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Clarification of “Comes to the Emergency Department”
(§489.24(a) and (b))
Set forth is the text of the commentary to the final EMTALA regulations as published in the
September 9, 2003 Federal Register clarifying "comes to the emergency department". The final regulations can be viewed
here and are
effective November 10, 2003.
A. Background
Section 1867(a) of the Act and our existing regulations at §489.24(a) provide, in part, that if any individual
comes to the emergency department of a hospital and a request is made on that individual’s behalf for examination or
treatment of a medical condition, the
hospital must provide an appropriate medical screening examination within the capability of the hospital’s emergency department. Section 1867(b) of the Act and our existing regulations at §489.24(c) provide, in part, that if the hospital determines that such an individual has an emergency medical condition, the hospital is further obligated to provide either necessary stabilizing treatment or an appropriate transfer. Occasionally, questions have arisen as to whether these EMTALA requirements apply to situations in which an individual comes to a hospital, but does not present to the hospital’s emergency department.
B. Provisions of the Proposed Rule
In the May 9, 2002 proposed rule (67 FR 31472), we proposed to consolidate the
EMTALA requirements for screening (currently in §489.24(a)) and for
stabilization or appropriate transfer (currently in §489.24(c)) into a
single revised paragraph (a). This consolidation was not intended to change
the substance of the requirements, but only to set forth more concisely,
in a single opening paragraph, the essential requirements of EMTALA.
In proposed paragraph (b), we proposed to clarify the criteria for determining
under what conditions a hospital is obligated by EMTALA to screen and, if necessary,
stabilize or transfer an individual who comes to a hospital, presenting either at
its dedicated emergency department, as we proposed to define, or elsewhere on hospital property, and requests examination or treatment, or has such a request made on his or her behalf.
In developing the proposed criteria, we recognized that sometimes individuals come to hospitals seeking examination or treatment for medical conditions that could be emergency medical conditions, but present for examination or treatment at areas of the hospital other than the emergency department. In recognition of this possibility, and for other reasons explained in the preamble to the proposed rule (including the need to assure that an individual is not denied services simply because he or she failed to actually enter the hospital’s designated emergency department), we proposed to clarify under proposed §489.24(b) that an individual can “come to the emergency department,” creating an EMTALA obligation on the part of the hospital, in one of two ways: The individual
can present at a hospital’s dedicated emergency department (as we proposed to define that term) and request examination or treatment for a medical condition; or the individual can present elsewhere on hospital property in an attempt to gain access to the hospital for emergency care (that is, at a location that is on hospital property but is not part of a dedicated emergency department), and request examination or treatment for what they believe to be an emergency medical condition.
Because of the need to clarify the applicability of EMTALA to a particular individual depending on where he or she presents on hospital property in order to obtain emergency care, we proposed to define “dedicated emergency department.” We proposed that “dedicated emergency department” would mean a specially equipped and staffed area of the hospital that is used a significant portion of the time for the initial evaluation and treatment of outpatients for emergency medical conditions, as defined in §489.24(b), and is either located: (1) on the main hospital campus; or (2) off the main hospital campus and is treated by Medicare under §413.65(b) as a department of the hospital.
The EMTALA statute was intended to apply to individuals presenting to a hospital for emergency care services. Accordingly, we believe it is irrelevant whether the dedicated emergency department is located on or off the hospital main campus, as long as the individual is presenting to “a hospital” for those services. Therefore, we proposed in our definition of “dedicated emergency department” that such a department may be located on the main hospital campus, or it may be a department of the hospital located off the main campus. (We note that the proposed definition would encompass not only what is generally thought of as a hospital’s “emergency room” but would also include other departments of hospitals, such as labor and delivery departments and psychiatric units of hospitals, if these departments provide emergency psychiatric or labor and delivery services, or both, or other departments that are held out to the public as an appropriate place to come for medical services on an urgent, nonappointment basis.)
In the May 9, 2002 proposed rule, we solicited public comments on whether this proposed definition should more explicitly define what is a “dedicated emergency department” (67 FR 31472). Specifically, we sought comments on whether a “significant portion of time” should be defined more objectively; for example, in terms of some minimum number or minimum percent of patients (20, 30, 40 percent or more of all patients seen) presenting for emergency care at a particular area of the hospital in order for it to qualify as a dedicated emergency department. As an alternative, we proposed considering a qualifying criterion that is based on determining whether the facility is used “regularly” for the evaluation or treatment of emergency medical conditions, and how we could define “regularly.” We further sought comments from hospitals, physicians, and others on how hospitals currently organize themselves to react to situations in which individuals come to a hospital requesting a screening examination or medical treatment, or both.
