What is a Compliance Plan? Key Elements & OIG Guidelines
Healthcare compliance is highly complex, with 629 discrete regulatory requirements across nine domains and multiple distinct regulatory bodies. From HIPAA to the False Claims Act (FCA), each regulation requires extensive work, with the threat of multi-million dollar fines, reputational damage, and jail time for significant violations.
An effective compliance program is therefore essential for any healthcare organization. But given the complexity and cost of these programs, detailed planning is required to avoid waste and ensure every area of compliance is covered.
This article explores what such a compliance plan looks like and why it is so important. Using OIG guidelines on compliance program effectiveness, we’ll reveal what is required to keep your organization safe from growing regulatory enforcement.
But first, let’s establish some key definitions.
Compliance Program vs. Compliance Plan: What’s the Difference
While there is considerable crossover, it’s important to understand the difference between compliance programs and compliance plans:
- Compliance Programs: The ongoing process of meeting or exceeding the legal, ethical, and professional standards applicable to an organization, which includes their written guidance and actions to prevent and detect violations of laws, regulations, and other standards that could give rise to liability. The framework for compliance programs is the seven standard elements of a compliance program established by the U.S. Sentencing Commission and adopted by the OIG in their compliance guidance.
- Compliance Plans: Statements of intent and proposed actions for doing or achieving compliance objectives. It is contrasted with a compliance program that relates to actions taken in furtherance of the plan, along with the results of actions taken.
While almost all healthcare organizations have some form of compliance program, many lack a properly organized and centralized plan to implement effective measures.
What Makes an Effective Program Plan?
Effective Compliance Programs have been defined in many ways by different authorities; however, it might be summed up as a program that reduces the likelihood or minimizes actions that could give rise to legal or regulatory penalties and potential civil litigation.
The DOJ Guidelines used by prosecutors in assessing compliance program effectiveness focus on whether a compliance program is: “well designed”; “being applied earnestly and in good faith”; and “works in practice.”
Seven Standard Elements of Compliance Programs
The OIG has set out official standards by which compliance programs should be evaluated; these are based on standards first defined in the United States Sentencing Commission “Guidelines for Organizations”. They include:
- Implementing written policies and procedures and the Code of Conduct
- Designating a compliance officer and a compliance committee
- Conducting effective training and education
- Developing effective lines of communication (e.g., Hotline)
- Conducting internal monitoring and auditing
- Enforcing standards through well-publicized disciplinary guidelines
- Responding promptly to detected problems and undertaking corrective action.
These steps have formed the foundation of the OIG’s Compliance Program Guidance since 1997. They are considered a means to promote the development of voluntary compliance programs for various sectors of the health care industry, including hospitals, nursing homes, third-party billers, and durable medical equipment suppliers.
But what do they actually look like in practice?
OIG Guidance in Practice: Building an Effective Compliance Plan
Let’s imagine a 200-bed community hospital developing its annual compliance plan. The organization must address multiple regulatory risks while managing limited resources across departments.
Here’s how they might structure their plan around the OIG’s seven key elements:
1. Written Policies and Code of Conduct
- Update policies quarterly to reflect new CMS guidance
- Develop an accessible digital policy library for all staff
- Create role-specific conduct guidelines for clinical vs. administrative teams
- Establish clear anti-kickback and self-referral protocols
2. Compliance Officer & Committee
- Appoint a Chief Compliance Officer reporting directly to the CEO
- Form a committee with representatives from billing, clinical operations, HR, and IT
- Schedule monthly meetings with documented action items
- Allocate a dedicated budget for compliance initiatives
3. Training & Education
- Mandate annual HIPAA training for all employees
- Provide specialized fraud and abuse training for billing staff
- Conduct quarterly case-study sessions on real compliance scenarios
- Track completion rates and enforce 100% participation
4. Communication Channels
- Launch an anonymous 24/7 compliance hotline
- Publicize reporting mechanisms in break rooms and employee portals
- Guarantee non-retaliation for good-faith reports
- Establish a 48-hour response protocol for all submissions
5. Internal Monitoring & Auditing
- Perform monthly billing audits on high-risk procedure codes
- Review medical necessity documentation for the top 10 DRGs
- Conduct surprise HIPAA access log reviews
- Generate quarterly risk assessment reports
6. Disciplinary Standards
- Define tiered consequences for policy violations
- Document all disciplinary actions in personnel files
- Communicate enforcement outcomes organization-wide (anonymized)
- Ensure consistent application across all departments
7. Corrective Action
- Establish rapid-response team for identified violations
- Implement self-disclosure protocols for potential FCA violations
- Develop remediation timelines with specific milestones
- Conduct post-correction audits to verify effectiveness
This structured approach transforms abstract requirements into concrete, actionable steps. Each element connects to specific workflows and accountability measures, ensuring the plan moves beyond paper into practice.
Develop Your Compliance Plan with Strategic Management Services
Crafting detailed compliance plans is not only time-consuming—it requires a level of expertise across multiple domains that most healthcare organizations lack.
That’s why many leaders trust Strategic Management Services to help them evaluate their existing compliance programs and build new plans to deliver more effective protections for their patients, reputation, and bottom line.
Want to make your program more comprehensive?
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