An Ambulance ‘Owned’ by a Hospital Must Also Be ‘Operated’ by the Hospital to Trigger EMTALA Obligations

By Robert A. Bitterman, MD, JD, FACEP Contributing Editor

Federal Circuit Court of Appeals ruling diminishes hospital liability under EMTALA related to hospital-owned ambulances.

Whenever an individual enters an ambulance (or medical helicopter) “owned and operated” by a hospital, the federal government deems the person to have “come to the hospital’s emergency department” for purposes of triggering the hospital’s obligations under the Emergency Medical Treatment and Labor Act (EMTALA).1 Thus, even if the ambulance is not on hospital property, the hospital has a legal duty to provide medical screening and/or stabilization to that person in the ambulance.2

This EMTALA duty begs a number of questions. Does this mean the hospital-owned ambulance must transport the patient back to the hospital’s own ED for examination and treatment? What if the patient should be taken to a closer, “more appropriate” hospital? What if the ambulance is directed by operation of community-wide EMS protocols?

The Case of Beller v. Wishard Memorial Hospital3

Facts. A Wishard Hospital ambulance was dispatched to the Beller home via a county 911 call. The paramedics ascertained the patient to be 34 weeks pregnant with a prolapsed umbilical cord. The medics tried to relieve pressure on the cord, and after consulting with a nurse at the mom’s obstetrician’s office, transported the patient to the nearest hospital, which did not have an obstetrics facility, rather than to Wishard Hospital. The accepting hospital promptly transferred the mom, in the same Wishard ambulance, to a tertiary facility, which performed an emergency cesarean section, but the child ended up with severe hypoxic brain damage.3

Allegations. Beller sued Wishard Memorial Hospital under EMTALA for failure to stabilize the obvious emergency medical condition. The plaintiffs alleged that the mom was in an ambulance “owned and operated” by Wishard and, as a consequence, had “come to the ED” of Wishard. Therefore, Wishard had a legal duty under EMTALA to stabilize the emergency by delivering the child, rather than transferring mom to another hospital.3-5

The hospital admitted it “owned” the ambulance, but argued that it didn’t “operate” the ambulance because the ambulance was instead controlled by community-wide emergency medical services (EMS) protocols. Therefore, the hospital contended that since the mom had not “come to the emergency department,” it had no EMTALA obligation to screen or stabilize her emergency condition.3

District Court Rulings. The incident occurred in 2001, so the court looked to the Centers for Medicare and Medicaid Services (CMS) regulations in effect at the time, which simply stated “comes to the emergency department,” meaning that the person is on “hospital property.” CMS included “ambulances owned and operated by the hospital” as hospital property even if the ambulance was not on hospital grounds.6

Wishard contended that the standard practice was to “sidestep” this interpretation to avoid applying the definition of “comes to the emergency department” to hospital-owned ambulances that served as community-wide emergency response vehicles. The court, however, while granting that it may have been standard practice at the time, still determined that the regulations created a genuine dispute as to whether plaintiffs had “come to the emergency department” under the law, and, thus, it was for a jury to decide.3 Interestingly, neither the hospital nor the court cited CMS’ interpretive guidelines then in effect, which expressly stated that “compliance with local, state, or regionally approved EMS transport of individuals with an emergency is usually deemed to indicate compliance with EMTALA.”7

Wishard also argued that two exceptions to the “comes to the ED” definition, which CMS promulgated in 2003, applied retroactively to the facts in this case and, therefore, the hospital could not be held liable as a matter of law. These exceptions were:

• An ambulance owned and operated by the hospital is not considered to have “come to the hospital’s emergency department” if:

(i) the ambulance is operated under community-wide EMS protocols that direct it to transport the individual to a hospital other than the hospital that owns the ambulance; for example, to the closest appropriate facility.

