CMS-R-142_Supporting_Statement_Part_A_

Supporting Statement – Part A
Examination and Treatment for Emergency Medical Conditions and Women in Labor (EMTALA), 42 CFR
482.12, 488.18, 489.20, and 489.24
(CMS-R-142; OMB-0938-0667)
A. Background
Congress was concerned about the increasing number of reports that hospital emergency rooms were refusing
to accept or treat individuals with emergency conditions, including medically unstable individuals, if the
individuals could not pay for the services or did not have medical insurance. Additionally, Congress had
received reports that individuals in an unstable condition were transferred improperly, often without the
consent of the receiving hospital. As a means to begin to address these concerns, Congress imposed new
requirements, under the Consolidated Omnibus Budget Reconciliation Act (COBRA) of 1985 which became
effective August 1, 1986, on hospitals that choose to participate in the Medicare program.
Therefore, since August 1, 1986, sections 1866(a)(1)(I) and 1867 of the Social Security Act (Act) mandate
that Medicare-participating hospitals with emergency medical departments must perform medical screening
examinations of any individual who comes to the emergency department, to determine whether or not the
individual has an emergency medical condition or is a woman in labor. If an emergency medical condition is
found, the hospital must then provide necessary stabilizing treatment within its capabilities. If the hospital
does not have the capability to treat the individual’s emergency medical condition, it must follow prescribed
steps to provide for an appropriate transfer to another facility that has the capability (unless the individual or
the individual's representative refuses treatment or transfer).
Subsequent to the COBRA, Congress added new provisions to sections 1866 and 1867 of the Act which
strengthened and refined existing requirements through the Omnibus Budget Reconciliation Act of 1989
(OBRA ‘89, effective July 1, 1990) and the Omnibus Budget Reconciliation Act of 1990 (OBRA ‘90,
effective February 1, 1991). To begin, OBRA ‘89 added a new category of hospital provider known as a
"rural primary care hospital" (as defined in section 1861(mm)(1) of the Act) and the Balanced Budget Act of
1997 redesignated this provider category as "critical access hospitals" (CAHs). Therefore, for purposes of the
EMTALA statute, all further references to the term hospital will be assumed to include the term "critical
access hospital."
OBRA ‘89 also amended section 1867 to protect the unborn children of women in labor and to protect
pregnant women until their placentas are delivered. OBRA ‘89 and OBRA ‘90 further amended sections 1866
and 1867 to include many other additional requirements for Medicare participating hospitals with emergency
departments, such as:
1.
Maintaining a list of on-call physicians available for duty to provide stabilizing treatment for
individuals with emergency conditions;
2.
Requiring the capability of a facility's emergency department to include ancillary services customarily
available to the emergency department;

3.
Informing individuals (or persons acting on their behalf) of the risks and benefits to the individual of
examination and treatment and/or transfer and to "take all reasonable steps to secure the individual's (or
person's) written informed consent to refuse such examination and treatment" and/or transfer, or to obtain a
written request for a transfer;
4.
Hospitals' transfer certifications must “include a summary of the risks and benefits upon which the
certification is based”;
5.
Specified certain information and records which must be included in the medical records of an
individual with an emergency medical condition who is being transferred to another medical facility;
6.
Medicare participating hospitals with special capabilities or facilities (such as burn units or shock
trauma units) must “. . . accept an appropriate transfer of an individual who requires such specialized
capabilities or facilities if the hospital has the capacity to treat the individual”; and
7.
Participating hospitals may not delay the provision of medical screening examination and/or treatment
"to inquire about the individual's method of payment or insurance status."
8.
Section 1154 of the Act was also amended to require utilization and quality improvement organizations
(QIOs) (with contracts under Part B of Title XI of the Act) to prepare a report, upon a request from CMS,
assessing whether an individual had an emergency condition which was not stabilized.
The Notice of Proposed Rulemaking (NPRM) was published June 16, 1988. On June 22, 1994, we published
an Interim Final Rule with a comment period (IFC). We had been operating through informal, interim
instructions based on COBRA ‘85, OBRA ‘89 and OBRA ‘90, but the 1994 regulations clarified the
procedures to promote uniform and thorough application of the requirements. On April 7, 2000, a Final Rule
with comment period was published. That rule stated explicitly that the prohibitions on patient dumping also
apply to hospital departments located off the hospital's main campus, and specified the obligations of
hospitals with respect to individuals who come to such departments and request examination or treatment for
a potential emergency medical condition. On May 9, 2002, a Proposed Rule to further clarify several
situations on EMTALA applicability was published. On September 9, 2003, a Final Rule clarifying
EMTALA applicability in those situations was published. The following is a summary of the provisions in
that rule:
•

