[Federal Register Volume 59, Number 119 (Wednesday, June 22, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-14926]
[[Page Unknown]]
[Federal Register: June 22, 1994]
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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
Medicare Program; Participation in CHAMPUS and CHAMPVA, Hospital
Admissions for Veterans, Discharge Rights Notice, and Hospital
Responsibility for Emergency Care
AGENCIES: Health Care Financing Administration (HCFA) and Office of
Inspector General (OIG).
ACTION: Interim final rule with comment period.
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SUMMARY: We are revising requirements for Medicare participating
hospitals by adding the following:
A hospital must provide inpatient hospital services to individuals
who have health coverage provided by either the Civilian Health and
Medical Program of the Uniformed Services (CHAMPUS) or the Civilian
Health and Medical Program of the Veterans Administration (CHAMPVA),
subject to limitations provided by regulations that require the
hospital to collect the beneficiary's cost-share and accept payment
from the CHAMPUS/CHAMPVA programs as payment in full.
A hospital must provide inpatient hospital services to military
veterans (subject to the limitations provided in 38 CFR 17.50 ff.) and
accept payment from the Department of Veterans Affairs as payment in
full.
A hospital must give each Medicare beneficiary (or his or her
representative) at or about the time of admission, a written statement
of his or her rights concerning discharge from the hospital.
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 revisions implement sections 9121 and 9122 of the
Consolidated Omnibus Budget Reconciliation Act of 1985 (as amended by
section 4009 of the Omnibus Budget Reconciliation Act of 1987), section
233 of the Veteran's Benefit Improvement and Health Care Authorization
Act of 1986, sections 9305(b)(1) and 9307 of the Omnibus Budget
Reconciliation Act of 1986, sections 6003(g)(3)(D)(xiv), 6018 and 6211
of the Omnibus Budget Reconciliation Act of 1989, and sections 4008(b),
4027(a), and 4027(k)(3) of the Omnibus Budget Reconciliation Act of
1990.
DATES: Effective date: This interim final rule with comment period is
effective July 22, 1994, with the exception of the new information
collection and recordkeeping requirements contained in Sec. 488.18,
Sec. 489.20(m), Sec. 489.20(r)(2) and (3), and Sec. 489.24(d) and (g),
which are not yet approved by OMB under the Paperwork Reduction Act of
1980. Following OMB approval, a document will be published in the
Federal Register announcing the effective date for those sections.
Comment date: Comments on changes to the June 16, 1988 proposed
rule resulting from provisions of the Omnibus Budget Reconciliation Act
of 1989 (OBRA 89) or the Omnibus Budget Reconciliation Act of 1990
(OBRA 90) will be considered if we receive them at the appropriate
address as provided below, no later than 5:00 p.m. on August 22, 1994.
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.
ADDRESSES: Mail comments (an original and three copies) to the
following address: Health Care Financing Administration, Department of
Health and Human Services, Attention: BPD-393-FC, P.O. Box 7517
Baltimore, MD 21207-0517.
If you prefer, you may deliver your comments (an original and three
copies) to one of the following addresses:
Room 309-G, Hubert H. Humphrey Building, 200 Independence Ave., SW.,
Washington, DC 20201, or
Room 132, East High Rise Building, 6325 Security Boulevard, Baltimore,
MD 21207.
Because of staffing and resource limitations, we cannot accept
comments by facsimile (FAX) transmission. In commenting, please refer
to file code BPD-393-FC. Comments received timely will be available for
public inspection as they are received, generally beginning
approximately 3 weeks after publication of a document, in Room 309-G of
the Department's offices at 200 Independence Avenue, SW., Washington,
DC, on Monday through Friday of each week from 8:30 a.m. to 5:00 P.M.
(Phone: 202-690-7890).
If you wish to submit comments on the information collection
requirements contained in this interim final rule with comment period,
you may submit comments to: Allison Herron Eydt, HCFA Desk Officer,
Office of Information and Regulatory Affairs, Room 3002, New Executive
Office Building, Washington, DC 20503.
Copies: To order copies of the Federal Register containing this
document, send your request to: New Orders, Superintendent of
Documents, P.O. Box 371954, Pittsburgh, PA 15250-7954. Specify the date
of the issue requested and enclose a check or money order payable to
the Superintendent of Documents, or enclose your Visa or Master Card
number and expiration date. Credit card orders can also be placed by
calling the order desk at (202) 783-3238 or by faxing to (202) 275-
6802. The cost for each copy is $6.00. As an alternative, you may view
and photocopy the Federal Register document at most libraries
designated as U.S. Government Depository Libraries and at many other
public and academic libraries throughout the country that receive the
Federal Register.
FOR FURTHER INFORMATION, CONTACT:
Arlene Ford, 410-966-4617--For provisions relating to the beneficiary
statement of discharge rights.
Tom Hoyer, 410-966-4607--For provisions relating to individuals with
emergency medical conditions.
Lindsey Bramwell, 410-966-6747--For PRO provisions relating to
responsibilities to determine whether the individual involved had an
emergency medical condition that had not been stabilized.
Joel Schaer, 202-619-0089--For OIG civil monetary penalty and physician
exclusion provisions relating to individuals with emergency medical
conditions.
Beverly Christian, 410-966-4616--For provisions relating to
participation in the CHAMPUS/CHAMPVA and VA health care programs.
Rose Sabo, 303-361-1178--For questions regarding CHAMPUS and CHAMPVA
programs.
Wanda Elam, 202-535-7434--For questions regarding the Department of
Veterans Affairs health care program.
SUPPLEMENTARY INFORMATION:
I. Background
On June 16, 1988, we published a proposed rule concerning
participation in the CHAMPUS and CHAMPVA programs, hospital admissions
for veterans, a requirement for a discharge rights notice, and hospital
responsibility for emergency care (53 FR 22513). Below is a discussion
of the issues for which we proposed regulations.
