Title: USC Healthcare Compliance Program
Standard #:	CO – 114	Issued:	11/01/2018	Reviewed/Revision Date:

PURPOSE

This policy:

1. provides the framework and key elements for the USC Healthcare Compliance Program;
2. promotes and supports ethical conduct by our healthcare professionals[1]; and
3. supports our commitment to compliance with applicable laws, regulations, university and departmental policies, and obligations under the USC Code of Ethics.

STANDARD

1. It is USC policy to maintain a healthcare program that is aligned with the key elements of an effective compliance program as described in the Department of Health and Human Services Office of the Inspector General’s Compliance Program Guidance for hospitals, physicians, and research grants, and other federal guidance including education, policies and procedures, monitoring, etc.
2. It is USC policy that healthcare professionals and providers comply with federal and state laws, regulations, payer contractual obligations, and USC Compliance Program policies.

ROLES AND RESPONSIBILITIES

Specific roles and responsibilities under the USC Healthcare Compliance Program include:

1. The Office of Culture, Ethics and Compliance (OOC):
   1. Oversees and monitors the USC Healthcare Compliance Program;
   2. Serves as a knowledgeable resource and definitive authority for matters relating to healthcare compliance and HIPAA privacy and security regulations;
   3. Ensures the effectiveness of the program, consistency and overall integration of compliance activities throughout USC’s healthcare enterprise;
   4. Aligns the healthcare compliance program with USC’s Mission, Values, Code of Conduct, policies, and applicable federal and state laws and regulations;
   5. Develops and coordinates the healthcare compliance education program;
   6. Develops policies or provides policy guidance as needed;
   7. Supports a culture that encourages the reporting of suspected fraud, waste and abuse or other improper conduct without fear of retaliation;
   8. Participates in various compliance committee meetings with physicians and operational business leaders;
   9. Coordinates and reports on monitoring activities;
   10. Receives and investigates reports of alleged unethical or illegal conduct or other allegations that violates USC’s healthcare policies, laws, or regulations;
   11. Reports on the status of the healthcare compliance program to the Audit and Compliance Committee of the USC Board of Trustees and to senior management;
   12. Periodically reviews the compliance program and recommends revisions to meet changes or emergent risks in the business and regulatory environments.
2. Healthcare Professionals and Providers shall:
   1. Comply with applicable laws, regulations, university and departmental policies, and obligations under the USC Code of Ethics;
   2. Comply with applicable coding, billing and documentation requirements;
   3. Cooperate with auditing and monitoring reviews designed to identify and manage coding and documentation risks;
   4. Complete required healthcare compliance and HIPAA education in addition to compliance-related hospital or clinic education that applies to their roles;
   5. Not be excluded from participation in federal and state healthcare programs and will immediately notify their supervisor if convicted of an offense that likely will result in their exclusion from participation in any federal and state healthcare programs;
   6. Cooperate fully in compliance investigations;
   7. Successfully complete all USC Healthcare Compliance Program requirements;
   8. Remain members in good standing with the USC Healthcare Compliance Program to successfully complete the credentialing and reappointment processes of USC Care Medical Group, USC School of Dentistry, or Keck Medicine of USC, as applicable.
3. Audit and Compliance Committee of the Board of Trustees
   1. Identifying current and emerging compliance risk areas that are relevant to the university’s mission and objectives and providing advice regarding compliance program priorities;
   2. Developing and implementing standards to assess whether the elements described above are being met.  The standards will assist compliance risk owners in designing and maintaining programs for their respective compliance functions and will establish roles and responsibilities, track compliance implementation across risk areas, identify gaps and trends in compliance efforts and report progress to senior management and the Audit and Compliance Committee;
   3. Assisting with development and review of education, policies and standards;
   4. Assisting with monitoring of identified compliance risks and implementing corrective action, as applicable;
   5. Sharing best practices across university compliance functions;
