|Lawrence Vernaglia is a partner in the Health Law Practice Group of Hinckley, Allen & Snyder LLP, a regional law firm with offices in Boston, Providence and Concord, N.H.
|Rebecca Hulse is an associate in the Corporate and Health Law Practice Group of Hinckley, Allen & Snyder LLP, a regional law firm with offices in Boston, Providence and Concord, N.H.
Since 1986, hospitals - and courts - have struggled to understand the limits of the Emergency Medical Treatment and Active Labor Act ("EMTALA") (S.S.A. ß 1867, 42 U.S.C. ß 1395dd), commonly known as the patient anti-dumping law, and its companion regulations enforced by the Centers for Medicare & Medicaid Services ("CMS"). In May 2002, CMS published a set of proposed regulations to address a growing list of concerns. On Sept. 9, 2003, CMS published a Final Rule implementing much of what was promised in the 2002 draft.1 The result is that as of Nov. 10, 2003, a number of significant changes and clarifications will make hospitals' compliance with EMTALA more logical and consistent with the realities of modern hospital operations.
The most significant changes in the new rules are to:
• Clarify what is and is not an "emergency department" for purposes of EMTALA;
• Further distinguish the range of EMTALA obligations that apply in emergency departments versus other areas of the hospital campus;
• Limit the applicability of EMTALA obligations for off-campus hospital departments and at all provider-based "entities";
• Lay out prior authorization rules to inform hospitals what they may and may not discuss with individuals prior to medical screening examinations;
• Clarify the required screening procedures for non-emergent patients;
• Remove EMTALA obligations from the care of inpatients; and
• Clarify on call obligations under EMTALA.
The following discussion elaborates on these highlights to assist providers in adhering to the changes.
'Comes to the emergency department'
Perhaps the most significant modification of current EMTALA regulations is a change in the interpretation of what it means for an individual to "come to an emergency department." It is the event of coming to an emergency department that triggers a hospital's obligation under EMTALA according to the statute on which the regulations are based.2 The regulations currently in effect interpret the phrase quite broadly, warning that for the purposes of the statute, coming to the emergency department means appearing anywhere on hospital property, defined as anywhere on the hospital campus, including parking lots, sidewalks and driveways, and at any facility located off the main campus but considered a department of the hospital. 42 CFR ß 489.24(b); 42 CFR ß 413.65. As can be expected from such an expansive read, some believe this interpretation exceeds congressional intent.
Acknowledging these concerns, the new regulations considerably narrow the scope of "coming to the emergency department" in several ways. First, the new rules distinguish the EMTALA standard applied to individuals who come to a "designated emergency department" (a "DED"), discussed below, versus those who present elsewhere on hospital property. Those who seek treatment at a DED - for any medical condition, emergency or otherwise - immediately receive EMTALA's protections (e.g., the right to a medical screening exam and, if needed, stabilizing treatment). The regulations impose on DEDs the burden of providing EMTALA screenings even to those individuals who do not request treatment, but who, to a prudent layperson, would appear in need of emergency services. Providers should note that this requirement theoretically places a high burden on DED staff to be cognizant of the medical conditions of all those present in a DED - not just patients who sit at the triage desk. If an individual is in a DED and does not make a request for treatment nor is one made on his or her behalf, the hospital may still have obligations under EMTALA if it could be deduced through the individual's appearance or behavior that examination or treatment would, in the judgment of a prudent layperson, be needed.
Those who present in areas outside a DED, on the other hand, must be seeking emergency treatment (or a prudent layperson must be able to deduct the individual is seeking emergency treatment) for EMTALA obligations take hold. The examples used by CMS to illustrate this point are instructive:
EMTALA is not triggered by a request for physical therapy (that is, for a medical condition) at the hospital's on-campus physical therapy department. However, EMTALA would be triggered by that same request inside a hospital's dedicated emergency department, since the statute clearly states that requests for examination or treatment of "medical conditions" at emergency departments trigger EMTALA. By the same token, request for treatment of a gunshot wound at the on-campus radiology department would also trigger EMTALA, since a gunshot wound is clearly an "emergency medical condition." 68 Fed. Reg. 53243.
Note from these examples that the non-DED rule is intended to apply to individuals who come to a non-emergency department seeking access to emergency care. It is not intended to apply to individuals seeking regular outpatient services who experience an emergency while doing so. In such circumstances, the individual does not satisfy the EMTALA condition of having "come to an emergency department" as he or she has already begun an encounter with a health professional at the outpatient department. 68 Fed. Reg. 53238. Any such patient would still be entitled to the protections of state licensing laws, the federal hospital conditions of participation ("CoPs"); as well as traditional malpractice tort law, but would not be able to add EMTALA to this list.
