Medicare Program; Emergency Medical Treatment and Labor Act (EMTALA) Technical Advisory Group (TAG) Meeting and Announcement of Members, 12691-12693 [05-5028]
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Federal Register / Vol. 70, No. 49 / Tuesday, March 15, 2005 / Notices
The Director, Management Analysis and
Services Office, has been delegated the
authority to sign Federal Register Notices
pertaining to announcements of meetings and
other committee management activities for
both CDC and the Agency for Toxic
Substances and Disease Registry.
Dated: February 23, 2005.
Alvin Hall,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. 05–5019 Filed 3–14–05; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–1269–N3]
Medicare Program; Emergency Medical
Treatment and Labor Act (EMTALA)
Technical Advisory Group (TAG)
Meeting and Announcement of
Members
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Notice of meeting.
AGENCY:
SUMMARY: In accordance with section
10(a) of the Federal Advisory Committee
Act (FACA) (5 U.S.C. Appendix 2), this
notice announces the first meeting of
the Emergency Medical Treatment and
Labor Act (EMTALA) Technical
Advisory Group (TAG). The purpose of
the EMTALA TAG is to review
regulations affecting hospital and
physician responsibilities under
EMTALA to individuals who come to a
hospital seeking examination or
treatment for medical conditions. This
notice also announces the newly
appointed members of the EMTALA
TAG. Interested parties are invited to
this meeting to present their comments
on the EMTALA regulations and
implementation.
DATES: Meeting Date: The meetings of
the EMTALA TAG announced in this
notice will be held on Wednesday,
March 30, 2005 and Thursday, March
31, 2005, from 9 a.m. until 5 p.m. each
day.
Registration Deadline for All
Participants: All presenters must
register by March 22, 2005.
Comment Deadline: Comments or
statements must be received by March
22, 2005.
ADDRESSES: Meeting Address: The
EMTALA TAG meeting will be held in
Room 305 A at the Hubert H. Humphrey
Building, 200 Independence Avenue,
SW., Washington, DC 20201.
VerDate jul<14>2003
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Jkt 205001
Mailing and E-mail Addresses for
Inquiries or Comments: Inquiries or
comments regarding this meeting may
be sent to—Beverly J. Parker, Division of
Acute Care, Centers for Medicare &
Medicaid Services, Mail Stop C4–08–06,
7500 Security Boulevard, Baltimore, MD
21244–1850. Inquiries or comments may
also be e-mailed to
EMTALATAG@cms.hhs.gov.
Web Site Address for Additional
Information: For additional information
on the EMTALA TAG meeting agenda
topics, updated activities, and to obtain
Charter copies, please search our
Internet Web site at: https://
www.cms.hhs.gov/faca/emtalatag/
emtalatagpage.asp.
Mailing Address for Copies of the
EMTALA TAG Charter: Written requests
for copies of the EMTALA TAG Charter
should be sent to—Marianne M. Myers,
Division of Acute Care, Centers for
Medicare & Medicaid Services, Mailstop
C4–08–06, 7500 Security Boulevard,
Baltimore, Maryland 21244–1850.
Submission of Comments or
Statements: Comments or statements
regarding EMTALA may be sent by
postal mail or e-mail to the inquiry/
comment addresses listed above. We
will accept written comments/
statements of three single-spaced, typed
pages or less that are received by March
22, 2005.
FOR FURTHER INFORMATION CONTACT:
Beverly J. Parker, (410) 786–5320.
Press inquiries are handled through
the CMS Press Office at (202) 690–6145.
SUPPLEMENTARY INFORMATION:
I. Background
Sections 1866(a)(1)(I), 1866(a)(1)(N),
and 1867 of the Social Security Act (the
Act) impose specific obligations on
Medicare-participating hospitals that
offer emergency services. These
obligations concern individuals who
come to a hospital emergency
department and request or have a
request made on their behalf for
examination or treatment for a medical
condition. EMTALA applies to all these
individuals, regardless of whether or not
they are beneficiaries of any program
under the Act. Section 1867 of the Act
sets forth requirements for medical
screening examinations for emergency
medical conditions, as well as necessary
stabilizing treatment or appropriate
transfer. In addition, section 1867(h) of
the Act specifically prohibits a delay in
providing required screening or
stabilization services in order to inquire
about the individual’s payment method
or insurance status. Section 1867(d) of
the Act provides for the imposition of
civil monetary penalties on hospitals
PO 00000
Frm 00047
Fmt 4703
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12691
and physicians responsible for
negligently violating a requirement of
that section.