•

The April 7, 2000 OPPS Final Rule clarified that EMTALA applies to all provider-based departments
of a hospital, even those off the main campus. In the EMTALA Final Rule, CMS stated that
EMTALA does not apply to emergency patients presenting at off-campus departments of hospitals
that do not routinely provide emergency services. Instead, we provide that the hospital would have to
adopt protocols for such departments under the Conditions of Participation to deal with emergencies.
In late 1998, the United States Supreme Court considered a case (Roberts v. Galen of Virginia) that
involved the question of whether EMTALA applies to inpatients in a hospital. In the context of that
case, the United States Solicitor General told the Supreme Court that the Department of Health and
Human Services (HHS) would develop a regulation clarifying its position on that issue. Pursuant to
that commitment, CMS has provided that EMTALA does not apply to individuals who have been

•
•
•

•

admitted as inpatients in a hospital, if the admission was undertaken in good faith and not as a pretext
for avoiding EMTALA.
CMS clarified the limits on hospital and physician responsibility in the circumstances in which
physicians, particularly specialty physicians, must serve on hospital medical staff “on-call” lists.
CMS clarified that hospital-owned ambulances can be more fully integrated with citywide and local
community EMS procedures for responding to medical emergencies.
CMS clarified that a participating hospital may not seek authorization from the individual’s insurance
company until after the hospital has provided the appropriate medical screening examination required
by EMTALA, and any required stabilizing treatment has been initiated.
CMS clarified that EMTALA does not apply to hospital outpatients who had begun to receive
outpatient services before the emergency began.

On April 25, 2006, an NPRM to further clarify several situations on EMTALA applicability was published.
On August 18, 2006, a Final Rule clarifying EMTALA applicability in those situations was published. That
rule clarified the obligation of all participating hospitals with specialized capabilities to accept appropriate
transfers, and revised the definition of “labor” to allow certain nonphysician qualified medical persons to
determine whether a woman having contractions is in false labor.
On May 3, 2007, an NPRM to implement EMTALA provisions included in the Pandemic and All Hazards
Preparedness Act (P.L. 109-417) enacted by Congress on December 19, 2006 was published. On August 22,
2007, a Final Rule implementing the NPRM was published. The rule made changes to section 489.24(a)(2)
of the regulations to state that sanctions do not apply for an inappropriate transfer of an individual who has
not been stabilized or for the redirection or relocation of an individual to receive medical screening at an
alternate location under section 1135 if a waiver has been granted. The rule also stated that a waiver of
sanctions is limited to 72 hours beginning with the implementation of a hospital disaster protocol, except if
the public health emergency involves a pandemic infectious disease, the duration of the waiver is determined
in accordance with section 1135(e) of the Act.
On April 30, 2008 an NPRM to clarify several aspects of EMTALA was published. Specifically, the NPRM
addressed the applicability of EMTALA to hospital inpatients, the requirement to maintain an on-call list,
community on-call, and the nonapplicability of EMTALA sanctions under a section 1135 waiver. The NPRM
also included a brief description of the EMTALA Technical Advisory Group (TAG) and a summary of which
of the TAG’s recommendations had been addressed by CMS to date. On August 19, 2008, we published a
Final Rule. In that Final Rule we clarified that if an individual is admitted in good faith, the admitting
hospital has satisfied its EMTALA obligation with respect to that individual even if the individual continues
to have an unstabilized emergency medical condition and a hospital with specialized capabilities does not
have an EMTALA obligation to accept a transfer of that individual. We made this change by amending the
regulations at 489.24(f) to include a paragraph (2). We finalized our proposed policy to move the language
regarding maintaining an on-call list from section 489.24(j)(1) to 489.20(r)(2) and revised the language to
make it consistent with our policy on community call. We finalized our policy on community call by stating
that hospital can meet the on-call requirements at section 489.20(r)(2) by having a formal community call
plan and we specified what elements a formal community call plan must include. We also finalized our
technical change to the regulations at section 489.24(a)(2) regarding the nonapplicability of EMTALA
sanctions as proposed.