(ii) the ambulance is operated at the direction of a physician who is not employed or otherwise affiliated with the hospital that owns the ambulance.8

Initially, the court refused to consider the exceptions since they were part of the changes in the EMTALA regulations that CMS issued more than two years after the incident that gave rise to the lawsuit.3 However, the court reversed itself after the hospital pointed to 7th Circuit case precedent, which allowed retroactive application of government regulations if they merely “clarified” the agency’s interpretation of the statute and did not represent a “substantive change” in the definition.9 Since it was clear that the hospital’s ambulance was indeed operating under community-wide EMS protocols at the time it transported the mom to the nearest hospital, the court granted the hospital’s motion to dismiss the case once it decided that CMS’ 2003 regulations only “clarified” CMS’ interpretation of when EMTALA applied to hospital-owned ambulances.3

The plaintiffs appealed, arguing that the new regulation was, in fact, a substantive change in the law, not merely a clarification of CMS’ interpretation. Moreover, the plaintiffs asserted that even if CMS did characterize it as a clarification (which they claimed wasn’t clear), the district court gave undue deference to CMS’ determination and erred in failing to conduct its own analysis to ascertain whether the amendment was a substantive change or a clarification.3

Appellate Court Ruling. Applying CMS’ 2003 rules retroactively depended on whether its 2003 amendment of the regulatory definition of “comes to the emergency department” was merely a clarification of the meaning of that phrase, or whether it represented a substantive change in the definition.3

Under U.S. Supreme Court precedent, “an administrative agency may not promulgate retroactive rules unless Congress provided the agency with express authority to do so and, even if such authority is given, an agency rule will not be accorded retroactive effect unless the agency uses language in the rule expressly requiring that result.”10

The 7th Circuit Court noted, however, that not all rules or regulations create substantive changes — some simply clarify unsettled or confusing areas of law. Furthermore, since those rules merely restate what the law has always been according to the agency, rather than changing the law, they may be applied retroactively.9

CMS believed that EMTALA’s reach over hospital-owned ambulances operating under EMS protocols had been a constant source of confusion for hospitals, in that an ambulance could be owned by a hospital but not operated under its direction.11 It wanted to avoid federal requirements that were inconsistent with local EMS requirements.12 Furthermore, CMS specifically stated that its reason for adopting the 2003 regulation was “to clarify the responsibilities of hospital-owned ambulances so that these ambulances can be more fully integrated with city-wide and local community EMS procedures for responding to medical emergencies” and “reiterations and clarifying changes are needed to ensure uniform and consistent application of policy and to avoid any misunderstanding of EMTALA requirements by individuals, physicians, or hospital employees.”13 Thus, it “clarified” that EMTALA does not apply if the ambulance is operating under a community-wide EMS protocol that requires it to transport the individual to a hospital other than the hospital that owns the ambulance.12

Lastly, the court deemed it entirely appropriate that the district court gave deference to CMS’ determination that the changes were clarifications to its interpretation of the statute. Legal precedent requires the courts to accord great weight to the intent of the promulgating agency, and they will not overturn the agency unless the prior interpretation of the regulation is “patently inconsistent” with the later one.9

The court found that the 2003 definition merely provided “clarifying” guidance as to what it means for an ambulance to be “operated by” a hospital.3 The 2003 amendment specifically clarified the status of two situations in which the ambulance was owned by the hospital but not as a practical matter operated by the hospital during that time — first in which the ambulance is operated under community-wide EMS protocols that direct it to transport the individual to a hospital other than the hospital that owns the ambulance, and second in which it is operated at the direction of a physician who is not employed or otherwise affiliated with the hospital that owns the ambulance.8

It ruled that CMS’ intent was to clarify its interpretation of EMTALA with respect to hospital-owned ambulances operating under community-wide EMS protocols, and this was the quintessential classic situation of a clarifying regulation. Therefore, the 2003 amendment applied retroactively to this case.3

Comment

This case and the interpretation by CMS of when a hospital-owned ambulance “comes to the ED” for purposes of triggering EMTALA make perfect sense. It would create havoc in the EMS world if the federal government pre-empted or prohibited communities from establishing systemwide protocols that control the utilization and flow of ambulances operating in their medical-alert zones. Considering a number of recent scenarios submitted may help explain the various ramifications of EMTALA on hospital-owned ambulances.14

Senario 1. An instructor for The Advanced Cardiac Life Support course (ACLS) was concerned one of the course test questions didn’t provide enough information to answer correctly.

ACLS Question: You receive a radio report from EMS en route to your hospital with a patient who may be having an acute stroke. The hospital’s CT scanner is not working at this time. What should you do in this situation?

