[Federal Register: June 22, 1994]
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Note: This section contains the original EMTALA
regulations with comments. The original
regulations were published together with CHAMPUS regulations, that is the
Civilian Health and Medical Program of the Uniformed Services. The mixing of the two regulations make
reading very difficult. Therefore
sections and references to CHAMPUS have been removed. Areas deleted have been marked.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Care
Financing Administration
42 CFR
Parts 405 and 489
Office of
Inspector General
42 CFR Part
1003 [BPD-393-IFC] RIN 0938-AC58
SUMMARY: A hospital (including a rural primary care
hospital) with an emergency department must provide, upon request and within
the capabilities of the hospital or rural primary care hospital, an appropriate
medical screening examination, stabilizing treatment and/or an appropriate
transfer to another medical facility to any individual with an emergency
medical condition, regardless of the individual's eligibility for Medicare.
The statute provides for the termination of a
provider's agreement for violation of any of these provisions….
…. These changes generally concern the
responsibility of Medicare
participating hospitals in emergency cases. The specific new provisions in this
area from OBRA 89 and OBRA 90 are discussed in section II.D.2 of this preamble.
We will also accept comments on Appendix II to this interim final rule.
Appendix II instructs hospitals with emergency departments on their
responsibilities concerning the posting of signs specifying rights of
individuals under section 1867 of the Act with respect to examination and
treatment for emergency medical conditions. We will not consider comments on
provisions that remain unchanged from the June 16, 1988 proposed rule or on
provisions that were changed based on public comments.
SUPPLEMENTARY INFORMATION
Sections A, B and C address CHAMPUS and have been
removed.
D. Responsibilities of Medicare
Participating Hospitals in Emergency Cases
Hospitals that choose to participate in the Medicare program agree in writing to
meet various requirements included in section 1866 of the Social Security Act
(the Act). Before enactment of COBRA on April 7, 1986, the Act did not
specifically address the issue of how hospitals with emergency medical
departments must handle individuals who have emergency medical conditions or
who are in labor.
In its Report accompanying H.R. 3128, the House Ways and
Means Committee indicated that Congress was concerned about the increasing
number of reports that hospital emergency rooms were refusing to accept or
treat individuals with emergency conditions if the patients did not have
medical insurance.
In addition, the Report stated that there were
reports that individuals in an unstable condition were transferred improperly,
sometimes without the consent of the receiving hospital. Because Congress
believed that this situation may have worsened since the Medicare
prospective payment system for hospitals became effective, the Report stated
that 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.'' (H.R.
Rep. No. 99-241, 99th Cong., 1st Sess. 27 (1985).) Subsequently, section 9121
of COBRA, sections 6003(g)(3)(D)(XIV), 6018, and 6211 of the Omnibus Budget
Reconciliation Act of 1989 (OBRA 89), Pub. L. 101-239, and sections 4008(b),
4027(a), and 4027(k)(3) of the Omnibus Budget Reconciliation Act of 1990 (OBRA
90), Pub. L. 101-508, have all addressed this concern.
D. Responsibilities of Medicare
Participating Hospitals in Emergency Cases
Set forth below is a summary of the current
legislative provisions concerning the responsibilities of Medicare
participating hospitals (including rural primary care hospitals) in emergency
cases. This legislative summary first sets forth the major provisions of
section 1867 of the Act, as originally enacted by COBRA on April 7, 1986, and
including all amendments that have occurred since that time. The summary then
describes separately the amendments made by OBRA 89 and OBRA 90, which were
enacted after the publication of the June 16, 1988, notice of proposed
rulemaking.
1.
Current Provisions [As of 1994]
Section 9121 of COBRA added a paragraph (I) to
section 1866(a)(1) of the Act and added a new section 1867 to the Act. As
amended, these sections prohibit hospitals (including rural primary care
hospitals) with emergency medical departments from refusing to treat individuals
with unstable emergency medical conditions and also contain provisions designed
to halt the inappropriate transfers of these individuals to other medical
facilities. (Note: For purposes of this preamble, all further references to
``hospital'' in the context of a ``Hospital's Responsibility for Emergency
Care'' include rural primary care hospitals.)
Section
1866(a)(1)(I) of the Act requires that a hospital participating in the Medicare
program must agree to comply with the requirements of section 1867 of the Act
to the extent applicable. Section 1867 of the Act currently provides the
following:
·
A hospital with an emergency department must,
within the capabilities of its emergency department (including ancillary
services routinely available to the emergency department), provide an
appropriate medical screening examination to any individual who comes to the
emergency department for examination or treatment of a medical condition and on
whose behalf the examination or treatment is requested; the purpose of the
examination is to determine whether the individual has an emergency medical
condition. This requirement applies regardless of the individual's eligibility
for Medicare
benefits.
·
If an individual, regardless of eligibility for Medicare
benefits, has an emergency medical condition, the hospital must either provide
for further examination and treatment (within its capabilities) to stabilize
the medical condition or make an appropriate transfer, with a proper
certification, of the individual to another medical facility, unless the
treatment or transfer is refused.
·
A hospital may not transfer an individual unless—
+ --The individual, or a
legally responsible person acting on his or her behalf, requests the transfer,
or
--A physician, or other
qualified medical personnel, after consulting with a physician (who later
countersigns the certification because a physician is not physically present in
the emergency department), has certified that the medical benefits expected
from the treatment at the receiving facility outweigh the increased risks to
the individual and, in the case of labor, to the unborn child, from effecting
the transfer; and
+ The transfer is an
``appropriate transfer'', that is, a transfer—
--Where the transferring
hospital provides the medical treatment within its capacity that minimizes the
risks to the individual's health and, in the case of a woman in labor, the
health of the unborn child;
--In which the receiving
facility has available space and qualified personnel for the treatment of the
individual and has agreed to accept the transfer and to provide appropriate
medical treatment;
--In which the transferring hospital sends to the
receiving facility all appropriate medical records (or copies) available at the
time of transfer that are related to the emergency condition for which the
individual has presented including records related to the individual's
emergency medical condition, observation of signs or symptoms, preliminary
diagnosis, treatment provided, results of any tests and informal written
consent or certification (or copies), and the name and address of any on-call
physician who has refused or failed to appear within a reasonable time to
provide necessary stabilizing treatment;
--In which the transfer
is effected through qualified personnel and transportation equipment, as
required, including the use of necessary and medically appropriate life support
measures during the transfer; and
--That meets other
requirements as the Secretary may find necessary in the interest of the health
and safety of the patient.
·
A hospital that fails to meet the requirements of
section 1867 of the Act—
+ Is subject to
termination of its Medicare provider agreement if it fails to comply with
section 1867; and
+ Is subject to civil
monetary penalties if it negligently violates section 1867 of the Act. The
penalty cannot exceed $25,000 for each violation committed between August 1,
1986 (the effective date of the statute) and December 21, 1987, or $50,000 for
violations on or after December 22, 1987. (The amount was raised by section
4009(a)(1) of the Omnibus Budget Reconciliation Act of 1987 (OBRA 87), Pub. L.
100-203, effective December 22, 1987.)
(Exception: If the hospital has fewer than 100
State-licensed, Medicare-certified beds, then the maximum civil monetary
penalty is $25,000. See discussion of section 4008 of OBRA 90 below.)
·
Each physician who is responsible for the
examination, treatment or transfer of an individual (including a physician who
is on-call for the care of such individual) is also subject to a civil money
penalty of not more than $25,000 for each violation ($50,000 for violations on
or after December 22, 1987), including—
+ The signing of transfer
certifications if the physician knew or should have known that the benefits of
transfer did not outweigh the risks, and
+ Misrepresenting an
individual's condition or other information, including a hospital's obligations
under this section.
A physician may also be
excluded from participation in the Medicare and State health care
programs for a violation that is gross and flagrant or repeated.
·
If a
hospital violates the requirements of section 1867 of the Act and a
patient suffers personal harm as a direct result, he or she may, in a civil
action against the participating hospital, obtain damages for personal injury
under the law of the State in which the hospital is located and may obtain such
equitable relief as is appropriate.
·
Any medical facility that suffers a financial loss
as a direct result of a participating hospital's violation of section 1867 of
the Act may obtain damages available in a civil action against the
participating hospital, under the law of the State in which the hospital is
located, and may obtain such equitable relief as is appropriate.
·
No civil action to obtain damages, as described
above, may be brought more than 2 years after the date of the violation with
respect to which the action is brought.
·
The following terms are defined for purposes of
section 1867 of the Act: ``emergency medical condition,'' ``hospital,''
``participating hospital,'' ``to stabilize,'' ``stabilized,'' and ``transfer.''
·
The provisions of section 1867 of the Act do not
preempt any State or local law except where they directly conflict.
·
Participating hospitals are not to delay a medical
screening examination or treatment to ask about an individual's status or
method of payment.
·
Participating hospitals with specialized
capabilities or facilities are obligated to accept the appropriate transfer of
an individual requiring such services if the hospital has the capacity to treat
them.
·
Except when a delay would jeopardize the health and
safety of individuals, or when there was no screening examination, the
appropriate PRO will assess whether the individual had an emergency condition
that had not been stabilized before the Office of Inspector General (OIG)
imposes a civil monetary penalty or exclusion.
·
Hospitals are required, among other things, to
maintain medical and other records related to individuals transferred to and
from a hospital for a period of 5 years from the transfer date. Each hospital
must maintain a list of on-call physicians available to provide stabilizing
treatment. Each hospital must also post a conspicuously placed sign in its
emergency department that lists the individuals' rights regarding their
examination and treatment.
·
Hospitals are not to penalize or take an adverse
action against a physician or a qualified medical person who refused to
authorize the transfer of an unstabilized individual with an emergency medical
condition or against a hospital employee because the employee reported a
violation.
2.
Summary of the Related OBRA 89 and OBRA 90
Provisions
Set forth below is a brief summary of the new and
revised provisions from OBRA 89 (enacted December 19, 1989) and OBRA 90
(enacted November 5, 1990) that were added to strengthen and clarify the
requirements concerning the examination, treatment and transfer of individuals
with emergency medical conditions.
a.
OBRA 89 Provisions
·
Rural primary care hospitals. A new category of
provider, rural primary care hospitals, was established (section 6003(g)(3) of
OBRA 89). Only facilities currently certified as hospitals and not in violation
of any conditions of participation (42 CFR part 482) could be designated by the
Secretary as rural primary care hospitals.
·
Compliance requirements (section 6018 of OBRA 89).
Hospitals are required to—
+
Adopt and enforce a policy to ensure compliance with section 1867 of the Act;
+
Maintain medical and other records related to individuals transferred to or
from a hospital for a period of 5 years from the transfer date; and
+
Maintain a list of on-call physicians available for duty to provide treatment
needed to stabilize an individual with an emergency medical condition.
·
Posted information (section 6018 of OBRA 89).
Participating hospitals must post conspicuously in their emergency departments—
+
A sign listing the rights of individuals under section 1867 of the Act
regarding examination and treatment for emergency medical conditions; and
+
Information indicating whether the facility participates in the Medicaid
program under a State plan approved under title XIX of the Act. Both posted
items are to be in a form specified by the Secretary.
·
Additional requirements for Medicare
participating hospitals with emergency departments (section 6211 of OBRA 89).
+
The medical screening requirement was changed to indicate that the capability
of the facility's emergency department includes ``ancillary services routinely
available to the emergency department.''
+
Participating facilities are now required to inform each individual (or a
person acting on his or her 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.
+
Changes were made relating to the restrictions on transfers to include—
--A requirement that participating facilities
obtain written requests for transfer to another medical facility after
informing individuals (or legally responsible persons acting on their behalf)
of the hospital's obligations and the risk of transfer;
--An explicit statement that there should be
consideration of the risks and benefits to unborn children of women in labor in
determining whether the physician should certify that the benefits outweigh the
risks of transfer;
--A requirement that transfer certifications by participating
facilities include a summary of the risks and benefits upon which the
certification is based;
--A requirement that when a qualified medical
person signs the certification, it be done in consultation with a physician and
that the physician later countersign the certification;
--A requirement that the hospital provide medical
treatment within its capacity to minimize the risks of transfer; and
--A requirement that the transferring hospital
include specified documents in the medical records sent to receiving hospitals.
·
Civil monetary penalties (section 6211(e) of OBRA
89).
+
Physicians, including on-call physicians, are subject to civil monetary
penalties and exclusion from Medicare and the State health care
programs for violations of section 1867 of the Act, including—
--The signing of transfer certifications if the
physician knew or should have known that the benefits of transfer did not
outweigh the risks; or
–-Misrepresenting an individual's condition or
other information on the transfer certification.
+ A participating
facility or an on-call physician is subject to a penalty if the on-call
physician fails or refuses to appear within a reasonable period of time when
notified by an emergency department physician that his or her services are
needed and the emergency physician orders a transfer because he or she
determines that without the services of the on-call physician the benefits of
transfer outweigh the risks of transfer.
·
Specialty hospitals (section 6211(f) of OBRA 89).
Participating hospitals with special capabilities or facilities are obligated
to accept the appropriate transfer of an individual who requires such
specialized capabilities or facilities if the hospital has the capacity to
treat the individual.
·
No delay in examination or treatment (section
6211(f) of OBRA 89). Participating hospitals are not to delay the provision of
a medical screening examination, treatment, or both, to inquire about the
individual's method of payment or insurance status.
·
Whistleblower protections (section 6211(f) of OBRA
89). Participating hospitals may not take action against a physician because he
or she refused to authorize the transfer of an unstabilized individual with an
emergency medical condition.
·
Definitions.
+
The term ``responsible physician'' is no longer used in section 1867(d) of the
statute. It was changed to ``a physician who is responsible for the
examination, treatment or transfer of an individual'' under section
1867(d)(1)(B) of the Act. (Section 6211(e)(1) of OBRA 89.)
+
The term ``patient'' was replaced with the term ``individual.'' (Section
6211(g) of OBRA 89.)
+
The term ``emergency medical condition'' now includes a pregnant woman who is
having contractions, either when there is inadequate time to effect safe transfer,
or when the transfer may pose a threat to the health or safety of a pregnant
woman or her unborn child. The term ``active labor'' was deleted. (Section
6211(h) of OBRA 89.)
+
The terms ``to stabilize'' and ``stabilized'' now take into account what might
occur during a transfer and explicitly extend the protection of section 1867 of
the Act to a pregnant woman until delivery (including the delivery of the
placenta). (Section 6211(h) of OBRA 89.)
All
of the provisions described above were effective beginning July 1, 1990, with
the exception of the definition of the term ``rural primary care hospital'',
which was effective upon enactment.
b. OBRA 90 Provisions
·
Civil monetary penalties.
+
The standard for liability for imposing civil monetary penalties against
hospitals and physicians was changed from ``knowingly'' to ``negligently.''
(Sections 4008(b)(1) and 4027(a)(2) of OBRA 90.)
+
Hospitals with fewer than 100 State-licensed, Medicare-certified beds are
subject to a civil monetary penalty of not more than $25,000, while all other
hospitals remain subject to a maximum CMP of $50,000. (Section 4008(b)(2) of
OBRA 90.)
·
Termination of hospital provider agreements
(section 4008(b)(3) of OBRA 90).
+
The provision in section 1867(d)(1) of the Act that subjected violating
hospitals to termination or suspension of their Medicare provider agreements
was deleted.
+
Hospitals are now required, under section 1866(a)(1)(I)(i), to adopt and
enforce a policy to ensure compliance with the requirements of section 1867 in
order to participate in and receive payments under the Medicare
program.
·
PRO assessment (section 4027(a)(1) of OBRA 90).
+
In considering allegations of violations, before the OIG imposes a sanction,
HCFA is required to request the appropriate PRO (with a contract under part B
of title XI) to assess whether the individual involved had an emergency medical
condition that had not been stabilized, except when a delay would jeopardize
the health and safety of individuals.
+
The PRO must provide—
--An
assessment of the alleged violation to determine whether the individual
involved had an emergency medical condition that had not been stabilized and a
report of the violation to the Secretary;
--Reasonable notice of the review to the physician
and hospital involved;
--Within the time allotted by the Secretary,
reasonable opportunity for the affected physician and the hospital to discuss
the case with the PRO and to submit additional information before the PRO
issues its report. The Secretary will request such a review, except when delay
would jeopardize the health or safety of individuals or when there was no
screening examination, before effectuating a sanction. When a delay would not
jeopardize the health or safety of individuals, the PRO will have at least 60
calendar days to complete its review.
·
Standard for excluding physicians (section
4027(a)(3) of OBRA 90). The standard for excluding physicians, including
on-call physicians, from participation in the Medicare and State health care
programs was changed from ``knowing and willful or negligent'' to ``gross and
flagrant or is repeated.''
·
Revised whistleblower protections (section
4027(k)(3) of OBRA 90). The prohibition of a hospital from penalizing or taking
adverse action against a physician because he or she refused to authorize the
transfer of an unstabilized individual with an emergency medical condition was
extended to protect a qualified medical person. Also, a hospital is prohibited
from taking action against a hospital employee because the employee reported a
violation of these requirements.
·
Drafting errors. We note that the drafters of OBRA
90 misnumbered the section following section 4206, calling it section 4027. The
drafters also misnumbered the subsections of section 4027, so that what should
have been section 4027(k) was misnumbered as section 4027(m). The error in
misnumbering the subsections was corrected between the submission of the
conference report and the enrolled bill, Pub. L. 101-508. The error in
misnumbering the section was not corrected, however. Therefore, the correct
section numbers at present for the relevant sections of OBRA 90 are 4008(b),
4027(a) and 4027(k)(3). The above provisions were effective May 1, 1991, with
the exception of the provisions of section 4027(a)(1), which were effective
February 1, 1991, and the provisions of section 4027(k)(3), which were
effective upon enactment.
D. Hospital Emergency
Care
The revisions to the
regulations we proposed on June 16, 1988 would have been revisions and
additions to 42 CFR Part 489, Provider Agreements under Medicare,
and revisions to 42 CFR Part 1001, Program Integrity--Medicare,
and Part 1003, Civil Money Penalties and Assessments. Basically, the proposed
provisions paralleled the statutory requirements that were then in effect. We
note that, as discussed above in section II.D. of this preamble, OBRA 89 and
OBRA 90 included amendments to section 1867 of the Act.
1. Requirements for
Hospitals With Emergency Care Departments
·
We proposed to revise Sec. 489.20, which discusses
basic commitments, by adding a new paragraph to require hospitals with
emergency departments, as part of their participation agreement, to agree to
comply with the new Sec. 489.24, which incorporates the statutory requirements.
·
We proposed to add a new section Sec. 489.24,
Special responsibilities of Medicare hospitals in emergency cases, to set forth
requirements for emergency cases for all hospitals that have provider
agreements with Medicare. We planned to require a hospital to take the
following measures:
+ Medical screening
requirement—
For
any individual, regardless of his or her eligibility for Medicare,
for whom emergency treatment or examination is requested, we proposed to
require a hospital with an emergency department to provide for an appropriate
medical screening examination within the emergency department's capability to
determine whether an emergency medical condition exists or whether the
individual is in active labor, as defined below. The examinations would be
conducted by individuals determined qualified by hospital by-laws and who meet
the requirements of Sec. 482.55, which are that emergency services be
supervised by a qualified member of the medical staff and that there be
adequate medical and nursing personnel qualified in emergency care to meet the
written emergency procedures and needs anticipated by the facility. We proposed
to allow hospitals maximum flexibility in their utilization of emergency care
personnel by not including specific requirements concerning education or
credentials for individuals conducting emergency medical examinations.
+ Necessary stabilizing
treatment for emergency medical conditions and active labor—
If
the individual has an emergency medical condition or is in active labor, we
proposed that the hospital be required to provide either further medical
examination and treatment to stabilize the medical condition or treatment of
the labor or transfer the individual appropriately to another medical facility.
We would not hold the hospital responsible if the individual, or a legally
responsible person acting on the individual's behalf, refuses to consent in
writing to the further examination and treatment or the appropriate transfer to
another hospital.
Under
these provisions, the hospital would be responsible for treating and
stabilizing any individual, regardless of eligibility for Medicare,
who presents himself or herself with an emergency condition at the hospital,
and for providing such care until the condition ceases to be an emergency or
until the individual is properly transferred to another facility. We
interpreted this to mean, for example, that if a hospital were to admit and
then transfer an individual before his or her condition is stabilized, except
as provided below, it would be a violation of section 1867 of the Act.
+ Transfers and
restrictions—
If
an individual at a hospital has an emergency medical condition that has not
been stabilized or the individual is in active labor, the hospital could not
appropriately transfer the individual unless one of the following conditions
exist:
--The individual (or a
legally responsible person acting on the individual's behalf) requests the transfer.
--A physician (or other
qualified medical personnel if a physician is not readily available in the
emergency department) has certified in writing that, based upon the reasonable
risks and benefits to the individual and the information available at the time,
the medical benefits reasonably expected from the provision of appropriate
medical treatment at the other facility outweigh the increased risks to the
individual's medical condition from the transfer.
We
considered a transfer to be appropriate only if the receiving medical facility
has available space and qualified personnel for the treatment of the individual
and has agreed to accept the transfer of the individual and to provide
appropriate medical treatment. The transferring hospital would have to furnish
the receiving medical facility with timely appropriate medical records (for
example, copies of the available history, examination, and treatment records as
well as any available reports of diagnostic studies performed). The patient
would have to be accompanied by qualified personnel during the transfer;
transportation arrangements would have to include the use of necessary and
medically appropriate life support measures.
Although
the statute authorized the Secretary to find that the transfer must meet
``other requirements'' in the interest of the health and safety of individuals
transferred, we did not propose to adopt any. We did, however, specifically
invite public comment concerning any ``other requirements'' the Secretary
should consider adopting regarding the health and safety of emergency
department patients being transferred between medical facilities.
·
Definitions.
We proposed to include in
Sec. 489.24 the following definitions as included in the statute, without
interpretation—
+
``Active labor'' means labor at a time when delivery is imminent, there is
inadequate time to effect safe transfer to another hospital before delivery, or
a transfer may pose a threat to the health and safety of the patient or the
unborn child.
+
An ``emergency medical condition'' means a medical condition manifested by
acute symptoms of sufficient severity (including severe pain) that the absence
of immediate medical attention could reasonably be expected to result in: (a)
Placing the patient's health in serious jeopardy; (b) serious impairment to
bodily functions; or (c) serious dysfunction of any bodily organ or part.
+
``To stabilize'' means, with respect to an emergency medical condition, to
provide the medical treatment of the condition necessary to assure, within
reasonable medical probability, that no material deterioration of the condition
is likely to result from the transfer of the individual from a facility.
+
``Stabilized'' means, with respect to an emergency medical condition, that no material
deterioration of the condition is likely, within reasonable medical
probability, to result from the transfer of an individual from a facility.
+
``Transfer'' means the movement (including the discharge) of a patient to
outside a hospital's facilities at the direction of any person employed by (or
affiliated or associated with, directly or indirectly) the hospital, but it
does not include moving a patient who has been declared dead or who leaves the
facility without the permission of any person responsible for directing
transfers.
For
the purpose of these definitions, the term ``hospital'' means a Medicare
facility certified as a hospital with its own provider number.
We
did not plan to define ``participating provider'' in part 489; 42 CFR 400.202
defines terms applicable to all of 42 CFR Chapter IV and already defines
``provider''. A provider by definition agrees to participate in Medicare.
We proposed to add a definition of ``participating hospital'' and the remaining
statutory definition, that of ``responsible physician'', to 42 CFR Chapter V
(Parts 1001 and 1003), since these terms are used in conjunction with monetary
penalties, which is under the jurisdiction of the Office of Inspector General.
We discuss the proposed definition of ``responsible physician'' below under
``Civil Monetary Penalties.''
·
We proposed to amend 42 CFR Parts 489, 1001 and
1003 to provide for types of sanctions that would be applied by the Department,
as appropriate—
+
Resolution of allegations and determination of liability.
