1. Introduction

1.1. The primary purpose of the Office of Institutional Integrity (OII) is to aid in fulfilling the goals of East Carolina University (ECU) which include education of future healthcare providers, improvement of the health status of citizens in eastern North Carolina, and research to advance patient care. OII enhances this mission by ensuring that ECU conducts its patient care activities, research, and operations in an ethical and law-abiding manner. OII is committed to building and maintaining a culture of compliance that encourages employees, students, contractors, and faculty to conduct all ECU operations with honesty and integrity.

1.2. The Office of Institutional Integrity is committed to maintaining the highest level of integrity as it relates to our billing and reimbursement practices. OII works to ensure ECU is following documentation and billing standards set forth by the Federal Programs.

1.3. Definitions

1.3.1. Abuse - actions that may, directly or indirectly, result in unnecessary costs to a Federal or state payor program.

1.3.2. Clinical Research Study – any human subject research which includes the provision of items or services that have the potential to be billable to any governmental payor.

1.3.3. Contractor – a person or legal entity that enters into a written contract with ECU.

1.3.4. Electronic Health Record (EHR) – is an electronic version of a patient’s medical health record.

1.3.5. Fraud - knowingly and willfully executing, or attempting to execute, a scheme or artifice to defraud any health care benefit program or to obtain, by means of false or fraudulent pretenses, representations, or promises, any of the money or property owned by, or under the custody or control of, any health care benefit program.

1.3.6. Healthcare Provider – a doctor of medicine or osteopathy, podiatrist, dentist, chiropractor, clinical psychologist, optometrist, nurse practitioner, nurse-midwife, physician assistant, clinical social worker, or any other provider of billable health care services who is authorized to practice by the State and performing within the scope of their practice as defined by State law.

2. Purpose

2.1. The purpose of this Regulation is to establish ECU’s framework for achieving healthcare compliance among employees, faculty, students, and agents by functioning within applicable state and federal healthcare laws and regulations.

3. Procedure

3.1. Healthcare Compliance Manual

3.1.1. The Healthcare Compliance Manual is a compilation of East Carolina University’s Compliance and Integrity rules that provide guidance to employees, faculty, students, contractors and agents of ECU. This manual includes healthcare compliance topics associated with documentation billing, clinical research billing, fraud and abuse laws, and other healthcare compliance areas.

3.1.2. The Healthcare Compliance Manual, once reviewed and approved through the process identified in this Regulation, shall have the same force and effect as this Regulation. The Healthcare Compliance Manual shall be maintained on and accessible through OII’s website, and all workforce members shall be responsible for following and enforcing the applicable standards in the Manual.

3.2. Policy Oversight

3.2.1. Any revisions to the Healthcare Compliance Manual must be reviewed and approved.Once a standard has been developed or revised, the Office of University Counsel will review and advise with recommendations. The following committees or individuals will then review and approve the standard before it becomes an official part of the Healthcare Compliance manual:

3.2.1.1. Vice Chancellor of Health Sciences; and

3.2.1.2. Other appropriate healthcare compliance committees as identified by OII; and

3.2.1.3. The Director of Student Health Services.

4. Governance

4.1. This regulation and the Healthcare Compliance Manual created pursuant to the procedure outlined in this regulation apply to all employees, faculty, students, and agents of East Carolina University.

4.2. All workforce members must abide by and enforce this PRR and related policies, rules, procedures, guidelines, and regulations.

4.3. The federal rules and regulations included in this document are subject to periodic updates or amendments. Any revision to the corresponding Healthcare Compliance Manual will follow the outlined policy oversight mentioned above.