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.
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 [OFR:
Insert 60 days after the date of publication].
FOR FURTHER INFORMATION CONTACT:
Thomas Gustafson, (410) 786-4487
SUPPLEMENTARY INFORMATION:
Availability of Copies and Electronic
Access
Copies: To order copies of the Federal
Register containing this
document, send your request to:
New Orders, Superintendent of Documents, P.O. Box 371954,
Pittsburgh, PA 15250-7954.
Specify the date of the issue requested and enclose a check or money
order payable to the Superintendent of Documents, or enclose your Visa or
Master Card number and expiration date.
Credit card orders can also be placed by calling the order desk at (202)
512-1800 or by faxing to (202) 512-2250.
The cost for each copy is $10.00.
As an alternative, you can view and photocopy the Federal Register document at most libraries designated as
Federal Depository Libraries and at many other public and academic libraries
throughout the country that receive the Federal Register.
This
Federal Register document is
also available from the Federal Register online database through GPO Access, a service of the U.S. Government Printing
Office. Free public access is available
on a Wide Area Information Server (WAIS) through the Internet and via
asynchronous dial-in. Internet
users can access the database by using the World Wide Web; the Superintendent
of Documents home page address is http://www.access.gpo.gov/nara__docs/, by
using local WAIS client software, or by telnet to swais.access.gpo.gov, then
login as guest (no password required).
Dial-in users should use communications software and modem to call (202)
512-1661; type swais, then login as guest (no password required).
I. Background
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
2.
Definition of
Stability
3.
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
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
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 §489.24 provides for the
following:
• 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))
• Defines certain terms, including
“comes to the emergency department,” “emergency medical
condition,” “stabilized,” and “to stabilize.” (Paragraph (b))
• 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, §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
§§489.20(l), (m), (q), and (r)(1), (r)(2), and (r)(3). Those regulations deal with 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 §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.
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 §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 §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
§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:
• 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.
• 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.
• 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.
• 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 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 §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 (§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 §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 §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 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.
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
§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
§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
§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.
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 §489.24(d)(4)(iii) should be
deleted because, in the commenter's view, it implies that some contacts with individuals'
physicians might be 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.
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 §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 §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” (§489.24(a) and (b))
A. Background
Section 1867(a) of the Act and our existing regulations at §489.24(a) provide, in part, that if any individual comes to the emergency department of a hospital and a request is made on that individual’s behalf for examination or treatment of a medical condition, the hospital must provide an appropriate medical screening examination within the capability of the hospital’s emergency department. Section 1867(b) of the Act and our existing regulations at §489.24(c) provide, in part, that if the hospital determines that such an individual has an emergency medical condition, the hospital is further obligated to provide either necessary stabilizing treatment or an appropriate transfer. Occasionally, questions have arisen as to whether these EMTALA requirements apply to situations in which an individual comes to a hospital, but does not present to the hospital’s emergency department.
B. Provisions of the Proposed Rule
In the May 9, 2002 proposed rule (67 FR 31472), we proposed to consolidate the EMTALA requirements for screening (currently in §489.24(a)) and for stabilization or appropriate transfer (currently in §489.24(c)) into a single revised paragraph (a). This consolidation was not intended to change the substance of the requirements, but only to set forth more concisely, in a single opening paragraph, the essential requirements of EMTALA. In proposed paragraph (b), we proposed to clarify the criteria for determining under what conditions a hospital is obligated by EMTALA to screen and, if necessary, stabilize or transfer an individual who comes to a hospital, presenting either at its dedicated emergency department, as we proposed to define, or elsewhere on hospital property, and requests examination or treatment, or has such a request made on his or her behalf.
In developing the proposed criteria, we recognized that sometimes individuals come to hospitals seeking examination or treatment for medical conditions that could be emergency medical conditions, but present for examination or treatment at areas of the hospital other than the emergency department. In recognition of this possibility, and for other reasons explained in the preamble to the proposed rule (including the need to assure that an individual is not denied services simply because he or she failed to actually enter the hospital’s designated emergency department), we proposed to clarify under proposed §489.24(b) that an individual can “come to the emergency department,” creating an EMTALA obligation on the part of the hospital, in one of two ways: The individual can present at a hospital’s dedicated emergency department (as we proposed to define that term) and request examination or treatment for a medical condition; or the individual can present elsewhere on hospital property in an attempt to gain access to the hospital for emergency care (that is, at a location that is on hospital property but is not part of a dedicated emergency department), and request examination or treatment for what they believe to be an emergency medical condition.
Because of the need to clarify the applicability of EMTALA to a particular individual depending on where he or she presents on hospital property in order to obtain emergency care, we proposed to define “dedicated emergency department.” We proposed that “dedicated emergency department” would mean a specially equipped and staffed area of the hospital that is used a significant portion of the time for the initial evaluation and treatment of outpatients for emergency medical conditions, as defined in §489.24(b), and is either located: (1) on the main hospital campus; or (2) off the main hospital campus and is treated by Medicare under §413.65(b) as a department of the hospital.