A. Participation in the CHAMPUS and CHAMPVA Programs
CHAMPUS (Civilian Health and Medical Program of the Uniformed
Services) and CHAMPVA (Civilian Health and Medical Program of the
Veterans Administration) programs pay for health care services
furnished to dependents and survivors of military personnel, to
retirees and their dependents, and to veterans. Generally, the programs
have paid hospitals based on the hospital's charges. Section 931 of the
Department of Defense Authorization Act, 1984 (Pub. L. 98-94),
authorized these programs to pay (to the extent practicable) for
inpatient hospital services using Medicare payment procedures. Because
the Medicare prospective payment system (the system whereby we pay a
hospital a predetermined amount based on the patient's diagnosis and
any surgical procedures performed, rather than by the number of days
hospitalized) results in Medicare cost savings, the Department of
Defense (DoD) expected to realize similar savings if it were to use a
model similar to Medicare's prospective payment system. Paying on the
basis of a fixed rate appropriate to the particular diagnosis involved
has been shown to be an equitable method of paying for hospital care.
Therefore, the Office of Civilian Health and Medical Program of the
Uniformed Services (OCHAMPUS) published a final rule on September 1,
1987, that included provisions for the implementation of a DRG-based
payment system modeled after Medicare's prospective payment system for
CHAMPUS inpatient hospital admissions occurring on or after October 1,
1987 (52 FR 32992).
Hospitals that furnish services to CHAMPUS and CHAMPVA
beneficiaries are authorized to provide services to these beneficiaries
following an approval process similar to that used for Medicare
participation. Generally, that means the hospital is licensed and
accredited by the Joint Commission on Accreditation of Healthcare
Organizations (JCAHO), and otherwise meets CHAMPUS requirements. A
hospital certified and participating under Medicare may be deemed to
meet CHAMPUS requirements.
``Participation'' has a different meaning for CHAMPUS and CHAMPVA
than for Medicare. Providers have been able to decide on a claim-by-
claim basis whether to ``participate'' in the program and thus accept
the CHAMPUS/CHAMPVA-determined allowable amount, plus the patient cost-
share, as payment in full. Beneficiaries are required to pay a cost-
share for each hospital admission. The CHAMPUS/CHAMPVA payment, plus
the beneficiary's cost-share, constitute payment in full for the
covered services when the provider signs and submits an appropriately
completed program claim form that indicates participation. Under
Medicare, hospitals must agree to bill the program for all
beneficiaries and accept the CHAMPUS/CHAMPVA payment as payment in full
(less applicable deductibles, coinsurance amounts, and noncovered
items).
As indicated above, Medicare hospitals also may be authorized
providers in CHAMPUS and CHAMPVA on the basis of their JCAHO-approved
status or may be deemed authorized providers based on their Medicare-
approved status. The benefits to the DoD of requiring the providers to
be paid either under a DRG-based payment system or based on reasonable
cost are lost, however, if the hospitals can selectively participate in
the CHAMPUS and CHAMPVA programs.
Under section 9122 of the Consolidated Omnibus Budget
Reconciliation Act of 1985 (COBRA), Pub. L. 99-272, all Medicare
hospitals are now required, beginning January 1987, to participate in
CHAMPUS or CHAMPVA as authorized providers (that is, they must bill
CHAMPUS or CHAMPVA and accept the CHAMPVA/CHAMPUS-determined allowable
amount as payment in full, less applicable deductible, patient cost-
share, and noncovered items).
B. Participation in the Department of Veterans Affairs (VA) Health Care
Program
Broadly speaking, a veteran can only receive services from a non-VA
hospital for a service-connected disability when there is a medical
emergency or when a VA facility is not available. In such cases, the VA
in the past paid for the services based on usual and customary charges.
As this type of payment is more expensive than payment made on a
prospective basis or based on reasonable costs, the VA has implemented
a national prospective payment system.
To alleviate hospital expenses for the VA, Congress passed section
233 of the Veterans' Benefit Improvement and Health-Care Authorization
Act of 1986 (Pub. L. 99-576). This section requires Medicare hospitals
to be participating providers of medical care to veterans eligible to
receive care at the hospital. The hospital then receives payment for
the services under the applicable VA payment system, in accord with the
recent regulations concerning the payment methodology and amounts that
the VA provides for those hospitals that furnish inpatient hospital
care to veterans whose care has been authorized or will be sponsored by
the VA (55 FR 42848). This rule was developed jointly by VA and HHS,
and the VA payment system conforms to Medicare's hospital inpatient
prospective payment system in most cases.
C. Statement of Beneficiary Rights
After the prospective payment system became effective for the
Medicare program, we began to hear allegations that Medicare
beneficiaries were discharged too early from the hospital. We also
began to receive complaints that patients did not understand their
rights as Medicare beneficiaries in cases in which they were advised
that discharge was appropriate but they disagreed. On April 17, 1985,
we revised 42 CFR 466.78(b)(3) to require all hospitals to provide
Medicare beneficiaries with information about Utilization and Quality
Control Peer Review Organization (PRO) review, including beneficiary
appeal rights (50 FR 15331). In further response to concerns about
early discharges and lack of adequate appeal information, we began
requiring all hospitals to furnish each Medicare beneficiary upon
admission a specific statement developed by HCFA (that is, ``An
Important Message from Medicare'' (see Appendix I)) telling a
beneficiary of his or her rights to be fully informed about decisions
affecting Medicare coverage or payment and about his or her appeal
rights in response to any hospital's notice to the effect that Medicare
will no longer cover the care. The ``Message'' we developed also
advises the patient of what to do when he or she receives such a
hospital statement and how to elicit more information. The requirements
relating to ``An Important Message from Medicare'' were incorporated
into the program's operating instructions.
Congress subsequently passed section 9305(b) of the Omnibus Budget
Reconciliation Act of 1986 (OBRA 86). Now, as part of its participation
agreement with Medicare, each hospital (including those not paid under
the prospective payment system) must agree to furnish each Medicare
beneficiary with a notice, at or about the time of admission, that
explains the patient's rights in detail.
