[Federal Register Volume 68, Number 174 (Tuesday, September 9, 2003)]
[Rules and Regulations]
[Pages 53222-53264]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-22594]
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Part II
Department of Health and Human Services
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Centers for Medicare & Medicaid Services
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42 CFR Parts 413, 482, and 489
Medicare Program; Clarifying Policies Related to the Responsibilities
of Medicare-Participating Hospitals in Treating Individuals With
Emergency Medical Conditions; Final Rule
Federal Register / Vol. 68, No. 174 / Tuesday, September 9, 2003 /
Rules and Regulations
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Parts 413, 482, and 489
[CMS-1063-F]
RIN 0938-AM34
Medicare Program; Clarifying Policies Related to the
Responsibilities of Medicare-Participating Hospitals in Treating
Individuals With Emergency Medical Conditions
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Final rule.
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SUMMARY: This final rule clarifies policies relating to the
responsibilities of Medicare-participating hospitals in treating
individuals with emergency medical conditions who present to a hospital
under the provisions of the Emergency Medical Treatment and Labor Act
(EMTALA).
The final rule responds to public comments received on a May 9,
2002 proposed rule (67 FR 31404) that both reiterated the agency's
interpretations under EMTALA and proposed clarifying changes relating
to the implementation of the EMTALA provisions. These reiterations and
clarifying changes related to, among other areas, seeking prior
authorization from insurers for services, emergency patients presenting
at off-campus outpatient clinics that do not routinely provide
emergency services, the applicability of the EMTALA provisions to
hospital inpatients and outpatients, the circumstances under which
physicians must serve on hospital medical staff ``on-call'' lists, and
the responsibilities of hospital-owned ambulances.
These reiterations and clarifying changes are needed to ensure
uniform and consistent application of policy and to avoid any
misunderstanding of EMTALA requirements by individuals, physicians, or
hospital employees.
DATES: The provisions of this final rule are effective on November 10,
2003.
FOR FURTHER INFORMATION CONTACT: Thomas Gustafson, (410) 786-4487.
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Table of Contents
I. Background
II. Special Advisory Bulletin on EMTALA Obligations
III. Summary of the Provisions of the May 9, 2002 Proposed Rule
Relating to EMTALA and Hospital Responsibility for Communication
with Medicare+Choice Organizations Concerning Post-Stabilization
Care Services
A. Summary of the Proposed Provisions Relating to EMTALA
B. Summmary of the Proposed Provisions Relating to Communication
with Medicare+Choice Organizations Concerning Post-Stabilization
Care Services
IV. General Comments on the Proposed Rule
V. Prior Authorization
A. Provisions of the Proposed Rule
B. Summary of Public Comments and Departmental Responses
1. General Comments
2. Concurrent Authorization and Furnishing of Stabilizing
Services
3. Authorization Requests by Nonphysician Practitioners
4. Medical Staff Communications
5. Out-of-Network Coverage
C. Provisions of the Final Rule on Prior Authorizations
VI. Clarification of ``Come to the Emergency Department''
A. Background
B. Provisions of the Proposed Rule
C. Summary of Public Comments and Departmental Responses
1. General Support
2. Objective Test of ``Significant Portion of the Time''
3. Nature of Care
4. State Law Criterion
5. Held Out to the Public Standard
6. Labor and Delivery Departments and Psychiatric Units
7. Use of Arizona State Bill Language Defining Freestanding
Urgent Care Center
8. Urgent Care Centers
9. Evaluation and Treatment Issue
10. Prudent Layperson Observer Standard
11. Specially Equipped and Staffed Area
12. Unscheduled Appointments Criterion
13. Related Definition of ``Hospital with an Emergency
Department''
14. Other Related Suggested Revisions
D. Provisions of the Final Rule Regarding Clarification of
``Comes to the Emergency Department''
VII. Applicability of EMTALA: Individuals Come to the Dedicated
Emergency Department for Nonemergency Services
A. Background
B. Provisions of the Proposed Rule
C. Summary of Public Comments and Departmental Responses
D. Provisions of the Final Rule
VIII. Applicability of EMTALA: Individuals Present at an Area of the
Hospital's Main Campus Other than the Dedicated Emergency Department
A. Background
B. Provisions of the Proposed Rule
C. Summary of Public Comments and Departmental Responses
1. Presentation Outside the Dedicated Emergency Department
2. Prudent Layperson Standard
3. Determination of ``What May Be an Emergency Medical
Condition''
4. Other Issues
D. Provisions of the Final Rule
IX. Scope of EMTALA Applicability to Hospital Inpatients
A. Background and Provisions of the Proposed Rule
B. Summary of Public Comments and Departmental Responses
1. Applicability of EMTALA to Inpatients
1. Definition of Stability
2. Logs on EMTALA Patients
4. Other Issues
C. Provisions of the Final Rule
X. Applicability of EMTALA to Provider-Based Entities
A. Applicability of EMTALA to Off-Campus Hospital Departments
1. Background
2. Provisions of the Proposed Rule
3. Summary of Public Comments and Departmental Responses
4. Provisions of the Final Rule
B. On-Campus Provider-Based Applicability
1. Background
2. Provision of the Proposed Rule
3. Summary of Public Comments and Departmental Responses
4. Provisions of the Final Rule
XI. EMTALA and On-Call Requirements
A. Background
B. Provisions of the Proposed Rule
C. Summary of Public Comments and Departmental Responses
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1. General Comments
2. Minimal Interpretation of On-Call Responsibilities
3. Recommended Definition of ``Best Meets the Needs of the
Hospitals' Patients''
4. Physicians' Responsibility for On-Call Coverage
5. Hospital Responsibility for On-Call Coverage
6. Simultaneous Call and Performance of Other Physician Services
While On Call
7. Limiting On-Call Responsibility by Subspecialty
8. Other On-Call Issues
D. Provisions of the Final Rule
XII. EMTALA Applicability to Hospital-Owned Ambulances
A. Background
B. Provisions of the Proposed Rule
C. Summary of Public Comments and Departmental Responses
D. Provisions of the Final Rule
XIII. Conditions of Participation for Hospitals
XIV. Other Issues
A. Editorial/Clarifying Changes
B. Out-of-Scope Public Comments
XV. Information Collection Requirements
XVI. Regulatory Impact Analysis
A. Introduction
1. Executive Order 12866
2. Regulatory Flexibility Act
3. Effects on Rural Hospitals
4. Unfunded Mandates
5. Federalism
B. Anticipated Impact
C. Office of Management and Budget Review
List of Subjects
Regulation Text
I. Background
Sections 1866(a)(1)(I), 1866(a)(1)(N), and 1867 of the Social
Security Act (the Act) impose specific obligations on Medicare-
participating hospitals and critical access hospitals (CAHs) that offer
emergency services. (Throughout this final rule, when we reference the
obligation of a ``hospital'' under these sections of the Act and in our
regulations, we mean to include CAHs as well.) These obligations
concern individuals who come to a hospital emergency department and
request examination or treatment for medical conditions, and apply to
all of these individuals, regardless of whether or not they are
beneficiaries of any program under the Act. Section 1867 of the Act
sets forth requirements for medical screening examinations for medical
conditions, as well as necessary stabilizing treatment or appropriate
transfer. In addition, section 1867(h) of the Act specifically
prohibits a delay in providing required screening or stabilization
services in order to inquire about the individual's payment method or
insurance status. Section 1867(d) of the Act provides for the
imposition of civil monetary penalties on hospitals and physicians
responsible for the following: (a) Negligently failing to appropriately
screen an individual seeking medical care; (b) negligently failing to
provide stabilizing treatment to an individual with an emergency
medical condition; or (c) negligently transferring an individual in an
inappropriate manner. (Section 1867(e)(4) of the Act defines
``transfer'' to include both transfers to other health care facilities
and cases in which the individual is released from the care of the
hospital without being moved to another health care facility.)
These provisions, taken together, are frequently referred to as the
Emergency Medical Treatment and Labor Act (EMTALA), also known as the
patient antidumping statute. EMTALA was passed in 1986 as part of the
Consolidated Omnibus Budget Reconciliation Act of 1985 (COBRA).
Congress enacted these antidumping provisions in the Social Security
Act because of its concern with an ``increasing number of reports''
that hospital emergency rooms were refusing to accept or treat
individuals with emergency conditions if the individuals did not have
insurance:
``* * * the Committee is most concerned that medically unstable
patients are not being treated appropriately. There have been reports
of situations where treatment was simply not provided. In numerous
other situations, patients in an unstable condition have been
transferred improperly, sometimes without the consent of the receiving
hospital.
``There is some belief that this situation has worsened since the
prospective payment system for hospitals became effective. The
Committee wants to provide a strong assurance that pressures for
greater hospital efficiency are not to be construed as license to
ignore traditional community responsibilities and loosen historic
standards.
``[Under the statute] [a]ll participating hospitals with emergency
departments would be required to provide an appropriate medical
screening examination for any individual who requests it (or has a
request made on his [or her] behalf) to determine whether an emergency
medical condition exists or if the patient is in active labor.'' (H.R.
Rept. No. 99-241, Part I, 99th Cong., 1st Sess. (1985), p.27.)
In addition, section 1867(d)(2) of the Act provides for a private
right of enforcement for any individual who is harmed as a ``direct
result'' of a violation of the Act. In enacting this section of the
law, Congress did not intend for the statute to be used as a Federal
malpractice statute. Indeed, many courts are in agreement that EMTALA
is not a Federal malpractice statute (for example, Bryan v. Rectors and
Visitors of University of Virginia, 95 F.3d 349, 351 (4th Cir. 1996);
Lopez-Soto v. Hawayek, 175 F.3d 170, 177 (1st Cir. 1999); and Baker v.
Adventist Health, Inc., 260 F.3d 987, 994 (3rd Cir. 2001).
The regulations implementing section 1867 of the Act are found in
42 CFR 489.24, Special responsibilities of Medicare hospitals in
emergency cases. Existing Sec. 489.24 provides for the following:
[sbull] Requires that when an individual presents to a hospital's
emergency department and a request is made on the individual's behalf
for examination or treatment of a medical condition, the hospital must
provide for an appropriate medical screening examination to determine
whether or not an emergency medical condition exists. (Paragraph (a))
[sbull] Defines certain terms, including ``comes to the emergency
department,'' ``emergency medical condition,'' ``stabilized,'' and ``to
stabilize.'' (Paragraph (b))
[sbull] Addresses procedures a hospital must follow when it
determines, with respect to a patient, that an emergency medical
condition exists. If the hospital determines that an emergency medical
condition exists, the hospital must provide for further medical
examination and treatment as required to stabilize the individual. If
the hospital does not have the capabilities to stabilize the
individual, an appropriate transfer to another facility is permitted.
(Paragraph (c)) A transfer is appropriate when the medical benefits of
the transfer outweigh the medical risks of the transfer and other
requirements, specified in the regulations, are met. (Paragraph (d)) In
addition, the hospital may transfer an unstable patient who makes an
informed written request. A hospital may not delay an appropriate
medical screening examination, or further examination or treatment, to
inquire about the patient's payment method or insurance status.
(Paragraph (c))
In addition, Sec. 489.24 addresses: (a) Restriction of a transfer
until the individual is stabilized; (b) the responsibilities of the
receiving hospital; (c) termination of the provider agreement for
failure to comply with EMTALA requirements; and (d) matters concerning
consultation with Quality Improvement Organizations (QIOs). (Paragraphs
(d) through (h), respectively)
Some EMTALA-related requirements are implemented under regulations
at Sec. Sec. 489.20(l), (m), (q), and (r)(1), (r)(2), and (r)(3).
Those regulations deal with
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a hospital's obligations to report the receipt of patients whom it has
reason to believe may have been transferred inappropriately; to post
signs in the emergency department describing an individual's rights to
emergency treatment under section 1867 of the Act; and to maintain
patient records, physician on-call lists, and emergency room logs. We
are including this brief description for informational purposes but,
because we are not changing the regulations in Sec. 489.20, they will
not be discussed further in this document.
In promulgating these cited regulatory sections and in enforcing
the provisions of EMTALA, we are aware of the necessary balance between
the hospital's and a physician's legal duty to provide examination and
treatment (both under the statute and under the common law) and the
practical realities of the manner in which hospitals and medical staffs
are organized and operated on a day-to-day basis, as well as proper
mobilization of resources within hospitals in order to comply with
these legal duties. Reports of overcrowding are common in many parts of
the country. Within the requirements of EMTALA, individuals should be
treated at the appropriate site of care.
Hospitals and physicians have now had over 15 years of experience
in organizing themselves to comply with the provisions of EMTALA.
Therefore, in a proposed rule published in the Federal Register on May
9, 2002 as part of the annual proposed rules for the acute care
hospital inpatient prospective payment system (67 FR 31469), we
solicited comments from hospitals, physicians, patients, and
beneficiary groups on certain proposed changes to the EMTALA policies
as discussed in sections III. through XIV. of this preamble.
II. Special Advisory Bulletin on EMTALA Obligations
On November 10, 1999, CMS (then HCFA) and the Office of the
Inspector General (OIG) published jointly in the Federal Register a
Special Advisory Bulletin addressing the requirements of the EMTALA
statute and the obligations of hospitals to medically screen all
individuals seeking emergency services and to provide stabilizing
medical treatment as necessary to all individuals, including enrollees
of managed care plans, whose conditions warrant it (64 FR 61353). The
Special Advisory Bulletin addressed issues of dual staffing of hospital
emergency rooms by managed care and nonmanaged care physicians, prior
authorization requirements of some managed care plans, use of advance
beneficiary notices (ABNs) or other financial responsibility forms,
handling of individuals' inquiries about financial liability for
emergency services, and voluntary withdrawal of a treatment request.
Although it did not amend the Code of Federal Regulations, the Special
Advisory Bulletin informs individuals of HHS policy regarding
application of the EMTALA statute and offers advice on the best
practices to follow to avoid violation of the requirements imposed
under that statute.
As discussed further in section V. of this preamble, in the May 9,
2002 proposed rule, we proposed to codify certain policies on prior
authorization that are currently stated only in the Special Advisory
Bulletin. We believe these changes in the regulations are needed to
ensure uniform and consistent application of policy and to avoid any
misunderstanding of EMTALA requirements by patients, physicians, or
hospital employees.
III. Summary of the Provisions of the May 9, 2002 Proposed Rule
Relating to EMTALA and Hospital Responsibility for Communication With
Medicare+Choice Organizations Concerning Post-Stabilization Care
Services
A. Summary of the Proposed Provisions Relating to EMTALA
Recently, a number of questions have been raised about the
applicability of Sec. 489.24 to specific situations. These questions
arise in the context of managed care plans' requirements for prior
authorization, case experiences involving elective procedures, and
situations where individuals have been admitted as inpatients without
being stabilized, or patients who had been stabilized later experience
a deterioration in their medical condition. Some hospitals are
uncertain about whether various conditions of participation (CoPs)
found in 42 CFR part 482 apply to these situations or whether the
EMTALA requirements included in the provider agreement regulations at
Sec. 489.24 apply, or both. Some representatives of the provider
community have asked us to reexamine CMS policy on the applicability of
EMTALA to physicians who are ``on call'' and to hospitals that own
ambulances when those ambulances operate under communitywide emergency
medical services (EMS) protocols.
To help promote consistent application of the regulations
concerning the special responsibilities of Medicare-participating
hospitals in emergency cases, in the May 9, 2002 proposed rule (67 FR
31469), we proposed changes to Sec. 489.24 to clarify its application
in these situations and at the same time address concerns about EMTALA
raised by the Secretary's Advisory Committee on Regulatory Reform.
These changes are discussed more fully below and include the following:
[sbull] We proposed to change the requirements relating to
individuals who present with what may be emergency medical conditions
at off-campus outpatient clinics and facilities that do not routinely
provide emergency medical services. We believe these changes will
enhance the quality and promptness of emergency care by permitting
individuals to be referred to appropriately equipped emergency
facilities close to such clinics, rather than being transported to the
main campus emergency department, which may be located at a greater
distance from the clinic.
[sbull] We proposed to clarify the extent to which EMTALA applies
to inpatients and outpatients. We believe these clarifications will
enhance understanding for hospitals as to what their obligations are
under EMTALA, so that they more clearly understand to whom they are
obligated under this provision of the statute, and whose care will be
governed by the Medicare hospital CoPs.
[sbull] We proposed to clarify the circumstances in which
physicians, particularly specialty physicians, must serve on hospital
medical staff ``on-call'' lists. We expect these clarifications will
help improve access to physician services for all hospital patients by
permitting hospitals local flexibility to determine how best to
maximize their available physician resources. We are currently aware of
reports of physicians, particularly specialty physicians, severing
their relationships with hospitals, especially when those physicians
belong to more than one hospital medical staff. Physician attrition
from these medical staffs could result in hospitals having no specialty
physician service coverage for their patients. We proposed
clarification of the on-call list requirements to permit hospitals to
continue to attract physicians to serve on their medical staffs and
thereby continue to provide services to emergency room patients.
[sbull] We proposed to clarify the responsibilities of hospital-
owned ambulances so that these ambulances can be more fully integrated
with citywide and local community EMS procedures for responding to
medical emergencies and thus use these
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resources more efficiently for the benefit of these communities.
In the May 9, 2002 proposed rule, we specifically solicited
comments on all of these proposed changes. In response to the proposed
rule, we received approximately 600 pieces of correspondence, most of
which contained multiple comments. A large number of these comments
were received on the last day of the comment period for the proposed
rule (July 8, 2002). Because of the number and nature of the public
comments we received on our proposed clarifications and our limited
timeframe for developing the final acute care hospital inpatient
prospective payment system regulations for publication by the statutory
deadline of August 1, we decided, with one exception (application of
the EMTALA provisions to provider-based entities), to address the
public comments and finalize the proposed clarifications relating to
implementation of EMTALA in a separate document. This final rule is
that separate document.
In the next several sections of the preamble of this final rule, we
summarize the public comments received on the proposed EMTALA
clarifications and present our responses to those comments, including
any further revisions that we are making in this final rule to the
proposed regulation changes as a result of these comments.
B. Summmary of the Proposed Provisions Relating to Communication with
Medicare+Choice Organizations Concerning Post-Stabilization Care
Services
In the May 9, 2002 proposed rule (67 FR 31471), we proposed to
specify that a hospital must promptly contact the Medicare+Choice
organization after a Medicare+Choice enrollee who is treated for an
emergency medical condition is stabilized (proposed Sec.
489.24(d)(6)). We received a number of public comments on this proposed
provision. However, we are not addressing public comments received on
this provision in this final rule but plan to address them in future
policy guidance.
IV. General Comments on the Proposed Rule
Comment: Some commenters expressed overall support for our proposed
clarifying changes to establish more flexible standards on EMTALA, but
did not offer specific recommendations for modifying them. However, one
commenter, the administrator of a small rural hospital in the Midwest,
expressed concern that our proposals appear to represent a shift from
national requirements to community-based standards, under which the
level of emergency care available in a community would be determined by
the medical staffs of individual hospitals. This commenter stated that,
in many cases, it is possible to continue to maintain emergency
department services in the local community only because of the pressure
exerted on physicians by EMTALA to continue to see patients in the
emergency department. Therefore, the commenter recommended that any
changes in EMTALA regulatory requirements be directed to making those
requirements more stringent and specific and stated that relaxing
EMTALA requirements as proposed will only undermine the efforts of
small rural hospitals to maintain viable emergency services for their
patients.
Response: We appreciate the commenters' support, and have kept
their views in mind in considering the comments of those respondents
who recommended revisions. In regard to the commenter's recommendations
that we make the EMTALA requirements more stringent (rather than
relaxing them) for the benefit of small rural hospitals, we note that
we received many comments expressing concern that the current
requirements may be too burdensome, and therefore, the commenters
recommended more flexible EMTALA rules. We considered all of the
comments received when finalizing our policy.
V. Prior Authorization (Sec. 489.24(d)(4))
A. Provisions of the Proposed Rule
Some managed care plans may seek to pay hospitals for services only
if the hospitals obtain approval from the plan for the services before
providing the services. Requirements for this approval are frequently
referred to as ``prior authorization'' requirements. However, EMTALA
(specifically, section 1867(h) of the Act and our existing regulations
at Sec. 489.24(c)(3)) explicitly prohibit hospitals from delaying
screening or stabilization services in order to inquire about the
individual's method of payment or insurance status. Thus, prior
authorization requirements are a matter of concern because a hospital's
actions in seeking prior authorization from an insurer could result in
a delay in the provision of services required by EMTALA. Our existing
policy prohibits a participating hospital from seeking authorization
from the individual's insurance company for screening services or
services required to stabilize an emergency medical condition until
after the hospital has provided the appropriate medical screening
examination required by EMTALA to the individual and has initiated any
further medical examination and treatment that may be required to
stabilize the patient's emergency medical condition.
In the May 9, 2002 proposed rule, we solicited public comments as
to whether the regulations should be revised to state that the hospital
may seek other information (apart from information about payment) from
the insurer about the individual, and may seek authorization for all
services concurrently with providing any stabilizing treatment, as long
as doing so does not delay required screening and stabilization
services (67 FR 31471).
In addition, we proposed to clarify that an emergency physician is
not precluded from contacting the patient's physician at any time to
seek advice or information regarding the patient's medical history and
needs that may be relevant to the medical screening and treatment of
the patient, as long as this consultation does not inappropriately
delay required screening services or stabilizing treatment.
As explained earlier, this policy was stated in a Special Advisory
Bulletin published jointly by CMS (then HCFA) and the OIG. We proposed
to clarify the existing language at Sec. 489.24(c)(3) (which was
proposed to be redesignated as paragraph (d)(4)) in the proposed rule
to include this policy in the regulations.
B. Summary of Public Comments and Departmental Responses
1. General Comments
Comment: Several commenters expressed general approval of our
proposals without recommending more specific changes.
Response: We appreciate the commenters' support of the proposals
and have taken their views into account in considering the comments of
those respondents who recommended revisions.
2. Concurrent Authorization and Furnishing of Stabilizing Services
Comment: Two commenters recommended that we delete any reference to
seeking authorization for post-stabilization services concurrently with
the provision of stabilizing treatment. The commenters believed
clinical staff cannot easily distinguish between screening services and
stabilizing treatment, and thus may be uncertain as to when stabilizing
treatment has begun in order to seek authorization for the services.
Another
[[Page 53226]]
commenter believed that allowing such concurrent authorization serves
no useful purpose and leaves the hospital open to charges that the
steps taken to obtain concurrent authorization actually delay
stabilization services. This commenter also recommended that the
regulations not allow the concurrent authorization of stabilizing
treatment and the furnishing of actual stabilizing treatment.
Response: We recognize that the distinction between screening
services and stabilizing treatment may be difficult to define outside
the context of a specific case. However, we believe clinicians will be
able, when dealing with a particular patient or case, to identify
clearly when the assessment of an individual has concluded and they
have begun stabilizing the patient with an emergency medical condition.
We expect that these clinical judgments will be the basis for
determining when contact will be appropriate, and that surveyors will
use their own clinical training and experience in evaluating
clinicians' actions.
Regarding the comment that authorization serves no useful purpose,
we note that the regulation merely permits, but does not require,
hospitals to seek concurrent authorization with the furnishing of
stabilizing treatment. We do not believe it is appropriate to prohibit
the practice in all cases and, therefore, are not making any revision
to the proposed language, which we are adopting in this final rule,
based on this comment.
We would like to clarify again that hospitals that choose to seek
concurrent authorization while administering stabilizing treatment must
not delay such treatment in order to obtain authorization. Even if the
approving insurer or physician denies authorization for the stabilizing
treatment, the hospital is obligated under EMTALA to provide the
necessary stabilizing treatment (if the hospital has such
capabilities).
Comment: Some commenters stated that restrictions on contact with a
patient's insurer are not appropriate because a hospital's
administrative staff might not be fully aware of the status of an
individual's treatment (that is, whether a screening has occurred and
stabilizing treatment has been initiated) and that a hospital might,
therefore, violate this requirement inadvertently by requesting
authorization prematurely, even though no delay in the screening or
stabilization actually occurs.
Response: We recognize the possibility pointed out by the
commenter, but believe that hospitals will be able to develop
procedures to alert administrative staff as to when contact may be
initiated.
3. Authorization Requests by Nonphysician Practitioners
Comment: Five commenters recommended that we state more
specifically that CMS' policies on prior authorization apply to
authorization for both hospital and physician (and nonphysician
practitioner) services. In addition, the commenters recommended that
the regulations be revised to clarify whether EMTALA policies also
apply to emergency medical or stabilizing services furnished by
nonphysician practitioners.
A number of commenters recommended that the regulations be revised
to state that nurse practitioners and all other medical or hospital
personnel involved in the individual's treatment, and not just
emergency physicians, are permitted to contact the patient's physician
for information and advice relevant to the patient's medical history
and needs, as long as screening services or stabilizing treatment are
not inappropriately delayed.
Another commenter recommended a change in the wording of proposed
Sec. 489.24(d)(4)(iii) regarding contacts between emergency physicians
and individuals' personal physicians. The commenter believed that the
regulations should also allow such contacts with the individual's
physician to be initiated by a qualified medical person other than a
physician, such as a physician assistant or nurse practitioner.
Response: We agree with the commenters that the prior authorization
policies apply equally to hospital services, physician services, and
nonphysician practitioner services, and are revising Sec.