Second, the new regulations modify the definition of hospital property. Hospital property is now defined as the entire hospital campus, but excludes several areas that were not expressly excluded in prior regulatory iterations. 68 Fed. Reg. 53263. If an individual presents with an emergency condition at any of the following locations, EMTALA is not implicated: "areas or structures of the hospital's main building that are not part of the hospital, such as physician offices, rural health clinics, skilled nursing facilities, or other entities that participate separately in Medicare, or restaurants, shops, or other non-medical facilities." 42 CFR ß 489.24(b). These exclusions, according to the Final Rule's preamble, are expressly intended to clarify, among other things, that on-campus provider based "entities," like rural health clinics, as opposed to provider-based hospital departments, are not subject to EMTALA. 68 Fed. Reg. 53250.
What is a dedicated emergency department?
A dedicated emergency department is one that is:
(1) Licensed by the state as an emergency department;
(2) Held out to the public as providing care for emergency medical conditions on an urgent, non-appointment basis; or
(3) If in the prior calendar year, the site served at least one-third of its patients for emergency conditions on an urgent basis without an appointment.
Sites meeting these requirements (whether held out as "urgent care centers" or by any other name) will be subject to all EMTALA obligations, including maintaining an emergency log and on-call requirements. Individuals who present at such locations requesting treatment for a medical condition, or on whose behalf a request is made, must be screened under EMTALA and, if an emergency medical condition exists, provided necessary stabilizing treatment.
Hospitals should be careful to recognize that the "dedicated emergency department" may include areas of the hospital other than the main emergency room. These rules include departments providing psychiatric or labor and delivery services, so long as they meet one of the three criteria above. Hospitals with departments on the fringe of the new DED definition - such as orthopedic or even radiology departments depending on their volume of emergency traffic - may want to consider how they are administered to ensure that those who cannot practicably meet the stringent EMTALA standards for DEDs do not fall within one of the three tests set forth above.
Application to provider-based facilities
DEDs may be either on the hospital's main campus or off-campus. Under the existing regulations, all off-campus provider-based hospital departments must comply with EMTALA. 42 CFR ß 413.65(g)(1). In the context of large multi-specialty departments, and dedicated urgent or emergency care centers, where the staff likely is trained to handle emergency cases, this application poses few unusual burdens. However, for other departments designed around primary care or specialty/ancillary models, EMTALA and its obligations are quite foreign.
Under CMS's revised regulations, EMTALA applies to off-campus sites only if the site contains a "dedicated emergency department." Thus, unlike for on-campus provider-based departments, a patient cannot "come to the emergency department" by presenting at a provider-based facility that is not a DED. Provider-based departments that do not meet the DED tests are not subject to EMTALA, though hospitals must have appropriate protocols in place to deal with persons seeking emergency care. 42 CFR ß 482.12(f)(2). Thus, it would be appropriate for staff to call EMS if they cannot treat the patient, and furnish whatever assistance they can to the individual while waiting.
Most provider-based sites held out as urgent care centers will remain subject to EMTALA.3 However, a number of other sites may well be washed into EMTALA under the "objective" tests established by CMS. For example, many walk-in or drop-in centers, or primary care clinics where patients may come as an initial reaction to what later is found to be an emergency, could fall within the one-third test described above. Hospitals operating such centers should promptly assess their prior year's cases at the sites to determine whether the one-third test is met.
Special operations issues for off-campus sites under EMTALA
Many off-campus sites are single-specialty operations (like OB/GYN departments), and are not well suited to treating the emergency conditions covered by EMTALA. For such locations, CMS clarified that the same DED at which the patient presents need not be the site of the ultimate treatment and stabilization services. Thus, if a patient presents at such a site, the patient may be transported to the main hospital's DED without a violation of the regulations. In another important acknowledgement, though not a technical change to the regulation, CMS confirmed that satellite facilities subject to EMTALA may transfer patients with emergency conditions to the nearest hospital, even if it is not the satellite's main provider, if a lengthy ambulance ride to the affiliated hospital presents an unacceptable risk. 68 Fed. Reg. 53231. Of course, the satellite should not have a policy of referring all EMTALA cases to the unrelated provider. It is also worthy of note that such urgent care centers (and any other DED for that matter) may choose to open and staff emergency departments on less than a 24-hour, seven-day week basis if local shortages of emergency care or limited demand for emergency care so warrant. 68 Fed. Reg. 53231.
A final clarification of "comes to the emergency department" provided by the new rules is to again reassess CMS's position on the question of EMTALA obligations for hospital-owned ambulances. As in the past, an individual is considered to have come to the emergency department if the individual is in an ambulance owned and operated by a hospital, even if the ambulance is not on hospital property. 42 CFR ß 489.24(b). However, the regulations now clearly exempt ambulances operating under communitywide EMS protocols requiring the ambulance to transport the individual to a hospital other than the hospital that owns the ambulance. In addition, CMS makes clear that the new rules apply equally to ground and air ambulances.