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.
II. Legislation
A. Participation in CHAMPUS and CHAMPVA Programs
Section 9122 of COBRA amended section 1866(a)(1) of the Act by
adding a new paragraph (J), which requires hospitals in the Medicare
program to be participating providers of medical care, for inpatient
services only, under any health plan contracted for under 10 U.S.C.
1079 or 1086 (CHAMPUS) or under 38 U.S.C. 613 (CHAMPVA), in accordance
with admission practices and payment methodology and amounts as
prescribed under joint regulations issued by the Secretaries of Health
and Human Services, Defense, and Transportation. This requirement
applies to services furnished to CHAMPUS and CHAMPVA beneficiaries
admitted on or after January 1, 1987.
(Section 9122 of COBRA also required that the legislation apply to
all agreements entered into on or after April 7, 1986, but this
requirement was deleted by section 1895(b)(6) of the Tax Reform Act of
1986 (Pub. L. 99-514), enacted October 22, 1986.)
B. Participation in the Veterans Administration Health Care Program
Section 233 of the Veterans' Benefit Improvement and Health-Care
Authorization Act of 1986 (Pub. L. 99-576) was enacted on October 28,
1986. It added a new paragraph (L) to section 1866 (a)(1) of the Act.
It requires hospitals that participate in Medicare to be participating
providers under 38 U.S.C. 603, in accordance with the admissions
practices, and payment methodology and amounts, prescribed under joint
regulations issued to implement this section by the Secretary of HHS
and the Administrator of the VA. This provision applies to services
furnished to veterans admitted on or after July 1, 1987.
C. Statement of Beneficiary Rights
Section 9305(b)(1) of OBRA 86, which was enacted on October 21,
1986, added a new paragraph (M) to section 1866(a)(1) of the Act. That
paragraph requires a hospital that is eligible to participate in the
Medicare program to agree to furnish a beneficiary, or an individual
acting on his or her behalf, at or about the time of admission, with a
written statement of the beneficiary's discharge rights. The statement
must explain:
(a) The individual's rights to benefits for inpatient hospital
services and for posthospital services under Medicare;
(b) The circumstances under which the individual will and will not
be liable for charges for continued stay in the hospital;
(c) The individual's right to appeal denials of benefits for
continued inpatient hospital services, including the practical steps to
initiate the appeal;
(d) The individual's liability for services if the denial of
benefits is upheld on appeal; and
(e) Additional information that the Secretary specifies.
Section 9305(b)(2) of OBRA 86 requires that we prescribe the
language to be used in the statement not later than 6 months after the
effective date of OBRA 86. After development of the revised language
for the statement required under OBRA 86, the hospitals must comply
with the requirement to give the revised statement to beneficiaries
upon admission.
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
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.
III. Proposed Regulations
As noted earlier, on June 16, 1988 (53 FR 22513), we published a
notice of proposed rulemaking to implement the legislative changes
enacted before that date. Following is a summary of that proposal.
A. Participation in CHAMPUS and CHAMPVA Programs
We proposed to revise Sec. 489.20, Basic commitments, to show that
a participating Medicare hospital must agree to participate in the
CHAMPUS and CHAMPVA programs and accept payment from the CHAMPUS/
CHAMPVA program as payment in full in accordance with a new
Sec. 489.25, which incorporates statutory provisions.
In new Sec. 489.25, we would require Medicare participating
hospitals to be participating providers in the CHAMPUS and CHAMPVA
programs. We proposed to require the hospitals to comply with DoD
regulations governing admissions practices and payment methodology and
amounts for such services. As noted above, CHAMPUS published a final
rule on September 1, 1987, that contains provisions for the
implementation of a DRG-based payment system. We would continue the
policy that hospitals participating in CHAMPUS and CHAMPVA that also
participate in Medicare must meet all Medicare conditions of
participation. Thus, if CHAMPUS or CHAMPVA have requirements for
participating that differ from Medicare's, Medicare's requirements also
would have to be met.
We proposed to require hospitals to accept payment from CHAMPUS/
CHAMPVA programs as payment in full for the services provided to these
beneficiaries (less applicable deductible, patient cost-share, and
noncovered items).
In addition, we intended to add a new paragraph (11) to
Sec. 489.53, Terminations by HHS, to show that a hospital that does not
meet the requirements of Sec. 489.25 would be subject to possible
termination.
The proposed changes would apply only to inpatient hospital
services furnished to beneficiaries admitted on or after January 1,
1987.
B. Participation in the Department of Veterans Affairs (VA) Health Care
Program
To implement section 233 of Pub. L. 99-576, we proposed to add a
new Sec. 489.26. Hospitals do not enter into participation agreements
with the Department of Veterans Affairs program as they do if they
choose to participate in the Medicare program or the CHAMPUS or CHAMPVA
programs. Instead, the VA authorizes payment for the treatment, usually
on a preadmission basis at a designated hospital that furnishes the
service. We proposed to require a Medicare participating hospital to
admit any veteran whose hospitalization is authorized by the VA under
38 U.S.C. 603 (this includes emergency cases, which may be authorized
after admission). The hospital would have to meet the requirements of
38 CFR Part 17 regarding admission practices and payment methodology
and amounts published October 24, 1990 (55 FR 42848). This arrangement
would not affect the hospital's need to meet all Medicare hospital
conditions of participation.
We also proposed to revise Sec. 489.20, Basic commitments, to
require hospitals to admit veterans whose admission is authorized under
38 U.S.C. 603 and to meet the requirements of Sec. 489.26.
We also proposed to revise Sec. 489.53, Termination by HCFA, to
show that HHS may terminate any hospital that fails to meet the
requirements of Sec. 489.26.
The proposed regulations would apply to inpatient services
furnished to veterans admitted on or after July 1, 1987.
