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:
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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