Charter

DREXEL UNIVERSITY COLLEGE OF MEDICINE
COMPLIANCE AND ETHICS PLAN
COMPLIANCE AND ETHICS PLAN CHARTER

STATEMENT OF PURPOSE
The Philadelphia Health and Education Corporation d/b/a Drexel University College of Medicine and each of its schools, divisions, subsidiaries, and operating or business units (the “University”) operates in a highly competitive environment and under complex and rapidly changing laws and regulations. The University is an educational institution comprised of four Schools: the School of Medicine, the School of Health Professions, the School of Nursing and the School of Public Health.

This Compliance and Ethics Plan was created to define the scope of conduct expected of trustees, officers, faculty, employees, agents and students of the University (hereinafter collectively referred to as “Members of the University Community”). However, compliance with these laws and regulations is challenging because they are complex and are constantly changing. Compliance is also difficult because the laws and regulations frequently do not provide sufficient guidance or answers to specific questions. Therefore, this Compliance and Ethics Plan is not intended to be all-inclusive. The University relies on each individual’s sense of fairness, honesty and integrity to meet the challenges (s)he may face in providing quality health care.

With this Compliance and Ethics Plan, the University intends to promote compliance with the legal duties imposed upon it as a health care entity (in addition to those already contained in University policies), to foster and assure ethical conduct, and to provide guidance to Members of the University Community for their conduct. This Compliance and Ethics Plan has been developed to assist Members of the University Community in complying with all University policies and procedures, including the Compliance and Ethics Plan, and applicable federal, state and local laws and regulations, including Medicare and Medicaid requirements (hereinafter collectively referred to as “Applicable Rules”). In addition, the Compliance and Ethics Plan has been designed to comply with the OIG’s Compliance and Ethics Plan Guidance for Hospitals, which is based on the Federal Sentencing Guidelines.

The Compliance and Ethics Plan has the following components:

Establishment of a written Code of Conduct and written policies and procedures that govern the actions of all Members of the University Community.
The appointment of a Chief Compliance Officer (“CCO”) and a Compliance Committee, who are charged with the responsibility of directing the University’s compliance efforts, including implementing the Compliance and Ethics Plan.
The development and implementation of education and training of all affected Members of the University Community.
Maintenance of a process, such as a Hotline, for Members of the University Community to report instances of possible non-compliance with Applicable Rules without fear of retaliation, and the adoption of procedures to protect the anonymity of complainants.
The establishment of a system to respond to allegations of improper or illegal activities and the enforcement of appropriate disciplinary action against Members of the University Community who have violated the Applicable Rules.
The use of audits or reviews to assess compliance and to assist in the reduction of identified problem areas.
The investigation and correction of identified systemic problems, and the development of policies addressing the non-employment or retention of sanctioned individuals.

The Compliance and Ethics Plan is primarily intended to establish a framework for ethical responsibilities and legal compliance by the University. It is not intended to set forth all the substantive Compliance and Ethics Plans and practices of the University that are designed to achieve compliance, nor is it intended to replace the University’s moral commitments and values. The University already maintains various corporate practices which are aimed at monitoring the University’s activities, and those practices will continue to be a part of its overall legal compliance efforts.

