[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