[Federal Register Volume 75, Number 246 (Thursday, December 23, 2010)]
[Proposed Rules]
[Pages 80762-80765]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-32267]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Part 489
[CMS-1350-ANPRM]
RIN 0938-AQ51
Medicare Program; Emergency Medical Treatment and Labor Act:
Applicability to Hospital and Critical Access Hospital Inpatients and
Hospitals With Specialized Capabilities
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Advance notice of proposed rulemaking with comment.
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SUMMARY: This advance notice of proposed rulemaking announces the
intention of CMS to solicit comment on the need to publish a proposed
rule to address two policies related to the Emergency Medical Treatment
and Labor Act (EMTALA). Specifically, this document serves as a request
for comments regarding our need to revisit the policies articulated in
the September 9, 2003 Federal Register (68 FR 53243) and the August 19,
2008 Federal Register (73 FR 48656) concerning the applicability of
EMTALA to hospital inpatients and the responsibilities of hospitals
with specialized capabilities, respectively.
DATES: To be assured consideration, comments must be received at one of
the addresses provided below, no later than 5 p.m. EST on February 22,
2011.
ADDRESSES: In commenting, please refer to file code CMS-1350-ANPRM.
Because of staff and resource limitations, we cannot accept comments by
facsimile (FAX) transmission.
You may submit comments in one of four ways (please choose only one
of the ways listed):
1. Electronically. You may submit electronic comments on this
regulation to http://www.regulations.gov. Follow the ``Submit a
comment'' instructions.
2. By regular mail. You may mail written comments to the following
address ONLY:
Centers for Medicare & Medicaid Services, Department of Health and
Human Services, Attention: CMS-1350-ANPRM, P.O. Box 8013, Baltimore, MD
21244-8013.
Please allow sufficient time for mailed comments to be received
before the close of the comment period.
3. By express or overnight mail. You may send written comments to
the following address ONLY:
Centers for Medicare & Medicaid Services, Department of Health and
Human Services, Attention: CMS-1350-ANPRM, Mail Stop C4-26-05, 7500
Security Boulevard, Baltimore, MD 21244-1850.
4. By hand or courier. If you prefer, you may deliver (by hand or
courier) your written comments before the close of the comment period
to either of the following addresses:
a. For delivery in Washington, DC--
Centers for Medicare & Medicaid Services, Department of Health and
Human Services, Room 445-G, Hubert H. Humphrey Building, 200
Independence Avenue, SW., Washington, DC 20201.
(Because access to the interior of the Hubert H. Humphrey Building
is not readily available to persons without Federal government
identification, commenters are encouraged to leave their comments in
the CMS drop slots located in the main lobby of the building. A stamp-
in clock is available for persons wishing to retain a proof of filing
by stamping in and retaining an extra copy of the comments being
filed.)
b. For delivery in Baltimore, MD--
Centers for Medicare & Medicaid Services, Department of Health and
Human Services, 7500 Security Boulevard, Baltimore, MD 21244-1850.
If you intend to deliver your comments to the Baltimore address,
please call telephone number (410) 786-7195 in advance to schedule your
arrival with one of our staff members.
Comments mailed to the addresses indicated as appropriate for hand
or courier delivery may be delayed and received after the comment
period.
FOR FURTHER INFORMATION CONTACT: Renate Dombrowski (410) 786-4645.
SUPPLEMENTARY INFORMATION: Inspection of Public Comments: All comments
received before the close of the comment period are available for
viewing by the public, including any personally identifiable or
confidential business information that is included in a comment. We
post all comments received before the close of the comment period on
the following Web site as soon as possible after they have been
received: http://www.regulations.gov. Follow the search instructions on
that Web site to view public comments.
Comments received timely will also be available for public
inspection as they are received, generally beginning approximately 3
weeks after publication of a document, at the headquarters of the
Centers for Medicare & Medicaid Services, 7500 Security Boulevard,
Baltimore, Maryland 21244, Monday through Friday of each week from 8:30
a.m. to 4 p.m. To schedule an appointment to view public comments,
phone 1-800-743-3951.
