Compliance Today - March 2023. EMTALA confusion: Clinically stable, stable for transfer, and stabili
[author: Mary Ellen Palowitch]
The terms clinically stable and stable for transfer are frequently used by and familiar to emergency department and hospital staff. When it comes to compliance with the Emergency Medical Treatment and Labor Act (EMTALA) in hospitals, however, the key term is stabilized.
This article will provide clarity on the use of these important terms in everyday clinical practice as well as their impact on EMTALA complaint investigations. This information will be helpful to clinical, compliance, and administrative staff working in Medicare-participating hospitals.
Background
EMTALA was signed into law in 1986. The law was passed to address nationwide outrage against what was then known as “patient dumping.”[1] Some hospitals refused to provide care to individuals without insurance, the right type of insurance, or the ability to pay. Hospital staff would send patients to public hospitals, frequently with minimal or no treatment for their emergency medical conditions. This inappropriate “dumping” of patients resulted in harm and even death.
Hospitals, including critical access hospitals, that receive Medicare funding are required to comply with Medicare provider agreement requirements, which include compliance with EMTALA. EMTALA requires hospitals to provide a screening examination of all individuals who “come to the emergency department” for evaluation of possible emergency medical conditions.[2] The hospitals must then provide stabilizing treatment for any emergency medical conditions identified or if unable to stabilize the patient, arrange appropriate transfers to facilities with the capabilities and capacity to provide the necessary treatment. The EMTALA requirements are located in the Medicare provider agreement regulations.[3]
EMTALA applies to all individuals—not just Medicare and Medicaid beneficiaries—regardless of insured status, type of insurance, or ability to pay. Hospitals cannot refuse to provide emergency care to individuals based on race, color, national origin, age, disability, or sex. EMTALA also applies to individuals from outside of the United States who present to hospitals for evaluation of potential emergency medical conditions without regard to country of residency or immigration status.
Compliance and enforcement
Compliance with EMTALA is a complaint-driven process. In contrast to the routine compliance assessment of the Medicare conditions of participation for recertification or reaccreditation (which typically occurs every three years), EMTALA is not routinely surveyed.
Complaints to the Centers for Medicare & Medicaid Services (CMS) or the state survey agencies in state departments of health come from various sources including patients, family, friends, physicians, nurses, and other healthcare professionals. News reports can also generate complaints. CMS analysts are responsible for determining if an onsite investigation will be performed—even if the complaint is initially submitted to the state survey agency or another state health department division. The CMS Locations (previously known as Regional Offices) review the complaint and may even reinterview the complainant as needed. If the allegations of the complaint are determined to be serious enough to potentially result in an immediate jeopardy or condition-level finding, an on-site survey will be authorized. Complaint processes of Medicare and Medicaid providers and suppliers are described in “Chapter 5—Complaint Procedures” of the CMS State Operations Manual.[4]
State and occasionally federal surveyors will present on-site to investigate the complaint’s allegations. The investigation will include a thorough assessment of all EMTALA requirements—not only the requirement(s) potentially implicated by the allegations. For example, suppose the complainant says they did not receive a complete medical screening examination (MSE). Then the survey will review medical record documentation of other emergency department patients to determine the presence and appropriateness of their MSEs. In addition, the investigation will also assess compliance with all other EMTALA requirements (e.g., stabilizing treatment, transfers, logs, on-call lists, signage, policies, procedures, etc.).
The on-site surveyors determine if the allegations of the complaint are substantiated and whether the hospital is currently in compliance with all EMTALA requirements. Additional unrelated findings may also be identified. The surveyor(s) complete the statement of deficiencies on Form CMS–2567, but the CMS analyst will make the final determination of compliance for the hospital.[5]
If the provision of clinical care is in question, CMS will send the case to one of the Beneficiary and Family Centered Care Quality Improvement Organizations (QIO) for physician review. The QIO physicians will not weigh in on the compliance determination but will address questions regarding the care provided based on the capabilities and capacity of the hospital. The CMS analyst will review both the state investigation materials and the QIO physician reviewer comments on the CMS Exhibit 138 EMTALA Physician Review Worksheet to make the final determination of compliance.[6]
The hospital will be notified of the survey results. If noncompliance is identified, the notification will include whether the hospital is at risk of termination in 23 days (immediate jeopardy level) or 90 days (condition level). The hospital must then submit a plan of correction within 10 days to address each issue. The CMS analyst will review the plan and, if deemed acceptable, will authorize a revisit survey by the state to ensure compliance has been achieved. The revisit survey must be completed prior to the tentative termination date. The process from initial to final survey can occur over a few weeks but may also last months.
OIG enforcement
Separately, the results of the CMS enforcement action may be sent to the U.S. Department of Health & Human Services Office of Inspector General (OIG) for review and potential imposition of civil monetary penalties on the hospital and/or physician(s) involved. Penalties are adjusted annually, and the maximum is currently set at over $119,000 for hospitals with 100 beds or more and over $60,000 for smaller hospitals. Physicians are subject to the same penalty amounts. The fines can be imposed for each instance of noncompliance on both the hospital and/or physician(s) involved.