The EMTALA statute was intended to apply to individuals presenting to a hospital for emergency care services. Accordingly, we believe it is irrelevant whether the dedicated emergency department is located on or off the hospital main campus, as long as the individual is presenting to “a hospital” for those services. Therefore, we proposed in our definition of “dedicated emergency department” that such a department may be located on the main hospital campus, or it may be a department of the hospital located off the main campus. (We note that the proposed definition would encompass not only what is generally thought of as a hospital’s “emergency room” but would also include other departments of hospitals, such as labor and delivery departments and psychiatric units of hospitals, if these departments provide emergency psychiatric or labor and delivery services, or both, or other departments that are held out to the public as an appropriate place to come for medical services on an urgent, nonappointment basis.)
In the May 9, 2002 proposed rule, we solicited public comments on whether this proposed definition should more explicitly define what is a “dedicated emergency department” (67 FR 31472). Specifically, we sought comments on whether a “significant portion of time” should be defined more objectively; for example, in terms of some minimum number or minimum percent of patients (20, 30, 40 percent or more of all patients seen) presenting for emergency care at a particular area of the hospital in order for it to qualify as a dedicated emergency department. As an alternative, we proposed considering a qualifying criterion that is based on determining whether the facility is used “regularly” for the evaluation or treatment of emergency medical conditions, and how we could define “regularly.” We further sought comments from hospitals, physicians, and others on how hospitals currently organize themselves to react to situations in which individuals come to a hospital requesting a screening examination or medical treatment, or both.
C. Summary of Public Comments and Departmental Responses
1. General Support
Comment: Many commenters supported our proposed revised definition of “dedicated emergency department.” The commenters believed the proposed revised definition is clear and did not need to be further revised.
Response: We appreciate the support of the commenters and have taken their views into account in considering the comments of those respondents who recommended revisions.
2. Objective Test of “Significant Portion of the Time”
Comment: Some commenters believed that an objective test (such as a percentage of emergency patients seen or treated for emergency medical conditions) to determine dedicated emergency department status would reduce confusion in the provider industry. Several other commenters stated that while a finite, objective test, such as a standard of 20, 30, 40 percent of more of all patients seen, would be desirable because of the certainty and consistency it would provide in determining a “significant portion of the time” for purposes of “dedicated emergency department” determination, the commenters believed the percentages cited by us are too low.
One
commenter asked us to clarify what is meant by patients who “seek
emergency care” in our discussion of whether "significant portion of
the time" should be defined more objectively. For instance, the commenter stated the view that while many
patients present for immediate care of nonemergency problems (and these
patients must be screened for an emergency under EMTALA regulations), they
should not be counted in determining whether a department is considered a dedicated emergency department.
Response: After consideration of these comments and the following related comments in this section VII.C. of this preamble, we believe that providing an objective criterion as part of the definition of "dedicated emergency department" for purposes of EMTALA will provide predictability and consistency to the health care industry, as the commenters suggest. Therefore, as one part of the definition of "dedicated emergency department," as described in more detail below, we are specifying in this final rule that a department or facility that does not otherwise qualify as a “dedicated emergency department” based on State licensure or the way it is held out to the public will nevertheless be considered to be a dedicated emergency department if, during the calendar year immediately preceding the calendar year in which a determination is being made, based on a representative sample of patient visits that occurred during that calendar year, the department or facility provided at least one-third of all its outpatient visits for the treatment of emergency medical conditions on an urgent basis without requiring a previously scheduled appointment. We adopted this definition because we believe it adds the element of objectivity requested by many commenters and thus enables hospitals to know in advance whether they will be subject to EMTALA. We included a reference to a "representative sample" of visits for two reasons. First, we believe any determination under this definition must be based on information that accurately represents the type and mix of services delivered by the department or facility over a period of time, not merely during certain parts of the year. However, we also recognize that the large number of visits provided by some departments or facilities will make it a practical necessity to sampling techniques to obtain information on the type of care furnished instead of attempting to review all records of all visits by all patients during a year. Therefore, we intent to issue instructions, through interpretative guidelines, to our surveyors on how to determine such a representative sample. In addition, we may develop a series of questions and answers for posting on our website that will provide further clarification and guidance to providers.
In response to the comment regarding visits for the care of nonemergency problems, we agree that such visits should not normally be counted as being for the treatment of emergency medical conditions. However, as discussed in section VIII. of this preamble, individuals who suffer an unexpected emergency medical condition after they arrive at the hospital for an outpatient visit but before they begin an outpatient encounter and individuals whose appearance or behavior would cause a prudent layperson observer to believe they need examination or treatment for an emergency medical condition would be counted toward the "one-third" standard.