I. Overview
We are issuing this advance notice of proposed rulemaking (ANPRM)
to solicit public comments on the need to revisit through a notice of
proposed rulemaking CMS' current policy on the applicability of the
Emergency Medical Treatment and Labor Act (EMTALA). Specifically, this
notice concerns the applicability of EMTALA to individuals who are
determined in the hospital's dedicated emergency department to have an
emergency medical condition (EMC) who, prior to being stabilized, are
subsequently admitted to the hospital as inpatients, and then need to
be transferred to another hospital with
[[Page 80763]]
specialized capabilities for stabilizing treatment.
II. Background
Sections 1866(a)(1)(I), 1866(a)(1)(N), and 1867 of the Social
Security Act (the Act) were enacted as parts of the Emergency Medical
Treatment and Labor Act (EMTALA). These statutory provisions impose
specific obligations on certain Medicare-participating hospitals and
critical access hospitals (CAHs). (Throughout this advance notice of
proposed rulemaking, 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's ``dedicated emergency department'' (as defined at 42
CFR 489.24(b)), and request examination or treatment for a medical
condition, and apply to all of these individuals, regardless of whether
they are beneficiaries of any program under the Act.
EMTALA, also known as the patient antidumping statute, was passed
in 1986 as part of the Consolidated Omnibus Budget Reconciliation Act
of 1985 (COBRA), Public Law 99-272. Congress incorporated these
antidumping provisions within the Social Security Act to ensure that
any individual with an EMC, regardless of the individual's insurance
coverage, is not denied essential lifesaving services. Under section
1866(a)(1)(I)(i) of the Act, a hospital that fails to fulfill its
EMTALA obligations under these provisions may be subject to termination
of its Medicare provider agreement, which would result in the loss of
all Medicare and Medicaid payments. In addition, section 1867(d) of the
Act provides for the imposition of civil monetary penalties on a
hospital and physician who negligently violate a requirement of EMTALA
under section 1867 of the Act.
Section 1867 of the Act sets forth requirements for medical
screening examinations for individuals who come to the hospital and
request examination or treatment for a medical condition. The section
further provides that if a hospital finds that such an individual has
an EMC, it is obligated to provide that individual with either
necessary stabilizing treatment or an appropriate transfer to another
medical facility where stabilization can occur. The EMTALA statute also
outlines the obligation of hospitals to receive appropriate transfers
from other hospitals. Section 1867(g) of the Act states that a
participating hospital that has specialized capabilities or facilities
(such as burn units, shock-trauma units, neonatal intensive care units
or with respect to rural areas, regional referral centers as identified
by the Secretary in regulation) shall not refuse to accept an
appropriate transfer of an individual who requires these specialized
capabilities or facilities if the hospital has the capacity to treat
the individual. The regulations implementing section 1867 of the Act
are found at 42 CFR 489.24. The regulations at 42 CFR 489.20(l), (m),
(q), and (r) also refer to certain EMTALA requirements outlined in
section 1866 of the Act. The Interpretive Guidelines concerning EMTALA
are found at Appendix V of the CMS State Operations Manual: http://www.cms.gov/manuals/Downloads/som107ap_v_emerg.pdf.
A. Applicability of EMTALA to Hospital Inpatients
Although the focus of EMTALA routinely involves the treatment of
individuals who present to a hospital's dedicated emergency department
with a request for treatment of a medical condition, concerns have also
arisen about the applicability of EMTALA to hospital inpatients. We
have previously discussed the applicability of EMTALA to hospital
inpatients in the May 9, 2002 Hospital Inpatient Prospective Payment
System (IPPS) proposed rule (67 FR 31475) and the September 9, 2003
stand-alone final rule on EMTALA (68 FR 53243).
