On May 13, 2004, CMS released revised Interpretive Guidelines relating to the Emergency Medical Treatment and Labor Act (EMTALA). The revised Guidelines were effective immediately upon issuance.

Although many of the additions to the revised Guidelines simply restate the 2003 EMTALA final rule, 68 Fed. Reg. 53,221 (Sept. 9, 2003), there are several interpretations and clarifications of that rule that hospitals may wish to reflect in their policies. In addition, on two matters - the time frame for reporting EMTALA violations and the definition of a "dedicated emergency department" (DED) - the revised Guidelines arguably go beyond existing EMTALA regulations.

72-hour Reporting Window
EMTALA mandates that recipient hospitals report improperly transferred individuals. No law or regulation, however, requires that report to be made to CMS or the State Survey Agency within 72 hours. Although 72-hour reporting was discussed in the preamble to the 1994 EMTALA regulations, 59 Fed. Reg. 32,086, 32,094 (June 22, 1994), the tight time frame was never incorporated into regulation. Notwithstanding that fact, the revised Interpretive Guidelines state "Notification should occur within 72 hours of the occurrence." Hopefully, given the absence of any legal mandate, surveyors will treat this inclusion as a desirable goal and not as grounds for an EMTALA violation. A hospital may well need more than 72 hours to review the facts and circumstances and determine that it must report another hospital for patient dumping.

The One-third Requirement
Equally troublesome is the approach adopted by the revised Guidelines for determining when a hospital department is a DED based on unscheduled visits in the preceding year that involve the treatment of an Emergency Medical Condition (EMC). The revised Guidelines instruct surveyors to pull a sample of 20 to 50 patient records, focusing on those where the diagnosis or presenting complaint is likely to be associated with an EMC. If a third of this biased sample consists of cases where a patient with an EMC was treated on an urgent basis and without prior appointment, the hospital department is to be considered a DED. This interpretation departs sharply from the 2003 EMTALA rule on DEDs. The federal regulation says only if one-third of all cases treated by a hospital department in the preceding year involve the treatment of EMCs on unscheduled patients is the department a DED. The cost and consequences to hospitals of CMS's distortion of the federal definition are likely to be significant.

On-call Clarifications
Hospitals and physicians alike were hoping the revised Guidelines would provide clear guidance regarding on-call responsibilities. In fact, the revised Interpretive Guidelines clarify somewhat but not enough of what appears in the 2003 final rule. The new clarifications include the following:

Physicians can meet their on-call responsibilities using telemedicine only when the patient's geographic location makes it impossible for the on-call physician to physically assess the patient. This may be the case, the Guidelines state, for a patient presenting at a hospital in a rural health professionals shortage area or in a county outside of a metropolitan statistical area.
Physicians who take call for patients of their medical practice or a colleague's practice but refuse to be included on the hospital's on-call list may violate EMTALA. A hospital that permits such selective call would violate EMTALA.
Hospital policies must include the response time - in minutes - within which the on-call physician must arrive at the hospital to provide emergency screening or treatment. The use of terms such as "reasonable" or "prompt" to describe required response time, says CMS, is unenforceable and therefore inappropriate.
While on call, a physician may see patients in his private office, but the DED may not send an emergency patient to the on-call physician's office for examination and treatment unless that office is on the hospital campus and part of a hospital-owned facility with the same Medicare provider number as the hospital. Even in that event, there must be a bona fide medical reason to move the patient, appropriate medical personnel must accompany the patient, and all persons with the same medical condition must be similarly moved.

The "Stable" Patient
The old Interpretive Guidelines distinguished between "stable for transfer" and "stable for discharge." The revised Interpretive Guidelines do not. Under the revised Guidelines, a patient is stable when his EMC has been resolved. Thereafter, depending on the patient's condition, the physician may discharge the patient home, admit him to the hospital, or transfer him to another health care facility.

If a question is raised about the stability of a patient on transfer, the burden of proof lies with the transferring hospital. For patients with an emergency medical condition, the transferring facility must be able to show that, at the time of transfer, it was a reasonable medical probability that the patient's condition would not materially deteriorate during transfer or as a result of transfer. For the psychiatric patient, the transferring facility must ensure that the patient is protected and prevented from injuring or harming himself or others. Thus, the administration of chemical or physical restraints appears to be explicitly sanctioned for purposes of transferring a patient with an emergency psychiatric condition from one facility to another. When in doubt about the stable condition of an individual's EMC, however, the hospital is advised to implement an "appropriate transfer" as that term is defined in the EMTALA law and regulations.

