In the wake of the Supreme Court’s decision overturning Roe v. Wade, the Centers for Medicare & Medicaid Services (CMS) issued guidance to health care providers on July 11, 2022, underscoring that the federal Emergency Medical Treatment and Labor Act (EMTALA) applies to patients who present at a hospital emergency department (ED) in need of abortion care to address an emergency medical condition.1 Immediately on the heels of this guidance, one state—Texas—filed a lawsuit against the U.S. Department of Health and Human Services (HHS) challenging the guidance’s legality. These developments collectively reinforce the murky waters that hospitals, physicians and other providers must navigate as they seek to ensure compliance with Medicare program requirements amidst a patchwork of conflicting state abortion laws. This makes it all the more important for institutional health care providers to ensure that physicians and other health care personnel on the front lines are adequately equipped with the knowledge, training and tools necessary to respond to these new uncertain realities.
Background on EMTALA
EMTALA provides that, when a patient presents to the “dedicated emergency department” of a Medicare-enrolled hospital, the hospital must perform an appropriate medical screening examination.2 A “dedicated emergency department” is deemed to include any hospital department or facility that is licensed by the state as an emergency room or ED, is held out to the public as a place that provides care for emergency medical conditions (EMCs), or during the immediately preceding calendar year provided at least one-third of all outpatient visits for the treatment of EMCs.3 Under this definition, hospital labor and delivery units may qualify as “dedicated emergency departments” subject to EMTALA.
If a patient presenting to the ED is identified as having an EMC, the hospital must provide stabilizing treatment within the hospital’s capability.4 As a general matter, the responsibility to determine whether an EMC exists rests with the examining physician(s) or other qualified medical personnel of the hospital.5 An EMC generally means a “medical condition manifesting itself by acute symptoms of sufficient severity . . . such that the absence of immediate medical attention could reasonably be expected to result in”: (i) placing the health of the individual in serious jeopardy; (ii) serious impairment to bodily functions; or (iii) serious dysfunction of any bodily organ or part.6 An EMC may include a condition that is likely or certain to become emergent without stabilizing treatment.7 In the case of pregnant patients specifically, per CMS guidance, EMCs may include, but are not necessarily limited to, ectopic pregnancy, complications of pregnancy loss, or emergent hypertensive disorders, such as preeclampsia with severe features.8
The penalties for violating EMTALA’s screening and stabilization requirements can be significant. Any physician responsible for examination, treatment or transfer of an individual presenting to the ED who violates EMTALA, including by misrepresenting the individual’s condition, may be liable for civil monetary penalties (CMPs) of up to $119,942 per violation.9 If the violation is gross and flagrant or repeated, the Office of Inspector General for HHS (OIG) may also exclude the physician from participation in Medicare, Medicaid and all other federal health care programs.
Any Medicare-participating hospital that violates EMTALA’s requirements may be subject to a CMP of up to $59,973 per violation (if the hospital has fewer than 100 beds) or $119,942 per violation (if the hospital has 100 or more beds).10 Most significantly, CMS may also make a determination in extreme cases to terminate the hospital’s Medicare participation agreement.
Updated EMTALA Guidance and Legal Challenges
The CMS guidance released on July 11 seeks to provide clarity and certainty to providers surrounding their legal obligations under EMTALA in the wake of the Dobbs decision. CMS underscores that the guidance does not revise existing law or set forth a new policy, but rather “reminds” providers of their long-standing obligations under EMTALA. Specifically, the guidance directs that hospitals and physicians must ensure pregnant patients receive an appropriate medical screening examination, stabilizing treatment and transfer, if necessary, regardless of any state laws or mandates that restrict abortion care. Thus, “[i]f a physician believes that a pregnant patient presenting at an emergency department is experiencing an [EMC] as defined by EMTALA, and that abortion is the stabilizing treatment necessary to resolve that condition, the physician must provide that treatment.”11
In the guidance, CMS emphasizes that state laws that prohibit abortion—with no exception for the life and health of the mother or a narrower exception than contemplated by EMTALA’s EMC definition—are preempted by federal law. Similarly, the guidance notes that any state actions against a physician who provides an abortion in order to stabilize an EMC for a pregnant woman presenting to a hospital’s ED likewise would be preempted by EMTALA. Finally, per the guidance, a hospital is precluded from citing conflicting state law or practice as the basis for a transfer. In other words, “[f]ear of violating state law through the transfer of [a] patient” to obtain abortion care at another hospital does not constitute a legitimate basis for declining to effectuate the transfer when the original hospital lacks the capability to provide such services.12
Before the ink had time to dry on the July 11 guidance, the state of Texas, acting through its attorney general, sued HHS over the new guidance. The lawsuit asserts that HHS’s guidance represents an “unconstitutional exercise of authority” in the wake of the Supreme Court’s decision and seeks a declaratory judgment that the new guidance is unenforceable as a matter of law.13 The state of Texas further claims that the guidance imposes “a number of new requirements related to the provision of abortions that do not exist under federal law,” exceeds HHS’s statutory authority, and is arbitrary and capricious.