ACLS Answer: Divert the patient to a hospital 15 minutes away with CT capability.

The instructor was troubled by the fact that the question didn’t state whether the EMS unit was owned by the hospital; or, if the EMS unit was not hospital-owned, whether it was on hospital property at the time of the radio call. If we assume the EMS unit was operating under community-wide protocols, then ownership of the ambulance wouldn’t matter, because in either case, the ambulance would not have been “operated by” the hospital, so EMTALA wouldn’t apply. Similarly, even if the ambulance was on the hospital’s property, it could be diverted to a more appropriate hospital without triggering EMTALA’s duty to screen or stabilize because CMS would not deem the patient to have “come to the ED” for purposes of triggering EMTALA under its clarifying regulations.

Scenario 2. Hospital A wanted to use its hospital-owned ambulances for two different purposes: first, to participate in the community-wide EMS system operating under its protocols; and second, to do “home health checks” on patients who are the high-users of EMS and the hospital’s emergency department to keep them medically stable and reduce utilization of emergency services. The hospital was worried about the application of EMTALA, particularly whether its ambulance staff (or the ED itself) would be required to do medical screening exams on these patients, as well as over its potential liability under EMTALA if it did not transport the patient to a hospital, either its own ED or another nearby ED.

First, if the hospital-owned ambulance is responding to a 911 call:

Once the patient is in the ambulance, the patient has “come to the ED” for purposes of EMTALA. However, there still must be a “request” of the hospital for examination or treatment for a medical condition before EMTALA is triggered (i.e., both prongs must be met) — “comes to the ED” and the “request.” If the patient doesn’t request to go to the hospital, or if the patient refuses examination or treatment, there is no EMTALA duty.

If the patient never gets in the ambulance (i.e., the medics attend to the patient in his home and don’t move the patient to the ambulance), then the patient has never been on hospital property (in the ambulance) and, therefore, there is no EMTALA duty.

Second, if it’s a scheduled visit, not a 911 call:

A scheduled visit would meet the CMS definition of a “scheduled outpatient encounter” to which EMTALA does not apply, even if the patient is on hospital property (including in the ambulance) and makes a request for emergency care.15

Furthermore, if the medics discover an emergency condition that requires transport to a hospital emergency department, EMTALA would still not apply, since the outpatient encounter would have already begun (the assessment by the medics)14 and/or because the ambulance would then re-engage operation under the community protocols regarding the care provided and where to take the patient.8

Scenario 3. An ED medical director expressed concern when the administration informed its EMS crews that patients who are in hospital-owned ambulances at the scene while waiting for helicopter transport are subject to EMTALA laws as if they were in the hospital’s ED. The new policy required the EMS crew to contact the ED physician, obtain agreement that this is a medical emergency, document the contact as a screening exam, and then have the ED arrange transfer as if the patient were in the ED. The medical director questioned the accuracy of the administration’s EMTALA interpretation and also noted that inclement weather often dictates placing the patient in the ambulance in the field for medical assessment and/or to prevent environmental exposure while the patient waits for the helicopter.

First, it is true, according to CMS, that if an individual is in a hospital-owned and operated ambulance, that individual has “come to the ED” for purposes of EMTALA. However, as noted in the second scenario, “comes to the ED” is only half of the requirement that must be satisfied before the hospital has a duty to screen or stabilize. The second half is that the patient must request examination or treatment for a medical condition from the hospital. This request can be made by the patient or anyone on behalf of the patient such as EMS, police, family, etc. In this scenario, though, the patient is not requesting care back at your hospital, but is instead requesting care at the hospital that will receive the helicopter (either at the patient’s request or because medical control or the EMS crew believe the other hospital is the most appropriate place to take the patient.) Therefore, under this scenario, the hospital does not have an EMTALA duty to the patient.

Second, this situation is analogous to use of a hospital’s helipad, which CMS agrees does not come under the umbrage of EMTALA.16 Any patient in a non-hospital-owned ambulance that is on hospital property awaiting use of the hospital’s helipad for transport to an appropriate trauma center is deemed to have “come to the ED” because the patient is on hospital property (like the ambulance “hospital property” waiting for the helicopter in scenario 3). However, the hospital does not have a duty to screen or stabilize under EMTALA because the “request” is for use of the helipad, not for examination or treatment of a medical condition by the hospital.15,17 (Note that if the medics request help from the hospital’s ED, such as airway control, then EMTALA is triggered.)

