On November 20, 2024, the Office of Inspector General (“OIG”) for the U.S. Department of Health and Human Services (“HHS”) issued new Industry Segment-Specific Compliance Program Guidance For Nursing Facilities (“Nursing Facility ICPG”) for nursing home members of the health care compliance community. Motivating factors for issuing the Nursing Facility ICPG included long-standing issues such as staffing, infection control, emergency preparedness, background checks, adverse events experienced by residents, inappropriate use of medications and other compliance and quality issues.
Previously, OIG released voluntary compliance program guidance (“CPG”) for nursing facilities in 2000 and supplemented the CPG in 2008. The CPG was designed to encourage nursing facilities to develop and implement internal monitoring controls to assure adherence to applicable statutes, regulations and compliance program requirements. OIG carried forward certain pertinent risk areas and relevant considerations from those program guidance memos into the Nursing Facility ICPG.
The Nursing Facility ICPG describes risk areas for nursing facilities, recommendations and practical considerations for mitigating those risks, and other important information OIG believes nursing facilities should consider when implementing, evaluating and updating their compliance and quality programs. Nursing Facility ICPG, together with OIG’s General Compliance Program Guidance (“GCPG”) issued in November 2023, serve as OIG’s updated and centralized source of voluntary compliance program guidance for nursing facilities. Nursing facilities should use the Nursing Facility ICPG to help identify their own risks and implement an effective compliance and quality program to reduce those risks.
The Nursing Facility ICPG applies to all nursing facilities and discusses key aspects of general compliance risks and compliance program infrastructure for nursing facilities. More specifically, it addresses (i) compliance risk areas and recommendations for mitigation; and (ii) other compliance, quality and resident safety considerations. OIG clarifies that the Nursing Facility ICPG does not constitute a model compliance program; it is not designed to be one-size-fits-all or all-inclusive of compliance and risk considerations for nursing facilities.
The Nursing Facility ICPG is the first of many Industry Segment Specific Compliance Program Guidances expected to be released by OIG in the coming years. OIG plans to publish many Industry Segment Specific Compliance Program Guidances for a variety of providers, suppliers and other participants in health care industry subsectors or ancillary industry sectors relating to the federal health care programs.
Key Highlights of the Nursing Facility ICPG
Much of what is covered in the Nursing Facility ICPG is familiar to the nursing facility compliance industry. Many compliance program provisions in the Nursing Facility ICPG reinforce best practices and recommendations from previous nursing facility CPGs, as well as insights learned from Corporate Integrity Agreements and various other OIG guidance.
Several key points of emphasis in the Nursing Facility ICPG:
1. Quality of Care and Quality of Life
OIG identified that beyond the Requirements of Participation for Long Term Care Facilities in 42 CFR 483, the failure to provide quality care and promote quality of life poses a risk of fraud and abuse for nursing facilities. When a nursing facility submits a claim to Medicare or Medicaid for reimbursement, the claim submission form includes certifications that the claimed services were provided in compliance with all applicable statutes, regulations and rules. If a nursing facility fails to meet its obligations regarding the provision of care in accordance with professional standards of quality, or regarding the provision of services in an environment that promotes quality of life, claims for reimbursement may be considered false.
OIG highlighted some common risk areas for nursing facilities associated with providing quality of care and quality of life for residents:
- Staffing Levels, Shortages and Competencies
- Appropriate Resident Care Plans and Resident Activities
- Challenges Due to Demographic Changes in the Resident Profile, Higher Resident Acuity Levels and Behavioral Health Issues
- Medication Management
- Appropriate Use of Medications
- Resident Safety
2. Medicare and Medicaid Billing Requirements
Ensuring compliance with Medicare and Medicaid billing requirements should be a core function of nursing facility compliance program operations. OIG emphasized that submitting a false claim or causing a false claim to be submitted to a federal health care program may subject an individual, entity or both to criminal prosecution, civil liability under the False Claims Act or Civil Monetary Penalties Law, and exclusion from participation in federal health care programs, as described in the GCPG. OIG called for nursing facilities to take proactive measures to ensure compliance with program rules, including conducting regular reviews to ensure billing and coding practices are current and accurate, as well as performing regular internal billing and coding audits. The Nursing Facility ICPG provides that, even if an entity makes an isolated billing error, the entity still has an obligation to repay the overpayment to the government to avoid False Claims Act liability, as explained in the GCPG.
The Nursing Facility ICPG covers some of the risk areas related to Medicare and Medicaid billing requirements for nursing facilities and recommendations for addressing those risks. It is intended only to assist nursing facilities in evaluating and mitigating their own particular risk areas. This list of risk areas is not exhaustive and includes:
- SNF Prospective Payment System
- Value-Based Payment Models and Programs
- Medicare Advantage and Medicaid Managed Care
- Medicare Part D
- Medicare Health Plan Enrollment for Nursing Facility Residents
3. Federal Anti-Kickback Statute
OIG identified that nursing facilities must comply with the federal Anti-Kickback Statute (“AKS”).