489.24(d)(4)(ii) to clarify this point. We also agree that qualified
medical personnel other than physicians, such as nonphysician
practitioners (physician assistants and nurse practitioners), should be
permitted to initiate such contacts, and are revising Sec.
489.24(d)(4)(iii) in this final rule accordingly.
Comment: A number of commenters recommended that the final rule be
revised to state that concurrent contact with an individual's insurer
(that is, contact undertaken by administrative staff not involved in
patient screening or treatment that occurs while clinical staff
continue to screen the individual) is not a violation of EMTALA as long
as it does not delay screening or stabilization.
Response: We recognize that section 1867(h) of the Act states only
that a hospital may not delay an EMTALA screening or stabilization in
order to inquire about the individual's method of payment or insurance
status, and does not specifically address the issue of when it is
appropriate for contact with the individual's insurer to be made.
Hospitals have in the past expressed a need for further guidance on the
agency's policy in this area and the Special Advisory Bulletin cited
earlier was developed to provide guidance on this and other issues. We
do not wish to be overly prescriptive on this issue, but do believe
that hospitals should have a clear statement of the agency's policy and
that the policy should strike a reasonable balance between the need to
avoid creating circumstances in which screening or stabilization will
be likely to be delayed and the equally important need to protect the
individual from avoidable liability for the costs of emergency health
care services. We believe the policy in the Special Advisory Bulletin
and reiterated in proposed rule strikes that balance. Therefore, we are
not adopting the commenters' suggestion.
Further, we note that many insurers now provide a ``window'' of at
least 24 hours following emergency department treatment during which
authorization can be obtained. In addition, many States have enacted
revisions to their insurance statutes over the past several years that
explicitly contemplate the existence of the Federal EMTALA statute. As
a practical matter, we believe this feature of private insurance
contracts, as well as State laws governing health insurance contracts,
will allow screening and stabilization to go forward without
compromising the individual's rights to have care covered under his or
her health plan.
4. Medical Staff Communications
Comment: Two commenters objected to the proposed language under
which contact by an emergency physician with the individual's physician
is not prohibited as long as the consultation does not inappropriately
delay EMTALA-mandated screening or stabilization. One commenter stated
that it is never appropriate for regulations to restrict physicians'
communications with one another. The other commenter stated that
section 1867(h) of the Act governs only contacts for the purpose of
insurance information and does not relate in any way to contact with
the individual's physician. The commenter believed the proposed
language at Sec. 489.24(d)(4)(iii) should be deleted because, in the
commenter's view, it implies that some contacts with individuals'
physicians might be
[[Page 53227]]
prohibited by EMTALA, and that making such contacts therefore could
expose the hospital or the emergency physician to sanctions.
Response: We agree that physician communication regarding patient
medical status and information is essential. We expect the regulations
will dispel any possible concerns about the appropriateness of this
communication. Therefore, we do not believe it is necessary to make any
change in the regulations in this final rule based on this comment.
Comment: Two commenters stated that the proposed language regarding
contact with the patient's physician not being prohibited as long as
the consultation does not inappropriately delay EMTALA-mandated
screening or stabilization is unclear, and recommended that it be
revised to state that such contact is not inappropriate as long as it
does not otherwise delay the start of the medical screening
examination.
Response: We do not believe the language as proposed is less clear
than the commenters' recommended alternative. The commenters'
alternative could suggest instead that delays in stabilizing treatment
would be acceptable. Therefore, we are not adopting the recommendation
of the commenters.
Comment: One commenter suggested that CMS clarify the proposed
regulatory language by citing lists of appropriate referral physicians
or participating providers as examples of the types of information that
may appropriately be obtained as long as prior authorization is not
sought.
Response: We agree that it would not be inappropriate to discuss
the types of information the commenter cited with the patient's
attending physician. However, we do not believe these types of
information are representative samples of the types of information that
such contacts should elicit. Therefore, we are not making any change in
the final rule based on this comment.
5. Out-of Network Coverage
Comment: Some commenters stated that they understood the need to
avoid delaying EMTALA screening or stabilization to obtain prior
authorization, but suggested that, if such authorization is not
obtained, patients might be left with substantial financial
responsibility. The commenters noted that individuals may request
information about the costs of services while awaiting a screening
examination. They stated that, while it is important to avoid even the
appearance of coercion of an individual to leave the emergency
department, it is also important to recognize the patient's right to be
informed of potential financial liability for services (including
increased liability for out-of-network services) before, rather than
after, the services are furnished. These commenters recommended that
the regulations be revised to state that a hospital may request
financial or coverage information as long as doing so does not delay
screening or stabilization. The commenters also recommended that we
state that there may be discussion of the limits of an individual's
health insurance coverage if the individual asks about the charges for
the emergency department visit.
Response: As noted in the Special Advisory Bulletin cited earlier
(64 FR 61355), current Interpretive Guidelines indicate that hospitals
may continue to follow reasonable registration processes for
individuals presenting with an emergency medical condition. Reasonable
registration processes may include asking whether an individual is
insured and, if so, what that insurance is, as long as that inquiry
does not delay screening or treatment. Reasonable registration
processes should not unduly discourage individuals from remaining for
further evaluation. As requested by the commenter, in this final rule,
we are revising proposed Sec. 489.24(d)(4) by adding a new paragraph
(iv) to clarify this policy. To avoid any misunderstanding of the
requirement, we have revised the language of the interpretative
guidelines to state that reasonable registration processes must not
unduly discourage individuals from remaining for further evaluation.
Regarding a hospital's response to an individual's inquiry about
financial liability for emergency services, the Special Advisory
Bulletin states that any such inquiry should be answered by a staff
member who is well-trained and knowledgeable and that the staff member
should explain to the individual that, regardless of the individual's
ability to pay, the hospital stands ready and willing to provide any
necessary screening or stabilization services or both. Staff should
encourage the individual to defer further discussion of financial
responsibility issues, if possible, until after any necessary screening
has been performed. We do not believe that this explanation needs to be
included in the regulations.
Comment: One commenter suggested that, in the interest of avoiding
any appearance that an individual's screening or stabilization may have
been influenced by the individual's perceived ability or inability to
pay, financial information collected by registration or billing staff
should not be included in the patient chart that goes back to the
clinical staff who are caring for the individual.
Response: We agree that such a procedure could help avoid the
perception of improper financially based influences on screening or
treatment decisions. We do not believe it is necessary to revise the
final rule to require that such information be excluded from the
patient's chart.
C. Provisions of the Final Rule on Prior Authorizations
In summary, we are adopting the proposed changes relating to prior
authorization for necessary stabilizing treatment for emergency medical
conditions under Sec. 489.24(d)(4) as final, with the following
modification:
We are revising paragraph (d)(4)(ii) to indicate that prior
authorization policies apply to services furnished by a hospital, a
physician, or a nonphysician practitioner.
We are revising paragraph (d)(4)(iii) to specify that an emergency
physician as well as any nonphysician practitioner involved in the
emergency treatment is not precluded from contacting the individual's
physician at any time to seek advice regarding the individual's medical
history as long as the consultation does not delay screening and
stabilizing services.
We are adding a new paragraph (d)(4)(iv) to specify that hospitals
may follow reasonable registration processes for individuals for whom
examination or treatment is required under EMTALA, as long as the
procedures do not result in a delay in screening or treatment.
VI. Clarification of ``Comes to the Emergency Department'' (Sec.
489.24(a) and (b))
A. Background
Section 1867(a) of the Act and our existing regulations at Sec.
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
Sec. 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
[[Page 53228]]
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 Sec.
489.24(a)) and for stabilization or appropriate transfer (currently in
Sec. 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
Sec. 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 Sec. 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 Sec. 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 or 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
[[Page 53229]]
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.
[[Page 53230]]
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
[[Page 53231]]
posted or advertised name, meets the following requirements:
(a) Is a department of a hospital and is intended to routinely
provide unscheduled medical services; or
(b) Meets any one of the following requirements:
(1) Is open 24 hours a day to provide unscheduled medical care,
excluding, at its option, weekends or certain holidays;
(2) 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 (Sec. 482.55) and CAHs (Sec. 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.
[[Page 53232]]
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
Comment: 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
[[Page 53233]]
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 Sec. 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 Sec. 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 Sec. 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 Sec. 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 Sec.
489.24(b) to state that it means a hospital with a dedicated emergency
department as defined in Sec. 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 Sec. 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
Sec. 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.
[[Page 53234]]
We are revising the proposed definition of ``dedicated emergency
department'' at Sec. 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:
(1) It is licensed by the State in which it is located under
applicable State law as an emergency room or emergency department;
(2) 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
(3) During the calendar year immediately preceding the calendar
year in which a determination under Sec. 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.''
VII. Applicability of EMTALA: Individuals Come to the Dedicated
Emergency Department for Nonemergency Services (Sec. 489.24(c))
A. Background
We sometimes receive questions whether EMTALA's requirements apply
to situations in which an individual comes to a hospital's dedicated
emergency department, but no request is made on the individual's behalf
for emergency medical evaluation or treatment. In view of the specific
language of section 1867 of the Act and the discussion in section VII.
of this preamble, which addresses the definition of a hospital's
dedicated emergency department, we believe that a hospital must be seen
as having an EMTALA obligation with respect to any individual who comes
to the dedicated emergency department, if a request is made on the
individual's behalf for examination or treatment for a medical
condition, whether or not the treatment requested is explicitly for an
emergency condition. A request on behalf of the individual would 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 a medical condition.
This does not mean, of course, that all EMTALA screenings must be
equally extensive. The statute plainly states that the objective of the
appropriate medical screening examination is to determine whether or
not an emergency medical condition exists. Therefore, hospitals are not
obligated to provide screening services beyond those needed to
determine that there is no emergency medical condition.
In general, a medical screening examination is the process required
to reach, with reasonable clinical confidence, a determination about
whether a medical emergency does or does not exist. We expect that in
most cases in which a request is made for medical care that clearly is
unlikely to involve an emergency medical condition, an individual's
statement that he or she is not seeking emergency care, together with
brief questioning by qualified medical personnel, would be sufficient
to establish that there is no emergency condition and that the
hospital's EMTALA obligation would thereby be satisfied.
B. Provisions of the Proposed Rule
To clarify our policy in this area, in the May 9, 2002 proposed
rule (67 FR 31473), we proposed to redesignate paragraphs (c) through
(h) of Sec. 489.24 as paragraphs (d) through (i) (we proposed to
remove existing paragraph (i)) and to add a new paragraph (c) to state
that if an individual comes to a hospital's dedicated emergency
department and a request is made on his or her behalf for examination
or treatment for a medical condition, but the nature of the request
makes it clear that the medical condition is not of an emergency
nature, the hospital is required only to perform such screening as
would be appropriate for any individual presenting in that manner, to
determine that the individual does not have an ``emergency medical
condition'' as defined in the regulations. (In the May 9, 2002,
proposed rule, we included an Example 1 as illustrative of application
of this policy (67 FR 31473).)
C. Summary of Public Comments and Departmental Responses
Comment: Many commenters addressed our proposed clarification of
presentments of individuals to dedicated emergency departments for
nonemergency services at 67 FR 31473. One commenter stated that only
those individuals requesting a ``medical examination'' be required to
receive a medical screening examination by a physician or other
qualified medical personnel. Another commenter recommended that EMTALA
not apply to requests for nonemergency care inside the dedicated
emergency department. One commenter believed that EMTALA should not
apply to individuals coming to the dedicated emergency department to
obtain previously scheduled or followup care.
Response: At 67 FR 31473, et seq., of the preamble to the May 9,
2002 proposed rule, and also above, we explicitly clarified the issue
concerning when an individual comes to a hospital's dedicated emergency
department but no request is made on the individual's behalf for
emergency medical evaluation or treatment. To address this scenario, we
stated that hospitals are not obligated to provide screening services
beyond those needed to determine whether an emergency medical condition
exists. In addition, we proposed regulatory language to address the
issue (proposed Sec. 489.24(c)) to specify that if an individual comes
to a hospital's dedicated emergency department and a request is made on
his or her behalf for examination or treatment for a medical condition,
but the nature of the request makes it clear that the medical condition
is not of an emergency nature, the hospital is required only to perform
such screening as would be appropriate for any individual presenting in
that manner, to determine that the individual does not have an
emergency medical condition. Therefore, while EMTALA does apply to any
individual who presents to a hospital's dedicated emergency department
with a medical condition, it does so only to the extent that the
individual must be screened for emergency medical conditions and
supplied necessary stabilizing treatment.
Section 1867(a) of the Act clearly states that a hospital with an
emergency department is required to provide an appropriate medical
screening examination to every individual who presents at the
hospital's emergency department with a medical condition. However, this
screening is only necessary to the extent it takes the hospital to
determine whether the individual has an emergency medical condition.
Once the individual is screened and it is determined the individual has
only presented to the dedicated emergency department for a
[[Page 53235]]
nonemergency purpose, such as followup care, the hospital's EMTALA
obligation ends for that individual at the completion of the medical
screening examination.
Comment: One commenter noted that, in many cases, individuals come
to the dedicated emergency department of the hospital at which their
regular physician practices and ask to be seen for nonemergency medical
conditions that could appropriately be treated in the physician's
office. The commenter asked whether, in these circumstances, a
registered nurse or other qualified medical person on duty at the
dedicated emergency department could perform a screening to rule out
the presence of an emergency medical condition and, if it is determined
that the patient does not have an emergency medical condition, refer
the patient to the physician's office for treatment.
Another commenter stated that we should provide more guidance to
allow busy emergency departments to refer patients without an
``emergency medical condition'' to primary care or specialty care
clinics, or both.
Response: As stated in proposed Sec. 489.24(c), if an individual
comes to a dedicated emergency department and a request is made for
examination or treatment of a medical condition, but the nature of the
request makes it clear that the condition is not of an emergency
nature, the hospital is required to perform only such screening as
would be appropriate for any individual presenting in that manner, to
determine that the individual does not have an emergency medical
condition. Under the circumstances described by these commenters, the
regulations would not require that such screening be done by a
physician. On the contrary, we believe the individual could be screened
by the appropriate nonphysician emergency department staff and, if no
emergency medical condition is found to exist, referred to his or her
physician's office for further treatment. Because we believe that
proposed paragraph (c) clearly would permit such a referral, we do not
believe a further regulations change is needed in this final rule to
clarify this point. We note that while EMTALA does not require that all
screenings be performed by an M.D. or D.O., any nonphysician (such as
an emergency room registered nurse) who performs such screening should
be an individual whom the hospital has designated as a ``qualified
medical person'' for purposes of appropriate transfer certification
under Sec. 489.24(d)(1)(ii)(C) (redesignated in this final rule as
Sec. 489.24(e)(1)(ii)(C)).
Comment: Many commenters believed that the final rule should make
clear that EMTALA does not apply to nonemergency services delivered in
a dedicated emergency department and does not apply to a site other
than a dedicated emergency department unless emergency services are
requested.
Similarly, several commenters requested that we clarify that a
hospital has no obligation under EMTALA to an individual who presents
at a dedicated emergency department but does not request examination or
treatment for a medical condition. Specifically, one commenter believed
that we should clarify that hospitals are not required under EMTALA to
provide medical screening examinations to individuals who request a
medical service that is not examination or treatment for a medical
condition, such as preventive care services, pharmaceutical services,
or medical clearances for law enforcement purposes (such as blood
alcohol tests required by police).
Response: We agree that a hospital has no obligation under EMTALA
to an individual who comes to a dedicated emergency department if there
is no request made by or on behalf of the individual for examination or
treatment for a medical condition, and the individual's appearance or
behavior would not cause a prudent layperson observer to believe that
examination or treatment for a medical condition is needed and that the
individual would request that examination or treatment if he or she
were able to do so. We do not agree that a hospital has no obligation
under EMTALA to an individual who presents at a dedicated emergency
department for ``nonemergency purposes'' because such a purpose can be
a medical one and the statute requires that a hospital perform a
medical screening examination to any individual who presents to the
emergency department with a medical condition. We agree with another
commenter that if an individual presents to a dedicated emergency
department and requests services that are not examination or treatment
for a medical condition, such as preventive care services, the hospital
is not obligated to provide a medical screening examination under
EMTALA to this individual.
We note that pharmaceutical services in a dedicated emergency
department may be for medical conditions and are, therefore, subject to
EMTALA. We also wish to emphasize that the applicable principle is that
presentments to a dedicated emergency department that meet other
applicable criteria for EMTALA applicability will be considered to be
subject to EMTALA if there is a request by or on behalf of the
individual for examination or treatment for a medical condition, or the
appearance or behavior of the individual would cause a prudent
layperson observer to believe that the individual needed such
examination or treatment and that the individual would request that
examination or treatment if he or she were able to do so. Under this
general principle, we will evaluate specific presentments, including
requests by law enforcement authorities for medical clearance of
persons who are about to be incarcerated or for blood alcohol or other
tests to be used as evidence in criminal proceedings, on a case-by-case
basis.
For example, an individual being maintained on psychotropic
medication may come to an emergency department and complain of
experiencing suicidal or homicidal urges because he or she has
exhausted his or her supply of medication. If examination of the
individual verifies the existence of an emergency medical condition and
a supply of the patient's normal medication is required to stabilize
that condition, then EMTALA would require that the hospital provide
that medication. Of course, this does not mean that hospitals are
required by EMTALA to provide medication to patients who do not have an
emergency medical condition, simply because the patient is unable to
pay or does not wish to purchase the medication from a retail pharmacy.
We will address these types of issues in our interpretative guidelines.
Comment: One commenter noted that the issue of nonemergency patient
care that takes place in the dedicated emergency department and
overcrowding is a significant concern. The commenter stated that
education aimed at the public by CMS to help them understand
appropriate alternatives could contribute to reducing abuse.
Response: We agree that it is worthwhile to encourage patients to
seek more appropriate sources of nonemergency care, and will take this
into account as we develop EMTALA-related patient information and
education material.
Comment: One commenter described a situation where hospitals use
their emergency departments as an access point for registration
purposes for the entire hospital after the normal registration area is
closed. The commenter asked whether every individual would be covered
under EMTALA and would require a medical screening even though not
everyone is
[[Page 53236]]
coming to the emergency department seeking emergency medical treatment.
Similarly, another commenter stated that some hospitals,
particularly rural ones, have found that it is most cost-effective for
the hospital if it was configured to have one hospital entrance for
patients who present for emergency care and for patients who do not
present for emergency care. The commenter requested clarification on
whether an EMTALA screening would be required for both types of
patients who walk through that one entrance.
One commenter described a situation where a hospital operates
ambulatory care centers and other facilities (such as primary care
clinics) in tandem with the hospital's dedicated emergency department.
The commenter believed the nondedicated emergency department of the
hospital should be explicitly excepted from the definition of
``dedicated emergency department'' to address this ``tandem'' scenario.
Response: Regarding the first two comments, we agree that EMTALA
does not apply to individuals who may pass through a hospital's
emergency department but do not request examination or treatment for a
medical condition, have such a request made on their behalf, or
indicate through their appearance or behavior that examination or
treatment for a medical condition would, in the judgment of a prudent
layperson, be needed. We have not revised the final rule on this point,
but intend to take it into account in developing interpretative
guidelines and training materials for EMTALA surveyors. The third
comment does not raise an issue of EMTALA policy, but merely shows that
it will be necessary in some cases to determine exactly which physical
locations constitute a hospital's dedicated emergency department. Such
decisions will be made a case-by-case basis by CMS, based on
information provided by the State survey agency.
Comment: One commenter suggested that we define whether there has
been a request for examination or treatment under EMTALA by the
resources that it would take to fulfill the request. The commenter gave
an example of a request for unscheduled medical services that would
require the service of a ``qualified medical provider.'' The commenter
stated that a request to take out stitches does not require a doctor or
consultation with a doctor unless there is an additional complaint
expressed.
Response: While this is an interesting suggestion, we believe that
it is one that would be difficult to implement as an objective
standard, because estimates of resources needed will necessarily be
subjective. Therefore, we are not revising the final rule based on this
comment.
Comment: One commenter believed that the standard stated at
proposed Sec. 489.24(c), ``the nature of the request makes it clear
the medical condition is not of an emergency nature'', is too
subjective. The commenter believed it would almost certainly invite
State surveyors to second guess the determination of the qualified
medical person.
Response: The purpose of conducting an EMTALA investigation is to
ascertain whether or not the hospital has violated the requirements of
Sec. 489.24 or the related requirements of Sec. 489.20. The survey is
conducted in accordance with applicable CMS survey procedures and
policies. The surveyor's recommendation of a violation determination is
based on facts uncovered by the onsite investigation. The CMS regional
office will make the final compliance determination with information
obtained after the onsite investigation by the State survey agency.
Comment: Several commenters believed that triage of the individual
presenting to the dedicated emergency department should be adequate for
purposes of fulfilling EMTALA screening obligations. Specifically, one
commenter did not believe that EMTALA should apply to individuals who
present to the dedicated emergency department with no ``significant
distress or risk'' as determined by triage of vital signs, and ``who
are comfortable and active'' in a waiting area whereby they are well
provided for while they are waiting for care or treatment.
Another commenter asked us to clarify whether vital signs must be
obtained in every medical screening examination upon presentment to a
hospital's dedicated emergency department.
Response: Section 1867(a) of the Act requires that individuals
coming to the emergency department be provided a medical screening
examination. The statute states:
``In the case of a hospital that has a hospital emergency
department, if any individual (whether or not eligible for benefits
under this title) comes to the emergency department and a request is
made on the individual's behalf for examination or treatment for a
medical condition, the hospital must provide for an appropriate medical
screening examination within the capability of the hospital's emergency
department, including ancillary services routinely available to the
emergency department, to determine whether or not an emergency medical
condition (within the meaning of subsection (e)(1)) exists.''
Triaging is not equivalent to a medical screening examination.
Triaging merely determines the ``order'' in which patients will be
seen, not the presence or absence of an emergency medical condition. If
the medical screening examination is appropriate and does not reveal an
emergency medical condition, the hospital has no further obligation
under Sec. 489.24.
The decision to take vital signs may be required by the qualified
medical professional or the hospital's emergency department's policies
and procedures, or both. Vital signs are indicators of a patient's
level of wellness and are valuable parameters to assist health
professionals in making medical decisions concerning a patient's health
needs. The patient's medical condition and the discretion of the
practitioner will determine the need for monitoring of vital signs.
We do not believe the taking of a patient's vital signs is required
for every presentment to a hospital's dedicated emergency department.
As we have stated above, we expect that, in most cases in which a
request is made for medical care that clearly is unlikely to involve an
emergency medical condition, an individual's statement that he or she
is not seeking emergency care, together with brief questioning by
qualified medical personnel, would be sufficient to establish that
there is no emergency medical condition and the hospital's EMTALA
obligation would thereby be satisfied.
Comment: One commenter requested that we modify proposed Sec.
489.24(c) to provide that EMTALA imposes no minimum requirements for
conducting medical screening examinations for cases falling within this
paragraph. The commenter stated that the extent of the necessary
examination is within the sole discretion of the qualified medical
personnel performing the examination.
Response: As required by statute, we believe that a hospital must
be seen as having an EMTALA obligation with respect to any individual
who comes to the dedicated emergency department for examination or
treatment for a medical condition. While we will refrain from dictating
what type of medical screening examination is required for each
individual who presents to the dedicated emergency department, we
believe that such screenings should be provided to each individual
commensurate with the condition that is presented. As we have stated
previously, this does not mean that all EMTALA screenings must be
equally extensive. Hospitals are not obligated to
[[Page 53237]]
provide screening services beyond those needed to determine that there
is no emergency medical condition.
We agree with the commenter that the extent of the necessary
examination is generally within the judgment and discretion of the
qualified medical personnel performing the examination. However, we
note that the extent and quality of the screening by the qualified
medical personnel are subject to review (by QIOs and State surveyors,
for example), in the case of a complaint filed in accordance with
section 1867 of the Act.
Comment: One commenter expressed concern about enforcement of the
standard stated in proposed Sec. 489.24(c). The commenter was
concerned with the scenario in which it is later determined that an
individual who had presented to the dedicated emergency department for
such medical treatment as suture removal (as used in the example at 67
FR 31473) was, in fact, suffering from an emergency medical condition,
and this emergency medical condition was not detected during this less
extensive examination.
Response: As we stated in the proposed rule, hospitals are not
obligated to provide screening services in the dedicated emergency
department beyond those needed to determine that there is no emergency
medical condition. We assume that qualified medical personnel or
physicians will be performing the medical screening examination
(however modified for the condition presented) to determine whether the
individual is suffering an emergency medical condition. If it is later
found that the individual had been suffering an emergency medical
condition upon presentment to the dedicated emergency department but
only asks for examination or treatment for the suture removal, or some
lesser medical condition, and a complaint is filed for an alleged
dumping in accordance with section 1867 of the Act, as stated above,
the extent and quality of the screening by the qualified medical
personnel would be subject to review by State surveyors to permit a
determination to be made as to whether there was an EMTALA violation.
We note that if, upon investigation of the alleged dumping, it is found
that an adequate medical screening had been performed, the hospital
would not be found liable under EMTALA.
Comment: One commenter asked why CMS needed to add a new Sec.