These provisions, taken together,
frequently referred to as the Emergency
Medical Treatment and Labor Act
(EMTALA), are also known as the
patient antidumping statute. EMTALA
was passed in 1986 as part of the
Consolidated Omnibus Budget
Reconciliation Act of 1985 (COBRA).
Congress enacted these antidumping
provisions in the Social Security Act
because of its concern with an
‘‘increasing number of reports’’ that
hospital emergency rooms were refusing
to accept or treat individuals with
emergency conditions if the individuals
did not have insurance.
Regulations implementing the
EMTALA legislation are set forth at 42
CFR 489.20(l), (m), (q) and (r)(1), (r)(2),
(r)(3), and 489.24. These regulations
incorporate changes made by a final rule
published in the September 9, 2003
Federal Register (68 FR 53222). We
published a final rule to clarify policies
relating to the responsibilities of
Medicare-participating hospitals and
physicians, under the provisions of
EMTALA, in treating individuals with
emergency medical conditions who
present to a hospital.
Section 945 of the Medicare
Prescription Drug, Improvement, and
Modernization Act of 2003 (MMA) (P.L.
108–173), requires that the Secretary
establish a Technical Advisory Group
(TAG) for advice concerning issues
related to EMTALA regulations and
implementation.
Section 945 of the MMA specifies that
the EMTALA TAG—
• Shall review the EMTALA
regulations;
• May provide advice and
recommendations to the Secretary
concerning these regulations and their
application to hospitals and physicians;
• Shall solicit comments and
recommendations from hospitals,
physicians, and the public regarding
implementation of such regulations; and
• May disseminate information
concerning the application of these
regulations to hospitals, physicians and
the public.
Section 945 of the MMA also specifies
the structure of the EMTALA TAG. It
states that the EMTALA TAG will be
composed of 19 members including the
Administrator of the Centers for
Medicare & Medicaid Services (CMS)
and the Inspector General of the
Department of Health and Human
Services (DHHS) in addition to the
number and type of individuals as
specified in each of the following
categories:
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Federal Register / Vol. 70, No. 49 / Tuesday, March 15, 2005 / Notices
• Four representatives of hospitals,
including at least one public hospital,
that have experience with the
application of EMTALA and, at least,
two hospitals that have not been cited
for EMTALA violations;
• Seven practicing physicians drawn
from the fields of emergency medicine,
cardiology or cardio-thoracic surgery,
orthopedic surgery, neurosurgery,
pediatrics or a pediatric subspecialty,
obstetrics-gynecology and psychiatry,
with not more than one physician from
any particular field;
• Two representatives of patients;
• Two staff persons involved in
EMTALA investigations from different
CMS regional offices;
• One representative from a State
survey agency involved in EMTALA
investigations and one representative
from a Quality Improvement
Organization, both of whom shall be
from areas other than the regions
represented by the CMS regional offices.
The EMTALA TAG, as chartered
under the legal authority of section 945
of the MMA, is also governed by the
provisions of the Federal Advisory
Committee Act (FACA) (5 U.S.C.
Appendix 2) for the selection of
members and the conduct of all
meetings.
In the May 28, 2004 Federal Register
(69 FR 30654), we specified the
statutory requirements regarding the
charter, general responsibilities, and
structure of the EMTALA TAG. That
notice also solicited nominations for
members based on the statutory
requirements for the EMTALA TAG. In
the August 27, 2004 Federal Register
(69 FR 52699), we solicited nominations
again for members in two categories
(patient representatives and a State
survey agency representative) for which
no nominations were received in
response to the May 28, 2004 Federal
Register notice.
II. Membership Selection
The following individuals have been
selected by the Secretary, to serve on the
EMTALA TAG along with Mark
McClellan, M.D., Adminstrator, CMS
and Daniel R. Levinson, Acting
Inspector General, DHHS:
• Hospital Representatives—Julie
Mathis Nelson, J.D., Coopersmith,
Gordon, Schnermer, Owens & Nelson,
P.L.C.; Carlos Perez, South Manhattan
Healthcare Network; Richard T. Perry,
M.D., P.C., F.A.C.S.; and Brian C.
Robinson, Hospital Corporation of
America’s Las Vegas Market/Sunrise
Hospital and Medical Center.
