Compliance Reporting Policy

Purpose

The purpose of this policy is to provide accessible means of reporting actual or suspected violations of federal and state law or regulations, including the Federal and North Carolina False Claims Acts, the DUHS Code of Conduct and DUHS policies and procedures and to provide assurance that there will be no adverse consequences to the reporting party. Further, DUHS wants to ensure that none of Duke Medicine Workforce feel obligated to participate in practices they consider illegal or unethical. The reporting channels referenced in this policy have been designed to serve as a resource for those who may need additional information regarding activities or practices they may question.

Policy

Duke Medicine Workforce members who may, in the course of their activities, observe actual or suspected violations of federal or state laws or regulations, including the False Claims Act, or DUHS policies, including possible criminal activity or other illegal, unethical or wrongful conduct, regardless of whether such violations are intentional or not, are required to promptly report such situations. It is important that such situations be brought to the attention of the DUHS Compliance Office promptly, in order that an appropriate investigation may be undertaken and resolution achieved.

It is a violation of the False Claims Act for anyone to knowingly submit, or cause another person or entity to submit false claims for payment of government funds. Examples of actions that could violate the False Claims Act include:

• Filing a claim for services that were not rendered;
• Filing a claim for services that were rendered but not medically necessary; or
• Submitting a claim containing information known to be false.

Penalties for violations of the False Claims Act range from 5 years in prison and/or $25,000 in fines per claim plus civil penalties of between $5,500 to $11,000 per claim, and up to triple the damages sustained.

Non-retaliation/Non-retribution

No person who in good faith reports an actual or suspected violation of law or DUHS policies as provided herein shall experience any retaliation or retribution as a result of such reporting, regardless of whether or not, upon investigation, a violation is found to have occurred. Retaliation, itself, is a violation of the DUHS Compliance Program, will not be tolerated, and must be reported immediately.

• Reports of retaliation or retribution will be investigated thoroughly and expeditiously and will, if appropriate, result in disciplinary action, up to and including termination of employment. An employee who reports a matter involving his or her own misconduct or a violation of a law, regulation or policy will not be immune or otherwise protected from discipline. However, discipline shall not be increased because a party reported his or her own violation or misconduct. Prompt and complete disclosure of a violation may be considered as a mitigating factor in determining disciplinary action.
• A reporting party will not be afforded the protection of this non-retaliation/ non-retribution policy if his or her allegation of a violation was knowingly fabricated or was knowingly exaggerated or otherwise distorted to adversely affect another person or to protect the reporting party.

Procedure

Duke Medicine Workforce members will promptly report situations in which they suspect that violations of federal or state law or regulations, including the False Claims Act, the DUHS Compliance Program or Code of Conduct or other policies or procedures have occurred or are occurring or threatened, utilizing the reporting channels described below (Manner of Reporting).

Those departments responsible for monitoring organizational compliance (e.g., Duke University Internal Audit, DUHS Risk Management, and DUHS Accreditation & Regulatory Affairs) will notify the DUHS Compliance Office of any suspected compliance violations of federal or state law or regulations, the DUHS Compliance Program or Code of Conduct or other policies or procedures reported to them or discovered during the course of their reviews. The DUHS Compliance Office will assume oversight responsibility of investigations.

Manner of Reporting

Duke Medicine Workforce members should report all compliance concerns and may do so in any of the following ways:

• To their immediate supervisor.
• To their Department Chair, head of the Department or Division, or up the normal chain of command.
• To their facility compliance officer or the DUHS Compliance Office.
• To the Duke Medicine Integrity Line (1-800-826-8109) for anonymous and confidential reporting.

The supervisor, Department Chair, Department/Division head, or Facility-Based Compliance Officer should notify the DUHS Compliance Office to coordinate efforts for investigating suspected violations.

Anyone receiving a report of possible noncompliance with a request that the person making the report remain anonymous will, to the extent practicable, honor the request for anonymity.