489.24(c) to reinforce the requirement that all visits to the emergency
department triggers EMTALA obligations, whether the individual is
requesting emergency services or coming for nonemergency services. The
commenter indicated that ``any individual'' who comes to the emergency
department requesting care is already covered by EMTALA.
Another commenter stated that the real issue is when a hospital is
required to perform a medical screening examination and when it is not
required to perform one. The commenter indicated that staff of hospital
emergency departments should be able to ask patients why they have come
to the emergency department.
Response: In proposed Sec. 489.24(c), and accompanying language in
the preamble at 67 FR 31473, we attempted to provide some guidance to
hospitals and physicians as to whether EMTALA's requirements apply to
situations in which an individual comes to a hospital's dedicated
emergency department, but no request is made for emergency medical
evaluation or treatment. While we have repeatedly stated that we are
refraining from dictating to hospitals standards for medical screening
examinations, we hoped to address some concerns in the provider
community that all EMTALA screenings must be equally extensive to each
individual who presents to the dedicated emergency department. Rather,
once an individual states that he or she is not at a hospital's
dedicated emergency seeking emergency care as the commenter suggested,
some brief questioning by qualified medical personnel of why the
individual is there would be adequate to fulfill the requirements of
the medical screening examination for purposes of EMTALA.
Comment: One commenter asked for clarification on whether EMTALA
applies to individuals who seek outpatient services from the hospital
on an unscheduled basis; for example, when an individual's physician
directs the individual to go to the hospital to obtain laboratory and
x-rays so that the physician may determine whether the individual has
pneumonia or another condition.
Response: As explained elsewhere in this preamble, whether EMTALA
applies to a specific individual will depend on whether the individual
presents to the hospital's dedicated emergency department or to another
area of the hospital, and on what type of request for examination or
treatment is made. For example, an individual being sent to a hospital
for specific diagnostic tests ordered by a physician outside the
hospital would normally be directed by that physician to go to the
hospital's laboratory and radiology department, not to the dedicated
emergency department. In either setting, a simple request for a
diagnostic test or image generally would not be considered a request
for examination or treatment for what may be an emergency medical
condition, so the hospital would have no EMTALA obligation to that
individual. However, if the individual were to tell the hospital staff
at the laboratory or radiology department that he or she needed
emergency care, EMTALA would apply. EMTALA also would apply if, in the
absence of a verbal request, the individual's appearance or behavior
were such that a prudent layperson observer would believe the
individual needed examination or treatment for an emergency medical
condition and that the individual would request that examination or
treatment if he or she were able to do so. Of course, in any actual
complaint investigation, the State survey agency and, where
appropriate, the QIO would review all actual relevant facts and
circumstances to ensure that the regulations are applied appropriately
in that case.
Comment: One commenter was concerned with the example at 67 FR
31473 of the proposed rule of a woman presenting to a hospital's
emergency department with a request for suture removal. The commenter
asked for information on the location of the outpatient clinic to which
the qualified medical nurse refers the woman for the suture removal
after the nurse screens the woman for any emergency medical conditions
and also the timing of the clinic's evaluation. The commenter also
stated that it would be helpful to clarify that ``same-day on-campus
referral'' to another medical facility outside the dedicated emergency
department is not mandatory for EMTALA purposes.
Response: By the commenter's request for information about the
location of the outpatient clinic to which the patient is referred, we
assume the commenter is interested in whether the outpatient clinic in
the example is a department of the hospital (that is, provider-based).
We do not see this as a particularly relevant fact, nor do we see the
issue of timing of that outpatient clinic's evaluation to the issue of
the applicability of EMTALA to that patient on the part of the
hospital.
However, we do believe that it would not be an EMTALA obligation
for the qualified medical nurse in the example to make the referral to
the outpatient clinic upon finding that the woman does not have an
emergency medical condition. Nevertheless, it would appear to us that
good standards of practice would dictate that any qualified medical
personnel screening the patient would refer the patient elsewhere for
treatment of her obvious medical
[[Page 53238]]
condition, rather than simply sending her out of the emergency
department upon finding that she did not have an emergency medical
condition.
D. Provisions of the Final Rule
We are adopting, as final, the proposed provisions under Sec.
489.24(c).
VIII. Applicability of EMTALA: Individual Presents at an Area of the
Hospital's Main Campus Other Than the Dedicated Emergency Department
(Sec. 489.24(b))
A. Background
Routinely, individuals come to hospitals as outpatients for many
nonemergency medical purposes. If such an individual initially presents
at an on-campus area of the hospital other than a dedicated emergency
department, we would expect that the individual typically would not be
seeking emergency care. Under most of these circumstances, EMTALA would
therefore not apply (this concept is further discussed in section IX.B.
of this preamble). However, questions have arisen as to whether a
hospital would incur an EMTALA obligation with respect to an individual
presenting at that area (that is, an on-campus area of the hospital
other than a dedicated emergency department) who requests examination
or treatment for what is believed to be an emergency medical condition,
or had such a request made on his or her behalf.
B. Provisions of the Proposed Rule
In the May 9, 2002 proposed rule (67 FR 31473 and 31506), we
proposed to specify in the regulations (Sec. 489.24(b), definition of
``come to the emergency department'') that, for an individual who
presents on hospital property other than the dedicated emergency
department and requests examination or treatment for what may be an
emergency medical condition, a request would be considered to exist if
the individual requests examination or treatment for what the
individual believes to be an emergency medical condition. We further
explained that if there is no actual request, for example, if the
individual is unaccompanied and is physically incapable of making a
request, the request from the individual would be considered to exist
if a prudent layperson observer would believe, based upon the
individual's appearance or behavior, that the individual needs
treatment for an emergency medical condition. We stated that the
proposed policy was appropriate because section 1867 protections should
not be denied to those individuals whose need for emergency services
arises upon arrival on hospital property at the hospital's main campus,
but before they have presented to the dedicated emergency department.
Under the proposed policies, a request for examination or treatment
by an individual presenting for what is believed to be an emergency
medical condition at an on-campus area of the hospital other than the
dedicated emergency department would not have to be expressed verbally
in all cases. In some cases, the request may be inferred from what a
prudent layperson observer would conclude from an individual's
appearance or behavior. While there may be a request (either through
the individual or a prudent layperson), thereby triggering an EMTALA
obligation on the part of the hospital, this policy does not mean that
the hospital must maintain emergency medical screening or treatment
capabilities in each department or at each door of the hospital, nor
anywhere else on hospital property, other than the dedicated emergency
department.
Our proposal, and the considerations on which it is based, are
further discussed in the preamble to the May 9, 2000 proposed rule (67
FR 31473). We also specifically solicited comments from hospitals and
physicians on examples of ways in which hospitals presently react to
situations in which individuals request emergency care in areas of the
hospital other than the hospital's emergency department.
In the May 9, 2002 proposed rule, we also proposed that EMTALA
would not apply to an individual who experiences what may be an
emergency medical condition if the individual is an outpatient (as that
term is defined in 42 CFR 410.2). We explained that we would consider
such an individual to be an outpatient if he or she has begun an
encounter (as that term is defined in 42 CFR 410.2) with a health
professional at the outpatient department. Because such individuals are
patients of the hospital already, we believe it is inappropriate that
they be considered to have ``come to the hospital'' for purposes of
EMTALA. However, we note that such an outpatient under our proposal who
experiences what may be an emergency medical condition after the start
of an encounter with a health professional would have all protections
afforded to patients of a hospital under the Medicare hospital CoPs (as
discussed in section XIV. of the preamble). Hospitals that fail to
provide treatment to these patients could face termination of their
Medicare provider agreements for a violation of the CoPs. In addition,
as patients of a health care provider, these individuals are accorded
protections under State statutes or common law (for example, State
malpractice law and patient abandonment torts) as well as under general
rules of ethics governing the medical profession. Our proposal, and the
considerations on which it is based, are further discussed in the
preamble to the May 9, 2002 proposed rule (67 FR 31473 through 31474).
In the proposed rule, we also proposed to retitle the definition of
``property'' at Sec. 489.24(b) to ``hospital property'' and relocate
it as a separate definition. In addition, we proposed to clarify which
areas and facilities are not considered hospital property.
C. Summary of Public Comments and Departmental Responses
1. Presentation Outside the Dedicated Emergency Department
Comment: Regarding our proposed clarifications on the applicability
of EMTALA for presentments on hospital property outside the dedicated
emergency department, one commenter believed that, while the
clarifications were necessary, ``it is perhaps a sad indictment of our
healthcare system that we actually have to mandate medical providers
that someone unconscious must receive immediate medical care. * * *
Anyone doing this sort of denial of care deserves more than an EMTALA
citation.'' Many other commenters expressed concern about the absence
from the proposed regulatory text of qualifying language that is set
forth in the preamble of the proposed rule. Specifically, one commenter
cited the proposed preamble language at 67 FR 31473 that states:
``* * * EMTALA is triggered in on-campus areas of the hospital
other than a dedicated emergency department where, in an attempt to
gain access to the hospital for emergency care, an individual comes to
a hospital and requests an examination or treatment for a medical
condition that may be an emergency.'' (Emphasis added.) The commenter
further cited the preamble at 67 FR 31474:
``We are proposing that EMTALA would not apply to * * * an
individual who * * * experiences what may be an emergency medical
condition if the individual is an outpatient (as that term is defined
at 42 CFR Sec. 410.2) who has come to the hospital outpatient
department for the purpose of keeping a previously scheduled
appointment. We would consider such an individual to be an outpatient
if he or she has begun an encounter (as that term is
[[Page 53239]]
defined at Sec. 410.2) with a health professional at the outpatient
department.'' (Emphasis added.)
The commenter then compared this language in the preamble to the
proposed regulatory text at Sec. 489.24(b) that would hold a hospital
accountable under EMTALA when an individual 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 or her behalf. * * *'' The
commenter was concerned that neither of the preamble's purported tests
for EMTALA's applicability outside of the dedicated emergency
department that are quoted above is referenced in the proposed
regulatory text: neither the test of whether the individual came to the
hospital in an attempt to gain access to the hospital for emergency
care, nor the objective test of whether the patient has begun an
encounter with a health professional at the outpatient department. This
commenter believed that the regulatory text should be revised to
clearly state that EMTALA is not applicable to outpatients who have
initiated an encounter with a health professional in a hospital
outpatient department other than a dedicated emergency department.
Another commenter suggested that we substitute the term ``member of
the public'' for ``outpatients'' in the definition of dedicated
emergency department (``a 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''). The
commenter believed that the clear implication of the definition is that
an outpatient may be covered under EMTALA, a conclusion that is
inconsistent with other provisions in the proposed rule.
Other commenters requested that we clarify that EMTALA would not
apply when individuals arrive on the orders of their physicians, such
as when a pregnant woman or a psychiatric patient arrives upon a
physician's order either for testing or because he or she is in need of
immediate medical care. In addition, some commenters believed that CMS
should clearly state that only the Medicare hospital CoPs and not
EMTALA would apply to individuals with scheduled outpatient
appointments or procedures.
Another commenter disagreed with the CMS statement in the preamble
to the proposed rule that EMTALA does not apply to ``established
patients'' who need emergency care while on hospital property. The
commenter stated that it may be impossible to distinguish such a
patient from anyone else experiencing a similar emergency also on
hospital property, and was concerned that the concept of excluding an
established patient from EMTALA will raise many definitional and
logistical issues.
One commenter believed that we intended for EMTALA not to apply in
situations where the individual has arrived for an appointment, even if
they had not yet been assisted. The commenter urged clarification on
this issue.
One commenter stated that there may be occasions where individuals
present to the hospital for outpatient services where no orders are
necessary to provide services to the individual, such as annual
mammograms or health fairs. The commenter requested that EMTALA should
not apply to individuals in these circumstances.
Response: As we describe above, in the preamble to the May 9, 2002
proposed rule, we proposed that EMTALA would not apply to an individual
who experiences what may be an emergency medical condition if the
individual is an outpatient (as that term is defined at 42 CFR 410.2)
who has come to a hospital outpatient department for the purpose of
keeping a previously scheduled appointment. In response to the comments
requesting further clarification of the text of the regulations, and in
consideration of the role of the Medicare hospital CoPs in protecting
the health and safety of hospital outpatients, we are revising the
final rule to state that EMTALA does not apply to any individual who,
before the individual presents to the hospital for examination or
treatment for an emergency medical condition, has begun to receive
outpatient services as part of an encounter, as defined in 42 CFR
410.2, other than an encounter that the hospital is obligated by EMTALA
to provide. We believe this revised language sufficiently encompasses
any individuals who come to a hospital to receive nonemergency services
and have begun to receive those services. Such individuals would be
included under this policy, regardless of whether or not they began the
nonemergency encounter in order to keep a previously scheduled
appointment or under orders of a physician or other medical
practitioner. We also assume that specific mention of outpatient
registration is unnecessary in the revised language because we believe
all individuals who have begun an encounter under Sec. 410.2 are
registered outpatients in the hospital's records. This change is
reflected in the revision of the proposed definition of ``patient''
under Sec. 489.24(b) in this final rule. As we stated in the preamble
to the proposed rule, we believe it is inappropriate to consider such
individuals, who are hospital outpatients who have protections under
the CoPs, to have ``come to the hospital'' for purposes of EMTALA as
well, even if they subsequently experience an emergency medical
condition.
We note that individuals who are already patients of a hospital and
who experience emergency medical conditions are protected by existing
Medicare hospital CoPs. We discuss these CoPs in greater detail in
section XIII. of this final rule. Hospitals that fail to provide
treatment to these patients could face termination of their Medicare
provider agreements for a violation of the CoPs. In the January 24,
2003 Federal Register (68 FR 3435 through 3436), we describe the
process by which we enforce compliance with these CoPs. For example, we
explained that if our surveyors discover noncompliance with the
hospital CoPs, ``the hospital will be scheduled for termination from
the Medicare and Medicaid programs.'' Thus, for violations of the CoPs,
as well as for violations of EMTALA (compliance with which is a
Medicare participation requirement) hospitals face the extreme sanction
of termination from the Medicare program. In addition, as patients of a
health care provider, these individuals are accorded protections under
State statutes or common law as well as under general rules of ethics
governing the medical professions.
In response to the comment concerning the individual who comes to
the hospital for purposes of an annual mammogram or health fair, with
or without an order or referral by a physician, that individual is not
presenting to the hospital with a particular emergency medical
condition. Therefore, EMTALA would not apply. We believe this is
consistent with our policy stated elsewhere in this preamble.
Of course, where EMTALA applies to a particular individual who has
presented to the hospital for examination or treatment for an emergency
medical condition, EMTALA's application does not end just because the
individual has begun an outpatient encounter; only screening and, where
necessary, stabilization, admission for inpatient services, or
appropriate transfer end the hospital's EMTALA obligation to the
individual (see section VIII. of this preamble for further discussion
of the issue of when an EMTALA obligation ends). The fact
[[Page 53240]]
that protections under the CoPs may later be afforded to an outpatient
who is already protected by EMTALA does not end the individual's EMTALA
protection.
In response to the commenter's concern that we incorporate the
language regarding coming to the hospital in order ``to gain access to
the hospital for emergency care'' into the regulation text, while in
most emergency cases individuals will come to a hospital in order to
gain access to emergency care at the hospital, not all emergency
patients start out that way. Some individuals may come to the on-campus
hospital property for reasons other than to seek medical services for
themselves (examples would include a hospital employee, or a visitor of
the hospital). Such individuals would not be protected by the hospital
CoPs if they happen to experience what may be an emergency medical
condition while on hospital property, since they are not hospital
patients. Therefore, we are clarifying here that we consider such
individuals to have ``come to the emergency department.'' Under section
1867(a) of the Act, such individuals are protected by EMTALA and
hospitals must provide them with screening and necessary stabilizing
treatment.
To address the comment concerning the substitution of the term
``outpatients'' in the proposed definition of ``dedicated emergency
department'', we mention the comment in this section of the preamble of
this final rule because, as the commenter pointed out, it would appear
to be inconsistent with our policy in our proposed regulations text at
Sec. 489.24 that EMTALA would not apply to any patient, as defined in
proposed Sec. 489.24(b), who would include ``outpatients'' as defined
at Sec. 410.2, and yet we would use the term ``outpatients'' in our
application of EMTALA for individuals that present at dedicated
emergency departments. In addition, we also proposed in the preamble to
the proposed rule that EMTALA would not apply to outpatients with
emergency medical conditions that arise during an encounter. We are
clarifying in this final rule that EMTALA will apply to any individual
who presents to the hospital for examination or treatment for an
emergency medical condition, but EMTALA will not apply to individuals
who have begun to receive outpatient services as part of an encounter,
as defined in Sec. 410.2, other than an encounter that the hospital is
obligated by EMTALA to provide.
In this final rule, in response to comments, we are revising our
definition of ``dedicated emergency department'' at Sec. 489.24(b) to
specify that such a department is a unit in the hospital that meets at
least one of three criteria, one of which is that it is any department
or facility of the hospital that provides for the examination or
treatment of emergency medical conditions for at least one-third of all
of its outpatient visits, based on a representative sample of patient
visits for the calendar year immediately preceding the calendar year in
which a determination is being made. This revised language avoids using
the term ``individuals'' or ``member of the public'' and would
sufficiently encompass any person, including hospital staff who may
become ill, who comes to a hospital's emergency department for medical
care.
In addition, we are revising the proposed definition of ``patient''
under Sec. 489.24(b) to indicate that EMTALA does not apply to an
individual who has begun to receive outpatient services as part of an
encounter, as defined in Sec. 410.2, other than an encounter that the
hospital is obligated by EMTALA to provide.
Comment: One commenter asked us to clarify whether EMTALA is
triggered for an individual who comes to the hospital as an outpatient
for a scheduled appointment and who, after treatment has commenced,
experiences an emergency medical condition, and is then moved to the
dedicated emergency department for treatment. Similarly, the commenter
asked whether an individual transported by the hospital to the
dedicated emergency department from an off-campus department that is
not a dedicated emergency department is an EMTALA patient upon arrival.
The commenter asked whether individuals in these two settings should be
handled differently.
Response: As we have described above, in this final rule, we are
providing that individuals who have begun to receive outpatient
services during an encounter are not protected under EMTALA if they are
later found to have an emergency medical condition (even if they are
then transported to the hospital's dedicated emergency department).
These individuals are considered patients of the hospital and are
protected by the Medicare hospital CoPs and relevant State law. In
addition, as we describe below, individuals who present to a provider-
based, off-campus department that is not a dedicated emergency
department with emergency conditions are not protected by EMTALA, but
rather by the hospital CoPs as well as relevant State law.
Comment: A number of commenters expressed concern about EMTALA
applicability to individuals who present at a hospital for emergency
care outside the dedicated emergency department. One commenter stated
that establishing a ``different set of expectations'' for departments
that are not dedicated emergency departments when an individual
presents for care is likely to cause confusion and is asking
potentially nonclinical persons to make clinical judgments they have no
training to make. Another commenter stated that medical personnel
cannot be at all hospital locations to conduct screening and
stabilization services, and believed that we should revise how medical
staff are required to respond to medical emergencies in nonemergency
department locations.
Response: As we have expressed above, whether an individual
presents for care at a hospital's dedicated emergency department, or
elsewhere on hospital property, if EMTALA is triggered, the hospital
has the same obligations to that individual. It is up to the hospital
to determine how best to provide the screening and necessary
stabilizing treatment to the individual who presented. In either case,
the hospital is responsible for treating the individual within the
capabilities of the hospital as a whole, not necessarily in terms of
the particular department at which the individual presented. Whether
the hospital sets up procedures to immediately transport the individual
to the hospital's dedicated emergency department, or whether the
hospital sets up procedures to send a ``trauma crew'' or ``crash team''
of physicians and nurses out to the individual on site, we do not
believe it is appropriate for us to dictate to hospitals how best to
treat individuals who present for emergency care in hospital
departments other than dedicated emergency department locations.
In addition, we do not believe treatment of an emergency patient
would involve having nonclinical hospital staff making determinations
about an individual's medical condition; rather, we envision that, as
stated above, hospitals would set up procedures to provide for
emergency care to individuals who present in hospital departments other
than dedicated emergency department locations on the hospital campus.
2. Prudent Layperson Standard
Comment: A number of commenters expressed concern about our
proposed ``prudent layperson'' standard. We stated in the proposed rule
that, for both presentments inside the dedicated
[[Page 53241]]
emergency department and also elsewhere on hospital property, a request
for examination or treatment would 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 (or examination or treatment for a medical
condition for presentments inside the dedicated emergency department).
Many other commenters supported our proposed prudent layperson
standard; they believed that the standard would ensure that the obvious
emergency situation would be addressed, even if the individual were
unable to verbalize the request.
Several other commenters requested that we substitute the term
``obvious implied request'' or ``implied request,'' instead of relying
on the perceptions of a prudent layperson for individuals who are
unable to articulate their needs.
Many commenters believed that hospitals must be on notice of an
individual's presentment in order for EMTALA to be triggered to that
individual. One commenter stated: ``Because an EMTALA obligation is
triggered by a patient-generated request, hospital personnel must be
made aware of the individual's presence and observe the appearance or
behavior or both of that person in order to respond appropriately.
Additionally, all hospitals need policies that describe steps to be
taken to assure that a person in clear need, for example, a visitor who
collapses in the cafeteria, receives medical attention.''
Several commenters requested that the final rule make clear that
EMTALA does not apply to an individual presenting on on-campus hospital
property other than a dedicated emergency department unless emergency
services are requested.
Response: First, we agree with the commenters that hospital
personnel must be aware of the individual's presence and observe the
appearance or behavior, or both, of that person in order for EMTALA to
be triggered. Obviously, the hospital must be on notice of the
individual's existence and condition for any violation of the statute
to take place. This also applies to presentments for off-campus
dedicated emergency departments; only if the hospital's staff are aware
of an individual's presence in the department for examination or
treatment for a medical condition is EMTALA triggered.
We also agree with the commenters that EMTALA does not apply
elsewhere on on-campus hospital property other than a dedicated
emergency department unless emergency services are requested. As we
clarified in section V.J.8 of the preamble of the May 9, 2002 proposed
rule (67 FR 31473 through 31474), and also as we discuss in section IX.
of the preamble, a request for treatment would be considered to exist
if the individual requests examination or treatment for what the
individual believes to be an emergency medical condition. Where there
is no actual request because, for example, the individual is
unaccompanied and physically incapable of making the request, the
request from the individual will be considered to exist if a prudent
layperson observer would believe, based upon the individual's
appearance or behavior, that the individual needs examination or
treatment for an emergency medical condition.
However, to address the commenters who requested an ``obvious
implied request standard'' instead of the ``prudent layperson
standard'', we believe the prudent layperson standard is necessary for
both presentments inside the dedicated emergency department and
elsewhere on hospital property. We are concerned about the circumstance
where hospital staff observe the appearance or behavior of an
individual who clearly has an emergency medical condition, but do
nothing to provide treatment for that individual.
In addition, the term ``prudent layperson'' is consistent with the
Medicare and Medicaid programs, in general. We believe it is
appropriate and realistic to utilize this objective standard in the
EMTALA context as well, because it reflects a standard for judging
whether the hospital should have acted--it does not shift control of
events to any particular individual layperson.
Comment: One commenter who supported the prudent layperson standard
suggested that the proposed regulatory language at paragraphs (1) and
(2) under the definition of ``comes to the emergency department'' under
Sec. 489.24(b) is too broad and could encompass situations for which
CMS did not intend EMTALA to apply. The commenter recommended that CMS
modify the language in those paragraphs to state: ``a request on behalf
of the individual will be considered to exist if the individual is
unable to make the request and a prudent layperson observer would
believe. * * *'' The commenter stated that an individual need not rely
on the prudent layperson observer if he or she is able to request
examination or treatment for himself or herself.
Another commenter requested that CMS limit application of the
prudent layperson language to circumstances where the need for
emergency services is clear and the individual cannot make the request
and there is no one to make the request on behalf of the individual.
Response: We agree with the commenters that the prudent layperson
standard is to be relied upon only in circumstances where the
individual is unable to make the request for examination or treatment
of himself or herself. However, we do not agree that a change in the
regulatory language is needed. We believe that our proposed regulatory
language in that section, which states: ``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
* * *'' (emphasis added), encompasses any situation in which an
individual has come to the hospital and a prudent layperson observer
would believe the individual may have an emergency medical condition
and that the individual would request examination or treatment if he or
she were able to do so, whether or not the individual is unaccompanied.
Comment: One commenter stated that hospital staff do not want to be
in the position of interpreting the ``prudent layperson'' terminology.
Another commenter was concerned that some members of a hospital's staff
may not be ``prudent laypeople'' who are in the position of determining
whether someone needs emergency care. For example, a hospital may
employ a disabled worker to provide basic yard services. A third
commenter stated that many hospitals use volunteers to staff courtesy
desks to assist patient families and provide directions in and around
the hospital. The commenter was concerned that requesting volunteer
hospital staff to provide emergency care for individuals presenting at
the hospital outside of the dedicated emergency department is
``excessive.'' The commenter stated that if volunteers are assigned
this responsibility, they may no longer provide volunteer services and
the hospital would need to add paid staff, which would increase the
cost of care. The commenter added that these volunteers or other staff
would need training to comply with this new definition and
responsibility.