Finally, echoing the ruling in the Beller case, if in this scenario the hospital-owned ambulance is operating under community-wide EMS protocols that direct transport of the patient to a different hospital, then the patient is not deemed to have “come to the hospital’s ED” and it does not have any EMTALA obligations under these circumstances.8 Consequently, the EMS crew would not have to contact the ED physician, obtain agreement that this is a medical emergency, document the contact as a screening exam, or have the ED arrange transfer as if in the ED.

In summary, whenever a hospital-owned ambulance is operating under established community-wide protocols, CMS does not consider the ambulance to be “operated by”the hospital, and, therefore, under its regulations, the ambulance has not “come to the ED,” so the hospital does not incur any EMTALA obligations.

References.

1. 42 CFR 489.24(b)(3).

2. 42 USC 1395dd(a)&(b) and 42 CFR 489.24(a) ... assuming the person (or someone on their behalf) is requesting examination or treatment for a medical condition.

3. Beller v. Health and Hospital Corp. of Marion County, Indiana d/b/a Wishard Memorial Hospital d/b/a Wishard Ambulance Service, No. 11-3691 (7th Cir. Dec. 20, 2012). Note that if a person in a hospital-owned ambulance has ‘come to the ED’ for purposes of EMTALA, then transporting the person to another hospital would indeed be a ‘transfer’ as defined by EMTALA - “the movement (including the discharge) of an individual outside a hospital’s facilities [in this case the hospital’s ambulance] at the direction of any person employed by or affiliated with the hospital.” 42 USC § 1395dd(e)(4). Also note, the ONLY way to stabilize a pregnant woman with contractions who has an emergency medical condition is to ‘deliver the baby and the placenta.’ 42 USC 1395dd(e)(3)(A).

4. 42 C.F.R. 489.24(b) (2000).

5. CMS Interpretive Guidelines 1998, pages V23-V24, Tag 407.

6. 42 CFR 489.24(b)(3)(i)&(ii) (2003). Effective date September 9, 2003.

7. Treadway v. Gateway Chevrolet Oldsmobile Inc., 362 F3d 971 (7th Cir. 2004) and Clay v. Johnson, 264 F3d 744 (7th Cir. 2001).

8. Bowen v. Georgetown University Hospital, 488 U.S. 204 (1988). (“Substantive legislation will not be given retroactive effect unless such be the unequivocal and inflexible import of the statutory terms, and the manifest intention of the legislature.”)

9. Pope v. Shalala, 998 F.2d 473, 483 (7th Cir. 1993), holding that a regulation “simply clarifying an unsettled or confusing area of the law ... does not change the law, but restates what the law according to the agency is and has always been”).

10. 68 Fed Reg 53,222 (September 9, 2003).

11. 68 Fed. Reg. 53222, 53224-53225 (September 9, 2003) (emphasis added). “Medicare Program; Clarifying Policies Related to the Responsibilities of Medicare-Participating Hospitals in Treating Individuals With Emergency Medical Conditions.”

12. This case is distinguishable from two other notable EMS EMTALA cases, Arrington v. Wong, 237 F.3d 1066 (9th Cir. 2001), and Morales v. Sociedad Espanola de Auxilio Mutuo y Beneficencia, 524 F.3d 54 (1st Cir. 2008), in which a federal court did impose EMTALA liability on the hospital. In Beller, the ambulance was owned by the hospital but operating under community-wide EMS protocols; in both Arrington and Morales, the ambulance was not hospital-owned, the ambulance was not being directed by EMS protocols, and the hospitals were not on diversion status at the time they rerouted the ambulances to other hospitals.

13. 42 CFR 489.24(b).

14. CMS State Operations Manual (SOM), Appendix V – Interpretive Guidelines – Responsibilities of Medicare Participating Hospitals in Emergency Cases – EMTALA, Revision 60, Effective July 16, 2010. Available at: http://www.cms.gov/manuals/downloads/som107ap_v_emerg.pdf

15. 42 USC 1395dd(a); 42 CFR 489.24(a).