On November 20, 2024, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued the Nursing Facility Industry Segment-Specific Compliance Program Guidance (Nursing Facility ICPG). This document provides voluntary, nonbinding recommendations to assist nursing facilities in developing effective compliance programs tailored to their unique operational challenges. It builds upon the OIG’s General Compliance Program Guidance (GCPG) released in November 2023, which offered broad compliance strategies for the healthcare sector.

Key Compliance Risk Areas

The Nursing Facility ICPG identifies several critical risk areas:

1. Quality of Care and Quality of Life: The guidance emphasizes the necessity of adequate staffing, comprehensive resident care plans, and vigilant medication management. Deficiencies in these areas can lead to non-compliance with federal regulations and potential fraud and abuse. The OIG notes that poor quality of care may result in the submission of false claims, which could be actionable under the False Claims Act.
2. Medicare and Medicaid Billing Requirements: The guidance stresses the importance of compliance with billing protocols under various payment models, such as the Prospective Payment System (PPS). OIG advises regular reviews and audits to ensure accurate billing and coding practices, highlighting the importance of proper documentation and coding of resident characteristics.
3. Federal Anti-Kickback Statute (AKS): The OIG urges facilities to scrutinize arrangements with referral sources and recipients to prevent violations of the AKS. The guidance provides examples of potentially risky arrangements and recommends structuring them to satisfy AKS exceptions or safe harbors. Particular attention is given to arrangements involving free or below-fair-market-value goods and services, discounts, and joint ventures.
4. Other Risk Areas: These include related-party transactions, physician self-referral law (Stark Law), anti-supplementation policies, HIPAA Privacy and Security Rules, and adherence to civil rights laws, including anti-discrimination requirements. The guidance suggests incorporating these areas into compliance training and monitoring processes to mitigate associated risks.

Recommendations for Mitigation

To address these risks, the Nursing Facility ICPG offers several recommendations:

• Leadership Commitment: Executive management should actively oversee compliance programs, setting a tone that prioritizes quality care and regulatory adherence. The guidance emphasizes the importance of leadership in fostering a culture of compliance.
• Competency-Based Training: Implement training programs that ensure staff possess the necessary skills and knowledge to deliver high-quality care and maintain compliance. The OIG highlights the need for ongoing education to keep staff informed about compliance requirements and best practices.
• Regular Risk Assessments: Conduct annual assessments to identify and address compliance vulnerabilities, tailoring strategies to the facility’s specific risk profile. The guidance recommends proactive risk management to prevent compliance issues.
• Effective Communication Channels: The OIG suggests that open communication is vital for an effective compliance program. Compliance and quality teams should not be siloed, rather they should work together. Additionally, leadership should establish multiple avenues for staff to report compliance concerns, fostering an environment where issues can be raised without fear of retaliation.

Implications for Nursing Facilities

While the Nursing Facility ICPG is voluntary, it serves as a valuable tool for identifying compliance risks. Facilities should to review the guidance and consider ways to integrate its recommendations into their operations, considering their unique circumstances and regulatory obligations. By doing so, they can improve resident care, reduce regulatory risks, and promote a culture of compliance.