Response: Our rationale for the prudent layperson standard is to
determine whether an EMTALA obligation has been triggered toward a
particular individual. It is a legal standard that would be used to
determine whether EMTALA was
[[Page 53242]]
triggered--it is not meant for hospital staff, including volunteers, to
be ``interpreting'' the prudent layperson standard. Rather, we foresee
that in cases in which hospital staff or other individuals at the
hospital have witnessed the behavior of the individual upon his or her
presentation to the hospital, the prudent layperson standard will be
applied to the facts (the appearance and behavior of the presenting
individual) to determine if EMTALA had been triggered.
Comment: One commenter stated that EMTALA should apply only in
situations where the prudent layperson believes the individual needs
emergency examination or treatment, and not simply examination or
treatment at some later date or time.
Response: We proposed the prudent layperson standard to apply to
presentments both inside and outside the dedicated emergency
department. Therefore, for presentments inside the dedicated emergency
department, the proposed standard is that the prudent layperson
observer would believe, based on the individual's appearance or
behavior, that the individual needs examination or treatment for a
medical condition. For presentments on hospital property outside the
dedicated emergency department, the prudent layperson would believe the
individual needs examination or treatment for an emergency medical
condition. However, we do agree with the commenter that the standard is
that the prudent layperson would believe that the individual needs the
examination or treatment at the time of the presentment (when the
hospital is on notice of the individual's existence on hospital
property), and not at a later date or time.
Comment: One commenter describes a scenario where an individual
with a bad cough and wheezing visits a family member in the dedicated
emergency department. The commenter believed that, even though the
individual may need examination or treatment, the hospital should have
no duty to offer or provide care unless that individual actually asks
for care. The commenter indicated that in such a case it should not
matter whether a prudent layperson observer would believe that the
individual needs care.
Response: We agree with the commenter that the prudent layperson
standard should not be applied so broadly as to mandate EMTALA
screenings for individuals who are fully capable of making a verbal
request for examination or for a medical condition, but elect not to do
so. Inherent in such a standard is not only the notion that the
individual's appearance or behavior would lead a prudent layperson
observer to believe that the individual needs examination or treatment
for a medical condition, but a belief by the prudent layperson that
there has been no verbal request only because the individual's medical
condition, or some other factor beyond the individual's control, such
as a language barrier, makes a verbal request impossible. We are not
revising the final rule based on this commenter's concern because we
believe it is not feasible to attempt to codify all of the various
conditions and circumstances under which a verbal request would not be
possible. However, we will keep this concern in mind as we develop
interpretative guidelines or other instructional material for State
surveyors.
3. Determination of ``What May Be an Emergency Medical Condition''
Comment: Several commenters did not agree with the language used in
the regulatory standard for EMTALA applicability outside the dedicated
emergency department that the presenting individual requests
examination or treatment for what may be an emergency medical
condition. One commenter stated that the universe of conditions that
may be emergency medical conditions is extraordinarily broad and
recommended that this standard be clarified to avoid unnecessary and
excessive EMTALA obligations to individuals presenting outside of
dedicated emergency departments. The commenter recommended that EMTALA
is triggered outside of the dedicated emergency department only when
the individual ``requests examination or treatment for what more likely
than not is an emergency medical condition.''
Response: When we proposed the ``what may be an emergency medical
condition'' language in the definition of ``come to the emergency
department'' at Sec. 489.24(b), we did so to clarify that an emergency
medical condition would not actually have to exist upon examination of
such an individual presenting outside the dedicated emergency
department. Instead, the individual presenting (or the prudent
layperson observer) must believe he or she needs emergency care. We do
not believe it is necessary to adopt the commenter's suggested
clarifying language. We believe we have provided sufficient explanation
about ``what may be an emergency medical condition'' both in our
response above and in the preamble to the proposed rule (67 FR 31473).
Comment: One commenter requested that CMS clarify that the proposed
standard language ``such a request would be considered to exist if the
individual requests examination or treatment for what the individual
believes to be an emergency condition'' (67 FR 31473) (emphasis added),
is an objective standard. The commenter was concerned about our
enforcement of this standard; specifically, the concern was that the
determination as to whether an EMTALA obligation has been triggered
would hinge on a subjective belief that an emergency medical condition
exists.
Response: EMTALA is triggered when there has been a request for
medical care inside the dedicated emergency department or for emergency
care on hospital property outside the dedicated emergency department.
The request can only be made by or on behalf of the individual or the
request from the individual would be considered to exist if a prudent
layperson would believe the individual needs emergency care. We believe
this standard for when EMTALA is triggered is based on objective
criteria; that is, the act of the individual or someone acting on his
or her behalf requesting medical care for what the individual believes
or what the person accompanying the individual believes to be an
emergency medical condition. It is also objective when the prudent
layperson standard is considered in determining whether, based on the
appearance, signs, and symptoms of the individual presenting to the
hospital, a prudent layperson would believe that the individual has a
medical condition (in the dedicated emergency department) or an
emergency medical condition (in a nondedicated emergency department).
4. Other Issues
Comment: One commenter requested that we clarify that, although it
may be appropriate for staff of the dedicated emergency department to
leave the department in order to provide emergency medical treatment to
an individual who has presented on hospital property outside the
dedicated emergency department, it is not required that an emergency
department ``physician'' leave to respond and provide treatment to an
individual.
Response: Under these circumstances, EMTALA requires that the
hospital must provide treatment to the individual within its
capabilities; if the hospital lacks, for instance, sufficient specific
staff, the hospital should must provide alternative means of treating
such an individual, within its capabilities, or provide an appropriate
transfer. Or if the hospital decides to send other medical staff rather
than physician staff to an emergency patient who has presented on
hospital property
[[Page 53243]]
outside the dedicated emergency department, that action is within the
hospital's discretion. CMS would look to see what type of capabilities
the hospital has in responding to such emergency cases and whether the
hospital responded appropriately.
Comment: One commenter believed that having different EMTALA
policies based on which door of the hospital the individual enters is
fundamentally flawed and exacerbates the confusion about when the
EMTALA duty has been met. The commenter requested that we simplify the
issue by delineating that EMTALA applies in any case of any individual
who comes to the dedicated emergency department and for whom a request
for emergency care is made, until that individual is stabilized or
admitted.
Another commenter found it confusing to have a separate definition
of dedicated emergency department. The commenter stated that it is
already well-established and accepted that any individual who arrives
anywhere on hospital property, whether it is the emergency department
or a sidewalk within 250 yards of the main building and requests care
for a emergency medical condition triggers EMTALA obligations for the
hospital. Therefore, the commenter added, it is immaterial whether or
not an individual presents to a ``dedicated emergency department,''
since arrival anywhere on a hospital campus automatically triggers
EMTALA.
Response: As we explain in the discussion above regarding
clarification of the definition of ``dedicated emergency department,''
and also in the proposed rule, there has been much confusion on the
applicability of EMTALA to individuals who present for emergency care,
but do not make it to a hospital's emergency department. We have stated
previously that an individual may not be denied emergency services
simply because a person failed to actually enter a hospital's emergency
department. That is, under certain conditions, an individual does not
need to present at a hospital's emergency department in order to be
protected by EMTALA.
Thus, in clarifying our policy, it is necessary to address where
and under what conditions the individual is presenting in order to
determine whether EMTALA is triggered. EMTALA is not triggered by a
request for physical therapy (that is, for a medical condition) at the
hospital's on-campus physical therapy department. However, EMTALA would
be triggered by that same request inside a hospital's dedicated
emergency department, since the statute clearly states that requests
for examination or treatment of ``medical conditions'' at emergency
departments trigger EMTALA. By the same token, request for treatment of
a gunshot wound at the on-campus radiology department would also
trigger EMTALA, since a gunshot wound is clearly an ``emergency medical
condition.''
We believe that, in making our clarification of ``dedicated
emergency department,'' we are assisting in clarifying a hospital's
responsibilities under EMTALA to screen and provide necessary
stabilizing treatment to an individual who comes to a hospital,
presenting either at its dedicated emergency department or elsewhere on
hospital property; that is, we are clarifying at what point EMTALA is
triggered. The ``which door'' concept is integral to this analysis. An
individual can ``come to the emergency department'' under the statute
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 and request examination or treatment for a medical
condition; or the individual can present elsewhere on hospital property
(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 an emergency medical condition.
D. Provisions of the Final Rule
In summary, in consideration of the comments discussed under this
section, in this final rule, we are--
[sbull] Adopting as final the proposed definition of hospital
property under Sec. 489.24(b) with one clarifying editorial change
concerning the language in the proposed definition about excluding
other areas or structures that are located within 250 yards of the
hospital's main building.'' We are removing the proposed phrase
``located within 250 yards of the hospital's main building'' because
the phrase is duplicative of the language in the definition of ``us''
at Sec. 413.65(b). ``Campus'' includes the 250 yards concept in its
definition; therefore, by referencing Sec. 413.65(b) in the definition
of ``hospital property'' under EMTALA, we are already including the
concept of 250 yards.
[sbull] Adopting as final the proposed definition of patient under
Sec. 489.24(b), with a modification to reflect the nonapplicability of
EMTALA to an individual who has begun to receive outpatient services at
an encounter at the hospital other than an encounter that the hospital
is obligated by EMTALA to provide.
IX. Scope of EMTALA Applicability to Hospital Inpatients (Sec.
489.24(d)(2))
A. Background and Provisions of the Proposed Rule
While most issues regarding EMTALA arise in connection with
ambulatory patients, questions have occasionally been raised about
whether EMTALA applies to inpatients. In late 1998, the United States
Supreme Court considered a case (Roberts v. Galen of Virginia, 525 U.S.
249 (1999)) that involved, in part, the question of whether EMTALA
applies to inpatients in a hospital. In the context of that case, the
United States Solicitor General advised the Supreme Court that the
Department of Health and Human Services (DHHS) would develop a
regulation clarifying its position on that issue. After reviewing the
issue in the light of the EMTALA statute, in the May 9, 2002 proposed
rule (67 FR 31475), we proposed that EMTALA would apply to admitted
emergency patients until they have been stabilized.
As we noted in the proposed rule, once a hospital has incurred an
EMTALA obligation with respect to an individual, that obligation
continues while the individual remains at the hospital, so that any
transfer to another medical facility or discharge of the individual
must be in compliance with the rules restricting transfer until the
individual is stabilized under existing Sec. 489.24(d). In these
cases, we stated that the hospital continues to be obligated under
section 1867 of the Act, irrespective of the inpatient admission, and
that an individual's emergency medical condition will be considered to
have been stabilized only when the criteria in Sec. 489.24(b) are met.
That is, the individual's condition must be such that no material
deterioration of the condition is likely, within reasonable medical
probability, to result from or occur during a transfer of the
individual from the facility or, if the patient is a pregnant woman who
is having contractions, that the woman has delivered the child and the
placenta. We believed that such a policy would provide protections
under the statute to those patient populations that are most
vulnerable--individuals who are experiencing emergency medical
conditions (including women in labor who are admitted to the hospital).
In addition, we proposed to clarify in the proposed rule that an
individual who goes in and out of apparent stability with sufficient
rapidity or frequency would not be considered ``stabilized'' within the
meaning of Sec. 489.24; transient stability of such an individual does
not relieve the hospital
[[Page 53244]]
of its EMTALA obligation (67 FR 31475). We proposed that such an
individual would continue to be covered by EMTALA until the
individual's overall medical stability with respect to all conditions
is achieved.
Based on an analysis of the statute (sections 1867(b)(1)(A),
(c)(2), and (e)(1) of the Act) and the legislative history (131 Cong.
Rec. 28.587 and 28.588 (1985) and H.R. Rept. No. 241 (I)(1985),
reprinted in 1986 U.S.C.C.A.N. 579, 605.), we explained why we believed
that EMTALA continued to apply to admitted emergency patients until
they have been stabilized or appropriately transferred.
For a detailed discussion of the proposed policy on the
applicability of EMTALA to admitted patients with unstabilized
emergency medical conditions, see the preamble to the May 9, 2002
proposed rule at 67 FR 31475.
In addition, except for the limited circumstances described above,
we proposed to clarify that EMTALA does not apply to nonemergency
hospital inpatients. Most hospital admissions do not consist of
emergency cases. In most cases, an individual who comes to the hospital
and requests admission does so to obtain elective (nonemergency)
diagnosis or treatment for a medical condition. We noted that once a
hospital admits an individual as a patient, that hospital has a variety
of other legal, licensing, and professional obligations with respect to
the continued proper care and treatment of such patients.
We proposed to redesignate paragraph (c) of Sec. 489.24 as
paragraph (d), and include stabilization requirements under a new
proposed Sec. 489.2(d)(2). (Proposed redesignated paragraph (d) was
proposed to be revised further as explained in section V.K.9.b. of the
preamble of the May 9, 2002 proposed rule (67 FR 31456).) In addition,
we proposed to include the requirements for nonapplicability of EMTALA
to nonemergency hospital inpatients under proposed redesignated Sec.
489.24(d)(2).
B. Summary of Public Comments and Departmental Responses
1. Applicability of EMTALA to Inpatients
Comment: Many commenters expressed concern about our clarification
in the proposed rule on the applicability of EMTALA to hospital
inpatients. Some commenters agreed with the entirety of the CMS
proposed policy that a hospital's EMTALA stabilization and transfer
obligations should continue to apply to an admitted emergency patient.
One commenter stated that ``this clarification will allow hospitals to
find an endpoint to their EMTALA obligations, specifically when the
patient's emergency [medical] condition is stabilized.''
However, many commenters expressed the view that EMTALA should not
apply to any inpatient, even one who was admitted through the dedicated
emergency department and for whom the hospital had incurred an EMTALA
obligation to stabilize. Several commenters noted that hospitals have
extensive CoPs responsibilities with respect to inpatients or State
tort law obligations, and argued that the hospital's assumption of
responsibility for the individual's care on an inpatient basis should
be deemed to meet the hospital's obligation under EMTALA. Many
commenters recommended that the regulations be revised to state that a
hospital's EMTALA obligation may be met by admitting an individual as
an inpatient.
Two commenters stated that CMS has ``no evidence there is a current
problem'' for the dumping of inpatients with emergency medical
conditions. Therefore, the commenters believed EMTALA applicability
should end upon inpatient admission.
One commenter (a group of neurosurgeons and neurologists) believed
that EMTALA was not intended to apply to an inpatient admitted through
the dedicated emergency department. Several commenters cited the recent
ruling by the Court of Appeals for the Ninth Circuit in Bryant v.
Adventist Health System (289 F.3d 1162 (9th Cir. 2002)) that EMTALA
generally ceases to apply once an individual is admitted for inpatient
care; these commenters believed we should adopt the opinion for the
national policy.
Response: In attempting to resolve the issue about EMTALA
applicability to admitted emergency patients, we were assisted by
referring to cases in which the courts have had to address the same
issue. In several instances, the courts concluded that a hospital's
obligations under EMTALA end at the time that a hospital admits an
individual to the facility as an inpatient. See Bryan v. Rectors and
Visitors of the University of Virginia, 95 F.3d 349 (4th Cir. 1996);
Bryant v. Adventist Health Systems/West, 289 F.3d 1162 (9th Cir. 2002);
and Harry v. Marchant, 291 F.3d 767 (11th Cir. 2002). In reaching this
result, the courts focused on the definition of ``to stabilize'' set
out in the statute at section 1867(e)(3)(A) of the Act. In this
definition, the Congress defined this concept by specifically linking
the hospital's obligation to provide stabilizing treatment to
individuals presenting with emergency medical conditions to the context
in which the services are provided.
In particular, the courts found that the statute requires that
stabilizing care must be provided in a way that avoids material
deterioration of an individual's medical condition if the individual is
being transferred from the facility. The courts gave great weight to
the fact that hospitals have a discrete obligation to stabilize the
condition of an individual when moving that individual out of the
hospital to either another facility or to his or her home as part of
the discharge process. Thus, should a hospital determine that it would
be better to admit the individual as an inpatient, such a decision
would not result in either a transfer or a discharge, and,
consequently, the hospital would not have an obligation to stabilize
under EMTALA. The courts have generally acknowledged that this
limitation on the scope of the stabilization requirement does not
protect hospitals from challenges to the decisions they make about
patient care; only that redress may lie outside EMTALA. For example, a
hospital may face liability for negligent behavior that results in harm
to persons it treat after they are admitted as inpatients, but such
potential liability would flow from medical malpractice principles, not
from the hospital's obligations under EMTALA.
As many courts have ruled, EMTALA does not purport to establish a
medical malpractice cause of action nor establish a national standard
of care. In our view, apart from the possible malpractice implications
redressable outside the statute, hospitals that fail to meet their
obligations to provide quality care to inpatients may also face
consequences affecting their Medicare certification under the
applicable CoPs at 42 CFR Part 482. We discuss these CoPs and the
process by which we enforce compliance with these CoPs in greater
detail in section XIII. of this preamble. In a January 24, 2003 final
rule (68 FR 3435), we explained that if our surveyors discover
noncompliance with the hospital CoPs, ``the hospital will be scheduled
for termination from the Medicare and Medicaid programs.'' Thus, for
hospital CoPs violations, as well as for EMTALA violations (compliance
with which is a Medicare participation requirement), hospitals face the
extreme sanction of termination from the Medicare program.
As a result of these court cases, and because we believe that
existing hospital CoPs provide adequate, and in some cases, superior
protection to patients, we are interpreting hospital
[[Page 53245]]
obligations under EMTALA as ending once the individuals are admitted to
the hospital inpatient care. As an example of a case in which the
hospital CoPs provide protection superior to that mandated by EMTALA,
the discharge planning CoP in 42 CFR 482.43 includes specific
procedural requirements that must be satisfied to show that there has
been adequate consideration given to a patient's needs for post-
discharge care. EMTALA does not include such specific requirements.
We believe that, as the agency charged with enforcement of EMTALA,
it is appropriate to pay deference to the numerous Federal courts of
appeal that have decided upon this issue. Although the decisions of the
courts in these EMTALA private right of action cases are not
necessarily binding for our enforcement purposes, we do believe that
consistent judicial interpretation of this matter, when combined with
the many comments received on this matter, dictate the policy that we
articulate in this final rule.
Moreover, given the numerous hospital CoPs that protect inpatients,
as well as patients' rights under State law, we believe that patients
are sufficiently protected under our policy as we have articulated it
in this final rule. However, a hospital cannot escape liability under
EMTALA by ostensibly ``admitting'' a patient, with no intention of
treating the patient, and then inappropriately transferring or
discharging the patient without having met the stabilization
requirement. If it is discovered upon investigation of a specific
situation that a hospital did not admit an individual in good faith
with the intention of providing treatment (that is, the hospital used
the inpatient admission as a means to avoid EMTALA requirements), then
liability under EMTALA may attach.
2. Definition of Stability
Comment: One commenter took issue with our proposed regulatory
language on when EMTALA ends for hospital inpatients at Sec.
489.24(d)(2)(ii), which states:
``If a hospital admits an individual with an unstable emergency
medical condition for stabilizing treatment, as an inpatient,
stabilizes that individual's emergency medical condition, and this
period of stability is documented by relevant clinical data in the
individual's medical record, the hospital has satisfied its special
responsibilities under this section with respect to that individual. If
the patient is stable for a transfer of the type usually undertaken
with respect to patients having the same medical conditions, the
hospital's special responsibilities under this section are satisfied *
* *.''
The commenter believed the proposed standard, ``stable for a
transfer of the type usually undertaken with respect to patients having
the same medical conditions,'' could undermine both patient safety and
the EMTALA statute if hospitals only document that a patient is as
stable as similarly situated patients for an appropriate transfer. The
commenter requested that the final rule specify that the hospital may
satisfy its EMTALA obligations to an admitted patient only by
documenting that it has provided stabilizing treatment to the point
that the emergency medical condition has been resolved.
Response: As stated earlier in this section of the preamble, in
this final rule we have decided not to interpret EMTALA as requiring
hospitals to continue to provide stabilizing treatment (as that term is
understood under EMTALA) to individuals once the individuals are
admitted in good faith to the hospital for inpatient care. Therefore,
the above comment on documenting stability for inpatients is no longer
an issue that we need to address in the inpatient setting. However, as
we have also stated above, a hospital that admits patients but do not
so do in good faith may face consequences under both EMTALA and the
applicable Medicare CoPs.
Comment: Many commenters asked for clarification of when, how, and
if EMTALA applies to transfers from the inpatient care setting (when
the individual has not yet been stabilized) to another acute care
hospital. In addition, many commenters asked for clarification of the
issue of ``stability'' in the inpatient setting. On the one hand, the
commenters stated, we have stated that if the admitted emergency
patient could have been transferred as ``stable'' under the statute,
the hospital has satisfied its EMTALA obligation by meeting the
statutory requirement of providing stabilizing treatment to the point
of stability for transfer, and the hospital's obligation under EMTALA
ends (67 FR 31476). However, some commenters pointed out that the
statute appears to support a ``stable for discharge'' standard to end
the EMTALA obligation.
Another commenter recommended that we clarify that a hospital
inpatient may be stable for transfer or stable for discharge for
purposes of EMTALA.
One commenter stated that because of possible confusion on the part
of the emergency department staff of what constitutes ``stable'' under
the EMTALA regulations in the inpatient setting, many patients may be
identified as stable who are technically medically unstable. The
commenter recommended that CMS clarify who the reasonable parties are,
to determine whether a patient is stable and can be transported to
provide the best outcome for that patient.
Another commenter requested that CMS clarify that once an inpatient
has been stabilized for discharge, EMTALA no longer applies, even if
the patient requires followup care. The commenter requested guidance on
whether, for example, the fact that a patient who is being discharged
will eventually need to receive a cast or risk further injury
influences the point of stabilization for EMTALA purposes.
One commenter recommended that CMS clarify the EMTALA followup care
requirements, for ``stable for discharge,'' until the individual's
emergency medical condition is resolved. The commenter suggested that
the hospital merely be required to present the individual with a plan
for followup care, listing, for example, names of physicians who are
qualified to provide the individual's care or who are on the
individual's health care plan.
Response: As noted earlier, we are clarifying in this final rule
that EMTALA does not apply to individuals who have been admitted in
good faith to inpatient sections of the hospital, regardless of whether
the individuals are experiencing emergency medical conditions.
Therefore, transfer and stability issues for that individual, once he
or she is admitted, would be governed by the Medicare hospital CoPs,
State law, and professional considerations, not EMTALA requirements.
Regarding the situation of an outpatient who is being released from the
hospital but is expected to need followup care at a later time, we note
that the EMTALA definition of ``to stabilize'' requires only that such
medical treatment of the condition be provided as may be necessary to
assure, within reasonable medical probability, that no material
deterioration of the individual's condition is likely to result from
the transfer (including discharge) of the individual from the facility.
Thus, a hospital clearly may stabilize an individual, thereby
satisfying its EMTALA obligation to that individual, even though
followup care may be needed.
Comment: One commenter asked us to clarify the preamble language at
67 FR 31475 that discusses the provision that a hospital inpatient
admitted with an unstabilized emergency medical condition who goes in
and out of apparent stability with sufficient rapidity or frequency
would not be
[[Page 53246]]
considered ``stabilized'' within the meaning of Sec. 489.24. The
commenter requested clarification of the term ``medically stable'; that
is, whether ``stable'' in this context refers to the medical definition
of ``stable.''
Response: Again, because we are clarifying in this final rule that,
except in limited circumstances, EMTALA does not apply to hospital
inpatients, the comment above on stability as an inpatient is not
relevant for purposes of EMTALA.
Comment: Several commenters asked us to clarify that EMTALA would
not apply to inpatients who are stable but who are scheduled for
inpatient surgery for an emergency medical condition, such as patients
who need an angiogram or bypass surgery, after seeing their physician
for chest pain. One commenter requested clarification on the issue of
individuals directly admitted to the hospital for an emergency medical
condition, for example, appendicitis, although the individual is not
seeking emergency services from the hospital.
Response: As we have clarified above, once an individual has been
admitted as an inpatient (including individuals who have been directly
admitted as inpatients upon presentation to the hospital), EMTALA no
longer applies, except in the limited circumstances discussed above
concerning admissions not made in good faith.
3. Logs on EMTALA Patients
Comment: One commenter who supported our proposed policy on the
applicability of EMTALA to admitted emergency patients asked whether
the hospital inpatient departments would be required to post signs
specifying the EMTALA rights of patients and keep a log of patients who
are still covered by EMTALA. The commenter also asked whether the
inpatient departments would be required to have EMTALA policy and
procedure manuals.
Response: Because we have decided in this final rule that EMTALA
does not apply to individuals who are admitted as inpatients in good
faith, the comment above concerning the posting of signs, maintenance
of logs on inpatients covered by EMTALA, and policies and procedures
for EMTALA purposes as described by the commenter will not be required.
4. Other Issues
Comment: One commenter believed that the CMS proposed approach of
EMTALA nonapplicability to admitted elective inpatients is
inappropriate. The commenter gave several reasons for this belief:
Every court in the United States that has considered the issue of
hospital obligation has concluded that EMTALA application commenced
when the hospital or its agents ``became aware'' that the individual
had an emergency medical condition or was unstable as provided by the
law; the U.S. Supreme Court case in Roberts v. Galen of Virginia, 525
U.S. 249 (1999) specifically stated that the obligations to stabilize,
provide additional care or provide an appropriate transfer, or both,
are completely unrelated to whether or not the patient came to the
emergency department under section 1867(a) of the Act; and Lopez-Soto
v. Hawayek, 175 F.3d 170 (1st Cir. 1999), interpreted the Roberts case
and addressed and rejected the arguments made by CMS in support of the
CMS interpretation of the law and held that once the patient was in the
hospital, EMTALA attached when the hospital or doctor knew of the
unstable condition.
