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Summary of Final Changes to EMTALA Regulations
By M.
Steven Lipton
[September 2003]
On August 29, 2003, the Center for Medicare & Medicaid
Services (CMS) released the long-anticipated final regulations
revising the EMTALA obligations for hospitals and physicians.
The regulations are scheduled to be published in the Federal
Register on Sept. 9, 2003, and will be effective on Nov. 10,
2003.
In summary, the final regulations attempt to define more clearly
to whom EMTALA applies, and where and when the EMTALA requirements
begin and end. The revised regulations therefore define the
obligations with respect to these persons:
In addition, the final rules also clarify on-call
obligations, prior authorization requirements,
and the application of EMTALA during national
emergencies.
INDIVIDUALS WHO PRESENT TO A DEDICATED EMERGENCY
DEPARTMENT
Current Rules. Under the current regulations,
the EMTALA obligations begin when an individual “comes
to the emergency department” and makes a request for examination
or treatment for a medical condition. The draft rules proposed
to clarify the EMTALA obligations that apply when an individual
presents at a “dedicated emergency department” or
elsewhere on hospital property.
New Rules. The final rules apply EMTALA to
an individual who presents at a dedicated emergency department
of a hospital and requests examination or treatment for a medical
condition or has such a request made on his/her behalf. In the
absence of a request for services, EMTALA applies if a prudent
layperson observer would believe, based on the individual’s
appearance or behavior, that the individual needs examination
or treatment for a medical condition.
| 1. |
Definition of “Dedicated Emergency
Department.” The final rules define the term
"dedicated emergency department" as a department
or facility of a hospital that is located on the main hospital
campus or off-campus, and meets at least one of the following
requirements: |
- The department or facility is licensed by the state as an
emergency room or department.
- The department or facility is held out to the public (by
name, 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
- The department or facility, based on a representative sample
of patient visits within the immediately preceding calendar
year, provides 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.
In the preamble to the final regulations, CMS states that
it will issue guidance to surveyors on making a representative
sampling and will post questions and answers on the CMS website
to provide further clarification and guidance to providers.
| 2. |
Application to Labor and Delivery
and Psychiatric Units. CMS notes that the proposed
definition of dedicated emergency department includes
not only what is generally considered to be a hospital's
"emergency room," but also other hospital departments,
such as labor and delivery and psychiatric units. CMS
states in the preamble to the final regulations that “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 listing them
on an outpatient basis, would be considered a dedicated
emergency department…” (emphasis in original). |
| 3. |
Application to Hospital Urgent Care Centers.
In the preamble to the final regulations, CMS rejects
a request to exclude hospital urgent care centers from
the EMTALA requirements, stating:
We believe that 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…. 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. |
INDIVIDUALS WHO PRESENT ELSEWHERE ON
THE HOSPITAL’S MAIN CAMPUS OTHER THAN THE DEDICATED EMERGENCY
DEPARTMENT
Current Rules. Under the current EMTALA Interpretive
Guidelines, a hospital must provide for a medical screening
examination for any individual seeking care and treatment on
the hospital campus. The draft rules reaffirmed the view of
CMS that a hospital incurs an EMTALA obligation if an individual
presents at any on-campus area seeking examination or treatment
for what may be an “emergency” medical condition.
New Rules. In the preamble to the final rules,
CMS reaffirms that “EMTALA does not apply elsewhere on
on-campus hospital property other than a dedicated emergency
department unless emergency services are requested (emphasis
in original).” The final rules provide:
| 1. |
Request for Emergency Services. EMTALA
applies to an individual who has presented on “hospital
property,” other than a dedicated emergency department,
and requests examination or treatment for what may be an
emergency medical condition or has such a request made on
his/her behalf. In the absence of a request for services,
EMTALA will also apply if a prudent layperson observer would
believe, based on the individual’s appearance or behavior,
that the individual needs emergency examination or treatment. |
| 2. |
Definition of Hospital Property. For
the purpose of determining when the EMTALA obligations are
triggered for an individual who is on the hospital campus,
“hospital property” will continue to be defined
by the 250-yard test for describing the hospital-campus
(including parking lots, sidewalks and driveways) under
the provider-based rules. However, “hospital property”
does not include physician offices, rural health clinics,
skilled nursing facilities, other entities that participate
in Medicare separately from the hospital, and businesses
such as restaurants, shops and other non-medical activities. |
INDIVIDUALS WHO COME TO THE DEDICATED
EMERGENCY DEPARTMENT FOR NONEMERGENCY SERVICES
Current Rules. The current regulations require
a hospital to provide a medical screening examination to an
individual who presents at an emergency department seeking medical
treatment. The draft rules proposed to distinguish between individuals
who present to a dedicated emergency department for emergency
services and individuals who present to a dedicated emergency
department for nonemergency services.