C. Summary of Public Comments and Departmental Responses
1. General Support
Comment: Many commenters supported our proposed revised definition of “dedicated emergency department.” The commenters believed the proposed revised definition is clear and did not need to be further revised.
Response: We appreciate the support of the commenters and have taken their views into account in considering the comments of those respondents who recommended revisions.
2. Objective Test of “Significant Portion of the Time”
Comment: Some commenters believed that an objective test (such as a percentage of emergency patients seen or treated for emergency medical conditions) to determine
dedicated emergency department status would reduce confusion in the provider industry. Several other commenters stated that while a finite, objective test, such as a standard of 20, 30, 40 percent of more of all patients seen, would be desirable because of the certainty and consistency it would provide in determining a “significant portion of the time” for purposes of “dedicated emergency department” determination, the commenters believed the percentages cited by us are too low.
One commenter asked us to clarify what is meant by patients who “seek emergency care” in our discussion of whether "significant portion of the time" should be defined more objectively. For instance, the commenter stated the view that while many patients present for immediate care of nonemergency problems (and these patients must be screened for an emergency under EMTALA regulations), they should not be counted in determining whether a department is considered a dedicated emergency department.
Response: After consideration of these comments and the following related comments in this section VII.C. of this preamble, we believe that providing an objective criterion as part of the definition of "dedicated emergency department" for purposes of EMTALA will provide predictability and consistency to the health care industry, as the commenters suggest. Therefore, as one part of the definition of "dedicated emergency department," as
described in more detail below, we are specifying in this final rule that a department or facility that does not otherwise qualify as a “dedicated emergency department” based on State licensure or the way it is held out to the public will nevertheless be considered to be a dedicated emergency department if, during the calendar year immediately preceding the calendar year in which a determination is being made, based on a representative sample of patient visits that occurred during that calendar year, the department or facility provided at least one third of all its outpatient visits for the treatment of emergency medical conditions on an urgent basis without requiring a previously scheduled appointment. We adopted this definition because we believe it adds the element of
objectivity requested by many commenters and thus enables hospitals to know in advance whether they will be subject to EMTALA. We included a reference to a "representative
sample" of visits for two reasons. First, we believe any determination under this definition must be based on information that accurately represents the type and mix of
services delivered by the department or facility over a period of time, not merely during certain parts of the year. However, we also recognize that the large number of visits provided by some departments or facilities will make it a practical necessity to sampling techniques to obtain information on the type of care furnished instead of attempting to review all records of all visits by all patients during a year. Therefore, we intend to issue
instructions, through interpretative guidelines, to our
surveyors on how to determine such a representative sample. In addition, we may develop a series of questions and answers for posting on our website that will provide
further clarification and guidance to providers.
In response to the comment regarding visits for the care of nonemergency problems, we agree that such visits should not normally be counted as being for the treatment of emergency medical conditions. However, as discussed in section VIII. of this preamble, individuals who suffer an unexpected emergency medical condition after they arrive at the hospital for an outpatient visit but before they begin an outpatient encounter and individuals whose appearance or behavior would cause a prudent layperson observer to believe they need examination or treatment for an emergency medical condition would be counted toward the "one-third" standard.
Comment: One commenter recommended that we use the term "regularly" instead of “a significant portion of the time” in the definition of dedicated emergency department.
The commenter opposed the use of additional qualifying
criteria (percentages) to determine whether a facility is
used “regularly” for the evaluation and treatment of
emergency medical conditions and believed that hospitals
should have maximum flexibility to determine which part of
their facility is appropriate for the delivery of emergency
care.
Response: As explained in the response to the
previous comment, we believe that an objective criterion
relating to the percentage of visits for the treatment of emergency medical conditions, such as the one we are
including in this final rule for purposes of EMTALA,
provides needed predictability for those who are
determining dedicated emergency department status. In
addition, we believe this objective criterion in the
definition of dedicated emergency department, along with
the other two criteria in the definition in this final
rule, provides the most flexibility for determining
dedicated emergency department status, as the commenter
suggested.