On May 22, 2009, an NPRM to further refine the regulations at section 489.24(a)(2) to make them consistent
with the statutory text at section 1135 of the Act was published. We proposed to amend the regulations to
state that a waiver of EMTALA sanctions for an inappropriate transfer is only valid if the transfer arises out
of the circumstances of the emergency. We proposed to clarify that the Secretary has the authority to apply
the waiver of EMTALA sanctions to one or more hospitals in a portion of an emergency area or a portion of
an emergency period. We proposed to clarify in the regulations that a waiver of EMTALA sanctions for an
inappropriate transfer or for the redirection or relocation of an individual to receive a medical screening
examination are only in effect if the hospital to which the waiver applies does not discriminate on the source
of an individual’s payment or ability to pay. On August 27, 2009, a Final Rule was published in which we
clarified that a waiver of EMTALA sanctions for an inappropriate transfer is only valid if the transfer is
necessitated by the circumstances of the declared emergency, we also finalized our other proposals regarding
section 489.24(a)(2) of the regulations.
On December 23, 2010, an Advance Notice of Proposed Rulemaking with Comment (ANPRM) was
published. The ANPRM, in addition to summarizing CMS’ previously published proposed and final rules
related to the applicability of EMTALA to hospital inpatients and the responsibilities of hospitals with
specialized capabilities, requested commenters to provide specific examples to demonstrate whether CMS
should revisit the policies articulated in the September 3, 2009 Final Rule and the August 19, 2008 Final
Rule. In addition, we requested real world examples that would inform our understanding of the current
policy’s impact on patients’ access to care for an emergency medical condition and that demonstrate whether
it would be beneficial to revisit our existing policies. We also requested comments regarding the
responsibilities of hospitals with specialized capabilities.
On February 2, 2012 we published a Notice with Comment. In that Notice with Comment we stated that in
response to comments we received on the December 23, 2010 ANPRM, we were maintaining our current
policy regarding the applicability of EMTALA to hospital inpatients. We also stated that we were making no
proposals with respect to our policies regarding the applicability of EMTALA to hospitals with specialized
capabilities, however, we would continue to monitor whether it may be appropriate to reconsider this issue in
the future.
B. Justification
1. Need and Legal Basis
Pursuant to section 1866(a)(1)(I) of the Act, Congress has mandated that the Secretary enforce section 1867
of the Act. Under section 1867, effective August 1, 1986, hospitals may continue to participate in the
Medicare program only if they are not out of compliance with its provisions. Continued Paper Work
Reduction Act (PRA) approval of the regulation sections cited below will promote uniform and thorough
application of the section 1866 and 1867 requirements. They will also provide information when requested by
Congress and other interested parties regarding the implementation of the statute.
During 2004 through 2018, approximately 8,146 complaints were received, approximately 7,770 of those
complaints were investigated, and approximately 3,567 EMTALA deficiencies were found. During Federal

fiscal years 2001 through 2005 the Inspector General's Office imposed civil monetary penalties on hospitals
in 105 cases, for a total of $2,645,750 in penalties.
An audit completed by the Office of Inspector General (OIG) (entitled, Office of Inspector General:
Implementation and Enforcement of the Examination and Treatment for Emergency Medical Conditions and
Women in Labor by the Health Care Financing Administration, April 1995, A-06-93-00087) determined that
CMS’s implementation of the Act was generally effective, but Regional Offices (RO) were not consistent
with conducting timely investigations, sending acknowledgments to complaints, ensuring that investigations
were thorough, or ensuring that violations were referred to the OIG in accordance with CMS policy for
possible civil monetary penalty action. OIG further concluded that without proper compliance, there is an
increased risk that individuals with emergency medical conditions will not receive the treatment needed to
stabilize their condition, which may place them in greater risk of death.
(a) Section 482.12(f)
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 collection requirement is subject to the PRA, we believe the burden
associated with this requirement is exempt from the PRA as stipulated under 5 CFR 1320.3(b)(2) & (b)(3).
(c) Section 489.20(m)
Based on sections 1861(e)(9) and 1866 of the Act, section 489.20, Basic commitments, requires a hospital to
notify CMS or the State Survey Agency of any suspected incident in violation of 489.24(d). Section
489.24(e) restricts transfers of individuals in an unstable emergency medical condition until such individuals
are stabilized and pregnant women until their placentas are delivered, or a transfer request is made by or on
behalf of the individual, or the hospital certifies that the transfer is in the individual's best interests, and the
transfer is effected through qualified personnel and transportation equipment.
An Office of Inspector General (OIG) study (Office of Inspector General, Patient Dumping After COBRA:
Assessing the Incidences and Perspectives of Health Care Professionals, August 11, 1988), showed a marked
reluctance on the part of hospitals to report suspected inappropriate transfers, that a number of individuals in
unstable conditions have been transferred improperly, and that the cases are not reported to CMS. However,
this may be the result of the absence of OMB approval at the time so hospitals were not obligated to file a
report. Incidentally, OMB approval was published September 29, 1995 (60 FR 50443). Some hospitals did
file reports anyway, however, an accurate number is not available at this time. Nonetheless, these reporting
requirements are needed to assure that we are aware of such instances of improper transfers which may
needlessly jeopardize people's lives so that specific action may be taken. When a hospital violates its duties
under these provisions, CMS must take immediate and prescribed actions to prevent that hospital from
jeopardizing the health and safety of the next person who may seek help in an emergency situation. Hospitals
are in the best position to determine when an inappropriate transfer has taken place. Further, this provision
should encourage hospitals to cooperate in planning for appropriate transfers. It is also important to note that
the OIG study also identified incidents of improper transfers being reported to State Survey Agencies that
were not then reported to CMS.