WRITTEN GUIDELINES, POLICIES AND PROCEDURES
1. Compliance and Ethics Plan Manual
  1. Compliance and Ethics Plan Charter
    The Compliance and Ethics Plan Charter articulates the purpose of the University’s Compliance and Ethics Plan, describes its scope, and prescribes how it will be implemented.
  2. Code of Conduct
    A Code of Conduct setting forth the principles and standards to which the University employees are expected to adhere is included under Tab “C.” The Code of Conduct contains principles articulating the policy of the organization and standards, which are intended to provide additional guidance to persons functioning in managerial or administrative capacities.
  3. Policies and Procedures
    Integral to the Compliance and Ethics Plan are the Compliance Policies and Procedures (“Policies”). These Policies establish the expected actions or work-related behaviors of all Members of the University Community. These Policies may be updated from time to time as is necessary to reflect new situations or expectations of those providing services for the University, or to reflect changes in the Applicable Rules.
  4. Defined Terms
    All defined terms in either the Compliance and Ethics Plan Charter or the Code of Conduct shall have the associated meaning when used in any of the Policies or in any other document which is incorporated into the Compliance and Ethics Plan Manual.
2. Bulletins and Notices
  From time to time, as necessary, the University will issue additional bulletins, notices and policies relating to compliance issues. Once these are issued, they will become part of the Compliance and Ethics Plan.
ORGANIZATIONAL INFRASTRUCTURE
1. Compliance Committee
  The Compliance Committee is an administrative committee of the University and is responsible for implementing the Compliance and Ethics Plan. It provides guidance and support to the CCO. The responsibilities of the Compliance Committee include the following:
  1. Recommending and monitoring the University’s Compliance and Ethics Plan;
  2. Assisting in the development of strategies, policies and procedures to promote organizational and departmental compliance;
  3. Analyzing and assessing the University’s regulatory compliance environment; and
  4. Assisting in the development or modification of systems to solicit, evaluate and respond to complaints and potential issues.
  The Compliance Committee is composed of:
  1. CCO
  2. CEO, DUP
  3. Chair DUP Executive Committee
  4. COO, DUP
  5. General Counsel or designee
  6. Director Internal Audit, COM
  7. Chief Financial Officer or designee
2. Chief Compliance Officer and Staff
  Responsibility for implementing and managing the Compliance and Ethics Plan within the University is assigned to a designated individual who will be called the CCO. The CCO will, with the assistance of other organizational personnel, as appropriate, perform the following activities:
  1. Oversee and monitor the implementation of, and periodic expansion of or revisions to, the Compliance and Ethics Plan;
  2. Report directly to the General Counsel;
  3. Report on a periodic basis to the University’s Board of Trustees, Finance Committee and Compliance Committee as directed by the General Counsel;
  4. Assist departments in the review, formulation, revision (and help ensure completeness) of any non-billing related departmental compliance policies and procedures;
  5. Assist departments in the review, formulation, revision (and help ensure completeness) of appropriate organizational or departmental policies and procedures to guide the documentation of billing activities with respect to all services provided by the University’s employees or by others (“billing activities” are broadly defined to include charge generation and related supporting documentation in the medical record; patient demographic and insurance data collection; insurance verification; DRG, diagnosis and procedure coding; claim generation; payment and write-off application, etc.);
  6. Assist and ensure that appropriate departmental procedures are established so that all billing regulations, fiscal intermediary and carrier regulatory transmittals and updates are received, that billing policies and procedures are modified when appropriate, and that this relevant information is properly communicated and understood by appropriate billing staff and key revenue-producing personnel;
  7. Assist and ensure that appropriate organization-wide and department-specific compliance educational and training materials and programs are developed and presented to staff on a regular and timely basis;
  8. Work with the Compliance Committee on all facets of the Compliance and Ethics Plan’s implementation and on-going activities;
  9. Oversee billing and other compliance audits or reviews (quality assurance or legal) conducted by both internal and external auditors, and consultants;
  10. Respond to all inquiries regarding interpretation of new billing regulations or other compliance-related matters not satisfactorily resolved within the operational department(s), seeking outside assistance when appropriate;
  11. Review any inquiries or reports of possible noncompliance with the Code of Conduct, billing regulations or Applicable Rules by University personnel or contractors; if a suspected incident of noncompliance has occurred, develop an appropriate response in conjunction with the Office of General Counsel, or outside counsel as applicable (hereinafter collectively referred to as “University Counsel”), and Administration;
  12. Develop appropriate corrective action plans to address any regulatory compliance issues;
  13. Assist and ensure that personnel issues are properly coordinated with appropriate individuals;
  14. Prepare an annual report to the Board of Trustees summarizing the efforts of the Compliance and Ethics Plan and identify changes that may be made to enhance compliance.
The CCO will work closely with representatives of the various departments to foster and enhance compliance with all applicable billing requirements and to ensure appropriate and accurate billing. The CCO has the authority to direct specific billing practices where necessary. Before directing such practices, the CCO will consult with other University personnel in an effort to resolve issues through consensus. The CCO will have University Counsel as a resource for guidance on regulatory and legal matters.
TRAINING AND EDUCATION
The CCO is responsible to ensure that education and training of the Compliance and Ethics Plan and the Code of Conduct are provided to all employees. This general education may take a variety of forms including, for example, the use of an educational video and Employee Handbook.
Additionally, the CCO will assist and ensure that education and training of billing policies and procedures are effectively communicated and understood by applicable staff. To accomplish that objective, the CCO will work with the faculty, administrative heads, the Chief Financial Officer, the Deans of each School, and any billing consultants that the University chooses to engage from time to time to ensure that there is a systematic and on-going training Compliance and Ethics Plan that enhances and maintains awareness of compliance policies among existing staff and that introduces new personnel to the organization’s billing policies and Applicable Rules. Training materials related to compliance issues must be submitted to the CCO for review and approval before being used.