If
the evidence available establishes that a hospital knowingly and willfully, or
negligently, failed to provide the appropriate screening and treatment or
transfer as explained above, it would be subject to either termination of its
provider agreement by HCFA in accordance with section 1866(b) of the Act, or
suspension of its provider agreement by the OIG. In addition, the OIG could
also impose civil monetary penalties for knowing violations.
When
the Department receives a complaint, or any information or allegation, to the
effect that a Medicare hospital did not appropriately comply with the
emergency medical screening, stabilizing, treatment or transfer requirements,
HCFA would, upon receipt of all available information and evidence, conduct
sufficient review to determine whether the complaint falls within the
jurisdiction of section 1867. If so, HCFA would consider the complaint a
substantial allegation and would investigate the allegation thoroughly.
If
complaints allege acts of discrimination in violation of the civil rights laws,
HCFA will refer them to the Office for Civil Rights. In the case of other
complaints, HCFA would send each complainant a letter acknowledging receipt of
the complaint, advising him or her of his or her rights to consider
independently the civil enforcement provisions of section 1867 and stating that
it will refer the complaint to other agencies if, during the complaint
investigation, it determines that the matter falls under the jurisdiction of
other agencies. Thus, HCFA would refer a complaint to the Office for Civil
Rights if it determines that a hospital may be in violation of the Hill-Burton
Subpart G Community Service regulations at 42 CFR 124.603(b)(1), which require Medicare
participating hospitals that receive Hill-Burton construction grants and loans
to provide emergency medical services to any person who resides (or, in the
case of some hospitals, works) in the hospital's designated health service
area. HCFA would, of course, inform complainants of the outcome of its
investigations.
HCFA
would notify State Medicaid authorities, State licensing bodies, the Office of
Inspector General, appropriate PROs and the Office for Civil Rights concerning
all complaint investigations and all termination actions.
HCFA
would determine whether the hospital knowingly and willfully, or negligently,
failed to comply with the requirement of Sec. 489.24 based on evidence of: (a)
Inadequate treatment or treatment not being provided; (b) patients in unstable
condition or in active labor not being properly transferred as defined in Sec.
489.24(d)(2); (c) the hospital's actions, or lack of actions, causing a
patient's or infant's death or serious or permanent impairment to a patient's
bodily functions; or (d) a hospital's actions placing a patient's health in
serious jeopardy. HCFA would determine the hospital to have been negligent if
the hospital and its personnel failed to exercise care that should normally be
supplied to a patient experiencing an emergency medical condition or active
labor as defined in Sec. 489.24(b).
+
Termination of a provider agreement by HCFA.
HCFA's
termination authority under this provision was designed so that quick action
may be taken to protect Medicare beneficiaries and other individuals from any
potential harm. The termination of a provider agreement was to be the initial
action contemplated against a hospital that knowingly and willfully, or
negligently, failed to meet the requirements set forth in Sec. 489.24. This
section would allow for the termination of the hospital's provider agreement
under Medicare
in accordance with section 1866(b) of the Act. The termination requirement was
to be contained in Sec. 489.24(e). (The authority to terminate has been
delegated from HHS through the HCFA Administrator to HCFA Regional Offices.)
HCFA
was to revise Sec. 489.53, Termination by HCFA, to include in paragraph (b)
failure to comply with the requirements of Sec. 489.24 as a mandatory cause for
termination of a provider agreement. HCFA would also revise paragraph (c) to
state that, if it determines that a hospital is in violation of Sec. 489.24(a)
through (d), HCFA would usually consider the violation to pose an immediate and
serious threat to the health and safety of persons presenting themselves to the
hospital for emergency services and would terminate the hospital's approval for
Medicare
participation within 2 days of the determination unless the violation is
corrected.
In
those instances in which HCFA determined that a hospital was in violation of
the requirements of the Act, it would initiate termination action. When that
action was resolved, HCFA would refer the case to the OIG for possible
imposition of civil monetary penalties. If the OIG, upon further investigation,
discovered past violations that did not form the basis of the termination
action, it could decide that a sanction is warranted and exercise its authority
to impose a suspension against the reinstated provider. (See the next section.)
In
instances where HCFA found no violation, and therefore did not take an action,
the closed case would still be transmitted to the OIG. If the OIG, upon
reviewing the case file, believed that further case development was warranted,
it would be free to do so. If OIG's investigation indicated that there were
additional violations that were not reflected in HCFA's case file, it would
refer the new case information back to HCFA with a recommendation on whether
HCFA should terminate the hospital's provider agreement based on the new
findings.
Whether
or not HCFA took a termination action on a given case, all investigated cases
were to be referred to the OIG for possible imposition of civil monetary
penalties.
+
Suspension of a provider agreement by the OIG and imposition of civil monetary
penalties.
We
proposed for the OIG to suspend providers, impose monetary penalties on
violators and exclude responsible physicians. The proposed rule stated that the
OIG would not be precluded from suspending a hospital if, upon further
investigation, it determined there were additional violations of section 1867
beyond those warranting the HCFA termination that indicated a pattern of
dumping more widespread than initially believed by HCFA, or that additional
instances of dumping were so egregious that a penalty of suspension was
appropriate. In addition, the proposed rule stated that the OIG could also
impose a civil monetary penalty (of not more than $50,000 per violation) for a
hospital knowingly violating the screening, treatment and transfer requirements
of the statute and a civil monetary penalty (also of not more than $50,000)
against each responsible physician. The proposed regulations also stated that,
in addition to imposing civil monetary penalties, the OIG may exclude the
responsible physician from Medicare participation for up to five years.
Congress
repealed the suspension authority in section 4008(b) of OBRA 90.
·
Civil enforcement.
An
individual who suffers personal harm, or a medical facility that suffers a
financial loss, as a direct result of the hospital's violation of a requirement
in Sec. 489.24, may bring a civil action, in an appropriate Federal district
court, against the hospital for damages and other equitable relief as
appropriate. No civil action may be brought more than 2 years after the date of
the violation. The Federal district court will apply the law of the State in
which the hospital is located.
We
continue to believe that it was neither necessary nor appropriate to revise the
regulations to reflect this provision.
·
Preemption of State law.
The
legislation provides that it does not preempt State or local law except where
there is a conflict with the statutory provision. Since Federal law ordinarily
supersedes State law where there is a conflict, it was not necessary to propose
this provision for the regulations.
2.
Responsibilities of Hospitals Receiving Improperly
Transferred Individuals
Preliminary findings of a
study being conducted by the OIG (``Patient Dumping After COBRA: Assessing the
Incidences and the Perspectives of Health Care Professionals'' (August 1988))
confirmed that a number of individuals in unstable condition have been
transferred improperly and that the cases were not reported to HCFA. Because we
needed to know about all improper transfers, we proposed to add new paragraphs
Sec. 489.20(g) and Sec. 489.24(f) to require a hospital that suspects it may
have received an improperly transferred individual to promptly report the
matter to HCFA and to the State survey agency. To be in compliance with this
requirement, the receiving hospital would have to report any suspected incident
within 72 hours of its occurrence; this requirement would appear in manual
instructions.
We also proposed to add
material to Sec. 489.53(a) to show that failure to report improper transfers
may subject the receiving hospital to termination of its provider agreement.
In those instances in
which HCFA determines that a hospital is in violation of Sec. 489.20(g) and
Sec. 489.24(f), we proposed to initiate termination action.
3.
State Survey Agency Responsibilities
The preliminary findings
of the OIG study previously cited also identified incidents of improper
transfer being reported to the State survey agency that were not then reported
to HCFA.
To assure that we are
aware of all instances of improper transfer, we also proposed to require the
State survey agencies to report promptly any credible complaints (that is,
complaints that are specific and detailed enough to be investigated) related to
violations of section 1867 of the Act. Therefore, we intended to revise Sec.
405.1903 (recodified as Sec. 488.18), Documentation of findings, by adding a
new paragraph (d) that would require State survey agencies to inform HCFA of
credible reports of violations of Sec. 489.24.
We received comments from
68 commenters on the anti-dumping provisions as they existed before the passage
of OBRA 89. Commenters included hospitals, professional health organizations,
State hospital associations and medical societies, State agencies, physicians,
attorneys and other individuals. We have taken into account the OBRA 89 and
OBRA 90 statutory changes when responding to the comments we received, and we
are adding the OBRA 89 and OBRA 90 requirements to this interim final rule. We
are doing this without publishing a second notice of proposed rulemaking
pertaining to the OBRA 89 and OBRA 90 requirements because we believe the
extensive detail of the statute makes many provisions self-executing and
because commenters suggested changes similar to many of those embodied in the
legislation.
(Please note that, with
respect to the anti-dumping provisions, the statute now uses the term
``individual'' and not ``patient.'' While our response to comments refers to
``individuals,'' we have not made the parallel change when the term ``patient''
appears in a commenter's statement.)
Comment: A number of
commenters suggested that HCFA require hospitals to post signs in their
emergency departments advising patients of the hospital's obligation to provide
emergency care. Two other commenters recommended that we require emergency room
personnel to give emergency room patients both written and oral notice of the
hospital's obligations and the patient's rights under these regulations.
Response: The provisions
of section 1867 of the Act address what is appropriate performance on the part
of hospitals in meeting medical needs of individuals who need emergency
services. Additionally, as amended by section 6018(a)(2) of OBRA 89, section
1866(a)(1)(N)(iii) of the Act explicitly directs the Secretary to require Medicare
participating hospitals to post conspicuously in all emergency departments a
sign (in a form specified by the Secretary) specifying rights of individuals
under section 1867 of the Act with respect to examination and treatment for
emergency medical conditions and women in labor. Further, since some hospitals
do not have traditional emergency departments, we are amending Sec. 489.20 to
include a new paragraph (q)(1) to reflect this statutory requirement and to
specify other hospital areas in which such signs should be posted. It should be
noted that Medicare
participating hospitals that do not offer emergency services do not have to
comply with this requirement. However, all hospitals do have to comply with the
provision of section 1866(a)(1)(N)(iv) of the Act, as also amended by section
6018(a)(2) of OBRA 89, that directs hospitals to post conspicuously (in a form
specified by the Secretary) information indicating whether or not the hospital
participates in the Medicaid program under a State plan approved under title
XIX. (See Sec. 489.20(q)(2).)
We have also published an
interim manual instruction (IMI)(IM-90-1, June 1990) in HCFA Pub. 10, the Medicare
Hospital Manual, listing minimum criteria for the signs and an example of
language for this sign that would meet such criteria. We are including the IMI
language as shown in the IMI exhibit for informational purposes in Appendix II
to this final rule and request comments on the exhibit.
We believe that the
statutory requirement for the posting of signs, which does not also require
individual written or oral notice, is adequate for the general purpose of
informing patients of their rights to a medical screening and stabilizing
treatment under the anti-dumping statute. This is consistent with the overall
drafting of section 1867 of the Act, which specifically requires individual
notice in other situations such as consent to transfer. Accordingly, when an
individual's specific treatment is involved, we agree with the commenters that
it is essential for patients to be fully informed about all the critical
medical issues with which they are faced. That is why we require a more
detailed process for ensuring that hospitals obtain the informed consent of an
individual who is faced with the prospect of a transfer. (See Sec. 489.24(c).)
In such cases, we agree that both oral and written interaction are necessary.
Comment: A number of
commenters objected to our proposal concerning furnishing emergency services on
the grounds that our rule applies to all patients (rather than Medicare
patients only). They believe that any problems were of limited scope and noted
that implementation of the requirement will establish an adversarial
relationship among HCFA, providers, and patients.
Response: The protections
of the statute are expressly extended to all individuals who come to a facility
regardless of whether the individual is eligible for benefits under Medicare.
The Federal Government has always viewed that a provider's obligation is to all
persons, regardless of entitlement. This obligation has been well understood
and universally applied to all providers. Congress, in apparent awareness of
this universal obligation, has in some instances limited the scope of a
provider's obligation. An example of this is discharge planning, as provided
under section 1861(ee) of the Act, which limits the scope of this requirement
specifically to individuals covered under the Act. Since Congress has not
chosen to narrow the scope of section 1867 by limiting it only to persons
entitled to benefits under the Act, we are confident that the provisions of
section 1867 of the Act extend to all persons.
We believe that section
1867 of the Act also applies to all individuals who attempt to gain access to
the hospital for emergency care. An individual may not be denied services
simply because the person failed to actually enter the facility's designated
emergency department. To read the statute in such a narrow fashion would in our
view frustrate the objectives of the statute in many cases and lead to
arbitrary results. For the same reason, a facility may not prevent an
individual from gaining access to the facility in order to circumvent these
requirements. If an individual is on a facility's property, which includes
ambulances owned and operated by the facility, even if the ambulance is not on
hospital property, and a request is made on the individual's behalf for
examination or treatment for a medical condition, we believe the statute
reasonably requires the facility to provide a screening examination and
treatment or transfer in accordance with section 1867 of the statute. An
individual in a nonhospital-owned ambulance on hospital property is considered
to have come to the hospital's emergency department. However, an individual in
a nonhospital-owned ambulance located off hospital property is not considered
to have come to the hospital's emergency department if someone staffing the
ambulance contacts the hospital by telephone or telemetry communications and
informs the hospital that they want to transport the individual to the hospital
for examination and treatment. This is in accordance with the recent court
decision that, for purposes of section 1867 of the Act, a hospital-operated
telemetry system is distinct from the same hospital's emergency department.
(See Johnson v. University of Chicago Hospitals, 1992 U.S. App. Lexis 25096
(7th Cir. 1992).) Thus, the hospital may deny such access when it is in
``diversionary'' status because it does not have the staff or facilities to
accept any additional emergency patients at that time. However, if the
ambulance disregards the hospital's instructions and does bring the individual
on to hospital grounds the hospital cannot deny the individual access to
hospital services whether or not the hospital is in ``diversionary'' status.
Comment: A number of
commenters noted that these requirements could have a greater impact on some
hospitals than on others. For example, rural hospitals would have a greater
recordkeeping burden in documenting transfers because they have smaller
emergency room (ER) staffs; hospitals with high ER rates for non-Medicare
or Medicaid patients would have to provide care for which these programs will
not directly compensate, and some hospitals will have to accept larger numbers
of indigent patients presenting themselves for treatment.
Response: The law
specifically applies to all hospitals that participate in Medicare
and that offer emergency services. We have, therefore, inserted the following
definition in Sec. 489.24(b): ``Hospital with an emergency department means a
hospital that offers services for emergency medical conditions (as defined in
this paragraph) within its capability to do so.'' It is also clear that the
statute only requires hospitals that offer emergency services to provide
screening and stabilizing treatment within the scope of their capabilities
(sections 1867(a) and (b) of the Act). We acknowledge, however, that any
participating hospital providing emergency services, regardless of size or
patient mix, must provide screening and stabilizing treatment, as needed, to
individuals who present themselves for examination or treatment. We recognize
that this could create uneven uncompensated care burdens on some hospitals
because of larger than usual concentrations of indigent patients; however, we
do not believe that this will often be the case. Since the requirements apply
to all 6,700 Medicare
participating hospitals, among 7,000 U.S. hospitals offering emergency
services, we also believe that the statute will lighten the burden on some
hospitals now subject to increased patient loads due to inappropriate transfers
because patients are more likely to be treated and stabilized at the hospitals
where they first present themselves for treatment.
Comment: Two commenters
stated that a hospital should not be required to designate in its by-laws which
personnel are qualified to perform the initial medical screening examination
because it is unreasonable to require a hospital to amend its by-laws. A
recommendation was made that those personnel qualified to perform screening
examinations be approved by the medical director of the emergency department.
Another recommendation was made that those personnel qualified to perform
screening examinations be set forth in the rules and regulations governing the
medical staff and not the by- laws.
Response: It is important to require the hospital to
determine formally what type of personnel is qualified to perform the initial
medical screening examinations because such a formal determination will insure
that the hospital's governing body recognizes the ``capability of the
hospital'' and is properly accountable for this function. For this reason, we
believe that the delegation should be set forth in a document that is approved
by the governing body of the hospital, rather than merely allowing the medical
director of the emergency department to make what may be informal delegations
that could frequently change. If the rules and regulations are approved by the
board of trustees or other governing body, we agree that those personnel
qualified to perform these examinations may be set forth in the rules and regulations,
instead of placing this information in the hospital by- laws. We are amending
Sec. 489.24(a) to reflect this change. Although we are requiring the hospital
to specify in its by-laws or its rules and regulations who is a ``qualified
medical person'' for purposes of providing an appropriate medical screening
examination, this does not mean that HHS must accept the hospital's
specification when determining whether an appropriate medical screening
examination was done. So, for example, if a hospital specifies that a nurse is
always the ``qualified medical person'' who should do the medical screening
examination, HHS may, in some instances, determine that there was not an
appropriate medical screening examination because the condition of the
individual required the expertise of a physician to determine whether that
individual had an emergency medical condition.
Comment: Several
commenters suggested that the regulations require hospitals to perform the
medical screening examination without first inquiring about an individual's
ability to pay because such inquiries may encourage patients to refuse
treatment or request transfer, even when it is not in the best interests of the
patient's health.
Response: We agree with
the commenter, as did Congress as evidenced by the provisions added to section
1867(h) of the Act by section 6211(f) of OBRA 89:
A participating hospital may not delay provision of an appropriate medical screening examination required under subsection (a) or further medical examination and treatment required under subsection (b) in order to inquire about the individual's method of payment or insurance status.
We have included this language in the regulations at Sec. 489.24(c)(3). However, we note that we believe that it means hospitals may continue to follow reasonable registration processes for emergency room individuals, including requesting information about insurance, as long as these procedures do not impede provision of necessary treatment and as long as all individuals to whom the procedures apply are treated similarly. That is, all individuals who have an emergency medical condition are served regardless of the answers they may give to insurance questions asked during routine admissions screening. A hospital should not delay treatment to any individual while it verifies information provided.
Comment: Three commenters
recommended that the regulations affirmatively state that every patient,
regardless of ability to pay, should receive a medical screening examination
performed by a physician.
Response: Section 1867(a)
of the Act provides that a hospital must give an appropriate medical screening
examination to all individuals who come to the emergency department and request
examination or treatment. While it may be prudent for a hospital to require a
physician to conduct this screening examination in every instance, there may be
hospitals, especially rural primary care hospitals, in which a physician is not
available to provide a medical screening examination. Even when physicians are
present in the hospital, there may be circumstances that are so clearly not
emergency medical conditions that other qualified medical personnel may conduct
the initial screening examination. However, although it is up to the hospital
to determine under what circumstances a physician is required to perform an
appropriate medical screening examination, that does not mean that HHS must
accept the hospital's determination of what circumstances require that the
screening exam be performed by a physician.
Comment: Several
commenters asked us to define ``appropriate medical screening examination,'' so
that hospitals and physicians are subject to unambiguous requirements for
carrying out the statutory mandate.
Response: It is
impossible to define in advance all of the circumstances in which an individual
may come to a hospital emergency department. What constitutes an appropriate
medical screening examination will vary according to the condition and past
history of the individual and the capabilities of the hospital's emergency
department--both its facilities and available personnel. Within those
capabilities, the examination must be sufficient to permit the hospital to
decide whether or not the individual has an emergency medical condition.
Because the law does not require hospitals, among which there are variations in
staffing and procedures, to adopt standard procedures or use standard staffing
to meet these requirements, determinations about whether a hospital is in
compliance with these regulations must be based on the facts in each individual
case.
Comment: One commenter
stated that the regulations should permit other qualified medical personnel to
perform an initial medical screening examination if a physician is not
available in the emergency department. Another asked if hospitals could use
labor and delivery nurses, in consultation by phone with an obstetrician, to
examine emergency obstetric patients to determine whether they are in labor.
Response: The regulations
presently allow a hospital to delegate its responsibility to perform initial
medical screening examinations to qualified medical personnel if it does so in
its by-laws or in its rules and regulations. Such a delegation must also be
consistent with the provisions of Sec. 482.55 with respect to emergency
services personnel. Obviously, the Department cannot anticipate every situation
in which an individual with an emergency medical condition may come to an
emergency department. Hence, we cannot state unequivocally that an examination
by a nurse or other non-physician medical personnel will be appropriate under
all circumstances. Capability
Comment: One commenter
suggested that we revise the regulation to permit a hospital to transfer an
unstabilized patient when it does not have the personnel or equipment to
stabilize the patient's condition within the meaning of the statute.
Response: No revision is
necessary. A hospital is only required to treat individuals with the staff and
facilities available at the hospital. Under Sec. 482.55(b)(2), a hospital must
have available ``adequate medical and nursing personnel qualified in emergency
care to meet the written emergency procedures and needs anticipated by the
facility.'' Subject to the discussion below concerning on-call physicians, if
the hospital does not have at its disposal the personnel or equipment necessary
to stabilize a particular person's emergency medical condition, section
1867(c)(1) of the Act permits an unstabilized individual to be transferred if
(a) the individual or the individual's representative has been informed of the
risks and benefits of the transfer and requests the transfer in writing; or (b)
the individual has not refused an appropriate transfer and the physician signs
a written certification that the benefits of appropriate treatment at another
facility outweigh the risks associated with the transfer.
Comment: One commenter
recommended that the services of on-call physicians should be considered in
determining the capabilities of the staff and facilities ``available'' to
conduct a medical screening examination and further treatment that may be
necessary to stabilize the emergency medical condition or treat the labor.
Another asked that the regulations specify that a hospital is deemed to be
capable of providing emergency services in all fields in which the hospital is
normally engaged, regardless of the staff's reluctance to be available for
emergency services.
Response: We agree that
on-call physicians and ancillary services should be considered available to the
hospital. This was further clarified in section 6018(a)(1) of OBRA 89, which
amended section 1866(a)(1) of the Act to require hospitals to maintain a list
of physicians who are on call and available to provide treatment needed to
stabilize individuals with emergency medical conditions. Accordingly, we have
amended Sec. 489.20 to include a new paragraph (r)(2) requiring hospitals to
comply with this OBRA 89 provision.
The statute (as revised by COBRA, OBRA 89, and OBRA 90) and the current regulations state that the hospital must provide a medical screening examination, within the capability of the hospital's emergency department, including ancillary services routinely available to the emergency department, to determine if the patient has an emergency medical condition. If a hospital chooses to meet its responsibility under Sec. 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, then the capability of its emergency department includes the services of its on-call physicians. The statute (as revised by COBRA, OBRA 89, and OBRA 90) and current regulations also require the hospital to provide whatever further examination and treatment are necessary to stabilize the medical condition or to provide for treatment of the labor within the staff and facilities available at the hospital. If a staff physician is on call to provide emergency services or to consult with an emergency room physician in the areas of his or her expertise, that physician would be considered to be available at the hospital.
We also believe that when COBRA was
enacted, Congress intended that the resources of the hospital and the staff
generally available to patients at the hospital would be considered available
for the examination and treatment of individuals coming to the hospital's
emergency department, regardless of whether staff physicians had heretofore
been obligated by the hospital to provide services to those coming to the
hospital's emergency department. This was also clarified by section 6211(a) of
OBRA 89, which specifies that the capability of hospital emergency departments
must include ``ancillary services routinely available to the emergency
department.'' Therefore, if a hospital has a department of obstetrics and
gynecology, the hospital is responsible for adopting procedures under which the
staff and resources of that department are available to treat a woman in labor
who comes to its emergency department.
Comment: One commenter
expressed concern about the liability of small rural hospitals because many
times they are not equipped to treat certain emergencies, in which case the
patient must be transferred. Another commenter asked if each hospital's
emergency room is required to treat emergency psychiatric disorders regardless
of the hospital's capabilities.
Response: Neither the
statute nor the regulations mandate that hospitals expand their resources or
offer more services. Rather, they focus on a hospital's existing capabilities.
The thrust of the statute is that a hospital that offers emergency services to
some members of a community who need their emergency services (for example,
those that can pay) cannot deny such services to other members of the community
with a similar need.