No EMTALA liability relating to inpatients
A notable position staked-out by CMS is that EMTALA does not apply to the care of inpatients, affirming court rulings in cases such as Bryant v. Adventist Health System/West, 289 F.3d 1162 (9th Cir. 2002). This issue took on a life of its own with the First Circuit decision in Lopez-Soto v. Hawakek, 175 F.3d 170 (1st Cir. 1999) - a case that proves what kind of law is made from tough facts. Lopez-Soto held that a child born to a mother admitted as an inpatient qualified for EMTALA's protections. Given the potential conflict between Lopez-Soto and the newly issued regulations, it is far from clear how providers in the First Circuit (Massachusetts, Maine, New Hampshire, Rhode Island and Puerto Rico) should proceed on this question. While CMS notes that it is not bound by judicial precedent to which CMS is not a party, it is unclear whether providers in these states are obligated to follow the First Circuit Court of Appeals interpretation of congressional intent or that of CMS. While agencies are entitled to great deference in their interpretation of the statutes they are charged to enforce, a private plaintiff with a similarly hard case might persuade a court that the Lopez-Soto holding should control under the private right of action. Under the Final Rule, CMS expressly states that inpatients are not covered by EMTALA. See 42 CFR ß 489.24(d)(2). We believe that future courts should read EMTALA in harmony with the EMTALA regulations that hospitals are required to follow.
Prior authorization and other communications with insurers
A central goal under EMTALA has been to prevent the undue delay of emergency care while hospitals investigate the individual's coverage. Current EMTALA rules, in particular 42 CFR ß 489.24(c)(3), have been interpreted flatly to prohibit hospitals from seeking not only prior authorization, but also any other information from payors until a patient has been screened and, if needed, stabilized. Responding to concerns that EMTALA needlessly prevents hospitals from seeking relevant information from insurers and others, the new rules clarify that, while hospitals still may not seek prior authorizations, hospitals may seek other information ("apart from payment information") from insurers about individuals, so long as the inquiry (1) is performed by a staff member who is well-trained and knowledgeable, and (2) does not delay screening or treatment or unduly discourage individuals from remaining for further evaluation. 68 Fed. Reg. 53227.
Another important area where CMS has signaled flexibility is in the nature of EMTALA screening obligations. Under earlier interpretations, once EMTALA obligations triggered, providers were responsible for performing screening and treatment services, with little regulatory recognition of the various nuances of patients' needs and department capabilities. The new regulations state expressly that not all EMTALA screenings must be equal: "a hospital is required only to perform such screening as would be appropriate for any individual presenting in that manner, to determine that the individual does not have an emergency medical condition." 42 CFR ß 489.24(b). "In most cases in which a request is made for medical care that clearly is unlikely to involve an emergency medical condition" explains CMS in its preamble, "an individual's statement that he or she is not seeking emergency care, together with brief questioning by qualified medical personnel, would be sufficient to establish that there is no emergency condition and that the hospital's EMTALA obligation would thereby be satisfied." 68 Fed. Reg. 53234.
On-call duties required by EMTALA have been one of the most contentious of those raised by the statute. Hospitals must maintain a list of physicians on-call to provide treatment necessary to stabilize individuals with emergency medical conditions. 42 USC ß 1395cc(a)(1)(I)(iii). Failure or refusal to respond within a reasonable period of time results in a punishable EMTALA violation. The new regulations attempt to give hospitals and physicians greater flexibility in setting on-call policies. The new rules require that each hospital maintain an on-call list "in a manner that best meets the needs of the hospital's patients who are receiving services required [by EMTALA] in accordance with the resources available to the hospital, including the availability of on-call physicians." 42 CFR ß 489.24(j)(1). CMS requires that written policies are in place to govern situations where particular specialties are not available or the on-call physician cannot respond due to circumstances beyond his or her control. CMS expressly declined to mandate that hospitals maintain referral agreements with other hospitals to facilitate coverage and/or transfers, though the preamble strongly recommends doing so.
A second clarification regarding on-call requirements is to specify that hospitals may elect to permit on-call physicians to schedule elective surgery when on call, and to permit on-call physicians to have simultaneous on-call duties. When hospitals do so elect, however, hospitals are reminded that written policies must be in place to ensure that, despite such election, emergency services remain available to meet the needs of patients with emergency medical conditions. 42 CFR ß 489.24(j)(2)(ii). This is consistent with prior guidance by the agency in this regard.
It is important to remember that none of these changes fundamentally alters the protections afforded to hospital patients. Emergency room patients will still be protected not only by EMTALA, but also by myriad other common law, state statutory and regulatory and Medicare requirements. However, these changes offer some needed relief to hospitals struggling to implement EMTALA policies that are both compliant with the rule, and functional in the real world.
1. See 68 Fed. Reg. 53222 - 53264.
2. See 42 USC ß 1395dd(a) ("In the case of a hospital that has a hospital emergency department, if any individual (whether or not eligible for benefits under this subchapter) comes to the emergency department and a request is made on the individual's behalf for examination or treatment for a medical condition, the hospital must provide for an appropriate medical screening examination within the capability of the hospital's emergency department…) (emphasis added).
3. See 68 Fed. Reg. 53230