Comment: One commenter suggested that we not include
an objective standard of “significant portion of the time” for the determination of a hospital’s “dedicated emergency
department.” The commenter believed that an objective
standard for “significant” may have the unintended effect
of creating a benchmark that some providers might use to
avoid their EMTALA obligations. For example, the commenter
stated, if the standard for “significant portion of the
time” is set at 30 percent, a hospital’s labor and delivery
department may determine that its staff spend only 15 percent of their time evaluating and treating outpatients
who meet the regulatory definition of emergency medical
condition. The commenter stated that if the majority of
the staff’s time is spent caring for inpatients in active
labor, such a hospital may then decide that its labor and
delivery department no longer has to provide an emergency
medical screening examination to all women who present with
contractions, since the department does not meet the
objective criteria of being used a significant portion of
the time for the initial evaluation and treatment for
emergency medical conditions.
Another commenter did not support the percentage-based
definition of dedicated emergency department proposed
because the commenter believed “it potentially could result
in a patient having or not having EMTALA protections based
on a fraction of a percentage point and dependent on the
accounting method chosen to determine volume.” Also, the
commenter believed that volumes fluctuate by days, weeks,
and months, among other things. The commenter stated that
fluctuating volume could potentially cause an area or
department to move in and out of EMTALA coverage as the
volume fluctuates.
Response: We agree with the commenters that using
objective criteria in the determination of a hospital’s
dedicated emergency department may lead to some cases in
which the standard is exceeded or not met by a narrow
margin. However, this result is an unavoidable consequence
of any objective standard. By assessing a facility’s
performance over a calendar year, we believe that the
effects of seasonal or other variations in utilization will
be mitigated.
In response to the comment concerning labor and
delivery departments, we would like to clarify that CMS
believes that EMTALA requires that a hospital’s dedicated
emergency department would not only encompass what is
generally thought of as a hospital’s "emergency room," but
would also include other departments of hospitals, such as
labor and delivery departments and psychiatric units of
hospitals, that provide emergency or labor and delivery
services, or both, to individuals who may present as
unscheduled ambulatory patients but are routinely admitted
to be evaluated and treated. Because labor is a condition
defined by statute as one in which EMTALA protections are
afforded, any area of the hospital that offers such medical
services to treat individuals in labor to at least one-third of the ambulatory
individuals who present to the area
for care, even if the hospital’s practice is to admit such
individuals as inpatients rather than treating them on an
outpatient basis, would be considered a dedicated emergency
department under our revised definition in this final rule.
In such cases, whether the department of the hospital
chooses to directly admit the emergency patient upon
presentment is irrelevant to the determination of whether
the department is a dedicated emergency department.
3. Nature of Care
Comment: Some commenters believed that the amount of
time a facility is used for emergency screening and
treatment is not relevant, and that it is the “nature of
the care provided” that distinguishes it as a dedicated
emergency department.
Response: We appreciate the comment concerning the
“nature of the care provided” as determinative of meeting
the definition of “dedicated emergency department” rather
than the amount of time a facility is used for emergency
screening and treatment. However, if we used the suggested
language of “nature of the care provided” as the standard
for determining “dedicated emergency department” status, we
believe that treatment for one emergency case by one
hospital clinic would meet the suggested standard. We
believe that the suggested standard is too general in its
reach and would encompass too many departments of
hospitals. Therefore, we are not adopting the commenters’
proposed language.
4. State Law Criterion
Comment: Several commenters suggested that “dedicated
emergency department” status should be determined by State
law in the State in which the hospital is located. Another
commenter suggested that we define “dedicated emergency
department” as any facility licensed by the State in which
it is situated as an emergency department. The commenter
stated that this would avoid the confusion as to whether
urgent care or walk-in clinics do or do not devote a
"significant portion of time" to the provision of emergency
services.
Response: As explained under section VII.D. of this
preamble, based on consideration of all of the comments
received, in this final rule we are revising the proposed
definition of “dedicated emergency department" to state
that a facility licensed by the State as an emergency
department will be recognized as such under Federal EMTALA
rules. However, because of the variations in State
licensure laws, we do not agree that only facilities that
are licensed as emergency departments by the State should
be considered dedicated emergency departments for purposes
of EMTALA, and have therefore included other criteria for
dedicated emergency department status, as specified in this
final rule.