This requirement is also supported by two other current statutes. Section 1861(e)(9) of the Act permits the
Secretary to impose on hospitals such other requirements as she/he finds necessary in the interests of the
health and safety of individuals who are furnished services in the institution. It is under this authority that the
Secretary has obligated hospitals that participate in Medicare to report when they receive patients that have
been inappropriately transferred. Under sections 1866(b)(2)(A) and (B) of the Act, the Secretary may
terminate the provider agreement of a hospital that is not complying substantially with the statute and
regulations under title XVIII or that no longer substantially meets the provisions of section 1861 of the Act.
We estimate that close to half of the section 1867 violation reports we received were submitted (by telephone)
by hospitals. The calls were usually made by physicians, who review pertinent records before making their
calls, usually to the State, rarely to CMS. While the American Hospital Association (AHA) has noted that this
requirement is the only significant reporting issue raised by their constituents, CMS believes that this
requirement serves and protects the patient and is mandated by statute. As such, CMS does not believe this
requirement can be altered without impacting negatively on the quality of the health care provided to the
patient. These ICRs are exempt for the following reasons: The alleged complaints are received on an
individual case-by-case basis, and are, therefore, not subject to the PRA as stipulated at 5 CFR 1320.3(c), and
are pursuant to the conduct of an investigation or audit against specific individuals or entities. [5 CFR
1320.4(a)(2)]
(d) Section 489.20(r)(2)
Based upon section 1866(a)(1)(I)(iii) of the Act, both transferring and receiving hospitals must maintain a list
of physicians who are on-call for duty after an initial examination to provide treatment needed to stabilize an
individual with an emergency medical condition. Congress, under section 6018(a)(1) of OBRA ‘89, added
this requirement to the original COBRA requirements in order to add the capabilities of such physicians to
the emergency department staff. This is also an extension of the concept contained in the OBRA ‘89
requirement (section 6211(a)), which defines a hospital's emergency department capabilities to include
"ancillary services routinely available to the emergency department." It is also an extension of a hospital's
responsibility under 42 CFR 482.55 to provide adequate medical personnel to meet its anticipated emergency
needs by using on- call physicians either to staff or to augment its emergency department. Section 42 CFR
489.20(r)(2) is also one of the requirements hospitals must meet to receive accreditation from the Joint
Commission (previously known as the Joint Commission on Accreditation of Healthcare Organizations). In
the August 19, 2008 Final Rule, we revised the regulation text at section 489.20(r)(2) by moving the language
regarding maintaining an on-call list from the regulations at section 489.24(j)(1) to section 489.20(r)(2) and
incorporating language pertaining to community call.
The burden associated with the list of on-call physicians is very limited. These lists are maintained routinely
by hospitals. While these ICRs are subject to the PRA, the burden associated with these ICRs are exempt
because the time, effort, and financial resources necessary to comply with these requirements would be
incurred by persons in the normal course of their activities (e.g., in compiling and maintaining business
records). [5 CFR 1320.3(b)(2)]
(e) Section 489.20(r)(3)
Based upon sections 1861(e)(9) and 1866 of the Act, hospitals are required to maintain a central log on all
individuals who come to their emergency departments seeking assistance. The log must indicate whether the
individual refused treatment, was refused treatment, was transferred, admitted and treated, stabilized and

transferred, or discharged. Such a record will permit CMS and Medicare State Survey Agencies to select and
gain access to individual medical records for further inquiry and will help to determine whether the person
was transferred appropriately under the statute. The log is one method of enforcing the intent of the Congress
to protect individuals with emergency conditions and women in labor against possible erroneous transfers. It
will also educate hospital personnel regarding the section 1867 requirements, will provide an audit trail to
assist CMS in performing its monitoring and enforcement duties, in many cases will cause receiving hospital
physicians to receive appropriate medical information for each individual, and will deter dumping. This
central log requirement is also an accreditation requirement for Joint Commission hospitals.
The previously cited OIG study reported that lack of a central record on the disposition of persons seeking
emergency services hinders CMS's ability to monitor compliance with the statute. Additionally, a report by
the House Committee on Government Operations, March 25, 1988, report #100-531, recommended the
establishment of such a central log.
Hospitals routinely maintain logs on individual patients receiving care in the emergency room setting. When
this rule was promulgated, hospitals were required to centralize the information in the logs. While this
requirement may have imposed a one-time burden, the requirement improved the maintenance, retention, and
ease of retrieval of existing hospital records. Therefore there is no burden associated with this requirement.
[5 CFR 1320.3(b)(2)]
(f) Section 489.24(d)(2)
If a hospital admits an individual with an unstable emergency medical condition as an inpatient in good faith
in order to stabilize the emergency medical condition, the admission must be documented in the individual's
medical record, to show that the hospital has satisfied its special responsibilities under this section with
respect to that individual. While this collection requirement is subject to the PRA, we believe the burden
associated with this requirement is exempt from the PRA as stipulated under 5 CFR 1320.3(b)(2) & (b)(3).
(g) Section 489.24(d)(3)
Based upon section 1867 of the Act, an individual's medical record must contain a description of the
examination and/or treatment refused by or on behalf of an individual. The hospital must also try to obtain a
written informed consent for such refusal which should indicate the person's knowledge of the risks and
benefits of the examination or treatment. Congress believed that this decision must be an informed one and
therefore, under section 6211(b) of OBRA ‘89, a hospital is required to inform an individual or their
representative of the risks and benefits of the examination and treatment and to “take all reasonable steps to
secure the individual's (or person's) written informed consent to refuse such examination and treatment.” This
helps prevent hospitals from coercing individuals into making judgments which may be against their best
interests, helps ensure that the individual or the person acting on their behalf is aware of the hospital's
obligations, and may reduce litigation concerning whether examination and/or treatment was refused or
requested.
The recording in the patient’s medical record of the description of the examination and/or treatment that was
refused by or on behalf of an individual is standard industry practice. The information is recorded by either a
physician or a nurse and signed or initialed by a physician if recorded by a nurse. The written informed
consent to refuse the examination and/or treatment, including recording the risks and benefits of the
examination and/or treatment, is usually written by either a physician or a nurse and signed by or on behalf of

