CMS Emergency Preparedness Rule Updates: What Clinical and Critical Access Hospitals Need to Know Post-COVID

By Drew Duffy

Founder, ClearPath Compliance

The COVID-19 pandemic permanently altered the healthcare regulatory landscape, and no area has seen more substantial post-pandemic scrutiny than emergency preparedness. As hospital systems navigate the new normal, the Centers for Medicare & Medicaid Services (CMS) has updated and re-emphasized the Emergency Preparedness Rule, signaling a more aggressive enforcement posture and higher expectations for clinical and critical access hospitals.

Below, we break down the key updates, enforcement trends, and practical compliance strategies for providers.

1. The Regulatory Backdrop: CMS's Renewed Emphasis on Emergency Preparedness

Originally finalized in 2016, the CMS Emergency Preparedness Rule (42 CFR § 482.15 for hospitals) requires participating providers and suppliers to establish and maintain comprehensive emergency preparedness programs. These programs must address all hazards, ensure continuity of care, and be reviewed and updated at least annually.

Post-COVID, CMS has made clear that emergency plans must go beyond theoretical exercises and reflect real-world events, such as pandemics, cybersecurity attacks, and climate-related disasters.

2. What’s Changed Since COVID-19?

While the Emergency Preparedness Rule’s core framework remains intact, CMS’s guidance and surveyor training post-COVID have led to practical changes in how compliance is evaluated:

A. Increased Focus on Infectious Disease Planning

CMS now expects emergency plans to explicitly address infectious disease outbreaks — not generically, but with reference to real lessons learned during COVID-19. Hospitals are expected to show:

• Infection control integration with emergency planning

• Surge capacity protocols

• Staffing contingency strategies

• PPE acquisition and burn-rate forecasting

B. Surveyor Guidance Emphasizes Operationalization

Surveyors are being trained to evaluate not just whether a hospital has a plan, but whether the plan is actively integrated into operations. Expect increased scrutiny of:

• Real-world drill outcomes

• After-action reports

• Policy updates reflecting those learnings

C. Updated Risk Assessments Must Reflect All-Hazards – Including Cybersecurity

The “all-hazards” approach now formally includes cybersecurity threats, ransomware events, and digital infrastructure failures. Hospitals must demonstrate that their risk assessments and response frameworks cover these domains.

D. Training & Testing: No Longer Just a Checkbox

Annual testing and staff training requirements have shifted in tone from a documentation exercise to a functional expectation. CMS expects that hospitals:

• Conduct two emergency preparedness exercises annually (one full-scale, one table-top or equivalent)

• Use actual events as part of their drill documentation when applicable

• Can demonstrate staff awareness and involvement at multiple levels

3. Compliance Risks and Deficiency Trends

Increased surveyor training and focus have led to a rise in condition-level deficiencies tied to emergency preparedness — especially in critical access hospitals. Common pitfalls include:

• Outdated risk assessments

• Failure to conduct or document required exercises

• Insufficient integration of infection control policies

• Inadequate communication plans with local and regional emergency management systems

For clinical and critical access hospitals already operating under resource constraints, these deficiencies can quickly escalate to citation risk, potential loss of deemed status, and even payment suspensions.

4. Strategic Compliance Recommendations

Given the renewed enforcement landscape, we recommend hospitals take the following actions:

✅ Conduct a Gap Analysis Immediately

Evaluate your current Emergency Preparedness Plan against:

• Updated CMS guidance (QSO-20-41 and beyond)

• Lessons learned from COVID-19 response

• Cybersecurity readiness

✅ Integrate Emergency Planning with Infection Control and Supply Chain Teams

Your Infection Preventionist, Supply Chain Officer, and Compliance Officer should be active contributors to emergency plan development and review.

✅ Document Real-World Events as Testing Equivalents

CMS allows real emergencies to substitute for required testing. Ensure that all such events are formally documented with:

• A timeline of actions

• Stakeholder roles

• Outcomes and after-action findings

✅ Re-train and Re-test Staff Annually

Develop role-specific emergency scenarios. For example, train ICU nurses on surge capacity protocols, or HIM staff on continuity of operations during a cyberattack.

✅ Engage Legal and Compliance Early

Emergency preparedness intersects with HIPAA, EMTALA, and accreditation standards. Legal and compliance leaders should proactively review policies for alignment.

Conclusion: A Moment of Recalibration

The post-COVID era is not about rewriting the Emergency Preparedness Rule, but about enforcing it with new urgency. Clinical and critical access hospitals must pivot from theoretical compliance to operational readiness. With CMS surveyors applying more rigorous standards and accrediting bodies following suit, the time to act is now.

Our team at ClearPath Compliance has deep experience helping hospitals navigate emergency preparedness audits, build resilient response plans, and meet CMS expectations. Contact us to schedule a compliance risk assessment or drill facilitation session.

Stay Compliant. Stay Prepared. Stay Operational.