some thought provoking compliance activities (quiz, crossword puzzle and matching game) for you to complete, if you so desire. Today, we begin by exploring the concept of "Think Compliance First."

Remember - compliance with internal and external policies and procedures is the responsibility of everyone, not just the compliance office staff.

HEALTHCARE LAWS

While it is important to ensure the billing of a service is clearly supported in the documentation, it even more imperative to make certain contractual arrangements between OUHSC and vendors do not violate health care laws. Let's look at two of these laws.

• 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.

OUHSC Compliance Program states: No University-employed health care professional or University department or college may pay or accept a payment to induce the referral of a patient in violation of the federal or state Anti-kickback statutes. No one acting on behalf of the University, or one if its departments or colleges, may offer gifts of more than nominal value, loans, rebates, services, or payment of any kind to a referral source or to a patient without consulting the Director of Compliance.

A number of safe harbor regulations have been adopted under the Federal Anti-Kickback Statute. Analysis of an activity under the Anti-Kickback Statute and its safe harbors is complex and depends upon the specific facts and circumstances of each case. University employees should not make unilateral judgments on the availability of a safe harbor for a financial transaction, payment practice, discount or other financial arrangement. Such situations should be brought to the attention of the Director of Compliance prior to implementation.

• Stark II - (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.

OUHSC Compliance Program states: The Physician Self-Referral Statute, more commonly known as "Stark II," prohibits a physician's referral of a patient for a designated health service to an entity with which the physician has a financial relationship unless an exception is met. Compensation and ownership relationships with physicians, including physician employment and independent contractor arrangements, must satisfy an exception to Stark II. Analysis of whether an exception is met depends upon a number of specific facts. University employees should not make a unilateral judgment on the availability of an exception.

Health care rules are complex. The penalties for violating these two rules are high. We all must do our part to ensure compliance with health care laws.

HEALTHCARE COMPLIANCE DAY

Governor Mary Fallin proclaimed May 9, 2012 as Healthcare Compliance Day. This corresponds with National Compliance Week May 6 - 12, 2012. Healthcare Compliance Programs champion ethical practices and standards to provide the necessary resources for healthcare professionals and others who share these principals. A resource available to all HSC employees is the Compliance and Quality Improvement Program. This can be found by going to the following site http://ouhsc.edu/compliance/complianceprogram.asp

Section VI of this site is where you will find information regarding the Standard of Conduct. The Standards of Conduct (“Standards”) is a non-exclusive compilation of guidelines regarding ethical and legal standards that all University employees are expected to follow when performing services for or on behalf of the University that are related to the areas covered by this Program. The clues/answers to the crossword puzzle (see attachment above) can be found by clicking on the link above to the Compliance and Quality Improvement Program.

RESEARCH BILLING

Clinical trials are research studies, funded by an industry, nonprofit foundation, governmental agency or other source, which is designed to answer a specific question about the safety and/or efficacy of drugs, devices, treatments, diagnostics, preventive measures or interventions in human subjects.

Billing for clinical services provided to patients enrolled in clinical trials is complex because often more than one entity is responsible for the costs incurred in a trial. The protocol for a research study, for example, may include routine medical treatment (standard of care) for a condition which the patient would receive whether or not he is enrolled in the trial. Generally, these routine costs may be billed to the patient or his insurer. In cases where a sponsor provides funding for items that are normally considered standard of care, the patient or his insurer may not be billed for these services.

Many times, protocols for clinical trials include services, drugs, devices or treatments that are solely for research purposes. As a general rule, these costs are paid by the sponsor and may not be billed to the patient or his insurer.

Costs related to complications caused by participation in a research study may be the responsibility of the sponsor, the patient or his insurer. The investigator/sponsor contract and the informed consent signed by the research subject should clearly reflect who will bear these costs.

Investigators, coordinators, faculty and staff must work together to ensure that clinical services associated with a clinical trial are billed appropriately and in compliance with relevant laws and regulations. Any research related billing must be coded and charged based on actual services rendered; must be allowable by regulations governing medical billing practices; and must be consistent with the informed consent signed by the research subject.

It is important that a sastifactory plan be in place to ensure that all services are billed to the proper party throughout the study. For more information on Clinical Trials, please visit your Billing Compliance Office website: www.ouhsc.edu/bc Click on the "Clinical Trial Resources" link. You will find articles, regulations, and web-based training regarding research billing. How much do you know about research billing?

OFFICE OF INSPECTOR GENERAL (OIG)

The Office of Inspector General's mission is to protect the integrity of Department of Health & Human Services (HHS) programs as well as the health and welfare of program beneficiaries. HHS OIG is the largest inspector general's office in the Federal Government, with more than 1,700 employees dedicated to combating fraud, waste and abuse and to improving the efficiency of HHS programs. A majority of OIG's resources goes toward the oversight of Medicare and Medicaid — programs that represent a significant part of the Federal budget and that affect this country's most vulnerable citizens. OIG's oversight extends to programs under other HHS institutions, including the Centers for Disease Control and Prevention, National Institutes of Health, and the Food and Drug Administration. OIG develops and distributes resources to assist the health care industry in its efforts to comply with the Nation's fraud and abuse laws and to educate the public about fraudulent schemes so they can protect themselves and report suspicious activities.

Criminal and Civil Enforcement - May 2012

Click on the following links to find out information about recent nationwide fraud schemes investigated by the OIG.

May 2, 2012; U.S. Attorney; Northern District of Illinois

Chicago Area Man Charged In $1 Million Medicare Fraud Scheme
CHICAGO - A south suburban resident who purported to provide psychotherapy services to Medicare patients was charged with participating in a $1 million health care fraud scheme, the Departments of Justice and Health and Human Services announced today.

May 2, 2012; U.S. Department of Justice and Department of Health and Human Services

Medicare Fraud Strike Force Charges 107 Individuals for Approximately $452 Million in False Billing
Attorney General Eric Holder and Health and Human Services (HHS) Secretary Kathleen Sebelius announced today that a nationwide takedown by Medicare Fraud Strike Force operations in seven cities has resulted in charges against 107 individuals, including doctors, nurses and other licensed medical professionals, for their alleged participation in Medicare fraud schemes involving approximately $452 million in false billing.

May 9, 2012; U.S. Attorney; Middle District of Florida

Occupational Therapy Assistant Sentenced For Medicare And Medicaid Fraud
Tampa, FL - United States Attorney Robert E. O'Neill announces today that United States District Judge Elizabeth A. Kovachevich sentenced Patrick Timothy Crisler (46, Inverness) to 30 months in federal prison for defrauding Medicare and Medicaid. The court also ordered Crisler to forfeit $455,537.30, which are proceeds traceable to his offense.

Coding and Billing Resources

The following websites are great resources to help ensure accurate coding and billing.

OUHSC Billing Compliance - http://www.ouhsc.edu/bc/

OIG Work Plan - http://www.oig.hhs.gov/reports-and-publications/workplan/index.asp#current

Oklahoma Health Care Authority - http://www.okhca.org/providers.aspx?id=122

Centers for Medicare and Medicaid (Regulations and Guidance) - http://www.cms.gov/Regulations-and-Guidance/Regulations-and-Guidance.html

Thank you for participating in Corporate Compliance & Ethics Week activities. Remember to "Think Compliance First." Your Billing Compliance Office will continue to "serve as a guiding light in navigating the turbulent seas of billing regulations."