5. Held Out to the Public Standard
Comment: Many commenters agreed with statements in
the preamble of the proposed rule to the effect that a
“held out to the public standard” is appropriate for
determining “dedicated emergency department” status. One
commenter specifically suggested that a “dedicated
emergency department” should be defined as “the department
of a hospital that is held out to the public as the
appropriate place to go for the examination and treatment
of emergency medical conditions as defined in this
section.”
Similarly, another commenter stated that a “24/7” rule
with routine emergency care may be more appropriate to
designating a “dedicated emergency department” rather than
our proposal of tracking patients and developing some
minimum percentage of emergency patients. The commenter
stated that if the area is not open and staffed on a
continuous basis, and it is not held out to the public as
such, then it should not be considered a dedicated
emergency department.
Response: As explained in section VI.D. of this
preamble, we are revising the proposed definition of
“dedicated emergency department” in several areas. In the
revised definition of dedicated emergency department that
we are adopting in this final rule, we state that a
department or facility that is held out to the public (by
name, posted signs, advertising, or other means) as a place
that provides care for emergency medical conditions on an
urgent basis without requiring a previously scheduled
appointment will be considered to be a dedicated emergency
department. Consistent with what we have stated above, we
believe that most provider-based urgent care centers that
are held out to the public as such will meet the revised
definition of dedicated emergency department for purposes
of EMTALA.
6. Labor and Delivery Departments and Psychiatric Units
Comment: Several commenters addressed our
clarification in the preamble of the proposed rule at
67 FR 31472 that other types of hospital departments, such
as labor and delivery and psychiatric units, could qualify
as a dedicated emergency department for purposes of EMTALA
under our proposed definition.
One commenter stated that if a hospital has a
department held out to the public as the place to go for a
labor or psychiatric emergency medical condition, that
department should fall under the definition of “dedicated
emergency department” for purposes of EMTALA.
Two commenters stated that it was unclear which of the
EMTALA requirements (such as the EMTALA log) would apply to
the labor and delivery unit and the psychiatric unit that
meet the definition of “dedicated emergency department.”
In addition, these commenters asked whether EMTALA would
apply to all patients who present to these locations or
only to obstetrical and psychiatric patients who present
under orders of their physicians at the locations.
Response: As explained further below, under the
revised definition in this final rule, departments of the
hospital will be considered to be “dedicated emergency
departments” if they are held out to the public as places
that provide care for emergency medical conditions on an
urgent, nonappointment basis. These departments will be
subject to EMTALA requirements applicable to dedicated
emergency departments, including requirements related to
maintenance of an emergency department log and on-call
requirements. Individuals who present at these locations
and request examination or treatment for a medical
condition or have such a request made on their behalf must
be screened under EMTALA and, if an emergency medical
condition is determined to exist, provided necessary
stabilizing treatment, because these locations are
dedicated emergency departments.
We note that the dedicated emergency department to
which an individual presents does not necessarily have to
be the one to do EMTALA screening and stabilization. For
example, if a man with cold symptoms or another medical
condition were to seek treatment in the obstetrics and
gynecology department rather than the general emergency
department, this presentation would create an EMTALA
obligation for the hospital, but the hospital would not be
prohibited from transporting the individual to its general
emergency department for screening and stabilization if
that action were medically indicated.
7. Use of Arizona State Bill Language Defining
Freestanding Urgent Care Center
Comment: One commenter cited language of a State bill
(Arizona SB1098 (1999)) that, if enacted, would amend the
Arizona State statutes to create standards in Arizona for
"freestanding urgent care centers." The commenter
suggested that we adopt the legislative language for a
"freestanding urgent care center" as the Medicare
definition of “dedicated emergency department.”
Specifically, the commenter suggested that the definition
state:
An "emergency department" means a medical facility
that, regardless of its posted or advertised name, meets
the following requirements:
Is a department of a hospital and is intended to
routinely provide unscheduled medical services; or
Meets any one of the following requirements:
Is open 24 hours a day to provide unscheduled
medical care, excluding, at its option, weekends or certain
holidays;
By its posted or advertised name, give the
impression to the public that it provides medical care for
urgent, immediate or emergency conditions; or
(3) Routinely provides ongoing unscheduled medical
services for more than 8 consecutive hours for an
individual patient.