Response: We disagree with the commenter. After reviewing the
EMTALA statute and its legislative history, we find no indication that
Congress intended EMTALA to apply to hospital inpatients. To the
contrary, the legislative history makes several references to
individuals who were denied emergency medical care at hospital
emergency rooms, but we find no references to similar problems faced by
hospital inpatients. (See H.R. Rept. No. 99-241 (I), at 27 (1985),
reprinted in 1986 U.S.C.C.A.N. 579, 605.) Therefore, we believe that
Congress intended for EMTALA to address the issue of inadequate
emergency care for individuals who presented with emergency medical
conditions seeking such care from hospital emergency departments.
Moreover, while we are not bound by judicial precedent in cases in
which we were not a party, we are familiar with the Roberts v. Galen,
525 U.S. 249 (199), and Lopez-Soto v. Hawayek, 175 F.3d 170 (1st Cir.
1999) cases and believe that they do not pose any barrier to the
position we are taking in this rule.
In Roberts, the Court addressed the issue of whether an individual
must prove that a hospital acted with an improper motive in failing to
stabilize that individual and concluded that the stabilization
provision found in the Social Security Act at section 1867(b)(1)
contained no such requirement. The Court did not address the issue of
when a hospital's EMTALA obligation to stabilize an individual ends.
However, the Lopez-Soto case did address the stabilization issue, and
in that case the court concluded that a hospital has an obligation to
stabilize an individual with an emergency medical condition before
arranging a transfer of that person to another facility, regardless of
whether the individual presented to the emergency department with the
emergency medical condition or elsewhere at the hospital.
Because the court in Lopez-Soto was not clear about the inpatient
status of the individual, a baby, it is not clear to us whether this
decision is necessarily inconsistent with the view of the statute we
are taking in this final rule. For example, if the baby in Lopez-Soto
was not an inpatient at the time it presented with an emergency medical
condition, then we would agree that the hospital, under this final
rule, would be obligated to respond to the baby's condition as if it
had been initially presented to the hospital's emergency department. On
the other hand, if the baby were, in fact, an inpatient at the time the
emergency first presented itself to hospital staff, the court's holding
would be inconsistent with the views adopted in this final rule, and,
to this extent, we would disagree with the court's conclusion. As we
have explained elsewhere in this preamble, we believe such a conclusion
oversteps the requirement of the statute that limits its scope to
individuals who have presented themselves to a hospital prior to the
time they become an inpatient of that facility. However, this is not to
say that hospitals are without patient obligations in these cases.
Hospitals clearly owe a duty to inpatients, but those obligations
derive from the Medicare hospital CoPs at section 1861(e) of the Act
and the implementing regulations at 42 CFR Part 482, not from EMTALA.
In addition, as we have stated, if it is discovered upon investigation
of a specific situation that a hospital did not admit an individual in
good faith with the intention of providing treatment, but instead used
the inpatient admission merely as a means to avoid EMTALA requirements,
then liability under EMTALA may attach.
Comment: One commenter who did not support our proposed policy on
the nonapplicability of EMTALA to admitted elective patients requested
that we clarify the EMTALA obligations to such individuals who
experience an emergency after being admitted to the hospital.
Specifically, the commenter was concerned about the transfer of such an
unstable individual to a hospital that has special capabilities to
treat the individual.
Response: Since EMTALA is not triggered for admitted elective
patients who experience an emergency during the inpatient admission,
(except in limited circumstances), the EMTALA transfer requirements
would not apply
[[Page 53247]]
to the transfer of such an individual to another hospital.
Comment: One commenter stated that our language in the preamble
that discusses the applicability of EMTALA to ``admitted emergency
patients'' (67 FR 31476) appears to apply only to patients admitted via
the emergency department, whereas the language in the proposed
regulatory text at Sec. 489.24(d)(2)(ii) states that EMTALA applies to
inpatient care ``if a hospital admits an individual with unstable
emergency medical condition for stabilizing treatment.'' The commenter
requested us to clarify whether EMTALA applies in the inpatient setting
but only to an individual admitted via the dedicated emergency
department or whether it applies to any individual who has an emergency
medical condition.
Response: As stated earlier, our decision in this final rule is
that EMTALA no longer applies to any individual who is admitted as an
inpatient (except in limited circumstances of circumvention.)
Comment: One commenter recommended that the definition of
``inpatient'' for purposes of EMTALA would specifically include
patients who have been admitted to the hospital but, due to bed
availability, are being ``boarded'' and physically located in the
dedicated emergency department.
Another commenter asked us to clarify whether EMTALA would apply to
the stabilization of individuals with emergency medical conditions
while awaiting admission in the dedicated emergency department or to an
unstable patient who is being ``held'' or ``boarded'' in the operating
room or angiography suite prior to movement to an inpatient bed.
Response: As we have stated, EMTALA applies to an individual who
presents to the hospital with an emergency medical condition. If such a
condition is found when the individual is screened, the hospital must
provide stabilizing treatment, even if the individual is awaiting
admission in the dedicated emergency department. Once the individual
has been stabilized, the EMTALA obligations end.
In response to the issue about the definition of ``inpatient'' for
purposes of EMTALA, we are revising our proposed definition of
``patient'' under Sec. 489.24(b) that specified that an inpatient is
one who is ``receiving inpatient hospital services as defined in Sec.
409.10(b).'' Upon further consideration, we believe it would be more
helpful to adopt the definition of ``inpatient'' from Section 210 of
the Medicare Hospital Manual (CMS Publication Number 10 (1989)), which
is a well-utilized definition in the Medicare program for purposes of
Medicare payment. Under that section, an ``inpatient is a person who
has been admitted to a hospital for bed occupancy for purposes of
receiving inpatient hospital services. Generally a person is considered
an inpatient if formally admitted as an inpatient with the expectation
that he [or she] will remain at least overnight and occupy a bed even
though it later develops that he [or she] can be discharged or
transferred to another hospital and does not actually use a hospital
bed overnight.'' We believe adopting such a definition for EMTALA
purposes would provide further guidance in determining who is an
inpatient.
To respond specifically to the commenter, 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. We believe
such an expectation would be documented based on the information in the
individual's medical record.
Comment: One commenter compared the proposed regulatory language
regarding the application of EMTALA to inpatients in proposed Sec.
489.24(d)(2)(i) to the language in proposed Sec. 489.24(d)(2)(ii). The
commenter stated that although paragraph (d)(2)(i) requires the
hospital to have found the emergency medical condition and have actual
knowledge that the condition exists, before it can incur a duty to
stabilize under EMTALA, paragraph (d)(2)(ii) does not require that the
hospital be aware that the individual had an emergency medical
condition at the time of admission.
Response: Proposed Sec. 489.24(d)(2) was based on the proposed
policy that EMTALA applied to an individual who was admitted as an
inpatient. In this final rule, we are revising our policy to state that
EMTALA obligations end toward an individual upon inpatient admission,
regardless of the stability of the individual (except in limited
circumstances of circumvention). Because we are revising the regulation
text to reflect this revised policy, the above comment on proposed
Sec. 489.24(d)(2) is no longer relevant.
Comment: One commenter suggested that the final rule should clarify
the application of the psychiatric specific definitions of ``stable for
transfer'' and ``stable for discharge'' in the State Operations Manual.
Response: In the 1998 State Operations Manual at Tag A407 on page
V-9, we state: ``for purposes of transferring a patient from one
facility to a second facility for psychiatric conditions, the patient
is considered to be stable when he/she is protected and prevented from
injuring himself/herself or others. For purposes of discharging a
patient (other than for the purpose of transfer from one facility to a
second facility), for psychiatric conditions, the patient is considered
to be stable when he/she is no longer considered to be a threat to him/
herself or to others.'' However, we note that, generally, psychiatric
patients with emergency medical conditions are treated no differently
for purposes of EMTALA than any other individual who presents to the
hospital with an emergency medical condition. We intend to address the
issue of treatment of individuals with psychiatric conditions for
purposes of EMTALA in future operating instructions for our State
surveyors.
Comment: The commenter also suggested that the final rule clarify
that any retrospective review of a physician's determination that an
individual is stable will only be based upon the information and
clinical data readily available at the time of such determination.
Response: We will keep in mind the commenter's suggestion about
retrospective review when we develop future operating instructions for
our State surveyors. In addition, the commenter has stated our current
position as specified in the 1998 State Operations Manual, page V-9:
``the purpose of the professional medical review (physician review) is
to provide peer review using information available to the hospital at
the time the alleged violation took place.''
Comment: One commenter asked for clarification on the point of
whether EMTALA should apply when an ambulance delivers an individual
through the dedicated emergency department as a direct admit.
Response: As we have clarified above, whenever there is a direct
admission of a particular individual as an inpatient, EMTALA no longer
applies.
C. Provisions of the Final Rule
In this final rule, we are adopting as final the proposed
definition of ``patient'' under Sec. 489.24(b) with modifications. We
are further clarifying what ``outpatients'' are not subject to the
EMTALA obligations.
We also are providing that a hospital's obligations under EMTALA
end once an individual is admitted for inpatient care. As explained
above, we believe
[[Page 53248]]
that this is the appropriate policy because existing hospital CoPs
provide adequate, and in some cases, superior protection to inpatients.
(See section XIII. of this preamble for a detailed discussion of
regarding the hospital CoPs). In addition, numerous courts have held
that EMTALA obligations end upon inpatient admission. At least two
courts ruled on the identical issue after we published our May 9, 2002
proposed rule.
We also are adding language to adopt our established definition of
``inpatient'' in section 210 of the Medicare Hospital Manual (CMS
Publication No. 10) who are also not subject to the EMTALA obligations.
In addition, we are adopting as final the proposed Sec. 489.24(d)(2)
with modifications. We are clarifying that a hospital is required to
provide care to its inpatients in accordance with the Medicare hospital
CoPs.
X. Applicability of EMTALA to Provider-Based Entities (Sec. Sec.
413.65(g)(1), 482.12(f), 489.24(b), and 489.24(i))
On April 7, 2000, we published a final rule specifying the criteria
that must be met for a determination regarding provider-based status
(65 FR 18504). The regulations in that final rule were subsequently
revised to incorporate changes mandated by section 404 of Public Law
106-554 (66 FR 59856, November 30, 2001). However, those revisions did
not substantively affect hospitals' EMTALA obligations with respect to
off-campus departments.
A. Applicability of EMTALA to Off-Campus Hospital Departments
(Sec. Sec. 489.24(b) and (i) and Sec. 413.65(g)(1))
1. Background
In the April 7, 2000 final rule (65 FR 18504), we clarified the
applicability of EMTALA to hospital departments not located on the main
provider campus. At that time, we revised Sec. 489.24 to include a new
paragraph (i) to specify the antidumping obligations of hospitals with
respect to individuals who come to off-campus hospital departments for
the examination or treatment of a potential emergency medical
condition. As explained in the preamble to the April 7, 2000 final
rule, we made this change because we believed it was consistent with
the intent of section 1867 of the Act to protect individuals who
present on hospital property (including off-campus hospital property)
for emergency medical treatment. Since publication of the April 7, 2000
final rule, it has become clear that many hospitals and physicians
continue to have significant concerns with our policy on the
applicability of EMTALA to these off-campus locations.
2. Provisions of the Proposed Rule
After further consideration, in the May 9, 2002 proposed rule (67
FR 31476), we proposed to clarify the scope of EMTALA's applicability
in this scenario to those off-campus departments that are treated by
Medicare under Sec. 413.65(b) to be departments of the hospital, and
that are equipped and staffed areas that are used a significant portion
of the time for the initial evaluation and treatment of outpatients for
emergency medical conditions. That is, we proposed to narrow the
applicability of EMTALA to only those off-campus departments that are
``dedicated emergency departments'' as defined in proposed revised
Sec. 489.24(b).
As proposed, this definition would include such departments,
whether or not the words ``emergency room'' or ``emergency department''
were used by the hospital to identify the departments. The definition
would also be interpreted to encompass those off-campus hospital
departments that would be perceived by an individual as appropriate
places to go for emergency care. Therefore, we proposed to revise the
definition of ``Hospital with an emergency department'' at Sec.
489.24(b) to account for these off-campus dedicated emergency
departments and also to amend the definition of ``Comes to the
emergency department'' at Sec. 489.24(b) to include this same
language. We believe these proposed changes would enhance the quality
of emergency care by facilitating the prompt delivery of emergency care
in those cases, thus permitting individuals to be referred to nearby
facilities with the capacity to offer appropriate emergency care.
In general, we expect that off-campus departments that meet the
proposed definitions stated above would in practice be functioning as
``off-campus emergency departments.'' Therefore, we believe it is
reasonable to expect the hospital to assume, with respect to these off-
campus departments, all EMTALA obligations that the hospital must
assume with respect to the main hospital campus emergency department.
For instance, the screening and stabilization or transfer requirements
described in section V.K.1. of the preamble of the May 9, 2002 proposed
rule (``Background'') would extend to the off-campus emergency
departments, as well as to any such departments on the main hospital
campus.
In conjunction with this proposed change in the extent of EMTALA
applicability with respect to off-campus facilities, we also proposed
to delete all of existing Sec. 489.24(i), which, as noted above, was
established in the April 7, 2000 final rule. We proposed to delete this
paragraph in its entirety because its primary purpose is to describe a
hospital's EMTALA obligations with respect to patients presenting to
off-campus departments that do not routinely provide emergency care.
Under the proposals outlined above, however, a hospital would have no
EMTALA obligation with respect to individuals presenting to such
departments. Therefore, it would no longer be necessary to impose the
requirements in existing Sec. 489.24(i). Even though off-campus
provider-based departments that do not routinely offer services for
emergency medical conditions would not be subject to EMTALA, some
individuals may occasionally come to them to seek emergency care. Under
such circumstances, we believe it would be appropriate for the
department to call an emergency medical service (EMS) if it is
incapable of treating the patient, and to furnish whatever assistance
it can to the individual while awaiting the arrival of EMS personnel.
Consistent with the hospital's obligation to the community and similar
to the Medicare hospital CoP under Sec. 482.12(f)(2) that apply to
hospitals that do not provide emergency services, we would expect the
hospital to have appropriate protocols in place for dealing with
individuals who come to off-campus nonemergency facilities to seek
emergency care.
To clarify a hospital's responsibility in this regard, in the May
9, 2002 proposed rule, we proposed to revise Sec. 482.12(f) by adding
a new paragraph (3) to state that if emergency services are provided at
the hospital but are not provided at one or more off-campus departments
of the hospital, the governing body of the hospital must assure that
the medical staff of the hospital has written policies and procedures
in effect with respect to the off-campus department(s) for appraisal of
emergencies and referral when appropriate. (We note that, in a separate
document (62 FR 66758, December 16, 1997), we proposed to relocate the
existing Sec. 482.12(f) requirement to a new section of Part 482. The
change to Sec. 482.12(f) in this final rule will be taken into account
in finalizing the December 16, 1997 proposal.) However, the hospital
would not incur an EMTALA obligation with respect to the individual.
In summary, we proposed in existing Sec. 489.24(b) to revise the
definitions of ``comes to the emergency department'' and ``hospital
with an emergency
[[Page 53249]]
department'', and to include these off-campus departments in our new
definition of ``dedicated emergency department.'' We solicited comments
on whether this new term is needed or if the term ``emergency
department'' could be defined more broadly to encompass other
departments that provide urgent or emergent care services. We proposed
to delete all of existing Sec. 489.24(i) and to make conforming
revisions to Sec. 413.65(g)(1).
3. Summary of Public Comments and Departmental Responses
Comment: Numerous commenters expressed strong support for the
proposal to limit the applicability of EMTALA, in cases of off-campus
departments, to only those departments that qualify as dedicated
emergency departments. Some commenters stated that EMTALA should not
apply to an off-campus department that does not hold itself out as an
emergency department. Other commenters believed this would be
appropriate because a prudent layperson would not regard the department
as an appropriate place at which to seek emergency care. These
commenters stated that an individual with a broken arm might regard the
hospital's orthopedic department as an appropriate source of care, but
that this should not mean that the orthopedic department should be
treated as a dedicated emergency department.
Other commenters stated that EMTALA should not apply to any off-
campus department unless CMS provides a narrower definition of
``dedicated emergency department'' and clarifies whether or under what
circumstances EMTALA will apply to urgent care facilities. However, the
commenters did not provide any indication of why the definition is
believed to be too broad or how they would recommend changing it.
Several commenters stated that EMTALA should not apply to an off-
campus urgent care center unless the center is functioning and holding
itself out to the public as an emergency department.
Response: We agree that EMTALA should apply to off-campus
departments only if they qualify as dedicated emergency departments,
and have addressed the commenters' suggestion as part of the revision
of the definition of a dedicated emergency department. In addition, we
are adopting in this final rule the proposed standard under Sec.
482.12(f)(3) that hospitals have appropriate protocols in place for
dealing with individuals who come to off-campus nonemergency facilities
to seek emergency care.
Regarding the suggestion that a hospital's orthopedic department
might be determined to be a dedicated emergency department because an
individual person would look to it for emergency orthopedic care, as we
have noted above, the definition of ``dedicated emergency department''
in section VIII. of this preamble does not include ``prudent
layperson'' standard. Rather, with this final rule, ``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 (1) is licensed by the State in which it is
located under applicable State law as an emergency room or emergency
department; (2) 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 (3) during the calendar year
immediately preceding the calendar year in which a determination under
Sec. 489.24 is being made, based on a representative sample of patient
visits that occurred during that calendar year, provides at least one-
third of all of its outpatient visits for the examination or treatment
of emergency medical conditions. If the orthopedic department does not
meet any of these three criteria for dedicated emergency department
status, it is not a dedicated emergency department for EMTALA purposes,
regardless of what the individual may believe as to the status of the
department.
4. Provisions of the Final Rule
We are adopting, as final with modifications as discussed in
earlier sections of this preamble, the proposed revisions of the
definition of ``come to the emergency department,'' ``hospital with an
emergency department,'' and ``dedicated emergency department'' at Sec.
489.24(b), which encompass off-campus hospital departments that would
be perceived by individuals as appropriate places to go for emergency
care. We also are adopting as final the related proposed deletion of
the provisions under Sec. 489.24(i) and the conforming change to Sec.
413.65(g)(1). In addition, we are adopting, as final, the proposed new
Sec. 482.12(f)(3) which provides that the governing body of a hospital
must assure that the medical staff has written policies and procedures
in effect with respect to off-campus departments for appraisal of
emergencies and referrals, when appropriate.
B. On-Campus Provider-Based Applicability
1. Background
At existing Sec. 413.65(g)(1), we state, in part, that if any
individual comes to any hospital-based entity (including an RHC)
located on the main hospital campus, and a request is made on the
individual's behalf for examination or treatment of a medical
condition, the entity must comply with the antidumping rules at Sec.
489.24. Since provider-based entities, as defined in Sec. 413.65(b),
are not under the certification and provider number of the main
provider hospital, this language, read literally, would appear to
impose EMTALA obligations on providers other than hospitals, a result
that would not be consistent with section 1867, which restricts EMTALA
applicability to hospitals.
2. Provisions of the Proposed Rule
To avoid confusion on this point and to prevent any inadvertent
extension of EMTALA requirements outside the hospital setting, in the
May 9, 2002 proposed rule (67 FR 31477), we proposed to clarify that
EMTALA applies in this scenario to only those departments on the
hospital's main campus that are provider-based; EMTALA would not apply
to provider-based entities (such as RHCs) that are on the hospital
campus.
In addition, we proposed in Sec. 489.24(b) to revise the
definition of ``Comes to the emergency department'' to include an
individual who presents on hospital property, in which ``hospital
property'' is, in part, defined as ``the entire main hospital campus as
defined at Sec. 413.65(b) of this chapter, including the parking lot,
sidewalk, and driveway, but excluding other areas or structures that
may be located within 250 yards of the hospital's main building but are
not part of the hospital, such as physician offices, RHCs, SNFs, or
other entities that participate separately in Medicare, or restaurants,
shops, or other nonmedical facilities.'' We specifically sought
comments on this proposed revised definition. Generally, the proposed
language would clarify that EMTALA does not apply to provider-based
entities, whether or not they are located on a hospital campus. This
language is also consistent with our policy as stated in questions and
answers published on the CMS Web site: http://www.cms.gov (CMS EMTALA
guidance, 7/20/01, Q/A 1) that clarifies that EMTALA does not
apply to other areas or structures located on the hospital campus that
are not part of the hospital, such as fast food
[[Page 53250]]
restaurants or independent medical practices.
We stated that if this proposed change limiting EMTALA
applicability to only those on-campus departments of the hospital
became final, we believe that if an individual comes to an on-campus
provider-based entity or other area or structure on the campus not
applicable under the new policy and presents for emergency care, it
would be appropriate for the entity to call the emergency medical
service if it is incapable of treating the patient, and to furnish
whatever assistance it can to the individual while awaiting the arrival
of emergency medical service personnel. However, the hospital on whose
campus the entity is located would not incur an EMTALA obligation with
respect to the individual.
In the May 9, 2002 proposed rule, we solicited comments from
providers and other interested parties on the proper or best way to
organize hospital resources to react to situations on campus where an
individual requires immediate medical attention.
We proposed in Sec. 489.24(b) to revise the definition of ``Comes
to emergency department'' (specifically, under proposed new paragraph
(1)) and make conforming changes at Sec. 413.65(g)(1).
In the August 1, 2002 final rule issued following the May 9, 2002
proposed rule (67 FR 50090), we only adopted as final the deletion of
the second sentence of the existing Sec. 413.65(g)(1) that address the
nonapplicability of EMTALA to provider-based entities. We did not adopt
other proposed clarifications concerning application of EMTALA to
provider-based departments, on or off the campus, or any other
proposals concerning EMTALA.
3. Summary of Public Comments and Departmental Responses
Comment: Several commenters expressed general approval of the
proposed clarifications of the definition of ``hospital property'' for
purposes of the EMTALA regulations and stated that the proposals will
lead to more precise interpretation of the regulations.
Response: We agree, and are adopting the proposed clarifications as
part of this final rule.
Comment: One commenter expressed strong opposition to the proposed
clarification under which on-campus provider-based entities would not
be subject to EMTALA. The commenter noted that individuals seeking
emergency treatment may be severely confused or agitated, so that they
would be unable to determine whether a particular area or facility is a
dedicated emergency department, and that in some cases such individuals
may also be physically unable to proceed to the dedicated emergency
department. The commenter also stated that provider-based departments
frequently are located close to the main hospital campus, typically
receive higher reimbursement from Medicare by virtue of their provider-
based status, and may be indistinguishable, especially to an individual
in a crisis situation, from areas at which emergency care is provided.
The commenter suggested that, in view of this, it is not unreasonable
to expect the provider-based entity to assume responsibility for
ensuring that individuals who present with emergency care needs receive
screening and stabilization. Therefore, the commenter recommended that
we require that provider-based entities either ensure that transfer to
a dedicated emergency department occurs safely, or provide screening
and stabilization at the entity if it is able safely to do so.
Response: We understand and share the commenter's concern for
individuals seeking emergency services who come to provider-based
entities for assistance, but note that the legislative provision under
which EMTALA responsibilities apply (section 1867 of the Act) is
specific to hospitals, and does not extend to nonhospital entities
(such as rural health clinics or physician offices), even where those
entities may be located adjacent to hospital facilities and owned or
operated by hospitals, or both. Therefore, we are not making a revision
in this final rule based on this comment.
4. Provisions of the Final Rule
We are adopting, as final with minor editorial changes as explained
earlier in this preamble, the proposed revision of ``come to the
emergency department'' and ``hospital property'' in which hospital
property is, in part, defined as ``the entire main hospital campus as
defined at Sec. 413.65(b) of this chapter, including the parking lot,
sidewalk, and driveway, but excluding other areas or structures of the
hospital's main building that are not part of the hospital, such as
physician offices, RHCs, SNFs, or other entities that participate
separately in Medicare, or restaurants, shops, or other nonmedical
facilities.'' This will clarify that on-campus provider-based entities
would not be subject to EMTALA.
We are also adopting as final without modification the proposed
clarifying change to Sec. 413.65(g)(l).
XI. EMTALA and On-Call Requirements (Sec. 489.24(j))
A. Background
We have frequently received inquiries concerning the statutory
requirement that hospitals maintain an ``on-call'' list of physicians
to provide services to patients who seek care in hospital emergency
departments. We believe there are a number of misconceptions in the
provider industry concerning these on-call requirements. Therefore, as
in the May 9, 2002 proposed rule (67 FR 31478), we are including a
section that clarifies what kinds of obligations physicians and
hospitals have to provide on-call coverage under EMTALA.
Section 1866(a)(1)(I)(iii) of the Act states, as a requirement for
participation in the Medicare program, that hospitals must maintain a
list of physicians who are on call for duty after the initial
examination to provide treatment necessary to stabilize an individual
with an emergency medical condition. If a physician on the list is
called by a hospital to provide emergency screening or treatment and
either fails or refuses to appear within a reasonable period of time,
the hospital and that physician may be in violation of EMTALA as
provided for under section 1867(d)(1)(C) of the Act.