Although liability under the AKS depends in part on a party’s intent, it is incumbent on nursing facilities to identify arrangements with referral sources and referral recipients that present a potential for fraud and abuse under the AKS. The GCPG provides some illustrative questions to consider when attempting to identify problematic arrangements. Those questions—and appropriate follow-up questions—can help nursing facilities identify, address and avoid potentially problematic arrangements.
OIG highlighted several risk areas for nursing facilities under the AKS and recommendations for mitigation of those risks. Nursing facilities should scrutinize the listed risk areas as part of their risk assessment, internal review and monitoring processes. These risk areas include, but are not limited to the following:
- Free (or Below Fair Market Value) Goods and Services
- Discounts – Price Reductions and Swapping
- Arrangements for Services and Supplies
- Long-Term Care Pharmacy and Consultant Pharmacist Arrangements
- Hospital Arrangements
- Hospice Arrangements
- Care Coordination and Value-Based Care Arrangements
- Joint Ventures
4. Additional Risk Areas
OIG mentioned certain other risk areas that nursing facilities should consider including in their compliance and quality training, risk assessment, internal review and monitoring processes:
- Related-Party Transactions
- Physician Self-Referral Law
- Anti-Supplementation
- HIPAA Privacy, Security, and Breach Notification Rules
- Civil Rights
5. Additional Compliance, Quality and Resident Safety Considerations
Since the risk areas and recommendations in the Nursing Facility ICPG are not exhaustive, OIG calls for nursing facilities to closely review the GCPG and the Nursing Facility ICPG in light of their own risk profile as they work to implement, evaluate and update compliance program operations.
OIG listed the following other compliance, quality and resident safety considerations for nursing facilities:
- Oversight Role of Responsible Individuals. OIG emphasized that nursing facilities may be more successful in achieving compliance and quality objectives when responsible individuals set an appropriate tone for an organization and demonstrate an interest in ensuring the quality of care and quality of life for residents and a supportive working environment for staff.
- Compliance Officer Experience. OIG pointed out that nursing facilities should consider recruiting a compliance officer with sufficient experience in managing compliance programs and involvement with quality assurance efforts centered on quality of care, quality of life and resident safety.
- Role of the Compliance Committee in Supporting Collaboration and Alignment Between Compliance and Quality Functions. OIG stressed that the nursing facility’s compliance committees should play a pivotal role in supporting collaboration and alignment between compliance and quality functions at nursing facilities and in assisting compliance officers in overseeing regulatory compliance.
- Competency-Based Training. OIG highlighted that nursing facilities should continually focus on ensuring that training achieves the competencies that are reflected in the regulations and that all staff have the knowledge, skill and ability to support the delivery of high-quality care and to promote quality of life through the performance of individual job responsibilities.
- Risk Assessment, Internal Review and Monitoring Processes. OIG recommended that each nursing facility develop and implement a centralized annual risk assessment, internal review and monitoring process to identify and address risks associated with the nursing facility’s participation in federal health care programs, including risk areas discussed in this Nursing Facility ICPG.
- Reporting Requirements. OIG pointed out that a nursing facility’s compliance and quality programs should coordinate efforts and provide regular comprehensive training to all staff to ensure a high level of integrity and accuracy in compiling and calculating data the facility provides to meet all reporting obligations.
Practical Takeaways
- The Nursing Facility ICPG will likely be considered the primary resource and the minimum standard for nursing facility compliance programs moving forward.
- Each nursing facility’s compliance team should comprehensively review the Nursing Facility ICPG and reference it when assessing whether your current program conforms with OIG’s expectations.
- OIG believes that the Nursing Facility ICPG will help nursing facilities proactively detect, assess and remediate quality concerns before residents are harmed and before such concerns give rise to an enforcement action.
- Since OIG intends to keep the Nursing Facility ICPG current and reflective of the needs of the nursing facility industry and welcomes any feedback from industry stakeholders related to nursing facility compliance considerations and risk areas, we recommend that nursing facilities submit questions and comments to the OIG at compliance@oig.hhs.gov.
For assistance in evaluating and enhancing your current compliance program, developing a compliance program or for more information on the Nursing Facility ICPG, please contact:
- Sean Fahey at (317) 977-1472 or sfahey@hallrender.com;
- Katherine Kuchan at (414) 721-0479 or kkuchan@hallrender.com;
- Brian Jent at (317) 977-1402 or bjent@hallrender.com;
- Todd Selby at (317) 977-1440 or tselby@hallrender.com; or
- Your regular Hall Render attorney.
Hall Render blog posts and articles are intended for informational purposes only. For ethical reasons, Hall Render attorneys cannot—outside of an attorney-client relationship—answer specific questions that would be legal advice.