Comment: One commenter recommended that we use the term "regularly" instead of “a significant portion of the time” in the definition of dedicated emergency department. The commenter opposed the use of additional qualifying criteria (percentages) to determine whether a facility is used “regularly” for the evaluation and treatment of emergency medical conditions and believed that hospitals should have maximum flexibility to determine which part of their facility is appropriate for the delivery of emergency care.
Response: As explained in the response to the previous comment, we believe that an objective criterion relating to the percentage of visits for the treatment of emergency medical conditions, such as the one we are including in this final rule for purposes of EMTALA, provides needed predictability for those who are determining dedicated emergency department status. In addition, we believe this objective criterion in the definition of dedicated emergency department, along with the other two criteria in the definition in this final rule, provides the most flexibility for determining dedicated emergency department status, as the commenter suggested.
Comment: One commenter suggested that we not include an objective standard of “significant portion of the time” for the determination of a hospital’s “dedicated emergency department.” The commenter believed that an objective standard for “significant” may have the unintended effect of creating a benchmark that some providers might use to avoid their EMTALA obligations. For example, the commenter stated, if the standard for “significant portion of the time” is set at 30 percent, a hospital’s labor and delivery department may determine that its staff spend only 15 percent of their time evaluating and treating outpatients who meet the regulatory definition of emergency medical condition. The commenter stated that if the majority of the staff’s time is spent caring for inpatients in active labor, such a hospital may then decide that its labor and delivery department no longer has to provide an emergency medical screening examination to all women who present with contractions, since the department does not meet the objective criteria of being used a significant portion of the time for the initial evaluation and treatment for emergency medical conditions.
Another commenter did not support the percentage-based definition of dedicated emergency department proposed because the commenter believed “it potentially could result in a patient having or not having EMTALA protections based on a fraction of a percentage point and dependent on the accounting method chosen to determine volume.” Also, the commenter believed that volumes fluctuate by days, weeks, and months, among other things. The commenter stated that fluctuating volume could potentially cause an area or department to move in and out of EMTALA coverage as the volume fluctuates.
Response: We agree with the commenters that using objective criteria in the determination of a hospital’s dedicated emergency department may lead to some cases in which the standard is exceeded or not met by a narrow margin. However, this result is an unavoidable consequence of any objective standard. By assessing a facility’s performance over a calendar year, we believe that the effects of seasonal or other variations in utilization will be mitigated.
In response to the comment concerning labor and delivery departments, we would like to clarify that CMS believes that EMTALA requires that a hospital’s dedicated emergency department would not only encompass what is generally thought of as a hospital’s "emergency room," but would also include other departments of hospitals, such as labor and delivery departments and psychiatric units of hospitals, that provide emergency or labor and delivery services, or both, to individuals who may present as unscheduled ambulatory patients but are routinely admitted to be evaluated and treated. Because labor is a condition defined by statute as one in which EMTALA protections are afforded, any area of the hospital that offers such medical services to treat individuals in labor to at least one-third of the ambulatory individuals who present to the area for care, even if the hospital’s practice is to admit such individuals as inpatients rather than treating them on an outpatient basis, would be considered a dedicated emergency department under our revised definition in this final rule. In such cases, whether the department of the hospital chooses to directly admit the emergency patient upon presentment is irrelevant to the determination of whether the department is a dedicated emergency department.
3. Nature of Care
Comment: Some commenters believed that the amount of time a facility is used for emergency screening and treatment is not relevant, and that it is the “nature of the care provided” that distinguishes it as a dedicated emergency department.
Response: We appreciate the comment concerning
the “nature of the care provided” as determinative of meeting the
definition of “dedicated emergency department” rather than the
amount of time a facility is used for emergency screening and treatment. However, if we used the suggested
language of “nature of the care provided” as the standard for
determining “dedicated emergency department” status, we believe
that treatment for one emergency case by one hospital clinic would meet the
suggested standard. We believe
that the suggested standard is too general in its reach and would encompass too
many departments of hospitals.
Therefore, we are not adopting the commenters’ proposed language.
Comment: Several commenters suggested that “dedicated emergency department” status should be determined by State law in the State in which the hospital is located. Another commenter suggested that we define “dedicated emergency department” as any facility licensed by the State in which it is situated as an emergency department. The commenter stated that this would avoid the confusion as to whether urgent care or walk-in clinics do or do not devote a "significant portion of time" to the provision of emergency services.
Response: As explained under section VII.D. of this preamble, based on consideration of all of the comments received, in this final rule we are revising the proposed definition of “dedicated emergency department" to state that a facility licensed by the State as an emergency department will be recognized as such under Federal EMTALA rules. However, because of the variations in State licensure laws, we do not agree that only facilities that are licensed as emergency departments by the State should be considered dedicated emergency departments for purposes of EMTALA, and have therefore included other criteria for dedicated emergency department status, as specified in this final rule.
