Practical Compliance Strategies to Minimize Anti-Kickback Statute Risk

The Anti-Kickback Statute (“AKS”) remains one of the most complex and heavily enforced healthcare laws. As enforcement intensifies, healthcare organizations must move beyond reactive compliance and embed AKS risk management into everyday operations.

Executives, investors, operators, and compliance officers share responsibility for maintaining compliance. By taking proactive, practical steps, stakeholders can protect enterprise value, reduce exposure, and demonstrate to regulators that compliance is a core part of the business model—not an afterthought.

Build a Compliance Framework That Fits the Business

Every healthcare organization has unique risk points based on its structure, service lines, and financial relationships. A strong compliance framework starts with understanding where AKS risk arises and how to control it.

Leadership should identify and map relationships that involve payments, incentives, or potential referral streams. That includes physician compensation models, vendor contracts, joint ventures, and marketing arrangements. Once identified, the organization should classify these relationships by risk level and apply tiered oversight—routine audits for lower-risk areas and detailed reviews for high-risk ones.

Compliance programs should reflect operational reality. Overly generic policies satisfy checklists but fail in practice. Programs that align with how the organization actually conducts business are more defensible when regulators come calling.

Incorporate Fair Market Value Analysis Early

Fair market value (“FMV”) is the cornerstone of AKS compliance. Regulators view compensation above or below FMV as a red flag because it may indicate improper influence on referrals.

Executives should involve valuation professionals early, before finalizing deals or compensation terms. FMV opinions should document both methodology and assumptions, not just a final number. Investors should request and review these reports during diligence to confirm compliance and reduce post-closing risk.

Operators and compliance officers should also monitor FMV over time. As market conditions and business models evolve, valuations can become outdated. Regular reviews ensure ongoing compliance and maintain defensibility.

Leverage OIG Advisory Opinions

When uncertainty exists, stakeholders can seek an advisory opinion from the U.S. Department of Health and Human Services Office of Inspector General (“OIG”). These opinions provide insight into how the OIG views specific arrangements under the AKS.

While advisory opinions apply only to the requesting party, they offer valuable guidance for the broader industry. Organizations can use them to anticipate enforcement priorities and benchmark compliance strategies. For complex or novel arrangements—particularly in areas like telehealth, technology integration, or private equity-backed structures—an advisory opinion can prevent future disputes.

Integrate Compliance Into Deal Diligence

Mergers, acquisitions, and private equity investments often uncover AKS exposure. Buyers and investors should make AKS risk assessments part of every diligence process.

This includes reviewing target contracts, physician arrangements, and vendor relationships, as well as assessing whether past conduct might create successor liability. Buyers should confirm that compliance programs exist, that they are followed, and that any self-disclosures or corrective actions have been documented.

Integrating compliance into diligence protects buyers and investors from inheriting problems and positions them to improve compliance post-acquisition.

Train and Empower Leadership

Compliance begins at the top. Leadership teams must understand their organization’s AKS risk profile and set expectations for ethical conduct. Training should not focus only on what the statute prohibits but also on how compliance supports sustainable business growth.

Executives and managers should receive targeted, scenario-based training that connects regulatory concepts to their daily decisions. Compliance officers should track attendance and reinforce accountability through performance metrics.

When leaders demonstrate commitment, compliance becomes part of the organization’s culture—not just its paperwork.

Document, Audit, and Improve

Documentation remains the best defense in an AKS investigation. Organizations should maintain written agreements, valuation reports, business purpose memoranda, and board approvals. Consistent recordkeeping allows compliance officers to demonstrate intent, process, and good faith.

Auditing and continuous improvement complete the cycle. Regular internal reviews test compliance controls and identify weaknesses before regulators or whistleblowers do. When issues arise, prompt self-disclosure to the OIG can mitigate penalties and demonstrate cooperation.

Conclusion

Effective AKS compliance does more than prevent violations—it builds credibility with regulators, investors, and business partners. Organizations that view compliance as part of strategic planning strengthen their position in the market and reduce costly disruptions.

By building tailored programs, validating fair market value, integrating compliance into diligence, training leadership, and maintaining strong documentation, executives, investors, operators, and compliance officers can minimize AKS risk and promote sustainable growth.

This post is for informational purposes only and does not constitute legal advice. For guidance tailored to your organization, contact Mooradian Law at info@mooradian.law or (734) 219-4890.