Training is mandatory for all healthcare professionals employed by the University whose services are reflected on patient bills, as well as for all billing, registration, coding and collection personnel. In addition, training may be mandatory for clinical staff or other positions identified by the CCO and Administration. The CCO is responsible for making sure that a system is developed to document that such training has occurred. The CCO can require that any healthcare professionals whose services are reflected on patient bills, or any employee engaged in billing, registration, coding or collection activities, as well as any medical practitioners employed by the University, shall attend training sessions on particular issues.

The CCO will also coordinate compliance training for University faculty. The CCO will consult with the Chief Financial Officer as to the selection of outside billing consultants to ensure that compliance-related matters are given appropriate attention.
COMMUNICATION
1. Communication Protocols
  All Members of the University Community are responsible for abiding by the University’s Compliance and Ethics Plan. In addition, all supervisory personnel are responsible for compliance by those they supervise. Any individual who is aware of, or suspects, any violations of Applicable Rules, can make an appointment to meet with the CCO to discuss the matter or (s)he may notify his/her supervisor of the concern. The CCO will determine whether cause exists for further investigation or action on the matter. Members of the University Community who report possible compliance issues will NOT be subjected to retaliation or harassment as a result of reporting a potential violation.
  The University is governed by complex and ever-changing rules and regulations in its business dealings as it relates to the provision of health care services. As a result, this creates areas of uncertainty for Members of the University Community. Questions and concerns about the appropriate way to handle various situations may and often do arise. The University has several resources that are available to Members of the University Community who encounter any situation that raises a compliance concern. If a question or issue arises concerning the application of Applicable Rules, or if a Member of the University Community becomes aware of activities or practices that may violate Applicable Rules, that person must follow the following guidelines set forth below:
  1. Contact his/her supervisor (if that person was not involved in the matter of concern) immediately by telephone or in writing to request assistance or to report suspected improper activities or practices.
  2. If the supervisor does not resolve the employee’s concerns or was involved in the matter of concern, the employee must contact the CCO, the Office of General Counsel, or the Confidential Hotline phone number.
    - Chief Compliance Officer [215-762-2023]
    - Confidential Hotline [215-762-1010]
    - Office of General Counsel [215-762-7885]
  3. The supervisor or CCO will respond promptly to every question or comment brought by a Member of the University Community. The CCO may seek the advice of University Counsel, or may direct the individual to discuss the issue or concern directly with University Counsel.
  4. Members of the University Community should not seek assistance from or report suspected improper activities or practices to other employees (except their supervisor or the CCO), family members, friends or other persons, without first reporting the matter to the CCO or University Counsel and giving the University a reasonable opportunity to conduct an appropriate investigation and take any needed remedial action.
  The University intends that every Member of the University Community will read, understand and comply with these guidelines for identifying and reporting potential violations of the Applicable Rules. Failure to report potential violations of the Applicable Rules to the appropriate supervisor or the CCO may subject any Member of the University Community to discipline or to other sanctions, including termination.