the individual. While this information collection is subject to the PRA, the burden associated with these ICRs
are exempt because the time, effort, and financial resources necessary to comply with these requirements
would be incurred by persons in the normal course of their activities (e.g., in compiling and maintaining
business records). [5 CFR 1320.3(b)(2)]
(h) Section 489.24(d)(5)
Under section 1867 of the Act, if a transfer is refused by or on behalf of an individual in an unstabilized
emergency condition or a woman in labor, the individual's medical record must contain a description of the
transfer that was refused. The hospital must also attempt to obtain the individual's (or person's) written
informed consent to refuse such transfer and the refusal should indicate the person’s knowledge of the risks
and benefits of the transfer and the reasons for the refusal. This requirement will help prevent such a refusal
from being obtained by coercion or by the hospital misrepresenting its obligations under the statute. This
requirement will also help ensure that the refusal is informed, is not obtained under duress, is in the
individual's best interests, and will help prevent the hospital from being subject to ambiguous requirements
for carrying out the statute's mandate. Further, this requirement closely parallels the statute, and as such,
reflects Congressional intent. We expect this provision increases the incentives for hospitals to avoid
improper transfers, thus improving emergency care for uninsured individuals. We also expect this provision
makes emergency services available to more individuals.
The recording in a patient's medical record of the description of the transfer that was refused by or on behalf
of a patient is standard industry practice. The information is recorded by either a physician or a nurse and
signed or initialed by a physician if recorded by a nurse. The written informed consent to refuse the transfer,
including a description of the risks and benefits of the transfer, is usually written by either a physician or a
nurse and signed by or on behalf of an individual. While these ICRs are subject to the PRA, the burden
associated with these ICRs are exempt because the time, effort, and financial resources necessary to comply
with these requirements would be incurred by persons in the normal course of their activities (e.g., in
compiling and maintaining business records). [5 CFR 1320.3(b)(2)]
(i) Section 489.24(e)(1)(ii)(A)
Based on section 1867 of the Act, under this section of the regulation if an individual in an unstable
emergency condition, or a woman in labor, or someone acting on their behalf requests a transfer, the request
must be in writing, must indicate the reasons for the request and that the person making the request is aware
of the risks and benefits of the transfer. These provisions will verify that the person has made an informed
decision and will help ensure that the request is not coerced. Moreover, this requirement will reduce litigation
regarding whether or not an individual requests transfer.
We believe that hospitals operating in a manner that potentially subjects individuals to the threat of summary
transfer without treatment, poses an immediate and serious threat to individuals who may present themselves
to the hospital for treatment of emergency conditions or labor, and these requirements will help to ensure that
such individuals will be stabilized before transfer. This requirement will also educate hospital personnel to
provide a record of enforcement of the statute, help assure that the receiving physicians receive appropriate
medical information to treat each individual, will deter dumping, and will help to detect inappropriate
transfers.

