Medicare and Medicaid Programs; Approval of the Joint Commission's Continued Deeming Authority for Critical Access Hospitals, 30584-30587 [E9-14778]
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30584
Federal Register / Vol. 74, No. 122 / Friday, June 26, 2009 / Notices
ascertain whether there have been any
adverse events or medication errors
associated with the doxycycline hyclate
tablet emergency kit. If any such adverse
events or medication errors have not
previously been reported to FDA as outlined
in paragraph H, they must be reported within
15 days to FDA. FDA has authorized ASPR’s
Form entitled ‘‘Questions to Determine
Status of Your Household Antibiotic Kit
(HAK)’’ (Kit Status form). Any revision of the
Kit Status form is subject to FDA’s prior
approval. USPS, in conjunction with
appropriate local public health authorities,
will be responsible for ensuring that
completed Kit Status forms are maintained
until notified by FDA. A report summarizing
the information collected on Kit Status forms
under this paragraph will be submitted to
FDA within 30 days of gathering such
information. Associated records will be made
available to FDA for inspection upon request.
L. USPS will be responsible for collecting
any expired doxycycline hyclate tablet
emergency kits and turning them over to the
participating public health authority(ies).
The participating public health authority(ies)
will be responsible for disposing of expired
doxycycline hyclate tablet emergency kits as
instructed by ASPR at that time. The
participating public health authority(ies) will
ensure that drug accountability records are
maintained and reconciled. Such records
shall be made available to FDA for inspection
upon request.
M. USPS and the participating public
health authority(ies) will be responsible for
ensuring that completed Health Assessment
Forms, Healthcare Provider Quality
Checklists, and any other records associated
with this EUA are maintained until notified
by FDA. Such records will be made available
to FDA for inspection upon request.
N. As a condition of this EUA, all
advertising and promotional descriptive
printed matter relating to the use of
doxycycline hyclate tablet emergency kits
authorized under this EUA shall be
consistent with the Fact Sheets, home
preparation instructions, and placard
information, as well as the terms set forth in
this EUA and other requirements set forth in
the Act and FDA regulations.
O. Upon termination of the declaration of
emergency under section 564(b)(2) of the Act
or upon revocation of this EUA under section
564(g) of the Act, USPS will be responsible
for collecting all doxycycline hyclate tablet
emergency kits and turning them over to the
participating public health authority(ies).
The participating public health authority(ies)
will dispose of doxycycline hyclate
emergency kits as instructed by ASPR at that
time. The participating public health
authority(ies) will ensure that drug
accountability records are maintained and
reconciled. Such records will be made
available to FDA for inspection upon request.
P. HHS will notify FDA of its decision to
add a CRI location and its decision to initiate
distribution of doxycycline hyclate tablet
emergency kits under this EUA to particular
CRI locations.
The emergency use of doxycycline hyclate
tablet emergency kits as described in this
letter of authorization must comply with the
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conditions above and all other terms of this
authorization.
V. Duration of Authorization
This EUA will be effective until the
declaration of emergency is terminated under
section 564(b)(2) of the Act or the EUA is
revoked under section 564(g) of the Act.
Randall W. Lutter, Ph.D.
Deputy Commissioner for Policy
Dated: June 17, 2009.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E9–15044 Filed 6–25–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–2896–FN2]
Medicare and Medicaid Programs;
Approval of the Joint Commission’s
Continued Deeming Authority for
Critical Access Hospitals
AGENCY: Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Final Notice of Removal of
Conditional Probationary Status.
SUMMARY: Based on our review and
observations, we have determined that
the Joint Commission’s accreditation
standards for critical access hospitals
(CAHs) meet or exceed our
requirements. Therefore, this final
notice announces our decision to
approve without condition the Joint
Commission’s request for continued
recognition as a national accreditation
program for CAHs seeking to participate
in the Medicare or Medicaid programs.
DATES: Effective Date: This final notice
of approval is effective November 21,
2008 through November 21, 2011.
FOR FURTHER INFORMATION CONTACT:
Cindy Melanson, (410) 786–0310.