ENFORCEMENT

Accountability
Failure to adhere and comply with the Compliance and Ethics Plan principles is grounds for disciplinary action. The level of disciplinary action, including the potential for employment termination, will be determined in accord with the flagrancy of the violation. The University maintains a “zero tolerance” policy towards any illegal conduct. Any Member of the University Community engaging in a violation of the anti-kickback and self-referral (Stark) laws, or any other Applicable Rules (depending on the magnitude of the violation), may be terminated from employment. The University shall not accord any weight to an individual’s claim that any improper conduct or undertaking was for the benefit of the University. Any such conduct is not for the University's benefit in any way and is expressly prohibited. Where appropriate, discipline shall be enforced against Members of the University Community for failing to detect or report wrongdoing.
The standards established in the Compliance and Ethics Plan shall be consistently enforced with disciplinary proceedings and sanctions. This includes informal reprimands, formal reprimands, demotion, financial penalties, suspension, and termination. In determining the appropriate discipline for any violation of the Compliance and Ethics Plan, the University organization shall not take into consideration a particular Member of the University Community’s economic benefit to the University.
Internal Investigations
Whenever a Member of the University Community becomes aware of conduct that may be inconsistent with the Applicable Rules, that individual must make sure that the incident is promptly reported to his or her supervisor or to the CCO. Issues should generally be reported to the supervisor prior to being brought to the attention of the CCO. However, Members of the University Community are encouraged to contact the CCO directly if the supervisor fails to resolve the issue after a reasonable period of time, or if that individual believes that it would be inappropriate to pursue the matter with the supervisor. Supervisors should promptly report all unresolved or questionable compliance issues which are brought to their attention to the CCO.

The CCO will log all inquiries and complaints and conduct an investigation of such issues or (s)he will direct the supervisor in undertaking such an investigation. Members of the University Community who may be suspected of involvement in the issue under investigation may be temporarily removed from their work site and relieved of their responsibilities if it is felt that their on-going presence could jeopardize the satisfactory completion of the investigation. This investigation will be undertaken with the assistance of University outside legal counsel (“Legal Counsel”), if the CCO deems involvement to be advisable. If Legal Counsel is involved, Legal Counsel will review and investigate, and with the input of the CCO, will prepare a report of findings. In cases where Legal Counsel is not involved, the report will be prepared by the CCO or at the CCO’s direction.

Members of the University Community may report possible compliance issues anonymously but must cooperate with any investigations undertaken by the CCO (or their department supervisor), the Office of General Counsel of Health and Human Services, the Federal Bureau of Investigation, or the University Counsel.

Members of the University Community who report possible compliance issues will NOT be subjected to retaliation or harassment as a result of the report. Concerns about possible retaliation or harassment should be reported to the CCO. In addition, the CCO will adopt procedures to reasonably maintain the anonymity of individuals who report compliance issues to the CCO.

External Investigations
Various external organizations may contact the University, or individuals within, to initiate a compliance-related investigation into a suspected violation of the Applicable Rules. These agencies (e.g. U.S. Department of Justice, Office of Inspector General, Federal Bureau of Investigation, Medicare Fiscal Intermediary or Carrier) have certain rights by law which must be honored to ensure that an independent investigation is conducted. The University also has a responsibility to ensure that an independent investigation is conducted appropriately, while at the same time safeguarding information that may be privileged under the attorney-client privilege. The University will have an opportunity to research any alleged wrongdoing.

Members of the University Community must advise the CCO before responding to any requests which are outside the ordinary scope of routine reports that are regularly made to governmental authorities. The University’s procedures concerning externally initiated compliance investigations will be followed should any Member of the University Community be contacted by a governmental investigator.

The appropriate supervisor will ensure that all potential records (both on and off-site) are secured, and that normal destruction of old records is stopped until the investigation is completed.

AUDITING AND MONITORING

Departmental Monitoring
Each administrative head is responsible for developing and maintaining appropriate on-going, periodic quality assurance to ensure compliance with billing policies and procedures, and with Applicable Rules. The development, maintenance and scope of this monitoring activity must be reviewed with and approved by the CCO in advance of implementation.
If any of these departmental reviews identify instances of possible noncompliance, the CCO shall report that to the appropriate individual(s) in Administration, and, if appropriate, to University Counsel. In consultation with University Counsel, the CCO shall investigate the situation to determine whether there has been any activity inconsistent with the University’s billing policies and procedures, laws or regulations.
University Monitoring
Under the supervision of the CCO, a sample of medical records and corresponding bills for each department will be periodically reviewed for compliance with the University’s billing policies and procedures and with Applicable Rules. Each such department shall be reviewed at least annually, but the CCO may require more frequent reviews. Moreover, at the direction of the President, the CCO shall engage an external billing expert to review a sample of records drawn from a cross-section of patients.