As previously indicated,
the statute and the regulations specifically state that the hospital must
provide treatment that is within the capabilities of the staff and facilities
it has available. If a hospital does not have the capability to treat
psychiatric disorders or a small rural hospital lacks the staff or resources to
treat certain emergencies, it must determine whether the benefits to an
individual's medical condition outweigh the risks associated with transferring
the individual. If a physician certifies that the benefits of transfer to a
more suitable facility outweigh the risks, the hospital may transfer the
individual to a facility that has the capability to treat that individual and
agrees to accept transfer. The certification may be signed by a qualified
medical person if a physician is not physically present in the emergency
department and that qualified medical person first consults with a physician
who later countersigns the certification. Also, a person seeking medical
treatment may make an informed decision to request transfer to such a facility.
Comment: Several
commenters asked whether the determination of liability and penalties will be
the same for a hospital that has limited capabilities as that for a hospital
that has a trauma center.
Response: Any
participating hospital that offers emergency services is liable for violations
of the statute regardless of whether it is a small rural hospital or a major
metropolitan tertiary care facility with a trauma center. The statute requires
any subject hospital to provide for treatment within the capabilities of the
staff and facility it has available. However, hospitals with fewer than 100
State- licensed, Medicare-certified beds are subject to a maximum civil
monetary penalty of $25,000, as compared to a maximum civil monetary penalty of
$50,000 for hospitals with 100 or more State-licensed, Medicare-certified
beds.
Comment: One commenter
questioned the responsibility of a hospital that is a Medicare
certified hospital but does not have an emergency department. Another wanted to
exempt from the reach of the statute facilities, such as college infirmaries,
that provide emergency services exclusively to students.
Response: The statute and
these regulations apply only to hospitals that participate in the Medicare
program and that offer emergency services. HHS considers any participating
hospital that provides emergency services to have an emergency department and
thus to be subject to the provisions of the statute and these regulations.
However, even a Medicare participating hospital that does not provide
emergency services must continue to meet the standard of Sec. 482.12(f), which
requires hospitals to have written policies and procedures for appraisal of
emergencies, initial treatment, and referral where appropriate. Also, to our
knowledge, college infirmaries are not hospitals having Medicare
provider agreements and are thus not subject to section 1867 of the Act.
Hospital
Comment: One commenter
noted that in the proposed regulations and COBRA, the term ``hospital'' is
defined as ``a Medicare facility certified as a hospital with its own
provider number.'' The commenter recommended that the definition be expanded to
require that the transfer be made to the ``nearest appropriate facility'' that
happens to be a Medicare provider, so that Medicare
providers will be required to receive transfers from other hospitals.
Response: The intent of
the statute is to provide equal treatment for all individuals who come to a
hospital and request a medical screening examination or treatment for an
emergency medical condition, as well as to provide for protected transfers of
individuals who have unstabilized emergency medical conditions. Such
individuals are at the greatest risk of severe physical impairment,
dysfunction, or delivery of a baby in the absence of immediate medical
attention. We believe that after assessing an individual's medical condition
and weighing the risks versus benefits of effectuating an appropriate transfer
to another facility, the amount of travel time required to transport the
individual should be considered. Situations will occur where an individual's
condition requires a hospital to effectuate a transfer to the nearest
appropriate facility that has the capability and capacity to treat in order to
minimize the risks to the individual by reducing the transportation time as
much as possible. Transfer of an unstabilized patient to a hospital with which
there is a prior transfer agreement can be justified when the condition of the
unstabilized individual is such that the additional travel time would not
increase the danger to the patient. Emergency Department
Comment: Two commenters
believe that we should define emergency department to include the provision of
emergency services, as not all hospitals have a formal ``emergency
department.''
Response: We believe that
section 1867 of the Act applies to all Medicare participating facilities
that offer emergency services. It was not Congress' intent to limit the scope
of the provision to only those facilities that have organized areas
specifically labelled as emergency departments or emergency rooms. If so, a
facility could easily circumvent its responsibilities under the Act simply by
renaming the department to something other than ``emergency department'' or by
using an approach other than departmentalization in providing hospital
services. This would clearly contravene the underlying principle of the statute
that obligates hospitals to render emergency care within their capacity when
they normally undertake to render such care in individual cases.
For example, many psychiatric hospitals do not have
organized emergency departments. However, many of these facilities offer
24-hour psychiatric services on a walk-in basis for persons who are not
patients of the hospital. Although these hospitals do not have organized
emergency departments, they are presenting themselves to the public as
providing care for psychiatric emergencies. We believe this type of facility
must comply with the requirements of section 1867 of the Act and render
emergency care within their capability to do so (or provide for a transfer in
accordance with section 1867(c) of the Act).
In order to clarify this
issue, we believe it is helpful if the regulations define the term ``hospital
with an emergency department'' to clarify which hospitals are subject to the
requirements of section 1867. Therefore, as we previously indicated, we have
inserted in Sec. 489.24(b) the definition of a hospital with an emergency department.
Comment: One commenter
noted that the first sentence of proposed Sec. 489.24(a) contains a conflict in
language as it appears to refer to individuals coming in alone and then refers
to a request made on the individual's behalf.
Response: The statute and
the regulations focus on the individual coming to an emergency department who
may need treatment, whether or not that individual is alone or with his or her
entire family. However, we are clarifying the language to state that the
request for treatment may be made by the individual or on the individual's
behalf.
Comment: Eleven
commenters questioned the hospital's responsibility to a patient who refuses
treatment or refuses a medically appropriate transfer.
Response: The statute
deems a hospital as having met its statutory obligations under this provision
if an individual refuses treatment or a medically appropriate transfer. We are
adding requirements, discussed below, to ensure that the individual's refusal
is informed and not obtained under duress.
Comment: One commenter
stated that proposed Sec. 489.24(c) (2) and (3) are inconsistent in that an
individual's refusal to consent to treatment must be in writing, but a refusal
to consent to transfer does not. Other commenters urged HCFA to require that
refusals to consent to treatment be in writing and that they reflect that the
individual, or a legally responsible person acting on his or her behalf,
understands the hospital's obligations under the statute and is aware of the risks
of refusing treatment.
Response: We agree that
the decision to refuse or consent to treatment must be an informed one, and we
believe that the hospital is obliged to inform the individual (or the person
requesting examination or treatment on his or her behalf) of the reasonably
foreseeable risks and benefits of refusing or consenting to treatment. Sections
6211(b) (1) and (2) of OBRA 89 amended section 1867(b) of the Act to require
hospitals to inform 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,''
transfer, or both. We are therefore amending Sec. 489.24(c) (2) and (4) to
comply with these OBRA 89 requirements. Thus, the medical record should contain
a description of the examination and treatment offered to the individual. We
also believe that hospitals should not attempt to coerce individuals into
making judgments against their best interest by informing them that they will
have to pay for their care if they remain, but that their care will be free or
at low cost if they transfer to a charity hospital.
It should also be noted
that hospitals generally require an individual's consent to treatment to be in
writing. (See Sec. 482.24(c)(2)(v) requiring properly executed informed consent
forms for procedures and treatments specified by hospital medical staff or
Federal or State law requirements.)
Comment: One commenter
stated that HCFA should require a request for transfer to be in writing to
ensure that it is not coerced. It should acknowledge the individual's awareness
of his or her right to emergency treatment under the statute and outline the
benefits and risks of transfer.
Response: We agree and,
based upon this comment and section 6211(c)(1) of OBRA 89, are revising Sec.
489.24(d)(1)(ii)(A) to provide that requests for transfer must be in writing
and signed by the individual requesting the transfer or by a legally
responsible person acting on the individual's behalf. The requests should
contain a brief statement of the hospital's obligations under the statute and
the benefits and risks that were outlined to the person signing the request.
The request should be made a part of the patient's medical record, and a copy
of it should be sent to the receiving facility along with the individual
transferred. It is reasonable to conclude that, by permitting requests for
transfer to be made only by the individual or a legally responsible person
acting on the individual's behalf, Congress intended requests to be documented
in the manner suggested by the commenter. Moreover, this requirement will
reduce litigation about whether an individual requested the transfer.
Comment: Three commenters
recommended that a person acting on the patient's behalf does not have to be
``legally'' responsible for the patient.
Response: We agree and
are revising Secs. 489.24(c)(2) and (c)(4) to reflect this change because
section 9307 of OBRA 86 deleted the phrase ``legally responsible'' from
sections 1867(b)(2) and (b)(3) of the Act. However, as section 1867(c) of the
Act continues to contain the phrase ``legally responsible'', it is being
retained in Sec. 489.24(d).
Comment: Three commenters
suggested we specify in the regulations what constitutes a certification that a
transfer is in the patient's best interests. They asked if an entry in the
patient's medical record would be sufficient certification.
Response: Before an
unstabilized individual may be transferred in the absence of a request for
transfer, the statute requires a physician to sign a certification that based
upon the information available at the time, the medical benefits reasonably
expected from appropriate medical treatment at another medical facility
outweigh the increased risks to the individual and, in the case of labor, to
the unborn child, from effecting the transfer. If a physician is not physically
present in the emergency department at the time of transfer, a qualified
medical person may sign the certification after consulting with a physician who
later countersigns that certification. Section 1867(c)(1)(A)(ii) and (iii) of
the Act, both as added by COBRA (section 9121(b)) and revised by OBRA 89
(section 6211(c)(4)), requires an express written certification by a physician
or other qualified medical personnel attesting to the elements just delineated;
the certification, while it may be written explicitly into the medical record,
cannot simply be inferred from the findings in the medical record and the fact
that the individual was transferred.
We agree with the Fifth
Circuit, in Burditt v. U.S. Dept. of Health and Human Services, 934 F.2d 1362 (5th
Cir. 1991) wherein the court, in addressing whether there had been a knowing
violation of section 1867 of the Act, held that:
A hospital may violate [the certification]
provision in four ways. First, before transfer, the hospital might fail to
secure the required signature from the appropriate medical personnel on a
certification form. But the statute requires more than a signature; it requires
a signed certification. Thus, the hospital also violates the statute if the
signer has not actually deliberated and weighed the medical risks and the
medical benefits of transfer before executing the certification. Likewise, the
hospital fails to make the certification required by 42 U.S.C.
1395dd(c)(1)(A)(ii) if the signer makes an improper consideration a significant
factor in the certification decision. Finally a hospital violates the statute
if the signer actually concludes in the weighing process that the medical risks
outweigh the medical benefits of transfer, yet signs a certification that the
opposite is true.
Section 1867(d)(1)(B)(i)
of the Act, as amended by section 6211(e) of OBRA 89, now allows imposition of
civil monetary penalties if the physician ``knew or should have known that the
benefits did not outweigh the risks.'' We are therefore revising Sec.
489.24(d)(1)(ii)(B) to require that a certification state the reasons for the
transfer and include a summary of the risks and benefits upon which it is
based. As the statute requires that a physician or other qualified medical
personnel in consultation with a physician weigh the benefits and risks
associated with the transfer before an unstabilized individual may be
transferred, it should not be unduly burdensome for the physician or other
medical personnel to state the risks and benefits that have been weighed. It
should be noted, however, that, under the statute, the physician, not the
qualified medical personnel, makes the transfer determination in all cases. The
narrative rationale need not be a lengthy discussion of the individual's
medical condition reiterating facts already contained in the medical record,
but it should give a complete picture of the benefits to be expected from
appropriate care at the receiving facility and the risks associated with the
transfer, including the time away from an acute care setting necessary to
effect the transfer.
Revised Sec.
489.24(d)(2)(iii) (formerly a part of paragraph (d)(2)(ii)) requires that the
certification be included in the individual's medical record and that it be
sent to the receiving hospital along with the transferred individual. We
believe that this will assist the receiving hospitals in determining whether
the individual was transferred appropriately under the statute.
Comment: Three commenters
believe it is unreasonable and burdensome to require physicians to sign for
every patient transferred and that it is unduly harsh to assess a criminal
penalty for a decision that could be a mistake.
Response: Section
1867(c)(1)(A)(ii) of the Act requires a physician to certify patient transfers
because it was the intent of Congress to protect emergency patients and women
in labor against erroneous transfers. However, the statute and the regulations
do allow other qualified medical personnel, in consultation with a physician,
to certify patient transfers when a physician is not physically present in the
emergency department so long as the physician later countersigns. Penalties,
however, are civil in nature, not criminal.
Comment: One commenter
wants the regulations revised to require that medical records accompany not
only unstabilized but stabilized patients being transferred.
Response: We see no need
to revise these medical record requirements of the regulation. Records must
accompany an individual whether or not his or her condition is stabilized.
Under Sec. 489.24(d)(2)(iii) (formerly paragraph (d)(2)(ii)), hospitals
transferring unstabilized individuals must provide the receiving facility with
all medical records related to the emergency condition for which the individual
has presented in addition to other information required by the statute and
regulations. Under the current conditions of participation for hospitals (Sec.
482.21(b)(2)), all patients, including stabilized patients being discharged
from hospitals to other facilities and agencies, must be accompanied by
necessary medical information. This is a routine requirement that was in place
before the dumping statute was enacted.
Comment: One commenter
stated that in order for a receiving hospital to make an informed assessment
about whether a transferring hospital has inappropriately transferred an
individual, the transferring hospital should be required to send a memorandum
of transfer, any consent or refusal forms signed by the patient, and reports by
the doctors.
Response: We agree that
it would be helpful for many reasons for the receiving hospital to have the
individual's medical record at the time the individual is actually transferred.
The medical record usually includes doctors' reports, consent or refusal forms
and transfer certifications. We are therefore amending proposed Sec.
489.24(d)(2)(ii) (now paragraph (d)(2)(iii)) to require a transferring hospital
to send with the transferred individual whatever records are available at the
time and place of the transfer.
Comment: Four commenters
wanted the regulations to specify what information is to be in the
``appropriate medical records'' and listed what they thought should be in them,
including, in one case, records of previous admissions.
Response: We agree with
this comment, and section 6211(d)(2) of OBRA 89 amended section 1867(c)(2)(C)
of the Act to address this issue. The statute now directs transferring
hospitals to send receiving hospitals all medical records related to the
individual's emergency condition ``available at the time of transfer'' (note
next Comment and Response) and specifically lists some of the information that
should be included in these records. We have, therefore, amended proposed Sec.
489.24(d)(2)(ii) (now paragraph (d)(2)(iii)) to reflect the new legislative
requirements. The conditions of participation in Sec. 482.24(c) contain other
Federal requirements relating to medical records. To the extent that services
are performed before transfer we expect them to be reflected in the records
transferred, consistent with the conditions of participation. Although it may
be desirable, depending on the patient's condition, to send along records of
previous admissions, the patient's transfer should not be delayed.
Comment: Several
commenters recommended that ``timely'' medical records be defined as those
available at the time the patient is transferred. Those commenters also
recommended that records, such as test results, that were not available at the
time of transfer should be sent to the receiving hospital as soon as possible.
Response: We agree with
both points, and we have amended proposed Sec. 489.24(d)(2)(ii) (now paragraph
(d)(2)(iii)) accordingly to require that a transferring hospital send with the
transferred individual whatever records (including copies of results of
diagnostic studies or telephone reports of the studies) are available at the
time and place of the transfer. If a transfer is in an individual's best
interests, it should not be delayed until records are retrieved or test results
come back from the laboratory. Whatever documents are available at the time the
individual is transferred should be sent to the receiving hospital with the
individual. Test results that become available after the individual is
transferred should be telephoned to the receiving hospital. Records that become
available after the patient is transferred, such as hard copies of test results
or relevant records of earlier admissions, for example, should be sent to the
receiving hospital as expeditiously as possible.
Comment: Two commenters
wanted us to define what medical personnel may be qualified, in addition to the
physician, to certify that a transfer is appropriate.
Response: The regulations
require hospitals to determine which of their personnel are qualified to certify,
in consultation with a physician who later countersigns, that a transfer is
appropriate. This decision will vary among hospitals and States as
availability, qualifications, and practice limitations of a particular category
of staff differ. HCFA holds the governing body of a hospital responsible for
assuring that its staff functions within the bounds of State law and this and
other federal health and safety regulations. Based upon these comments and
section 6211(c)(2)(D) of OBRA 89, we are amending Sec. 489.24(d)(1)(ii)(C) to
specify that, if a physician is not physically present in the emergency
department at the time an individual is transferred, a qualified medical person
may sign a certification stating that the transfer is in the individual's best interest.
However, the qualified medical person may sign a transfer certification only
after a physician, in consultation with the qualified medical person, has made
the determination to transfer. The physician must subsequently countersign the
certification. The regulation also provides that the hospital must determine
who are ``other qualified medical personnel.''
Comment: One commenter
wanted us to recognize that requiring trained emergency medical technicians to
accompany a patient being transferred will meet the requirements that a
transfer be effected through ``qualified personnel'' as required under proposed
Sec. 489.24(d)(2)(iii) (now paragraph (d)(2)(iv)) because, in many communities,
transfers are made by volunteer rescue squads with trained emergency medical
technicians.
Response: We cannot state
unequivocally that emergency medical technicians are ``qualified personnel''
for purposes of transferring an individual under these regulations. Depending
on the individual's condition, there may be situations in which a physician's
presence, or some other specialist's presence, might be mandatory.
Comment: One commenter
proposed that we amend the regulations to clarify that the hospital is
responsible for providing transportation services, either directly or
indirectly, stating that the proposed regulations did not address the need for
the hospital to provide transportation services to carry out the physician's
orders.
Response: We disagree.
The statute (section 1867(c)(2)(C) of the Act) imposes a duty on the hospital
to ensure that the transfer is effected through qualified personnel and
transportation equipment. Frequently the determination of what equipment and
personnel will be required will be a medical decision. The hospital by-laws,
rules and regulations, or State law may dictate that the decision be made by
the transferring physician. If the hospital delegates its duty under the
statute to the transferring physician, both the hospital and physician would be
obligated to ensure that the transfer is effected through qualified personnel
and necessary equipment. To say that the hospital is ultimately responsible for
ensuring that the transfer is appropriately effected is not, however, to
dictate the means by which it meets that responsibility. Neither the statute
nor the regulations requires a hospital to operate an emergency medical
transport service. To this extent, the hospital may meet its obligations as it
sees fit; however, that does not mean HHS must accept the hospital's determination.
We also note that with
regard to the general area of transportation, although no specific comments
were received concerning ``transportation equipment'', the term has now been
interpreted to include all physical objects reasonably medically necessary for
safe patient transfer. Burditt v. U.S. Dept. of Health and Human Services, 934
F.2d 1362, 1373 (5th Cir. 1991). We agree with this interpretation. To limit
the appropriate transfer requirement to just that equipment that is necessary
and medically appropriate for life support measures is too narrow an
interpretation. Other Requirements
Comment: Five commenters
wrote in response to our request for comments concerning the ``other
requirements'' the Secretary may find necessary in the best interests of
transferred patients' health and safety. They recommended that we require the
use of a standardized memorandum of transfer to be sent with every transferred
patient to be signed by both transferring and receiving physicians and to
include information regarding the patient's medical condition, treatment
received and reasons for transfer. One of the commenters also recommended that
calls between hospitals requesting transfers be tape recorded.
Another commenter
suggested that the certification requirement in proposed Sec.
489.24(d)(1)(i)(B) (now Sec. 489.24(d)(1)(ii)(B)) be made a part of a standard
transfer form. The commenters believed these suggestions would educate hospital
personnel, provide a record for enforcement of the statute, help assure that
the receiving physicians receive appropriate medical information for each
patient, and deter patient dumping.
Response: We believe that
the requirements for requests for transfer, certification, and the sending of
medical records are sufficient to provide the information necessary for the
receiving hospital to treat the individual and to detect inappropriate
transfers in order to fulfill its reporting requirement. While a memorandum of
transfer might provide a useful summary, we do not believe it is necessary in
light of our other requirements. Also note the earlier Comment and Response
concerning another recommendation for the use of memoranda of transfer.
Hospitals that frequently receive inappropriate transfers may choose to
document their transfers by tape recording telephone requests in accordance
with applicable State laws; however, we believe it both costly and impractical
to require all hospitals to invest in technology to document transfer
circumstances verbatim in this way. In addition, since these additional
requirements would need to be adopted through the rulemaking process and the
Secretary has not elected to establish further requirements in this regulation,
we are not including in this final rule the language in proposed Sec.
489.24(d)(2)(iv) concerning other requirements to avoid the implication that
there may be additional requirements not included in this regulation.
``Appropriate'' Transfer
Comment: One commenter
raised the issue of whether all transfers must be appropriately made (that is,
effectuated) or whether the rules governing appropriateness applied only to a
physician-directed transfer.
Response: All transfers
must be effectuated appropriately and the statute and regulations already make
this point. It is true that an individual may demand a transfer that the
physician does not believe is appropriate, but once the decision to transfer
has been made--by the physician or the individual--the regulations and the law
require that it be done appropriately.
Also with regard to appropriate
transfers, we note that the Secretary has taken the position that in proving
that a hospital or physician violated section 1867 of the Act, there is no
requirement to prove that the transfer was effected due to some ``impermissible
motive.'' This position has been upheld in Burditt v. U.S. Dept. of Health and
Human Services, 934 F.2d 1362, 1373 (5th Cir. 1991), wherein the court rejected
Dr. Burditt's argument that the statute requires proof that the transfer was
motivated by an improper or nonmedical reason.
Comment: One commenter
thought that the phrase ``without prior arrangement'' in Sec. 489.20(g) may
imply that a hospital may transfer a patient in violation of Sec. 489.24 if it
is done with prior arrangement.
Response: We agree and
are removing the phrase ``without prior arrangement.''
Comment: Two commenters
believed that we should make the requirements for
appropriate transfer more specific. Another raised
a series of hypothetical questions and asked how the regulations would apply.
Response: We decline the
invitation to attempt to define in advance all circumstances making the
transfer of an unstabilized individual ``appropriate.'' There will be many
medical emergencies arising in a variety of settings. The proper handling of
those emergencies will depend upon the resources available and the exercise of
medical judgment focused on the best interest of the individual's health and
safety. We find the broad guidelines offered by Congress in section
1867(c)(2)(C) of the Act sufficiently specific to guide the exercise of that
discretion and our evaluation of cases in which dumping is alleged. For the
present we do not believe that any additional elaboration is required or
desirable.
Comment: One commenter
suggested that the regulations prevent any transfers, including those of stable
patients, unless that patient requires services or facilities not available at
the hospital when the patient first arrived. Another commenter wanted
``stable'' patients to be subject to the same ``appropriate transfer'' criteria
as patients in unstable condition because the regulatory definition of
``stabilized'' does not require the emergency medical condition to be
alleviated; it only requires that no material deterioration be likely.
Response: To accept these
comments would go beyond the scope of the statute, which does not regulate the
transfer of stabilized individuals. The statute allows hospitals to transfer an
individual, without meeting the requirements of an appropriate transfer, after
his or her emergency medical condition is stabilized. The statute does require,
however, that the transferring hospital provide whatever medical treatment it
can, within its capacity, to minimize the risks to the individual with an
unstabilized medical condition, and, in the case of a woman in labor, to the
unborn child.
Comment: One commenter
wanted the regulations to define the situations in which obstetrical transfers
are appropriate because in the commenter's State, hospitals that do not offer
obstetrical services must always transfer pregnant patients in active labor,
especially high risk patients.
Response: It is not
necessary to revise the regulations to be this specific. Regardless of
practices within the State, COBRA and OBRA 89 permit a woman in labor or with
an unstabilized emergency medical condition to be transferred only if she (or
someone acting on her behalf) requests the transfer or if a physician signs a
certification that the benefits outweigh the risks. If the hospital does not
provide obstetrical services, the benefits may outweigh the risks of transfer
or the woman or her representative may request a transfer. However, we cannot
say categorically and in all cases that this will be true. (Note also Response
to next Comment.) Regardless of State law or practice, a hospital must fulfill
the requirements of the statute and cannot simply cite State law or practice as
the basis for a transfer under the statute. We note that OBRA 89 removed the
term ``active labor'' from section 1867 of the Act and included the full range
of symptoms that term was intended to include within the scope of the term
``emergency medical condition,'' which it redefined.