The CMS State Operations Manual (SOM) further clarifies a
hospital's responsibility for the on-call physician. The SOM (Appendix
V, page V-15, Tag A404) states:
[sbull] Each hospital has the discretion to maintain the on-call
list in a manner to best meet the needs of its patients.
[sbull] Physicians, including specialists and subspecialists (for
example, neurologists), are not required to be on call at all times.
The hospital must have policies and procedures to be followed when a
particular specialty is not available or the on-call physician cannot
respond because of situations beyond his or her control.
Thus, hospitals are required to maintain a list of physicians on
call at any one time, and physicians or hospitals, or both, may be
responsible under the EMTALA statute to provide emergency care if a
physician who is on the on-call list fails to or refuses to appear
within a reasonable period of time. However, Medicare does not set
requirements on how frequently a hospital's staff of on-call physicians
are expected to be available to provide on-call coverage; that is a
determination to be made between the hospital and the physicians on its
on-call roster. We are aware that practice demands in treating other
patients, conferences, vacations,
[[Page 53251]]
days off, and other similar factors must be considered in determining
the availability of staff. We also are aware that some hospitals,
particularly those in rural areas, have stated that they incur
relatively high costs of compensating physician groups for providing
on-call coverage to their emergency departments, and that doing so can
strain their already limited financial resources. CMS allows hospitals
flexibility to comply with EMTALA obligations by maintaining a level of
on-call coverage that is within their capability.
We understand that some hospitals exempt senior medical staff
physicians from being on call. This exemption is typically written into
the hospital's medical staff bylaws or the hospital's rules and
regulations, and recognizes a physician's active years of service (for
example, 20 or more years) or age (for example, 60 years of age or
older), or a combination of both. We wish to clarify that providing
such exemptions to members of hospitals' medical staff does not
necessarily violate EMTALA. On the contrary, we believe that a hospital
is responsible for maintaining an on-call list in a manner that best
meets the needs of its patients as long as the exemption does not
affect patient care adversely. Thus, CMS allows hospitals flexibility
in the utilization of their emergency personnel.
We also note that there is no predetermined ``ratio'' that CMS uses
to identify how many days a hospital must provide medical staff on-call
coverage based on the number of physicians on staff for that particular
specialty. In particular, CMS has no rule stating that whenever there
are at least three physicians in a specialty, the hospital must provide
24 hour/7 day coverage in that specialty. Generally, in determining
EMTALA compliance, CMS 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.
B. Provisions of the Proposed Rule
To clarify our policies on EMTALA requirements regarding the
availability of on-call physicians, in the May 9, 2002 proposed rule,
we proposed to add to Sec. 489.24 a new paragraph (j) to specify that
each hospital has the discretion to maintain the on-call list in a
manner to best meet the needs of its patients. This proposed paragraph
further specified that physicians, including specialists and
subspecialists (for example, neurologists), are not required to be on
call at all times, and that the hospital must have policies and
procedures to be followed when a particular specialty is not available
or the on-call physician cannot respond because of situations beyond
his or her control.
C. Summary of Public Comments and Departmental Responses
1. General Comments
Comment: Numerous commenters expressed strong support for the
proposal to clarify in regulations that physicians are not required to
be on call at all times and that a hospital is responsible for
maintaining an on-call list in a manner that best meets the needs of
its patients.
Response: We appreciate these commenters' support and have kept
their views in mind in evaluating the other comments recommending
specific changes in the proposed rule for this final rule.
2. Minimal Interpretation of On-Call Responsibility
Comment: One commenter recommended that the requirement for an
explicit list of on-call physicians be eliminated because, in the
opinion of the commenter, physicians may be less willing to agree to be
on call if they are required to commit in advance to be available at
specific times. Numerous commenters did not request elimination of the
requirement but stated that the requirement should be interpreted
narrowly, as meaning only that the list of physicians willing to be on
call is to be maintained and available in the emergency department, and
that on-call services of those physicians must be available to each
patient regardless of ability to pay. The commenters asked that the
regulations be revised to specify that the on-call requirement does not
require hospitals to maintain any particular level of on-call coverage,
since hospitals are not legally authorized or practically empowered to
control physician availability for on-call coverage.
Response: We cannot eliminate the requirement for an on-call list
from the regulations, as that requirement is mandated by section
1866(a)(1)(I)(iii) of the Act. While we understand the rationale for
interpreting section 1866 of the Act as imposing only a minimal on-call
requirement, we also note that on-call physician services, like other
services for the examination and treatment of emergency medical
conditions, must be made available within the capability of the
hospital, under sections 1867(a) and (b) of the Act. Therefore, we are
not adopting these commenters' recommendations.
Comment: Some commenters expressed concern that the proposed
changes allowing hospitals and physicians more flexibility to set on-
call policies might actually increase overcrowding in hospital
emergency departments. The commenters stated that patients who require
specialty physician care often must wait in the emergency department
for extended periods, since the physician's presence is needed to
authorize either admission or an appropriate transfer.
One commenter suggested that adoption of the more flexible
regulations on on-call responsibility would only exacerbate this
problem. To prevent that, the commenter recommended that a hospital
that is unable to maintain full-time specialty coverage in one or more
areas be required to have a transfer agreement with a hospital that has
that level of coverage and will accept all patients in that specialty
or subspecialty area. The commenter also recommended that we prescribe
a maximum time for which patients could be required to wait in the
emergency department for specialty care and that provision be made for
patients who must be held beyond that time to be admitted either to an
inpatient bed or to an outpatient holding area outside the emergency
department, to await the arrival of a specialist. The commenter noted
that this placement would not end the hospital's EMTALA obligation, but
would free emergency department resources to permit more emergency
patients to be treated.
Response: We agree that it is appropriate for hospitals to have
referral agreements with other hospitals to facilitate appropriate
transfers of patients who require specialty physician care that is not
available within a reasonable period of time at the hospital to which
the patient is first presented. Hospitals that cannot maintain full-
time on-call coverage in specific medical specialties should also keep
local EMS staff advised of the times during which certain specialties
will not be available, thereby minimizing the number of cases in which
individuals must be transferred due to lack of complete on-call
coverage. However, we are not mandating the maintenance of such
agreements in this final rule. Even though such agreements may be
desirable, we recognize that hospitals may be unable, despite their
best efforts, to secure such advance agreements from specialty
hospitals. (We note that, even in the absence of an advance agreement,
[[Page 53252]]
a participating hospital with specialized capabilities or facilities
that has the capacity to treat an individual but refuses to accept an
appropriate transfer would thereby violate the EMTALA requirement on
nondiscrimination (section 1867(g) of the Act) and could be liable for
termination of its provider agreement or civil money penalties, or
both.)
We also agree that it would be appropriate for hospitals to limit
individuals' waiting time in the emergency department, and to either
admit the individual as an inpatient or move him or her to another
appropriate outpatient area for treatment in cases where the arrival of
a specialist is unavoidably delayed. However, given the heavy demand on
emergency department resources and the variations in numbers of
patients needing emergency care, we do not believe it is feasible to
mandate uniform national limits on how long patients may be held in
emergency departments.
3. Recommended Definition of ``Best Meets the Needs of the Hospital's
Patients''
Comment: Some commenters recommended that the requirement to
maintain an on-call list that best meets the needs of the hospital's
patients be revised to specifically recognize potential limits on on-
call physician availability, by stating that the list must best meet
the needs of patients in accordance with the resources available to the
hospital, including the availability of on-call physicians. Another
commenter recommended that the regulation be revised to mandate
maintenance of an on-call list that meets patient needs to the extent
permitted by the physician resources available to the hospital through
its organized medical staff. Still another commenter recommended that
the list be one that best meets the needs of the hospital's patients in
accordance with the resources available to the hospital. Another
commenter stated that the language as proposed does not clarify whether
the on-call coverage must be determined by the needs of the hospital's
inpatients or its outpatients, and suggested that the regulation be
clarified to state that the on-call list be maintained in a manner that
best meets the needs of the hospital's patients who are receiving
services required under EMTALA.
Response: After consideration of these comments, we agree that the
regulations should be further revised to explicitly acknowledge the
limits on availability of on-call staff in many specialties and
geographic areas. Therefore, we are revising proposed Sec. 489.24(j)
in this final rule to state that the list must be maintained in a
manner that best meets the needs of the hospital's patients who are
receiving services required under EMTALA in accordance with the
capability of the hospital, including the availability of on-call
physicians.
Comment: One commenter recommended that the regulations be revised
to state that hospitals are not required to provide on-call physician
coverage in specialties not available to the hospital's inpatients.
Some commenters also stated that, at a minimum, CMS should require that
if a hospital offers a service to the public, the service must be
available through on-call coverage at the emergency department. For
example, one commenter stated that some hospitals have departments of
neurology and may have as many as 10 to 20 board-certified neurologists
on its medical staff, but do not offer on-call services of neurologists
to emergency patients. This commenter believed further specificity as
to on-call obligations would avoid this problem.
Response: We agree that a hospital would not be required to
maintain on-call physician coverage for types of services it does not
routinely offer, but there are many reasons why a hospital would not
have physician specialty care available on an on-call basis, even if
such specialty care is above the range of specialty care available to
inpatients. Therefore, we are not adopting this comment in this final
rule.
Regarding the recommendation that a hospital be required to provide
on-call coverage in any specialty offered to the hospital's patients,
we agree that this would be a reasonable expectation and note that
interpretative guidelines for EMTALA in the Medicare State Operations
Manual (CMS Publication No. 7), page V-15, state that if a hospital
offers a service to the public, the service should be available through
on-call coverage of the emergency department. However, we are concerned
that if this expectation were adopted as a requirement for all
hospitals with emergency departments as part of this final rule, it
might establish an unrealistically high standard that not all hospitals
could meet. Therefore, we are not adopting this comment in this final
rule.
Comment: One commenter recommended that the regulations be revised
to clarify how CMS will deal with situations in which two hospitals
with similar numbers of physicians on staff provide widely varying
levels of on-call coverage. For example, one hospital with 3
neurosurgeons on staff might be able to provide ``24/7'' coverage,
while another hospital with 3 neurosurgeons on staff might provide
coverage only 10 days per month.
Response: We agree that a situation of the type described by the
commenter could raise questions regarding the second hospital's
commitment to obtaining on-call coverage, but note that many factors,
including the overall supply of specialty physicians in an area, the
extent to which hospitals offer specialty care through the use of
``itinerant'' physicians from other areas, and the availability of
specialty care at other nearby hospitals, might all influence the
hospital's decisions regarding the level of on-call coverage it can
reasonably expect to provide. Because we are concerned that
establishing overly prescriptive standards might impose an
unrealistically high burden for some hospitals, we are not adopting any
further regulatory requirements for handling situations in which
hospitals' levels of on-call coverage vary significantly. We will
continue to investigate such situations in response to complaints and
will take appropriate action if the level of on-call coverage is
unacceptably low.
4. Physicians' Responsibility for On-Call Coverage
Comment: Some commenters suggested that the proposal to allow
hospitals greater flexibility to maintain on-call coverage that best
meets the needs of their patients may be more restrictive than
necessary to prevent discrimination or may have the unintended effect
of reducing access to on-call services. These commenters argued for a
more precise description of how patient needs can best be met, or for
elimination of the ``best meets the needs'' clause. Some commenters
stated that by allowing a hospital flexibility and declining to adopt
any specific standards as to when a hospital may or may not be required
to provide on-call coverage, CMS may be placing the EMTALA on-call
burden on hospitals with no corresponding responsibility on the part of
physicians, whose participation is necessary for the hospital to meet
its obligation.
Some commenters recommended that the regulations be further revised
to more specifically address the responsibilities of physicians to make
themselves available when on call, the accountability of physicians for
EMTALA compliance, and the acceptability of transferring patients when
specialty physicians are not available. Other commenters recommended
that more specific rules
[[Page 53253]]
be adopted regarding the times at which physicians are expected to be
on call.
Another commenter cited a study by the University of California at
Los Angeles titled ``A Day in the Life of a California Emergency
Department: Waiting Times and Resources, Trends in Use and Capacity,
and Perceptions of Emergency Professionals.'' The commenter stated that
the study finding indicated that, during the study period (December
2000 through May 2001), a significant number of on-call physicians
either did not respond to call at all or responded only after a delay
of at least 20 minutes, and that many took longer than 35 minutes to
arrive. The commenter stated that the study documents the refusal of
many on-call physicians to fulfill their on-call responsibilities and
argued that hospitals should not be held responsible in such cases.
Another commenter also believed the proposed rules unfairly burden
hospitals with the responsibility for maintaining on-call coverage but
do not provide any guidance on a medical staff member's obligation to
participate in on-call panels. The commenter expressed concern that the
proposed language would, if adopted, allow physicians to either refuse
to be on call, shift their practices to facilities not requiring on-
call service, or demand exorbitant payment for on-call service. To
avoid these effects, the commenter recommended that CMS either furnish
additional detailed guidance on how hospitals can obtain on-call
coverage when physicians refuse to provide it, or mandate that
participation on on-call panels at hospitals subject to EMTALA is
required as a condition of being a Medicare-participating physician.
Response: We understand the commenters' concern, but do not believe
it would be practical or equitable to attempt to adopt more
prescriptive rules on such matters as the number of hours per week
physicians must be on call or the numbers of physicians needed to
fulfill on-call responsibilities at particular hospitals. We believe
these are local decisions that can be made reasonably only at the
individual hospital level through coordination between the hospitals
and their staffs of physicians.
Regarding situations in which physicians may irresponsibly refuse
to fulfill the on-call responsibilities they have agreed to accept, we
note that current law (section 1867(d)(1)(B) of the Act) provides
penalties for physicians who negligently violate a requirement of
section 1867 of the Act, including on-call physicians who refuse to
appear when called. We further note that physicians who practice in
hospitals do so under privileges extended to them by those hospitals,
and that hospitals facing a refusal by physicians to assume on-call
responsibilities or to carry out the responsibilities they have assumed
could suspend, curtail, or revoke the offending physician's practice
privileges. Moreover, when an EMTALA violation involving on-call
coverage is found to have occurred, surveyors and CMS regional office
staff will review all facts of the situation carefully to ensure that
hospitals that have acted in good faith to ensure on-call coverage are
not unfairly penalized for failure by individual physicians to fulfill
their obligations.
Therefore, we are not making any change in the final rule based on
these comments.
5. Hospital Responsibility for On-Call Coverage
Comment: One commenter stated that when the initial EMTALA
legislation was enacted in 1986, emergency physicians were finding it
virtually impossible to find specialists willing to come to the
emergency department to treat emergency patients, and that the 1988
amendments to the EMTALA statute making it explicit that physicians are
covered by on-call requirements have significantly improved the
availability of on-call services in hospital emergency departments.
Because of this improvement, the commenter stated that CMS should not
give credence to allegations that EMTALA is making on-call coverage
more difficult to obtain. The commenter further stated that even though
the proposed regulatory language is virtually identical to the position
CMS has taken in the past regarding on-call responsibilities, in the
current climate the language is very likely to be viewed as offering
assurances that physicians have no obligation to provide on-call
coverage. To avoid this result, which the commenter believed would
compromise the quality of patient care and lead to patient deaths, the
commenter recommended that CMS clearly state that the proposed
regulatory language does not represent a change in policy and that
hospitals and physicians that fail to meet their on-call obligations as
determined by EMTALA will be cited for noncompliance. The commenter
also recommended that a safe harbor be created for EMTALA compliance,
but does not describe the specific terms under which the safe harbor
should be made available.
Other commenters also expressed concern about diminished access to
on-call services as a result of perceptions of the proposals. These
commenters stated that, because public hospitals typically are the only
hospitals in a community committed to maintaining full-time on-call
coverage in many specialties, other hospitals may view flexible
requirements in this area as an opportunity to reduce their on-call
coverage, thus further unfairly shifting the on-call burden to public
hospitals and the physicians who practice in them. The commenters
believed CMS should issue guidance stating more specifically how
hospitals that maintain less than full-time on-call coverage will be
evaluated under EMTALA.
Response: We understand the concerns expressed by the commenters
about possible reductions in access to on-call services and wish to
emphasize that the proposals are not intended to signal any change in
CMS' position regarding hospitals' responsibility to comply with
EMTALA. We also understand the desire by some for more specific
guidance regarding the level of on-call coverage to be provided and the
types of services for which on-call coverage must be available.
However, under section 1867(a) of the Act, the EMTALA screening must be
provided ``within the capability of the hospital's emergency
department'' and that under section 1867(b) of the Act, further medical
screening and stabilizing treatment must be made available only
``within the staff and facilities available at the hospital.'' Given
the wide variation in the size, staffing, and capabilities of the
institutions that participate in Medicare as hospitals, we do not
believe it is feasible for us to mandate any particular minimum level
of on-call coverage that must be maintained by all hospitals subject to
EMTALA, or to specify that on-call coverage is required for all
services offered at the hospital. Therefore, we are not making any
changes to our proposal in this final rule based on this comment.
Comment: Several commenters expressed support for the clarification
that EMTALA does not require 24/7 on-call coverage at all hospitals,
but some of the commenters suggested that the regulations be further
strengthened to prohibit hospitals from maintaining such coverage when
their capacity does not support it. Another commenter stated that we
should not only clarify that EMTALA does not require ``24/7'' on-call
coverage at all hospitals, but should prohibit hospitals from requiring
physicians to be on call 24 hours a day, 7 days a week. Another
commenter stated that CMS should prohibit hospitals from requiring
physicians to be on call at times when they are
[[Page 53254]]
already committed to being on call at another hospital. One commenter
stated that CMS should at least establish a grievance procedure that
would allow physicians to challenge on-call requirements that the
physicians believe are unreasonable.
Response: We appreciate the commenters' expression of support for
the proposed clarification of our policy in this area, and agree with
commenters that EMTALA does not require any physician to be on call at
all times. However, we do not believe it would be appropriate for CMS
to prescribe levels of on-call coverage; on the contrary, these matters
should be worked out between individual hospitals and their medical
staff. Therefore, we have not included any provision on the level of
on-call coverage hospital may require. Also, we have no statutory
authority to mandate the kind of appeals procedure for on-call
requirements that was recommended. Therefore, we are not making any
change in this final rule based on grievance procedures.
Comment: One commenter suggested that hospitals may be reducing
physician staffing in some specialties (below the levels needed to
treat all patients, including insured and uninsured patients) and
relying on on-call coverage to meet the need to care for indigent
patients. The commenter suggested that the regulations be revised to
prohibit this practice.
Response: We understand the commenter's concern, but do not believe
we can establish realistic objective standards for levels of physician
staffing. However, we will keep the comment in mind as we prepare
interpretive guidelines and conduct surveyor training, and will review
any actual case situations involving understaffing of emergency
departments carefully, to determine whether services mandated by EMTALA
are, in fact, being provided within the capability of the hospital.
6. Simultaneous Call and Performance of Other Physician Services While
on Call
Comment: A number of commenters stated that, because of shortages
of physicians in certain specialties (for example, orthopedics or
neurosurgery) in some areas, the proposed regulations regarding on-call
coverage should be revised to state explicitly that it is not a
violation of EMTALA for a physician to be on call simultaneously at two
or more hospitals, as long as each hospital has a back-up plan for
ensuring that needed care is received from another physician or through
an appropriate transfer when the on-call physician is not in fact
available. The commenters also recommended that the regulations be
revised to clarify that it is not a violation of EMTALA for a physician
to schedule and perform elective surgery while he or she is on call, if
such a back-up plan is in place at each hospital for which the
physician is on call.
Some commenters suggested that the physician's performance of
elective surgery that a physician has freely undertaken should be used
as an example of a circumstance that is beyond the physician's control.
One of these commenters recommended that physicians who have agreed to
be on call, but subsequently engage in activities that make it
impossible to fulfill their commitment, should be allowed to make
alternative arrangements for responding to calls. Another commenter
recommended that the regulations be revised to provide specific
examples of situations beyond a physician's control.
Still another commenter recommended that proposed paragraph (j) be
revised to state that physicians may provide simultaneous call at more
than one hospital, provided the number and geographic proximity of the
hospitals are such that a single physician can reasonably provide on-
call services at each facility. The commenter recommended that further
language be added to state that physicians who are on call may schedule
office visits or elective surgery without incurring penalties under
EMTALA. The commenter believed the policies and procedures of the
hospital for responding to situations in which the particular specialty
is not available or the on-call physician cannot respond because of
circumstances beyond the physician's control should be developed in
consultation with the hospital's medical staff and that the examples of
situations beyond a physician's control should include situations when
the physician is already treating another patient. Some commenters
stated that a Program Memorandum issued by CMS on June 13, 2002, stated
that when a physician is performing surgery while being on call, having
another physician available to respond to calls is an acceptable way to
fulfill the physician's on-call responsibility but that having the
capability to arrange appropriate transfers is also an acceptable form
of compliance. The commenters recommended that CMS revise proposed
Sec. 489.24(j) to reflect this policy.
Another commenter stated that the regulation should state more
specifically what types of back-up plans would be acceptable when a
physician has scheduled elective surgery while on call.
Response: We agree that it is important that policy regarding
simultaneous call and scheduling of elective surgery while on call be
clearly communicated to, and understood by, affected hospitals and
physicians. Therefore, on June 13, 2002, we issued Survey and
Certification Letter No. S&C-02-35, to clarify that we believe
hospitals should continue to have the flexibility to meet their EMTALA
obligations by managing on-call physician coverage in a manner that
maximizes patient stabilizing treatment as efficiently and effectively
as possible. The letter further states that when the on-call physician
is simultaneously on-call at more than one hospital in the geographic
area, all hospitals involved must be aware of the on-call schedule, as
each hospital independently has an EMTALA obligation.
In addition, the letter clarifies that hospitals must have policies
and procedures to follow when an on-call physician is simultaneously on
call at another hospital and is not available to respond. Hospital
policies may include, but are not limited to, procedures for back-up
on-call physicians, or the implementation of an appropriate EMTALA
transfer according to Sec. 489.24(d). The letter reaffirms CMS' view
that hospitals have flexibility in adopting specific policies and
procedures to meet their EMTALA obligations, so long as they meet the
needs of the individuals who present for emergency care.
To avoid any misunderstanding of our policies in this area, we are
revising proposed Sec. 489.24(j) in this final rule to state the
conditions under which simultaneous calls and elective surgery while on
call are permitted.
7. Limiting On-Call Responsibility by Subspecialty
Comment: Some commenters stated that physicians' hospital
privileges are typically more expansive than their actual scope of
practice, in that a physician privileged in a broad specialty might in
fact function only within a much narrower subspecialty. For example, a
physician privileged by the hospital to treat all orthopedic cases
might in fact limit his or her practice to pediatric cases. The
commenters expressed concern that such a subspecialty physician might
be disadvantaged by agreeing to be on call, since he or she could then
be expected to treat types of patients that the physician would not
normally see. To prevent this outcome, the commenters recommended that
the EMTALA
[[Page 53255]]
regulations be revised to authorize such a physician to decline to come
in when called if he or she believes that another physician can more
competently care for the patient and should be called in.
Another commenter suggested that while subspecialists may be better
qualified in their general specialties than emergency physicians,
generalists may not necessarily be equally competent for all patients.
For example, an ophthalmologist specializing in corneal or retinal
surgery may have greater expertise in general ophthalmology than an
emergency physician, but a fully competent general surgeon may
nevertheless not have the specialized training and experience needed to
perform emergency surgery on an infant. The commenter recommended that
the regulations be revised to make it clear that, in such cases, the
on-call physician is permitted to fulfill his or her on-call obligation
by calling in another physician who has the necessary skills to care
for the patient. The commenter also recommended formation of a private-
public work group, similar to that described in proposed legislation
(H.R. 3191, the ``Medicare Appeals, Regulatory, and Contracting
Improvement Act of 2001'') to assist in resolving on-call issues.
Another commenter recommended that the regulations be revised to state
that physicians are not required to respond to calls for types of care
for which they do not hold privileges.
Response: We agree with the commenter who stated the general
principle is that patients should receive the best emergency care
available. However, as pointed out by another commenter, 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 to bear skills and
expertise that are not available to the emergency physician or other
qualified medical personnel at the hospital. While the emergency
physician and the on-call specialist may need to discuss the best way
to meet the individual's medical needs, we also believe any
disagreement between the two regarding the need for an on-call
physician to come to the hospital and examine the individual 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. We understand the
concern of the commenter who believed the final rule should state that
physicians are not required to respond to calls for types of care for
which they do not have privileges. However, we do not agree that a
revision to the regulation is needed. On the contrary, we believe that
it is the responsibility of the hospital that is maintaining the on-
call list to ensure that physicians on the list are granted whatever
privileges they would need to furnish care in the facility. Therefore,
we are not revising the final rule as recommended by this commenter.
Comment: Some commenters recommended that the EMTALA regulations be
revised to state explicitly that there may be situations in which a
transfer to another medical facility, which may be either a hospital or
a physician office, would be appropriate because the skills and
experience of the local on-call physician may not be ideal for a
particular individual. One commenter explained that such a
clarification would help avoid inconveniencing on-call physicians, who
might otherwise be required to come to a hospital to attend to
relatively minor needs.