Response: We have considered this suggested Arizona
bill language defining urgent care centers for the State
and believe it has merits for further revision of the CMS
definition of “dedicated emergency department,” with some
modification.
Under subparagraph (2) of the revised definition in
this final rule, we are adopting as one of three options
that a “dedicated emergency department” may be any
department or facility of a hospital, regardless of whether
it is located on or off the main hospital campus, that 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. We have not
limited the definition to a hospital "department" because
we do not believe it would be appropriate to exclude
facilities that otherwise function as dedicated emergency
departments from that definition solely because they may
not fully meet the requirements for departments of
providers in 42 CFR 413.65.
Second, under subparagraph (3) of the revised
definition in this final rule, we are adopting the
criterion that during the calendar year immediately
preceding the calendar year in which a determination is being made, based on a representative sample of patient
visits that occurred during that calendar year, the
department or facility provided at least one-third of all
of its outpatient visits for the treatment of emergency
medical conditions on an urgent basis without requiring a
previously scheduled appointment. We are not using the
Arizona bill 24-hour or 8-hour requirements because we
believe an objective measure based on outpatient visits for
the treatment of emergency medical conditions will be easier to understand and implement and better reflects the
operating patterns of some emergency departments, including
those at small or rural hospitals, or both, that may not
offer treatment for emergency medical conditions
continuously on a 24-hour, 7 days a week basis. (The
hospital CoPs governing emergency services of hospitals
(§482.55) and CAHs (§485.618) do not require that emergency
departments be operated continuously. Under some
circumstances, such as local shortages of emergency care
personnel or limited demand for emergency services,
hospitals and CAHs may choose to open and staff their
emergency departments on less than a 24-hour, 7 days a week
basis.)
8. Urgent Care Centers
Comment: Many commenters were concerned that hospital
"urgent care centers" or "acute care centers" would be
included, inappropriately, as "dedicated emergency
departments" for purposes of EMTALA. The commenters stated
that urgent care centers "are capable of responding to an
urgent need, but not an emergency medical condition."
Several commenters suggested that only those urgent
care centers that are functioning and holding themselves
out to the public as an emergency department should be
considered a dedicated emergency department for purposes of
EMTALA.
Response: We believe it would be very difficult for
any individual in need of emergency care to distinguish
between a hospital department that provides care for an
“urgent need” and one that provides care for an “emergency
medical condition” need. Indeed, to CMS, both terms seem
to demonstrate a similar, if not exact, functionality.
Therefore, we are not adopting the commenters’ suggestion
to except urgent care centers from dedicated emergency
department status. As we have discussed above, if the
department or facility is held out to the public as a place
that provides care for emergency medical conditions, it
would meet the definition of dedicated emergency
department. An urgent care center of this kind would fall
under this criterion for dedicated emergency department
status.
Although not specifically stated in a comment, an
underlying issue is that urgent care centers, participating
in Medicare through a hospital, and which operate as
satellite facilities off the main hospital campus, would
meet the current definition of a dedicated emergency
department, but would generally not have the capacity on
site to treat patients who had been screened and determined
to have serious emergency conditions. In this situation,
some might argue that it would be inappropriate for such a
facility to refer a patient in an unstable condition to the
main hospital campus (which could be 30 miles or more away
and involve a lengthy ambulance ride) rather than to a
nearby hospital that would be able to treat a patient.
Both under past and current rules, a transfer from an
urgent care center to a nonaffiliated hospital is allowed
under EMTALA where the facility at which the individual
presented cannot stabilize the individual and the benefits
of transfer exceed the risks of transfer and certain other
regulatory requirements are met. Thus, our rules permit a
satellite facility covered under the definition of
dedicated emergency department, in this example, to screen
and determine whether the case is too complex to be treated
on site, that a lengthy ambulance ride to an affiliated
hospital would present an unacceptable risk to the
individual, and then conclude that the benefit of transfer
exceeds the risk of transfer. In this case, the satellite
facility could then transfer the individual to an
appropriate nearby medical facility.