Comment: A number of
commenters suggested that we require a hospital to accept a transfer when it
has the capacity to treat the patient and the requesting hospital does not. One
suggested that we require, as JCAHO does, that hospitals help to develop and
promote community-based plans for providing emergency services.
Response: If an
individual is to be transferred, section 1867(c)(2)(B)(ii) of the Act requires
that the hospital obtain agreement from the receiving hospital before a
transfer is made. The changes made to title XVIII of the Act by COBRA did not
require hospitals to accept all transfers, even when the transfer would be in
the individual's best interest. However, under the nondiscrimination provision
of section 1867(g) of the Act, as added by section 6211(f) of OBRA 89,
hospitals with specialized capabilities or facilities (including, but not
limited to, facilities such as burn units, shock- trauma units, neonatal
intensive care units, or (with respect to rural areas) regional referral
centers as defined in Sec. 412.96), cannot refuse to accept an appropriate
transfer of an individual who requires such specialized capabilities or
facilities if the hospital has the capacity to treat the individual.
Accordingly, we have added the nondiscrimination provision to Sec. 489.24 as
new paragraph (e).
In determining whether
new Sec. 489.24(e) applies, we will assess whether the individual required the
recipient hospital's specialized capabilities or facilities and if the hospital
had the capacity to treat the individual. The recipient hospital with
specialized capabilities or facilities has an obligation under section 1867(g)
of the Act to accept a transfer if the individual has an unstabilized emergency
medical condition and if the hospital has the capacity to treat the individual.
If a hospital desires to transfer an individual to another hospital and the
individual does not require any treatment beyond the capabilities or facilities
available at the transferring hospital, the intended receiving hospital may
refuse to accept the transfer of the individual in accordance with section
1867(c)(2)(B)(ii) of the Act.
The purpose of this
requirement is to prevent hospitals with emergency departments from
automatically transferring patients before screening simply because the
hospital does not offer a particular service. For example, a hospital with an
obstetrical department is not required to accept a transfer of a woman in labor
just because the transferring hospital does not have an obstetrical department.
If the woman in labor is having a normal, uncomplicated delivery, and the first
hospital has the capacity to handle a normal, uncomplicated delivery, despite
the fact that it does not have an obstetrical department, the first hospital is
required under section 1867(b) of the Act to provide the necessary stabilizing
treatment, that is to deliver the baby and the placenta, or to effect an
appropriate transfer to another hospital willing to accept the patient.
Similarly, for an individual with a simple, closed fractured arm, a hospital
with an orthopedic department and orthopedic physicians on call would not be
required to accept a transfer of the individual just because the transferring
hospital does not have an orthopedic service. The first hospital is required
under section 1867(b) of the Act to provide the necessary stabilizing treatment
or to effect an appropriate transfer to another hospital willing to accept the
patient.
If a transferring
hospital does not have the specialized capabilities necessary to stabilize the
patient's condition, the intended receiving hospital with the specialized
capabilities and facilities must accept the patient under 1867(g) of the Act if
it has the capacity to treat the individual. The number of patients that may be
occupying a specialized unit, the number of staff on duty, or the amount of
equipment on the hospital's premises do not in and of themselves reflect the
capacity of the hospital to care for additional patients. If a hospital
generally has accommodated additional patients by whatever means (for example,
moving patients to other units, calling in additional staff, borrowing equipment
from other facilities) it has demonstrated the ability to provide services to
patients in excess of its occupancy limit. For example, a hospital may be able
to care for one or more severe burn patients (a common example of specialized
service) without opening up a ``burn unit.'' In this example, if the hospital
has the capacity, the hospital would have a duty to accept an appropriate
transfer of an individual requiring the hospital's capabilities, provided the
transferring hospital lacked the specialized services required to stabilize the
individual.
Situations may arise
where a hospital in another country desires to transfer an individual to a
United States hospital because of the United States hospital's specialized
capabilities or facilities. However, we note that the provisions of section
1867 of the Act are applicable only when the transferring hospital is located
within the boundaries of the United States. Accordingly, Medicare
participating hospitals are not obligated to accept transfers from hospitals
located outside of the boundaries of the United States. This does not change
the requirement that a Medicare participating hospital that offers emergency
services, must provide, upon request and within its capabilities, an
appropriate medical screening examination, stabilizing treatment, and/or an
appropriate transfer to another medical facility to any individual with an
emergency medical condition, even if the individual is not a United States
citizen.
Concerning community
plans, the use of cooperative agreements to facilitate appropriate transfers
would be a positive step, and we recognize that a suggestion for using the
JCAHO approach is constructive; however, we do not believe that this regulation
is an appropriate vehicle to mandate community-based plans for the delivery of
emergency services.
Comment: One commenter
suggested that after a patient is stabilized we require hospitals to undertake
either medically indicated treatment or transfer the patient, rather than
discharge him or her. The commenter stated that a person in stable condition
could be seriously ill and, if discharged, the condition could worsen.
Response: Section 1867 of
the Act does not impose any requirements on hospitals with respect to the
treatment or transfer of individuals whose emergency condition has been
stabilized.
Comment: One commenter
suggested that we revise the definition of ``appropriate transfer'' to state
that the receiving hospital ``has indicated that it has available space and
qualified personnel for the treatment of the patient.'' This would clarify the
responsibility for determining the capability of the receiving hospital.
Response: We do not
believe it is necessary to add any further specificity to this requirement
because, as indicated above, it is understood that the records will have to
verify that the receiving hospital has indicated to the transferring hospital
that it has agreed to treat the individual, which implies that it had the
available space and qualified personnel to treat that individual.
Comment: Two commenters
recommended that the regulations specify which person(s) at the receiving
hospital may consent to receive the patient.
Response: We believe it
is properly the receiving hospital's decision as to who may consent to receive
patients and how to implement this policy among its staff.
Comment: One commenter
suggested that the regulations specifically state that the transferring
physician is legally responsible for the patient's care until the patient is
admitted to the receiving hospital.
Response: We do not
believe it is appropriate to make this an explicit requirement of the
regulations. The statute makes clear that the transferring hospital is
responsible for ensuring that when the individual is transferred, the transfer
is ``appropriate.'' The hospital, in ensuring that the individual is
appropriately transferred, may, for example, delegate to the transferring
physician the duty to ensure that the transfer is made through the use of
appropriate personnel or equipment. Further, section 1867 of the Act and the
regulations require that the hospital must provide medical care within its
capabilities to minimize the risks associated with transfer; this too may be
delegated to a physician. In this way, the physician may be responsible for the
patient's care during the transfer.
Comment: One commenter suggested that we
allow transferring and receiving hospitals an opportunity to work out an
agreement for handling transfers before we mandate formal reporting procedures,
which might have the unintended result of pitting one hospital against another.
Response: We encourage
local hospitals, municipalities, and States to develop cooperative transfer
agreements; however, the formal reporting procedures are an integral part of
the Department's enforcement scheme to ensure that hospitals are complying with
the statute. To the extent that hospitals do have agreements for handling
transfers in accordance with the statute, and act in accordance with that
agreement, then the statute will not be violated and the necessity for
reporting violations will be diminished.
Comment: Four commenters
believe that the requirement that hospitals report suspected violations of
section 1867 of the Act within 72 hours of their occurrence is too rigid and
should be changed to ``with reasonable promptness'' to deter excessive
reporting and to allow for investigation by the hospital to assure that
reporting is warranted.
Response: If transfers
occur that needlessly jeopardize people's lives, HCFA must have that
information immediately to meet its responsibility to assure that these
inappropriate transfers cease quickly. Therefore, we have made no changes.
Comment: One commenter
recommended that the 72-hour reporting requirement for receiving hospitals
suspecting improper transfers should begin from the time a problem is first
identified rather than from the date of the transfer.
Response: The time of the
receipt of an improperly transferred patient is the time of the occurrence. We do
not see any substantive time difference between the time of receipt and the
time of identification that a patient had been improperly transferred. However,
to make reporting less onerous, we are revising Sec. 489.20(m) and Sec.
489.53(a)(10) to require a hospital to report to either HCFA or the State
agency, rather than both as proposed.
Comment: One commenter
suggested that the regulation be amended to permit HCFA to terminate a
receiving hospital only for a ``knowing'' failure to report suspected violations.
Response: We see no
reason to require that HCFA prove that a hospital ``knowingly'' violated its
obligation to report instances of suspected dumping before it may take action
against a non-complying hospital. As with other conditions of participation
imposed on providers for the protection of the health and safety of those
benefitted by title XVIII, including those protected by section 1867 of the
Act, whether a hospital fails to meet its obligations knowingly is of little
concern to those the requirement is designed to benefit. We believe this is
especially true since section 4008(b)(3) of OBRA 90 deleted the provision under
which HCFA had to show first that the hospital's actions were either knowing
and willful or negligent before terminating the hospital's provider agreement.
We do not believe the enhanced enforcement and, hence, deterrence, behind
requiring receiving hospitals to report instances of suspected dumping, would
be advanced by adding any requirement that the violation be knowing before a
hospital's failure to report could result in its termination. We expect
hospitals to have and enforce policies and procedures to require its employees
and staff physicians to report to the administration instances where an
individual has been inappropriately transferred under this statute.
Comment: Two commenters
believe that HCFA and State survey agencies should protect the receiving
hospitals and their personnel from legal actions for reporting alleged cases of
improper transfer.
Response: We do not have
the authority to confer immunity on a provider that identifies an alleged
improper transfer under these regulations. However, HCFA has a history of
protecting the identity and confidentiality of entities who report program
violations and this protection will be extended to hospitals and individuals
reporting improper transfers. Additionally, we also note that section
4027(k)(3) of OBRA 90 amended section 1867(i) of the Act (Whistleblower
Protections), which was enacted under OBRA 89, to prevent a hospital from
penalizing or taking adverse action against any hospital employee because the
employee reported a violation of this requirement. We have revised Sec.
489.24(d)(3) of the regulations to reflect this statutory amendment.
Comment: Eight commenters
claimed that the statute does not support the obligation to report suspected
dumping or provide for the termination of a provider that does not report
suspected violations. Five commenters suggested that we extend the
responsibility to report suspected dumping violations to all Medicare
providers and suppliers; ambulance service suppliers, in particular, are in a
position to suspect violations if the hospital to which the ambulance is
transporting the patient refuses to accept that patient. Several commenters
recommended that the reporting requirements be extended to physicians and that
a failure to comply with these requirements would subject the physician to a
civil monetary penalty.
Response: We believe our
requirements relating to reporting instances of dumping are supported by
current law. Section 1861(e)(9) of the Act permits the Secretary to impose on
hospitals such other requirements as he finds necessary in the interest 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 section 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. Application of the anti-dumping provisions to all Medicare
providers and suppliers should occur through a statutory amendment. Section
1867 of the Act imposes duties directly only on hospitals that provide
emergency services to which individuals come for screening or treatment. No
similar statutory authority generally exists to regulate the conduct of
non-providers, suppliers and practitioners.
Comment: Many commenters
believe that we should not require receiving hospitals to report suspected
cases of dumping, since it may lead to overreporting or malicious reporting in
addition to unnecessary work and extra costs for HCFA and hospitals.
Response: We disagree. We
are looking to those institutions in the best position to discern when an
inappropriate transfer has taken place in violation of the statute, because
Congress regards them also as victims of ``dumping''. (See section
1867(d)(2)(B) of the Act.) This reporting requirement is not, however, an
impediment to negotiation among hospitals for the care of emergency patients.
Indeed, it should encourage hospitals to cooperate in planning for appropriate
emergency care by eliminating inappropriate transfers.
Comment: Several
commenters wanted us to define ``suspected,'' so hospitals will have further
guidance concerning when they must report violations. These commenters also
recommended that we define which individuals in the hospital must hold the
suspicion.
Response: We agree that
``suspected'' is a vague term. As a result we are revising proposed Sec.
489.53(a)(10) to require a hospital to report violations when a hospital has
reason to believe that a violation has occurred. However, we see no need to
define which individuals in a hospital must hold the suspicion since we do not
want to narrow the source of reports. Definitions Active Labor Comment: Several
commenters recommended that we adopt the definition of active labor used by the
Office for Civil Rights (OCR) in enforcing a hospital's Hill-Burton obligations
contained in 42 CFR 124.603(b). One commenter stated that there are also written
decisions and directives interpreting this issue and that using the OCR
definition would relieve Hill-Burton facilities of the risk of being required
to comply with inconsistent treatment standards for women in active labor.
Response: We have not adopted
the commenters' suggestion, because section 6211(h)(1)(B) of OBRA 89 deletes
the definition of ``active labor'' in section 1867(e)(2) of the Act. However,
the concepts contained in that definition have now been clarified and included
in the definition of ``emergency medical condition'' defined in section
1867(e)(1) of the Act.
Comment: One commenter
asked us to make it clear that even though it may be difficult to state whether
delivery is imminent, a woman would be in ``active labor'' as that term is
defined in section 1867(e)(2) of the Act (as added by COBRA), if there was
either inadequate time to effect safe transfer to another hospital before
delivery or if a transfer might pose a threat to the health and safety of the
woman or the unborn child.
Response: We agree. The
proposed regulation restated the statutory definition, and, hence, reiterated
that the transfer of a woman in labor is subject to the provisions of section
1867 of the Act if any of the following three conditions pertain: (a) delivery
is imminent; (b) there is inadequate time to effect safe transfer to another
hospital prior to delivery; or (c) a transfer may pose a threat to the health
and safety of the woman or the unborn child. Section 6211(h)(2) of OBRA 89
amended section 1867(e) of the Act by deleting both the term ``active labor''
and the part of the definition that covers women in labor where delivery is
imminent. The definition of ``emergency medical condition'', however, was
expanded to include a woman who is having contractions when there is inadequate
time to effect safe transfer to another hospital before delivery or a woman who
is having contractions where the transfer may impose a threat to the health or
safety of the woman or the unborn child. The OBRA 89 amendments clarified the
scope of the statutory protections. We have amended Sec. 489.24(b) accordingly.
In addition, the statute also refers to women in labor. We have defined the
term ``labor'' in Sec. 489.24(b).
Comment: Two commenters
wanted the regulations to emphasize that the ``active labor'' definition
applies only in prenatal situations in which no other prenatal emergency is
present and that a pregnant woman with an emergency medical condition should be
admitted even if not yet in active labor.
Response: The regulations
that apply to emergency medical conditions apply equally to a pregnant woman
whose emergency condition does not involve active labor. As noted above, OBRA
89 changes eliminated the term ``active labor'' and included pregnant women
within the meaning of the term ``emergency medical condition.''
Comment: Many commenters recommended that we adopt
the definition of ``emergency'' used by the American College of Emergency
Physicians (ACEP), standards that are already widely applied in the profession.
Response: We believe that
the ACEP definition is not suitable for purposes of requirements under section
1867 of the Act because it is designed to assure that cases in which the
patient believes that an emergency medical condition exists are, in fact,
emergencies. We believe that section 1867 of the Act only applies to actual
emergencies as determined by appropriate medical screening. Therefore, we have
not adopted this recommendation.
Comment: One commenter
asked us to cite the court cases from which the phrases ``serious impairment to
bodily function'' and ``serious dysfunction of any bodily organ or part''
emanated.
Response: These phrases
are taken directly from the definitions in section 1867(e)(1) of the statute.
There is no legislative history that indicates that Congress took them from
reported court decisions.
Comment: One commenter
wanted the phrase ``placing the patient's health in serious jeopardy'' removed
from the definition of emergency medical condition because it is not a result
or an outcome from not providing emergency medical treatment but rather is only
speculation.
Response: We do not agree
to delete the phrase ``placing the patient's health in serious jeopardy.'' The
definition parallels the statute and as such reflects Congressional intent. All
of the phrases contained in the definition of emergency medical condition
describe outcomes that are likely to result from the denial of immediate
attention upon the exercise of medical judgment to predict what would happen to
the individual if appropriate medical attention was not provided immediately.
Comment: Nine commenters
wanted the definition to include psychiatric emergency; one commenter wanted
the definition to include acute alcohol or drug intoxication.
Response: We believe that
the statutory definition already encompasses these types of cases. However, for
clarification purposes, we have revised Sec. 489.24(b) to add acute alcohol or
drug intoxication (substance abuse) and psychiatric manifestations as
sufficiently severe medical symptoms to warrant the label ``emergency medical
condition.''
Comment: Nine commenters
stated that the definitions of ``stabilized'' or ``stabilization'' are too
vague or ambiguous to be useful in determining whether a patient was
appropriately transferred. Some commenters suggested alternative definitions
while others suggested we prohibit transfers not based solely on explicit
medical reasons.
Response: The statutory
and regulatory definitions of ``to stabilize'' and ``stabilized'' are
necessarily broad to apply to all types of emergency medical conditions. The
basic precept of these definitions is to ensure that no material deterioration
occurs to a patient's condition either as a result of the transfer or because
the patient is outside a hospital, and thus without the facilities and services
available in a hospital. We do believe, however, that at least one clarifying
revision should be incorporated into the regulations to ensure that a patient with
an emergency medical condition will not be transferred unless, within
reasonable medical probability, no material deterioration of the condition is
likely to result from, or occur during, the transfer. This revision is also
consistent with section 6211(h)(1)(C)(ii) of OBRA 89. The regulations are being
revised accordingly. The regulations do prohibit hospital-initiated transfers
that are not based solely on explicit medical reasons. This does not imply,
however, in proving that a hospital or physician violated section 1867 of the
Act, that the Secretary must prove the transfer was effected due to an
impermissible or nonmedical motive. (See Burditt v. U.S. Department of Health
and Human Services, 934 F.2d 1362, 1373 (5th Cir. 1991).) It should be noted that
the regulations also allow an individual to request and receive a transfer for
any reason as long as the individual is aware of the risks and benefits of the
transfer.
Comment: One commenter
stated that a woman in active labor should never be considered stabilized until
after the baby is born.
Response: COBRA and the
proposed regulations require emergency medical conditions to be stabilized. We
agree with the commenter and pursuant to sections 6211(c)(3)(A), 6211(c)(5)(B)
and 6211(h)(1) of OBRA 89 we are revising Sec. 489.24(b), (d)(1)(ii)(B) and
(d)(2)(i) to indicate that a woman falling within the scope of section
1867(e)(1)(B) of the Act is not stabilized at least until the child and the
woman's placenta are delivered.
Comment: One commenter
suggested that the regulations mandate that if an individual is going through
alcohol detoxification, 5 to 7 days is necessary to stabilize the condition.
Response: We cannot
specify the length of time that it will take to stabilize a specific condition,
as a specific time period would rarely be applicable in all cases. The
statutory definition, as applied, prevents a hospital from transferring an
individual who is going through alcohol detoxification if that condition
constitutes an emergency medical condition, until that individual can make the
transfer without a material deterioration of the condition occurring during, or
resulting from, the transfer. Therefore, we are not adopting this suggestion.
Comment: Several
commenters asked us to define the term ``appropriate medical screening
examination'' so that hospitals and physicians are not subject to ambiguous
requirements.
Response: It is
impossible to define in advance all of the circumstances in which an individual
may come to a hospital emergency department. What will constitute an
appropriate medical screening examination will vary according to the condition
of the individual and the capabilities of the hospital's emergency
department--both its facilities and available personnel, including on-call
physicians. Within those capabilities, the examination must be sufficient to
detect whether or not the individual has an emergency medical condition or is
in labor because the law only requires hospitals to provide screening and stabilizing
treatment within their existing capabilities. Our current condition of
participation for emergency departments contains basic requirements, the
specificity of which were subject to public comment in connection with the
revision of the hospital conditions of participation.
Comment: Six commenters
recommended that HCFA should notify the involved hospital or physician of a
decision to investigate.
Response: HCFA ordinarily
conducts only unannounced surveys in response to complaints, as to do otherwise
could compromise the investigation.
Comment: One commenter
stated that we have not been informing complainants of the outcome of
investigations; another recommended that we consult with complainants during
the course of investigations, especially when there is conflicting evidence or
the hospital raises mitigating circumstances.
Response: On June 4,
1987, HCFA issued interim implementing procedures requiring HCFA regional
offices to notify complainants of the outcome of investigations. This is HCFA
practice; complainants may address their specific inquiries to their respective
HCFA regional offices. Complainants are consulted when there are conflicts.
Comment: Two commenters
recommended that the OIG seek the maximum civil monetary penalty for every
violation of the statute. One commenter believes that there should be a
presumption in favor of imposing the statutory maximum and that a lack of prior
offenses should not be considered a mitigating circumstance unless the hospital
can produce a log of prior transfers showing its history of compliance.
Response: Congress did
not specify a fixed monetary penalty for every violation. Instead, it provided
for hospitals and responsible physicians to be subject to a civil monetary
penalty ``of not more than'' $25,000 for violations occurring before December
22, 1987 and ``of not more than'' $50,000 for violations occurring on or after
that date. The civil monetary penalty section was amended in OBRA 90 to provide
a maximum penalty of $25,000 for hospitals with fewer than 100 state-licensed, Medicare-certified
beds. By setting a maximum amount, Congress implied that the Secretary was to
exercise her discretion in selecting an appropriate amount up to that maximum.
The OIG will not consider
the lack of a prior history of offenses to be a mitigating circumstance, but it
may consider a history of inappropriate transfers to be a factor that would
warrant imposition of a penalty at or near the statutory maximum. Only if a
hospital or physician could offer positive evidence of a history of statutory
compliance (for example, by producing logs of its disposition of individuals
who had come to the emergency department) would the OIG be inclined to regard
the violation as an isolated aberration.
Comment: One commenter
suggested that if the hospital has identified, evaluated, and taken action or
determined that action need not be taken to correct a transfer or emergency
care problem, a penalty should not be imposed against the hospital or
responsible physician.
Response: We disagree. To
deter future violations of the statute, Congress intended that violations be
sanctioned regardless of whether a violating hospital took remedial action.
Such remedial action may prevent the hospital from suffering the consequences
of a termination of its provider agreement and the resulting loss of Medicare
payment, but it does not shield it from liability for civil monetary penalties
if the violations were negligent. Congress enacted section 1867 of the Act
because it perceived that hospitals were not policing themselves sufficiently
to prevent inappropriate transfers.
Comment: One commenter
questioned how the regulations can impose a civil monetary penalty of up to
$50,000 when the statute only allows a penalty of up to $25,000.
Response: Section
4009(a)(1) of OBRA 87 amended section 1867(d) of the Act to increase the
maximum civil monetary penalty from $25,000 to $50,000, effective December 22,
1987. Any violation occurring after December 22, 1987 is therefore subject to a
maximum fine of up to $50,000 while violations occurring prior to December 22,
1987 are only subject to a maximum fine of up to $25,000. We are amending 42
CFR 1003.103 accordingly. However, section 4008(b)(2) of OBRA 90 again amended
the statute by reducing the maximum penalty against hospitals with fewer than
100 state-licensed, Medicare-certified beds of $25,000.
Comment: One commenter
stated that civil monetary penalties of up to $50,000 constituted a criminal
sanction that will place physicians in the position of balancing responsible
medical judgment against the fear of fines for an unanticipated event that may
occur during transfer; this will have negative effect on emergency care.
Response: The maximum
amount of the penalty is determined by the statute and cannot be changed in
these regulations. The statute expressly provides for a civil monetary penalty
of not more than $50,000 if a hospital or physician who is responsible for the
examination, treatment or transfer of an individual in a participating hospital
violates a provision of section 1867 of the Act. This penalty is civil in
nature and does not constitute a criminal sanction.
Comment: One commenter
stated that there is no statutory authority or Congressional intent allowing
citizens to bring suit in the Federal courts for personal harm.
Response: Section
1867(d)(2)(A) of the Act specifies that an individual who suffers personal harm
as a direct result of a hospital's violation may bring a civil action against
the participating hospital, thus creating a Federal private right of action by
such an individual. See Bryant v. Riddle Memorial Hospital, 689 F. Supp. 490
(E.D. Pa. 1988).