5. Held Out to the Public Standard
Comment: Many commenters agreed with statements in the preamble of the proposed rule to the effect that a “held out to the public standard” is appropriate for determining “dedicated emergency department” status. One commenter specifically suggested that a “dedicated emergency department” should be defined as “the department of a hospital that is held out to the public as the appropriate place to go for the examination and treatment of emergency medical conditions as defined in this section.”
Similarly, another commenter stated that a
“24/7” rule with routine emergency care may be more appropriate to
designating a “dedicated emergency department” rather than our
proposal of tracking patients and developing some minimum percentage of
emergency patients. The commenter
stated that if the area is not open and staffed on a continuous basis, and it
is not held out to the public as such, then it should not be considered
a dedicated emergency department.
Response: As explained in section VI.D. of this preamble, we are revising the proposed definition of “dedicated emergency department” in several areas. In the revised definition of dedicated emergency department that we are adopting in this final rule, we state that a department or facility that is held out to the public (by name, posted signs, advertising, or other means) as a place that provides care for emergency medical conditions on an urgent basis without requiring a previously scheduled appointment will be considered to be a dedicated emergency department. Consistent with what we have stated above, we believe that most provider-based urgent care centers that are held out to the public as such will meet the revised definition of dedicated emergency department for purposes of EMTALA.
6. Labor and Delivery Departments and Psychiatric Units
Comment: Several commenters addressed our clarification in the preamble of the proposed rule at 67 FR 31472 that other types of hospital departments, such as labor and delivery and psychiatric units, could qualify as a dedicated emergency department for purposes of EMTALA under our proposed definition.
One commenter stated that if a hospital has a department held out to the public as the place to go for a labor or psychiatric emergency medical condition, that department should fall under the definition of “dedicated emergency department” for purposes of EMTALA.
Two commenters stated that it was unclear
which of the EMTALA requirements (such as the EMTALA log) would apply to the
labor and delivery unit and the psychiatric unit that meet the definition of
“dedicated emergency department.” In addition, these commenters asked whether EMTALA would
apply to all patients who present to these locations or only to obstetrical and
psychiatric patients who present under orders of their physicians at the
locations.
Response: As
explained further below, under the revised definition in this final rule,
departments of the hospital will be considered to be “dedicated emergency
departments” if they are held out to the public as places that provide
care for emergency medical conditions on an urgent, nonappointment basis. These departments will be subject to
EMTALA requirements applicable to dedicated emergency departments, including
requirements related to maintenance of an emergency department log and on-call
requirements. Individuals who
present at these locations and request examination or treatment for a medical
condition or have such a request made on their behalf must be screened under
EMTALA and, if an emergency medical condition is determined to exist, provided
necessary stabilizing treatment, because these locations are dedicated
emergency departments.
We note that the dedicated emergency
department to which an individual presents does not necessarily have to be the
one to do EMTALA screening and stabilization. For example, if a man with cold symptoms or another medical
condition were to seek treatment in the obstetrics and gynecology department
rather than the general emergency department, this presentation would create an
EMTALA obligation for the hospital, but the hospital would not be prohibited
from transporting the individual to its general emergency department for
screening and stabilization if that action were medically indicated.
7. Use of Arizona State Bill Language Defining Freestanding Urgent Care Center
Comment: One commenter cited language of a State
bill (Arizona SB1098 (1999)) that, if enacted, would amend the Arizona State
statutes to create standards in Arizona for "freestanding urgent care
centers." The commenter
suggested that we adopt the legislative language for a "freestanding
urgent care center" as the Medicare definition of “dedicated
emergency department.”
Specifically, the commenter suggested that the definition state:
An
"emergency department" means a medical facility that, regardless of
its posted or advertised name, meets the following requirements:
(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 (§482.55) and CAHs (§485.618) do not require that emergency departments be operated continuously. Under some circumstances, such as local shortages of emergency care personnel or limited demand for emergency services, hospitals and CAHs may choose to open and staff their emergency departments on less than a 24-hour, 7 days a week basis.)
8. Urgent Care Centers
Comment: Many commenters were concerned that hospital "urgent care centers" or "acute care centers" would be included, inappropriately, as "dedicated emergency departments" for purposes of EMTALA. The commenters stated
that urgent care centers "are capable of responding to an urgent need, but not an emergency medical condition."
Several commenters suggested that only those urgent care centers that are functioning and holding themselves out to the public as an emergency department should be considered a dedicated emergency department for purposes of EMTALA.
Response: We believe it would be very difficult
for any individual in need of emergency care to distinguish between a hospital
department that provides care for an “urgent need” and one that
provides care for an “emergency medical condition” need. Indeed, to CMS, both terms seem to
demonstrate a similar, if not exact, functionality. Therefore, we are not adopting the commenters’
suggestion to except urgent care centers from dedicated emergency department
status. As we have discussed
above, if the department or facility is held out to the public as a place that
provides care for emergency medical conditions, it would meet the definition of
dedicated emergency department. An
urgent care center of this kind would fall under this criterion for dedicated
emergency department status.
