On November 27, 2024, the Centers for Medicare & Medicaid Services (“CMS”) issued a final rule (“Final Rule”) updating the Medicare Conditions of Participation (“CoPs”) for hospitals subject to 42 CFR Part 482 and critical access hospitals (“CAHs”) subject to 42 CFR Part 485. These updates establish a progressive rollout of nationwide standards for both emergency services and obstetrical care aimed at improving patient outcomes and addressing the maternal health crisis in the United States.

Background and Timeline

In the Final Rule, CMS established new health and safety standards under the CoPs for hospitals and CAHs. These updates primarily aim to enhance patient safety and promote high-quality care, with a particular focus on addressing the maternal health crisis. As CMS states, the changes are intended to “advance the health and safety of pregnant, birthing, and postpartum women.”[1]

The Final Rule introduces a three-phase rollout from 2025 through 2027, giving facilities time to meet the new standards. By 2027, hospitals and CAHs must be in full compliance with:

  1. Phase 1, Effective July 1, 2025:
    1. Emergency Services Readiness: Hospitals (§ 482.55) and CAHs (§ 485.618) must adopt written protocols based on nationally recognized, evidence-based guidelines. Annual staff training on these protocols is required.
    2. Transfer Protocols: Hospitals (§ 482.43) must implement written policies for both inpatient and inter-hospital transfers. Annual training for applicable staff is required. NOTE: This requirement applies only to hospitals, as CAHs are already subject to similar transfer-related requirements under existing CoPs.
  1. Phase 2, Effective January 1, 2026:
    1.  Obstetrical Services: Organization, Staffing and Delivery of Services: Applies to hospitals (§ 482.59(a)-(b)) and CAHs (§ 485.649(a)-(b)).
  1. Phase 3, Effective January 1, 2027:
    1. Annual Obstetrics Staff Training: Required for hospitals (§ 482.59(c)) and CAHs (§ 485.649(c)).
    2. Quality Assessment and Performance Improvement Program Implementation for Obstetrics: Applies to hospitals (§ 482.21) and CAHs (§ 485.641).

Phase 1: Effective July 1, 2025

While the overall initiative centers on improving obstetric care, Phase 1 of the new standards applies more broadly (i.e., including services beyond obstetrics) and requires compliance by July 1, 2025. As stated above, Phase 1 has two main parts: (1) Emergency Services Readiness and (2) Transfer Protocols.

Emergency Services Readiness (42 CFR §§ 482.55 and 485.618)

Hospitals and CAHs must comply with a new “Emergency Services Readiness” standard, regardless of whether they offer obstetric services. The goal is to improve outcomes and ensure the safety of all patients, and particularly to ensure “baseline health, safety, and training standards for the care of patients with emergency conditions.”[2] This update also aligns hospital and CAH CoPs with those of Rural Emergency Hospitals.

The new standards require hospitals and CAHs to:

  • Identify and adopt protocols consistent with a nationally recognized, evidence-based guideline.
  • Train applicable staff annually on the adopted protocols.

In addition, the new standards require hospitals to maintain adequate provisions (equipment, supplies and medications) at the hospital to meet the needs of the hospital’s emergency services patients.

NOTE: This requirement is specific to hospitals because existing CoPs for CAHs already mandate comparable supply standards. As such, CMS did not propose new emergency services equipment, supplies or medication requirements for CAHs.

At a minimum, the new hospital-specific regulation states these provisions must include:

  • Drugs, blood and blood products and biologicals commonly used in life-saving procedures;
  • Equipment and supplies commonly used in life-saving procedures; and
  • Each emergency services treatment area must have a call-in mechanism (for example, call buttons or alarms) available to each patient or their caregiver for the purpose of summoning assistance or alerting staff to emergencies and concerns.[3]

Transfer Protocols (42 CFR § 482.43)

The new Transfer Protocol standards apply only to hospitals and do not extend to CAHs, as CAHs are already subject to existing transfer-related requirements, including maintaining transfer agreements and ensuring the provision of necessary medical information during patient transfers.

Under the new Transfer Protocols, hospitals must establish written policies and procedures pertaining to all patient transfers. Of note, these new standards require hospital transfer policies to include and apply to inpatient transfers, including intra-hospital transfers between a hospital’s inpatient units, as well as inpatient transfers from one hospital to another. The new Transfer Protocols are intended to “ensure that patients are transferred to the appropriate level of care promptly and without undue delay, in order to meet their needs.”[4]

The hospital must ensure that all applicable staff are trained annually on these policies and procedures.

Practical Takeaways

  • Hospitals and CAHs should review their current emergency services and transfer protocols to ensure alignment with the new Phase 1 requirements effective July 1, 2025.
  • Facilities should monitor for forthcoming subregulatory guidance from CMS, including updates to the State Operations Manual and other survey-related materials that will clarify expectations under the new standards.
  • Hospitals and CAHs should proactively prepare for Phase 2 and Phase 3 requirements, aligning internal practices and planning for compliance with the respective effective dates. We will publish additional guidance and insights on Phase 2 and Phase 3 requirements as their respective effective dates approach.

If you have questions or would like additional information about this topic, please contact:

Special thanks to Summer Associate Meredith Johnson-Monfort for her assistance in the preparation of this article.

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.

[1] Final Rule at p. 93912.

[2] FR at p. 94488.

[3] 42 C.F.R. 485.55(c)(2).

[4] FR at p. 94491.

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