Health Law Group Advisory Bulletin
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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