On November 10, 2003 hospitals participating in the Medicare program saw an easing of the rules governing the implementation of the Emergency Medical Treatment and Labor Act (EMTALA). See 68 Fed. Reg. 53,221 (Sept. 9, 2003). The most significant changes concern those parts of the hospital subject to the EMTALA requirements. Also significant is the determination that EMTALA will not apply to inpatients; once an individual is admitted to the hospital for inpatient care, the hospital's EMTALA obligations cease. For the rest, the new rules are evolutionary rather than revolutionary, clarifications rather than marked departures from existing rules or guidance.

Clarification of "Comes to the Emergency Department"
Under EMTALA, an individual may "come to the emergency department" in one of two ways: either by presenting anywhere on hospital property requesting or requiring emergency medical treatment, or by presenting at a dedicated emergency department requesting examination or treatment for any medical condition. It is with regard to this second presentation that the new rules depart from earlier existing and proposed requirements. The new rules define a dedicated emergency department as a department or facility of the hospital, whether on or off the hospital campus, that meets at least one of the following requirements:

It is licensed as an emergency room or emergency department under applicable state law;
It is held out to the public as a place that provides care for emergency medical conditions on an urgent basis without requiring a previously scheduled appointment; or
During the immediately preceding calendar year, at least one-third of its outpatient visits were for the treatment of emergency medical conditions on an urgent basis without a previously scheduled appointment.

To be a dedicated emergency department, the facility need not meet the definition of a hospital "department" under the Medicare rules. Any facility held out as treating emergencies on an unscheduled basis will qualify. Thus dedicated emergency departments include not only traditional emergency rooms, but also labor and delivery departments and psychiatric units providing emergency ambulatory care on an unscheduled basis. Urgent care facilities will also meet the definition if one-third of their unscheduled patients are treated (not just evaluated) for emergency medical conditions.

The welcome news is that all clinical departments off the hospital campus need not provide EMTALA-compliant medical screening examinations, stabilizing treatment, and/or transfers. Further, even dedicated emergency departments need not be similarly equipped and staffed. If an off-campus dedicated emergency department lacks the resources to screen and stabilize a patient, that patient may be transported to the hospital's main emergency department for the required evaluation and treatment. Indeed, under the new rules, the off-campus dedicated emergency department may even transfer the patient to a non-affiliated hospital if the off-campus department is unable to stabilize the patient and if the benefits of such a transfer outweigh the risks.

Individuals Presenting to a Dedicated Emergency Department for Non-emergency Services
More good news can be found in the government's position that not all arrivals in a dedicated emergency department trigger EMTALA. If no medical treatment is requested or required, EMTALA will not apply. EMTALA will not apply, for example, to a woman presenting at the dedicated emergency department for a screening mammogram, even if an emergency develops shortly after the preventive health screening has begun. If the person presenting in the dedicated emergency department is unable to state the purpose of the visit, the prudent layperson standard will apply to determine whether medical treatment is being sought.

Even when a person does request or require medical treatment, an intensive medical evaluation may not be necessary to satisfy EMTALA. The new rules state that, in most cases where the request for medical care is unlikely to involve an emergency medical condition, the patient's statement denying any emergency, coupled with brief questioning by a qualified medical person, will be sufficient to establish the absence of an emergency and satisfy the hospital's screening obligation. Even the taking of vital signs is not required in every instance. The extent of the medical screening examination is explicitly recognized to be within the judgment and discretion of the qualified medical person performing it. Of course, if an emergency medical condition is later found to exist, the extent and the quality of the medical evaluation will be subject to review by government investigators.

Additional clarifications set forth in the preamble to the final regulations include the following:

Individuals passing through the emergency department but not requesting or appearing to require examination or treatment will fall outside EMTALA. Thus, after regular hours, hospitals should be able to admit patients directly to an inpatient floor, with registration performed in the emergency department.
If a physician sends his patient directly to the hospital's laboratory or radiology department for a test, EMTALA will not apply. (If the patient is sent to the hospital's dedicated emergency department for the same test, however, it would be prudent to provide a medical screening and any necessary stabilizing treatment.)
The government will evaluate, on a case-by-case basis, whether EMTALA applies to tests, like blood alcohol levels, that are requested by law enforcement authorities.
Individuals on psychotropic medication who arrive in the ER complaining of suicidal or homicidal urges and requiring medication to stabilize their condition may trigger EMTALA. CMS will address this issue of using emergency rooms for medication supplies in interpretive guidelines.
If a visitor, employee, or other person on the hospital campus for reasons other than treatment suddenly experiences an emergency medical condition, that person has "come to the emergency department" for purposes of EMTALA.
EMTALA does not require that an emergency department physician leave the ER to treat an individual on the hospital property but outside the dedicated emergency department. The hospital may decide whether its procedures require the immediate transport of such a patient to the dedicated emergency department, sending out a trauma crew, or both. The hospital may also determine that it is appropriate to send clinical staff other than physicians to the scene. In assessing whether the hospital responded appropriately to the emergency, CMS will look to the hospital's capabilities.

Prior Authorization
The new regulations incorporate much but not all of the OIG's earlier guidance on prior authorizations. A hospital may not seek prior authorization from an insurer before providing the medical screening that EMTALA requires. This prohibition against prior authorization applies equally to hospital services, physician services, and nonphysician practitioner services. Even administrative staff not involved in the patient's screening are prohibited from contacting the insurer for authorization while clinical staff are in the process of evaluating the patient's condition. Further, even if a hospital seeks prior authorization and the insurer denies the care, the hospital is obligated to provide the medical screening and any necessary stabilizing treatments. At the same time, the new rules make clear that, so long as the required screening and stabilization are not delayed, the hospital may seek authorization for all services concurrently with providing stabilizing treatment. In addition, all medical and hospital personnel may contact a patient's physician for information or advice relevant to the patient's medical history and needs. Here, the caveat is that the required screening and stabilization may not be inappropriately delayed.