• Physicians—Cesar A. Aristeguieta,
M.D., Los Angeles County Paramedic
Training Institute; Carol Lynn Bayer,
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15:31 Mar 14, 2005
Jkt 205001
M.D., East Jefferson General Hospital
Metairie, Louisiana; James L. Biddle,
M.D., Rio Grande Regional Hospital and
McAllen Medical Center; John A.
Kusske, M.D., University of California;
James Nepola, M.D. Health Policy
Committee Orthopedic Trauma
Association; Michael J. Rosenberg, M.D.,
Assistant Professor/Private Practice; and
David W. Tuggle, M.D., University
Oklahoma College of Medicine
• Patient Representatives—Warren A.
Jones, M.D., Office of the Governor,
State of Mississippi; and Mark
Pearlmutter, M.D., St. Elizabeth’s
Medical Center.
• CMS Regional Office
Representatives—Gretchen A. Kane
CMS, and Charlotte S. Yeh, M.D.,
FACEP.
• State Survey Agency
Representative—Azzie Conley, RN,
State of North Carolina.
• QIO Representative—David Siegel,
M.D., J.D., FACEP, FACP, FCLM Senior
Physician Consultant and Clinical
Coordinator.
III. Meeting Format, Agenda, and
Suggested Presentation Topics
A. Meeting Format
The initial portion of the meeting will
involve opening remarks, introductions
and the swearing in of the EMTALA
TAG members by Michael O. Leavitt,
Secretary, DHHS. After which and in
accordance with section 945 of MMA,
the EMTALA TAG members will elect
their chairperson. The afternoon portion
of the first day and the morning portion
of the second day will be reserved for
statements from registered presenters.
The afternoon portion of the second day
will be reserved for the EMTALA TAG
members to ask questions, prioritize the
topics presented, and to conduct other
necessary business.
The time allotted for each
presentation will be approximately 5
minutes but will be based on the
number of registered presenters.
Presenters will speak in their assigned
order. If there are individuals who
cannot attend the meeting, we will
accept and present their comments/
statements at the meeting if their
comments/statements are received via
postal mail or email at the address list
in the ADDRESSES section of this notice
by March 22, 2005. Comments from
other participants (individuals that are
not registered presenters) may be heard
after the scheduled statements, if time
permits.
B. Tentative Meeting Agenda
The tentative agenda for the EMTALA
TAG meetings is as follows:
PO 00000
Frm 00048
Fmt 4703
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Day 1
• Welcome, call to order,
introductions, and opening remarks
• Administrative and housekeeping
issues
• Swearing in of members and selfintroductions
• Comments from registered
presenters
Day 2
• Comments from registered
presenters
• Discussion of current business
C. Suggested Presentation Topics
The following are suggested
presentation topics:
• Inpatient Transfers—Under current
EMTALA regulations, if a hospital
admits an individual in good faith for
stabilizing treatment on an inpatient
basis, the admission ends the hospital’s
EMTALA obligation to that individual.
Does the fact that an individual no
longer is covered by EMTALA at the
time transfer is sought make it more
difficult to find a suitable specialty
hospital transfer?
• Specialty Hospitals and EMTALA—
Some specialty hospitals apparently
accept patients on an appointment basis
only, and will accept patients only for
treatment of particular medical
conditions or for a narrow range of
services. There are reports that such
hospitals are refusing to accept transfers
of patients from general or community
hospitals, on the basis that because the
specialty hospital does not have a
dedicated emergency department as
defined in the new regulations, it has no
obligations under EMTALA.
• On-Call Issues—Some concerns
have been expressed that the revised
regulations regarding physician on-call
responsibilities are reducing the
willingness of physicians to take call,
especially at receiving hospitals, thus
leading to delays in arranging
appropriate transfers and thereby
delaying stabilization of patients.
• Psychiatric Patients—There
continues to be much concern about
determining stability for patients who
have a psychiatric condition, even if the
emergency medical condition is not
based on a psychiatric disorder.
• Certified Nurse Midwives—Under
current regulations, certified nurse
midwives (CNMs) are not able to certify
that a patient is in false labor. Current
regulations state that only a physician
may certify that a patient is in false
labor. There is concern that this policy
is not cost effective and is in conflict
with the authority provided CNMs by
state law.
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Federal Register / Vol. 70, No. 49 / Tuesday, March 15, 2005 / Notices
IV. Registration Instructions
The Center for Medicare Management
is coordinating meeting registration.