   6. Coordinating with other relevant committees and/or activities, including the university’s enterprise risk efforts.
4. Governing Boards of Keck Medicine of USC
   1. Annual and ad hoc reporting to the respective governing boards of Keck Medicine of USC for acknowledgement of the annual workplans, providing information regarding significant findings from monitoring and audits, and updates on regulatory and industry developments that could affect USC’s healthcare operations.
5. Healthcare Compliance Committees
   1. Healthcare Compliance Committee
      1. The Healthcare Compliance Committee is comprised of faculty physicians/providers as appointed by the chairs of the Clinical Departments of the Keck School of Medicine, the Deans of Dentistry and Pharmacy, and representatives of Keck and Norris Hospital.  Additional non-voting attendees include USC Care Administration, Department Senior Clinic Administrators, Hospital Administration, and representatives from the Office of Revenue Cycle Management.  The objectives of the committee are to:
         1. Provide a forum for compliance related communication specific to compliance updates and current/emerging risk areas affecting healthcare providers.
         2. Assist with the development and implementation of new policies and procedures;
         3. Ensure effective communication and understanding of healthcare-related compliance issues to departmental faculty and staff;
         4. The Committee supports regulatory consistency in implementing the USC Healthcare Compliance Program by:
            1. Identifying and discussing areas of potential compliance risk;
            2. Reviewing and sharing provider compliance monitoring results;
            3. Reviewing and responding to Compliance Monitoring Summary Reports provided by the Office of Culture, Ethics and Compliance;
            4. Designing implementation plans for compliance-related policies;
            5. Assisting with implementation of corrective action plans as applicable;
            6. Ensuring that education is delivered in accordance with policy.
   2. USC Care Executive Compliance Committee
      1. The USC Care Executive Compliance Committee supports the full implementation of USC’s Healthcare Compliance Program through:
         1. Identifying, prioritizing, and monitoring compliance risks;
         2. Recommending and/or implementing corrective action plans to address potential or actual risks;
         3. Assisting with the development of compliance policies and procedures;
         4. Developing tools and other resources to assist staff in complying with compliance and ethical standards, policies, procedures, rules and regulations;
         5. Tracking and trending reports of non-compliance;
         6. Ensuring the prompt implementation of corrective action resulting from investigations.
   3. Community Pharmacy Compliance Committee
      1. The Community Pharmacy Compliance Committee is chaired by an appointee of the Dean of the School of Pharmacy.  Specific responsibilities of this Committee include, but are not limited to:
         1. Identify and prioritize compliance risks within retail pharmacies;
         2. Define what are considered reportable events and develop a risk reporting process;
         3. Track, trend, and assess potential reportable events;
         4. Develop and implement a mock inspection and peer review process at retail pharmacies to measure the effectiveness of compliance with established retail pharmacy standards;
         5. Develop standard retail pharmacy policies and procedures and implement monitoring to validate compliance with these standards;
         6. Develop tools and other resources to assist retail pharmacy staff in learning and complying with compliance and ethical standards, policies, procedures, rules and regulations;
         7. Ensure prompt implementation of appropriate corrective action resulting from investigations;
         8. As appropriate, recommend and/or implement solutions to address potential or actual identified risks.
   4. Hospital Compliance Committee
      1. The Hospital Compliance Committee supports the full implementation of USC’s Healthcare Compliance Program through:
         1. Identifying, prioritizing, and monitoring compliance risks at the hospitals;
         2. Recommending and/or implementing corrective action plans to address potential or actual risks;
         3. Assisting with the development of compliance policies and procedures;
         4. Developing tools and other resources to assist hospital staff in complying with compliance and ethical standards, policies, procedures, rules and regulations;
         5. Tracking and trending hospital reports of non-compliance;
         6. Ensuring the prompt implementation of corrective action resulting from investigations.