C. Statement of Beneficiary Rights
We proposed to add a new Sec. 489.27, to require participating
hospitals that furnish inpatient hospital services to Medicare
beneficiaries to give every beneficiary (or individual acting on his or
her behalf) at or about the time of admission the publication ``An
Important Message from Medicare.'' We did not specify the contents of
the ``Message'' in the proposed rule, as hospitals are not responsible
for writing it. We have distributed and will continue to distribute to
hospitals the language of the ``Message'' that they are to use. A copy
of the ``Message'' is included as Appendix I to this interim final
rule.
We proposed to require hospitals to obtain a separate signed
acknowledgment from the beneficiary attesting to the receipt of ``An
Important Message from Medicare'' and to retain a copy of the
acknowledgment. Effective with admissions on and after March 24, 1986,
PROs were required to monitor each hospital to assure that the hospital
distributes ``An Important Message from Medicare'' to all Medicare
beneficiaries. Therefore, we proposed to require the hospital to obtain
the beneficiary's separate, signed acknowledgment attesting to the
receipt of the ``Message'' and to retain a copy of the acknowledgment.
We also proposed to revise Sec. 489.20, Basic commitments, to show
that a hospital must distribute ``An Important Message from Medicare''.
We planned to add a new paragraph (12) to Sec. 489.53, Terminations
by HHS, to show that a hospital failing to meet the requirements of
Sec. 489.27 may be terminated. Whether or not HHS would terminate a
provider would depend on HCFA's judgment as to the scope of the failure
and the hospital's correction or plan for correction of the failure. We
did not anticipate any hospital opposition to the requirement that the
``Message'' be distributed. We believe we already have full cooperation
from hospitals.
The revisions were to apply only to Medicare admissions beginning
after we distributed ``An Important Message from Medicare''.
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.
IV. Comments and Responses
A. Participation in the CHAMPUS, CHAMPVA and VA Health Care Programs
We received comments from nine commenters concerning the CHAMPUS/
CHAMPVA and VA issues. They were from hospitals, professional
organizations and one individual.
Comment: Two commenters raised numerous issues relating to the
operations of the CHAMPUS/CHAMPVA programs and the operation of the
prospective payment system under those programs (CHAMPVA payments are
made under CHAMPUS' DRG-based payment system). The issues concerned
such items as the status of hospitals operating under demonstration
programs conducted by those programs, and the obligation of CHAMPUS/
CHAMPVA patients for making cost-share amounts required under those
programs.
Response: The purpose of these regulations is to require hospitals
that participate in Medicare to participate as well in the CHAMPUS/
CHAMPVA and VA programs. These regulations do not relate to rules under
which those programs function and do not make any changes in their
operations. We have referred questions concerning operational issues to
appropriate administrative officials at OCHAMPUS who assure us that
providers who are participating in the CHAMPUS Reform Initiative area
will not be forced to accept payment less than the DRG amounts. They
also tell us that the adjusted standardized amount used in the CHAMPUS
DRG-based payment system contains a factor to reimburse hospitals for
CHAMPUS' share of the hospitals' bad debts. These regulations do not
change the beneficiary's obligation to pay required cost-share amounts.
Comment: Four commenters stated that the provider's freedom of
choice in making management decisions of participating or not in these
additional programs would be taken away by implementing these
regulations.
Response: The legislation clearly ties participation in Medicare to
acceptance, as well, of the CHAMPUS and CHAMPVA participation
responsibility. We recognize that this change in the law alters the
range of discretion that a hospital may have in selecting participation
options but the law offers no alternative to accepting all the programs
or declining to participate in Medicare.
Comment: One commenter believed that, as a provider of services to
CHAMPUS/CHAMPVA and VA beneficiaries for many years, his institution
has the right to receive a notice of government action and have a
chance to respond to the government decision-making. He received no
notice of government action until reading this notice of proposed
rulemaking.
Response: Under the Administrative Procedure Act (5 U.S.C. 553 et
seq.), it is the notice of proposed rulemaking that is the vehicle for
providing notice of this type of government action. Should a provider
be subject to termination for not being in compliance with requirements
added by this rule, we believe the procedures for termination by HCFA
located at Sec. 489.53 are fundamentally fair. These procedures include
our proposed rules under Sec. 489.53(a)(11) that allow HCFA to
terminate an agreement with any provider, if HCFA finds that the
provider no longer meets the appropriate conditions of participation
such as those found in new Sec. 489.25 or Sec. 489.26, which address
providing medical services to CHAMPUS/CHAMPVA or VA beneficiaries.
Before we find a hospital in violation, we expect, as discussed in the
preamble of the proposed rule, that efforts to resolve any problem will
have taken place. If problems are not resolved then the actual notice
of termination procedures listed in Sec. 489.53(c) will be initiated.
Comment: Four commenters stated that third party payors, such as
Medicaid and CHAMPUS, pay smaller and smaller proportions of the costs
these hospitals incur in serving those covered by these programs. In
their view, if hospitals are to continue to provide full access, then
Congress, HCFA, the Department of Defense, and State governments must
recognize their responsibility to adequately finance the care that they
require to be provided.
Response: We believe that the prospective payment system results in
fair payments. As implemented under Medicare, the prospective payment
system differentiates payments by location and type of provider as well
as by the relative resource intensity of individual cases. The CHAMPUS
and VA DRG-payment systems are similar to that used by Medicare;
however, they have been tailored to their own health care utilization
patterns. Under a prospective payment system, many of the operational
costs have been factored into the DRG.
We have been informed that under the CHAMPUS DRG-payment system the
cost sharing provisions have been changed to ensure that the amount of
the shared cost incurred by the beneficiary will be more equitable. In
fact, we have learned that most beneficiaries will pay less under this
new system than the old, and no beneficiary is expected to pay more in
cost share amounts. As under the Medicare prospective payment system,
annual evaluations to recalculate DRG weights are taking place under
the CHAMPUS DRG-based system using the most recent period of CHAMPUS
data. During annual evaluations, consideration can be given to any
problems which have surfaced.