While there is no registration fee,
individuals must register to attend. As
specified in the DATES section of this
notice, individuals who wish to attend
or make a presentation at the meeting or
both must register by March 22, 2005.
You may register by sending an e-mail
to EMTALATAG@cms.hhs.gov, sending
a fax to the attention of Ronda Allen at
fax number (410) 786–0681 or (410)
786–0169, or calling (410) 786–4548. All
registration requests must include your
name, name of the organization (if
applicable), address, telephone and fax
numbers, e-mail address (if available),
and topic to be addressed (if you want
to do a presentation). You will receive
a registration confirmation with
instructions for your arrival at the
Hubert H. Humphrey Building. If
seating capacity has been reached, you
will be notified that the meeting has
reached capacity. All registered
presenters must submit a hard copy of
their presentation to the EMTALA TAG
at the first meeting.
V. Security Information
Since this meeting will be held in a
Federal government building, Federal
security measures are applicable. In
planning your arrival time, we
recommend allowing additional time to
clear security. In order to gain access to
the building, participants must bring a
government-issued photo identification
(driver’s license, passport, etc.) and a
copy of your confirmation of registration
for the meeting. Access may be denied
to persons without proper
identification.
All persons entering the building
must pass through a metal detector. In
addition, all items brought to HHS,
whether personal or for the purpose of
demonstration or to support a
presentation, are subject to inspection.
We cannot assume responsibility for
coordinating the receipt, transfer,
transport, storage, set-up, safety, or
timely arrival of any personal
belongings or items used for
demonstration or to support a
presentation.
Authority: Section 945 of the Medicare
Prescription Drug, Improvement, and
Modernization Act of 2003 (MMA).
(Catalog of Federal Domestic Assistance
Program No. 93.773, Medicare—Hospital
Insurance; and Program No. 93.774,
Medicare—Supplementary Medical
Insurance Program)
VerDate jul<14>2003
15:31 Mar 14, 2005
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Dated: March 10, 2005.
Mark B. McClellan,
Administrator, Centers for Medicare &
Medicaid Services.
[FR Doc. 05–5028 Filed 3–14–05; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N–0083]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; General Licensing
Provisions: Biologics License
Application, Changes to an Approved
Application, Labeling, Revocation and
Suspension, and Forms FDA 356h and
2567
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
the information collection requirements
relating to the general licensing
provisions regarding biologics license
application, changes to an approved
application, labeling, and revocation
and suspension, and the use of Forms
FDA 356h and 2567.
DATES: Submit written or electronic
comments on the collection of
information by May 16, 2005.
ADDRESSES: Submit electronic
comments on the collection of
information to: https://www.fda.gov/
dockets/ecomments. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of Management
Programs (HFA–250), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–4659.
PO 00000
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12693
Under the
PRA (44 U.S.C. 3501–3520), Federal
agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
SUPPLEMENTARY INFORMATION:
General Licensing Provisions: Biologics
License Application, Changes to an
Approved Application, Labeling,
Revocation and Suspension, and Forms
FDA 356h and 2567 (OMB Control
Number 0910–0338)—Extension
Under Section 351 of the Public
Health Services Act (the PHS Act) (42
U.S.C. 262), manufacturers of biological
products must submit a license
application for FDA review and
approval before marketing a biological
product in interstate commerce.
Licenses may be issued only upon
showing that the establishment and the
products for which a license is desired
meets standards prescribed in
regulations designed to insure the
continued safety, purity, and potency of
such products. All such licenses are
issued, suspended, and revoked as
prescribed by regulations in part 601 (21
CFR part 601).
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]]>Agencies
[Federal Register Volume 70, Number 49 (Tuesday, March 15, 2005)]
[Notices]
[Pages 12691-12693]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-5028]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-1269-N3]
Medicare Program; Emergency Medical Treatment and Labor Act
(EMTALA) Technical Advisory Group (TAG) Meeting and Announcement of
Members
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Notice of meeting.
-----------------------------------------------------------------------
SUMMARY: In accordance with section 10(a) of the Federal Advisory
Committee Act (FACA) (5 U.S.C. Appendix 2), this notice announces the
first meeting of the Emergency Medical Treatment and Labor Act (EMTALA)
Technical Advisory Group (TAG). The purpose of the EMTALA TAG is to
review regulations affecting hospital and physician responsibilities
under EMTALA to individuals who come to a hospital seeking examination
or treatment for medical conditions. This notice also announces the
newly appointed members of the EMTALA TAG. Interested parties are
invited to this meeting to present their comments on the EMTALA
regulations and implementation.