Comment: Three commenters
expressed concerns about the statutory provision that states that section 1867
of the Act does not preempt State or local law except where they conflict. One
of these commenters thought that Federal law should not supersede State and
local law except where the State is not fulfilling its obligation under the
law; another commenter believed we should grant immunity to hospitals following
Federal statute in conflict with State law. The third commenter said this
provision would result in more State regulation where States have similar laws.
Response: Section 1867(f)
of the Act explicitly states that the provisions of section 1867 do not preempt
any State or local law requirement except in cases of a direct conflict. This
statutory statement cannot be removed based on negative public comment. We
believe, however, that the second commenter misunderstood the provision: when
Federal law conflicts with State law, Federal law prevails.
Comment: One commenter
believes that the investigative file on an alleged violation should not be
subject to public disclosure.
Response: The Freedom of
Information Act (5 U.S.C. 552) permits public access to agency records except
to the extent that such records or parts thereof fall within specified
exemptions under 5 U.S.C. 552(b). A statutory amendment would be required to
adopt the commenter's suggestion, since there is no blanket exemption under the
Freedom of Information Act for documents compiled in investigating complaints
of violations of section 1867 of the Act.
Comment: Twelve commenters
believe that it is not appropriate for HCFA to notify other components of the
Department about alleged violations as each will then conduct its own
investigations. The commenters recommended that HCFA notify the OIG and the
Office for Civil Rights only when it determines that there was a violation.
Response: The authority
for enforcing the requirements of this provision was delegated by law to the
Secretary of Health and Human Services. All of the components of the Department
mentioned by the commenters have responsibilities in connection with the
enforcement of this provision and/or other provisions, such as the civil rights
and rehabilitation acts. We believe it is entirely appropriate that these
components be notified early in the process and begin to carry out their
functions.
Comment: One commenter
expressed concern that a provider may be subject to double jeopardy if HCFA is
allowed to terminate the provider agreement for violating section 1867 of the
Act and then, for the same violation, the OIG is authorized to suspend the
provider. Several commenters expressed concern that a provider is subject to
double jeopardy since, for an alleged single inappropriate transfer, OIG may
suspend a provider and subject the provider to civil monetary penalties even if
HCFA determines there is no violation.
Response: A provider
agreement can no longer be suspended for a violation of section 1867 of the Act
since, as we previously indicated, section 4008(b)(3) of OBRA 90 deleted the
suspension provisions contained in the original legislation. If, however, HCFA
begins a termination action based on a violation of the statute, but the
hospital avoids termination by demonstrating to HCFA's satisfaction that it has
in place effective policies and procedures to prevent a recurrence, the OIG
remains free to seek civil monetary penalties against the hospital and
physician for the violation of the statute on which the termination action was
originally based.
Comment: Seven commenters
believe that when HCFA notifies a complainant and other entities about the
receipt of alleged violations, this implies guilt and may result in frivolous
lawsuits.
Response: HCFA notifies
organizations of complaints before investigating expressly to make the point
that no decision has been made about the complaint but that an investigation is
being conducted. We do not believe that the subject of a complaint should be
unaware of the complaint, and we certainly do not believe that receipt of a
complaint establishes or even implies that there is a violation.
Comment: One commenter
stated that, in order to avoid duplication of effort, the regulations should
limit OIG investigation to those cases where it finds a pattern of
noncompliance, with willful violation of the provisions, or where there is some
indication of fraud or abuse against the Medicare program.
Response: The law does
not require a pattern of violations or willful noncompliance for the Department
to invoke sanctions. The OIG may impose a civil monetary penalty for a single
violation of the statute. The statute was amended in OBRA 90, however, to allow
the OIG to exclude physicians from participation in the Medicare
and State health care programs only if the violation is ``gross and flagrant or
repeated.''
The term ``gross and
flagrant'' is also used in section 1156 of the Act, 42 U.S.C. 1320c-5, and has
been defined in regulations at 42 CFR 1004.1(b). This definition has been
challenged for being unconstitutionally vague and the courts have disagreed,
upholding the Department's interpretation of the term. See, for example,
Lavapies v. Bowen, 883 F.2d 465 (6th Cir. 1989); Doyle v. Secretary of Health
and Human Services, 848 F.2d 296 (1st Cir. 1988); Varandani v. Bowen, 824 F.2d
307 (4th Cir. 1987). It is against this background that Congress amended
section 1867 of the Act to allow a physician to be excluded only if the
violation is ``gross and flagrant or repeated.'' (``The legislature is presumed
to know the prior construction of the original act or code and if previously construed
terms in the unamended sections are used in the amendment, it is indicated that
the legislature intended to adopt the prior construction of those terms.''
Sutherland Stat. Const. Sec. 22.35 (4th Ed.).) As a result, we have defined
this term in Sec. 1003.105 to be consistent with the definition contained in
Sec. 1004.1(b). The regulation now states:
For purposes of this
section, a gross and flagrant violation is one that presents an imminent danger
to the health, safety, or well- being of the individual who seeks emergency
examination and treatment or places that individual unnecessarily in a
high-risk situation.
Comment: One commenter
believes that HCFA and the OIG should coordinate enforcement activities to
avoid duplication of effort and unnecessary administrative costs. In addition,
the commenter suggested there be a central review to prevent components from
taking multiple enforcement measures against a hospital or physician for the
same violation.
Response: We agree that
every effort should be made to coordinate enforcement actions. However, some of
the issues relating to multiple enforcement measures have been mitigated by the
amendments in OBRA 90 that deleted the suspension authority. HCFA's authority
is to determine compliance with the requirements of section 1867 of the Act.
The OIG has the authority
for civil monetary penalties and physician exclusion from the Medicare
program.
Comment: One commenter
objected to the OIG, rather than the Secretary, having the discretion to waive
an exclusion under Sec. 1003.105.
Response: The Secretary
has delegated the discretion to waive an exclusion under Sec. 1003.105 to the
OIG, and the regulations were amended in 1986 (51 FR 34777) to reflect this.
Comment: One commenter
objected to suspending a provider from the Medicare program for a single
instance of an inappropriate transfer.
Response: Section
4008(b)(3) of OBRA 90 deleted the suspension authority from section 1867(d) of
the Act.
Comment: One commenter
believes that the statute and the regulation will unduly penalize hospitals
that are making good faith efforts to comply with the provisions.
Response: We disagree. As
long as a hospital complies with the provisions it will not be subject to
penalty.
Comment: Two commenters
believe that active enforcement of these provisions will force many hospitals
to close their emergency departments to avoid potential liabilities.
Response: We disagree.
The impact of discontinuing an emergency services department, which is among
the top income producers in a hospital, will outweigh the risk of potential
losses due to violations of this regulation, especially since improved
management of emergency departments can avoid the risk of violation.
Comment: One commenter
stated that these regulations would give the government carte blanche authority
to investigate any and all records for suspected violations. He felt that this
ability would enable one hospital to slow down another with unnecessary,
costly, and time- consuming investigations if it makes frivolous complaints
about it.
Response: Congress has
mandated that the Secretary enforce section 1867 of the Act. All credible
alleged violations require a thorough investigation. Rather than
overzealousness, the OIG has to date found and reported a marked reluctance on
the part of hospitals to report suspected inappropriate transfers. (Office of
Inspector General, ``Patient Dumping After COBRA: Assessing the Incidences and
the Perspectives of Health Care Professionals'' (Aug. 1988).)
Comment: One commenter
believes that the HCFA Administrator should retain the termination authority,
rather than delegate it to the regional offices, as these termination decisions
are best administered on a national level.
Response: All
terminations are authorized by the respective HCFA regional office as part of
its general responsibility for operating the survey and certification function
for HCFA. This authority is delegated to the regional office because of its
knowledge of State and local matters and its proximity to the providers it is
overseeing and to the beneficiaries within its region.
Comment: Nineteen
commenters objected that 2 days was too short a period to correct a problem or
deficiency before a termination. One commenter agreed that the termination should
occur within 2 days.
Response: Violations of section 1867 of the
Act have the potential to be immediate and serious threats to patient health
and safety. Therefore, we believe that it is essential that a violation that
poses an immediate and serious threat be corrected as rapidly as possible.
In cases where it has
been determined that the violation poses an immediate and serious threat to
patient health and safety, a hospital will be placed on a 23-day termination
track. On day 1, the hospital will receive a preliminary notice of termination
from the regional office stating that a violation has been identified and that
the projected date of termination will be on day 23. The preliminary notice of
termination will also inform the hospital that the HCFA regional office will
issue a final notice of termination and inform the public of the date of
termination at least 2 days, but not more than 4 days, before the projected
date of termination. Thus, the final notice to the hospital and the public
concerning the termination of the hospital's provider agreement for a violation
that poses an immediate and serious threat to patient health and safety will be
issued between day 19 and day 21 of the 23-day termination track.
The preliminary notice of
termination will also inform the hospital that it may avoid the termination
action by either providing credible evidence of correction of the deficiencies
or by successfully showing that the deficiencies did not exist. The hospital
will have an opportunity to make such a showing to the regional office between
day 1 and day 19 of the termination process. If the hospital is successful, the
regional office will stop the termination process, and there will not be a
public notice of termination. If verification of correction does not occur
before the 19th day of the termination track, the hospital receives a final
notice of termination, and the public is concurrently notified by publication
of the effective date of the termination in the newspaper.
In cases that do not involve
an immediate and serious threat to patient health and safety, a hospital will
be placed on a 90-day termination track. The hospital will receive a
preliminary notice of termination on day 1, and will be notified that the
projected termination date will be on day 90. We will continue our current
practice, set forth in Sec. 489.53(c)(1), of issuing a final notice of
termination to the hospital and the public 15 days prior to the effective date
of termination. Thus, in situations where the violation does not constitute an
immediate and serious threat to patient health and safety, public notice of the
effective date of the termination will be given on approximately day 75 of the
90-day termination process unless the hospital successfully shows that correction
has occurred.
Comment: One commenter
requested that a hospital be given an opportunity to meet informally with the
State agency, HCFA and possibly a third party (such as a PRO) before HCFA makes
a determination that there is a violation. Problems could be resolved without
resorting to a termination.
Response: With regard to
possible civil monetary penalties or physician exclusion, OBRA 90 responds to
the commenter's suggestion. Under section 1154(a)(16) of the Act, as added by
section 4027(a)(1)(B) of OBRA 90, PRO must provide reasonable notice of the
review to the physician and hospital involved and a reasonable opportunity for
discussion and submission of additional information prior to providing their
report to HCFA. Thus, we believe that the commenter's concerns are mitigated by
this new statutory language.
With regard to
termination, HCFA regional office staff may meet with the hospital's
representatives before determining compliance or noncompliance if they decide
they need additional information to make a compliance determination. If, after
reviewing the State agency finding and medical review findings (if requested),
the regional office staff has sufficient information to make a determination,
they may decide not to meet informally with the hospital's representatives.
Options for resolving the deficiencies do not affect the compliance
determination.
Comment: One commenter
stated that mandatory termination is not consistent with the statute. Seven
commenters recommended that the regulations not state that any violation will
result in termination; termination should be imposed only for particularly
egregious violations or a pattern of repeated violations. Several commenters
questioned the basis for considering a violation to pose an immediate and
serious threat, especially when there is only one violation. Five of these
commenters thought single violations should be sanctioned with civil monetary
penalties.
Response: Section
1866(b)(2) of the Act permits HCFA to terminate but does not require HCFA to do
so. There are cases in which a violation has occurred but in which HCFA has not
chosen to terminate. For example, if a routine recertification survey shows
that a hospital's internal quality assurance identified a violation that
occurred 6 months ago, and since then the hospital has been functioning
effectively under a corrective action plan, and the hospital is in compliance
with all other conditions of participation, HCFA may determine that although
the hospital did violate the statute 6 months earlier, a termination is not
warranted at the time of the survey.
The statute does not
limit termination action to hospitals that have a pattern of violations. A
single violation may result in the initiation of termination procedures.
However, HCFA is more interested in hospitals correcting their deficiencies and
remaining available to serve patients than in terminating them from Medicare
participation. As a result, HCFA regional office staff have generally exercised
their authority to permit correction before the effective date of termination
as justification for rescinding the termination. On the other hand, hospitals
that do not correct the deficiencies that permitted a violation to occur may
represent an immediate and serious threat to people seeking emergency care. In
such a case, HCFA will move quickly to either assure that the deficiencies that
led to the violation are corrected or to terminate the hospital's provider
agreement. It should be noted that section 4008(b)(3) of OBRA 90 deleted the termination
and suspension language from section 1867(d) of the Act. Terminations due to
violations of section 1867 of the Act are now subject to the regular provider
agreement rules in section 1866 of the Act.
We believe that the
immediate and serious threat concept applies to a provider's potential for
causing harm as a result of lax policies and procedures as well as the danger
posed by patently unsafe physical conditions or staffing shortages. Thus, we
believe that operating in a manner that potentially subjects individuals to the
threat of summary transfer without treatment may pose an immediate and serious
threat to individuals who present themselves to the hospital for treatment. As
noted above, if the provider is able to demonstrate that this is not the case,
the termination is withdrawn and the provider's participation in the program is
uninterrupted.
Hence, while a single
violation may very well be sanctioned with civil monetary penalties, nothing in
the statutory scheme suggests that the authority to terminate a hospital's
provider agreement should be limited by the number of violations.
Comment: One commenter
objected to the application of ``fraud and abuse'' concepts to quality of care
issues; for example, degree of culpability of the hospital or responsible
physician.
Response: The factors to
be considered in determining the amount of civil monetary penalty that are set
forth in Sec. 1003.106(a)(4) are adapted from those mandated by section
1128A(d) of the Act. Section 1867(d)(1) of the Act requires that the provisions
of section 1128A of the Act other than subsection (a) and subsection (b) apply
to the imposition of a civil monetary penalty against a participating hospital
and physician.
As thus incorporated by
reference, section 1128A(d) of the Act requires that the OIG consider the
nature of claims and circumstances under which they were presented, the degree
of culpability, history of prior offenses, and financial condition of the
person presenting the claims, and such other matters as justice may require.
We are revising proposed
Sec. 1003.106(a)(4) to reflect the essence of these statutory considerations as
modified to fit violations of section 1867 of the Act. Section 1003.106(a)(4)
also now includes among the factors ``financial condition'' and ``nature and
circumstances of the violation.'' These were omitted from the notice of
proposed rulemaking but are required under section 1128A(d) of the Act.
Comment: One commenter
stated that, before termination, HCFA should consider all circumstances of the
case including such mitigating factors as: the previous sanction record of the
hospital; the hospital's willingness and ability to comply with its obligations
to emergency room patients; prior history of transfer; and the impact the termination
may have on the community.
Response: Congress has
provided that any hospital that has failed to comply with the requirements of
section 1867 of the Act is subject to termination of its provider agreement. It
did not provide, or suggest in legislative history, that the Secretary should
create a system of lesser measures to account for the factors mentioned by the
commenter. Rather, it intended the gravity of the sanction to cause hospitals
to comply with their obligations. When a hospital does violate its duties under
section 1867 of the Act, we must take immediate action to prevent that hospital
from jeopardizing the health and safety of the next person who may seek help in
an emergency situation. Vigorous enforcement of these provisions is essential to
remedy the problem that prompted Congress to legislate against the denial of
screening and/or treatment and the inappropriate transfer of individuals with
emergency medical conditions. A hospital will not suffer the loss of Medicare
funding if it can demonstrate to HCFA's satisfaction that it has taken the
steps necessary to ensure that the mandates of the statute are observed by its
employees, contractors, and staff. If a hospital demonstrates its unwillingness
or inability to meet that commitment within the time provided, it will be
terminated. When a hospital has had a history of violations, the situation may
make the regional office skeptical about the hospital's willingness and ability
to enforce its own policies to guarantee that emergency services are available
to all.
We recognize that the
termination of a hospital's provider agreement would have a serious impact on
the community. This is the remedy the law provides. We believe that this remedy
provides the hospital (and its community) with the incentive to assure
compliance.
Comment: One commenter
wanted us to notify a hospital that it is under investigation and will be
observed for a specific period of time to see if there is a pattern of
inappropriate care and, if one is found, will be given a period of time to
correct the problem before termination.
Response: In view of the
nature of the problems that this provision addresses, it is not appropriate to
take a general approach that permits a provided to avoid immediate inspection
in all cases. The HCFA regional office will determine whether there is an
advantage to conducting an unscheduled survey. We note, however, that when
continued monitoring is appropriate to assure that corrective action has been
taken, we will inform the provider of the period for which monitoring will
continue.
Comment: One commenter
believes that all violations, whether or not ``knowing and willful, or
negligent'', should be subject to penalty. Another thought termination should
only apply to knowing violations, as with civil monetary penalties.
Response: As we
previously indicated, section 4008(b)(3) of OBRA 90 deleted section 1867(d)(1)
of the Act, which provided for termination or suspension of a hospital's Medicare
provider agreement for ``knowingly and willfully, or negligently'' failing to
meet these statutory requirements. However, section 1866(a)(1)(I)(i) of the Act
was also amended to require hospitals to meet the provisions of section 1867 in
order to participate in the Medicare program. We have, therefore, revised Sec.
489.24(f) of this regulation to delete the requirement that a hospital must
knowingly and willfully, or negligently, fail to meet the regulation's
requirements to be subject to termination. It should also be noted that because
of the deletion of section 1867(d)(1) of the Act, hospitals are no longer
subject to suspension of their provider agreement based upon violation of these
provisions. By requiring that all hospitals comply with the provisions of
section 1867 of the Act, Congress indicated that section 1867 violations by
hospitals could result in termination of a hospital's Medicare
provider agreement and civil monetary penalties. In addition, as discussed
below, civil monetary penalties may now be imposed for a negligent, rather than
a knowing, violation.
Comment: Two commenters
suggested that the term ``knowingly'' be defined to include ``should have
known'' to prevent physicians from escaping liability because the physician did
not know of the law or the physician failed to inquire thoroughly about the
patient's condition.
Response: The language of
the statute does not permit us to adopt the commenter's suggestion.
``Knowingly'' is a legal term with a well- developed history. The accepted
meaning of the term does not include ``should have known.'' Indeed, the latter
term denotes a lack of knowledge and is used in those contexts where a person
is held liable for not knowing what he or she would have known had he or she
exercised due care. A person need not know the terms of the statute in order to
commit a knowing violation of the statute. A knowing violation of the statute
requires only that the person do a proscribed act, knowing the character of the
proscribed act. In this context, for example, a physician would knowingly
violate the statute if he or she certified that the transfer of an individual
with an emergency medical condition that had not been stabilized was in the
best interests of the patient if the physician knew that the patient had an
emergency condition that had not been stabilized and that the risks of transfer
outweighed the benefits the physician could reasonably expect by the delivery
of appropriate care in the receiving hospital. The physician would not need to
know that section 1867 of the Act prohibited such transfer.
Although the term
``knowingly'' does not encompass ``should have known,'' it does embrace the
concepts of ``reckless disregard'' and ``deliberate ignorance.'' That is, it
includes a form of constructive knowledge in which an individual is deemed to
have actual knowledge of the facts and circumstances about which he or she
would have had knowledge if the individual had not deliberately or recklessly
disregarded facts that were readily available. We are amending Sec. 1003.102(c)
to make it clear that the term ``knowingly'' encompasses these two concepts.
The statute was amended
in OBRA 90, however, changing the standard for imposing civil monetary
penalties from ``knowingly'' to ``negligently'' for violations on or after May
1, 1991. The term ``negligently'' encompasses the concept of ``should have
known.''
Comment: One commenter
suggested that Sec. 1003.114 be amended to read: ``The Inspector General must
prove by a preponderance of evidence that the hospital and responsible
physician or physicians knowingly failed to provide emergency care as described
in Sec. 1003.102(c).''
Response: Section
1003.114 was substantially rewritten in the OIG final regulations issued on
January 29, 1992 (57 FR 3298) to essentially reflect the substance of this
comment.
Comment: One commenter
contended that we should not find any hospital or physician in violation of
section 1867 of the Act until we have issued final regulations.
Response: We do not agree
with this comment. The detailed language of the statute contains sufficient
guidance to provide a legal basis for implementing its provisions before
regulations are issued.
Comment: One commenter
contended that the penalties in the proposed rule are too harsh because there
are too many emergency department personnel to control all the time.
Response: The penalties
in the proposed rule are statutory requirements and must be enforced by the
Secretary. Additionally, a hospital has always been responsible for the actions
of all personnel it allows to provide services on site.
Comment: Two commenters
believe we should include in the regulations the standards for determining what
is a violation that will lead to termination and the procedures to be followed;
otherwise, reviewing courts may find termination arbitrary.
Response: Hospitals in
violation of the statute are subject to termination and civil monetary
penalties. Thus, any substantiated violation may result in termination. Once
these regulations are published, specific guidelines for assessing whether a
case represents a violation will be included in the State Operations and
Regional Office Medicare Certification Manuals. While the manuals in no
way purport to be exhaustive in their description of potential section 1867
violations, they do provide a sense as to how HCFA intends to interpret this
provision. The manuals are sent to HCFA's regional offices and each State
agency. They are also available on a subscription basis from the Department of
Commerce's National Technical Information Service, 5825 Port Royal Road,
Springfield, Virginia, 22161. These manuals are continually updated to reflect
new regulations.
Comment: Twenty
commenters stated that we should not be able to terminate a provider without
providing due process such as a hearing before an administrative law judge or
some type of summary hearing; nine of the commenters asserted that the final
decision should be appealable before a Federal court.
Response: This is an
issue that has been litigated extensively in the past. The courts have widely
held that due process for providers of health services under the Medicare
program does not require a formal hearing before adverse action is taken. Our
regulations at Sec. 498.5(b) have long provided for a post-termination hearing
before an administrative law judge for providers that have been terminated.
Also, in accordance with Sec. 498.5(c), any provider dissatisfied with a
hearing decision may request Appeals Council review and has a right to seek
judicial review of the Council's decision.
In addition, of course,
providers that have been terminated always have the right to reapply for Medicare
certification after correcting the deficiencies that led to the termination.
Comment: Two commenters
believe that we should impose a timeframe on hospitals to obtain reinstatement.
Response: The statute at
section 1866(c)(1) of the Act provides that a hospital that has been terminated
from the Medicare
program may not file another agreement unless the Secretary finds that the
reason for the termination has been removed and that there is reasonable
assurance that it will not recur. Thus, terminated hospitals may reapply for Medicare
certification whenever they have corrected the deficiencies that caused the
termination. We reserve the right to determine an appropriate reasonable
assurance period before reinstatement on a case-by-case basis.
Comment: Four commenters
stated that we should clarify how HCFA will monitor and enforce compliance with
the regulations. They recommended that the regulations more specifically explain
what constitutes a violation of these provisions and how HCFA will investigate
violations and make negligence determinations.
Response: We will publish
in our State Operations and Regional Office Manuals our investigation and
enforcement procedures.
Comment: One commenter
suggested that HCFA disclose the names of violators to the public and include
them in the Medicare
Data Base for adverse decisions. Another recommended that we also notify
intermediaries and carriers.
Response: We agree. This
information is published and is included in the Medicare Data Base and is
passed on to intermediaries and carriers.
Comment: Two commenters
suggested that we negotiate with PROs to provide case-by-case monitoring of
patient dumping cases, since State survey agencies are not staffed or organized
to do this. Another commenter recommended that we require PROs to report
suspected violations and that we consider PRO information before concluding an
investigation.
Response: Section
1867(d)(3) of the Act, as added by section 4027(a)(1) of OBRA 90, sets forth
the role of PROs in patient dumping cases. Specifically, for sanctions imposed
on or after February 1, 1991, section 1867(d)(3) of the Act requires the
appropriate PRO to review the case prior to the imposition of a civil monetary
penalty or physician exclusion sanction, except when a delay would jeopardize
the health and safety of individuals or when an individual is denied a
screening examination. Given this statutory direction, we do not believe it
would be appropriate to place additional requirements on PROs in this regard.