The recording of the request for a transfer by the patient (or the patient’s legal representative) whose
condition has not been stabilized, including the reasons for the request and the risks and benefits of the
transfer, is a standard industry practice. The request statement and information are usually written by either a
physician or a nurse and signed by or on behalf of an individual. While these ICRs are subject to the PRA, the
burden associated with these ICRs are exempt because the time, effort, and financial resources necessary to
comply with these requirements would be incurred by persons in the normal course of their activities (e.g., in
compiling and maintaining business records). [5 CFR 1320.3(b)(2)]
(j) Sections 489.24(e)(1)(ii)(B) and (C)
Under section 1867 of the Act, before an individual in an unstabilized emergency condition or a woman in
labor may be transferred in the absence of a request for transfer, a physician or other qualified medical
personnel, in the absence of a physician, must sign a certification that based upon the information available at
the time of transfer, the medical benefits expected from appropriate medical treatment at another facility
outweigh the risks associated with transfer. The certification must contain a summary of the risks and benefits
upon which the certification is based. It is reasonable to conclude that Congress intended such
documentation, based upon the specificity of the statutory language in sections 1867(c)(l)(A)(ii) and (iii).
This provision will help receiving hospitals make informed decisions concerning whether the transfers are
appropriate. The statutory language is extremely specific because it was Congress' intent to protect
emergency patients, women in labor and their unborn children against possible erroneous transfers and the
certification cannot always be implied from the findings in the medical record and the fact that the individual
was transferred.
The statute and current industry practices routinely require a physician, or when a physician is not available,
other qualified medical personnel, to weigh the benefits and risks associated with the transfer and to
determine whether the transfer should take place of an individual in an unstabilized condition or a woman in
labor. While these ICRs are subject to the PRA, the burden associated with these ICRs are exempt because
the time, effort, and financial resources necessary to comply with these requirements would be incurred by
persons in the normal course of their activities (e.g., in compiling and maintaining business records). [5 CFR
1320.3(b)(2)]
(k) Section 489.24(f)
In the August 18, 2009 Final Rule we addressed the applicability of EMTALA to hospital inpatients by
stating that once an individual with an emergency medical condition has been admitted even if the individual
continues to have an unstabilized emergency medical condition, the admitting hospital no longer has an
EMTALA obligation and a hospital with specialized capabilities does not have an EMTALA obligation to
accept an appropriate transfer of that individual. We made this change by amending the regulations at section
489.24(f) to include a paragraph (2).
(l) Section 489.24(h)(1)
Pursuant to a complaint investigation, there may be cases where a medical opinion is necessary to determine a
physician’s or hospital’s liability under section 1867(d)(1). Therefore CMS requests the appropriate QIO
(with a contract under Medicare Part B, Title XI of the Act) to determine if there should be further action. As
such, these ICRs are exempt for the following reasons: These are individually-identified complaints. QIOs

are acting under contract, as agents of the Federal government during the conduct of an investigation or audit
against specific individuals or entities. [5 CFR 1320.4(a)(2)]
(m) Section 489.24(h)(2)
Based upon sections 1154, 1866 and 1867 of the Act, a civil monetary penalty (CMP) can be imposed against
a hospital or a physician or a physician can be excluded from the Medicare program for violating any of these
statutory requirements, and a QIO (with a contract under Part B of Title XI of the Act) must be asked to
prepare a report assessing whether the individual involved had an emergency condition which had not been
stabilized. The QIO must notify the physician and the hospital of the review and must provide the physician
and the hospital a reasonable opportunity to discuss the matter and to submit additional information, before
the QIO provides its report.
Congress enacted this provision as part of the OBRA '90 amendments (it became effective February 1, 1991)
to safeguard physicians and hospitals from CMP or exclusion actions by the government without another
opinion and to offer physicians and hospitals a medical review of the alleged violation before such actions are
taken.
(n) Section 489.24(j)(2)(iii)
In the August 19, 2008 Final Rule, we added the regulations at section 489.24(j)(2)(iii) to permit hospitals to
participate in formal community call plans, we outline the specific requirements of a formal community call
plan at section 489.24(j)(2)(iii)(A) – (F). We do not believe there is a burden associated with these provisions
because participation in a formal community call plan is optional and is meant to afford additional flexibility
to hospitals providing on-call services and improve access to specialty physician services for individuals in an
emergency department.
(o) Removal of previous section 489.24(i) and addition of section 482.12(f)(3)
As discussed above, the April 7, 2000 Final Rule finalized the policy that the prohibitions on patient dumping
would also apply to hospital departments located off the hospital's main campus. In the September 9, 2003
Final Rule, CMS eliminated the EMTALA requirements relating to emergency patients presenting at offcampus departments of hospitals that do not routinely provide emergency services. We deleted previous
section 489.24(i) because its primary purpose was 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
Final Rule, 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 previous section
489.24(i). In the same September 9, 2003 Final Rule, we added a requirement, in section 482.12(f)(3), stating
that if emergency services are provided at a hospital but are not provided at one or more off-campus
departments of the hospital, the governing body of the hospital is required to assure that the medical staff has
written policies and procedures for off-campus departments for appraisal of emergencies and referral when
appropriate In general, we believe that the burden associated with the requirements at section 482.12(f)(3)
will be significantly less than the burden under previous 489.24(i).
(b) Section 488.18(d)
Pursuant to section 1867 of the Act, this regulation added a new paragraph (d) to 42 CFR 488.18,
Documentation of Findings. This paragraph requires Medicare State Survey Agencies to promptly inform
CMS, via the Associate Regional Administrators, of information they receive concerning possible violations