EMTALA and On-call Requirements
The new EMTALA rules contain little that is new on on-call physician requirements. In essence, the new rules adopt earlier published CMS guidance, with the possible exception of preamble comments on the use of physician assistants. The preamble states that an on-call physician's decision on whether to respond in person or to direct a physician assistant to respond must be based on the individual patient's medical needs and the capabilities of the hospital, consistent with the state medical practice laws and the hospital's bylaw, rules and regulations. Thus, a physician assistant may be the appropriate first responder, but the on-call physician must make that decision on a case-by-case basis, based on the needs of the presenting patient. Standing orders will not meet the federal requirements.

As set forth in earlier guidance, a hospital must maintain its on-call list in the manner that best meets the needs of the hospital's patients who are receiving the services required under EMTALA, taking into account the hospital's capabilities, including the availability of on-call physicians. If a hospital offers a physician service to the public, CMS says that it is reasonable to expect that service to be available through on-call coverage; at the same time, CMS is not mandating such coverage because certain circumstances may place across-the-board coverage beyond the hospital's control. In determining whether the on-call requirements under the law have been met, CMS will consider all relevant factors, including the number of physicians on staff, the demands on these physicians, the frequency with which the hospital's patients typically require the services of on-call physicians, and the provisions the hospital has made for situations in which a physician in the specialty needed is not available or the on-call physician is unable to respond. CMS recommends that the hospital keep local EMS staff advised of those times when certain specialties will not be available at the hospital in order to avoid the transfer of inappropriate cases to the hospital. Referral agreements with other hospitals for coverage of needed specialty care are also advised.

Although CMS declines to place limits on how long patients may be held in emergency departments awaiting specialty care, the new rules state that CMS will take "appropriate action" if the level of on-call coverage is "unacceptably low." At the same time, provided the hospital has acted in good faith to ensure on-call coverage, CMS will not unfairly penalize the hospital if an individual physician fails to fulfill on-call obligations. Further, in the event the emergency department physician and the on-call specialist disagree on the best way to meet an individual patient's medical needs, the medical judgment of the emergency department physician or other practitioner who has personally examined the individual will control.

Inpatients and Patients in Hospital-owned Ambulances
A hospital's EMTALA obligations end once an individual is admitted to the hospital for inpatient care. Once admitted, the issues of stabilizing treatment and/or transfer are governed by the Medicare hospital Conditions of Participation (CoP), state law, and professional considerations, not by EMTALA requirements.

Generally, patients in hospital-owned ambulances are considered to be on hospital property, thereby triggering a hospital's EMTALA obligations to screen and stabilize. However, that rule will now not apply if the ambulance, operating under a community-wide EMS protocol or protocols mandated by state law, transports a patient to the closest appropriate facility and that facility is not the hospital that owns the ambulance. In addition, patients on board a hospital-owned ambulance will not trigger EMTALA obligations for the owner hospital if the physician providing the medical command and directing the ambulance to another facility is not employed or otherwise affiliated with the owner hospital. These exceptions for medical-directed transport, community-wide protocols, and protocols mandated by state law apply to air ambulances as well as ground ambulances. Finally, a patient may refuse transport from a planned pick-up site to the hospital that owns the ambulance. In this instance, the hospital is to treat the patient's refusal as a refusal to consent to treatment and document the matter accordingly.

The Conditions of Participation
A caution: What CMS gives with the new rules, it may well take back with the hospital CoPs. Where CMS finds certain matters to be outside EMTALA's purview, it notes that the Medicare hospital CoP will prevail. The hospital's compliance with the Medicare CoPs will be subject to state survey or review, and failure to comply will be punishable by termination of the hospital's participation in Medicare and Medicaid.

CMS highlights six CoPs in these final EMTALA rules as protections for patients when a particular matter is not subject to EMTALA. These are the CoPs affecting emergency services, the governing body, discharge planning, quality assessment and performance improvement, medical staff, and outpatient services. For example, Medicare CoPs on emergency services require hospitals to have written policies and procedures to deal with individuals who come to off-campus non-emergency facilities seeking care. CMS requires that these policies and procedures be operative during the hours when the off-campus facility is at normal staffing. Failure to follow these established protocols will be considered a violation of the CoPs, subjecting the hospital to the same threat of loss of Medicare certification as a violation of EMTALA does.

The CoP relating to discharge planning, in turn, requires that patient needs be identified and that transfers and referrals reflect adequate discharge planning. The medical staff and governing body CoPs hold the medical staff accountable to the governing body for any failure to provide care to an inpatient who develops an emergency medical condition. CMS also will look for effective hospital-wide quality assessment and performance improvement under the hospital CoPs. Finally, failure to appropriately treat or transfer an inpatient who later develops an emergency, CMS says, can be addressed under the hospital's quality assurance program.

The preamble to the new EMTALA rules states that the state agency will survey compliance with the CoPs using instructions provided in the State Operations Manual. Hospitals accredited by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) are deemed to meet the Medicare CoPs and are not routinely surveyed for compliance with the Conditions. Nonetheless, the preamble states, hospitals are required to be in compliance with the CoPs regardless of accreditation status. Apparently, evidence of accreditation will not suffice as evidence of compliance with the Medicare hospital CoPs.

Interesting times lie ahead with the enforcement of the new EMTALA rules and the reinvigorated enforcement of the Medicare hospital CoPs.