Comment: One commenter
recommended that HCFA require hospitals to maintain a record of the disposition
of all individiuals seeking emergency care. If the individual were transferred,
such a log would bear the initials of the physician authorizing the transfer
and identify the reasons for the transfer, the receiving hospital, and the
person accepting transfer for that hospital. Such records would educate
hospital personnel about the statutory requirements, deter violations, and
provide an audit trail to assist HHS in performing its monitoring and
enforcement duties.
Another commenter
suggested that we require each hospital to maintain a record of all patients it
transfers and of those it receives, as recommended by Report No. 100-531 of the
House Committee on Government Operations on March 25, 1988. Another commenter
believes HCFA should periodically review a random sample of transfer files from
every transferring and receiving hospital.
Response: We agree that
the hospital must maintain a central log or record of how it handles every
individual that comes to its emergency department for HHS and its agents to
monitor compliance with the statute. The OIG has reported that a lack of a central
record on the disposition of persons seeking emergency services hampers HHS'
ability to monitor compliance (Office of Inspector General, ``Patient Dumping
After COBRA: Assessing the Incidences and the Perspectives of Health Care
Professionals'' (August 1988)). Hence, we are amending the regulations at Sec.
489.20(r)(3) to require a hospital to maintain a central log of all individuals
who come to its emergency room seeking assistance and the disposition of such
individuals, whether they were or are refused treatment, transferred, admitted
and treated, stabilized and transferred, or discharged. Such a record will
permit HHS and the State survey and certification agencies to select and gain
access to individual medical records for further inquiry. However, we are not
prescribing a standard form at this time. Our condition of participation for
medical record services, at Sec. 482.24(b), requires hospitals to maintain a
medical record for each inpatient and outpatient. Additionally, our enforcement
procedures include a review of a simple of patient records. The sampling
technique takes into account emergency room triage and unreimbursed care.
Approximately 80 percent
of the 6600 hospitals participating in the Medicare program are
accredited by the Joint Commission on Accreditation of Healthcare Organizations
(JCAHO). JCAHO-accredited hospitals are required to maintain a control register
and initiate a medical record every time an individual visits the emergency
service (Standard ES.6). The JCAHO-mandated control register must contain at
least the names of all persons (including the names of individuals dead on
arrival) seeking care, as well as their age and sex; date, time, and means of
arrival; nature of the complaint; disposition; and time of departure. The
regulation at Sec. 489.20(r)(3) merely requires the name of the individual and
the disposition of his or her case. We believe maintaining a register of
individuals seeking care is an industry standard and will not impose an
additional burden on the 20 percent of hospitals that are not accredited. We
have found a control register or control log to be invaluable in identifying
records to be reviewed during our complaint investigations. We have not found
any hospital that is not maintaining a log of some sort.
Comment: One commenter
suggested that we clarify that hospitals and physicians investigated under
these provisions be held to the standard of care based on accepted medical
practice. Alternatively, they should be held to the standard of care utilized by
the PROs under section 1154(a)(6)(A) of the Act.
Response: All physicians
and hospitals are required to provide adequate medical care. PRO physician
reviewers base their assessments on their education, training and experience,
and assess the issues noted previously.
Comment: Two commenters
recommended that we include provisions similar to the PRO quality assurance
corrective action methods in section 1154 of the Act to allow for education and
other actions to bring about positive improvement, instead of resorting to
sanctions.
Response: This regulation
emphasizes correction over sanctions. Hospitals that have violated these
requirements are permitted the opportunity to correct the deficiencies and
avoid termination. To date, 96 percent of violating hospitals have been able to
avoid termination by correcting the deficiencies that led to the violations.
However, the Department's primary responsibility is toward people who need
health care, and in cases in which a hospital either cannot or does not correct
its deficiencies, we believe it is appropriate to terminate the hospital from
the Medicare
program quickly. In addition, the law includes authority to exclude physicians
and impose civil monetary penalties against hospitals and physicians. This
serves as both a remedial function and a deterrent function. This may also
motivate corrections and improvements to prevent future violations of the
statute.
Comment: Three commenters
indicated that hospitals should be involved in the investigation's fact finding
process and should be advised of all evidence before HCFA receives the
deficiency report. In addition, they recommended the hospital be permitted to
submit documentation regarding the evidence and a response to the information
submitted to HCFA, so that HCFA will have all the information before taking
action.
Response: When the onsite
investigation of a violation of section 1867 of the Act is completed, the
hospital's representatives have an opportunity to be informed of the scope of
the survey agency's investigation and findings at an exit conference. The
survey agency, however, will inform the hospital that, unlike other surveys, an
investigation of a violation of section 1867 of the Act usually does not end
with its onsite investigation; it may require medical review. The HCFA regional
office will make the final determination based on all of the relevant
information, including the results of medical review, if needed.
When the regional office
makes a determination of noncompliance, it will notify the hospital via a
preliminary determination letter. The date the hospital receives the
preliminary determination letter becomes the date for commencement of the
termination process, which lasts approximately 23 days in situations where it
has been determined that the violation resulted in an immediate and serious
threat to patient health and safety, or approximately 90 days where the
violation was not considered to pose an immediate and serious threat. If the
regional office receives additional information that proves the hospital did
not violate section 1867 of the Act, or regional office verification reveals
that the hospital has taken remedial action to prevent further violations
before the actual date of termination, the termination action will be rescinded.
As noted in a previous response to a comment, if there was a violation of
section 1867 of the Act and the hospital does not take corrective action, a
final termination letter will be sent to the hospital and the public will be
notified concurrently through a notice in the newspaper (at least 2 days, but
no more than 4 days, before the actual termination date in immediate and
serious threat situations, or at least 15 days before the actual termination
date in situations that do not pose an immediate and serious threat).
Therefore, the change in the notice requirement in immediate and serious threat
situations offers the provider approximately 19 days to correct the
deficiencies before termination becomes effective in immediate and serious
threat cases and continues to offer the provider approximately 75 days to
correct deficiencies before termination becomes effective for situations that
do not pose an immediate and serious threat.
From the onset, the
hospital is aware of the problem, HCFA's intended course of action, and that it
must take corrective action or prove that the violation did not exist in order
to halt the termination process. During and after this period, the hospital may
submit documentation regarding the violation if it chooses; however, the
termination process continues until proof is submitted to establish that a
violation had not occurred, corrective action is verified, or the termination
date is reached. HCFA's primary responsibility is to the people who come to the
hospital in emergency situations. Their urgent need for proper medical care is
a higher priority than providing for time-consuming historical re-review before
action is taken against a hospital with improper practices.
Comment: One commenter
believes the OIG should revise its policy of prohibiting the PRO from
consulting with the physician under investigation during the investigatory
stage in cases in which the OIG requests an evaluation from the local PRO.
Response: Section 4027(a)
of OBRA 90 added section 1867(d)(3) to the Act to require the OIG, in
considering whether to impose a civil monetary penalty or physician exclusion,
to obtain and consider PRO review except when a delay would jeopardize the
health or safety of individuals.
The PRO, in turn, is
required to assess whether the individual involved had an emergency medical
condition that had not been stabilized and to provide the physician and
hospital involved with a reasonable opportunity for discussion and to submit
additional information.
Comment: One commenter
disagreed with HCFA's intention to rely on State survey agencies to investigate
initial complaints of violation because in many States these agencies have an
inherent conflict of interest. The commenter recommended that, to guarantee
that there are no conflicts of interest, HCFA should at least apply certain
minimum performance standards and investigatory guidelines in determining in
which States the State survey agency can be entrusted with the role of
investigating complaints.
Response: As provided for
by section 1864(c) of the Act, HCFA contracts with the State survey agency to
conduct surveys to evaluate compliance with Federal health and safety
requirements. We provide training, survey report forms and interpretive
guidelines and perform Federal surveys and oversight to monitor the States'
performances. Consequently, we are confident of the States' abilities to
conduct compliant investigations.
Comment: One commenter
believes that complainants should be asked but not required to give their names
or other identifying information, as many anonymous complaints have proven
reliable in other health care enforcement contexts.
These complaints are
often made by hospital employees, who are in a position to know what
constitutes an actual violation and who are fearful of losing their jobs if
identified.
Response: We agree that
requesting, rather than requiring, a complainant's name would protect an
employee with anonymity. This will be reflected in HCFA's revised Medicare
Survey and Certification, State Operations and Regional Office Manuals
instructions. We also note, as previously indicated, under section 4027(k)(3)
of OBRA 90 hospitals are not allowed to penalize or take action against any
hospital employee because the employee reported a violation of these
provisions.
Comment: Two commenters
believe that our regulations dealing with documentation of findings at Sec.
405.1903(d) (recodified as Sec. 488.18(d)) should be revised to require State
survey agencies to forward all complaints to HCFA, not just those they deem
``credible'', in order to maintain the integrity of the enforcement process.
Response: We agree that
HCFA should decide whether a complaint alleges a violation of these
requirements and warrants an investigation. We are revising recodified Sec.
488.18(d), accordingly.
Comment: Three commenters
contended that the regulations should differentiate more between the roles and
responsibilities of physicians and hospitals in determining whether a hospital
has violated section 1867 of the Act, as hospitals do not have the legal
authority to admit, transfer or discharge patients.
Response: The statute
imposes duties on a hospital, many of which can only be effectively carried out
by physicians in some way affiliated with the hospital. Neither the statute nor
the regulations attempt to define the means by which the hospital meets its
statutory obligations to provide emergency screening examination, treatment or
transfer.
Comment: Three commenters
raised a question concerning the hospital's responsibility in a case in which a
physician who is not responsible for providing emergency care, but whose
specialty is required to perform stabilizing care, refuses to treat or examine
a patient.
Response: Although the
term ``responsible physician'' is no longer used in the statute, the Department
has maintained the term in these regulations, defining it to be consistent with
the present statute. Hence, the definition of a ``responsible physician'' as
drafted in these regulations includes any physician to whom the hospital has
delegated responsibility to examine, treat, or transfer an individual that
comes to the hospital emergency department seeking help. A hospital may use
physicians on its medical staff to carry out its responsibilities under the
statute. As indicated in the OBRA 89 amendments to section 1867, these
physicians, including those who provide emergency services on-call as a
condition of enjoying staff privileges, may be held liable for violating the
statute and regulations.
Comment: One commenter
recommended that ``responsible physician'' be defined to prevent a physician
from being held liable for not providing treatment that is beyond his clinical
area of competence or hospital privileges or for treatment decisions that are
made in the physician's absence when the physician is available only by
telephone.
Response: We do not
believe that the comment requires a change in the definition. The commenter is
concerned that a physician not be held responsible for aspects of an
individual's care that are beyond his competence or hospital privileges.
Consistent with the statute, the regulations use the term ``responsible
physician'' to denote a physician with the responsibility to examine, treat, or
transfer a patient. A hospital cannot require a physician to perform duties
that are either beyond the physician's competence or the scope of the
physician's hospital privileges.
On the other hand, where
a responsible physician makes treatment or transfer decisions by telephone, the
physician remains liable for such decisions.
Comment: Several
commenters believe that the definition of ``responsible physician'' should
include any physician on the hospital medical staff, including on-call
physicians.
Response: We have amended
the definition of ``responsible physician'' to comport with the OBRA 89
amendments to section 1867 of the Act. The definition encompasses any
physician, including those physicians on-call, to whom the hospital has
delegated responsibility to examine, treat, or transfer an individual that
comes to the hospital emergency department seeking help. A hospital may use
physicians on its medical staff to carry out its responsibilities under the
statute. OBRA 89 amended section 1866(a)(1)(I) of the Act to require the
hospital, as a condition of participation, to ``maintain a list of physicians
who are on-call for duty after the initial examination to provide treatment
necessary to stabilize an individual with an emergency medical condition.''
Comment: One commenter
asked about the hospital's liability when the attending physician determines
that the patient requires the skills of a specialist who has staff privileges,
but the specialist has never agreed to provide emergency services.
Response: As previously
indicated, pursuant to OBRA 89, the hospital has a duty to ensure that, within
the capabilities of the hospital's staff and facility, the medical needs of an
individual who comes to an emergency room can be met. The hospital's
capabilities include the skills of a specialist who has staff privileges to the
extent that the hospital can require the specialist to furnish these services.
However, it is up to the hospital to determine how it will comply with its
statutory obligations.
Comment: One commenter
recommended that the regulations exempt from liability a physician who attempts
to admit a patient if the hospital refuses admission.
Response: To be a
responsible physician under the terms of the statute and regulations, a
physician must be responsible for examining, treating, or transferring an
individual whom the statute protects. If an emergency room physician, for
example, is under contract with the hospital to provide emergency care and
treatment, but does not have admitting privileges, that physician is still
under an obligation to provide an appropriate medical screening examination and
either stabilizing treatment within the capabilities of the staff and
facilities of the hospital or an appropriate transfer under the statute.
Section 1867(d)(1)(C) of the Act specifically states that if a physician
determines that an ``individual requires the services of a physician listed by
the hospital on its list of on-call physicians . . . and notifies the on-call
physician and the on-call physician fails or refuses to appear within a
reasonable period of time, and the physician orders the transfer of the
individual because,'' without the on-call physician's services, the benefits of
transfer outweigh the risks of transfer, the transferring physician will not be
subject to penalties under section 1867 of the Act. However, this does not
absolve the hospital and the on-call physician from liability under the
statute.
Comment: One commenter
believes that these regulations may cause emergency room physicians to hesitate
to transfer patients when appropriate because their decisions might be reviewed
through hindsight and without consideration of the pressure of the specific
circumstances.
Response: We do not agree
with the commenter's contention. In reviewing allegations of patient dumping,
we will look at all the information available to the treating or transferring
physician at the time the decision is made. We believe that the physician's
concern should be for the patient rather than for possible consequences of this
requirement. To further strengthen the protection of emergency room physicians
with regard to their transfer decisions, section 6211(f) of OBRA 89 added
paragraph (i) to section 1867 of the Act to prevent hospitals from penalizing
physicians who refuse to authorize the transfer of an individual with an
unstabilized emergency medical condition. In addition, section 4027(k)(3) of
OBRA 90 amended section 1867(i) of the Act to provide similar protection to
qualified medical emergency room staff with regard to their transfer decisions
when a physician is not available in the emergency room. We are amending Sec.
489.24(d)(3) to include these new provisions so that it conforms to the statute
as amended.
Comment: One commenter
suggested that the regulations include the requirement that the patient or a
third party payer must pay for the patient's medical screening or examination.
Response: A patient's
obligations to pay for services provided by a hospital is beyond the scope of
these regulations. However, if an individual is unable to pay for services, the
hospital, nonetheless, remains subject to the requirements of the statute and
regulations with respect to that individual. Section 1867(h) of the Act, as
added by section 6211(f) of OBRA 89, states expressly that the ``hospital may
not delay provision of an appropriate medical screening examination . . . or
further medical examination and treatment . . . to inquire about the
individual's method of payment or insurance status.''
Comment: One commenter
stated that many managed health care plans require hospital emergency
departments to call the plan for permission to examine and treat the plan's
patients; the commenter believed that this violates the law. He also stated
that a plan can retroactively determine that an emergency condition did not
exist.
Response: Managed health
care plans cannot deny a hospital permission to examine or treat their
enrollees. They may only state what they will and will not pay for. However,
regardless of whether a hospital is to be reimbursed for the treatment, it is
obligated to provide the services specified in the statute.
Comment: One commenter
contended that hospitals should not be allowed to pass along the costs of any
civil monetary penalties to the Medicare or Medicaid programs.
Response: We agree; these
penalties are not reimbursed by the Medicare or Medicaid programs.
As stated above in
section II.D. of this preamble, Responsibilities of Medicare
Participating Hospitals in Emergency Cases, and in several responses to
comments, before imposing civil monetary penalties and exclusions, section
1867(d)(3) of the Act requires that we request the appropriate PRO to assess
whether the individual involved had an emergency medical condition that had not
been stabilized and report on its findings before the OIG may impose a civil
monetary penalty or exclusion. [Note: PRO review is not required in cases where
a delay in effecting a sanction would jeopardize the health or safety of
individuals or in situations where medical review is inappropriate, for
example, in cases where an individual was denied a medical screening
examination.] The Secretary must provide the PRO with at least 60 days for the
review. The PRO is required to provide reasonable notice of the review to the
hospital and physician involved. The PRO is also required to provide them with
a reasonable opportunity for discussion and an opportunity to submit additional
information. This provision is effective for sanctions imposed on or after
February 1, 1991. During the possible termination phase of a case's
development, the HCFA regional office has the responsibility and authority to
make a determination of compliance or noncompliance. Termination procedures
provide for an opportunity for the provider to comment. During this phase, the
HCFA regional office is not required to instruct the PRO to offer the affected
hospital an opportunity for discussion and submission of additional
information. Subsequent to this phase, the OIG has the responsibility and
authority to direct that the PRO conduct an assessment. In conducting such as
assessment, the PRO is required to offer the affected physician and/or hospital
an opportunity for discussion and submission of additional information before
the PRO issues its report.
We are adding a new
paragraph (g) to proposed Sec. 489.24 to implement the statutory provision that
PROs have at least 60 days to make their assessments and to specify that PROs
must provide affected physicians and hospitals reasonable notice of review and
opportunity for discussion and submission of additional information.
In addition, we are
adding a new Sec. 489.24(h) to clarify that, upon request, HCFA may release a
PRO assessment to the physician or hospital (or both where applicable), or the
affected individual, or his or her representative. However, we specify that the
PRO physician's identity is confidential unless he or she consents to release
his or her identity, in accordance with the PRO disclosure regulations set
forth at Secs. 476.132 and 476.133. If the case goes to litigation, the PRO is
required to provide expert testimony and it is preferable, but not required,
that the testifying physician be the same physician who reviewed and reported
on the case.
As stated earlier, the
statutory change requiring PRO review applies only in situations involving
civil monetary penalties and exclusions. Termination proceedings pursuant to
section 1866 of the Act as a result of violations of the anti-dumping
provisions of section 1866 and section 1867 do not require PRO review. We note
that a facility could be the subject of a termination proceeding and also be
assessed civil monetary penalties.
In this interim final rule with
comment period, we are adopting as final the provisions of the June 16, 1988
proposed rule, as amended by the revisions discussed below and clarifications
discussed elsewhere in this preamble. (To accommodate changes to the Code of
Federal Regulations since the publication of the June 16, 1988 proposed rule,
proposed paragraphs (k) through (q) of Sec. 489.20 have been redesignated as
paragraphs (l) through (r).) Unless otherwise noted, revisions are based on our
evaluation of public comments. …….
CHAMPUS comments deleted
… 3. Hospital responsibility for emergency care. We
are revising the proposed regulations as discussed below.
·
Section 489.20(m): We have clarified Sec. 489.20(m)
to eliminate any implication that a hospital may improperly transfer a patient
as long as it is done with prior arrangement. In addition, we are requiring
that when a hospital has reason to believe that an individual was transferred
in violation of the requirements of Sec. 489.24, it will report the violation
to either HCFA or the State survey agency, rather than to both, as required by
the proposed regulation. <
·
bullet> Section 489.20(q): We are adding
provisions based on section 6018(a)(2) of OBRA 89, requiring hospitals to post
conspicuously in their emergency departments signs specifying rights of
individuals under section 1867 of the Act with respect to examination and
treatment and to post conspicuously information indicating whether or not the
hospital participates in the Medicaid program under a State plan approved under
title XIX. Some public commenters also wrote in support of the posting of
signs.
·
Section 489.20(r)(1): Pursuant to section
6018(a)(1) of OBRA 89 and in response to public comment, we are adding the
requirement that both transferring and receiving hospitals maintain medical and
other records related to individuals transferred for a period of 5 years.
·
Section 489.20(r)(2): Also pursuant to section
6018(a)(1) of OBRA 89 and public comment, we are adding the requirement that a
hospital maintain a list of physicians who are on call for duty after the
initial examination to provide treatment.
·
Section 489.20(r)(3): We are requiring each
hospital (both transferring and receiving) to keep a log of each individual who
came to the emergency department seeking assistance and whether he or she
refused treatment or was refused treatment, transferred, admitted and treated,
stabilized and transferred, or discharged.
·
Section 489.24(b): We are expanding the definition
of ``emergency medical condition'' to include psychiatric disturbances,
symptoms of substance abuse, and situations with respect to pregnant women
having contractions. We add definitions of ``capacity'', ``comes to the
emergency department'', ``hospital'', ``hospital with an emergency department'',
``labor'', and ``participating hospital.'' We clarify other definitions to make
them consistent with other versions of the text. We have deleted the term
``active labor'' in accordance with section 6211(h)(1)(B) of OBRA 89.
·
Section 489.24(c) (2) and (4) and (d) (1) and (2):
We are adding provisions to require a written informed refusal from the patient
or individual acting on his or her behalf when the patient refuses treatment or
transfer. We specify that the medical record must contain a description of the
examination and treatment, or transfer, or refusal. The refusal must indicate
that the patient (or person acting on his or her behalf) is aware of the risks
and benefits of the transfer, or the examination or treatment.
·
Section 489.24(c)(3): We are adding the requirement
that a hospital may not delay providing an appropriate medical screening
examination in order to inquire about payment method or insurance status. This
is the result of public comment and section 6211(h) of OBRA 89.
·
Section 489.24(d)(1)(ii)(A): Based on section
6211(c)(1) of OBRA 89 and public comment, we are adding a requirement that an
individual (or legally responsible person acting on the individual's behalf)
who wants to be transferred must indicate in writing the reason for the request
for transfer and that he or she is aware of its risks and benefits.
·
Section 489.24(d)(3): Based on section 6211(i) of
OBRA 89 and section 4027(k)(3) of OBRA 90, we are prohibiting a hospital from
penalizing or taking adverse action against a physician or a qualified medical
person who refuses to authorize the transfer of an individual with an emergency
condition that has not been stabilized or against any hospital employee because
the employee reports a violation of this regulation.
·
Section 489.24(e): Based on section 6211(f) of OBRA
89 and public comment, we are requiring that a hospital with specialized
capabilities or facilities accept transfer of any individual requiring those
specialized capabilities or facilities if it has the capacity to treat the
individual.
·
Section 489.24(f): Because of section 4008(b)(3)(A)
of OBRA 90, the standard for terminating a hospital has changed. HCFA is no
longer required to prove that the hospital knowingly and willfully, or
negligently, failed to meet the requirements of this regulation. We may now
terminate such hospitals for failing to meet these requirements under section
1866 of the Act based upon section 4008(b)(3)(B) of OBRA 90, which requires
hospitals to meet the requirements of section 1867 of the Act in order to
participate in the Medicare program.
·
Section 489.24(g): Based on section 4027(a)(1) of
OBRA 90, we are requiring PRO review to assess whether the individual involved
had an emergency medical condition that had not been stabilized, in addition to
other medical issues, before imposing a civil monetary penalty or exclusion,
unless obtaining such review would cause delay that would jeopardize the health
or safety of individuals or if there is no medical issue to review (that is, no
screening examination was conducted). In cases that do not present jeopardy,
the PRO review and report to HCFA must be completed in 60 calendar days.
·
Section 489.24(h): We are clarifying in new Sec.
489.24(h) that, upon request, HCFA may release a PRO assessment to the
physician or hospital, or the affected individual or his or her representative.
·
Section 489.53(a): We are revising the proposed
rule to require a receiving hospital to report incidents it has reason to
believe may be violations.
·
Section 489.53(b): We are adding to the reasons for
termination--(a) a refusal of a hospital with specialized capabilities or
facilities that has the capacity to accept an appropriate transfer; (b) failure
to maintain an on-call duty roster, medical records for 5 years, and a log of
individuals seeking emergency assistance; and (c) failure to post notices as
required concerning participation in Medicaid and the rights of individuals
under 42 CFR part 489, subpart B.
·
Section 489.53(c)(2)(ii): We are specifying that a
hospital found in violation of Secs. 489.24(a) through (h) will receive a final
notice of termination and the public will be concurrently notified at least 2
but no more than 4 days before the effective date of the termination. This
allows a hospital approximately 19 to 21 days to correct or refute alleged
deficiencies. We also clarify that we will not terminate if the hospital has
corrected or refuted the deficiencies that gave rise to the termination.