Patricia Chmielewski, (410) 786–6899.
SUPPLEMENTARY INFORMATION:
I. Background
Under the Medicare program, eligible
beneficiaries may receive covered
services in a Critical Access Hospital
(CAH) provided certain requirements
are met. Sections 1820(c)(2)(B) and
1861(mm) of the Social Security Act
(the Act) establish distinct criteria for
facilities seeking designation as a CAH.
Under this authority, the minimum
requirements that a CAH must meet to
participate in Medicare are set forth in
regulations at 42 CFR part 485, subpart
F (Conditions of Participation: Critical
Access Hospitals (CAHs)) which
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determine the basis and scope of CAH
covered services. Conditions for
Medicare payment for CAHs are set
forth at § 413.70. Applicable regulations
concerning provider agreements are
located in 42 CFR part 489 (Provider
Agreements and Supplier Approval) and
those pertaining to facility survey and
certification are located in 42 CFR part
488, subparts A and B.
In general, we approve a CAH for
participation in the Medicare program if
it is participating as a hospital at the
time it applies for CAH designation, and
it is in compliance with part 482
(Conditions of Participation for
Hospitals) and part 485, subpart F
(Conditions of Participation: Critical
Access Hospital (CAHs)).
For a CAH to enter into a provider
agreement, a State survey agency must
certify that the CAH is in compliance
with the conditions or standards set
forth in section 1820 of the Act and part
485 of our regulations. Thereafter, the
CAH is subject to ongoing review by a
State survey agency to determine
whether it continues to meet the
Medicare requirements. There is,
however, an alternative to State
compliance surveys. Accreditation by a
nationally-recognized accreditation
program can substitute for ongoing State
review.
Section 1865(a)(1) of the Act provides
that, if a provider entity demonstrates
through accreditation by an approved
national accreditation organization (AO)
that all applicable Medicare conditions
are met or exceeded, we may ‘‘deem’’
that provider entity as having met the
requirements. Accreditation by an AO is
voluntary and is not required for
Medicare participation.
A national AO applying for approval
of deeming authority under part 488,
subpart A must provide us with
reasonable assurance that the AO
requires the accredited provider entities
to meet requirements that are at least as
stringent as the Medicare conditions of
participation. Our regulations
concerning re-approval of AOs are set
forth at § 488.4 and § 488.8(d)(3). The
regulations at § 488.8(d)(3) require AOs
to reapply for continued approval of
deeming authority every 6 years, or
sooner as we determine. The regulations
at § 488.8(f)(3)(i) provide CMS the
authority to grant conditional approval
of an AO’s deeming authority, with a
180-day probationary period, if the AO
has not adopted comparable standards
during the reapplication process.
We received a complete application
from the Joint Commission for
continued recognition as a national
accrediting organization for CAHs on
March 28, 2008. In accordance with the
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requirements at § 488.4 and
§ 488.8(d)(3), we published a proposed
notice on May 23, 2008 (73 FR 30107)
and a final notice announcing our
decision approving deeming authority
subject to probationary conditions on
October 24, 2008 (73 FR 63480). This
final notice is in response to the
conditional approval with a 180-day
probationary period granted to the Joint
Commission on October 24, 2008. The
Joint Commission did not adopt
comparable standards to meet the
requirements for distinct part units
(DPU) in CAHs during its reapplication
for renewal of deeming authority. This
final notice is required to be published
no later than July 19, 2009.
II. Deeming Applications Approval
Process
Section 1865(a)(3)(A) of the Act
provides a statutory timetable to ensure
that our review of deeming applications
is conducted in a timely manner. The
Act provides us with 210 calendar days
after the date of receipt of a complete
application to conduct our survey
activities and application review
process. Within 60 days of receiving a
complete application, we must publish
a notice in the Federal Register that
identifies the national accreditation
body making the request, describes the
request, and provides no less than a 30day public comment period. At the end
of the 210-day period, we must publish
an approval or denial of the application.