9. Evaluation and Treatment Issue
Comment: One commenter was concerned about the
“evaluation and treatment” aspect of our proposed
“dedicated emergency department” definition, and suggested
that the reference to evaluation would make the definition
overly inclusive, since an ambulatory clinic might have no
patients treated as emergencies, but many evaluated (and
ruled out) for emergencies. The commenter believed that
part of any prudent ambulatory practice is to consider
first the possibility of an emergency with all patients who
are seen. The commenter suggested dropping the “evaluation
and” portion of the definition to rely exclusively on an
area’s treatment of actual emergencies as the criterion.
Response: We agree that reference to evaluation may
make the definition of "dedicated emergency department"
overly inclusive, in that it would count any individuals
coming to emergency rooms who are evaluated but not treated
for such conditions to rule out emergency medical
conditions. Therefore, we are limiting the objective
criterion in the third part of the "dedicated emergency
department" definition in this final rule to a department
or facility that provides at least one-third of all its
outpatient visits for the treatment of emergency medical
conditions on an urgent basis without requiring a
previously scheduled appointment.
10. Prudent Layperson Observer Standard
Comment: Two commenters expressed opposing opinions
regarding our language at 67 FR 31477 of the preamble
portion of the proposed rule that stated that the
definition of "dedicated emergency department" would also
be interpreted to encompass those off-campus hospital
departments that would be perceived by a prudent layperson
as appropriate places to go for emergency care. One
commenter believed that while the prudent layperson
standard makes sense as it relates to the assessment of an
individual's medical condition, it is less appropriate with
respect to an individual’s assessment of an appropriate
site of service. The commenter stated that such
assessments would likely vary, depending on factors such as
perceived seriousness of the individual’s condition, and
urged CMS to adopt an objective test to avoid the
uncertainty inherent in a "prudent layperson standard" for
determinations of dedicated emergency department status.
Another commenter supported our proposed adoption of
the “prudent layperson standard” in determining whether a
facility is a dedicated emergency department and stated
that the prudent layperson standard is preferable to the
"significant portion of the time" or "regularly"
definitions or standards.
Response: We believe that our revised definition of
"dedicated emergency department" specified under section
VII.D. of this final rule establishes an objective standard
of determination. For instance, we believe it is an
objective standard of dedicated emergency department status
whether or not an emergency department is licensed by the
State. We also believe that it is an objective standard if
a hospital department holds itself out to the public as
providing emergency care.
We understand the comment concerning an individual's
assessment of an appropriate site of service. However, in
view of the revised “dedicated emergency department”
definition we are adopting in this final rule, we believe
the prudent layperson standard is unnecessary for
assessment of an area of the hospital as a dedicated
emergency department. We believe our revised criteria for
such status will permit the status of departments or
facilities to be objectively determined.
11. Specially Equipped and Staffed Area
Comment: Several commenters addressed the “specially
equipped and staffed area of the hospital” part of the
proposed definition of “dedicated emergency department.”
One commenter, a hospital, stated that it has a main campus
and several off-site locations, all of which are considered
departments of the hospital and that none of these off-site
departments are dedicated to the provision of emergency
care. They also indicated that none of the staff at these
off-campus departments are qualified to provide such care.
One commenter believed our definition of "dedicated
emergency department" should incorporate a provision that
staff be specially trained in providing emergency medical
care.
Another commenter requested that we clarify the terms
“specialized staff” and “specialized equipment” in the
proposed “dedicated emergency department” definition. The
commenter suggested that “true” emergency departments have
coding equipment and coding staff who know how to assign
appropriate billing codes.
Several commenters believed that we should clarify
that CMS will apply EMTALA only if a site is functioning as
a dedicated emergency department. Another commenter stated
that the obligations of EMTALA should apply to those
hospital departments or other off-site locations that
provide “traditional” emergency department services.
Response: As we explained earlier, based on our
review of comments on the proposed definition of “dedicated
emergency department,” we are adopting an alternative
definition of that term that does not include a reference
to special equipment or staffing. Therefore, we have not
attempted to further define “specialized staff” or
“specialized equipment” in this final rule.
We agree with the latter comments, but the range of
comments received on the definition of a dedicated
emergency department included in our proposed rule
illustrates that there are varying differences in opinion
as to what "functioning as a dedicated emergency
department" and "traditional emergency department services"
mean. Therefore, we do not believe these phrases alone are
sufficient to define a dedicated emergency department.
EMTALA applies not only to dedicated emergency departments
but also to presentments for emergency care anywhere on
hospital property.