·
We are adding ``or rural primary care hospital''
wherever ``hospital'' appears in Sec. 489.24, as required by section 6003(g) of
OBRA 89.
·
We are also removing all references to suspension
of the provider from the regulations at Secs. 489.24 and 489.53, based on the
deletion of the suspension authority by section 4008(b)(3) of OBRA 90.
·
We are making none of the proposed revisions to
part 1001, which all concerned suspension of providers. <bullet> Section
1003.100: We are revising the proposed section to conform with several
rulemaking documents that have been published since our proposed rule. The
requirements contained in proposed Sec. 1003.100(b)(1)(ii) are now set forth in
Sec. 1003.100(b)(1)(vi).
·
Section 1003.101: We are adding or revising in this
section the definitions for the terms ``participating hospital'' (to comport
with the statute), ``respondent'', and ``responsible physician''.
·
Section 1003.102: This section also has been
revised by several rulemaking documents since the publication of our June 16,
1988, proposed rule. In this interim final rule, we are clarifying in paragraph
(c)(2) that the term ``knowingly'' encompasses reckless disregard and
deliberate ignorance of a material fact. We are also revising this section to
comport with the OBRA 89 amendments that allow the Inspector General to impose
civil monetary penalties when a physician signs a certification when he or she
knew or should have known that the benefits did not outweigh the risks of
transfer, or when the physician misrepresents an individual's condition or
other information. We are also revising proposed Sec. 1003.102(d) to eliminate
the reference to a ``knowing'' standard (that is, a physician knowingly failed
to provide care). This results in a clearer approach that sets forth our basis
for imposing civil monetary penalties for violations of section 1867 of the Act
and is consistent with the statutory amendments and with other revisions to the
regulations.
·
Section 1003.103: We are revising this section in
accordance with section 1867(d) of the Act, as amended by section 4008 of OBRA
90, to clarify that the OIG may impose a penalty of not more than $50,000
against a participating hospital and a penalty of not more than $50,000 against
each responsible physician (and not more than $25,000 against a participating
hospital and each responsible physician for violations on or after August 1,
1986, but before December 22, 1987) for violations determined under Sec.
1003.102(d). For penalties imposed on or after May 1, 1991, if the hospital has
fewer than 100 State-licensed, Medicare-certified beds, the maximum
penalty will be $25,000.
·
Section 1003.105: We are revising this section to
comport with the OBRA 90 amendments to section 1867 of the Act by specifying in
Sec. 1003.105(a)(1) that a physician who grossly and flagrantly or repeatedly
violates the statute or Sec. 489.24 may be excluded from Medicare
and any State health care program. We are also revising Sec. 1003.105(b) to
clarify that, for determinations under Secs. 1003.102 (b)(2) and (b)(3), and
for violations under Sec. 1003.102(c)(1)(ii) occurring on or after December 22,
1987 and before July 1, 1990, a physician may not be excluded if the OIG
determines he or she is a sole community physician or the sole source of
specialized services in that community. We are moving references to limitations
in time periods of exclusion to Sec. 1003.107.
·
Section 1003.105: Effective December 22, 1987, the
statute was amended to allow the Secretary, pursuant to section 1842(j)(2) of
the Act, to exclude a physician who knowingly violated section 1867 of the Act.
In OBRA 89 Congress amended section 1867, allowing the Secretary, pursuant to
section 1128A (instead of section 1842(j)(2)), to exclude a physician who
knowingly and willfully or negligently violated the statute. The statute was
then amended in OBRA 90, changing the standard for exclusion from ``knowing and
willful or negligent'' to ``gross and flagrant or repeated'', effective May 1,
1991. We are implementing this provision in Sec. 1003.105(a)(1)(ii)(C). In
addition, in accordance with section 1842(j)(3) of the Act, the physician may
not be excluded if the physician is the sole community physician or sole source
of essential specialized services in a community. We are revising Sec.
1003.105(b) to include these exceptions.
·
Section 1003.106: As indicated in a response to one
of the comments, in accordance with the requirements of section 1128A(d) of the
Act, the final regulation includes two additional factors for consideration in
determining the amount of the penalty and the length of the exclusion under
part 1003: (1) ``The financial condition of the hospital and each responsible
physician who have violated any requirement of section 1867 of the Act,'' and
(2) ``The nature and circumstances of the violation.'' We are adding Sec. 1003.106(a)(4)
to reflect these provisions.
·
Section 1003.107: The regulations now reflect the
requirement of section 1842(j)(3) of the Act that if an exclusion is based upon
section 1842(j)(2) of the Act, then the access of beneficiaries to physician's
services must be considered.
·
Section 1003.108: We are revising this section to
include the terms ``assessment'' and ``exclusion.''
4. Technical revisions.
We have revised the
regulation to reflect the statutory amendments relating to the term ``active
labor.'' Section 6211(h)(1)(B) of OBRA 89 removed the term from the statutory
definitions section (section 1867(e) of the Act) and the concept it applied to
was incorporated into the definition of emergency medical condition. Hence, in
many areas of the regulations, only the term ``emergency medical condition'' is
included. However, the statute still uses the term ``labor'' in certain
circumstances, and the regulations reflect this where appropriate.
Under sections 6211(g)
(1) and (2) of OBRA 89, the words ``patient,'' ``patients'' and ``patient's''
are replaced by the words ``individual,'' ``individuals'' and ``individual's'',
respectively, each place they appear in Secs. 489.24 and 489.53 in reference to
hospitals. In addition, we have redesignated proposed Sec. 405.1903 in this
interim final rule as Sec. 488.18(d).
Unless the Secretary
certifies that an interim final rule will not have a significant economic
impact on a substantial number of small entities, we generally prepare a regulatory
flexibility analysis that is consistent with the Regulatory Flexibility Act
(RFA) (5 U.S.C. 601 through 612). For purposes of the RFA, we consider all
hospitals to be small entities. Individuals and states are not included in the
definition of a small entity.
In addition, section
1102(b) of the Act requires the Secretary to prepare a regulatory impact
analysis for any final rule that may have a significant impact on the
operations of a substantial number of small rural hospitals. Such an analysis
must conform to the provisions of section 604 of the RFA. For purposes of
section 1102(b) of the Act, we define a small rural hospital as a hospital that
has fewer than 100 beds and is located outside a Metropolitan Statistical Area.
The provisions of this
rule merely conform the regulations to the legislative provisions of sections
9121 and 9122 of COBRA (as amended by section 4009 of OBRA 87), section 233 of
the Veteran's Benefit Improvement and Health Care Authorization Act of 1986,
sections 9305 (b)(1) and 9307 of OBRA 86, section 4009 of OBRA 87, sections
6003(g)(3)(d)(XIV), 6018 and 6211 of OBRA 89 and sections 4008(b), 4027(a) and
4027(k)(3) of OBRA 90.
The provisions of this
rule will require Medicare participating hospitals to provide inpatient
services to individuals with insurance coverage under CHAMPUS, CHAMPVA, and VA
programs, provide each Medicare beneficiary a statement of his or her rights
concerning discharge from the hospital and provide an appropriate medical
screening examination to anyone who requests examination or treatment, and
stabilizing treatment in the emergency room to any individual with an emergency
medical condition.
As required by the
statute these provisions are in effect and are being enforced. Although
hospitals may incur incremental costs to ensure compliance with these
provisions, we believe the costs are minimal and the benefits to individuals
far outweigh those costs. These provisions will allow military personnel and
their families to receive inpatient services in hospitals that may be closer to
their homes as opposed to receiving services in military hospitals that may be
some distance away. Another benefit will be that all individuals will receive
medical screening and, if an emergency medical condition exists, will also
receive stabilizing treatment and protections against inappropriate transfers
regardless of the individual's eligibility for Medicare. We believe that
these provisions will improve access to care and reduce patient complaints. The
potential use of sanctions provides the incentive for hospitals to ensure
continued compliance with these provisions.
We included a voluntary
impact analysis in section VII of the preamble in the June 16, 1988 proposed
rule (53 FR 22513). We received no comments on that analysis, and we believe
that none of the changes incorporated into this interim final rule have any
significant impact. Therefore, we are not preparing a similar analysis.
For the reasons discussed
above, we have determined, and the Secretary certifies, that these final
regulations will not have significant economic impact on a substantial number
of small entities and will not have a significant impact on the operations of a
substantial number of small rural hospitals. Therefore, we have not prepared a
regulatory flexibility analysis or an analysis of effects on small rural
hospitals.
In accordance with the
provisions of Executive Order 12866, this regulation was reviewed by the Office
of Management and Budget.
Sections 488.18(d),
489.20 (m) and (r), and 489.24 (c), (d) and (g) of this interim final rule
contain information collection requirements that are subject to the Office of
Management and Budget review under the Paperwork Reduction Act of 1980. The
information collections in Secs. 488.18, 489.20(m), and 489.24 require the
State agencies to notify HCFA when hospitals are not in compliance with
provisions contained in the Medicare provider agreement. Section 489.20(m) also requires that a hospital report to HCFA or
a Medicare
state survey agency when the hospital believes it has received an individual
who has been transferred in an unstable emergency medical condition from
another hospital in violation of the requirements of Sec. 489.24(d). Section
489.20(r) now requires both transferring and receiving hospitals to develop and
maintain lists of on-call physicians and central logs containing information
about what services the individual did or did not receive and applicable
patient records on admissions, discharges, and transfers.
In addition, under Sec.
489.24 (c) and (d), transferring hospitals must send receiving hospitals an
individual's medical records (or copies) available at the time of the transfer,
and the individual's other medical records must be sent as soon as practicable
after the transfer. The provisions also require hospitals to record certain
information on individuals' medical records, require individuals to sign
consent forms pertaining to examinations, treatments and transfers, and require
physicians and other qualified medical personnel, when a physician is not
present in the emergency department but in consultation with the physician, to
sign transfer certifications containing specific information. Section 489.24(g) also requires PROs to
prepare reports regarding individuals' medical conditions when requested by
HCFA
Does not contain any EMTALA related comments.
x. Response to Comments
….:(d) If the State agency receives information to
the effect that a hospital or a rural primary care hospital (as defined in
section 1861(mm)(1) of the Act) has violated Sec. 489.24 of this chapter, the
State agency is to report the information to HCFA promptly.
B. Part 489 is amended as
follows:
PART 489--PROVIDER AGREEMENTS
UNDER MEDICARE
1.`The authority citation
for part 489 is revised to read as follows:
Authority: Secs. 1102,
1861, 1864, 1866, 1867, and 1871 of the Social Security Act (42 U.S.C. 1302,
1395x, 1395aa, 1395cc, 1395dd, and 1395hh), and sec. 602(k) of Pub. L. 98-21
(42 U.S.C. 1395ww note).
Subpart A--General
Provisions
2. In Sec. 489.20, the
introductory text is republished, and paragraphs (l) through (r) are added to
read as follows:
Sec. 489.20 Basic
commitments.
The provider agrees to
the following:
* * * * *
(l) In the case of a
hospital as defined in Sec. 489.24(b) to comply with Sec. 489.24.
(m) In the case of a
hospital as defined in Sec. 489.24(b), to report to HCFA or the State survey
agency any time it has reason to believe it may have received an individual who
has been transferred in an unstable emergency medical condition from another
hospital in violation of the requirements of Sec. 489.24(d)…
(q) In the case of a
hospital as defined in Sec. 489.24(b)—
(1) To post conspicuously
in any emergency department or in a place or places likely to be noticed by all
individuals entering the emergency department, as well as those individuals
waiting for examination and treatment in areas other than traditional emergency
departments (that is, entrance, admitting area, waiting room, treatment area),
a sign (in a form specified by the Secretary) specifying rights of individuals
under Section 1867 of the Act with respect to examination and treatment for
emergency medical conditions and women in labor; and
(2) To post conspicuously
(in a form specified by the Secretary) information indicating whether or not
the hospital or rural primary care hospital participates in the Medicaid
program under a State plan approved under title XIX.
(r) In the case of a
hospital as defined in Sec. 489.24(b) (including both the transferring and
receiving hospitals), to maintain—
(1) Medical and other
records related to individuals transferred to or from the hospital for a period
of 5 years from the date of the transfer;
(2) A list of physicians
who are on call for duty after the initial examination to provide treatment
necessary to stabilize an individual with an emergency medical condition; and
(3) A central log on each individual who
comes to the emergency department, as defined in Sec. 489.24(b), seeking
assistance and whether he or she refused treatment, was refused treatment, or
whether he or she was transferred, admitted and treated, stabilized and
transferred, or discharged.
3.
New Secs. 489.24 through 489.27 are added to read
as follows:
Sec. 489.24 Special responsibilities of Medicare
hospitals in emergency cases.
(a) General. In the case
of a hospital that has an emergency department, if any individual (whether or
not eligible for Medicare benefits and regardless of ability to pay) comes
by him or herself or with another person to the emergency department and a
request is made on the individual's behalf for examination or treatment of a
medical condition by qualified medical personnel (as determined by the hospital
in its rules and regulations), the hospital must provide for an appropriate
medical screening examination within the capability of the hospital's emergency
department, including ancillary services routinely available to the emergency department,
to determine whether or not an emergency medical condition exists. The
examinations must be conducted by individuals determined qualified by hospital
by-laws or rules and regulations and who meet the requirements of Sec. 482.55
concerning emergency services personnel and direction.
(b) Definitions. As used
in this subpart—
Capacity means the
ability of the hospital to accommodate the individual requesting examination or
treatment of the transferred individual. Capacity encompasses such things as
numbers and availability of qualified staff, beds and equipment and the
hospital's past practices of accommodating additional patients in excess of its
occupancy limits.
Comes to the emergency
department means, with respect to an individual requesting examination or
treatment, that the individual is on the hospital property (property includes
ambulances owned and operated by the hospital, even if the ambulance is not on
hospital grounds). An individual in a nonhospital-owned ambulance on hospital
property is considered to have come to the hospital's emergency department. An
individual in a nonhospital-owned ambulance off hospital property is not
considered to have come to the hospital's emergency department, even if a
member of the ambulance staff contacts the hospital by telephone or telemetry
communications and informs the hospital that they want to transport the
individual to the hospital for examination and treatment. In such situations,
the hospital may deny access if it is in ``diversionary status,'' that is, it
does not have the staff or facilities to accept any additional emergency
patients. If, however, the ambulance staff disregards the hospital's
instructions and transports the individual on to hospital property, the
individual is considered to have come to the emergency department.
Emergency medical
condition means—
(i) A medical condition
manifesting itself by acute symptoms of sufficient severity (including severe
pain, psychiatric disturbances and/or symptoms of substance abuse) such that
the absence of immediate medical attention could reasonably be expected to
result in--
(A) Placing the health of
the individual (or, with respect to a pregnant woman, the health of the woman
or her unborn child) in serious jeopardy;
(B) Serious impairment to
bodily functions; or
(C) Serious dysfunction
of any bodily organ or part; or
(ii) With respect to a
pregnant woman who is having contractions—
(A) That there is
inadequate time to effect a safe transfer to another hospital before delivery;
or
(B) That transfer may
pose a threat to the health or safety of the woman or the unborn child.
Hospital includes a rural
primary care hospital as defined in section 1861(mm)(1) of the Act.
Hospital with an
emergency department means a hospital that offers services for emergency
medical conditions (as defined in this paragraph) within its capability to do
so.
Labor means the process
of childbirth beginning with the latent or early phase of labor and continuing
through the delivery of the placenta. A woman experiencing contractions is in
true labor unless a physician certifies that, after a reasonable time of
observation, the woman is in false labor.
Participating hospital means (i) a hospital
or (ii) a rural primary care hospital as defined in section 1861(mm)(1) of the
Act that has entered into a Medicare provider agreement under section 1866 of the
Act.
Stabilized means, with
respect to an ``emergency medical condition'' as defined in this section under
paragraph (i) of that definition, that no material deterioration of the
condition is likely, within reasonable medical probability, to result from or
occur during the transfer of the individual from a facility or, with respect to
an ``emergency medical condition'' as defined in this section under paragraph
(ii) of that definition, that the woman has delivered the child and the
placenta.
To stabilize means, with
respect to an ``emergency medical condition'' as defined in this section under
paragraph (i) of that definition, to provide such medical treatment of the
condition necessary to assure, within reasonable medical probability, that no
material deterioration of the condition is likely to result from or occur
during the transfer of the individual from a facility or that, with respect to
an ``emergency medical condition'' as defined in this section under paragraph
(ii) of that definition, the woman has delivered the child and the placenta.
Transfer means the
movement (including the discharge) of an individual outside a hospital's
facilities at the direction of any person employed by (or affiliated or
associated, directly or indirectly, with) the hospital, but does not include
such a movement of an individual who (i) has been declared dead, or (ii) leaves
the facility without the permission of any such person. (c) Necessary
stabilizing treatment for emergency medical conditions--(1) General. If any
individual (whether or not eligible for Medicare benefits) comes to a
hospital and the hospital determines that the individual has an emergency
medical condition, the hospital must provide either—
(i) Within the
capabilities of the staff and facilities available at the hospital, for further
medical examination and treatment as required to stabilize the medical
condition; or
(ii) For transfer of the
individual to another medical facility in accordance with paragraph (d) of this
section.
(2) Refusal to consent to
treatment. A hospital meets the requirements of paragraph (c)(1)(i) of this
section with respect to an individual if the hospital offers the individual the
further medical examination and treatment described in that paragraph and
informs the individual (or a person acting on the individual's behalf) of the
risks and benefits to the individual of the examination and treatment, but the
individual (or a person acting on the individual's behalf) refuses to consent
to the examination and treatment. The medical record must contain a description
of the examination, treatment, or both if applicable, that was refused by or on
behalf of the individual. The hospital must take all reasonable steps to secure
the individual's written informed refusal (or that of the person acting on his
or her behalf). The written document should indicate that the person has been
informed of the risks and benefits of the examination or treatment, or both.
(3) Delay in examination
or treatment. A participating hospital may not delay providing an appropriate
medical screening examination required under paragraph (a) of this section or
further medical examination and treatment required under paragraph (c) in order
to inquire about the individual's method of payment or insurance status.
(4) Refusal to consent to
transfer. A hospital meets the requirements of paragraph (c)(1)(ii) of this
section with respect to an individual if the hospital offers to transfer the
individual to another medical facility in accordance with paragraph (d) of this
section and informs the individual (or a person acting on his or her behalf) of
the risks and benefits to the individual of the transfer, but the individual
(or a person acting on the individual's behalf) refuses to consent to the
transfer. The hospital must take all reasonable steps to secure the
individual's written informed refusal (or that of a person acting on his or her
behalf). The written document must indicate the person has been informed of the
risks and benefits of the transfer and state the reasons for the individual's
refusal. The medical record must contain a description of the proposed transfer
that was refused by or on behalf of the individual.
(d) Restricting transfer
until the individual is stabilized— (1) General. If an individual at a hospital
has an emergency medical condition that has not been stabilized (as defined in
paragraph (b) of this section), the hospital may not transfer the individual
unless—
(i) The transfer is an
appropriate transfer (within the meaning of paragraph (d)(2) of this section);
and
(ii)(A) The individual
(or a legally responsible person acting on the individual's behalf) requests
the transfer, after being informed of the hospital's obligations under this
section and of the risk of transfer. The request must be in writing and
indicate the reasons for the request as well as indicate that he or she is
aware of the risks and benefits of the transfer;
(B) A physician (within
the meaning of section 1861(r)(1) of the Act) has signed a certification that,
based upon the information available at the time of transfer, the medical
benefits reasonably expected from the provision of appropriate medical
treatment at another medical facility outweigh the increased risks to the
individual or, in the case of a woman in labor, to the woman or the unborn
child, from being transferred. The certification must contain a summary of the
risks and benefits upon which it is based; or
(C) If a physician is not
physically present in the emergency department at the time an individual is
transferred, a qualified medical person (as determined by the hospital in its
by-laws or rules and regulations) has signed a certification described in paragraph
(d)(1)(ii)(B) of this section after a physician (as defined in section
1861(r)(1) of the Act) in consultation with the qualified medical person,
agrees with the certification and subsequently countersigns the certification.
The certification must contain a summary of the risks and benefits upon which
it is based.
(2) A transfer to another
medical facility will be appropriate only in those cases in which—
(i) The transferring
hospital provides medical treatment within its capacity that minimizes the
risks to the individual's health and, in the case of a woman in labor, the
health of the unborn child;
(ii) The receiving
facility—
(A)
Has available space and qualified personnel for the treatment of the
individual; and
(B)
Has agreed to accept transfer of the individual and to provide appropriate
medical treatment;
(iii) The transferring
hospital sends to the receiving facility all medical records (or copies
thereof) related to the emergency condition which the individual has presented
that are available at the time of the transfer, including available history,
records related to the individual's emergency medical condition, observations
of signs or symptoms, preliminary diagnosis, results of diagnostic studies or
telephone reports of the studies, treatment provided, results of any tests and
the informed written consent or certification (or copy thereof) required under
paragraph (d)(1)(ii) of this section, and the name and address of any on-call
physician (described in paragraph (f) of this section) who has refused or
failed to appear within a reasonable time to provide necessary stabilizing
treatment. Other records (e.g., test results not yet available or historical
records not readily available from the hospital's files) must be sent as soon
as practicable after transfer; and
(iv) The transfer is
effected through qualified personnel and transportation equipment, as required,
including the use of necessary and medically appropriate life support measures
during the transfer.
(3) A participating hospital
may not penalize or take adverse action against a physician or a qualified
medical person described in paragraph (d)(1)(ii)(C) of this section because the
physician or qualified medical person refuses to authorize the transfer of an
individual with an emergency medical condition that has not been stabilized, or
against any hospital employee because the employee reports a violation of a
requirement of this section.
(e) Recipient hospital
responsibilities. A participating hospital that has specialized capabilities or
facilities (including, but not limited to, facilities such as burn units,
shock-trauma units, neonatal intensive care units, or (with respect to rural
areas) regional referral centers) may not refuse to accept from a referring
hospital within the boundaries of the United States an appropriate transfer of
an individual who requires such specialized capabilities or facilities if the
receiving hospital has the capacity to treat the individual.
(f) Termination of
provider agreement. If a hospital fails to meet the requirements of paragraph
(a) through (e) of this section, HCFA may terminate the provider agreement in
accordance with Sec. 489.53.
(g) Consultation with
Peer Review Organizations (PROs)--(1) General. Except as provided in paragraph
(g)(3) of this section, in cases where a medical opinion is necessary to
determine a physician's or hospital's liability under section 1867(d)(1) of the
Act, HCFA requests the appropriate PRO (with a contract under Part B of title
XI of the Act) to review the alleged section 1867(d) violation and provide a
report on its findings in accordance with paragraph (g)(2)(iv) and (v) of this
section. HCFA provides to the PRO all information relevant to the case and
within its possession or control. HCFA, in consultation with the OIG, also
provides to the PRO a list of relevant questions to which the PRO must respond
in its report.
(2) Notice of review and
opportunity for discussion and additional information. The PRO shall provide
the physician and hospital reasonable notice of its review, a reasonable
opportunity for discussion, and an opportunity for the physician and hospital
to submit additional information before issuing its report. When a PRO receives
a request for consultation under paragraph (g)(1) of this section, the
following provisions apply—
(i) The PRO reviews the
case before the 15th calendar day and makes its tentative findings.
(ii) Within 15 calendar
days of receiving the case, the PRO gives written notice, sent by certified
mail, return receipt requested, to the physician or the hospital (or both if
applicable).
(iii) (A) The written
notice must contain the following information:
(1)
The name of each individual who may have been the subject of the alleged
violation.
(2)
The date on which each alleged violation occurred.
(3)
An invitation to meet, either by telephone or in person, to discuss the case
with the PRO, and to submit additional information to the PRO within 30
calendar days of receipt of the notice, and a statement that these rights will
be waived if the invitation is not accepted. The PRO must receive the
information and hold the meeting within the 30-day period.