In accordance with § 488.8(f)(2), if CMS
determines, following the deeming
authority review that the organization
has failed to adopt requirements
comparable to CMS requirements, the
AO may be given a conditional approval
of its deeming authority for a
probationary period of up to 180 days to
adopt comparable requirements. Within
60 days after the end of this period, we
must make a final determination as to
whether or not the Joint Commission’s
CAH DPU accreditation requirements
are comparable to CMS requirements
and issue an appropriate notice that
includes the reasons for our
determination.
III. Provisions of the October 23, 2008
Final Notice
We revised the CAH requirements on
August 11, 2004 (69 FR 49272) to
include a new condition at § 485.647.
This condition of participation (CoP)
outlines the eligibility requirements for
CAHs that wish to have a psychiatric or
rehabilitation DPU. Under this
condition, a CAH can provide inpatient
psychiatric or rehabilitation services in
a DPU so long as the services furnished
in the DPU comply with the general
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hospital requirements specified at part
482, the requirements for excluded
hospital units at § 412.25, and the
additional requirements at § 412.27 for
excluded psychiatric units; and § 412.29
and § 412.30 for excluded rehabilitation
units as applicable. As a result, the Joint
Commission had to address all of the
DPU requirements set out at § 485.647,
including a crosswalk addressing the
Medicare hospital CoPs at part 482, as
part of its application for renewal of
CAH deeming authority. Review of the
Joint Commission’s accreditation
standards during the reapplication
submitted for renewal of deeming
authority revealed significant gaps
between the Joint Commission’s
standards and the Medicare CoPs. On
October 24, 2008, we conditionally
approved the Joint Commission’s
accreditation program for CAHs that
request participation in the Medicare
program with a 180 day probationary
period. Under section 1865(a)(2) of the
Act and our regulations at § 488.4 and
§ 488.8, we conducted a comparability
review of the Joint Commission’s CAH
DPU standards to CMS hospital
standards in part 482 and appropriate
provisions of part 412 in order to
determine compliance with the CAH
DPU requirements at § 485.647.
IV. Provisions of the Final Notice
A. Differences Between the Joint
Commission’s CAH DPU Standards and
Requirements for Accreditation and
Medicare’s Conditions and Survey
Requirements
During the 180-day probationary
period, we conducted a comparison of
the Joint Commission’s CAH DPU
accreditation standards to our current
Medicare CAH CoPs as outlined in the
State Operations Manual. We also
conducted a survey observation to
validate proper application of the
standards. Our review and evaluation of
the Joint Commission’s CAH DPU
standards yielded the following:
• To meet the requirements at
§ 482.12(b), the Joint Commission added
an element of performance (EP) to affirm
that only one individual or designee
may be the chief executive officer.
• To meet the requirements at
§ 482.12(e)(2), the Joint Commission
added a new EP to require hospitals to
maintain a list of all contracted services.
• To meet the requirements at
§ 482.12(f)(2), the Joint Commission
added a new EP to require that the
medical staff have written policies and
procedures for on-campus and offcampus locations appraising
emergencies, providing initial
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treatment, and for referring and
transferring patients.
• To meet the requirements at
§ 482.13(e)(1)(i),the Joint Commission
revised its EPs to include a definition of
restraints.
• To meet the requirements at
§ 482.13(e)(1)(ii), the Joint Commission
revised its EPs to include a definition of
seclusion.
• To meet the requirements at
§ 482.13(e)(5), § 482.13(e)(8)(ii),
§ 482.23(c), and § 482.23(c)(2), the Joint
Commission revised its EPs to include
the reference ‘‘as specified under
§ 482.12(c),’’ which addresses the care
of the patient.
• To meet the requirements at
§ 482.13(e)(10), the Joint Commission
revised its EP to address the staff
training requirements of individuals
that monitor patients in restraints and
seclusion.
• To meet the requirements at
§ 482.11(e)(11), the Joint Commission
revised its EPs to require physicians and
other licensed independent
practitioners authorized to order
restraints and seclusion have a working
knowledge of hospital policy regarding
the use of restraint and seclusion.