As we noted in these prior proposed and final rules, in 1999, 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 hospital inpatients. In the context of that
case, the United States Solicitor General advised the Court that HHS
would develop a regulation clarifying its position on this issue. In
the May 9, 2002 proposed rule, we proposed that EMTALA continue to
apply to admitted individuals who are not stabilized (who presented
under EMTALA), but that it would not otherwise apply to inpatients. We
indicated that individuals whose conditions go in and out of apparent
stability rapidly and frequently would not be considered ``stabilized''
and the hospital would continue to have an obligation to such
individuals even after they are admitted. However, for all other
inpatients we stated that EMTALA was intended to provide protection to
individuals coming to a hospital to seek care for an EMC. Therefore, we
stated that we believed the EMTALA requirements did not extend to
stabilized inpatients even if they subsequently become unstable because
those inpatients are protected by a number of Medicare conditions of
participation (CoPs) as well as the hospital's other legal, licensing,
and professional obligations with respect to the continued proper care
and treatment of its patients.
In the September 9, 2003 stand-alone final rule on EMTALA, we
refined this position to state that a hospital's obligation under
EMTALA ends either when the individual's EMC is stabilized or when that
hospital, in good faith, admits an individual with an unstable EMC as
an inpatient. That is, we stated that EMTALA does not apply to any
inpatient, even one who was admitted through the dedicated emergency
department, for whom the hospital had initially incurred an EMTALA
obligation to stabilize, and who remained unstabilized after admission
as an inpatient. We noted that other patient safeguards protect all
inpatients, including the hospital CoPs as well as State malpractice
law. In addition, judicial interpretation of the matter and comments we
received on the proposed rule helped shape the policy articulated in
the final rule. However, we also stated in the rule that a hospital
could not escape liability under EMTALA by admitting an individual with
no intention of treating the individual and then inappropriately
transferring or discharging that individual without having met the
stabilization requirement.
B. EMTALA Technical Advisory Group Recommendation Regarding
Responsibilities of Hospitals With Specialized Capabilities
Section 945 of the Medicare Prescription Drug, Improvement, and
Modernization Act of 2003 (MMA), Public Law 108-173, required the
Secretary to establish a Technical Advisory Group (TAG) to advise the
Secretary on issues related to the regulations and implementation of
EMTALA. The EMTALA TAG's functions, as identified in the charter for
the EMTALA TAG, were as follows: (1) Review EMTALA regulations; (2)
provide advice and recommendations to the Secretary concerning these
regulations and their application to hospitals and physicians; (3)
solicit comments and recommendations from hospitals, physicians, and
the public regarding the implementation of such regulations; and (4)
disseminate information concerning the application of these regulations
to hospitals, physicians, and the public. The TAG met 7 times during
its 30-month term, which ended on September 30, 2007. At its meetings,
the TAG heard testimony
[[Page 80764]]
from representatives of physician groups, hospital associations, and
others regarding EMTALA issues and concerns. During each meeting,
subcommittees established by the TAG developed recommendations, which
were then discussed and voted on by members of the TAG. One of these
recommendations, presented by the TAG during its September 2007 meeting
calls for CMS to revise its regulations to address the situation of an
individual who: (1) Presents to a hospital that has a dedicated
emergency department and is determined to have an unstabilized EMC; (2)
is admitted to the hospital as an inpatient for purposes of stabilizing
the EMC; and (3) subsequently needs a transfer to a hospital with
specialized capabilities to receive stabilizing treatment that cannot
be provided by the referring hospital that originally admitted the
individual.