For services provided to CHAMPVA patients, inpatient hospital
services are being reimbursed through the CHAMPUS DRG-based payment
system with, we expect, similar results. With regard to VA
beneficiaries, for admissions on or after November 23, 1990, hospital
reimbursements are being made in accordance with the regulations
published on October 24, 1990 (55 FR 42848) concerning the payment
methodology and amounts that the VA provides for those hospitals that
furnish inpatient hospital care to veterans whose care has been
authorized or will be sponsored by the VA. As noted in section I.B. of
this preamble, this rule was developed jointly by VA and HHS, and the
VA payment system conforms to Medicare's inpatient hospital prospective
payment system in most cases.
Comment: One commenter believes that, at a minimum,
disproportionate share providers should receive special protection. He
stated that since Congress recognized that additional Medicare payments
under the prospective payment system should be made to hospitals that
admit a disproportionate share of low-income patients, a similar
disproportionate share status may be necessary to protect Medicare
providers located in areas surrounding military bases or other military
installations.
Response: The preamble to the final rule implementing the CHAMPUS
DRG-Based Payment System (52 FR 32992) provides information to suggest
that there should not be a disproportionate number of CHAMPUS
beneficiaries seeking care in Medicare participating hospitals
(civilian hospitals). Specifically, when discussing ``emergency
treatment'' (page 32996, first column), it states that ``* * *all
CHAMPUS beneficiaries who live within catchment areas of military
treatment facilities (MTFs) are required to first seek inpatient care
at the MTF before going to a civilian hospital* * *'' The catchment
area is defined as within 40 miles of an MTF. On the other hand,
however, we have been informed that CHAMPVA beneficiaries are not
eligible for care in MTFs; therefore, they must use either VA or
civilian hospitals.
We believe the payment rates under CHAMPUS are adequate to pay for
treatment of its enrolled population. If the commenter believes
otherwise he should furnish the VA with data on this matter and present
detailed findings to support the need for a suggested adjustment to
payment rates.
Comment: Two commenters stated that these regulations should not be
imposed until the joint regulations are issued and thereafter should be
prospective in nature only.
Response: The joint regulations to which the statute refers are
regulations establishing payment procedures and amounts, not
regulations requiring participation. Such regulations have already been
published (55 FR 42848 for VA and 52 FR 32992 for CHAMPUS/CHAMPVA). In
addition, we consulted on these regulations with pertinent members of
OCHAMPUS and VA before publication; thus, these regulations are also a
joint action. They are also prospective, not retroactive.
B. Discharge Rights Notice
Twenty-five commenters addressed the hospital discharge rights
notice. These comments were from a physician, citizen organizations,
professional organizations, hospital associations, a consultant group,
and hospitals.
Comment: Three commenters suggested alternatives to the notice,
including the posting of signs in the hospital, sending a copy of the
notice with each beneficiary's social security check, and having the
hospital mail the notice to the beneficiary before his or her admission
to the hospital.
Response: We do not believe that most of these methods would serve
the purpose Congress intended. Posting a sign could still result in
many, if not most, beneficiaries not noticing it at all; a mass mailing
would be untimely for most patients and thus subject to being ignored.
Moreover, the law requires that the notice be furnished by the
hospital. Finally, many admissions are not planned or occur with little
advance notice; so, having the hospital mail the statement before
admission would be a viable method of informing some but not all
beneficiaries of their discharge rights on a timely basis. We note,
however, that hospitals may choose this approach with patients whose
admissions are planned in advance.
Comment: One commenter stated that the public had not had adequate
opportunity to participate in developing the discharge rights
statement.
Response: Section 1866(a)(1)(M) of the Act requires a Medicare
participating hospital to furnish a statement concerning discharge
rights to each Medicare beneficiary.
The law is self-implementing; that is, it did not require public
comment or regulations in order to be implemented. However, we did
consult extensively with major beneficiary and provider organizations
(such as the Gray Panthers, American Hospital Association, and the
American Association of Retired Persons) and have subsequently revised
the final version of ``An Important Message from Medicare'' (the
``Message'') after these consultations.
Comment: One commenter stated that the ``Message'' is inadequate,
especially as it pertains to discharge planning, and suggested either a
separate notice or an expanded notice to focus on the discharge
planning requirements of section 1861(e)(6) of the Act. Another
commenter asserted that the original ``Message'' was poorly written, as
it tries to cover legal requirements. The commenter also asserted that
there is a need for the ``Message'' to be more supportive and
informative.
Response: The revised ``Message'' contains several references to
the availability of hospital discharge planning and the need to consult
a physician or appropriate hospital staff for assistance. Beneficiaries
have a current need for the ``Message,'' and we do not believe it would
have been appropriate to delay its distribution until after the
condition of participation for discharge planning, proposed to be
included in our regulations at Sec. 482.43 (see 53 FR 22506, June 16,
1988), is published as a final rule. Requiring a notice of hospital
discharge rights and requiring hospitals to provide a discharge
planning process are two separate statutory provisions of OBRA 86 that
were not meant to be combined. Further, Congress did not specify
explicitly in section 1866(a)(1)(M) that discharge planning should be
included in the notice. We have revised the original ``Message'' to
improve its readability as well as its content. We note that it has
always been our intention to revise the ``Message'' in the future as
patient needs change.
Comment: One commenter thought we should include an explanation of
the content of the ``Message'' in the final rule and that an outline of
it in the regulations would aid in its later interpretation.
Response: We are including as Appendix I to this interim final rule
the current ``Message''; it is self-explanatory. We do not believe it
is necessary to outline its content in the regulations text, as the
``Message'' is readily available at hospitals.
Comment: One commenter thought we should advise the public how they
can obtain a copy of the ``Message'' or that we should send each
commenter a copy.
Response: The ``Message'' was distributed to all hospitals via
Medicare Hospital Manual Transmittal No. 545, dated July 1988. The
``Message'' is readily available to the public since it has been
reproduced in the 1989 through 1994 editions of ``The Medicare
Handbook.'' As stated above, we are also publishing it as Appendix I to
this final rule.