• To meet the requirements at
§ 482.13(f)(2), the Joint Commission
revised its EPs to address the
components of training, education, and
demonstrated knowledge on restraint
and seclusion.
• To meet the requirements at
§ 482.22(c)(5)(i), the Joint Commission
revised its EP to include ‘‘as defined in
section 1861(r) of the Social Security
Act,’’ which contains the definition of a
physician.
• To meet the requirements at
§ 482.23(b), the Joint Commission
revised its EP to address the nurse
staffing requirements, supervisory
personnel, and immediate availability of
a registered nurse for bedside care.
• To meet the requirements at
§ 482.23(c)(2), the Joint Commission
revised its EP to address the
requirements related to orders for drugs
and biologicals.
• To meet the requirements at
§ 482.23(c)(2)(ii), the Joint Commission
revised its EPs to address the
requirement that hospitals have policies
and procedures on who is authorized to
accept verbal orders.
• To meet the requirements at
§ 482.23(c)(3), the Joint Commission
added a new EP to require special
training for staff members administering
blood transfusions.
• To meet the requirements at
§ 482.24, the Joint Commission revised
its EPs to include medical records as an
essential service.
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• To meet the requirements at
§ 482.24(a), the Joint Commission added
a new EP that states the hospital must
be able to ensure prompt completion,
filing, and retrieval of records.
• To meet the requirements at
482.24(c)(1), the Joint Commission
added a new EP that requires all patient
medical records entries be timed.
• To meet the requirements at
482.24(c)(1)(i), the Joint Commission
revised its EP to address ‘‘all orders.’’
• To meet the requirements at
§ 482.24(c)(1)(iii), the Joint Commission
added a new EP to address the
timeframe requirement for verbal order
authentication.
• To meet the requirements at
§ 482.25, the Joint Commission revised
its EP to include a requirement that the
pharmacy must be directed by a
registered pharmacist.
• To meet the requirements at
§ 482.25(b)(1), the Joint Commission
revised its EP to require a pharmacist
supervise all compounding, packing,
and dispensing of drugs and biologicals.
• To meet the requirements at
§ 482.25(b)(2)(ii), the Joint Commission
revised its EP to require all controlled
substances included in Schedules II, III,
IV, and V of the Comprehensive Drug
Abuse and Prevention and Control Act
be locked and secure.
• To meet the requirements at
§ 482.25(b)(6), the Joint Commission
revised its EP to address the
requirement, if necessary, to report drug
administration errors, adverse drug
reactions and incompatibilities to the
hospital-wide quality assurance
program.
• To meet the requirements at
§ 482.26(c)(1), the Joint Commission
revised its EPs to state that a radiologist
is a doctor of medicine or osteopathy.
• To meet the requirements at
§ 482.27(a), the Joint Commission
revised its EP to include a statement
that hospitals must provide laboratory
services with a certified laboratory that
meet the requirements of part 493 of
title 42 of the Code of Federal
Regulations.
• To meet the requirements at
§ 482.27(a)(1), the Joint Commission
added a new EP requiring laboratory
services be available 24 hours a day.
• To meet the requirements at
§ 482.27(a)(4), the Joint Commission
added a new EP to require the medical
staff and pathologist establish which
tissue specimens require macroscopic
and microscopic examinations.
• To meet the requirements at
§ 482.27(b), the Joint Commission added
new EPs associated with potentially
infectious blood and blood components.
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• To meet the requirements at
§ 482.27(b)(5)(ii), the Joint Commission
revised its EP to include the
requirement that the plan to transfer
medical records must be ‘‘fully funded.’’
• To meet the requirements at
§ 482.27(b)(6)(ii), the Joint Commission
revised its EPs to include the statement
that if the hospital administered
potentially HIV or HCV infectious blood
or blood components and the physician
is unavailable or declines to make the
notification, the hospital must make
reasonable attempts to give this
notification to the patient, legal
guardian, or relative.
• To meet the requirements at
§ 482.28(a)(1)(iii), the Joint Commission
revised its EP to include that the full
time director of food and dietetic
services be qualified by experience or
training.