Although
not specifically stated in a comment, an underlying issue is that urgent care
centers, participating in Medicare through a hospital, and which operate as
satellite facilities off the main hospital campus, would meet the current
definition of a dedicated emergency department, but would generally not have
the capacity on site to treat patients who had been screened and determined to
have serious emergency conditions.
In this situation, some might argue
that it would be inappropriate for such a facility to refer a patient in an
unstable condition to the main hospital campus (which could be 30 miles or more
away and involve a lengthy ambulance ride) rather than to a nearby hospital
that would be able to treat a patient.
Both under past and
current rules, a transfer from an urgent care center to a nonaffiliated
hospital is allowed under EMTALA where the facility at which the individual
presented cannot stabilize the individual and the benefits of transfer exceed
the risks of transfer and certain other regulatory requirements are met. Thus, our rules permit a satellite
facility covered under the definition of dedicated emergency department, in
this example, to screen and determine whether the case is too complex to be
treated on site, that a lengthy ambulance ride to an affiliated hospital would
present an unacceptable risk to the individual, and then conclude that the
benefit of transfer exceeds the risk of transfer. In this case, the satellite facility could then transfer the
individual to an appropriate nearby medical facility.
9. Evaluation and Treatment Issue
Comment: One commenter was concerned about the “evaluation and treatment” aspect of our proposed “dedicated emergency department” definition, and suggested that the reference to evaluation would make the definition overly inclusive, since an ambulatory clinic might have no patients treated as emergencies, but many evaluated (and ruled out) for emergencies. The commenter believed that part of any prudent ambulatory practice is to consider first the possibility of an emergency with all patients who are seen. The commenter suggested dropping the “evaluation and” portion of the definition to rely exclusively on an area’s treatment of actual emergencies as the criterion.
Response: We agree that reference to evaluation may make the definition of "dedicated emergency department" overly inclusive, in that it would count any individuals coming to emergency rooms who are evaluated but not treated for such conditions to rule out emergency medical conditions. Therefore, we are limiting the objective criterion in the third part of the "dedicated emergency department" definition in this final rule to a department or facility that provides at least one-third of all its outpatient visits for the treatment of emergency medical conditions on an urgent basis without requiring a previously scheduled appointment.
10. Prudent Layperson Observer Standard
Comment: Two commenters expressed opposing opinions regarding our language at 67 FR 31477 of the preamble portion of the proposed rule that stated that the definition of "dedicated emergency department" would also be interpreted to encompass those off-campus hospital departments that would be perceived by a prudent layperson as appropriate places to go for emergency care. One commenter believed that while the prudent layperson standard makes sense as it relates to the assessment of an individual's medical condition, it is less appropriate with respect to an individual’s assessment of an appropriate site of service. The commenter stated that such assessments would likely vary, depending on factors such as perceived seriousness of the individual’s condition, and urged CMS to adopt an objective test to avoid the uncertainty inherent in a "prudent layperson standard" for determinations of dedicated emergency department status.
Another commenter supported our proposed adoption of the “prudent layperson standard” in determining whether a facility is a dedicated emergency department and stated that the prudent layperson standard is preferable to the
"significant portion of the time" or "regularly" definitions or standards.
Response: We believe that our revised definition of
"dedicated emergency department" specified under section VII.D. of this final rule establishes an objective standard of determination. For instance, we believe it is an objective standard of dedicated emergency department status whether or not an emergency department is licensed by the State. We also believe that it is an objective standard if a hospital department holds itself out to the public as providing emergency care.
We understand the comment concerning an individual's assessment of an appropriate site of service. However, in view of the revised “dedicated emergency department” definition we are adopting in this final rule, we believe the prudent layperson standard is unnecessary for assessment of an area of the hospital as a dedicated emergency department. We believe our revised criteria for such status will permit the status of departments or facilities to be objectively determined.
11. Specially Equipped and Staffed Area
Comment: Several commenters addressed the “specially equipped and staffed area of the hospital” part of the proposed definition of “dedicated emergency department.” One commenter, a hospital, stated that it has a main campus and several off-site locations, all of which are considered departments of the hospital and that none of these off-site departments are dedicated to the provision of emergency care. They also indicated that none of the staff at these off-campus departments are qualified to provide such care. One commenter believed our definition of "dedicated emergency department" should incorporate a provision that staff be specially trained in providing emergency medical care.
Another commenter requested that we clarify the terms “specialized staff” and “specialized equipment” in the proposed “dedicated emergency department” definition. The commenter suggested that “true” emergency departments have coding equipment and coding staff who know how to assign appropriate billing codes.
