Healthcare Compliance Forms and Tools

Purpose

The purpose of this policy is to provide an overview of the Compliance and Ethics Program for [organization name] and set expectations related to compliance.

Scope

All employees; all residents and physicians who are members of the medical staff; all members of the Board of Managers; and all contractors, subcontractors, and agents who perform services or act on behalf of the organization.

Policy

1. The organization is committed to conducting its business ethically and maintaining and promoting an enterprise-wide culture that emphasizes integrity; individual and institutional acceptance of responsibility; effective self-policing; and transparency in the relationships between the organization and its key stakeholders, including government officials and agencies. In furtherance of this commitment, the organization has established a Compliance and Ethics Program (Compliance Program) and abides by its requirements.

2. The Compliance Program is a dynamic program that provides a flexible framework for adapting to the changing environment in which the organization operates. It is continually evaluated by the chief compliance and ethics officer (CCO), the chief executive officer (CEO), the Executive Compliance Committee (ECC), and the Board of Managers (Board) to ensure that it functions as intended, serves the purpose for which it has been designed, and enables the organization to meet its high standards and commitment to compliance.

3. The Compliance Program encompasses the following elements:

   1. Program oversight and administration

      1. The organization has appointed a CCO who is charged with operating and monitoring the Compliance Program. The CCO has a direct reporting relationship to the Board and the CEO and can engage outside resources as necessary. The CCO regularly informs the CEO, the ECC, the Board, and applicable stakeholders on the Compliance Program and compliance risks, concerns, issues, or violations that may come to their attention.

      2. The organization has established the ECC to advise and assist the CCO in the effective operation of the Compliance Program.

      3. The Board has established the Governance, Compliance, and Ethics Committee as a standing committee of the Board to assist in its oversight of the operations and efficacy of the Compliance Program and compliance.

   2. Written standards, policies, and procedures

      1. The organization maintains and periodically updates a written Code of Conduct and Ethics (Code) that articulates its commitment to ethical behavior. The Code is the foundation of the Compliance Program and details the fundamental principles, values, and framework that guide everyday practice. Personnel must abide by the terms of the Code and periodically certify to such.

      2. The organization has developed policies and procedures that capture its commitment to compliance and effectively address compliance obligations. The policies and procedures also account for specific areas of compliance and ethics risks relevant to healthcare organizations. These policies and procedures will be periodically reviewed and revised as warranted and made available to all personnel.

      3. Compliance with the Code and all applicable policies and procedures is a condition of employment and an element in evaluating the performance of all employees.

   3. Training and education: The organization has developed and implemented regularly scheduled, comprehensive compliance training and education for all personnel, including the Board. When necessary, compliance training and education is targeted by function and topic to maximize its effectiveness. Satisfactory participation in and completion of required compliance and ethics training is a condition of continued employment. Failure to comply with training requirements may result in disciplinary action, up to and including termination.

   4. Risk assessment, auditing, and monitoring

      1. The organization conducts periodic, but no less than annual, compliance risk assessments to evaluate the compliance-related risks that have the potential for legal, financial, and operational damage and implements appropriate mitigation strategies as warranted.

      2. The organization has established a comprehensive auditing and monitoring program to support the prevention, detection, and correction of instances of noncompliance.

      3. Auditing and monitoring activities will be calibrated based on the results of compliance risk assessments, previous auditing and monitoring activities, and compliance investigations.

   5. Disclosure Program

      1. The organization has established and maintains a Disclosure Program that sets forth the duty of the organization’s personnel to report potential compliance issues, including any identified concerns, issues, or questions regarding suspected or potential violations of the Code, policies and procedures, and/or applicable laws and regulations.

      2. The Disclosure Program is well publicized and emphasizes our strict nonretaliation policy. The organization does not retaliate or take disciplinary action against any individual for reporting concerns in good faith, including acting as a whistleblower in accordance with the federal False Claims Act or other law. “In good faith” means the reporter believes that the information reported is true and correct to the best of their knowledge and ability.

      3. The Disclosure Program includes reporting channels that enable individuals to disclose potential compliance issues to the CCO or some other person who is not in the disclosing individual’s chain of command. This includes the Integrity Line, an anonymous reporting mechanism for which appropriate confidentiality is maintained.

      4. Upon receipt of a disclosure, the CCO or designee will promptly assess each disclosure to determine what type of response and/or action is warranted, including an internal or external review or investigation of the allegations set forth in the disclosure.