Notably, very few cases are selected for enforcement by OIG. The presence of adverse outcomes and egregious events may highlight the case for selection to serve as an example to other hospitals and physicians nationwide. OIG actions are not under the same time constraints as CMS actions. They may be processed up to six years following the initial incident under review.
Private right of action
EMTALA permits individuals who suffer personal harm due to noncompliance with EMTALA to file civil lawsuits against hospitals.[7] This civil action against the hospital is separate from any potential malpractice actions alleging harm or loss that may be filed against a specific physician or group of physicians.
In addition, hospitals that suffer financial loss because of another hospital’s noncompliance with EMTALA may seek damages to recover those losses. For example, one hospital may sue another for losses due to the sending hospital inappropriately transferring or “dumping” a patient on the receiving hospital. Civil actions filed by individuals or hospitals alleging hospital noncompliance with EMTALA must be initiated within two years of the incident.
Clinically stable
The term clinically stable is commonly used in clinical settings, hospitals, and other healthcare settings. The use of the subjective term does not necessarily provide any specific details or objective representation of the patient’s actual condition. The term can be used to send a message to clinicians and others, including family, that for at least that moment, the patient’s condition has reached a steady state or point of homeostasis. The determination of clinically stable may be based on any number of factors, including an examination, vital signs, lab work, diagnostic tests, presence or absence of symptoms, comparison with baseline, or specialist evaluation.
In an emergency department, the term can be useful when comparing the patient’s current condition to how they presented on arrival. It does not automatically imply that the patient’s condition is no longer serious or that the patient is improved and ready for discharge. Describing the patient as clinically stable can signal that the patient is not currently in an acute crisis.
The use of the term and determination of clinically stable is not limited to qualified medical physicians and practitioners, unlike the terms stabilized and unstabilized under the EMTALA regulations. Clinically stable is a term that is commonly found in patient medical record documentation.
Surveyors investigating compliance with EMTALA will review medical record documentation, including the use of statements such as clinically stable; however, that term alone does not mean the patient meets the threshold for stabilized as defined by EMTALA. The key to the appropriate use of clinically stable by hospital staff from an EMTALA standpoint is the supporting documentation of the patient’s condition to include vital signs, diagnostic test results, presence or absence of symptoms, improvements as compared to condition on arrival, and other clinical indicators.
Stable for transfer
Like the term clinically stable, the term stable for transfer is not referenced in the EMTALA regulations. Documentation of stable for transfer is frequently used when preparing to move patients from one location to another. This includes moving patients from the emergency department or other hospital location to another hospital, a nursing home or skilled nursing facility, or even home when hospital-arranged transportation is needed. The term is commonly seen on both hospital and transportation services transfer forms as a required selection prior to effectuating the transfer.
The determination of stable for transfer is not required by the EMTALA regulations but may be required by state licensure, hospital policy, and transportation service provider agreements. Many states require an authorized individual to acknowledge by written or electronic signature that the patient is stable for transfer before transport.
The term does not indicate that the patient is stabilized—as referenced in the EMTALA regulations—but only that the patient is ready to be moved. In actuality, the patient’s condition may be extremely unstable, but unless the patient is transported expeditiously to another hospital, the survival risk is minimal. Once the sending hospital has provided as much care as possible within their capabilities to minimize risk of deterioration during transfer—including when the patient is extremely unstable—the transfer form confirming stable for transfer can be signed. The signature confirms that the patient is ready for relocation to the next setting.
Separately, the EMTALA regulations require a physician—or other qualified practitioners in consultation with a physician—to certify that the benefits of transfer outweigh the risks when transferring a patient to another hospital for stabilizing treatment. The EMTALA physician certification requirements are not the same as hospital, health system, state licensure, or transportation service policies requiring a hospital representative to sign a form stating that the patient is stable for transfer and ready to be moved to another location.[8]
Since EMTALA protections end when the emergency medical condition has been stabilized, surveyed hospitals often point to medical record documentation that the patient was stable for transfer as justification for claiming EMTALA protections had ended. However, determination or documentation of stable for transfer in anticipation of patient movement from one location to another does not address whether the emergency medical condition is or has been stabilized for EMTALA purposes.
Stabilized
EMTALA protections apply to patients with unstabilized emergency medical conditions. The determination of stabilized versus unstabilized must be made by a qualified physician or practitioner, as required by EMTALA regulations.[9]
The EMTALA regulations define stabilized as follows:
“Stabilized means, with respect to an ‘emergency medical condition’ as defined in this section under paragraph (1) of that definition, that no material deterioration of the condition is likely, within reasonable medical probability, to result from or occur during the transfer of the individual from a facility or, with respect to an ‘emergency medical condition’ as defined in this section under paragraph (2) of that definition, that the woman has delivered the child and the placenta.”[10]
The EMTALA regulations do not define unstabilized, but the term’s meaning can be inferred from the regulatory definition listed above as follows:
. . . that material deterioration of the condition is likely, within reasonable medical probability, to result from or occur during the transfer of the individual from a facility or, with respect to an “emergency medical condition” . . . that the woman has not delivered the child and the placenta.