Comment: We received four comments, all from beneficiary
organizations, in favor of our requirement that the hospital obtain a
signed acknowledgement of the discharge rights notice. We also received
17 comments against it, primarily from hospitals and hospital
organizations. Four of these commenters stated that there is no need
for this requirement. They cited HCFA's statement in the preamble to
the proposed rule that, ``we believe we already have full cooperation
from hospitals.''
Response: We strongly believe that the requirement that a hospital
furnish a statement concerning discharge rights to each Medicare
beneficiary must be fully met. However, we are persuaded by the
commenters that full compliance has already been achieved in most
hospitals. Therefore, we have eliminated the requirement for a signed
acknowledgement. In its place, we now specify under Sec. 489.27 that a
hospital must be able to demonstrate that it complies with the
requirement that each beneficiary be furnished with a discharge rights
notice at or about the time of admission. We note, however, that signed
acknowledgements could be required as part of a plan of correction for
a hospital that was found to be out of compliance with this
requirement.
Comment: Fourteen commenters objected to the requirement that
hospitals retain the signed acknowledgement by the beneficiary, as they
anticipate it will be a tremendous burden in terms of cost of the
forms, storage of the acknowledgements, and added processing time by
the admissions staff.
Response: In conjunction with the elimination of the signed
acknowledgement requirement, we have deleted the accompanying retention
requirement from this interim final rule. When we published the
proposed rule, our PRO program was oriented towards review of hospital
medical records, and so we chose initially to implement the discharge
rights requirement specifically in terms of an acknowledgement in the
medical record. More recently, however, we have reoriented our PRO
program towards efforts more likely to bring about general improvements
in quality and have minimized our funding of more limited ``process''
requirements such as review of individual medical records. Accordingly,
we recognize that the proposed acknowledgement and retention
requirements have become obsolete and are eliminating them. Again, the
final rule does require hospitals to demonstrate compliance with the
discharge rights notification requirement, but does not specify the
manner of compliance. We expect some hospitals may continue to seek and
retain signed acknowledgements but believe they should have other, less
burdensome, options as well.
Comment: Eight commenters believed that this requirement would be a
burden on the beneficiary and his or her family as there are already
too many forms to complete at admission; one commenter felt that
securing a signed acknowledgement would do little to improve
beneficiary attention to the ``Message'' because it is the presence of
a problem, rather than the presence of the notice, that generates
beneficiary attention to discharge rights issues.
Response: We realize that being admitted to a hospital is a
stressful event for patients and their families. As noted above, we
have removed the requirement for a signed and dated acknowledgement, in
part because of its impact on beneficiaries. We expect in the future to
look more carefully at innovative ways to ensure that patients get the
information they need when they need it.
Comment: In addition to the concerns discussed above, commenters
also addressed specific aspects of the requirement that hospitals
obtain and retain signed acknowledgement statements. For example, one
commenter suggested that we require that the date and time of the
patient's signature on the acknowledgement statement be recorded;
another recommended that the acknowledgement statement be accompanied
by an additional statement that signing the acknowledgement in no way
compromises a patient's discharge rights; another suggested that the
acknowledgement specify that the beneficiary has been given the name of
an individual at the hospital who is available to explain the
``Message.'' Similarly, commenters asked that we specify where, in what
form, and for how long acknowledgements be retained. Finally, several
commenters recommended that we allow hospitals as much flexibility as
possible in implementing the acknowledgement and retention
requirements.
Response: Given that we have decided to eliminate the requirement
for a signed acknowledgement and its retention, most of these comments
are now moot. Thus, we agree with the commenters who believe that
hospitals should be given maximum flexibility in determining how they
can best comply with the requirement that all beneficiaries be
furnished with a notice of discharge rights. We do not intend to
specify the actual mechanics of having this notice presented to
patients. Instead, we expect individual hospitals to exercise their own
discretion in dealing with the associated administrative issues. We
emphasize that, for survey purposes, hospitals that do not choose to
obtain and retain signed acknowledgement statements must be able to
document compliance by some other means with the requirement for timely
distribution of the discharge rights notice.
Comment: One commenter contended that we should have done more
consulting with organizations knowledgeable about hospital management
practices before developing a proposal that related to the creation and
retention of a record.
Response: We believe that the publication of the proposed rule
represents a valuable form of consultation. The issue we dealt with in
the proposed rule was primarily an issue relating to beneficiary
awareness and the creation of a record that it has been successfully
accomplished. As discussed above, we received comments on the
recordkeeping and management aspects of the issue, and we have fully
considered them in developing the final regulation.
Comment: Some commenters believed that the regulations should
address those situations in which the patient is physically and/or
mentally unable to understand the message or to sign the
acknowledgement and has no one to perform these functions.
Response: We do not agree that the regulations themselves should
address these situation. Such situations will be relatively rare.
Hospitals will need to be in compliance with applicable State statutes
in dealing with informing patients who cannot receive information on
their own behalf. Program instructions are a more appropriate vehicle
for discussing specific difficulties if they occur and additional
guidance is needed.
Comment: One commenter recommended that we specify whether we are
requiring hospitals to educate Medicare beneficiaries about the
patient's rights listed in the ``Message'' and to assure that the
patient fully understands his or her rights.
Response: We are not requiring the hospital to educate
beneficiaries as to their rights, beyond having beneficiaries read the
``Message'' and signing an acknowledgement that they have read it, nor
are we requiring the hospitals to assure that the beneficiaries
understand their rights. Beneficiaries are instructed in the
``Message'' to consult the PRO, their physician or the hospital's
patient representative if they do have questions.
Comment: Four commenters believe HCFA, rather than the hospitals,
should educate beneficiaries about their rights. One commenter noted
that PROs, as part of their Federal contracts, are responsible for
community education programs.