C. Applicability of EMTALA to Hospital Inpatients and Responsibilities
of Hospitals With Specialized Capabilities
To further clarify our position on the applicability of EMTALA and
the responsibilities of hospitals with specialized capabilities to
accept appropriate transfers, the agency included as part of the April
30, 2008 IPPS proposed rule (73 FR 23669) two proposals that addressed
the issue of hospital inpatients. First in the proposed rule, we stated
that we believed that the obligation of EMTALA does not end for all
hospitals once an individual is admitted as an inpatient to the
hospital where the individual first presented with a medical condition
that was determined to be an EMC. Rather, we stated, once the
individual is admitted, the admission only affects the EMTALA
obligation of the hospital where the individual first presented (the
admitting hospital). In the proposed rule, we proposed that section
1867(g) of the Act (which refers to responsibilities of hospitals with
specialized capabilities) requires a receiving hospital with
specialized capabilities to accept a request to transfer an individual
with an unstable EMC so long as the hospital has the capacity to treat
that individual regardless of whether that individual was ultimately an
inpatient at the admitting hospital. We stated that we believed that
permitting inpatient admission at the admitting hospital to end EMTALA
obligations for another hospital would seemingly contradict the intent
of section 1867(g) of the Act to ensure that hospitals with specialized
capabilities provide medical treatment to individuals with EMCs in
order to stabilize those conditions. And we further noted that while a
hospital inpatient is protected under Medicare CoPs and may also have
additional protections under State law, the obligations of another
hospital under the CoPs apply only to that hospital's patients, and
there is no CoP that requires a hospital to accept the transfer of a
patient from an admitting facility. We proposed to interpret section
1867(g) of the Act as creating an obligation on hospitals with
specialized capabilities to accept appropriate transfers of individuals
for whom the admitting hospital originally had an EMTALA obligation
under section 1867 of the Act, if the hospital with specialized
capabilities has the capacity to treat the individuals. Thus, in the
April 30, 2008 IPPS proposed rule, we proposed that when an individual
originally covered by EMTALA is admitted as an inpatient at that
hospital and continues to have an unstabilized EMC, a hospital with
specialized capabilities has an EMTALA obligation to accept a transfer
of that individual, assuming that the transfer of the individual is an
appropriate transfer and that the participating hospital with
specialized capabilities has the capacity to treat the individual.
We received many comments opposing the proposal concerning
hospitals with specialized capabilities included in the April 30, 2008
IPPS proposed rule. The commenters stated that the proposed rule would
``reopen'' EMTALA for an admitting hospital by extending EMTALA's
requirements for an ``appropriate transfer'' despite the fact that the
admitting hospital's EMTALA obligations ended, under regulation, when
it admitted an individual as an inpatient. The commenters also stated
that, because the original admitting hospital may claim that it lacks
the capacity or capability to stabilize the individual's EMC,
finalizing the proposed policy would result in an increase in patient
dumping and inappropriate transfers, especially to teaching hospitals,
tertiary care centers, and urban safety net hospitals.
Commenters further asserted that finalizing CMS' policy as proposed
would exacerbate confusion surrounding the determination of whether an
individual is considered stable. That is, the admitting hospital would
be required to continuously monitor the individual to determine if at
any point in the emergency department or even as an inpatient, the
individual experienced a period of stability since such stability would
end EMTALA obligations for all hospitals that might otherwise have
obligations under the law. Under this scenario, the commenters asserted
that the hospital with specialized capabilities would be forced to
accept the transfer of an individual, potentially increasing the number
of inappropriate or unnecessary transfers, because that hospital would
be unable, with complete certainty, to determine whether or not the
individual being transferred had ever experienced a period of
stability.
As a result, in the August 19, 2008 IPPS final rule we stated that,
due to the many concerns that the commenters raised, we believe it is
appropriate to finalize a policy to state that if an individual with an
unstable emergency medical condition is admitted as an inpatient, the
EMTALA obligation has ended, even if the individual's EMC remains
unstabilized and the individual requires treatment only available at a
hospital with specialized capabilities. Put another way, we determined
that a hospital with specialized capabilities does not have an EMTALA
obligation to accept an appropriate transfer of an individual who had
been admitted in good faith as an inpatient at the first hospital. We
stated that we believed that finalizing the proposed policy might
negatively impact patient care, due to an increase in inappropriate
transfers, that could be detrimental to the physical and psychological
health and well-being of patients. We further stated that we were
concerned that finalizing the proposed rule could further burden the
emergency system and could force hospitals providing emergency care to
limit their services or care, thereby reducing access to emergency
treatment. In addition, we stated that we were concerned about the
possible disparate treatment of inpatients under the proposed policy
because an individual who presented to a hospital under EMTALA might
have different transfer rights than an inpatient who was admitted for
an elective procedure. And we generally agreed that hospitals with
specialized capabilities would accept the transfer of an inpatient with
an unstable EMC even if there was no legal requirement under EMTALA to
do so. We also noted that the recommendation provided by the TAG to
apply EMTALA to hospital inpatients was endorsed by the group on the
narrowest of margins, and that the majority of hospital representatives
serving on the TAG were opposed to the recommendation. And while we
adopted a final rule that limits the EMTALA responsibilities of a
hospital with specialized capabilities, we encouraged the public to
make us aware if the interpretation of section 1867(g) of the Act as
set forth in the rule resulted in harmful refusals by hospitals with
[[Page 80765]]
specialized capabilities to accept the transfer of inpatients whose EMC
remains unstabilized or any other unintended consequences.