Several commenters believed that we should clarify
that CMS will apply EMTALA only if a site is functioning as a dedicated
emergency department. Another
commenter stated that the obligations of EMTALA should apply to those hospital
departments or other off-site locations that provide “traditional”
emergency department services.
Response: As we explained earlier, based on our review of comments on the proposed definition of “dedicated emergency department,” we are adopting an alternative definition of that term that does not include a reference to special equipment or staffing. Therefore, we have not attempted to further define “specialized staff” or “specialized equipment” in this final rule.
We agree with the latter comments, but the range of comments received on the definition of a dedicated emergency department included in our proposed rule illustrates that there are varying differences in opinion as to what "functioning as a dedicated emergency department" and "traditional emergency department services" mean. Therefore, we do not believe these phrases alone are sufficient to define a dedicated emergency department. EMTALA applies not only to dedicated emergency departments but also to presentments for emergency care anywhere on hospital property.
Comment: One commenter brought to our attention a contradiction in the preamble to the proposed rule when we discuss the definition of “dedicated emergency department” at 67 FR 31472. On the one hand, the commenter recognized that we proposed to define “dedicated emergency department” as an area that is “specially staffed and equipped” for emergency care and that “is used a significant portion of the time” for evaluation of patients for emergency medical conditions. However, the commenter pointed out that, in the same paragraph, CMS proposed that EMTALA applicability also be extended to hospital departments "that are held out to the public as an appropriate place to come for medical services on an urgent, nonappointment basis.” Because the "held out to the public" test was not included in the proposed regulation text, the commenter requested clarification on this point.
One commenter believed that only an area of the hospital with an “Emergency” sign or a “well-accepted synonym in its title” should be impacted by the EMTALA regulations.
Response: As noted earlier, and as explained more
fully in section VII.D. of this preamble, we are adopting a revised definition
of “dedicated emergency department” that does not reference special
equipment or staffing, but does recognize departments or facilities that are
held out to the public as places that provide care for emergency medical
conditions on an urgent basis without requiring a previously scheduled
appointment. We believe this
revised definition will resolve any uncertainty about the “held out to
the public” test.
We agree that use of
the term “emergency” or a well-recognized synonym in a
facility’s signage would help to identify how the facility is held out to
the public and will keep this comment in mind as we develop interpretative
guidelines for EMTALA surveys.
However, we are not including the suggested language in the final rule
because we are concerned that it could be overly prescriptive.
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 equipped and staffed area of the hospital that is
primarily dedicated to "unscheduled" evaluation and treatment of
outpatients for emergency medical conditions.
One commenter suggested that our proposed definition of dedicated emergency department be revised to specify that departments of the hospital that accept walk-in or unscheduled patients for assessment are deemed to be dedicated emergency departments for the purposes of EMTALA. The commenter stated that this definition would exempt routine clinics or hospital-based physician offices that function on an appointment-only basis, administrative areas, inpatient units, and laboratory areas that provide testing but do not provide assessment or diagnosis services for patients.
Another commenter asked us to include places that are “held out to the public as an appropriate place to come for medical services on an urgent, nonappointment basis” under the definition of dedicated emergency department. This suggestion would include the labor and delivery department of a hospital, but would exclude outpatient clinics that permit “walk-in patients”, according to the commenter.
The commenter suggested that “dedicated emergency department” be defined as any area of the hospital that provides more than 10 percent of its nonscheduled patients treatment for outright emergencies.
Response: We agree
that the practice of accepting patients without requiring appointments is an
important indicator of emergency department status. After consideration of all of the comments on this issue, we
are adopting in this final rule a criterion in the definition of
“dedicated emergency department” that permits a department or
facility to be considered a dedicated emergency department if it is held out to
the public as a place that provides care for emergency medical conditions on an
urgent basis without requiring a previously scheduled appointment.
13. Related Definition of “Hospital with an Emergency
Department”
Comment: One
commenter requested that we amend the proposed regulatory text at
§489.24(a), consistent with our proposed definition of “dedicated
emergency department,” to state that EMTALA requirements apply to a
hospital that has a dedicated emergency
department. Other commenters
suggested that our proposed definition of “hospital with an emergency
department” at §489.24(b) should either be deleted or revised so
that it is defined as a “hospital with a dedicated emergency
department,” to make it consistent with our definition of "dedicated
emergency department."
Response: We considered the suggestion that we
amend the “Application” paragraph of §489.24(a) to limit
EMTALA applicability to hospitals with dedicated emergency departments. However, “hospital with an
emergency department” is a term of art from section 1867 of the Act that
we have separately included in the definitions under §489.24(b) to mean
generally “a hospital that offers services for emergency medical
conditions.” Thus, we
believe it would be preferable to keep the statutory language “hospital
with an emergency department” in the Application section in the
regulation text. To clarify our
policy in this area, we are revising the definition of “Hospital with an
emergency department” under §489.24(b) to state that it means a
hospital with a dedicated emergency department as defined in
§489.24(b).