PROCEDURE

The Code of Ethics describes USC’s commitment to ethical conduct and compliance with legal and regulatory requirements.  USC also has a comprehensive set of policies and procedures that address a wide range of compliance-related issues, including physician relationships, conflicts of interest, HIPAA Privacy and Security, and research compliance.  The Code of Ethics and these policies and procedures are available to every employee and provider at https://policy.usc.edu/.

USC’s Healthcare Compliance Program also has a set of standards and procedures regarding coding, billing, exclusion checks, and background screening.  These standards and procedures are available at https://ooc.usc.edu.

Additionally, USC’s various units, hospitals, departments, and schools may have their own departmental compliance-related policies within their service areas.

EDUCATION

USC requires that healthcare professionals complete Healthcare Compliance and HIPAA Privacy education upon hire and additional assigned education as appropriate.  In addition, healthcare professionals that provide services in high-risk regulatory compliance areas may receive additional compliance education, e.g., coding and documentation, billing practices, Medicare Part D fraud, waste, and abuse, and similar education.  Educational materials not developed by the Office of Culture, Ethics and Compliance relating to the above compliance risk areas must be submitted to the USC Office of Culture, Ethics and Compliance at least ten (10) days prior to the delivery of the education for review and approval[2].

In the event of a significant regulatory change, emergent compliance risk, or as part of a corrective action plan, the USC Office of Culture, Ethics and Compliance may provide or direct supplemental compliance education as required.

AUDITING AND MONITORING

Routine monitoring is based upon identified healthcare compliance risk areas as determined by the Office of Inspector General (OIG) Work Plan, past monitoring reviews, trending reports, audits, investigations, and risk assessments.  The monitoring and auditing program also includes monitoring compliance with USC’s policies.  Monitoring results are reported to the applicable Compliance Committees, Governing Boards, and the Audit and Compliance Committee of the USC Board of Trustees.

Healthcare professionals and providers have an obligation to implement corrective action plans based on the findings from monitoring and auditing.  The Office of Culture, Ethics and Compliance retains the authority to approve or modify any corrective action plans, set due dates, and determine when corrective action plans are completed.

COMPLIANCE REVIEWS AND INVESTIGATIONS

USC expects healthcare professionals and providers to report conduct or business practices that could result in a compliance violation to the Office of Culture, Ethics and Compliance.  At the direction of the Office of General Counsel, and with assistance from Audit Services when appropriate, the Office of Culture, Ethics and Compliance investigates alleged violations of laws, regulations, and policies.  The Office of Culture, Ethics and Compliance expects healthcare professionals and providers to cooperate fully in any investigation.

USC has a non-retaliation policy that protects any person who reports or provides information about a potential violation in good faith.  This policy does not protect a person from appropriate disciplinary action if an investigation determines the person engaged in misconduct or a business practice in violation of law or policy.

REPORTING INSTANCES OF NON-COMPLIANCE

USC takes all allegations of non-compliance seriously and investigates them promptly.  USC allows employees to report potential issues of non-compliance confidentially and in good faith through USC Report & Response:

USC Report & Response

(213) 740-2500 or (800) 348-7454

(or go to https://report.usc.edu/)

Any person who contacts USC Report & Response may choose to not identify themselves.  However, the Office of Culture, Ethics and Compliance encourages anyone who reports a matter to provide as much information as possible to enable a thorough investigation.

USC Report & Response may also be used to ask questions or seek guidance on healthcare compliance and HIPAA requirements.

GOVERNMENT REVIEWS AND INVESTIGATIONS

Federal and state agencies can review and investigate our healthcare operations.  USC’s policy is to cooperate with and properly respond to government inquiries and investigations.

USC expects employees to immediately notify the USC Office of Culture, Ethics and Compliance upon receiving a written or verbal contact from any outside agencies regarding a request for an interview, a review, or an investigation.

For additional guidance on outside agency requests, refer to applicable local policies.

This Standard is not meant in any way to deter USC employees from cooperating or assisting with any review or investigation.

ENFORCEMENT

A violation of federal, state, or local laws and regulations or USC’s policies will result in disciplinary action in accordance with established university policies.  Disciplinary action is determined according to the nature of the violation, case-specific considerations, and the individual’s work performance.

Violations may also result in notifications to law enforcement officials, regulatory bodies, and accrediting and licensure organizations when appropriate.

After a violation is discovered, USC will take all reasonable steps to address the area of concern, including making necessary modifications to the compliance program to prevent and detect violations and their recurrence.

It is USC’s policy that an employee or physician will be subject to disciplinary action if USC reasonably concludes that the report of wrongdoing was knowingly fabricated, distorted, exaggerated or minimized to protect herself/himself or others.

QUESTIONS

Questions regarding policies, procedures or interpretations should be directed to the USC Office of Culture, Ethics and Compliance at (323) 442-8588 or USC Report & Response at (213) 740-2500 or (800) 348-7454.

REFERENCES

[1] “USC Healthcare Professionals” includes those entities that comprise Keck Medicine of USC, including but not limited to, USC Norris Cancer Hospital, Keck Hospital of USC, USC’s employed physicians, nurses and other clinical personnel, those units of USC that provide clinical services within the Keck School of Medicine, School of Pharmacy, the Herman Ostrow School of Dentistry, Physical and Occupational Therapy as well as USC Care Medical Group, affiliated medical foundations of Keck and their physicians, nurses and clinical personnel, USC Verdugo Hills Hospital, its nurses and other clinical personnel, Verdugo Radiology Medical Group, Verdugo Hills Anesthesia, and Chandnish K. Ahluwalia, M.D., Inc. and those units that support clinical and clinical research functions, including the Offices of the General Counsel, Audit and Compliance.

[2] USC Healthcare Compliance Standard ED-200, Compliance Education