DATES: Meeting Date: The meetings of the EMTALA TAG announced in this
notice will be held on Wednesday, March 30, 2005 and Thursday, March
31, 2005, from 9 a.m. until 5 p.m. each day.
Registration Deadline for All Participants: All presenters must
register by March 22, 2005.
Comment Deadline: Comments or statements must be received by March
22, 2005.
ADDRESSES: Meeting Address: The EMTALA TAG meeting will be held in Room
305 A at the Hubert H. Humphrey Building, 200 Independence Avenue, SW.,
Washington, DC 20201.
Mailing and E-mail Addresses for Inquiries or Comments: Inquiries
or comments regarding this meeting may be sent to--Beverly J. Parker,
Division of Acute Care, Centers for Medicare & Medicaid Services, Mail
Stop C4-08-06, 7500 Security Boulevard, Baltimore, MD 21244-1850.
Inquiries or comments may also be e-mailed to EMTALATAG@cms.hhs.gov.
Web Site Address for Additional Information: For additional
information on the EMTALA TAG meeting agenda topics, updated
activities, and to obtain Charter copies, please search our Internet
Web site at: https://www.cms.hhs.gov/faca/emtalatag/emtalatagpage.asp.
Mailing Address for Copies of the EMTALA TAG Charter: Written
requests for copies of the EMTALA TAG Charter should be sent to--
Marianne M. Myers, Division of Acute Care, Centers for Medicare &
Medicaid Services, Mailstop C4-08-06, 7500 Security Boulevard,
Baltimore, Maryland 21244-1850.
Submission of Comments or Statements: Comments or statements
regarding EMTALA may be sent by postal mail or e-mail to the inquiry/
comment addresses listed above. We will accept written comments/
statements of three single-spaced, typed pages or less that are
received by March 22, 2005.
FOR FURTHER INFORMATION CONTACT: Beverly J. Parker, (410) 786-5320.
Press inquiries are handled through the CMS Press Office at (202)
690-6145.
SUPPLEMENTARY INFORMATION:
I. Background
Sections 1866(a)(1)(I), 1866(a)(1)(N), and 1867 of the Social
Security Act (the Act) impose specific obligations on Medicare-
participating hospitals that offer emergency services. These
obligations concern individuals who come to a hospital emergency
department and request or have a request made on their behalf for
examination or treatment for a medical condition. EMTALA applies to all
these individuals, regardless of whether or not they are beneficiaries
of any program under the Act. Section 1867 of the Act sets forth
requirements for medical screening examinations for emergency medical
conditions, as well as necessary stabilizing treatment or appropriate
transfer. In addition, section 1867(h) of the Act specifically
prohibits a delay in providing required screening or stabilization
services in order to inquire about the individual's payment method or
insurance status. Section 1867(d) of the Act provides for the
imposition of civil monetary penalties on hospitals and physicians
responsible for negligently violating a requirement of that section.
These provisions, taken together, frequently referred to as the
Emergency Medical Treatment and Labor Act (EMTALA), are also known as
the patient antidumping statute. EMTALA was passed in 1986 as part of
the Consolidated Omnibus Budget Reconciliation Act of 1985 (COBRA).
Congress enacted these antidumping provisions in the Social Security
Act because of its concern with an ``increasing number of reports''
that hospital emergency rooms were refusing to accept or treat
individuals with emergency conditions if the individuals did not have
insurance.
Regulations implementing the EMTALA legislation are set forth at 42
CFR 489.20(l), (m), (q) and (r)(1), (r)(2), (r)(3), and 489.24. These
regulations incorporate changes made by a final rule published in the
September 9, 2003 Federal Register (68 FR 53222). We published a final
rule to clarify policies relating to the responsibilities of Medicare-
participating hospitals and physicians, under the provisions of EMTALA,
in treating individuals with emergency medical conditions who present
to a hospital.
Section 945 of the Medicare Prescription Drug, Improvement, and
Modernization Act of 2003 (MMA) (P.L. 108-173), requires that the
Secretary establish a Technical Advisory Group (TAG) for advice
concerning issues related to EMTALA regulations and implementation.