of 42 CFR 489.24, Special responsibilities of Medicare hospitals in emergency cases (also based on section
1867 of the Act). This information is vital for CMS to meet its responsibility to assure that section 1867
violations cease promptly and Medicare State Survey Agencies are in an excellent position to determine when
a violation of these provisions has occurred.
Medicare State Survey Agencies who are under contract with HHS receive complaints regarding alleged
emergency services violations almost exclusively by telephone on an individual case basis. State agency staff,
in turn, log in the information, call in the alleged violation reports to CMS RO staff and keep track of all
actions resulting from the report. The written reports received are scanned and attached in the Automated
Survey Processing Environment (ASPEN) Complaints/Incidents Tracking System (ACTS) for review by the
CMS ROs. Some states, under their own initiative to meet their needs, have established "hot lines" which
may be used by the public to report alleged dumping violations.
The actual CMS process is as follows: CMS RO staff receives the reports by telephone, by mail, by email
message or via ACTS (if complaint submitted to the State Survey Agency first). CMS staff reviews, analyzes
and log in the reports, and for those reports determined to warrant investigation, they complete a form in
ACTS authorizing State Survey Agency investigation. Almost all reports received have been investigated.
As such, these Information Collection Requests (ICRs) are exempt for the following reasons: These are
individually-identified complaints. State agencies are acting under contract, as agents of the Federal
government during the conduct of an investigation or audit against specific individuals or entities. [5 CFR
1320.4(a)(2)]
(p) Removal of sections 489.24(i)(2) and (i)(2)(i), (i)(2)(ii), and (i)(3)
As explained above, in the September 9, 2003 Final Rule we eliminated the EMTALA requirements relating
to emergency patients presenting at off-campus departments of hospitals that do not routinely provide
emergency services. We deleted previous section 489.24(i) because its primary purpose was 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 Final Rule, however, a hospital would have no EMTALA
obligation with respect to individuals presenting to such departments.
(q) Removal of previous section 489.24(j)(1) and addition of section 489.24(j)(2)(iii)
As discussed above in the August 19, 2008 Final Rule, we moved the regulations regarding the requirement
to maintain an on-call list from previous section 489.24(j)(1) to section 489.20(r)(2), since that requirement is
found under section 1866 of the Social Security Act, which refers to provider agreements. We also revised
the regulations at section 489.24(j) by including a provision at section 489.24(j)(2)(iii) which details the
requirements of a formal community call plan. Participation in a formal community call arrangement is not a
requirement. We believe that adding the community call provision affords additional flexibility to hospitals
providing on-call services and improves access to specialty physician services for individuals in an
emergency department. We do not believe the burden associated with participating in a formal community
call plan (which is optional) will be significant.

2. Information Users
Pursuant to regulation sections 488.18, 489.20 and 489.24, during Medicare surveys of hospitals and State
Agencies CMS will review hospital records for lists of on-call physicians, and will review and obtain the
information which must be recorded on hospital medical records for individuals with emergency medical
conditions and women in labor, and the emergency department reporting information Medicare participating
hospitals and Medicare State survey agencies must pass on to CMS. Additionally, CMS will use the QIO
Report assessing whether an individual had an emergency condition and whether the individual was stabilized
to determine whether to impose a CMP or physician exclusion sanctions. Without such information, CMS
will be unable to make the hospital emergency services compliance determinations that Congress expects
CMS to make under sections 1154, 1866 and 1867 of the Act.
3. Use of Information Technology
EMTALA uses the Automated Survey Processing Environment (ASPEN) Complaints/Incidents Tracking
System (ACTS). State Survey Agency and CMS Staff use ACTS for documentation of EMTALA complaint
activity. EMTALA survey results and other EMTALA data is available from the ASPEN system.
Material collected during an EMTALA investigation is not collected electronically but is electronically
entered into ACTS as part of the survey documentation. ACTS is not available for use by hospitals or others
submitting EMTALA complaints. The system is for the use of State Survey Agency and CMS staff members.
EMTALA complaints may be submitted via email as well as by phone and mail, but there is no other current
electronic method available for submission of complaints. There are no plans at this time to give hospitals or
other complainants’ access to the surveyor documentation systems.
4. Duplication of Efforts
The ICRs contained in these regulations do not duplicate any other information collection system.
5. Small Businesses
These requirements do not affect small businesses.
6. Less Frequent Collection
This information is collected as needed. If it were collected on a less frequent basis, CMS would have greater
difficulty ensuring compliance and protecting future emergency patients and women in labor from potential
harm.
7. Special Circumstances
Absent a legislative amendment, we are unable to anticipate any circumstances that would change the
requirements of this package. EMTALA is a complaint driven process.

