General OIG Compliance Program Guidance

Chapter 2: General OIG Compliance Program Guidance

Introduction

  • Overview of the OIG's General Compliance Program Guidance (GCPG).

    • The GCPG is applicable to all individuals and entities in the healthcare industry.

    • Addresses key federal authorities involved in healthcare business.

    • Contains the following key aspects:

      • Seven elements of a compliance program.

      • Adaptations for small and large entities.

      • Other compliance-related considerations.

      • OIG processes and available resources.

  • Future compliance guidance expected in 2024:

    • Industry segment-specific compliance program guidance (ICPGS) for various healthcare providers and participants.

    • Focus on fraud and abuse risk areas unique to each industry subsector.

    • Recommendations for compliance measures to mitigate risks.

    • As of the publishing date, ICPGs had not been released.

  • Importance of an effective compliance program:

    • Essential for achieving internal operational goals.

    • Decreases errors and enhances quality and safety in patient care.

    • Aids in preventing, detecting, and addressing fraud, waste, and abuse.

    • The GCPG and ICPGs serve as tools for achieving compliance.

    • The GCPG is accessible at OIG website.

Objectives of the Chapter

  • Foster understanding of the following aspects:

    • Role and primary responsibilities of the compliance officer.

    • Relationship between an organization’s mission statement, code of conduct, and compliance standards.

    • Importance of fostering a culture of ethics and compliance.

    • Necessity of written policies and processes for their development, implementation, enforcement, and management.

    • Compliance training for high-risk areas.

    • Content and frequency of compliance education.

    • Implementation of non-retaliation and discrimination policies.

    • Significance of auditing and monitoring in safeguarding the organization.

    • Recognizing when audits are necessary and developing corrective action plans post-audit.

    • Essential components of incident reporting and management, including documentation and potential self-reporting requirements.

    • Building open communication lines and maintaining thorough documentation.

    • Core compliance objectives to minimize unlawful conduct.

OIG Compliance Program Guidance

  • Emphasizes the prioritization of patient care in physician practices.

    • Compliance Officers (COS) should adopt a 'patient first' compliance model.

    • Need to incorporate clinician buy-in by showing how compliance benefits patient care.

    • Example: Thorough medical record documentation lessens errors and improves outcomes.

  • Benefits of a well-defined compliance program:

    • Enhances claim processing and payment accuracy.

    • Protects patient privacy.

    • Decreases chances of audits.

    • Mitigates conflicts of interest and complies with statutory requirements such as self-referral and anti-kickback statutes (AKS).

  • A compliance program represents a good faith effort to submit claims accurately.

    • Reduces risk of prolonged investigations or fines from payers.

    • Requires a commitment to correctness, consistency, and effective communication.

    • It is a “living” document, not merely a set of guidelines.

    • Example scenario: If a compliance policy has not been updated since 2000, this could lead to legal and operational risks due to missed updates, like HIPAA rule changes.

Compliance Program Essentials
  • Inculcates a responsibility among employees to report errors without fear of retaliation, enhancing prompt corrective actions.

  • Properly publicized compliance policies increase employee understanding of billing errors and expectations of compliance education.

Compliance Measurement and Education

  • HCCA and OIG collaboration led to the guide "Measuring Compliance Program Effectiveness-A Resource Guide".

    • Available at HCCA-OIG Resource Guide.

    • Important for evaluating the effectiveness of compliance plans within organizations.

  • Education on the distinction between erroneous and fraudulent claims:

    • Fraud: Willful intent to receive payment for unrendered services.

    • Erroneous: Unintentional billing errors.

  • OIG expresses leniency for unintentional errors and advocates for self-reporting practices.

    • CMS mandates that any discovered billing errors be corrected and refunded within 60 days post-identification to maintain compliance.

  • The False Claims Act outlines penalties for knowingly submitting false claims or hiding obligations to repay.

Implementation of Compliance Programs
  • The GCPG outlines seven fundamental elements needed in an effective compliance program:

    1. Written Policies and Procedures:

    • Clearly define roles, workflows, and documentation standards for compliance.

    1. Compliance Leadership and Oversight:

    • Involvement of senior leadership and a designated compliance officer to oversee program operations.

    1. Training and Education:

    • Establish training programs tailored to organizational needs, focusing on compliance knowledge.

    1. Effective Communication Channels:

    • Open lines of communication for staff to raise compliance concerns.

    1. Enforcement of Standards:

    • Well-defined consequences and incentives to uphold compliance.

    1. Risk Assessment, Auditing, and Monitoring:

    • Regular audits to address identified risk areas and establish corrective actions.

    1. Responses to Detected Offenses:

    • Procedures for promptly addressing compliance violations through corrective actions.

  • Adaptations for small vs. large organizations:

    • Smaller practices may adopt components based on existing compliance needs.

    • Larger organizations often have the resources for systematic approaches and specific compliance committees.

  • Emphasizes that compliance is a continuous process requiring annual updates to remain effective.

Compliance Officer Responsibilities
  • The compliance officer is tasked with:

    • Overseeing compliance program implementation.

    • Reporting to senior leaders on compliance-related risks and needs.

    • Coordination with various departments to ensure comprehensive compliance strategies.

  • Essential traits include good judgment, respect, and sufficient resource allocation to fulfill compliance responsibilities.

Compliance Program Effectiveness

  • Annual verification of compliance training and audits to maintain organizational efficacy.

  • Regular updates in response to regulatory changes, Operational Reviews, and incident reports.

Conclusion

  • It is critical for compliance programs to evolve with regulations and organizational practices, ensuring ongoing education and awareness among all stakeholders.