Section 945 of the MMA specifies that the EMTALA TAG--
Shall review the EMTALA regulations;
May provide advice and recommendations to the Secretary
concerning these regulations and their application to hospitals and
physicians;
Shall solicit comments and recommendations from hospitals,
physicians, and the public regarding implementation of such
regulations; and
May disseminate information concerning the application of
these regulations to hospitals, physicians and the public.
Section 945 of the MMA also specifies the structure of the EMTALA
TAG. It states that the EMTALA TAG will be composed of 19 members
including the Administrator of the Centers for Medicare & Medicaid
Services (CMS) and the Inspector General of the Department of Health
and Human Services (DHHS) in addition to the number and type of
individuals as specified in each of the following categories:
[[Page 12692]]
Four representatives of hospitals, including at least one
public hospital, that have experience with the application of EMTALA
and, at least, two hospitals that have not been cited for EMTALA
violations;
Seven practicing physicians drawn from the fields of
emergency medicine, cardiology or cardio-thoracic surgery, orthopedic
surgery, neurosurgery, pediatrics or a pediatric subspecialty,
obstetrics-gynecology and psychiatry, with not more than one physician
from any particular field;
Two representatives of patients;
Two staff persons involved in EMTALA investigations from
different CMS regional offices;
One representative from a State survey agency involved in
EMTALA investigations and one representative from a Quality Improvement
Organization, both of whom shall be from areas other than the regions
represented by the CMS regional offices.
The EMTALA TAG, as chartered under the legal authority of section
945 of the MMA, is also governed by the provisions of the Federal
Advisory Committee Act (FACA) (5 U.S.C. Appendix 2) for the selection
of members and the conduct of all meetings.
In the May 28, 2004 Federal Register (69 FR 30654), we specified
the statutory requirements regarding the charter, general
responsibilities, and structure of the EMTALA TAG. That notice also
solicited nominations for members based on the statutory requirements
for the EMTALA TAG. In the August 27, 2004 Federal Register (69 FR
52699), we solicited nominations again for members in two categories
(patient representatives and a State survey agency representative) for
which no nominations were received in response to the May 28, 2004
Federal Register notice.
II. Membership Selection
The following individuals have been selected by the Secretary, to
serve on the EMTALA TAG along with Mark McClellan, M.D., Adminstrator,
CMS and Daniel R. Levinson, Acting Inspector General, DHHS:
Hospital Representatives--Julie Mathis Nelson, J.D.,
Coopersmith, Gordon, Schnermer, Owens & Nelson, P.L.C.; Carlos Perez,
South Manhattan Healthcare Network; Richard T. Perry, M.D., P.C.,
F.A.C.S.; and Brian C. Robinson, Hospital Corporation of America's Las
Vegas Market/Sunrise Hospital and Medical Center.
Physicians--Cesar A. Aristeguieta, M.D., Los Angeles
County Paramedic Training Institute; Carol Lynn Bayer, M.D., East
Jefferson General Hospital Metairie, Louisiana; James L. Biddle, M.D.,
Rio Grande Regional Hospital and McAllen Medical Center; John A.
Kusske, M.D., University of California; James Nepola, M.D. Health
Policy Committee Orthopedic Trauma Association; Michael J. Rosenberg,
M.D., Assistant Professor/Private Practice; and David W. Tuggle, M.D.,
University Oklahoma College of Medicine
Patient Representatives--Warren A. Jones, M.D., Office of
the Governor, State of Mississippi; and Mark Pearlmutter, M.D., St.
Elizabeth's Medical Center.
CMS Regional Office Representatives--Gretchen A. Kane CMS,
and Charlotte S. Yeh, M.D., FACEP.
State Survey Agency Representative--Azzie Conley, RN,
State of North Carolina.
QIO Representative--David Siegel, M.D., J.D., FACEP, FACP,
FCLM Senior Physician Consultant and Clinical Coordinator.
III. Meeting Format, Agenda, and Suggested Presentation Topics
A. Meeting Format
The initial portion of the meeting will involve opening remarks,
introductions and the swearing in of the EMTALA TAG members by Michael
O. Leavitt, Secretary, DHHS. After which and in accordance with section
945 of MMA, the EMTALA TAG members will elect their chairperson. The
afternoon portion of the first day and the morning portion of the
second day will be reserved for statements from registered presenters.
The afternoon portion of the second day will be reserved for the EMTALA
TAG members to ask questions, prioritize the topics presented, and to
conduct other necessary business.