(4)
A copy of the regulations at 42 CFR 489.24.
(B) For purposes of
paragraph (g)(2)(iii)(A) of this section, the date of receipt is presumed to be
5 days after the certified mail date on the notice, unless there is a
reasonable showing to the contrary.
(iv) The physician or
hospital (or both where applicable) may request a meeting with the PRO. This
meeting is not designed to be a formal adversarial hearing or a mechanism for
discovery by the physician or hospital. The meeting is intended to afford the
physician and/or the hospital a full and fair opportunity to present the views
of the physician and/or hospital regarding the case. The following provisions
apply to that meeting:
(A) The physician and/or
hospital has the right to have legal counsel present during that meeting.
However, the PRO may control the scope, extent, and manner of any questioning
or any other presentation by the attorney. The PRO may also have legal counsel
present.
(B) The PRO makes
arrangements so that, if requested by HCFA or the OIG, a verbatim transcript of
the meeting may be generated. If HCFA or OIG requests a transcript, the
affected physician and/or the affected hospital may request that HCFA provide a
copy of the transcript.
(C) The PRO affords the
physician and/or the hospital an opportunity to present, with the assistance of
counsel, expert testimony in either oral or written form on the medical issues
presented. However, the PRO may reasonably limit the number of witnesses and
length of such testimony if such testimony is irrelevant or repetitive. The
physician and/or hospital, directly or through counsel, may disclose patient records
to potential expert witnesses without violating any non-disclosure requirements
set forth in part 476 of this chapter.
(D) The PRO is not
obligated to consider any additional information provided by the physician
and/or the hospital after the meeting, unless, before the end of the meeting,
the PRO requests that the physician and/or hospital submit additional
information to support the claims. The PRO then allows the physician and/or the
hospital an additional period of time, not to exceed 5 calendar days from the
meeting, to submit the relevant information to the PRO.
(v) Within 60 calendar
days of receiving the case, the PRO must submit to HCFA a report on the PRO's
findings. HCFA provides copies to the OIG and to the affected physician and/or
the affected hospital. The report must contain the name of the physician and/or
the hospital, the name of the individual, and the dates and times the
individual arrived at and was transferred (or discharged) from the hospital.
The report provides expert medical opinion regarding whether the individual
involved had an emergency medical condition, whether the individual's emergency
medical condition was stabilized, whether the individual was transferred
appropriately, and whether there were any medical utilization or quality of
care issues involved in the case.
(vi) The report required
under paragraph (g)(2)(v) of this section should not state an opinion or
conclusion as to whether section 1867 of the Act or Sec. 489.24 has been
violated.
(3) If a delay would jeopardize
the health or safety of individuals or when there was no screening examination,
the PRO review described in this section is not required before the OIG may
impose civil monetary penalties or an exclusion in accordance with section
1867(d)(1) of the Act and 42 CFR part 1003 of this title.
(4) If the PRO determines
after a preliminary review that there was an appropriate medical screening
examination and the individual did not have an emergency medical condition, as
defined by paragraph (b) of this section, then the PRO may, at its discretion,
return the case to HCFA and not meet the requirements of paragraph (g) except
for those in paragraph (g)(2)(v).
(h) Release of PRO
assessments. Upon request, HCFA may release a PRO assessment to the physician
and/or hospital, or the affected individual, or his or her representative. The
PRO physician's identity is confidential unless he or she consents to its
release. (See Secs. 476.132 and 476.133 of this chapter.).
Sec. 489.53 Termination by HCFA.
(a) Basis for termination of agreement with any
provider. HCFA may terminate the agreement with any provider if HCFA finds that
any of the following failings is attributable to that provider:
* * * * *
(10) In the case of a hospital or a rural primary
care hospital as defined in section 1861(mm)(1) of the Act that has reason to
believe it may have received an individual transferred by another hospital in
violation of Sec. 489.24(d), the hospital failed to report the incident to HCFA
or the State survey agency. …
(b) Termination of provider agreement. (1) In the
case of a hospital or rural primary care hospital that has an emergency
department as defined in Sec. 489.24(b), HCFA may terminate the provider
agreement if—
(i) The hospital fails to comply with the
requirements of Sec. 489.24 (a) through (e), which require the hospital to
examine, treat or transfer emergency medical condition cases appropriately, and
require that hospitals with specialized capabilities or facilities accept an
appropriate transfer; or
(ii) The hospital fails to comply with Sec. 489.20
(m), (q), and (r), which require the hospital to report suspected violations of
Sec. 489.24(d), to post conspicuously in emergency departments or in a place or
places likely to be noticed by all individuals entering the emergency
departments, as well as those individuals waiting for examination and treatment
in areas other than traditional emergency departments, (that is, entrance,
admitting area, waiting room, treatment area), signs specifying rights of
individuals under this subpart, to post conspicuously information indicating
whether or not the hospital participates in the Medicaid program, and to
maintain medical and other records related to transferred individuals for a
period of 5 years, a list of on-call physicians for individuals with emergency
medical conditions, and a central log on each individual who comes to the
emergency department seeking assistance….
(2) Exception
(i) For a SNF with deficiencis that pose immediate
jeopardy to patients' health and safety, HCFA gives notice of termination at
least 2 days before the effective date of termination of the provider
agreement.
(ii) If HCFA finds that a hospital is in violation
of Sec. 489.24 (a) through (e), and HCFA determines that the violation poses
immediate and serious jeopardy to the health and safety of the individuals
presenting themselves to the hospital for emergency services, HCFA:
(A) Gives a preliminary notice of termination
notifying the hospital that it will be terminated in 23 days if it does not
correct or refute the identified deficiencies;
(B) Gives a final notice of termination and
concurrent notice to the public at least 2 and not more than 4 days before the
effective date of termination of the provider agreement.
* * * * *
3. Section 1003.101 is amended by adding
definitions for the terms ``participating hospital'' and ``responsible
physician,'' and by revising the definition of ``respondent'' to read as
follows:
Sec. 1003.101 Definitions. For purposes of this
part:
* * * * *
Participating hospital
means (1) a hospital or (2) a rural primary care hospital as defined in section
1861(mm)(1) of the Act that has entered into a Medicare provider agreement
under section 1866 of the Act.
* * * * *
Respondent means the person
upon whom the Department has imposed, or proposes to impose, a penalty,
assessment or exclusion. Responsible physician means a physician who is
responsible for the examination, treatment, or transfer of an individual who
comes to a participating hospital's emergency department seeking assistance and
includes a physician on call for the care of such individual.
* * * * *
4. Section 1003.102 is
amended by redesignating paragraph (c) as paragraph (d), adding a new paragraph
(c), and revising redesignated paragraph (d) to read as follows:
Sec. 1003.102 Basis for
civil money penalties and assessment. * * * * *
(c) (1) The Office of the
Inspector General (OIG) may impose a penalty for violations of section 1867 of
the Act or Sec. 489.24 of this title against—
(i) Any participating
hospital with an emergency department that--
(A) Knowingly violates
the statute on or after August 1, 1986 or;
(B) Negligently violates
the statute on or after May 1, 1991; and
(ii) Any responsible
physician who—
(A) Knowingly violates
the statute on or after August 1, 1986;
(B) Negligently violates
the statute on or after May 1, 1991;
(C) Signs a certification
under section 1867(c)(1)(A) of the Act if the physician knew or should have
known that the benefits of transfer to another facility did not outweigh the
risks of such a transfer; or
(D) Misrepresents an individual's condition
or other information, including a hospital's obligations under this section.
(2) For purposes of this
section, a responsible physician or hospital ``knowingly'' violates section
1867 of the Act if the responsible physician or hospital recklessly disregards,
or deliberately ignores a material fact.
(d) (1) In any case in
which it is determined that more than one person was responsible for presenting
or causing to be presented a claim as described in paragraph (a) of this
section, each such person may be held liable for the penalty prescribed by this
part, and an assessment may be imposed against any one such person or jointly
and severally against two or more such persons, but the aggregate amount of the
assessments collected may not exceed the amount that could be assessed if only
one person was responsible.
(2) In any case in which
it is determined that more than one person was responsible for presenting or
causing to be presented a request for payment or for giving false or misleading
information as described in paragraph (b) of this section, each such person may
be held liable for the penalty prescribed by this part.
(3) In any case in which
it is determined that more than one person was responsible for failing to
report information that is required to be reported on a medical malpractice
payment, or for improperly disclosing, using, or permitting access to
information, as described in paragraphs (b)(5) and (b)(6) of this section, each
such person may be held liable for the penalty prescribed by this part.
(4) In any case in which
it is determined that more than one responsible physician violated the
provisions of section 1867 of the Act or of Sec. 489.24 of this title, a
penalty may be imposed against each responsible physician.
(5) Under this section, a
principal is liable for penalties and assessments for the actions of his or her
agent acting within the scope of the agency.
5. Section 1003.103 is
amended by revising paragraph (a), and adding a new paragraph (e) to read as
follows:
Sec. 1003.103 Amount of
penalty.
(a) Except as provided in
paragraphs (b), (c), (d), and (e) of this section, the OIG may impose a penalty
of not more than $2,000 for each item or service that is subject to a
determination under Sec. 1003.102.
* * * * *
(e) For violations of
section 1867 of the Act or Sec. 489.24 of this title, the OIG may impose—
(1) Against each
participating hospital with an emergency department, a penalty of not more
than--
(i) $25,000 for each
knowing violation occurring on or after August 1, 1986 and before December 22,
1987;
(ii) $50,000 for each
knowing violation occurring on or after December 22, 1987; and
(iii) $50,000 for each
negligent violation occurring on or after May 1, 1991, except that if the
participating hospital has fewer than 100 State-licensed, Medicare-certified
beds on the date the penalty is imposed, the penalty will not exceed $25,000;
and
(2) Against each responsible
physician, a penalty of not more than—
(i) $25,000 for each
knowing violation occurring on or after August 1, 1986 and before December 22,
1987;
(ii) $50,000 for each
knowing violation occurring on or after December 22, 1987; and
(iii) $50,000 for each
negligent violation occurring on or after May 1, 1991.
6. Section 1003.105 is
revised to read as follows:
Sec. 1003.105 Exclusion
from participation in Medicare and State health care programs.
(a) (1) Except as set
forth in paragraph (b) of this section, the following persons may be subject,
in lieu of or in addition to any penalty or assessment, to an exclusion from
participation in Medicare for a period of time determined under Sec.
1003.107. The OIG will also direct each appropriate State agency to exclude the
person from each health care program for the same period of time--
(i) Any person who is
subject to a penalty or assessment under Sec. 1003.102 (a) or (b)(1) through
(b)(4).
(ii) Any responsible
physician who—
(A) Knowingly violates
section 1867 of the Act or Sec. 489.24 of this title on or after December 22,
1987, but before July 1, 1990;
(B) Knowingly and
willfully, or negligently, violates section 1867 of the Act or Sec. 489.24 of
this title on or after July 1, 1990 but before May 1, 1991; or
(C) Commits a gross and
flagrant, or repeated, violation of section 1867 of the Act or Sec. 489.24 of
this title on or after May 1, 1991. For purposes of this section, a gross and
flagrant violation is one that presents an imminent danger to the health,
safety or well-being of the individual who seeks emergency examination and
treatment or places that individual unnecessarily in a high-risk situation.
(2) Nothing in this
section will be construed to limit the Department's authority to impose an
exclusion without imposing a penalty.
(b)(1) With respect to
determinations under Sec. 1003.102 (b)(2) or (b)(3), or with respect to
violations occurring on or after December 22, 1987 and before July 1, 1990
under Sec. 1003.105(a)(1)(ii), a physician may not be excluded if the OIG
determines that he or she is the sole community physician or the sole source of
essential specialized services in a community.
(2)(i) With respect to
any exclusion based on liability for a penalty or assessment under Sec.
1003.102 (a), (b)(1), or (b)(4), the OIG will consider an application from a
State agency for a waiver if the person is the sole community physician or the
sole source of essential specialized services in a community. With respect to
any exclusion imposed under Sec. 1003.105(a)(1)(ii), the OIG will consider an
application from a State agency for a waiver if the physician's exclusion from
the State health care program would deny beneficiaries access to medical care
or would otherwise cause hardship to beneficiaries.
(ii) If a waiver is
granted, it is applicable only to the State health care program for which the
State requested the waiver.
(iii) If the OIG
subsequently obtains information that the basis for a waiver no longer exists,
or the State agency submits evidence that the basis for the waiver no longer
exists, the waiver will cease and the person will be excluded from the State
health care program for the remainder of the period that the person is excluded
from Medicare.
(iv) The OIG notifies the
State agency whether its request for a waiver has been granted or denied.
(v) The decision to deny
a waiver is not subject to administrative or judicial review.
(3) For purposes of this
section, the definitions contained in Sec. 1001.2 of this chapter for ``sole
community physician'' and ``sole source of essential specialized services in a
community'' apply.
(c) When the Inspector
General proposes to exclude a nursing facility from the Medicare
and Medicaid programs, he or she will, at the same time he or she notifies the
respondent, notify the appropriate State licensing authority, the State Office
of Aging, the long-term care ombudsman, and the State Medicaid agency of the
Inspector General's intention to exclude the facility.
7. Section 1003.106 is amended
by adding a heading to paragraph (a), adding paragraph (a)(4), and revising the
introductory text of paragraph (b) to read as follows:
Sec. 1003.106
Determinations regarding the amount of the penalty and assessment.
(a) Amount of penalty.
* * * * *
(4) In determining the
amount of any penalty in accordance with Sec. 1003.102(c), the OIG takes into
account—
(i) The degree of
culpability of the respondent;
(ii) The seriousness of
the condition of the individual seeking emergency medical treatment;
(iii) The prior history
of offenses of the respondent in failing to provide appropriate emergency
medical screening, stabilization and treatment of individuals coming to a
hospital's emergency department or to effect an appropriate transfer;
(iv) The respondent's
financial condition;
(v) The nature and
circumstances of the violation; and
(vi) Such other matters
as justice may require.
(b) Determining the
amount of the penalty or assessment. As guidelines for taking into account the
factors listed in paragraph (a)(1) of this section, the following circumstances
are to be considered—
* * * * *
8. Section 1003.107 is
revised to read as follows:
Sec. 1003.107
Determinations regarding exclusion.
(a) In determining
whether to exclude a person under this part and the duration of any exclusion,
the Department considers the circumstances described in Sec. 1003.106(a).
(b) With respect to
determinations to exclude a person under Secs. 1003.102(a) or (b)(1) through
(b)(4), the Department considers those circumstances described in Sec.
1003.106(b). Where there are aggravating circumstances with respect to such
determinations, the person should be excluded.
(c) In determining
whether to exclude a physician under Secs. 1003.102(b)(2) or (b)(3) or, with
respect to a violation occurring on or after December 22, 1987 and before July
1, 1990, under Sec. 1003.105(a)(1)(ii), the Department also considers the
access of beneficiaries to physicians' services.
(d) Except as set forth
in paragraph (e), the guidelines set forth in this section are not binding.
Nothing in this section limits the authority of the Department to settle any
issue or case as provided by Sec. 1003.126.
(e) An exclusion based on
a determination under Secs. 1003.102(b)(2) or (b)(3) or, with respect to a
violation occurring on or after December 22, 1987 and before July 1, 1990,
under Sec. 1003.105(a)(1)(ii), may not exceed 5 years.
9. Section 1003.108 is
revised to read as follows:
Sec. 1003.108 Penalty,
assessment, and exclusion not exclusive.
Penalties, assessments,
and exclusions imposed under this part are in addition to any other penalties
prescribed by law. 10. Section 1003.109 is amended by revising paragraphs (a)
introductory text and (a)(4) through (6), and by adding paragraphs (a)(7) and
(c) to read as follows:
Sec. 1003.109 Notice of proposed
determination.
(a) If the Inspector
General proposes a penalty and, when applicable, assessment, or proposes to
exclude a respondent from participation in Medicare or any State health
care program, as applicable, in accordance with this part, he or she must
deliver or send by certified mail, return receipt requested, to the respondent,
written notice of his or her intent to impose a penalty, assessment and
exclusion, as applicable. The notice includes--
* * * * *
(4) The amount of the
proposed penalty, assessment and the period of proposed exclusion (where
applicable);
(5) Any circumstances
described in Sec. 1003.106 that were considered when determining the amount of
the proposed penalty and assessment and the period of exclusion;
(6) Instructions for
responding to the notice, including—
(i) A specific statement
of respondent's right to a hearing, and
(ii) A statement that
failure to request a hearing within 60 days permits the imposition of the
proposed penalty, assessment and exclusion without right of appeal; and
(7) In the case of a
notice sent to a respondent who has an agreement under section 1866 of the Act,
the notice also indicates that the imposition of an exclusion may result in the
termination of the provider's agreement in accordance with section
1866(b)(2)(C) of the Act.
* * * * *
(c) If the respondent
fails, within the time permitted, to exercise his or her right to a hearing
under this section, any exclusion, penalty, or assessment becomes final.
(Catalog of Federal
Domestic Assistance Program No. 93.773, Medicare--Hospital Insurance)
Dated: May 27, 1994.
Bruce C. Vladeck, Administrator, Health Care Financing Administration. Dated:
May 27, 1994. June G. Brown, Inspector General, Department of Health and Human
Services. Dated: June 13,1994. Donna E. Shalala, Secretary.
Appendix I--An Important
Message From Medicare;
Your Rights While You Are a Medicare Hospital Patient
·
You have the right to receive all the hospital care
that is necessary for the proper diagnosis and treatment of your illness or
injury. According to Federal law, your discharge date must be determined solely
by your medical needs, not by ``Diagnosis Related Groups'' (DRGs) or Medicare
payments.
·
You have the right to be fully informed about
decisions affecting your Medicare coverage and payment for your hospital stay and
for any post-hospital services.
·
You have the right to request a review by a Peer
Review Organization (PRO) of any written Notice of Noncoverage that you receive
from the hospital stating that Medicare will no longer pay for your
hospital care. PROs are groups of doctors who are paid by the Federal
Government to review medical necessity, appropriateness and quality of hospital
treatment furnished to Medicare patients. The phone number and address of the
PRO for your area are:
Talk to Your Doctor About
Your Stay in the Hospital
You and your doctor know
more about your condition and your health needs than anyone else. Decisions
about your medical treatment should be made between you and your doctor. If you
have any questions about your medical treatment, your need for continued
hospital care, your discharge, or your need for possible post- hospital care,
don't hesitate to ask your doctor. The hospital's patient representative or
social worker will also help you with your questions and concerns about
hospital services.
If You Think You Are
Being Asked To Leave the Hospital Too Soon
·
Ask a hospital representative for a written notice
of explanation immediately, if you have not already received one. This notice
is called a Notice of Noncoverage. You must have this Notice of Noncoverage if
you wish to exercise your right to request a review by the PRO.
·
The Notice of Noncoverage will state either that
your doctor or the PRO agrees with the hospital's decision that Medicare
will no longer pay for your hospital care.
--If the hospital and your doctor agree, the PRO
does not review your case before a Notice of Noncoverage is issued. But the PRO
will respond to your request for a review of your Notice of Noncoverage and
seek your opinion. You cannot be made to pay for your hospital care until the
PRO makes its decision, if you request the review by noon of the first work day
after you receive the Notice of Noncoverage.
--If the hospital and your doctor disagree, the
hospital may request the PRO to review your case. If it does make such a
request, the hospital is required to send you a notice to that effect. In this
situation the PRO must agree with the hospital or the hospital cannot issue a
Notice of Noncoverage. You may request that the PRO reconsider your case after
you receive a Notice of Noncoverage, but since the PRO has already reviewed
your case once, you may have to pay for at least one day of hospital care
before the PRO completes this reconsideration.
If you do not request a
review, the hospital may bill you for all the costs of your stay beginning with
the third day after you receive the Notice of Noncoverage. The hospital, however,
cannot charge you for care unless it provides you with a Notice of Noncoverage.
How To Request a Review
of the Notice of Noncoverage
·
If the Notice of Noncoverage states that your
physician agrees with the hospital's decision.
--You must make your request for review to the PRO
by noon of the first work day after you receive the Notice of Noncoverage by
contacting the PRO by phone or in writing.
--The PRO must ask for your views about your case
before making its decision. The PRO will inform you by phone or in writing of
its decision on the review.
--If the PRO agrees with the Notice of Noncoverage,
you may be billed for all costs of your stay beginning at noon of the day you
receive the PRO's decision.
--Thus, you will not be responsible for the cost of
hospital care before you receive the PRO's decision.
·
If the Notice of Noncoverage states that the PRO
agrees with the hospital's decision:
--You should make your request for reconsideration
to the PRO immediately upon receipt of the Notice of Noncoverage by contacting
the PRO by phone or in writing.
--The PRO can take up to three working days from
receipt of your request to complete the review. The PRO will inform you in
writing of its decision on the review.
--Since the PRO has already reviewed your case
once, prior to the issuance of the Notice of Noncoverage, the hospital is
permitted to begin billing you the cost of your stay beginning with the third
calendar day after you receive your Notice of Noncoverage even if the PRO has
not completed its review.
--Thus, if the PRO continues to agree with the
Notice of Noncoverage, you may have to pay for at least one day of hospital
care.
Note: The process
described above is called ``immediate review.'' If you miss the deadline for
this immediate review while you are in the hospital, you may still request a
review of Medicare's
decision to no longer pay for your care at any point during your hospital stay
or after you have left the hospital. The Notice of Noncoverage will tell you
how to request this review.
Post-Hospital Care
When your doctor
determines that you no longer need all the specialized services provided in a
hospital, but you still require medical care, he or she may discharge you to a
skilled nursing facility or home care. The discharge planner at the hospital
will help arrange for the services you may need after your discharge. Medicare
and supplemental insurance policies have limited coverage for skilled nursing
facility care and home health care. Therefore, you should find out which
services will or will not be covered and how payment will be made. Consult with
your doctor, hospital discharge planner, patient representative, and your
family in making preparations for care after you leave the hospital. Don't
hesitate to ask questions.
Acknowledge of
Receipt--My signature only acknowledges my receipt of this Message from (name
of hospital) on (date) and does not waive any of my rights to request a review
or make me liable for any payment. _
----------------------------------------------------------------------
Signature of beneficiary or person acting on behalf
of beneficiary _
----------------------------------------------------------------------
Date of receipt
Appendix II--Posting of Signs
Section 6018(a)(2) of the Omnibus Budget
Reconciliation Act of 1989 (OBRA '89), effective July 1, 1990, requires
hospitals and rural primary care hospitals with emergency departments to post
signs which specify the rights (under section 1867 of the Social Security Act)
of women in labor and individuals with emergency medical conditions to
examination and treatment.
To comply with these requirements:
·
At a minimum, the signs must specify the rights of
unstable individuals with emergency conditions and women in labor who come to
the emergency department for health care services;
·
It must indicate whether the facility participates
in the Medicaid program;
·
The wording of the sign must be clear and in simple
terms understandable by the population serviced;
·
Print the signs in English and other major
languages that are common to the population of the area serviced;
·
The letters within the signs must be clearly
readable at a distance of at least 20 feet or the expected vantage point of the
emergency department patrons; and
·
Post signs in a place or places likely to be
noticed by all individuals entering the emergency department, as well as those
individuals waiting for examination and treatment (e.g., entrance, admitting
area, waiting room, treatment area). The sample on the following page, which
may be adapted for your use, contains sufficient information to satisfy these
requirements. It does not, however, satisfy the visibility requirement.
Appendix III--It's the Law! If You Have a Medical
Emergency or Are in Labor
You have the right to receive, within the
capabilities of this hospital's staff and facilities:
·
An appropriate medical Screening Examination.
·
Necessary Stabilizing Treatment (including
treatment for an unborn child) and if necessary.
·
An appropriate Transfer to another facility even if
you cannot pay or do not have medical insurance or you are not entitled to Medicare
or Medicaid.
This hospital (does/does
not) participate in the Medicaid program. [FR Doc. 94-14926 Filed 6-16-94; 1:43
pm] BILLING CODE 4120-01-P