Response: HCFA carries out a variety of activities to educate
beneficiaries and will continue to do so. However, section
1866(a)(1)(M) of the Act requires that this explanation of patient
rights be provided by the hospital. This is an appropriate hospital
responsibility since inpatient hospital care is under the control of
the hospital and the patient looks to the hospital for information
about rights and options concerning care. Also, these rights are
related to discharge planning, which is most appropriately a hospital
function.
Comment: One commenter wanted us to specify what, if any, changes a
hospital can make to the ``Message.'' The commenter also requested that
some monitoring requisites from the new PRO scope of work requirements
be included in the regulation.
Response: We believe these items are better addressed in program
operating instructions. Medicare Hospital Manual Transmittal No. 545,
dated July 1988, and subsequent transmittals, inform hospitals that
they may use their own letterhead but may not alter or change the
language of the ``Message.'' Peer Review Organization Manual
Transmittals instructions will be updated, as needed, to reflect this
final regulation.
Comment: Three commenters believed that termination for failure to
comply with provisions of this regulation is too extreme a penalty.
Response: Although a hospital may be terminated for failing to meet
our requirements we will not institute termination before providing an
opportunity for correction. As stated in the preamble to the proposed
rule, the speed with which we move to termination would depend on
HCFA's judgment as to the scope of the failure and the hospital's
correction or plan for correction of the failure. This approach will be
reflected in implementing program instructions.
Comment: One commenter thought that the acknowledgement requirement
should not be subject to the 2-day termination procedure.
Response: The 2-day termination procedure was not proposed to apply
to the discharge rights provision, but only to the ``anti-dumping''
provision.
C. Hospital Responsibility for Emergency Care
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.)
General
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.
Medical Screening Examination
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.
Patient Consent
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).
Medical Records and Certification
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.''
Transportation
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.
Reporting Violations
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.''
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.''
Stabilized
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.
Screening Examination
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.
Investigations
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.
Civil Enforcement
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).
Preemption of State and Local Laws
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.
Disclosure
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.
State Agency Involvement
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.
Physician Role
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.
Miscellaneous
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.
V. OBRA 90: Peer Review Organization Review
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.
VI. Summary of Revisions
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.
1. CHAMPUS, CHAMPVA and VA: We made no revisions.
2. Hospital discharge rights notice.
We have revised this section to eliminate the requirement that the
beneficiary or his or her representative acknowledge receipt of the
``Message'' by signing the acknowledgement statement on the
``Message.'' We have also eliminated the requirement that an
acknowledgement of the ``Message'' be retained by the hospital.
Instead, we will rely on hospitals to determine how they can best
comply with the requirement that each beneficiary be provided with a
discharge rights notice.
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.
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.
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).
VII. Impact Statement
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.
VIII. Paperwork Reduction Act
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.
Section 489.27 of the proposed rule required that hospitals that
participate in the Medicare program obtain from the beneficiary or his
or her representative a signed acknowledgement of receipt of a notice
of discharge rights. We also required these hospitals to retain both a
copy of the inpatient notice of discharge rights (``Message'') and of
the signed acknowledgement for 1 year. As discussed in section IV.B. of
this preamble, this interim final rule eliminates the requirement for
an acknowledgement statement. Thus, the accompanying recordkeeping
burden also is eliminated.
The annual reporting and recordkeeping burden imposed by these
information collection requirements is estimated, based on past
experience, to be as follows:
Sec. 488.18(d)--101.5 hours for Medicare State survey agencies
Sec. 489.20(m)--25.25 hours for all hospitals and 50.5 hours for
Medicare State survey agencies
Sec. 489.20(r)(2)--7,000 hours for all hospitals
Sec. 489.20(r)(3)--7,665,400 hours for all hospitals
Sec. 489.24(c)(2) and Sec. 489.24(c)(4)--373,900 hours for all
hospitals and 46,700 hours for the public for each subsection
Sec. 489.24(d)(1)(ii)(A)--46,700 hours for the public
Sec. 489.24(d)(1)(ii)(B) and Sec. 489.24(d)(1)(ii)(C)--373,900 hours
for all hospitals for each subsection
Sec. 489.24(g)--336 hours for all PROs
The new information collection and recordkeeping requirements
associated with Secs. 488.18, 489.20, and 489.24 have been sent to OMB
for approval in accordance with the Paperwork Reduction Act and will
not be effective until OMB approval is received. A notice will be
published in the Federal Register when approval is obtained.
Organizations and individuals desiring to submit comments on the burden
estimates, the usefulness of central logs for enforcement purposes, the
possibility of any unintended effects in connection with the use of
such logs, or other aspects of the information collection and
recordkeeping requirements in Secs. 488.18, 489.20, and 489.24 should
direct them to the OMB official whose name appears in the ADDRESSES
section of this preamble.
IX. Waiver of Proposed Rulemaking
The Administrative Procedure Act (5 U.S.C. 553) requires us to
publish general notice of proposed rulemaking in the Federal Register
and afford prior public comment on proposed rules. Such notice includes
a statement of the time, place and nature of the rulemaking proceeding,
reference to the legal authority under which the rule is proposed, and
the terms or substance of the proposed rule or a description of the
subjects and issues involved. However, this requirement does not apply
when an agency finds good cause that prior notice and comment are
impracticable, unnecessary, or contrary to the public interest, and
incorporates a statement of the finding and its reasons in the rules
instead.
This interim final rule with comment period includes a number of
revisions to our regulations that implement revisions to the Act under
OBRA 89 and OBRA 90 and for which we did not propose rulemaking. These
particular regulation revisions implement the statute without
interpretation; the statutory changes are self-implementing. Most of
the revisions are technical; some substantive ones (such as the notice
hospitals are required to post concerning Medicaid) have already been
implemented; others are changes that would respond to public comments
we have already received. Affording a proposed rulemaking process under
these circumstances is not in the public interest as it would delay the
promulgation of regulations that correspond to the current statute;
because the statutory revisions are self-implementing, we do not
anticipate that public comment would substantively modify regulations.
Therefore, we find good cause to waive proposed rulemaking for those
regulatory provisions necessary to implement OBRA 89 and OBRA 90.
