By John Fisher, JD, CHC, CCEP
Compliance Program Best Practices: Review of Effectiveness
Legal and Regulatory Considerations for Reassessing Compliance Program Effectiveness
Regulatory Context and Compliance Obligations
Historically, compliance programs were not imposed as a universal legal requirement for all providers. In the current regulatory environment, however, passive or outdated compliance efforts may expose an organization to heightened legal, regulatory, and enforcement risk. Many larger health care organizations adopted formal compliance programs to promote an institutional culture of compliance and to support potential mitigation considerations under the Federal Sentencing Guidelines. The Patient Protection and Affordable Care Act of 2010 further elevated the legal significance of compliance programs by establishing mandatory program requirements for many providers. Although the Office of Inspector General has not finalized the precise scope of providers subject to these requirements, prudent organizations should not defer action pending additional regulatory clarification.
Institutional health care compliance has developed substantially over the past decade and now constitutes a core component of effective governance, risk management, and legal oversight. The Office of Inspector General has underscored the importance of compliance through guidance directed to numerous sectors, including billing companies, physician practices, hospitals, home health agencies, long-term care facilities, ambulatory surgery centers, and other provider organizations. Providers that have not previously prioritized formal compliance programs should recognize the legal and operational imperative to adopt, implement, document, and maintain effective compliance plans before enforcement expectations exceed organizational readiness.
Elements of an Effective Compliance Program
A compliance program should not be regarded as a static policy document adopted for recordkeeping purposes only. A dormant or inadequately implemented program may create substantial exposure by failing to identify, prevent, investigate, remediate, or report compliance concerns in a timely manner. To address regulatory expectations, align with the Federal Sentencing Guidelines, and reduce organizational risk, a compliance program should be operationalized, monitored, documented, periodically reviewed, and updated as appropriate. The principal elements of an effective compliance program include the following:
- Adopt and maintain written compliance policies and procedures that are reasonably designed to address applicable legal, regulatory, and operational requirements.
- Designate a senior-level individual with appropriate authority, independence, and accountability to serve as the compliance officer.
- Implement and document a compliance training and education program for personnel at all relevant organizational levels.
- Maintain effective, accessible, and non-retaliatory reporting channels, including, where appropriate, a compliance hotline, through which individuals may report suspected or potential compliance concerns.
- Conduct ongoing internal auditing and monitoring activities to assess adherence to applicable requirements and internal standards.
- Maintain and enforce disciplinary and corrective action standards designed to promote accountability and consistent application of compliance obligations.
- Establish procedures for timely investigation, remediation, reporting, and follow-up with respect to identified compliance issues.
Ongoing Oversight, Documentation, and Remediation
An effective compliance program does more than satisfy a formal requirement; it provides a framework for organizational accountability, risk identification, and corrective action. The program should be tailored to the provider’s specific operations, risk profile, and applicable legal obligations, and it should be designed to evolve in response to changes in law, regulation, enforcement priorities, and organizational circumstances. When compliance issues are identified, timely revisions to the program, related policies, procedures, and controls may demonstrate that the organization exercised appropriate oversight and implemented reasonable corrective measures.
Mandatory compliance requirements further underscore the importance of active compliance oversight for institutions that already maintain formal programs. Such organizations should treat the evolving regulatory environment not merely as an administrative obligation, but as a legal and governance mandate requiring periodic reassessment of compliance infrastructure. Providers with established compliance plans should promptly evaluate whether those plans are effectively implemented, adequately documented, regularly monitored, and capable of demonstrating an active compliance process rather than a static written policy.