New Rules. In the preamble to the final rules,
CMS reaffirms its view that a hospital has an EMTALA obligation
with respect to any individual who comes to a dedicated
emergency department seeking examination or treatment for a
medical condition, even if the treatment is not for an emergency
condition.
The final regulations distinguish between individuals presenting
to a dedicated emergency department for emergency services as
opposed to nonemergency services. In the preamble, CMS reiterates
its view that all medical screenings have to be “equally
extensive.” Under the final rules, if an individual comes
to a dedicated emergency department and a request is made for
medical care that is not of an emergency nature, the hospital
is required to perform a medical screening that is appropriate
for any individual presenting in that manner to determine whether
the individual has or does not have an emergency medical condition.
CMS states that the examination may be limited to (i) the individual's
statement that he/she is not seeking emergency care, and (ii)
brief questioning by a qualified medical person that is sufficient
to establish that there is no emergency condition.
As an example, the preamble to the draft regulations included
a hypothetical case of an individual seeking removal of sutures.
The analysis indicated that the hospital may have an emergency
nurse, designated by the hospital as a qualified medical person
to perform a medical screening, perform the screening examination
by obtaining the patient’s history, conducting an examination
of the sutures and determining that the wound is healing appropriately.
If the nurse concludes that the patient does not have an emergency
medical condition, CMS stated that the EMTALA obligations would
be satisfied. In the final regulations, CMS noted, however,
that if it is later found that the individual who requested
the removal of sutures in fact had an emergency condition, the
extent and quality of the screening by the nurse would be subject
to review to determine whether the medical screening was adequate.
In other statements in the preamble to the final regulations,
CMS states:
- EMTALA does not apply to individuals who present to a dedicated
emergency department and request services that are not an
examination or treatment for a medical condition, “such
as preventive care services” (which are not defined
in the preamble);
- Pharmaceutical services in a dedicated emergency department
may be for medical conditions and are therefore subject to
EMTALA; and
- Requests by law enforcement for medical clearance of persons
for incarceration or blood alcohol or other tests to be used
as evidence in criminal proceedings will be reviewed on a
case-by-case basis as to whether they trigger the EMTALA obligations.
INDIVIDUALS RECEIVING OUTPATIENT SERVICES
Current Rules. The current rules are unclear
as to whether EMTALA applies to individuals with scheduled nonemergency
services at an on-campus area of the hospital other than a dedicated
emergency department. In the preamble to the proposed rules,
CMS stated that EMTALA should not apply in most of these circumstances.
New Rules. The final rules provide that the
EMTALA obligations do not apply to an individual who has begun
to receive outpatient services as part of an encounter other
than an encounter that triggers the EMTALA obligations. CMS
explains that the new rules apply to any person who comes to
a hospital department (other than a dedicated emergency department)
for nonemergency services (such as physical therapy or diagnostic
imaging) and has begun to receive those services. In the event
the patient develops an emergency condition during the outpatient
encounter, CMS states the hospital’s response will be
governed under the Medicare conditions of participation, not
EMTALA (even if the patient is moved to the dedicated emergency
department for follow-up examination and stabilizing treatment).
However, CMS also states that EMTALA will apply to individuals
on the hospital campus for other than outpatient services (such
as hospital employees or visitors) who experience what may be
an emergency medical condition.
OFF-CAMPUS DEPARTMENTS OF A HOSPITAL
Current Rules. Under the current regulations
(adopted in April 2000), the EMTALA obligations apply to an
off-campus provider-based outpatient department of a hospital.
In the draft rules, CMS proposed to limit the off-site application
of EMTALA only to a dedicated emergency department operated
by a hospital. As to all other off-campus provider-based outpatient
departments of a hospital, CMS proposed to repeal the regulations
extending EMTALA. Instead, CMS proposed to enact a new condition
of participation requiring hospitals to have policies and procedures
for appraisal of emergencies and referral of emergency patients
where appropriate.
New Rules. The final regulations apply EMTALA
to off-site dedicated emergency departments of a hospital, and
eliminate the extension of EMTALA to all other off-campus departments.