If any review identifies instances of possible noncompliance, the CCO shall report that to the appropriate individual(s) in Administration, including the head of the relevant department, and will coordinate referral of the information to University Counsel. In consultation with University Counsel, the CCO shall investigate the situation to determine whether there has been any activity inconsistent with the University’s billing policies and procedures or Applicable Rules.

Quality assurance and other auditing or monitoring activities will be developed and implemented from time-to-time as the University’s needs so require. These quality assurance activities will occur on a periodic basis to help ensure overall Compliance and Ethics Plan effectiveness.

RESPONSE AND CORRECTION

Corrective Action
Whenever a compliance issue has been identified through monitoring, reporting of possible issues, investigations, or otherwise, the CCO is directed to see that a plan is developed to address that issue. In developing a corrective action plan (which will include prompt identification of overpayments and restitution to affected parties, where necessary), the CCO shall obtain advice and guidance from Administration and University Counsel. The CEO will also consult with the appropriate clinical and billing personnel.
Corrective action plans should be designed to ensure not only that the specific issue is addressed but also that similar problems do not occur in other areas or departments. Corrective action plans may require that billing be handled in a designated way, that certain training take place, that restrictions be imposed on billing by particular faculty members or other health professionals, that repayment be made, or that the matter be disclosed externally. Sanctions, discipline, or other actions in accordance with University policies may also be recommended. If it appears that certain individuals have exhibited a propensity to engage in practices that raise compliance concerns, the corrective action plan should identify actions that will be taken to prevent such individuals, in the future, from exercising substantial discretion with regard to billing. The CCO and/or University Counsel shall determine the response as soon as practicable, which may include, but will not be limited to:
1. Presenting or providing to the President the results of the investigation of the suspected violations;
2. Preparing disciplinary recommendations;
3. Notifying the Board of Trustees; and
4. If appropriate, disclosing the incident to the appropriate governmental authorities.
When necessary, the University will amend the Compliance and Ethics Plan and applicable policies and procedures in an effort to avoid any future recurrence of a violation.
Procedure For Reporting and Disclosing Compliance Issues
The University’s President, in consultation with the Board of Trustees, will make the final determination as to whether a violation of the Applicable Rules has taken place. If the CCO (with input from University Counsel) preliminarily determines, based on credible evidence, that a violation has been committed, (s)he will disclose such fact to the appropriate Administrative representative and the President. The President and CCO will jointly disclose the matter to the Board of Trustees. In consultation with University Counsel, the CCO will be responsible for determining the steps that need to be taken to respond to the offense and to prevent similar occurrences in the future. A list of recommended actions will be submitted to the President (and then subsequently to the Board of Trustees if determined appropriate) within thirty (30) days of the date that the CCO first learns of the issue unless additional time is reasonably required.

Reporting of violations of billing policies and procedures or other Applicable Rules to the various Federal and/or State regulatory agencies will be based on the advice and legal opinion of University Counsel, with the final reporting determination being made by the President, in consultation with the Board of Trustees. Reporting will be initiated within sixty (60) days of the date that the CCO first learns of the issue unless additional time is reasonably required.

In the event of any infraction of the Code of Conduct or Applicable Rules, the responsible Member of the University Community shall be subject to the appropriate disciplinary action as determined by the Board of Trustees’ designee, the CCO and/or the University’s Human Resources Policies. Appropriate disciplinary action will be taken against all individuals involved.

CORRECTIVE ACTION PLANS

Whenever the Corporate Compliance Office staff confirms individual systematic error, a corrective action plan will be developed as directed by the progressive corrective action levels outlined below. Personal responsibility for systematic error may be a determination reached as a result of annual monitoring, unannounced monitoring follow-up or the completion of an investigation. The Chief Compliance Officer will meet with the Departmental Chair and the employee/faculty to review the findings and develop a corrective action plan within the department. If applicable, overpayments will be returned according to the sampling notification protocol. If and when the Chief Compliance Officer determines that departmental remedies (Level One) have not corrected the problem or problems, further corrective action (Level Two and Three), as described below, will be taken, depending upon the severity of the offense and status in the progressive corrective action process. In all cases, the employee/faculty will be given the opportunity to appeal decisions at the department (Level One) or school level (Level Two and Three) as appropriate. (School level is Dean of: Medicine, Public Health, or Nursing/Health Professions).