[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.

0
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

0
A. Part 413 is amended as follows:
0
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).


0
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

0
B. Part 482 is amended as follows:
0
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).

0
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

0
C. Part 489 is amended as follows:
0
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).

0
2. Section 489.24 is amended by--
0
A. Revising paragraph (a).
0
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.
0
E. Under the definition of ``Participating hospital'' under paragraph 
(b), redesignating paragraphs (i) and (ii) as paragraphs (1) and (2), 
respectively.
0
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.
0
G. Removing paragraph (i); and redesignating paragraph (c) through (h) 
as paragraphs (d) through (i), respectively.
0
H. Adding new paragraphs (c) and (j).
0
I. Revising newly redesignated paragraph (d).
0
J. Making the following cross-reference changes:
0
i. In redesignated paragraph (e)(1)(i), ``paragraph (d)(2)'' is removed 
and ``paragraph (e)(2)'' is added in its place.
0
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.
0
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.
0
v. In redesignated paragraph (e)(3), ``paragraph (d)(1)(ii)(C)'' is 
removed and ``paragraph (e)(1)(ii)(C)'' is added in its place.
0
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.
0
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