Response: While we agree that there may be some cases in which it
is more beneficial to an individual to be transferred to another
facility because of the greater availability of specialty physician
services, we do not believe any change to the regulations is needed to
acknowledge this possibility. On the contrary, existing regulations at
Sec. 489.24(c)(1) (now Sec. 489.24(d)(1) in this final rule) make it
quite clear that an appropriate transfer is one in which the expected
benefits of appropriate medical treatment at another facility outweigh
the risks associated with transfer. We also do not believe that
individuals being seen in emergency departments would regard their
emergency medical conditions as minor needs. Therefore, we are not
making any changes in the regulations in this final rule based on these
comments.
Comment: One commenter recommended that proposed Sec. 489.24(j) be
further revised to state that specialty hospitals, particularly those
without dedicated emergency departments, are not required to maintain
on-call lists under EMTALA.
Response: Existing regulations at Sec. 489.20(r)(2), which
implement the requirement for an on-call list, make it clear that this
requirement does not apply to any hospital other than one with a
dedicated emergency department. Therefore, we do not believe a change
in the regulations is needed to clarify this point.
8. Other On-Call Issues
Comment: Some commenters stated that some physicians may choose to
come to a hospital to see private patients at times when they are not
shown as being on call under the listing the hospital maintains for
EMTALA purposes. The commenters believed such physicians should not be
considered to be on call under EMTALA simply because they come to the
hospital under these circumstances, and expressed the belief that such
a policy would be consistent with EMTALA interpretive guidelines
stating that physicians are not expected to be on call whenever they
are visiting their own patients in a hospital.
Response: We understand that physicians may sometimes come to a
hospital to see their own patients, either as part of regular rounds or
in response to requests from the patient or the patient's family, and
agree that visits of this type should not necessarily be interpreted as
meaning that the physician is on call. On the other hand, some
physicians have in the past expressed a desire to refuse to be included
on a hospital's on-call list but nevertheless take calls selectively.
These physicians might, for example, respond to calls for patients with
whom they or a colleague at the hospital have established a doctor-
patient relationship, while declining calls from other patients,
including those whose ability to pay may be in question. Such a
practice would clearly be a violation of EMTALA. Because it may be
difficult to distinguish the two practices from one another outside the
context of a careful review of patient records, we are not making any
revision to this final rule based on this comment. However, we will
keep it in mind as we develop the interpretative guidelines and
training materials for implementing EMTALA.
Comment: One commenter expressed approval of the preamble statement
(67 FR 31478 of the May 9, 2002 proposed rule) that exempting senior
medical staff from on-call responsibilities does not necessarily
violate EMTALA. However, this commenter believed that statement should
also be reflected in the text of the final regulations.
Response: We continue to believe such exemptions are not
necessarily inconsistent with EMTALA, but they were mentioned in the
preamble to illustrate rather than define the types of flexibility a
hospital may exercise in maintaining its on-call list in a way that
best meets patient needs. Thus, we do not believe this one example of
[[Page 53256]]
flexibility should be singled out for inclusion in the regulations.
Comment: One commenter stated that Federally Qualified Health
Centers (FQHCs) are required under policies of the Public Health
Service to maintain referral arrangements with hospitals for acceptance
of health center patients, and that it is recommended that FQHCs
maintain admitting privileges at those hospitals for their patients.
However, the commenter was concerned that any monetary penalties for
noncompliance with EMTALA on-call responsibilities will have to be paid
by the health centers, and that physicians who learn that they will
incur an on-call responsibility at a hospital as a cost of being
privileged there may choose to stop practicing at the health centers,
thereby depriving the health centers' patients of the physicians'
services. Therefore, the commenter recommended that CMS provide some
safe harbors, such as unspecified personal services or a high volume of
patients needing care, that would protect physicians from EMTALA
liability if they fail to be on call or are on call but fail to come to
the hospital emergency department when called.
Response: As we noted above, this final rule makes explicit
provision for two of the occurrences that physicians and other
commenters have indicated to us are responsible for physicians'
inability to respond to calls even though they have agreed to do so. In
addition, we plan to direct State surveyors, in enforcing the EMTALA
provisions, to be aware of situations in which circumstances beyond a
physician's control may prevent him or her from responding promptly to
calls. We believe these actions on our part will ensure sufficient
flexibility and, therefore, we are not at this time further defining a
set of specific ``safe harbors.'' However, we will continue to monitor
the commenter's concerns and will undertake further rulemaking if
warranted in the future.
Comment: One commenter stated that some physicians, such as
orthopedists, frequently use physician assistants in their practices.
The commenter provided a number of examples of how a physician
assistant could respond appropriately to a call from an emergency
department, participate in the screening of an individual, and either
provide the necessary stabilization or post-stabilization services, or
arrange for the performance of those services by the physician. The
commenter asked us to clarify that, in some instances, physician
assistants may appropriately provide on-call coverage, by revising the
EMTALA regulations to state that physicians included on a hospital's
on-call list may delegate their on-call responsibilities to the
physician assistants they supervise, as long as all services provided
by the physician assistants are furnished in accordance with State
scope of practice laws and with hospital and medical bylaws.
Response: We agree that there may be circumstances in which a
physician assistant may be the appropriate practitioner to respond to a
call from an emergency department or other hospital department that is
providing screening or stabilization mandated by EMTALA. However, any
decision as to whether to respond in person or direct the physician
assistant to respond should be made by the responsible on-call
physician, based on the individual's medical needs and the capabilities
of the hospital, and would, of course, be appropriate only if it is
consistent with applicable State scope of practice laws and hospital
bylaws, rules, and regulations.
D. Provisions of the Final Rule
In this final rule, we are adopting the proposed Sec. 489.24(j) as
final with the following modifications: We are specifying that the on-
call list must be maintained in a manner that best meets the needs of
the hospital's patients who are receiving services required under
EMTALA, in accordance with the capability of the hospital, including
the availability of on-call physicians. We also are revising paragraph
(j) to state the conditions under which simultaneous call and elective
surgery while on call are permitted. For editorial reasons, we are
revising the language of Sec. 489.24 to state under paragraph
(j)(3)(ii) that hospitals must ``provide'' rather than ``insure'' that
emergency services are available. No change in policy is being made by
this editorial change.
XII. EMTALA Applicability to Hospital-Owned Ambulances (Sec.
489.24(b))
A. Background
We stated in the June 22, 1994 final rule (59 FR 32098) that if an
individual is in an ambulance owned and operated by a hospital, the
individual is considered to have come to the hospital's emergency
department, even if the ambulance is not on hospital property. This
policy, currently set forth at Sec. 489.24(b), was necessary because
we were concerned that some hospitals that owned and operated
ambulances at that time were transporting individuals who had called
for an ambulance to other hospitals, thereby evading their EMTALA
responsibilities to the individuals.
Concerns have since been raised by the provider industry about
applications of this policy to ambulances that are owned by hospitals
but are operating under communitywide EMS protocols that may require
the hospital-owned and other ambulances to transport individuals to
locations other than the hospitals that own the ambulances. For
instance, we understand that some community protocols require
ambulances to transport individuals to the closest hospital to the
individual geographically, whether or not that hospital owns the
ambulance.
B. Provisions of the Proposed Rule
To avoid imposing requirements that are inconsistent with local EMS
requirements, in the May 9, 2002 proposed rule, we proposed to clarify,
at proposed revised Sec. 489.24(b), in paragraph (3) of the definition
of ``Comes to the emergency department'', an exception to our existing
rule requiring EMTALA applicability to hospitals that own and operate
ambulances. We proposed to account for hospital-owned ambulances
operating under communitywide EMS protocols. Under our proposal, the
rule on hospital-owned ambulances and EMTALA does not apply if the
ambulance is operating under a communitywide EMS protocol that requires
it to transport the individual to a hospital other than the hospital
that owns the ambulance. In this case, the individual is considered to
have come to the emergency department of the hospital to which the
individual is transported, at the time the individual is brought onto
hospital property.
C. Summary of Public Comments and Departmental Responses
Comment: A number of commenters expressed strong support for the
proposal to clarify that EMTALA does not apply to a hospital-owned
ambulance when the ambulance is operating under communitywide protocols
that require it to transport an individual to a hospital other than the
hospital that owns the ambulance. One commenter asked whether a
hospital would have any EMTALA obligation with respect to a patient who
refuses transport from the planned pickup site (for example, the site
of an automobile accident), and whether EMTALA would apply if the
physician in the emergency department provides ``medical command.''
Another commenter recommended that the regulations be further
revised to state that individuals presenting to
[[Page 53257]]
hospital-owned ambulances are subject to EMTALA and must be transported
to the hospital that owns the ambulance, unless the hospital EMS
personnel on board the ambulance determine that doing so would put the
patient's life or safety at risk. The commenter further recommended
that if the on-board hospital EMS personnel believe that transporting
the individual to the owner hospital would risk the life or health of
the individual, the personnel should be authorized to redirect the
ambulance to the closest appropriate hospital without violating EMTALA.
Response: We appreciate the support of those commenters who
expressed approval of the proposal and have kept their views in mind in
responding to other comments on this issue. In regard to the comment
about an individual who refuses transport from a planned pickup site,
we believe such cases should be treated as refusals to consent to
treatment and should be handled in accordance with the requirements for
documenting such refusals in existing Sec. 489.24(c)(2) (redesignated
in this final rule as Sec. 489.24(d)(3)).
We understand that the term ``hospital-owned ambulances operating
under medical command'' describes a situation in which the destination
of an ambulance is not determined by the ambulance personnel but by a
physician in radio contact with ambulances in the community. We believe
individuals on board such ambulances would not be considered to have
``come to the hospital'' for EMTALA purposes if the physician providing
the medical command is not employed or otherwise affiliated with the
hospital that owns the ambulance. If the physician's direction of the
ambulance (medical command) is provided subject to communitywide
protocols that require the individual to be transported to a hospital
other than the hospital that owns the ambulance, such as the closest
appropriate hospital, the hospital would be considered to be operating
under communitywide protocols. With respect to situations in which
hospital EMS personnel on board the ambulance determine that
transporting the individual to the owner hospital would put the
patient's life or safety at risk, we recognize that there may be some
situations in which redirection of the ambulance is necessary to
protect the life or safety of the individual and that under these
circumstances it would not be an EMTALA violation to transport the
individual to the closest hospital capable of treating his or her
condition. However, we believe such cases can best be identified and
resolved on a case-by-case basis and, therefore, are not revising the
final regulations based on this comment.
Comment: One commenter recommended that the proposed clarification
of the nonapplicability of EMTALA to hospital-owned ambulances when the
ambulance is operating under communitywide protocols be extended to air
ambulances as well as ground ambulances.
Response: We agree and in this final rule are revising Sec.
489.24(b), the definition of ``come to the emergency department,''
accordingly.
Comment: One commenter recommended that guidance provided in the
State Operations Manual, to the effect that hospitals have no EMTALA
obligation with respect to individuals who are in ambulances that are
neither hospital-owned and operated nor on hospital property, be
incorporated into the regulatory language.
Response: We agree that this statement of policy is accurate, but
believe the proposed regulatory language makes this clear. Therefore,
we are not making revision in the final rule based on this comment.
Comment: One commenter referenced the recently issued CMS guidance,
in the form of letters to Regional Administrators and State Survey
Agencies, regarding EMTALA responsibilities in the event of a
bioterrorist attack. The commenter believed this guidance might be
viewed as being inconsistent with a hospital's statutory responsibility
to provide screening services under EMTALA, and suggested that the
regulatory language be revised to reflect the guidance, so that
hospitals that follow it are not at risk for a citation of
noncompliance with EMTALA.
Response: We agree that hospitals should be informed of their
EMTALA responsibilities in the event of a bioterrorist attack or other
national emergency. We also believe the commenter's suggestion is
consistent with the intent of section 143 of the Public Health Security
and Bioterrorism Preparedness and Response Act of 2002 (Pub. L. 107-
188, enacted June 12, 2002). That legislation amended section 1135 of
the Act to authorize the Secretary to temporarily waive or modify the
application of certain Medicare, Medicaid, and State Children's Health
Insurance Program (SCHIP) requirements, including requirements for the
imposition of sanctions for the otherwise inappropriate transfer of an
unstabilized individual, if the transfer arises out of the
circumstances of the emergency.
To help inform hospitals of their responsibilities in such
situations, we have added a new paragraph (a)(2) to Sec. 489.24(a).
The new paragraph specifies that sanctions under EMTALA for an
inappropriate transfer during a national emergency do not apply to a
hospital with a dedicated emergency department located in an emergency
area, as specified in section 1135(g)(1) of the Act. In the event of
such a national emergency, CMS would issue appropriate guidance to
hospitals.
Comment: One commenter stated that, in some areas of the country,
ambulance protocols requiring emergency patients to be taken to the
closest appropriate hospital are not determined on a community-by-
community basis. Instead, the protocols apparently are established by
individual ambulance service medical directors in conformity with State
law and are filed with the State EMS board. The commenter expressed
concern that the proposed regulatory language on communitywide EMS
protocols would not protect hospitals in such States from inappropriate
EMTALA liability, and cited several examples of situations in which a
hospital-owned and operated ambulance might be required to bypass
appropriate hospitals to reach the owner hospital. To avoid this
result, the commenter recommended that the regulations be revised
either to state that hospital-owned and operated ambulances are not
included in the definition of ``hospital property'' or to provide an
exemption for hospital-owned ambulances operated in accordance with
protocols on file with and approved by the State ambulance licensing
authority.
Response: We agree that protocols mandated by State law should be
given the same deference as those established on a communitywide basis.
However, we believe the reference in Sec. 489.24(b)(3)(i) to
communitywide EMS protocols which direct that the individual be
transported to a hospital other than the hospital that owns the
ambulance is broad enough to encompass those communitywide protocols
that have been adopted in conformity with State law. Therefore, we are
not revising the provision in the final rule based on this comment.
Comment: One commenter stated that most ambulance protocols direct
that individuals be taken to the ``closest appropriate facility''
rather than the ``nearest hospital'' and suggested that this change in
wording of the regulation text would be appropriate because, in some
cases, individuals may need to be taken to a freestanding emergency
facility or some other location that is not a hospital. The commenter
also recommended that hospital-owned and
[[Page 53258]]
operated ambulances be given an exemption from the requirements for
situations in which the individual or family asks that the individual
be transported to another facility other than the hospital that owns
the ambulance.
Response: We agree that it would be more appropriate to refer to
requirements that the individuals be taken to the ``closest appropriate
facility'' rather than the ``nearest hospital'', and are including this
change in paragraph (3) of the definition of ``come to the emergency
department'' under Sec. 489.24(b) of this final rule.
Regarding the redirection of an ambulance at the request of the
individual's family, we believe existing regulations at Sec.
489.24(c)(2) (now Sec. 489.24(d)(3) of this final rule) regarding
informed refusals of treatment would permit the ambulance to transport
the individual to another facility. A medical record for the individual
must be established and the refusal clearly documented in that record,
in accordance with these regulatory requirements.
D. Provisions of the Final Rule
We are adopting, as final, the proposed revision to paragraph (3)
under the definition of ``come to the emergency department'' under
Sec. 489.24(b) as it related to the applicability to EMTALA to
hospital-owned ambulances, with the following modifications:
We are specifying the nonapplicability of EMTALA to hospital-owned
``air'' ambulances (in addition to ground ambulances), when the
ambulance is operating under communitywide protocols.
We are specifying that an individual in an ambulance owned and
operated by the hospital is not considered to have ``come to the
emergency department'' if the ambulance is operated under communitywide
EMS protocols or EMS protocols ``mandated by State law'' that direct it
to transport the individual to a hospital other than the hospital that
owns the ambulance. We also are specifying that an individual in an
ambulance owned and operated by the hospital is not considered to have
``come to the emergency department'' if the ambulance is operated at
the direction of a physician who is not employed or otherwise
affiliated with the hospital that owns the ambulance or if the
physician's direction of the destination of the ambulance is subject to
communitywide protocols that require the individual to be transported
to a hospital other than the hospital that owns the ambulance.
We are changing the term ``closest hospital'' to ``closest
appropriate facility''.
In addition, we are adding a new Sec. 489.24(a)(2) to specify
EMTALA responsibilities in the event of a bioterrorist attack.
XIII. Conditions of Participation for Hospitals
We are reminding hospitals and others that while these final
regulations make it clear that, while stabilizing an individual with an
emergency medical condition (or admitting the individual to the
hospital as an inpatient) relieves the hospital of its EMTALA
obligations, it does not relieve the hospital of all further
responsibility for the patient who is admitted. Stabilization or
inpatient admission also does not indicate that the hospital is thus
free to improperly discharge or transfer the individual to another
facility. Inpatients who experience acute medical conditions receive
protections under the Medicare hospital CoPs, which are found at 42 CFR
part 482. In addition, as noted earlier in this preamble and in the May
9, 2002 proposed rule preamble, we believe that outpatients who
experience what may be an emergency medical condition after the start
of an encounter with a health professional would have all protections
afforded to patients of a hospital under the Medicare hospital CoPs.
There are six hospital CoPs that provide these protections: emergency
services, governing body, discharge planning, quality assessment and
performance improvement, medical staff, and outpatient services. In the
May 9, 2002 proposed rule, we proposed to make only one change in these
CoPs: one relating to the governing body having written policies and
procedures in effect for off-campus departments that do not offer
emergency services for appraisal of emergencies and referral when
appropriate (Sec. 482.12(f)(3)).
If a hospital inpatient develops an acute medical condition and the
hospital is one that provides emergency services, the hospital is
required to ensure that it meets the emergency needs of the patient in
accordance with accepted standards of practice. Similarly, regardless
of whether the hospital provides emergency services, if an inpatient
develops an acute medical condition, the governing body CoP (Sec.
482.12(f)(2), which applies to all Medicare-participating hospitals)
would apply. This CoP requires that the hospital governing body must
ensure that the medical staff has written policies and procedures for
appraisal of emergencies, initial treatment, and referral when
appropriate.
The discharge planning CoP (Sec. 482.43, which applies to all
Medicare-participating hospitals) requires hospitals to have a
discharge planning process that applies to all patients. This CoP
ensures that patient needs are identified and that transfers and
referrals reflecting adequate discharge planning are made by the
hospital. If an inpatient develops an acute medical condition and the
hospital either does not offer emergency services or does not have the
capability to provide necessary treatment, a transfer to another
hospital with the capabilities to treat the emergency medical condition
could be warranted. Hospitals are required to meet the discharge
planning CoP in carrying out such a transfer.
The hospital CoP governing medical staff (Sec. 482.22) requires
that the hospital have an organized medical staff that operates under
bylaws approved by the governing body and is responsible to the
governing body for the quality of medical care provided to patients by
the hospital. Should the medical staff not be held accountable to the
governing body for problems regarding a lack of provision of care to an
inpatient who develops an emergency medical condition, this lack of
accountability may be reviewed under the medical staff CoP, as well,
and may result in a citation of noncompliance at the medical staff
condition level for the hospital.
Finally, the quality assessment and performance improvement CoP
(Sec. 482.21, which applies to all Medicare-participating hospitals)
requires the governing body to ensure that there is an effective,
hospital-wide quality assessment and performance improvement program to
evaluate the provision of patient care. In order to comply with this
CoP, the hospital must evaluate the care it provides hospital-wide.
Complaints regarding a lack of provision of care to an inpatient who
develops an emergency medical condition must be addressed under the
hospital's quality assurance program and may be reviewed under the
quality assessment and performance improvement CoP.
A hospital's failure to meet the CoPs requirements cited above may
result in a finding of noncompliance at the condition level for the
hospital and lead to termination of the hospital's Medicare provider
agreement. As we explained in the preamble to the January 24, 2003
final rule (69 FR 3435), the CoPs are the requirements that hospitals
must meet to participate in the Medicare and Medicaid programs. The
[[Page 53259]]
CoPs are intended to protect patient health and safety and to ensure
that high quality care is provided to all patients. The State survey
agencies (SAs), in accordance with section 1864 of the Social Security
Act (the Act), survey hospitals to assess compliance with the CoPs. The
SAs conduct surveys using the instructions in the State Operations
Manual (SOM), (Health Care Financing Administration (HCFA) Publication
No. 7). The SOM contains the regulatory language of the CoPs as well as
interpretive guidelines and survey procedures and probes that elaborate
on regulatory intent and give guidance on how to assess provider
compliance. Under Sec. 489.10(d), the SAs determine whether hospitals
have met the CoPs and report their recommendations to us. The
standards, procedures, and SA personnel involved in developing
recommendations regarding EMTALA compliance are the same as those for
recommendations regarding CoP compliance, since alleged violations of
EMTALA are treated as allegations that a hospital has not complied with
a requirement for Medicare participation.
Under the authority of section 1865 of the Act and the regulations
at Sec. 488.5, hospitals accredited by the Joint Commission on
Accreditation of Healthcare Organizations (JCAHO) or the American
Osteopathic Association (AOA) are deemed to meet the requirements in
the CoPs, and therefore, are not routinely surveyed for CoP compliance
by the SAs. However, all Medicare and Medicaid participating hospitals
are required to be in compliance with our CoPs regardless of their
accreditation status.
Comment: Some commenters expressed general approval of the proposed
revision to Sec. 482.12(f), which is applicable to hospitals that
provide emergency services but have departments off campuses that do
not provide emergency services.
Response: We appreciate these commenters' support and have kept
their views in mind in evaluating the other comments recommending
specific changes in this final rule.
Comment: Some commenters stated that the proposed revision to Sec.
482.12(f) seems to imply that hospitals must have staff trained in
appraisal of emergencies on duty on a 24-hour per day, 7-day a week
basis to comply with the requirement. The commenters believed that this
would be an unreasonable requirement.
Response: We agree that such a requirement for off-campus
departments would be unreasonably stringent. Therefore, we plan to
clarify in the interpretive guidelines or training materials used to
implement this requirement that the policies and procedures in place
for appraisal of emergencies and referral when appropriate must be
implemented only within the hours of operation and normal staffing
capability of the facility.
Comment: Some commenters opposed adding a specific CoP provision
for off-campus departments of hospitals that have dedicated emergency
departments but do not offer emergency services at their off-campus
locations. The commenters believed this is an unnecessary burden on
hospital governing bodies and medical staffs.
Response: We do not agree that adding this condition will impose an
unnecessary burden on hospitals. First, the amount of burden will be
minimal, because the regulation does not require that the facilities
provide emergency care or add to their existing medical capabilities,
but only that appropriate policies and procedures be in place. While
developing and implementing these policies and procedures will require
some effort from facilities that do not have them in place, the effort
involved should be considerably less than that required to comply with
current regulations at Sec. 489.24(i) regarding EMTALA compliance by
hospitals with off-campus nonemergency departments, which are being
replaced by the condition. We also do not agree that any remaining
burden associated with the revised requirement is unnecessary. On the
contrary, the ability of such an off-campus facility to respond
promptly and appropriately to an unexpected request for emergency care
can be crucial to the health and safety of the individual with the
emergency condition.
Because we believe that the burden of having a plan in place to
deal with an occasional emergency is minimal and the potential benefit
to the individual of having such a plan is considerable, we are not
making changes to the proposed CoP in this final rule in response to
this comment.
XIV. Other Issues
A. Editorial/Clarifying Changes
In addition to the changes to Sec. 489.24 discussed in sections V.
through XIII. of this preamble, we are revising Sec. 489.24(d)(3)
(Refusal to consent to treatment) to refer to an individual or a person
acting on the individual's behalf who ``does not consent to the
examination or treatment,'' rather than referring to an individual or a
person acting on the individual's behalf who ``refuses to consent to
examination and treatment.'' We are making a parallel change in Sec.
489.24(d)(5) (Refusal to consent to transfer). We are making these
changes only for editorial reasons and in the interest of clarity;
these revisions do not represent any change in policy.
B. Out-of-Scope Comments
We received a number of public comments on issues that were not
addressed as part of the May 9, 2002 proposed rule. Because the issues
addressed in the comments were not part of the proposed rule, we are
not providing responses to them in this final rule. We will consider
them in the future if we consider changes in related policy areas.
XV. Information Collection Requirements
Under the Paperwork Reduction Act (PRA) of 1995, we are required to
provide 60-day notice in the Federal Register and solicit public
comment before a collection of information requirement is submitted to
the Office of Management and Budget (OMB) for review and approval. In
order to fairly evaluate whether an information collection should be
approved by OMB, section 3506(c)(2)(A) of the PRA of 1995 requires that
we solicit comment on the following issues:
[sbull] The need for the information collection and its usefulness
in carrying out the proper functions of our agency.
[sbull] The accuracy of our estimate of the information collection
burden.
[sbull] The quality, utility, and clarity of the information to be
collected.
[sbull] Recommendations to minimize the information collection
burden on the affected public, including automated collection
techniques.
Therefore, we are soliciting public comments on each of these
issues for the information collection requirements discussed below.
Sec. 482.12 Conditions of Participation: Governing Body
New Sec. 482.12(f)(3) specifies that, if emergency services are
provided at the hospital but are not provided at one or more off-campus
departments of the hospital, the governing body of the hospital must
assure that the medical staff have written policies and procedures in
effect with respect to the off-campus department(s) for appraisal of
emergencies and referral when appropriate.