Comment: One commenter brought to our attention a
contradiction in the preamble to the proposed rule when we
discuss the definition of “dedicated emergency department”
at 67 FR 31472. On the one hand, the commenter recognized
that we proposed to define “dedicated emergency department”
as an area that is “specially staffed and equipped” for
emergency care and that “is used a significant portion of
the time” for evaluation of patients for emergency medical
conditions. However, the commenter pointed out that, in
the same paragraph, CMS proposed that EMTALA applicability
also be extended to hospital departments "that are held out
to the public as an appropriate place to come for medical
services on an urgent, nonappointment basis.” Because the
"held out to the public" test was not included in the
proposed regulation text, the commenter requested
clarification on this point.
One commenter believed that only an area of the
hospital with an “Emergency” sign or a “well-accepted
synonym in its title” should be impacted by the EMTALA
regulations.
Response: As noted earlier, and as explained more
fully in section VII.D. of this preamble, we are adopting a
revised definition of “dedicated emergency department” that
does not reference special equipment or staffing, but does
recognize departments or facilities that are held out to
the public as places that provide care for emergency
medical conditions on an urgent basis without requiring a
previously scheduled appointment. We believe this revised
definition will resolve any uncertainty about the “held out
to the public” test.
We agree that use of the term “emergency” or a well recognized
synonym in a facility’s signage would help to
identify how the facility is held out to the public and
will keep this comment in mind as we develop interpretative
guidelines for EMTALA surveys. However, we are not including the suggested language in the final rule because
we are concerned that it could be overly prescriptive.
12. Unscheduled Appointments Criterion
Response: Several commenters addressed the issue of
defining dedicated emergency department as one that accepts
unscheduled appointments. One commenter suggested that the
definition of “dedicated emergency department” should focus
on why the patient is present at the hospital’s emergency
department. The commenter suggested that the definition
should include any location that the hospital holds out as
open to evaluate patients seeking unscheduled evaluation or
treatment for a medical condition. Similarly, another
commenter recommended that we revise the definition of
dedicated emergency department to state that it is a
specially equipped and staffed area of the hospital that is
primarily dedicated to "unscheduled" evaluation and
treatment of outpatients for emergency medical conditions.
One commenter suggested that our proposed definition
of dedicated emergency department be revised to specify
that departments of the hospital that accept walk-in or
unscheduled patients for assessment are deemed to be
dedicated emergency departments for the purposes of EMTALA.
The commenter stated that this definition would exempt
routine clinics or hospital-based physician offices that
function on an appointment-only basis, administrative
areas, inpatient units, and laboratory areas that provide
testing but do not provide assessment or diagnosis services
for patients.
Another commenter asked us to include places that are
“held out to the public as an appropriate place to come for
medical services on an urgent, nonappointment basis” under
the definition of dedicated emergency department. This
suggestion would include the labor and delivery department
of a hospital, but would exclude outpatient clinics that
permit “walk-in patients”, according to the commenter.
The commenter suggested that “dedicated emergency
department” be defined as any area of the hospital that
provides more than 10 percent of its nonscheduled patients
treatment for outright emergencies.
Response: We agree that the practice of accepting
patients without requiring appointments is an important
indicator of emergency department status. After
consideration of all of the comments on this issue, we are
adopting in this final rule a criterion in the definition
of “dedicated emergency department” that permits a
department or facility to be considered a dedicated
emergency department if 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.
13. Related Definition of “Hospital with an Emergency Department”
Comment: One commenter requested that we amend the
proposed regulatory text at §489.24(a), consistent with our
proposed definition of “dedicated emergency department,” to
state that EMTALA requirements apply to a hospital that has
a dedicated emergency department. Other commenters
suggested that our proposed definition of “hospital with an
emergency department” at §489.24(b) should either be
deleted or revised so that it is defined as a “hospital
with a dedicated emergency department,” to make it
consistent with our definition of "dedicated emergency
department."
Response: We considered the suggestion that we amend
the “Application” paragraph of §489.24(a) to limit EMTALA
applicability to hospitals with dedicated emergency
departments. However, “hospital with an emergency
department” is a term of art from section 1867 of the Act
that we have separately included in the definitions under
§489.24(b) to mean generally “a hospital that offers
services for emergency medical conditions.” Thus, we believe it would be preferable to keep the statutory
language “hospital with an emergency department” in the
Application section in the regulation text. To clarify our
policy in this area, we are revising the definition of
“Hospital with an emergency department” under §489.24(b) to
state that it means a hospital with a dedicated emergency
department as defined in §489.24(b).