• To meet the requirements at
§ 482.43, the Joint Commission added a
new EP to require hospitals have a
discharge planning process that applies
to all patients.
• To meet the requirements at
§ 482.43(b)(2), the Joint Commission
added a new EP to require RNs, social
workers or other appropriately qualified
personnel develop, or supervise the
development of the evaluation.
• To meet the requirements at
§ 482.43(b)(6), the Joint Commission
added a new EP to require the inclusion
of a discharge planning evaluation in
the medical record for use in
establishing an appropriate discharge
plan. The Joint Commission also
requires the hospital to discuss the
results of the discharge plan with the
patient or individual acting on behalf of
the patient.
• To meet the requirements at
§ 482.43(c), the Joint Commission added
new EPs to address the discharge
planning requirements.
• To meet the requirements at
§ 482.51(b)(1)(ii), the Joint Commission
revised its EPs to include a requirement
for an update within 24 hours after
admission or registration when the
medical history and physical
examination are completed within 30
days before admission or registration.
• To meet the requirements at
§ 482.52(a)(5), the Joint Commission
revised its EPs to include ‘‘as defined in
§ 410.69(c),’’ which provides the
definition of an anesthesiologist
assistant.
• To meet the requirements at
§ 482.52(b)(3), the Joint Commission
added a new EP to address the
requirements of the postanesthesia
evaluation.
• To meet the requirements at
§ 482.53(a)(1), the Joint Commission
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added a new EP to identify the nuclear
medicine services that must be
supervised and administered by a
doctor of medicine or osteopathy
qualified in nuclear medicine.
• To meet the requirements at
§ 482.53(b)(1), the Joint Commission
added a new EP to state that the ‘‘inhouse preparation’’ of
radiopharmaceuticals must be under the
supervision of an ‘‘appropriately trained
registered pharmacist or a doctor of
medicine or osteopathy.’’
• To meet the requirements at
§ 482.55(a)(1), the Joint Commission
added a new EP that requires a qualified
member of the medical staff direct
emergency services.
• To meet the requirements at
§ 482.55(a)(3), the Joint Commission
added an EP to clarify that the policies
and procedures governing medical care
provided in the emergency department
are established by and are a continuing
responsibility of the medical staff.
• To meet the requirements at
§ 482.55(b)(1), the Joint Commission
added a new EP to require a qualified
member of the medical staff supervise
emergency services.
• To meet the requirements at
§ 482.57(a)(1), the Joint Commission
added a new EP to address the
requirement that there must be a
director of respiratory services who is a
doctor of medicine or osteopathy.
• To meet the requirements at
§ 482.57(b)(3), the Joint Commission
added new EPs to state respiratory
services are provided only on and in
accordance with, the orders of a doctor
of medicine or osteopathy.
B. Term of Approval
Based on the review and observations,
we have determined that the Joint
Commission’s accreditation standards
for CAHs meet or exceed our
requirements. Therefore, we approve the
Joint Commission as a national
accreditation organization for CAHs that
request participation in the Medicare
program, effective November 21, 2008
through November 21, 2011. Under
§ 488.8(f)(4), notice was given to the
Joint Commission on October 24, 2008
(73 FR 63480) and this notice, although
not required by our regulations is being
published as a public service for
informational purposes.
V. Collection of Information
Requirements
This document does not impose
information collection and
recordkeeping requirements.
Consequently, it need not be reviewed
by the Office of Management and
Budget under the authority of the
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Paperwork Reduction Act of 1995 (44
U.S.C. 35).
Authority: Section 1865 of the Social
Security Act (42 U.S.C. 1395bb).
(Catalog of Federal Domestic Assistance
Program No. 93.778, Medical Assistance
Program; No. 93.773 Medicare—Hospital
Insurance Program; and No. 93.774,
Medicare—Supplemental Medical Insurance
Program)
Dated: May 7, 2009.
Charlene Frizzera,
Acting Administrator, Centers for Medicare
& Medicaid Services.