The patient is considered unstabilized when they need ongoing or additional medical, surgical, psychiatric, or other types of care and interventions, and without that additional treatment, the patient’s condition will decline. The determination of stabilized versus unstabilized may be based on objective and subjective data, which is determined by the qualified physician or practitioner responsible for the patient and based on nationally accepted standards of care. Documentation in the medical record should fully support the determination of stabilized or unstabilized, especially at time of transfer. While the patient’s emergency medical condition is unstabilized, including before and after transfer, all EMTALA protections continue to apply.
Once the patient meets the threshold for stabilized, EMTALA protections end. The end of EMTALA protections does not mean care necessarily ends. The patient may need ongoing treatment in the emergency department, including observation services, or to be admitted for inpatient services, discharged and referred to follow-up outpatient care, or transferred to another hospital for additional care and treatment. In this instance, once the emergency medical condition has been determined to be stabilized, the receiving hospital can then require insurance approval or pre-authorization, for example, prior to accepting the patient transfer.
It is an important reminder that the sending physician or practitioner with the patient in their care is responsible for determining stabilized, as opposed to a physician at a receiving facility who has agreed to accept the transfer but has yet to evaluate the patient in person.
Stable “trifecta”
In the emergency department, the use of the term stable varies. The terms clinically stable and stable fortransfer are frequently used by hospital staff and serve as communication tools between healthcare providers and others. However, stabilized and unstabilized, which are not commonly used by clinical staff, are the key terms related to EMTALA protections and the flexibilities extended to individuals needing examination and stabilizing treatment for their emergency medical conditions. Even when a patient is identified as clinically stable or stable for transfer, if the emergency medical condition is unstabilized, EMTALA protections continue. Conversely, if the condition is stabilized, EMTALA protections end.
The evaluation of compliance with EMTALA requirements is to ensure hospitals provide medical screening examinations to all individuals who present with potential emergency medical conditions, provide stabilizing treatment within the hospital’s capabilities for any emergency medical conditions identified, and arrange appropriate transfers of patients if unable to stabilize to facilities with the capabilities and capacity needed. Understanding when EMTALA protections apply and, more importantly, when they end is essential for hospitals to protect patients’ rights and to ensure compliance with the Medicare provider agreement requirements.
Takeaways
The key terms for compliance with Emergency Medical Treatment and Labor Act (EMTALA) are stabilized and unstabilized.
EMTALA protections apply when emergency medical conditions are unstabilized, regardless of documentation stating the patient is clinically stable or stable for transfer.
Clinically stable and stable for transfer are routinely used by hospital staff who may not be familiar with the EMTALA terms stabilized and unstabilized.
Centers for Medicare & Medicaid Services, Quality Improvement Organizations, and U.S. Department of Health & Human Services Office of Inspector General review documentation referencing clinically stable and stable for transfer, but compliance with EMTALA is specific to stabilized or unstabilized.
EMTALA protections provide for examinations, treatment, and transfers without regard to insured status or ability to pay.
1 Richard P. Kusserow, Inspector General, Patient Dumping After COBRA: Assessing the Incidence and the Perspective of Health Care Professionals, OAI-12-88-00831, August 1988, https://oig.hhs.gov/oei/reports/oai-12-88-00830.pdf.
342 C.F.R. § 489.24; additional EMTALA related regulations are codified at 42 C.F.R. § 489.20.
4 Centers for Medicare & Medicaid Services, “Chapter 5 – Complaint Procedures,” State Operations Manual, Publication 100-07, revised October 21, 2022, https://www.cms.gov/regulations-and-guidance/guidance/manuals/downloads/som107c05pdf.pdf.
5 U.S. Department of Health & Human Services, Centers for Medicare & Medicaid Services, “Statement of Deficiencies and Plan of Correction (CMS-2567),” revised March 18, 2022, https://www.cms.gov/medicare/cms-forms/cms-forms/downloads/cms2567.pdf.
6 Centers for Medicare & Medicaid Services, “Exhibit 138: EMTALA Physicians Review Worksheet,” State Operations Manual, Publication 100-07, revised October 21, 2022, https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/som107_exhibit_138.pdf.
742 U.S.C. § 1395dd; amended by Emergency Medical Treatment and Labor Act, Pub. L. No. 99-272, Title XVIII, § 1867(d)(2). 100 Stat. 164, 166.
842 C.F.R. §§ 489.24(e)(1)(ii)(B) and (C).
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