D. Litigation Related to the Applicability of EMTALA to Hospital
Inpatients
There have been several court cases involving the applicability of
EMTALA to hospital inpatients. For example, in Thorton v. Southwest
Detroit Hospital, 895 F.2d 1131, 1134 (6th Cir. 1990), the Sixth
Circuit stated that, ``once a patient is found to suffer from an [EMC]
in the emergency room, she cannot be discharged until the condition is
stabilized. * * * '' However, other courts have 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 System/West, 289 F.3d 1162 (9th
Cir. 2002), and Harry v. Marchant, 291 F.3d 767 (11th Cir. 2002).) In
Lima-Rivera v. UHS of Puerto Rico Inc., (D.P.R. No. 04-1798, 2007), the
U.S. District Court for the District of Puerto Rico rejected the claim
that EMTALA does not apply to inpatients. Most recently in Moses v.
Providence Hospital and Medical Centers Inc., 561 F.3d 573 (6th Cir.
2009), the court concluded that a hospital's EMTALA obligations to an
individual continue until that individual's EMC is stabilized
regardless of the individual's status as an inpatient or outpatient.
III. Intention of This Notice
We are aware that there continues to be a range of opinions even at
the Circuit Court level on the topic of EMTALA's application to
inpatients. There also continues to be various opinions regarding
whether EMTALA should apply to situations where a hospital seeks to
transfer an individual, admitted as a hospital inpatient after seeking
treatment for an EMC, to a hospital with specialized capabilities
because the admitted inpatient continued to have an unstabilized EMC
that required specialized treatment. Therefore, we are interested in
receiving comments that address whether we should revisit the policies
that were established in the September 9, 2003 final rule on EMTALA and
the August 19, 2008 IPPS final rule, respectively.
We would find it particularly helpful if commenters could submit
specific real world examples that demonstrate whether it would be
beneficial to revisit the policies articulated in the September 9, 2003
final rule on EMTALA or the August 19, 2008 IPPS final rule. We also
are interested in hearing whether commenters are aware of situations
where an individual who presented under EMTALA with an unstable EMC was
admitted to the hospital where he or she first presented and was then
transferred to another facility, even though the admitting hospital had
the capacity and capability to treat that individual's EMC.
We are also interested in receiving information regarding the
accuracy of our statement in the August 19, 2008 IPPS final rule that a
hospital with specialized capabilities would accept the transfer of an
inpatient with an unstabilized EMC absent an EMTALA obligation.
Specifically, we would be interested to know if commenters are aware of
situations where an individual with an unstabilized EMC was admitted as
an inpatient and continued to have an unstabilized EMC requiring the
services of a hospital with specialized capabilities that refused to
accept the transfer of the individual because current policy does not
obligate hospitals with specialized capabilities to do so.
IV. Collection of Information Requirements
This document does not impose information collection and
recordkeeping requirements. Consequently, it need not be reviewed by
the Office of Management and Budget under the authority of the
Paperwork Reduction Act of 1995.
V. Response to Comments
Because of the large number of public comments we normally receive
on Federal Register documents, we are not able to acknowledge or
respond to them individually. We will consider all comments we receive
by the date and time specified in the DATES section of this preamble,
and, when we proceed with a subsequent document, we will respond to the
comments in the preamble to that document.
Authority: (Catalog of Federal Domestic Assistance Program No.
93.773, Medicare--Hospital Insurance)
Dated: November 18, 2010.
Donald M. Berwick,
Administrator, Centers for Medicare & Medicaid Services.
Approved: December 14, 2010.
Kathleen Sebelius,
Secretary, Department of Health and Human Services.
[FR Doc. 2010-32267 Filed 12-22-10; 8:45 am]
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