Finally, an "appropriate transfer" appears always to be required for a woman in labor. A woman in labor is considered stabilized only when she has delivered the child and the placenta. A pregnant women may be transferred, the revised Guidelines note, only if she requests the transfer and if a physician has certified that the benefits to the women and/or unborn child outweigh the risks associated with the transfer. In the old Guidelines, that "and" was an "or."

Receiving Hospital Obligations
In addition to the 72-hour limit for reporting a suspect transfer, the revised Interpretive Guidelines provide several important clarifications for recipient hospitals. First, just as the referring facility must provide the services required by EMTALA without regard for an individual's insurance status or an insurer's prior authorization, so, too, must the recipient hospital. The recipient hospital will violate EMTALA if it delays accepting the transfer of a patient with an EMC until it has verified financial information.

If a patient with an EMC is moved to another hospital for diagnostic tests, an "appropriate transfer" within the meaning of EMTALA must be effectuated by the transferring facility. Once the tests are completed, however, and the recipient hospital is transferring the patient back, an appropriate EMTALA transfer is not necessary. The revised Interpretive Guidelines do note, however, that "it is reasonable" for the transferring hospital to expect the recipient hospital to communicate its medical findings to the transferring hospital and provide a status report on the patient both during and after the procedure.

Additional Clarifications
Additional isolated clarifications can be found throughout the revised Guidelines:

Treatment delays in the DED may lead to a survey of the hospital's compliance with the Medicare Conditions of Participation. The Interpretive Guidelines specifically state that if a DED lacks adequate staff and equipment to meet the needs of patients, its compliance with the Emergency Services Conditions of Participation should be assessed.
For individuals with psychiatric symptoms, the medical record should show an assessment of suicide or homicide attempt or risk, orientation, or assaultive behavior that indicates danger to self or others.
Surveys are to examine ambulance trip reports for evidence of patient stability and appropriateness of transfer.
Immediate jeopardy to patient health and safety - a CMS determination that justifies a fast-track termination of Medicare participation - will be found if the situation at the hospital prevents an individual from receiving a medical screening examination or treatment that reflects the capacity and capability of the hospital. Noncompliance that does not pose immediate jeopardy will be found only when EMTALA violations are essentially technical violations - for example, when a physician certification is unsigned, a central log has one incomplete day, or a written hospital policy is implemented but missing.
A minor child can request examination or treatment for an EMC. Hospital staff may wait for parental consent only after a screening determines that no EMC is present.
If an ambulance is owned by a hospital, it may be diverted away from the owner-hospital only if the diversion occurs pursuant to community-wide EMS protocols.
The hospital with a helipad on its property that is being used solely for the purpose of transit does not have an EMTALA obligation to provide medical screening and treatment so long as the sending hospital has conducted a medical screening examination prior to transporting the patient to the helipad. (How the helipad hospital is to know what has occurred at the sending hospital is not discussed.) The hospital with the helipad will, however, be obligated to provide a medical screening and stabilizing treatment if the patient's condition deteriorates while at the helipad or EMS personnel, the patient or an individual acting on the patient's behalf requests a screening and treatment for an EMC.
State and local laws requiring certain patients (such as psychiatric or indigent individuals) to be evaluated and treated at designated facilities do not trump EMTALA obligations. DEDs must provide a medical screening and stabilizing treatment for all patients who present or, when indicated, an "appropriate transfer" prior to referring the patient to the state-designated facility.
A hospital will violate EMTALA if it is operating beyond its capacity and does not attempt to transfer appropriately an individual identified on screening as having an EMC.
EMTALA does not apply to individuals presenting at a DED for non-emergency tests, preventive services (such as immunization, allergy shots) or the gathering of evidence for criminal law cases (such as sexual assault or blood alcohol tests). If law enforcement personnel request a "clearance for incarceration," the hospital has an EMTALA obligation to screen and treat.
If a patient requests medication, tread carefully. If the medication is needed to resolve or provide stabilizing treatment of an EMC, the hospital has an EMTALA obligation to screen and provide stabilizing treatment.
Hospital policy should delineate clearly which practitioners are responsible for writing admission orders. This is because the admission of a patient to the hospital in good faith - whether or not the patient's EMC has been stabilized - puts an end to the hospital's EMTALA obligation.
Certifications of the risks and benefits of transfer may not be backdated.
The Boards of hospitals without DEDs must assure that their medical staff has written emergency treatment and referral policies and procedures.

In brief, the revised Interpretive Guidelines provide insight into how CMS will determine compliance with EMTALA in a number of areas. Those looking for bright line guidance in key areas such on-call coverage and the definition of stability, however, are likely to be disappointed.