[FR Doc. E9–14778 Filed 6–25–09; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–2476–PN]
Medicare and Medicaid Programs;
Application by the American
Association for Accreditation of
Ambulatory Surgery Facilities for
Continued Deeming Authority for
Ambulatory Surgical Centers
AGENCY: Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Proposed notice.
SUMMARY: This proposed notice
acknowledges the receipt of an
application from the American
Association for Accreditation of
Ambulatory Surgery Facilities
(AAAASF) for continued recognition as
a national accrediting organization for
ambulatory surgical centers (ASCs) that
wish to participate in the Medicare or
Medicaid programs. The statute requires
that we publish, within 60 days of
receipt of an organization’s complete
application, a notice identifying the
national accrediting body making the
request, describing the nature of the
request, and providing at least a 30-day
public comment period.
DATES: To be assured consideration,
comments must be received at one of
the addresses provided below, no later
than 5 p.m. on July 27, 2009.
ADDRESSES: In commenting, please refer
to file code CMS–2476–PN. Because of
staff and resource limitations, we cannot
accept comments by facsimile (FAX)
transmission.
You may submit comments in one of
four ways (please choose only one of the
ways listed):
1. Electronically. You may submit
electronic comments on this regulation
to https://www.regulations.gov. Follow
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the instructions under the ‘‘More Search
Options’’ tab.
2. By regular mail. You may mail
written comments to the following
address ONLY: Centers for Medicare &
Medicaid Services, Department of
Health and Human Services, Attention:
CMS–2476–PN, P.O. Box 8010,
Baltimore, MD 21244–8010.
Please allow sufficient time for mailed
comments to be received before the
close of the comment period.
3. By express or overnight mail. You
may send written comments to the
following address ONLY: Centers for
Medicare & Medicaid Services,
Department of Health and Human
Services, Attention: CMS–2476–PN,
Mail Stop C4–26–05, 7500 Security
Boulevard, Baltimore, MD 21244–1850.
4. By hand or courier. If you prefer,
you may deliver (by hand or courier)
your written comments before the close
of the comment period to either of the
following addresses: a. For delivery in
Washington, DC—Centers for Medicare
& Medicaid Services, Department of
Health and Human Services, Room 445–
G, Hubert H. Humphrey Building, 200
Independence Avenue, SW.,
Washington, DC 20201
(Because access to the interior of the
Hubert H. Humphrey Building is not
readily available to persons without
Federal government identification,
commenters are encouraged to leave
their comments in the CMS drop slots
located in the main lobby of the
building. A stamp-in clock is available
for persons wishing to retain a proof of
filing by stamping in and retaining an
extra copy of the comments being filed.)
b. For delivery in Baltimore, MD—
Centers for Medicare & Medicaid
Services, Department of Health and
Human Services, 7500 Security
Boulevard, Baltimore, MD 21244–1850.
If you intend to deliver your
comments to the Baltimore address,
please call telephone number (410) 786–
9994 in advance to schedule your
arrival with one of our staff members.
Comments mailed to the addresses
indicated as appropriate for hand or
courier delivery may be delayed and
received after the comment period.
For information on viewing public
comments, see the beginning of the
SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT:
Lillian Williams, (410) 786–8636.
Patricia Chmielewski, (410) 786–6899.
SUPPLEMENTARY INFORMATION: Inspection
of Public Comments: All comments
received before the close of the
comment period are available for
viewing by the public, including any
personally identifiable or confidential
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30587
business information that is included in
a comment. We post all comments
received before the close of the
comment period on the following Web
site as soon as possible after they have
been received: https://
www.regulations.gov. Follow the search
instructions on that Web site to view
public comments.
Comments received timely will also
be available for public inspection as
they are received, generally beginning
approximately 3 weeks after publication
of a document, at the headquarters of
the Centers for Medicare & Medicaid
Services, 7500 Security Boulevard,
Baltimore, Maryland 21244, Monday
through Friday of each week from 8:30
a.m. to 4 p.m. To schedule an
appointment to view public comments,
phone 1–800–743–3951.
