Understanding the General Compliance Program Guidance: A Comprehensive Guide for Healthcare Compliance Stakeholders

Released on November 6, 2023, the GCPG brings together previously scattered compliance guidance into one unified document for all entities in healthcare. It offers a reference for federal healthcare laws such as the False Claims Act, Anti-Kickback Statute, Stark Law, and HIPAA Privacy and Security Rules. The GCPG is voluntary and nonbinding; it uses “should” to indicate recommended practices rather than mandatory rules.

The GCPG aims to help healthcare organizations—including hospitals, medical practices, nursing facilities, managed care plans, pharmaceutical manufacturers, and technology vendors—develop, implement, and improve compliance programs continuously. It recognizes differences in size and complexity among organizations and encourages tailoring compliance efforts accordingly. Small physician practices may have a compliance contact, while large health systems might build full compliance departments with chief and deputy compliance officers.

Seven Elements of an Effective Compliance Program

The GCPG expands on seven key elements for effective healthcare compliance programs. These include:

• Written Policies and Procedures
  Organizations should create comprehensive written policies aligned with federal laws and internal standards. These form the foundation of compliance culture and provide guidance on handling risks, reporting issues, and maintaining ethical behavior.
• Compliance Officer and Committee
  The guidance advises appointing a dedicated, independent compliance officer without overlapping legal or financial duties to avoid conflicts of interest. This officer reports directly to senior leadership or the board. A compliance committee supports oversight and strategy.
• Training and Education
  Organizations must provide ongoing customized compliance training to staff at all levels. Training should be role-specific and use different formats, such as online courses and videos. It should cover regulatory requirements and organization-specific risks.
• Effective Communication
  Accessible reporting channels for employees and contractors to raise concerns are important. Reporting should allow direct contact with compliance officers, bypassing supervisors if needed, to reduce fear of retaliation.
• Monitoring and Auditing
  Routine and risk-based audits, along with continuous monitoring, help identify vulnerabilities. Annual risk assessments led by compliance committees should use internal data like billing audits and external regulatory updates.
• Reporting and Enforcement
  Procedures should ensure timely investigation of potential violations and enforcement of standards. The GCPG encourages balancing corrective actions with incentives to encourage compliance participation instead of just punishment.
• Response and Prevention
  When issues arise, organizations should take prompt corrective steps. This can include self-disclosure to the OIG and making system improvements to prevent repeat problems.

Compliance Priorities: Quality and Patient Safety

The 2023 GCPG places more focus on integrating quality and patient safety into compliance programs. The OIG views these areas as important for compliance oversight, especially related to risks under the False Claims Act. Healthcare organizations are encouraged to involve quality assurance professionals in compliance committees and audits. This helps align compliance with clinical outcomes and patient safety efforts.

Including quality oversight means monitoring billing accuracy, coding integrity, and adherence to care standards at the same time. This approach supports regulatory compliance and the quality of care patients receive.

Independent Compliance Officer Role and Governance

The GCPG emphasizes that compliance officers should be independent. They should not supervise or report to legal or financial departments and should not provide legal advice. This separation helps avoid conflicts and supports effective compliance oversight.

Healthcare boards have an important role in overseeing compliance programs. The GCPG encourages board involvement through committees, rather than passive acknowledgment. Boards should understand compliance risks and hold management accountable for proper program implementation.

Risk Assessment and Management

Formal risk assessment, auditing, and monitoring are key elements in compliance programs. The GCPG advises annual risk assessments to identify current and new risks related to billing, marketing, referrals, quality of care, and business arrangements. Both internal performance data and external regulatory information should be used.

Special attention is needed regarding financial incentives and ownership arrangements. Organizations must evaluate risks from payment models and investments to prevent violations of anti-kickback and fraud laws.

Technology, Private Equity, and New Entrants’ Compliance Challenges

The updated guidance notes that private equity ownership and new players like technology companies face unique compliance challenges. These groups might be less familiar with healthcare regulations and need tailored compliance programs and ongoing training.

Medical practice administrators and IT managers in technology-focused healthcare settings must ensure their operations follow compliance standards. This includes transparent financial dealings, strong conflict-of-interest protocols, and thorough documentation and monitoring.

Industry Segment-Specific Compliance Program Guidance (ICPGs)

The OIG plans to release Industry Segment-Specific Compliance Program Guidance (ICPGs) throughout 2024. These will address compliance issues in areas like Medicare Advantage and nursing facilities. Healthcare organizations should use the GCPG as a base while preparing for these upcoming guidance documents.

Compliance Tools and Resources

Several federal agencies, including the OIG, DOJ, and CMS, offer resource toolkits, advisory opinions, and training materials to help healthcare entities. These include fraud alerts, advisory bulletins, podcasts, and videos tailored to different provider types.

An important compliance activity is exclusion screening. Organizations must ensure that employees, contractors, and vendors are not on federal or state exclusion lists, which bar participation in Medicare and Medicaid programs. Healthcare organizations ultimately hold responsibility for exclusion screening even when using contractors.

Automated solutions like Streamline Verify assist with exclusion screenings. These tools reduce administrative work by up to 60% and update data hourly from primary sources.

AI and Workflow Automation: Modern Tools to Enhance Healthcare Compliance

Artificial Intelligence (AI) and automation are increasingly used in healthcare compliance workflows. Medical practice administrators and IT managers can use AI-powered phone automation and answering services to streamline patient interactions while supporting compliance.

How AI Supports Compliance:

• Accurate Documentation and Reporting: AI tools can automatically capture patient communications, aiding audit trails and compliance records without extra administrative work.
• Error Reduction: Automation of routine patient calls and appointment reminders helps reduce errors that could affect billing or cause HIPAA violations.
• Compliance Risk Mitigation: AI-driven systems can include prompts and scripts to avoid unauthorized disclosure of sensitive health information, aligning with HIPAA rules.
• Workflow Efficiency: Automating front-office tasks frees staff to focus more on compliance training, auditing, and monitoring.
• Integration with Compliance Programs: Automated systems can be customized to follow internal policies and guide staff through compliant processes, reducing inconsistent practices.

Combining AI-driven automation with established compliance frameworks like the GCPG can improve operations while maintaining regulatory compliance. The OIG’s recognition of technology firms as healthcare participants highlights the need for technical compliance safeguards.

Practical Steps for Medical Practice Administrators and IT Managers

Given the complexity of healthcare compliance and the changes in the GCPG, administrators and IT managers may consider these actions:

• Establish or update compliance programs using the 2023 GCPG as a guide. Clarify compliance officers’ independent roles and communication with leadership.
• Implement annual risk assessments involving clinical, financial, and operational views to find compliance gaps.
• Enhance employee education using varied formats tailored to different roles and incorporating updates from OIG, DOJ, and CMS.
• Include quality and patient safety oversight in compliance activities in coordination with clinical staff.
• Use AI-based automation tools for administrative tasks such as patient phone handling and documentation to reduce risks.
• Conduct thorough exclusion screenings using automated tools regularly.
• Stay informed about upcoming Industry Segment-Specific Compliance Program Guidance to plan program updates according to sector needs.

The General Compliance Program Guidance is a significant federal update focusing on risk-based, quality-integrated, and incentives-based compliance approaches. For healthcare organizations in the United States, especially medical practices and technology teams, understanding and applying the GCPG will be essential for maintaining compliance, reducing risk, and supporting patient care in a regulated setting.