14. Other Related Suggested Revisions
Comment: One commenter recommended that the last
sentence in proposed paragraph (1) of the definition of
“Comes to the emergency department” in §489.24(b) be
revised to read:
"In the absence of such a request by or on behalf of
the individual, a request on behalf of the individual will
be considered to exist if a prudent layperson observer
would believe, based on the individual’s appearance or
behavior, that the individual needs examination or
treatment for an emergency medical condition." [New
language is underlined.]
(As proposed, this definition would require only that
the prudent layperson observer believe that the individual
needs examination or treatment for a medical condition.)
Response: Section 1867 of the Act requires a hospital
to provide examination and necessary stabilizing treatment
to any individual who “comes to the hospital” for emergency
care. We are interpreting this statutory requirement to
mean that individuals who present to areas of the hospital
other than departments that are labeled “Emergency” must
receive care from the hospital. We believe we have
clarified this requirement in prior rulemakings and in the
proposed rule. However, we are including this
clarification in this final rule, as well, as part of the
revised final definition of dedicated emergency department.
Comment: One commenter stated that if the proposed
rules are adopted as final, on-call physicians and
hospitals will refuse to accept transfers if the transfers
will be received through the hospital dedicated emergency
department. The commenter believed that if we apply EMTALA
to patients admitted via the dedicated emergency
department, it will create “perverse incentives” for
hospitals and physicians to avoid admitting patients
through the dedicated emergency department. The commenter
stated: “On-call physicians will be reluctant to agree to
accept patients for admission through the ED because then
their stabilizing care of the patient in the hospital will
subject them to civil monetary penalties and civil
liability under EMTALA.”
Response: It is a statutory requirement under section
1867(g) of the Act that receiving hospitals with special
capabilities must accept the transfer of an individual with
an unstable emergency medical condition. The receiving
hospitals must accept the patients whether or not they are
received through that hospital’s dedicated emergency
department--the EMTALA obligation for the receiving
hospital transfers with the individual until the condition
has been stabilized. Therefore, we do not believe on-call
physicians and hospitals would refuse to accept transfers
if the transfers are being received through the hospital
dedicated emergency department, as the commenter believed.
In particular, we hold this view because the EMTALA
obligation is incurred at the time of arrival of the
individual in accordance with an appropriate transfer,
regardless of which door the individual enters or whether
he or she is admitted immediately to the receiving
hospital.
D. Provisions of the Final Rule Regarding Clarification of "Come to the Emergency Department"
For the reasons discussed throughout section VII. Of
this preamble, and after full consideration of the public
comments received-
We are adopting as final the proposed organizational
changes to §489.24(a) on the application of EMTALA to
include both the screening and stabilization or transfer
requirements. (We note that later in this preamble under
section X., we make an additional change to paragraph (a)
to clarify that if the hospital admits the individual as an
inpatient for further treatment after screening, the
hospital’s obligation under EMTALA ends.)
We are adopting paragraphs (1) and (2) under the
proposed definition of "come to the emergency department"
as final without changes.
We are revising the proposed definition of “dedicated
emergency department” at §489.24(b), to read as follows:
“Dedicated emergency department” means any department
or facility of the hospital, regardless of whether it is
located on or off the main hospital campus, that meets at
least one of the following requirements:
It is licensed by the State in which it is
located under applicable State law as an emergency room or
emergency department;
It is held out to the public (by name, posted
signs, advertising, or other means) as a place that
provides care for emergency medical conditions on an urgent
basis without requiring a previously scheduled appointment;
or
During the calendar year immediately preceding
the calendar year in which a determination under §489.24 is
being made, based on a representative sample of patient
visits that occurred during that calendar year, it provided
at least one-third of all its outpatient visits for the
treatment of emergency medical conditions on an urgent
basis without requiring a previously scheduled appointment.
We believe this revised definition of “dedicated
emergency department” sufficiently addresses many of the
suggested proposals submitted by the commenters on
determining what is an emergency department for purposes of
EMTALA.
We are revising the proposed definition of "hospital
with an emergency department" to make it consistent with
our revised definition of "dedicated emergency department."
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