Comment: One commenter recommended that the last sentence in proposed
paragraph (1) of the definition of “Comes to the emergency
department” in §489.24(b) be revised to read:
"In
the absence of such a request by or on behalf of the individual, a request on
behalf of the individual will be considered to exist if a prudent layperson
observer would believe, based on the individual’s appearance or behavior,
that the individual needs examination or treatment
for an emergency medical condition." [New language is underlined.]
(As
proposed, this definition would require only that the prudent layperson
observer believe that the individual needs examination or treatment for a medical condition.)
Response: Section 1867 of the Act requires a hospital to provide examination and necessary
stabilizing treatment to any individual who “comes to the hospital”
for emergency care. We are
interpreting this statutory requirement to mean that individuals who present to
areas of the hospital other than departments that are labeled
“Emergency” must receive care from the hospital. We believe we have clarified this
requirement in prior rulemakings and in the proposed rule. However, we are including this
clarification in this final rule, as well, as part of the revised final
definition of dedicated emergency department.
Comment: One commenter stated that if the proposed rules are adopted
as final, on-call physicians and hospitals will refuse to accept transfers if
the transfers will be received through the hospital dedicated emergency
department. The commenter believed
that if we apply EMTALA to patients admitted via the dedicated emergency
department, it will create “perverse incentives” for hospitals and physicians
to avoid admitting patients through the dedicated emergency department. The commenter stated: “On-call physicians will be
reluctant to agree to accept patients for admission through the ED because then
their stabilizing care of the patient in the hospital will subject them to
civil monetary penalties and civil liability under EMTALA.”
Response: It is a statutory requirement under section 1867(g) of the
Act that receiving hospitals with special capabilities must accept the
transfer of an individual with an unstable emergency medical condition. The receiving hospitals must accept the
patients whether or not they are received through that hospital’s
dedicated emergency department--the EMTALA obligation for the receiving
hospital transfers with the individual until the condition has been stabilized. Therefore, we do not believe on-call
physicians and hospitals would refuse to accept transfers if the transfers are
being received through the hospital dedicated emergency department, as the
commenter believed. In particular,
we hold this view because the EMTALA obligation is incurred at the time of
arrival of the individual in accordance with an appropriate transfer,
regardless of which door the individual enters or whether he or she is admitted
immediately to the receiving hospital.
D. Provisions of the Final Rule Regarding
Clarification of "Come to the Emergency Department"
For the reasons discussed throughout section VII. of this preamble, and after full consideration of the public comments received--
We are adopting as final the proposed organizational changes to §489.24(a) on the application of EMTALA to include both the screening and stabilization or transfer requirements. (We note that later in this preamble under section X., we make an additional change to paragraph (a) to clarify that if the hospital admits the individual as an inpatient for further treatment after screening, the hospital’s obligation under EMTALA ends.)
We are adopting paragraphs (1) and (2) under the proposed definition of "come to the emergency department" as final without changes.
We are revising the proposed definition of “dedicated emergency department” at §489.24(b), to read as follows:
“Dedicated emergency department” means any department or facility of the hospital, regardless of whether it is located on or off the main hospital campus, that meets at least one of the following requirements:
(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 §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 (§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 §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 §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
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 §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
§489.24(d)(1)(ii)(C) (redesignated in this final rule as
§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 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
§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
§489.24 or the related requirements of §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 §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
§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 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 §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
§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 §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 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 §489.24(c).
VIII. Applicability of EMTALA: Individual Presents at an Area of the Hospital's Main Campus
Other Than the Dedicated Emergency Department (§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 (§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 §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 §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 defined at §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 §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 §410.2 are registered outpatients in the hospital’s records. This change is reflected in the revision of the proposed definition of “patient” under §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 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 §489.24 that EMTALA would not apply to any patient,
as defined in proposed §489.24(b), who would include
“outpatients” as defined at §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 §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 §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 §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 §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 a 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
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 §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 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 §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 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--
●
Adopting as final the proposed definition of “hospital
property” under §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 “campus” at §413.65(b). “Campus” includes the 250
yards concept in its definition; therefore, by referencing §413.65(b) in
the definition of “hospital property” under EMTALA, we are already
including the concept of 250 yards.
●
Adopting as final the proposed definition of “patient” under
§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 (§489.24(d)(2))
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
§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 §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
§489.24; transient stability of such an individual does not relieve the
hospital 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 §489.24 as paragraph (d), and
include stabilization requirements under a new proposed §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 §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 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 articulating 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.