      5. The organization shall maintain a disclosure log that summarizes each disclosure and the disposition, including any corrective actions taken.

   6. Enforcement and corrective actions

      1. The organization will take appropriate disciplinary action for established compliance violations and will identify corrective actions to help prevent the recurrence of similar violations. These may include, but are not limited to:

         1. Addressing any gaps in policies, practices, and training and opining on any misinterpretation of policies, practices, or training that may have contributed to a violation;

         2. Imposing a range of disciplinary measures, up to and including termination of employment or contract termination; and

         3. Reporting the violation to the appropriate government authorities when warranted.

      2. The organization will enforce its ethical and compliance standards through well- publicized disciplinary guidelines.

      3. Decisions regarding appropriate disciplinary action(s), if any, will be determined by the Office of Talent Management, Compliance and Legal functions, and the relevant functional area. The CCO or designee must concur with any disciplinary action imposed as a result of a compliance violation relevant to the CCO’s oversight responsibilities.

      4. As part of routine hiring and retention processes, the organization will not hire, contract with, use the items or services of, nor extend privileges to an individual or entity who is (a) currently excluded, debarred, suspended, or otherwise ineligible to participate in federal healthcare programs or (b) has been convicted of a criminal offense that falls within the scope of 42 U.S.C. § 1320a-7a(a) (collectively, “ineligible persons”).

         1. The organization conducts required regular screening of individuals and entities to identify ineligible persons.

         2. Such individuals and entities have an affirmative duty to promptly notify the Compliance and Ethics Department (Compliance Department) of any debarment, exclusion, suspension, or other event that makes the individual or entity an ineligible person.

4. Responsibilities

   1. The CEO, ECC, and Board are responsible for:

      1. Exemplifying a culture of compliance and ethics throughout the organization;

      2. Setting the expectation for compliance and ethics as a core responsibility for all personnel;

      3. Ensuring that the CCO and Compliance Department have sufficient staffing, resources, and financial support to perform their responsibilities under this policy;

      4. Advising the CCO on compliance matters and supporting the effective operation of a robust, dynamic, and flexible Compliance Program;

      5. Coordinating with the CCO and Compliance Department to periodically evaluate the Compliance Program to ensure that it (i) functions as intended, (ii) serves the purposes for which it has been designed, and (iii) enables the organization to meet its high standards and commitment to compliance and ethics.

      6. Promoting and maintaining a work environment where concerns can be raised, openly discussed, and reported without fear of retaliation; and

      7. As organization personnel, complying with all the requirements set forth in Section 4(C).

   2. The CCO is responsible for:

      1. Designing, implementing, and overseeing an effective Compliance Program that meets the expectations set forth in United States Sentencing Guidelines and Office of Inspector General’s Compliance Program Guidance;

      2. Staffing and leading a Compliance Department responsible for ensuring performance of the Compliance Program components enumerated in Section 3;

      3. Keeping informed of developments and trends in healthcare compliance and using such information to enhance the Compliance Program;

      4. Keeping the CEO, the members of the ECC, and the Board regularly informed of Compliance Program developments, as well as industry best practices and government enforcement actions related to the Compliance Program; and

      5. Periodically assessing the effectiveness of the Compliance Program to determine that it (i) functions as intended; (ii) serves the purposes for which it has been designed; (iii) is reflective of current laws, developments, and industry best practices; and (iv) enables the organization to meet its high standards and commitment to compliance.

   3. Personnel are responsible for:

      1. Acting in compliance with the performance of their duties and in their conduct, and otherwise supporting the Compliance Program (supervisors have a heightened responsibility to do so);

      2. Reading, understanding, and complying with the Code and all other policies and procedures;

      3. Completing all required compliance and ethics training in a timely manner;

      4. Reporting potential compliance issues to their supervisor, another member of the management team, the Office of Talent Management, the Compliance Department, or the Integrity Line; and

      5. Cooperating with the Compliance Department in the performance of compliance investigations and auditing and monitoring activities.

      6. Supervisors have additional responsibilities to:

         1. Demonstrate and emphasize the importance of compliance and ethics;

         2. Model behaviors in support of compliance and ethics;

         3. Assess compliance and ethics as part of performance measurement for all employees;

         4. Maintain an environment where individuals can comfortably ask questions or raise compliance concerns without fear of retaliation;

         5. Provide appropriate and timely responses to questions or concerns, in consultation with the Compliance Department, as needed; and

         6. Maintain communication with the Compliance Department about potential compliance and ethics concerns.