8. Federal Register/Outside Consultation
The 60-day Federal Register notice was published on November 19, 2019 (84 FR 63880).
No comments were received during the 60-day comment period.
The 30-day Federal Register notice was published on July 1, 2020 (85 FR 39570).
9. Payments/Gifts to Respondents
We do not plan to provide any payment or gift to respondents other than remuneration of contractors or
grantees.
10. Confidentiality
We do not pledge confidentiality because the information collected under these provisions are available to the
public and not subject to confidentiality.
11. Sensitive Questions
There are no questions of a sensitive nature associated with this information collection.
12. Burden Estimates (Hours & Wages)
EMTALA is a complaint driven process, the number of respondents is approximately 5,291. This estimate is
based on the approximate number of hospitals (including critical access hospitals) required to comply with
the EMTALA requirements as summarized in this supporting statement.
Since most of the requirements would be incurred by persons in the normal course of their activities, we
estimate an additional hour would be required for maintenance of these requirements. It is estimated that
approximately 5,291 Medicare participating hospitals are required to comply with EMTALA. Therefore, we
have calculated the burden as follows: 5,291 hospitals x 1 hour for maintenance of requirements = 5,291
burden hours (annual).
We believe emergency department staff similar to medical secretaries would most likely be responsible for
maintenance of EMTALA-related documentation. Based on the most recent Bureau of Labor and Statistics
Occupational Employment and Wages Data (May 2018) for Category 43-6013 (Medical Secretaries), the
mean hourly wage for a medical secretary is $17.83 1. We have added 100% of the mean hourly wage to
account for fringe and overhead benefits, which calculates to $35.66 ($17.83 + $17.83). We estimate the
total annual cost to be $188,677.06 (5,291 burden hours x $35.66/hour).
13. Capital Costs
There are no capital costs.

1

https://www.bls.gov/oes/current/oes436013.htm#nat

14. Cost to Federal Government
Central Office staff spends approximately two days (16 hrs.) a month compiling/reporting investigation
information received from the regions, at a salary of a GS-14, step 1 of about $56.15/hr. Total approximate
cost per year $10,780.80 is expended at the Central Office level.
RO staff time varies by state assignments. For instance, the regional representative for a state with a high
volume of complaints could spend up to 25 hours a week in processing time. Cost estimates for a GS-13, step
1, salary of about $46.66/hr., based on the mean salary of GS-13, step 1 among the 10 ROs, times 25 hours a
week equals $1,166.50 or about $60,658.00 a year ($1,166.50 x 52). The regional representative for a state
with a low volume of complaints could spend as little as 8 hours a week in processing time. Cost estimates
for a GS-13, step 1, salary of about $46.66/hr. times 8 hours a week equals $373.28 or about $19,410.56 a
year. Using the higher volume annual cost estimate of $60,658.00 and an average of 4 regional
representatives per region times 10 regions, the annual cost estimate for RO staff is $2,426,320.00
Central Office = $10,780.80
RO Estimate = $2,426,320.00
Total Annual Cost Estimate = $2,437,100.80
15. Changes to Burden
This extension request includes a change in the agency estimate resulting in an increase of 419 burden hours.
Previously our analysis included approximately 4,872 Medicare-participating hospitals, which included
hospitals paid under the Inpatient Prospective Payment System, critical access hospitals, and children’s
hospitals. However, we believe the specific requirements discussed in this supporting statement currently
apply to approximately 5,291 Medicare-participating hospitals, including hospitals paid under the Inpatient
Prospective Payment System, critical access hospitals, children’s hospitals, psychiatric hospitals, and 6
hospitals located in the Virgin Islands, Guam, the Northern Mariana Islands, and American Samoa paid in
accordance with the Tax Equity and Fiscal Responsibility Act of 1982.
Program
Change
Due to Agency
Discretion

Change Due to
Adjustment in
Agency
Estimate

5,291

0

0

+419

4,872

5,219

0

0

+419

4,872

0

0

n/a

n/a

Requested

Annual Number
of
Responses for
this IC
Annual IC Time
Burden (Hours)

Change
Due to
Potential
Violation
of the PRA

Program
Change
Due to New
Statute

Annual IC Cost $188,677.06
Burden (Dollars)

Previously
Approved

16. Publication/Tabulation Dates
We do not plan to publish any of the information collected under these provisions for statistical use.
17. Expiration Date
Upon receiving OMB approval, CMS will publish a notice in the Federal Register to inform the public of
both the approval as well as the expiration date.
18. Certification Statement
There are no exceptions to the certification statement contained in item 19 of OMB Form 83-I.