I. Background
Under the Medicare program, eligible
beneficiaries may receive covered
services from an ambulatory surgical
center (ASC) provided certain
requirements are met. Section
1832(a)(2)(F)(i) of the Social Security
Act (the Act) establishes distinct criteria
for facilities seeking designation as an
ASC. Regulations concerning provider
agreements are at 42 CFR part 489 and
those pertaining to activities relating to
the survey and certification of facilities
are at 42 CFR part 488. The regulations
at 42 CFR part 416 specify the
conditions that an ASC must meet in
order to participate in the Medicare
program, the scope of covered services
and the conditions for Medicare
payment for ASCs.
Generally, in order to enter into a
provider agreement with the Medicare
program, an ASC must first be certified
by a State survey agency as complying
with the conditions or requirements set
forth in part 416 of our regulations.
Thereafter, the ASC is subject to regular
surveys by a State survey agency to
determine whether it continues to meet
these requirements. There is an
alternative, however, to surveys by State
agencies.
Section 1865(a)(1) of the Act provides
that, if a provider entity demonstrates
through accreditation by an approved
national accrediting organization that all
applicable Medicare conditions are met
or exceeded, we will deem those
provider entities as having met the
requirements. Accreditation by an
accrediting organization is voluntary
and is not required for Medicare
participation.
If an accrediting organization is
recognized by the Secretary as having
standards for accreditation that meet or
exceed Medicare requirements, any
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Agencies
[Federal Register Volume 74, Number 122 (Friday, June 26, 2009)]
[Notices]
[Pages 30584-30587]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-14778]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-2896-FN2]
Medicare and Medicaid Programs; Approval of the Joint
Commission's Continued Deeming Authority for Critical Access Hospitals
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Final Notice of Removal of Conditional Probationary Status.
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SUMMARY: Based on our review and observations, we have determined that
the Joint Commission's accreditation standards for critical access
hospitals (CAHs) meet or exceed our requirements. Therefore, this final
notice announces our decision to approve without condition the Joint
Commission's request for continued recognition as a national
accreditation program for CAHs seeking to participate in the Medicare
or Medicaid programs.
DATES: Effective Date: This final notice of approval is effective
November 21, 2008 through November 21, 2011.
FOR FURTHER INFORMATION CONTACT: Cindy Melanson, (410) 786-0310.
Patricia Chmielewski, (410) 786-6899.
SUPPLEMENTARY INFORMATION:
I. Background
Under the Medicare program, eligible beneficiaries may receive
covered services in a Critical Access Hospital (CAH) provided certain
requirements are met. Sections 1820(c)(2)(B) and 1861(mm) of the Social
Security Act (the Act) establish distinct criteria for facilities
seeking designation as a CAH. Under this authority, the minimum
requirements that a CAH must meet to participate in Medicare are set
forth in regulations at 42 CFR part 485, subpart F (Conditions of
Participation: Critical Access Hospitals (CAHs)) which determine the
basis and scope of CAH covered services. Conditions for Medicare
payment for CAHs are set forth at Sec. 413.70. Applicable regulations
concerning provider agreements are located in 42 CFR part 489 (Provider
Agreements and Supplier Approval) and those pertaining to facility
survey and certification are located in 42 CFR part 488, subparts A and
B.
In general, we approve a CAH for participation in the Medicare
program if it is participating as a hospital at the time it applies for
CAH designation, and it is in compliance with part 482 (Conditions of
Participation for Hospitals) and part 485, subpart F (Conditions of
Participation: Critical Access Hospital (CAHs)).
For a CAH to enter into a provider agreement, a State survey agency
must certify that the CAH is in compliance with the conditions or
standards set forth in section 1820 of the Act and part 485 of our
regulations. Thereafter, the CAH is subject to ongoing review by a
State survey agency to determine whether it continues to meet the
Medicare requirements. There is, however, an alternative to State
compliance surveys. Accreditation by a nationally-recognized
accreditation program can substitute for ongoing State review.