The time allotted for each presentation will be approximately 5
minutes but will be based on the number of registered presenters.
Presenters will speak in their assigned order. If there are individuals
who cannot attend the meeting, we will accept and present their
comments/statements at the meeting if their comments/statements are
received via postal mail or email at the address list in the ADDRESSES
section of this notice by March 22, 2005. Comments from other
participants (individuals that are not registered presenters) may be
heard after the scheduled statements, if time permits.
B. Tentative Meeting Agenda
The tentative agenda for the EMTALA TAG meetings is as follows:
Day 1
Welcome, call to order, introductions, and opening remarks
Administrative and housekeeping issues
Swearing in of members and self-introductions
Comments from registered presenters
Day 2
Comments from registered presenters
Discussion of current business
C. Suggested Presentation Topics
The following are suggested presentation topics:
Inpatient Transfers--Under current EMTALA regulations, if
a hospital admits an individual in good faith for stabilizing treatment
on an inpatient basis, the admission ends the hospital's EMTALA
obligation to that individual. Does the fact that an individual no
longer is covered by EMTALA at the time transfer is sought make it more
difficult to find a suitable specialty hospital transfer?
Specialty Hospitals and EMTALA--Some specialty hospitals
apparently accept patients on an appointment basis only, and will
accept patients only for treatment of particular medical conditions or
for a narrow range of services. There are reports that such hospitals
are refusing to accept transfers of patients from general or community
hospitals, on the basis that because the specialty hospital does not
have a dedicated emergency department as defined in the new
regulations, it has no obligations under EMTALA.
On-Call Issues--Some concerns have been expressed that the
revised regulations regarding physician on-call responsibilities are
reducing the willingness of physicians to take call, especially at
receiving hospitals, thus leading to delays in arranging appropriate
transfers and thereby delaying stabilization of patients.
Psychiatric Patients--There continues to be much concern
about determining stability for patients who have a psychiatric
condition, even if the emergency medical condition is not based on a
psychiatric disorder.
Certified Nurse Midwives--Under current regulations,
certified nurse midwives (CNMs) are not able to certify that a patient
is in false labor. Current regulations state that only a physician may
certify that a patient is in false labor. There is concern that this
policy is not cost effective and is in conflict with the authority
provided CNMs by state law.
[[Page 12693]]
IV. Registration Instructions
The Center for Medicare Management is coordinating meeting
registration. While there is no registration fee, individuals must
register to attend. As specified in the DATES section of this notice,
individuals who wish to attend or make a presentation at the meeting or
both must register by March 22, 2005. You may register by sending an e-
mail to EMTALATAG@cms.hhs.gov, sending a fax to the attention of Ronda
Allen at fax number (410) 786-0681 or (410) 786-0169, or calling (410)
786-4548. All registration requests must include your name, name of the
organization (if applicable), address, telephone and fax numbers, e-
mail address (if available), and topic to be addressed (if you want to
do a presentation). You will receive a registration confirmation with
instructions for your arrival at the Hubert H. Humphrey Building. If
seating capacity has been reached, you will be notified that the
meeting has reached capacity. All registered presenters must submit a
hard copy of their presentation to the EMTALA TAG at the first meeting.
V. Security Information
Since this meeting will be held in a Federal government building,
Federal security measures are applicable. In planning your arrival
time, we recommend allowing additional time to clear security. In order
to gain access to the building, participants must bring a government-
issued photo identification (driver's license, passport, etc.) and a
copy of your confirmation of registration for the meeting. Access may
be denied to persons without proper identification.
All persons entering the building must pass through a metal
detector. In addition, all items brought to HHS, whether personal or
for the purpose of demonstration or to support a presentation, are
subject to inspection. We cannot assume responsibility for coordinating
the receipt, transfer, transport, storage, set-up, safety, or timely
arrival of any personal belongings or items used for demonstration or
to support a presentation.
Authority: Section 945 of the Medicare Prescription Drug,
Improvement, and Modernization Act of 2003 (MMA).
(Catalog of Federal Domestic Assistance Program No. 93.773,
Medicare--Hospital Insurance; and Program No. 93.774, Medicare--
Supplementary Medical Insurance Program)
Dated: March 10, 2005.
Mark B. McClellan,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 05-5028 Filed 3-14-05; 8:45 am]
BILLING CODE 4120-01-P