While this information collection requirement is subject to the
PRA, the fact that this requirement is a usual, customary, and prudent
business and
[[Page 53260]]
medical practice exempts the burden associated with this requirement
from the PRA as stipulated under 5 CFR 1320.3(b)(2). It is standard for
medical facilities to have written policies and procedures pertaining
to medical emergencies. Having written policies and procedures saves
time deciding what to do and thus benefits the patient; it also gives
the provider liability protection.
In the May 9, 2002 proposed rule (67 FR 31496), we solicited,
public comment on this information collection requirement. However, we
did not receive any public comments on this information collection
requirement.
Sec. 489.24 Special responsibilities of Medicare hospitals in
emergency cases.
Paragraph (d) of this section requires that, if the hospital offers
an individual the further medical examination and treatment described
in that paragraph and informs the individual (or a person acting on the
individual's behalf) of the risks and benefits to the individual of the
examination and treatment, but the individual (or a person acting on
the individual's behalf) does not consent to the examination or
treatment: (1) The medical record must contain a description of the
examination, treatment, or both if applicable, that was refused by or
on behalf of the individual; (2) the hospital must take all reasonable
steps to secure the individual's written informed refusal (or that of
the person acting on his or her behalf); and (3) the written document
should indicate that the person has been informed of the risks and
benefits of the examination or treatment, or both.
Paragraph (d) of this section also requires that, if the hospital
offers to transfer the individual to another medical facility in
accordance with paragraph (e) of this section and informs the
individual (or a person acting on his or her behalf) of the risks and
benefits to the individual of the transfer, but the individual (or a
person acting on the individual's behalf) does not consent to the
transfer: (1) The hospital must take all reasonable steps to secure the
individual's written informed refusal (or that of a person acting on
his or her behalf); (2) the written document must indicate the person
has been informed of the risks and benefits of the transfer and state
the reasons for the individual's refusal; and (3) the medical record
must contain a description of the proposed transfer that was refused by
or on behalf of the individual.
The burden associated with these requirements is the time it will
take a hospital to secure a written refusal, create a written document
containing the information the patient has been given, and describing
in the patient's record what was refused. These information collection
requirements are currently approved under 0938-0667.
Paragraph (j) of this section requires that each hospital must
maintain an on-call list of physicians on its medical staff in a manner
that best meets the needs of the hospital's patients who are receiving
services required under this section in accordance with the resources
available to the hospital, including the availability of on-call
physicians. It also requires that the hospital have written policies
and procedures in place to respond to situations in which a particular
specialty is not available or the on-call physician cannot respond
because of circumstances beyond the physician's control and 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 schedule elective surgery during the time that they are
on call or to permit on-call physicians to have simultaneous on-call
duties.
The burden associated with these requirements is the time it will
take to create the list and write down the policies and procedures. We
believe that these actions reflect usual, customary, and prudent
medical and business practices; the burden is exempt from the PRA under
5 CFR 1320.3(b)(2). We believe that the providers have the necessary
written information available to the staff in times of emergencies to
reduce the time it takes to contact a doctor or to decide what to do if
the doctor is unavailable. These actions benefit the patient and give
the provider liability protection.
We note that these requirements in paragraph (j) are revisions of
provisions that were included in the May 9, 2002 proposed rule.
We have submitted a copy of this final rule to OMB for its review
of the information collection requirements described above. These
requirements are not effective until they have been approved by OMB.
If you comment on any of these information collection and record
keeping requirements, please mail copies directly to the following:
Centers for Medicare & Medicaid Services, Office of Strategic
Operations and Regulatory Affairs, Regulations Development and
Issuances Group, Attn: Julie Brown, CMS-1063-F Room C5-16-03, 7500
Security Boulevard, Baltimore, MD 21244-1850; and
Office of Information and Regulatory Affairs, Office of Management and
Budget, Room 10235, New Executive Office Building, Washington, DC
20503, Attn: Brenda Aguilar, CMS Desk Officer.
Comments submitted to OMB may also be e-mailed to the following
address: e-mail: [email protected]; or faxed to OMB at (202) 395-
6974.
XVI. Regulatory Impact Analysis
A. Introduction
We have examined the impacts of this rule as required by Executive
Order 12866 (September 1993, Regulatory Planning and Review), the
Regulatory Flexibility Act (RFA) (September 16, 1980, Pub. L. 96-354),
section 1102(b) of the Social Security Act, the Unfunded Mandates
Reform Act of 1995 (Pub. L. 104-4), and Executive Order 13132.
B. Executive Order 12866
Executive Order 12866 (as amended by Executive Order 13258, which
merely reassigns responsibility of duties) directs agencies to assess
all costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety effects, distributive impacts, and equity). A
regulatory impact analysis (RIA) must be prepared for major rules with
economically significant effects ($100 million or more in any 1 year).
We have determined that this final rule is not a major rule as
defined in 5 U.S.C. 804(2). As explained below, we do not have
sufficient information to estimate the precise economic impact of this
final rule. However, in general, this final rule diminishes rather than
increases the EMTALA compliance burden on hospitals and physicians as
this burden exists under current regulations. In both the previous
EMTALA rules, the proposed EMTALA rule published on June 16, 1988 (53
FR 22513) and the preamble to the interim final rule published on June
22, 1994 (59 FR 32120), we explained, and the Secretary certified, that
those regulations would not have a significant impact on a substantial
number of small entities and would not have a significant impact on the
operations of a substantial number of small rural hospitals. As
explained above, this final rule further reduces compliance burden and
cost. Therefore, we estimate that the total impact of these changes
will be less than the threshold for a major rule ($100 million or more
in any 1 year).
[[Page 53261]]
C. Regulatory Flexibility Act
The RFA requires agencies to analyze options for regulatory relief
of small businesses. For purposes of the RFA, small entities include
small businesses, nonprofit organizations, and government agencies.
Most hospitals and most other providers and suppliers are small
entities, either by nonprofit status or by having revenues of $6
million to $29 million in any 1 year. Individuals and States are not
included in the definition of a small entity.
In the preamble of the May 9, 2002 proposed rule, we stated that we
believed it would be difficult to quantify the impact of the proposed
changes and solicited comments on how such an impact estimate could be
developed. We did not receive any comments on this point. Neither the
proposed EMTALA rule published on June 16, 1988 (53 FR 22513) nor the
interim final rule published on June 22, 1994 (50 FR 32086) included a
quantitative analysis of the economic impact of the rule. However, in
the preamble to each rule, we explained that because the great majority
of hospitals do not refuse to treat individuals or transfer patients
inappropriately based on their perceived inability to pay, the economic
impact of those rules was minimal. Since this rule is only a
modification of the previous EMTALA rules, we believe that the impact
of this final rule is also minimal. For the reasons explained above, we
are confident that the overall effect of this final rule will be to
reduce rather than increase the EMTALA compliance burden for hospitals
and physicians. For example, the compliance burden for hospitals will
be reduced because off-campus provider-based departments that are not
dedicated emergency departments will no longer have any EMTALA
responsibilities. The burden for physicians should be reduced by the
changes that allow them to be on call simultaneously at multiple
locations, and to schedule other procedures while they are on call.
Because we do not have enough information to precisely predict the
dollar amount of the reduced burden, we have not attempted to produce a
quantified estimate of the impact of this final rule. However, based on
the reduction in burden relative to current regulations, we have
determined that this final rule will not have a significant impact on a
substantial number of small entities.
D. Effects on Rural Hospitals
In addition, section 1102(b) of the Act requires us to prepare a
regulatory impact analysis if a rule may have a significant impact on
the operations of a substantial number of small rural hospitals. This
analysis must conform to the provisions of section 604 of the RFA. With
the exception of hospitals located in certain New England counties, for
purposes of section 1102(b) of the Act, we define a small rural
hospital as a hospital with fewer than 100 beds that is located outside
of a Metropolitan Statistical Area (MSA) or New England County
Metropolitan Area (NECMA). Section 601(g) of the Social Security
Amendments of 1983 (Pub. L. 98-21) designated hospitals in certain New
England counties as belonging to the adjacent NECMA. Thus, for purposes
of payments to hospitals, we classify these hospitals as urban
hospitals. As explained above, the compliance burden and cost
associated with this final rule is expected to be significantly less
than the burden associated with existing regulations. Based on the
reduction in burden relative to current regulations, we have determined
that this final rule will not have a significant impact on the
operations of small rural hospitals.
E. Unfunded Mandates
Section 202 of the Unfunded Mandates Reform Act of 1995 (Pub. L.
104-4) also requires that agencies assess anticipated costs and
benefits before issuing a final rule that has been preceded by a
proposed rule that may result in an expenditure in any 1 year by State,
local, or tribal governments, in the aggregate, or by the private
sector, of $110 million. This final rule will not mandate any
requirements that may result in an expenditure, in any 1 year for
State, local, or tribal governments or for the private sector of $110
million.
F. Federalism
Executive Order 13132 establishes certain requirements that an
agency must meet when it promulgates a proposed rule (and subsequent
final rule) that imposes substantial direct requirement costs on State
and local governments, preempts State law, or otherwise has Federalism
implications. We have reviewed this final rule in light of Executive
Order 13132 and have determined that it will not have any significant
impact on the rights, roles, and responsibilities of State, local, or
tribal governments.
G. Executive Order 12866
In accordance with the provisions of Executive Order 12866, this
final rule was reviewed by the Office of Management and Budget.
List of Subjects
42 CFR Part 413
Health facilities, Kidney diseases, Medicare, Puerto Rico,
Reporting and recordkeeping requirements.
42 CFR Part 482
Grant program-health, Hospitals, Medicaid, Medicare, Reporting and
recordkeeping requirements.
42 CFR Part 489
Health facilities, Medicare, Reporting and recordkeeping
requirements.
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For the reasons set forth in this preamble, the Centers for Medicare &
Medicaid Services amends 42 CFR chapter IV as set forth below:
PART 413--PRINCIPLES OF REASONABLE COST REIMBURSEMENT; PAYMENT FOR
END-STAGE RENAL DISEASE SERVICES; OPTIONAL PROSPECTIVELY DETERMINED
PAYMENT RATES FOR SKILLED NURSING FACILITIES
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A. Part 413 is amended as follows:
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1. The authority citation for part 413 continues to read as follows:
Authority: Secs. 1102, 1812(d), 1814(b), 1815, 1833(a), (i), and
(n), 1871, 1881, 1883, and 1886 of the Social Security Act (42
U.S.C. 1302, 1395d(d), 1395f(b), 1395g, 1395l(a), (i), and (n),
1395hh, 1395rr, 1395tt, and 1395ww).
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2. Section 413.65 is amended by adding introductory text under
paragraph (g) and revising paragraph (g)(1) to read as follows:
Sec. 413.65 Requirements for a determination that a facility or an
organization has provider-based status.
* * * * *
(g) Obligations of hospital outpatient departments and hospital-
based entities. To qualify for provider-based status in relation to a
hospital, a facility or organization must comply with the following
requirements:
(1) The following departments must comply with the antidumping
rules of Sec. 489.20(l), (m), (q), and (r) and Sec. 489.24 of this
chapter:
(i) Any facility or organization that is located on the main
hospital campus and is treated by Medicare under this section as a
department of the hospital; and
(ii) Any facility or organization that is located off the main
hospital campus that is treated by Medicare under this section as a
department of the hospital and is a dedicated emergency department, as
defined in Sec. 489.24(b) of this chapter.
* * * * *
[[Page 53262]]
PART 482--CONDITIONS FOR PARTICIPTION FOR HOSPITALS
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B. Part 482 is amended as follows:
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1. The authority citation for Part 482 continues to read as follows:
Authority: Secs. 1102 and 1871 of the Social Security Act (42
U.S.C. 1320 and 1395hh).
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2. Section 482.12 is amended by adding a new paragraph (f)(3) to read
as follows:
Sec. 482.12 Condition of participation: Governing body.
* * * * *
(f) Standard: Emergency services. * * *
(3) If emergency services are provided at the hospital but are not
provided at one or more off-campus departments of the hospital, the
governing body of the hospital must assure that the medical staff has
written policies and procedures in effect with respect to the off-
campus department(s) for appraisal of emergencies and referral when
appropriate.
PART 489--PROVIDER AGREEMENTS AND SUPPLIER APPROVAL
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C. Part 489 is amended as follows:
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1. The authority citation for Part 489 continues to read as follows:
Authority: Secs. 1102 and 1871 of the Act (42 U.S.C. 1302 and
1395hh).
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2. Section 489.24 is amended by--
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A. Revising paragraph (a).
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B. Republishing the introductory text of paragraph (b) and revising the
definitions of ``Comes to the emergency department'' and ``Hospital
with an emergency department''.
0
C. Adding definitions of ``Dedicated emergency department'', ``Hospital
property'', ``Inpatient'', and ``Patient'' in alphabetical order under
paragraph (b).
0
D. Under the definition of ``Emergency medical condition'' under
paragraph (b), redesignating paragraphs (i), (i)(A), (i)(B), (i)(C),
(ii), (ii)(A), and (ii)(B) as paragraphs (1), (1)(i), (1)(ii),
(1)(iii), (2), (2)(i), and (2)(ii), respectively.
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E. Under the definition of ``Participating hospital'' under paragraph
(b), redesignating paragraphs (i) and (ii) as paragraphs (1) and (2),
respectively.
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F. Under the definitions of ``Stabilized'' and ``To stabilize'' under
paragraph (b), ``paragraph (i)'' is removed and ``paragraph (1)'' is
added in its place; and ``paragraph (ii)'' is removed and ``paragraph
(2)'' is added in its place.
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G. Removing paragraph (i); and redesignating paragraph (c) through (h)
as paragraphs (d) through (i), respectively.
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H. Adding new paragraphs (c) and (j).
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I. Revising newly redesignated paragraph (d).
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J. Making the following cross-reference changes:
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i. In redesignated paragraph (e)(1)(i), ``paragraph (d)(2)'' is removed
and ``paragraph (e)(2)'' is added in its place.
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ii. In redesignated paragraph (e)(1)(ii)(C), ``paragraph
(d)(1)(ii)(B)'' is removed and ``paragraph (e)(1)(ii)(B)'' is added in
its place.
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iii. In redesignated paragraph (e)(2)(iii), ``paragraph (d)(1)(ii)'' is
removed and ``paragraph (e)(1)(ii)'' is added in its place.
0
iv. In redesignated paragraph (e)(2)(iii), ``paragraph (f)'' is removed
and ``paragraph (g)'' is added in its place.
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v. In redesignated paragraph (e)(3), ``paragraph (d)(1)(ii)(C)'' is
removed and ``paragraph (e)(1)(ii)(C)'' is added in its place.
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vi. In redesignated paragraph (g), ``paragraph (a) through (e)'' is
removed and ``paragraphs (a) through (f)'' is added in its place.
0
vii. In redesignated paragraph (h)(1), ``paragraph (g)(3)'' is removed
and ``paragraph (h)(3)'' is added in its place; and ``paragraph
(g)(2)(iv) and (v)'' is removed and ``paragraphs (h)(2)(iv) and (v)''
is added in its place.
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viii. In redesignated paragraph (h)(2) introductory text, ``paragraph
(g)(1)'' is removed and ``paragraph (h)(1)'' is added in its place.
0
ix. In redesignated paragraph (h)(2)(iii)(B), ``paragraph
(g)(2)(iii)(A)'' is removed and ``paragraph (h)(2)(iii)(A)'' is added
in its place.
0
x. In redesignated paragraph (h)(2)(vi), ``paragraph (g)(2)(v)'' is
removed and ``paragraph (h)(2)(v)'' is added in its place.
0
xi. In redesignated paragraph (h)(4), ``paragraph (g)'' is removed and
``paragraph (h)'' is added in its place; and ``paragraph (g)(2)(v)'' is
removed and ``paragraph (h)(2)(v)'' is added in its place.
The additions and revisions read as follows:
Sec. 489.24 Special responsibilities of Medicare hospitals in
emergency cases.
(a) Applicability of provisions of this section. (1) In the case of
a hospital that has an emergency department, if an individual (whether
or not eligible for Medicare benefits and regardless of ability to pay)
``comes to the emergency department'', as defined in paragraph (b) of
this section, the hospital must--
(i) Provide an appropriate medical screening examination within the
capability of the hospital's emergency department, including ancillary
services routinely available to the emergency department, to determine
whether or not an emergency medical condition exists. The examination
must be conducted by an individual(s) who is determined qualified by
hospital bylaws or rules and regulations and who meets the requirements
of Sec. 482.55 of this chapter concerning emergency services personnel
and direction; and
(ii) If an emergency medical condition is determined to exist,
provide any necessary stabilizing treatment, as defined in paragraph
(d) of this section, or an appropriate transfer as defined in paragraph
(e) of this section. If the hospital admits the individual as an
inpatient for further treatment, the hospital's obligation under this
section ends, as specified in paragraph (d)(2) of this section.
(2) Nonapplicability of provisions of this section. Sanctions under
this section for inappropriate transfer during a national emergency do
not apply to a hospital with a dedicated emergency department located
in an emergency area, as specified in section 1135(g)(1) of the Act.
(b) Definitions. As used in this section--
* * * * *
Comes to the emergency department means, with respect to an
individual who is not a patient (as defined in this section), the
individual--
(1) Has presented at a hospital's dedicated emergency department,
as defined in this section, and requests examination or treatment for a
medical condition, or has such a request made on his or her behalf. 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 a medical condition;
(2) Has presented on hospital property, as defined in this section,
other than the dedicated emergency department, and requests examination
or treatment for what may be an emergency medical condition, or has
such a request made on his or her behalf. 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 emergency examination or treatment;
(3) Is in a ground or air ambulance owned and operated by the
hospital for purposes of examination and treatment for a medical
condition at a hospital's
[[Page 53263]]
dedicated emergency department, even if the ambulance is not on
hospital grounds. However, an individual in an ambulance owned and
operated by the hospital is not considered to have ``come to the
hospital's emergency department'' if--
(i) The ambulance is operated under communitywide emergency medical
service (EMS) protocols that direct it to transport the individual to a
hospital other than the hospital that owns the ambulance; for example,
to the closest appropriate facility. In this case, the individual is
considered to have come to the emergency department of the hospital to
which the individual is transported, at the time the individual is
brought onto hospital property;
(ii) The ambulance is operated at the direction of a physician who
is not employed or otherwise affiliated with the hospital that owns the
ambulance; or
(4) Is in a ground or air nonhospital-owned ambulance on hospital
property for presentation for examination and treatment for a medical
condition at a hospital's dedicated emergency department. However, an
individual in a nonhospital-owned ambulance off hospital property is
not considered to have come to the hospital's emergency department,
even if a member of the ambulance staff contacts the hospital by
telephone or telemetry communications and informs the hospital that
they want to transport the individual to the hospital for examination
and treatment. The hospital may direct the ambulance to another
facility if it is in ``diversionary status,'' that is, it does not have
the staff or facilities to accept any additional emergency patients.
If, however, the ambulance staff disregards the hospital's diversion
instructions and transports the individual onto hospital property, the
individual is considered to have come to the emergency department.
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:
(1) It is licensed by the State in which it is located under
applicable State law as an emergency room or emergency department;
(2) 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
(3) During the calendar year immediately preceding the calendar
year in which a determination under this section is being made, based
on a representative sample of patient visits that occurred during that
calendar year, it 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.
* * * * *
Hospital property means the entire main hospital campus as defined
in Sec. 413.65(b) of this chapter, including the parking lot,
sidewalk, and driveway, but excluding other areas or structures of the
hospital's main building that are not part of the hospital, such as
physician offices, rural health centers, skilled nursing facilities, or
other entities that participate separately under Medicare, or
restaurants, shops, or other nonmedical facilities.
Hospital with an emergency department means a hospital with a
dedicated emergency department as defined in this paragraph (b).
Inpatient means an individual who is admitted to a hospital for bed
occupancy for purposes of receiving inpatient hospital services as
described in Sec. 409.10(a) of this chapter with the expectation that
he or she will remain at least overnight and occupy a bed even though
the situation later develops that the individual can be discharged or
transferred to another hospital and does not actually use a hospital
bed overnight.
* * * * *
Patient means--
(1) An individual who has begun to receive outpatient services as
part of an encounter, as defined in Sec. 410.2 of this chapter, other
than an encounter that the hospital is obligated by this section to
provide;
(2) An individual who has been admitted as an inpatient, as defined
in this section.
* * * * *
(c) Use of dedicated emergency department for nonemergency
services. If an individual comes to a hospital's dedicated emergency
department and a request is made on his or her behalf for examination
or treatment for a medical condition, but the nature of the request
makes it clear that the medical condition is not of an emergency
nature, the hospital is required only to perform such screening as
would be appropriate for any individual presenting in that manner, to
determine that the individual does not have an emergency medical
condition.
(d) Necessary stabilizing treatment for emergency medical
conditions.--(1) General. Subject to the provisions of paragraph (d)(2)
of this section, if any individual (whether or not eligible for
Medicare benefits) comes to a hospital and the hospital determines that
the individual has an emergency medical condition, the hospital must
provide either--
(i) Within the capabilities of the staff and facilities available
at the hospital, for further medical examination and treatment as
required to stabilize the medical condition.
(ii) For transfer of the individual to another medical facility in
accordance with paragraph (e) of this section.
(2) Exception: Application to inpatients. (i) If a hospital has
screened an individual under paragraph (a) of this section and found
the individual to have an emergency medical condition, and admits that
individual as an inpatient in good faith in order to stabilize the
emergency medical condition, the hospital has satisfied its special
responsibilities under this section with respect to that individual.
(ii) This section is not applicable to an inpatient who was
admitted for elective (nonemergency) diagnosis or treatment.
(iii) A hospital is required by the conditions of participation for
hospitals under Part 482 of this chapter to provide care to its
inpatients in accordance with those conditions of participation.
(3) Refusal to consent to treatment. A hospital meets the
requirements of paragraph (d)(1)(i) of this section with respect to an
individual if the hospital offers the individual the further medical
examination and treatment described in that paragraph and informs the
individual (or a person acting on the individual's behalf) of the risks
and benefits to the individual of the examination and treatment, but
the individual (or a person acting on the individual's behalf) does not
consent to the examination or treatment. The medical record must
contain a description of the examination, treatment, or both if
applicable, that was refused by or on behalf of the individual. The
hospital must take all reasonable steps to secure the individual's
written informed refusal (or that of the person acting on his or her
behalf). The written document should indicate that the person has been
informed of the risks and benefits of the examination or treatment, or
both.
(4) Delay in examination or treatment.
(i) A participating hospital may not delay providing an appropriate
medical screening examination required under paragraph (a) of this
section or further medical examination and treatment required under
paragraph (d)(1) of this section in order to inquire about the
individual's method of payment or insurance status.
[[Page 53264]]
(ii) A participating hospital may not seek, or direct an individual
to seek, authorization from the individual's insurance company for
screening or stabilization services to be furnished by a hospital,
physician, or nonphysician practitioner to an individual until after
the hospital has provided the appropriate medical screening examination
required under paragraph (a) of this section, and initiated any further
medical examination and treatment that may be required to stabilize the
emergency medical condition under paragraph (d)(1) of this section.
(iii) An emergency physician or nonphysician practitioner is not
precluded from contacting the individual's physician at any time to
seek advice regarding the individual's medical history and needs that
may be relevant to the medical treatment and screening of the patient,
as long as this consultation does not inappropriately delay services
required under paragraph (a) or paragraphs (d)(1) and (d)(2) of this
section.
(iv) Hospitals may follow reasonable registration processes for
individuals for whom examination or treatment is required by this
section, including asking whether an individual is insured and, if so,
what that insurance is, as long as that inquiry does not delay
screening or treatment. Reasonable registration processes may not
unduly discourage individuals from remaining for further evaluation.
(5) Refusal to consent to transfer. A hospital meets the
requirements of paragraph (d)(1)(ii) of this section with respect to an
individual if the hospital offers to transfer the individual to another
medical facility in accordance with paragraph (e) of this section and
informs the individual (or a person acting on his or her behalf) of the
risks and benefits to the individual of the transfer, but the
individual (or a person acting on the individual's behalf) does not
consent to the transfer. The hospital must take all reasonable steps to
secure the individual's written informed refusal (or that of a person
acting on his or her behalf). The written document must indicate the
person has been informed of the risks and benefits of the transfer and
state the reasons for the individual's refusal. The medical record must
contain a description of the proposed transfer that was refused by or
on behalf of the individual.
* * * * *
(j) Availability of on-call physicians. (1) Each hospital must
maintain an on-call list of physicians on its medical staff in a manner
that best meets the needs of the hospital's patients who are receiving
services required under this section in accordance with the resources
available to the hospital, including the availability of on-call
physicians.
(2) The hospital must have written policies and procedures in
place--
(i) To respond to situations in which a particular specialty is not
available or the on-call physician cannot respond because of
circumstances beyond the physician's control; and
(ii) 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 schedule elective surgery during the time
that they are on call or to permit on-call physicians to have
simultaneous on-call duties.
(Catalog of Federal Domestic Assistance Program No. 93.773,
Medicare--Hospital Insurance)
Dated: April 3, 2003.
Thomas A. Scully,
Administrator, Centers for Medicare & Medicaid Services.
Dated: June 27, 2003.
Tommy G. Thompson,
Secretary.
[FR Doc. 03-22594 Filed 8-29-03; 4:44 pm]
BILLING CODE 4120-01-P