Emergency services provided at an off-campus department (other
than a dedicated emergency department) must be in accordance
with written policies and procedures adopted by the hospital
governing body for appraisal of emergencies and referral when
appropriate. The new rules will be enforced under the Medicare
conditions of participation, not EMTALA. In the preamble to
the final rules, CMS states that it will clarify in the interpretive
guidelines or training materials that the policies and procedures
for appraisal and referral will apply only within the hours
of operation and normal staffing capability of the facility.
HOSPITAL INPATIENTS
Current Rules. The current EMTALA regulations
do not address whether the EMTALA obligations apply to inpatients.
Some federal courts have applied EMTALA to inpatient transfers
and discharges, while some federal courts have interpreted EMTALA
as not applying to inpatient services. The draft regulations
proposed to apply EMTALA to an inpatient with an emergency medical
condition who is admitted from the emergency department and
is not stabilized at the time of his/her inpatient admission
to the hospital.
New Rules. Under the final rules, EMTALA obligations
are terminated once an individual is admitted for inpatient
care. The regulations adopt the definition of “inpatient”
in the Medicare Hospital Manual as “a person who is has
been admitted to a hospital for bed occupancy for purposes of
receiving inpatient hospital services.” In other comments
in the preamble to the final regulations:
- CMS states that inpatients will continue to be subject to
the standards and protections of the conditions of hospital
participation.
- CMS clarifies that “individuals who are ‘boarded’
and admitted in the dedicated emergency department would be
determined to be inpatients for purposes of EMTALA if, generally,
they have been admitted by the hospital with the expectation
that they will remain at least overnight and occupy beds in
the hospital.”
- CMS notes that EMTALA will apply if a hospital does not
admit an emergency patient in good faith (i.e., to avoid EMTALA
requirements), and then inappropriately transfers or discharges
the individual without meeting the stabilization requirement.
INDIVIDUALS IN HOSPITAL-OWNED AMBULANCES
Current Rules. Under the existing regulations,
EMTALA applies to an emergency patient in a hospital-owned ambulance,
but generally does not apply to a patient in a non-hospital
owned ambulance unless the ambulance has arrived on hospital
property. The draft rules proposed that EMTALA does not apply
to hospital-owned ambulances that are integrated with community
EMS networks for responding to medical emergencies.
New Rules. The final regulations provide EMTALA
does not apply to hospital-owned air or ground ambulances if:
- The ambulance is operated under communitywide emergency
medical service protocols that direct it to transport the
individual to a hospital other than the hospital that owns
the ambulance (for example, the closest available hospital),
or
- The ambulance is operated at the direction of a physician
who is not employed or otherwise affiliated with the hospital
that owns the ambulance
ON-CALL OBLIGATIONS
Current Rules. The existing EMTALA regulations
require hospitals to have on-call rosters, but do not describe
specific obligations for on-call coverage. The basic rules for
on-call coverage are set forth in the EMTALA Interpretive Guidelines
published by CMS. The draft rules reaffirmed the existing Guidelines
by proposing simply that a hospital is responsible for maintaining
an on-call list in a manner that best meets the needs of its
patients. Subsequent to the issuance of the draft rules, CMS
published two memoranda on June 13, 2002 that, among other guidance,
clarified that hospitals have discretion to establish call panels
that meet patient needs and consider the availability of physicians
on the medical staff to take call.
New Rules. The final regulations adopt the
following standards for on-call coverage:
| 1. |
The On-Call Roster.
Hospitals must maintain an on-call list of physicians “in
a manner that best meets the needs of hospital’s patients”
who are receiving services required by EMTALA in accordance
with resources that are available to the hospital, including
the availability of on-call physicians. CMS reaffirms in
the preamble to the final rules that there is no requirement
under EMTALA for full-time on-call coverage by a specialty
(although state law may be different) or any predetermined
"ratio" that is used to identify how many days
that a hospital must provide on-call coverage based on the
number of physicians on staff for that particular specialty.