Potential Compliance Actions for Providers
The July 11 guidance is consistent with the Biden Administration’s defense of reproductive rights and suggests that HHS, through OIG, intends to actively—and perhaps aggressively—step up its enforcement activity for EMTALA violations that are linked to the failure to provide an appropriate medical screening examination, stabilizing treatment or transfer for a pregnant patient. At the same time, though a physician or hospital could assert its EMTALA obligations as a defense in any enforcement action under state abortion laws, EMTALA does not preclude a hospital or physician from being pursued in the first instance for significant fines, adverse licensure action or even criminal sanctions under applicable state laws. As such, the potential conflicts between EMTALA requirements and state abortion laws will likely remain a challenging landscape for hospitals and physicians to navigate for the foreseeable future.
In the face of this new reality, there are certain actions that hospitals and physicians should take to best protect themselves while ensuring the accessibility and availability of appropriate emergency care and treatment for pregnant patients. These include the following:
- Stay Informed on State Abortion Laws. Abortion laws differ widely from state to state, and the legal status of abortion across the country continues to change day by day. Accordingly, all hospitals and providers furnishing emergency medical care should seek clarity on any abortion care restrictions that may apply under their particular state’s laws and, most importantly, have a process in place to monitor for real-time changes.
- Refresh EMTALA Policies and Procedures. In light of the July 11 guidance, hospitals should take the opportunity to review and consider any changes or clarifications that might be desirable to their EMTALA policies and procedures. This could include the addition of new policy sections specifically addressing the sensitivities and special considerations surrounding abortion care.
- Provide Reeducation and Training on EMTALA. Hospitals should consider providing retraining for all departments and units that may be subject to EMTALA. Ensuring that staff have opportunities to ask questions and seek clarity on their obligations in the current climate will help reduce confusion when an emergency situation arises.
- Audit for EMTALA Compliance. Hospitals also may wish to consider adding EMTALA compliance to their annual auditing and monitoring process. This could include selecting a random sample of charts for pregnant patients who presented to the ED, with the results of the review used as a learning opportunity for hospital staff.
- Pay Close Attention to Documentation. Given that the determination of whether an EMC exists remains the responsibility of the examining physician or other qualified medical personnel, it is especially important that providers remember to clearly and accurately document their assessment and rationale around what is best for the patient in the medical record. This will not only help ensure compliance with any state laws that require specific documentation to support an exception to an abortion restriction, but also provide support for any defenses when EMTALA or state law is enforced.
Manatt Health will continue to track developments at the federal and state levels in the wake of the Supreme Court’s decision and publish updates on the impacts to health care providers as the legal landscape evolves. In the meantime, should you require assistance in navigating this challenging regulatory environment, please do not hesitate to contact Melinda Dutton at mdutton@manatt.com or Randi Seigel at rseigel@manatt.com.
1 Reinforcement of EMTALA Obligations Specific to Patients Who Are Pregnant or Are Experiencing Pregnancy Loss, QSO-22-22-Hospitals, Centers for Medicare & Medicaid Services (July 11, 2022), https://www.cms.gov/files/document/qso-22-22-hospitals.pdf (hereinafter, the “EMTALA Guidance”); see also Letter from X. Becerra to Health Care Providers (July 11, 2022), https://www.hhs.gov/sites/default/files/emergency-medical-care-letter-to-health-care-providers.pdf.
2 42 U.S.C. § 1395dd(a); 42 C.F.R. § 489.24(a)(1)(i).
3 42 C.F.R. § 489.24(b).
4 42 U.S.C. § 1395dd(b); 42 C.F.R. § 489.24(a)(1)(ii).
5 State Operations Manual, Appendix V, Tag A-2406/C-2406 (eff. July 16, 2010).
6 42 C.F.R. § 489.24(b).
7 EMTALA Guidance, at 1.
8 If an individual with an EMC is not stabilized, EMTALA restricts a hospital from transferring the individual to another facility. An individual is not “stabilized” under EMTALA unless no material deterioration of the individual’s condition is likely, “within reasonable medical probability,” to result from or occur during the transfer or, with respect to a woman in labor, the woman has delivered the child and the placenta. 42 C.F.R. § 489.24(b). An unstabilized individual may only be transferred if she requests the transfer after informed consent, or the medical benefits of such transfer outweigh the risks (e.g., because the hospital lacks the capability to stabilize the individual’s EMC). 42 U.S.C. § 1395dd(c)(1)(A); 42 C.F.R. § 489.24(e)(1).
9 42 U.S.C. § 1395dd(d)(1)(B); EMTALA Guidance, at 5.
10 42 U.S.C. § 1395dd(d)(1)(A); EMTALA Guidance, at 5.
11 EMTALA Guidance, at 1.
12 Id. at 4.
13 State of Texas v. Xavier Becerra, Civ. A. No. 5:22-cv-00185-H, State of Texas’s Original Complaint (July 14, 2022).