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Ep. 82 – Creating a Compliance Program from Scratch

By Susan Freed
October 9, 2025
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If your healthcare organization doesn’t yet have a formal compliance program, you’re not alone. Smaller providers like assisted living facilities and clinics, – or even larger organizations that never fully formalized compliance – often struggle with where to begin.

But if you bill Medicare, Medicaid, or any government payer, regulators expect you to have a formalized compliance program in place. More importantly, a strong program protects your organization, promotes accountability, and sets you up for long-term success.

On this week’s episode, we outline simple steps to formalize your program while moving it forward at the same time. Get our step-by-step checklist below (and more free resources here).

1. Designate a compliance officer and committee

The first step is assigning responsibility if you haven’t already. Identify your compliance officer right away – they’ll lead the effort. Depending on your size, consider forming a compliance committee. Even a small committee of three (the compliance officer plus two others) can be effective. Choose people whose roles intersect with compliance, such as billing, clinical operations/quality, or IT. Schedule committee meetings for the year and set a regular reporting cadence between your compliance officer and governing body.

2. Start drafting your compliance program manual

Begin building your written compliance manual. Use the OIG’s General Compliance Program Guidance as your framework, working through each element step by step. Distribute sections among your committee or adapt a sample manual, but tailor everything to your organization. Expect the process to take several months – it’s meant to be thorough and sustainable. Set an internal goal of when you’ll have your formal compliance manual completed, aiming for doing so within 6-12 months.

Do not, however, put off other aspects of your programming.  You can and should be moving your compliance activities forward while you work on your formal manual.

3. Implement basic compliance essentials

Next, establish or refresh a few foundational policies which will alert your employees to the importance of compliance.

  • Anonymous reporting mechanism for compliance concerns, paired with clear reporting procedures.
  • Code of conduct, either added to or updated in your employee handbook.

Consider doing a “communications blitz” to raise awareness of your anonymous reporting policy. Check out Episode 25 for tips on how to do this.

4. Schedule and plan a risk assessment

Don’t wait until your compliance manual is finished. A risk assessment identifies vulnerabilities and guides your first-year activities. Plan it early and use findings to shape compliance priorities and your first work plan. If you’ve never done a risk assessment before and aren’t sure where to start, check out Episode 10 and our free sample risk assessment.   

Your risk assessment will keep momentum going while you draft the more formal compliance program manual.

5. Develop & implement a first-year compliance work plan

Using your initial risk assessment, outline your compliance activities for the next 12 months. This might include targeted audits, additional training, or policy development. Focus on a few priority areas to build a manageable and realistic plan. Consider tackling fewer work items than you might expect in years to come while you work on formalizing your compliance program manual.

6. Develop & roll out basic compliance training

Once your formal compliance manual is complete, develop general compliance program training for all new employees and new hires moving forward.

By following these steps, you’ll create momentum, demonstrate progress, and begin embedding compliance into your organization’s culture – even before your manual is finalized. By the time your manual is finished, you will have had regular compliance committee meetings, raised awareness of the anonymous reporting policy and compliance expectations among your employees, conducted your first risk assessment, and implemented an initial work plan.

If you’re new to compliance or just beginning your program, explore more resources and past episodes TheHealthcareCompliancePod.com.



Ep. 82 – Compliance Program Startup ChecklistDownload
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Susan Freed

About Susan Freed

Susan helps health care providers and health plans operate successfully in a challenging regulatory and reimbursement landscape. She approaches each client’s problems with practical solutions tailored to the individual client’s needs.

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