Rather, CMS states it will consider all relevant factors,
including the number of physicians on staff, other demands
on these physicians, the frequency with which the hospital's
patients typically require services of on-call physicians,
and the provisions the hospital has made for situations
in which a physician in the specialty is not available or
the on-call physician is unable to respond. |
| 2. |
Policies When On-Call
Coverage is Unavailable. Hospitals must have written
policies and procedures to respond to situations when a
particular specialty is not available or the on-call physician
cannot respond due to circumstances beyond his/her control. |
| 3. |
Policies When On-Call
Physicians Schedule Elective Surgery or Maintain Simultaneous
Call. Hospitals must have written policies and
procedures to provide that emergency services are available
to meet the needs of patients with emergency medical conditions
if it elects to permit on-call physicians to (i) schedule
elective surgery when they are on call or (ii) have simultaneous
on-call duties for two or more hospitals. |
In the preamble to the final rules, CMS also clarifies its
views on the scope of on-call obligations. The comments include:
- Services offered to the public by a hospital should be available
through on-call coverage of the emergency department; however,
in response to a comment, CMS declined to adopt that standard
in the regulations, stating that that it may “establish
an unrealistically high standard that not all hospitals could
meet.”
- CMS reports that some commenters requested guidance on the
obligations of on-call physicians to respond to calls when
their clinical privileges are more expansive than their actual
scope of practice. In response, CMS notes that a physician
“who is in a narrow subspecialty may, in fact, be medically
competent in his or her general specialty, and in particular
may be able to promptly contribute to the individual’s
care by bringing skills and expertise that are not available
to the emergency physician…” CMS states that any
disagreement between the treating and on-call physicians regarding
the need to come to the hospital “must be resolved by
deferring to the medical judgment of the emergency physician
or other practitioner who has personally examined the individual
and is currently treating the individual.”
- Hospitals that do not maintain a dedicated emergency department
are not required to maintain an on-call roster.
- Physicians who come to the hospital to see their own patients
should not necessarily be interpreted as meaning that the
physician is on call (assuming that they are not listed on
the coverage roster as on-call for that time period).
- The practice of refusing to be listed on the on-call roster,
but taking calls selectively (for example, based on the ability
to pay), “would clearly be a violation of EMTALA.”
RELATIONSHIPS WITH INSURERS AND MANAGED
CARE PLANS
Current Rules. In the 1999 Special Advisory
Bulletin on EMTALA and Managed Care, CMS issued guidance that
a hospital may not seek prior authorization (or require a patient
to seek prior authorization) for emergency services until a
patient has received a medical screening examination and treatment
has been initiated to stabilize an emergency medical condition.
The draft regulations proposed to incorporate the guidance from
the Special Advisory Bulletin. In the preamble to the proposed
rules, CMS solicited comments on whether hospitals may seek
other information from health plans about an emergency patient.
New Rules.
| 1. |
Prior Authorization.
The final regulations: |
- Prior Authorization. Prohibit a hospital
from seeking prior authorization (or directing any other individual
to seek prior authorization) for screening or stabilization
services until after the hospital has provided the medical
screening and initiated further examination and treatment
that may be required to stabilize the emergency medical condition.
- Consultation. Clarify that the prior authorization
prohibition does not preclude the treating physician (or other
qualified medical personnel) from seeking advice on the patient’s
medical history and needs, so long as the consultation does
not inappropriately delay required emergency services.
- Patient Registration. Allow hospitals to
follow reasonable registration processes for emergency patients,
including asking for insurance status and information so long
as the inquiry does not delay the medical screening or treatment.
Reasonable registration processes may not “unduly discourage
individuals from remaining for further evaluation.”
| 2. |
Medicare+Choice Plans.
In the draft EMTALA rules, CMS proposed to require a hospital
to contact a Medicare+Choice plan after a patient is stabilized
if the patient will require an inpatient admission for follow-up
care. In the preamble to the final rules, CMS declined to
adopt the proposed rules, stating that it plans to address
them in future policy guidance. |
EMTALA IN NATIONAL EMERGENCIES
In the final rules, CMS adopted a new regulation that sanctions
under EMTALA for an inappropriate transfer during a national
emergency (such as a bioterroist attack) do not apply to a hospital
with a dedicated emergency department located in an emergency
area.
Any questions about this Advisory should be directed
to:
M.
Steven Lipton, San Francisco, (415) 276-6550, stevelipton@dwt.com
Lisa
Rediger Hayward, Seattle, (206) 628-7666, lisahayward@dwt.com
This Health Law Advisory is a publication
of the Health Law Group of Davis Wright Tremaine LLP. Our purpose
in publishing this Advisory is to inform our clients and friends
of developments in health care law. It is not intended, nor
should it be used, as a substitute for specific legal advice
as legal counsel may only be given in response to inquiries
regarding particular situations.
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