However, we are providing a 60-day period for public comment, as
indicated at the beginning of this rule, on changes to the regulations
resulting from the provisions of OBRA 89 and OBRA 90. After considering
comments that are received timely, we will respond to the comments,
include any changes in the rule that might be necessitated in light of
those comments, and publish a final rule in the Federal Register.
X. Response to Comments
Because of the large number of items of correspondence we receive
on a rulemaking document, we are not able to acknowledge or respond to
them individually. However, we will consider all comments that we
receive by the date and time specified in the ``Dates'' section of this
preamble, and, we will respond to the comments in the preamble of the
final rule.
List of Subjects
42 CFR Part 488
Health facilities, Medicare, Reporting and recordkeeping
requirements.
42 CFR Part 489
Health facilities, Medicare.
42 CFR Part 1003
Administrative practice and procedure, Fraud, Grant programs--
health, Health facilities, Health professions, Maternal and child
health, Medicaid, Medicare, Penalties.
Title 42 of the Code of Federal Regulations is amended as follows:
A. Part 488, subpart A, is amended as follows:
PART 488--SURVEY AND CERTIFICATION PROCEDURES
1. The authority citation for part 488 continues to read as
follows:
Authority: Secs. 1102, 1814, 1861, 1865, 1866, 1871, 1880, 1881,
1883, and 1913 of the Social Security Act (42 U.S.C. 1302, 1395f,
1395x, 1395bb, 1395cc, 1395hh, 1395qq, 1395rr, 1395tt, and 1396l).
Subpart A--General Provisions
2. Section 488.18 is amended by adding a new paragraph (d) to read
as follows:
Sec. 488.18 Documentation of findings.
* * * * *
(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).
(n) In the case of inpatient hospital services, to participate in
any health plan contracted for under 10 U.S.C. 1079 or 1086 or 38
U.S.C. 613, in accordance with Sec. 489.25.
(o) In the case of inpatient hospital services, to admit veterans
whose admission has been authorized under 38 U.S.C. 603, in accordance
with Sec. 489.26.
(p) In the case of a hospital that participates in the Medicare
program, to comply with Sec. 489.27 by giving each beneficiary a notice
about his or her discharge rights at or about the time of the
individual's admission.
(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. 489.25 Special requirements concerning CHAMPUS and CHAMPVA
programs.
For inpatient services, a hospital that participates in the
Medicare program must participate in any health plan contracted under
10 U.S.C. 1079 or 1086 (Civilian Health and Medical Program of the
Uniformed Services) and under 38 U.S.C. 613 (Civilian Health and
Medical Program of the Veterans Administration) and accept the CHAMPUS/
CHAMPVA-determined allowable amount as payment in full, less applicable
deductible, patient cost-share, and noncovered items. Hospitals must
meet the requirements of 32 CFR part 199 concerning program benefits
under the Department of Defense. This section applies to inpatient
services furnished to beneficiaries admitted on or after January 1,
1987.
Sec. 489.26 Special requirements concerning veterans.
For inpatient services, a hospital that participates in the
Medicare program must admit any veteran whose admission is authorized
by the Department of Veterans Affairs under 38 U.S.C. 603 and must meet
the requirements of 38 CFR part 17 concerning admissions practices and
payment methodology and amounts. This section applies to services
furnished to veterans admitted on and after July 1, 1987.
Sec. 489.27 Beneficiary notice of discharge rights.
A hospital that participates in the Medicare program must furnish
each Medicare beneficiary, or an individual acting on his or her
behalf, the notice of discharge rights HCFA supplies to the hospital to
implement section 1886(a)(1)(M) of the Act. The hospital must furnish
the statement at or about the time of admission. The hospital must be
able to demonstrate compliance with this requirement. This provision is
effective with admissions beginning on or after July 22, 1994.
Subpart E--Termination of Agreement and Reinstatement After
Termination
4. In Sec. 489.53, the introductory text of paragraph (a) is
republished, paragraphs (a) (10), (11), and (12) are added, and
paragraphs (b) and (c)(2) are revised to read as follows:
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.
(11) In the case of a hospital requested to furnish inpatient
services to CHAMPUS or CHAMPVA beneficiaries or to veterans, it failed
to comply with Sec. 489.25 or Sec. 489.26, respectively.
(12) It failed to furnish the notice of discharge rights as
required by Sec. 489.27.
(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) In the case of a SNF, HCFA terminates a SNF's provider
agreement if it determines that--
(i) The SNF no longer meets the requirements for long term care
facilities specified in part 483, subpart B of this chapter; and
(ii) The SNF's deficiencies pose immediate jeopardy to patients'
health and safety.
(c) Notice of termination.
* * * * *
(2) Exception.
(i) For a SNF with deficiencies 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.
* * * * *
C. Part 1003 is amended as follows:
PART 1003--CIVIL MONEY PENALTIES AND ASSESSMENTS
1. The authority citation for part 1003 is revised to read as
follows:
Authority: 42 U.S.C. 1302, 1320a-7, 1320a-7a, 1320b-10,
1395u(j), 1395u(k), 1395dd(d)(1), 11131(c) and 11137(b)(2).
2. In Sec. 1003.100, the introductory language in paragraph (b) is
republished, paragraphs (b)(1) introductory text, (b)(1)(iv) and
(b)(1)(v) are revised, and a new paragraph (b)(1)(vi) is added to read
as follows:
Sec. 1003.100 Basis and purpose.
* * * * *
(b) Purpose. This part--
(1) Provides for the imposition of civil monetary penalties and, as
applicable, assessments against persons who--
* * * * *
(iv) Fail to report information concerning medical malpractice
payments or who improperly disclose, use or permit access to
information reported under part B of title IV of Public Law 99-660, and
regulations specified in 45 CFR part 60;
(v) Misuse certain Medicare and Social Security program words,
letters, symbols and emblems; or
(vi) Violate a requirement of section 1867 of the Act or
Sec. 489.24 of this title;
* * * * *
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