Comment: One commenter took issue with our proposed regulatory
language on when EMTALA ends for hospital inpatients at §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
considered “stabilized” within the meaning of §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 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 §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 §489.24(b) that specified that an
inpatient is one who is "receiving inpatient hospital services as defined
in §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
§489.24(d)(2)(i) to the language in proposed §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
§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 §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 §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 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 §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
(§§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 (§§489.24(b) and (i) and §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 §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 §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
§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 §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 §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 §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 §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 §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 §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 §482.12(f) requirement to a new section of Part 482. The change to §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 §489.24(b) to revise the definitions of
"comes to the emergency department" and "hospital with an
emergency 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 §489.24(i) and to make conforming
revisions to §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 §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 §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 met 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 §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 §489.24(i) and the conforming change to
§413.65(g)(1). In addition,
we are adopting, as final, the proposed new §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.
1.
Background
At
existing §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 §489.24. Since
provider‑based entities, as defined in §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 §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
§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 website: 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
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 §489.24(b) to revise the definition of "Comes to
emergency department" (specifically, under proposed new paragraph (1)) and
make conforming changes at §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 §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 §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
§413.65(g)(l).
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:
• Each hospital has the discretion to maintain the on-call list in
a manner to best meet the needs of its patients.
• 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, 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.
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
§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, 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 §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 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 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 §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
§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 §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 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 §489.24(c)(1) (now §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 §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 §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 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 §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
§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.
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 §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.
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
§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.
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 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 §489.24(c)(2) (redesignated in this
final rule as §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
§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
§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
§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 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 §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
§489.24(c)(2) (now §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 §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 §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
(§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 (§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 (§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 (§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 (§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 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 § 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 § 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 §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
§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
§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 §489.24 discussed in sections V. through XIII. of this preamble, we are revising §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 §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:
• The need for the information collection
and its usefulness in carrying out the proper functions of our agency.
• The accuracy of our estimate of the
information collection burden.
• The quality, utility, and clarity of
the information to be collected.
• 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.
§482.12 Conditions of Participation: Governing Body
New §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 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.
§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 emailed to the following
address: email: baguilar@omb.eop.gov; or faxed to OMB at (202) 395-6974.
XVI. Regulatory Impact Analysis
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.
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).
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.
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 (Public Law 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.
Section 202 of the
Unfunded Mandates Reform Act of 1995 (Public Law 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.
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.
In accordance with the
provisions of Executive Order 12866, this final rule was reviewed by the Office
of Management and Budget.
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.
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
A. Part 413 is amended as follows:
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).
2. Section 413.65 is amended by adding
introductory text under paragraph (g) and revising paragraph (g)(1) to read as
follows:
§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 §489.20(l), (m), (q), and (r) and
§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 §489.24(b) of this chapter.
* * * * *
B. Part 482 is amended as follows:
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).
2. Section 482.12 is amended by adding a
new paragraph (f)(3) to read as follows:
§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
C. Part 489 is amended as follows:
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).
2. Section 489.24 is amended by--
A. Revising paragraph (a).
B. Republishing the introductory text of
paragraph (b) and revising the definitions of "Comes to the emergency
department" and "Hospital with an emergency department".
C. Adding definitions of "Dedicated
emergency department", "Hospital property",
“Inpatient”, and "Patient" in alphabetical order under
paragraph (b).
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.
E. Under the definition of
"Participating hospital" under paragraph (b), redesignating
paragraphs (i) and (ii) as paragraphs (1) and (2), respectively.
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.
G. Removing paragraph (i); and
redesignating paragraph (c) through (h) as paragraphs (d) through (i),
respectively.
H. Adding new paragraphs (c) and (j).
I. Revising newly redesignated paragraph
(d).
J. Making the following cross-reference
changes:
i. In redesignated paragraph (e)(1)(i),
"paragraph (d)(2)" is removed and "paragraph (e)(2)" is
added in its place.
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.
iii. In redesignated paragraph (e)(2)(iii),
"paragraph (d)(1)(ii)" is removed and "paragraph
(e)(1)(ii)" is added in its place.
iv. In redesignated paragraph (e)(2)(iii),
"paragraph (f)" is removed and "paragraph (g)" is added in
its place.
v. In redesignated paragraph (e)(3),
"paragraph (d)(1)(ii)(C)" is removed and "paragraph
(e)(1)(ii)(C) is added in its place.
vi. In redesignated paragraph (g),
"paragraph (a) through (e)" is removed and "paragraphs (a)
through (f)" is added in its place.
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.
viii. In redesignated paragraph (h)(2)
introductory text, "paragraph (g)(1)" is removed and "paragraph
(h)(1)" is added in its place.
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.
x. In redesignated paragraph (h)(2)(vi),
"paragraph (g)(2)(v)" is removed and "paragraph (h)(2)(v)"
is added in its place.
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:
§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 §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 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
§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 §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 §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.
(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:____________________
______________________________
Thomas A. Scully,
Administrator,
Centers for Medicare & Medicaid Services
Dated:______________________
___________________________
Tommy
G. Thompson,
Secretary