Compliance Program IntegrityLine

• DUHS has established a toll-free Compliance Program Integrity Line (1-800-826-8109), which is available at all times to any Duke Medicine Workforce member for the reporting of actual or suspected violations of law or policies.
• The IntegrityLine is intended particularly for use in those circumstances in which the reporting party does not feel that he or she can report the matter to his or her supervisor, Department Chair, Department or Division head, DUHS Facility Compliance Officer, DUHS Compliance Office or in which he or she wishes to remain anonymous.
• A caller to the IntegrityLine is not required to disclose his or her identity. However, the caller may do so in order to be of assistance to render further information about the matter reported. If the caller chooses to identify himself or herself, it will be held in confidence and treated as privileged to the fullest extent practicable and permitted by applicable law and regulations.
• Integrity Line personnel will maintain records of information received but will take all appropriate steps to avoid compromising those with whom they are in communication.

Investigations

• All reports of actual or suspected violations of law, regulations, DUHS Code of Conduct, or DUHS policies shall be transmitted either directly to the DUHS Compliance Office or to the Facility Compliance Officer of the affected DUHS facility. The DUHS Compliance Office will assign responsibility and monitor progress to assure that a thorough and expeditious investigation of the allegation is performed and documented in accordance with the DUHS Compliance Office Protocol Policy.
• The DUHS Chief Compliance Officer will notify the Office of Counsel when considered necessary. Procedures outlined in the DUHS Compliance Office Procedure, "Compliance Office and Legal Counsel Protocol", will be followed.
• The DUHS Chief Compliance Officer (CCO) will notify and seek input regarding the allegations under investigation from the appropriate members of DUHS management, who together will determine the severity of the issue. In doing so, the DUHS Chief Compliance Officer will consult with the Duke University Internal Audit Department, the DUHS Audit and Compliance Committee, external auditors, and/or others as necessary.
• In all cases, the DUHS Chief Compliance Officer will make an immediate determination and take appropriate action, including suspension of employees, to ensure that no further acts of possible noncompliance occur.

Post-Reporting Response

• The DUHS Chief Compliance Officer will consult with the Office of Counsel and appropriate members of DUHS management regarding the need to notify the DUHS Audit and Compliance Committee, external auditors and others of the final results of the investigation. The DUHS Compliance Office will notify the individual(s) that originally reported the compliance concern regarding the completion of the investigation and any other information related to the issue as is determined appropriate by the DUHS Compliance Office.
• The DUHS Chief Compliance Officer shall have the responsibility and authority, in consultation with the Office of Counsel and appropriate members of DUHS management, to ensure that any matter requiring external reporting, such as to a regulatory or law enforcement agency, is properly disclosed.

Reports to the DUHS Audit & Compliance Committee

• Any issues that put the organization at high risk for noncompliance will be brought to the attention of the Audit & Compliance Committee at the earliest practicable time. Such issues would include any findings of overpayments from government payors of $100,000 or more, or evidenced patterns of egregious noncompliance with federal or state law or regulations, including the False Claims Act, the DUHS Code of Conduct, and DUHS policies or procedures.

Reporting suspected Fraud or Material Adverse Events

• The DUHS Chief Compliance Officer and DUHS management will notify the Chair of the Audit and Compliance Committee at the earliest practicable time when an investigation’s findings reveals reasonable indication that intentional noncompliance with any criminal, civil or administrative law had occurred. In addition, DUHS management and the DUHS Chief Compliance Officer will notify the Office of Counsel. Procedures outlined in “Compliance Office and Legal Counsel Protocol and Procedures” will be followed.
• The DUHS Chief Compliance Officer and DUHS management will notify the Chair of the Audit and Compliance Committee at the earliest practicable time when an investigation’s findings reveals reasonable indication that the adverse event has the potential to have a financially material impact and may have an adverse effect on the DUHS externally audited financial statements. In addition, DUHS’ external auditors will be notified upon the initiation of the audit engagement.

Education

Compliance orientation and annual update training on compliance will cover this policy's intent and importance, review the proper treatment of employees and the creation of a work environment that permits open communication. All employees will be expected to participate in this training within the first ninety days of employment and annually thereafter.

Definitions

Duke Medicine Workforce:
Employees, medical staff members, students, volunteers, trainees, third party consultants, vendors, service providers, or other contractors whose conduct, in the performance of work for a covered entity is under the control of such entity, whether or not they are paid by the covered entity.