Section 1865(a)(1) of the Act provides that, if a provider entity
demonstrates through accreditation by an approved national
accreditation organization (AO) that all applicable Medicare conditions
are met or exceeded, we may ``deem'' that provider entity as having met
the requirements. Accreditation by an AO is voluntary and is not
required for Medicare participation.
A national AO applying for approval of deeming authority under part
488, subpart A must provide us with reasonable assurance that the AO
requires the accredited provider entities to meet requirements that are
at least as stringent as the Medicare conditions of participation. Our
regulations concerning re-approval of AOs are set forth at Sec. 488.4
and Sec. 488.8(d)(3). The regulations at Sec. 488.8(d)(3) require AOs
to reapply for continued approval of deeming authority every 6 years,
or sooner as we determine. The regulations at Sec. 488.8(f)(3)(i)
provide CMS the authority to grant conditional approval of an AO's
deeming authority, with a 180-day probationary period, if the AO has
not adopted comparable standards during the reapplication process.
We received a complete application from the Joint Commission for
continued recognition as a national accrediting organization for CAHs
on March 28, 2008. In accordance with the
[[Page 30585]]
requirements at Sec. 488.4 and Sec. 488.8(d)(3), we published a
proposed notice on May 23, 2008 (73 FR 30107) and a final notice
announcing our decision approving deeming authority subject to
probationary conditions on October 24, 2008 (73 FR 63480). This final
notice is in response to the conditional approval with a 180-day
probationary period granted to the Joint Commission on October 24,
2008. The Joint Commission did not adopt comparable standards to meet
the requirements for distinct part units (DPU) in CAHs during its
reapplication for renewal of deeming authority. This final notice is
required to be published no later than July 19, 2009.
II. Deeming Applications Approval Process
Section 1865(a)(3)(A) of the Act provides a statutory timetable to
ensure that our review of deeming applications is conducted in a timely
manner. The Act provides us with 210 calendar days after the date of
receipt of a complete application to conduct our survey activities and
application review process. Within 60 days of receiving a complete
application, we must publish a notice in the Federal Register that
identifies the national accreditation body making the request,
describes the request, and provides no less than a 30-day public
comment period. At the end of the 210-day period, we must publish an
approval or denial of the application. In accordance with Sec.
488.8(f)(2), if CMS determines, following the deeming authority review
that the organization has failed to adopt requirements comparable to
CMS requirements, the AO may be given a conditional approval of its
deeming authority for a probationary period of up to 180 days to adopt
comparable requirements. Within 60 days after the end of this period,
we must make a final determination as to whether or not the Joint
Commission's CAH DPU accreditation requirements are comparable to CMS
requirements and issue an appropriate notice that includes the reasons
for our determination.
III. Provisions of the October 23, 2008 Final Notice
We revised the CAH requirements on August 11, 2004 (69 FR 49272) to
include a new condition at Sec. 485.647. This condition of
participation (CoP) outlines the eligibility requirements for CAHs that
wish to have a psychiatric or rehabilitation DPU. Under this condition,
a CAH can provide inpatient psychiatric or rehabilitation services in a
DPU so long as the services furnished in the DPU comply with the
general hospital requirements specified at part 482, the requirements
for excluded hospital units at Sec. 412.25, and the additional
requirements at Sec. 412.27 for excluded psychiatric units; and Sec.
412.29 and Sec. 412.30 for excluded rehabilitation units as
applicable. As a result, the Joint Commission had to address all of the
DPU requirements set out at Sec. 485.647, including a crosswalk
addressing the Medicare hospital CoPs at part 482, as part of its
application for renewal of CAH deeming authority. Review of the Joint
Commission's accreditation standards during the reapplication submitted
for renewal of deeming authority revealed significant gaps between the
Joint Commission's standards and the Medicare CoPs. On October 24,
2008, we conditionally approved the Joint Commission's accreditation
program for CAHs that request participation in the Medicare program
with a 180 day probationary period. Under section 1865(a)(2) of the Act
and our regulations at Sec. 488.4 and Sec. 488.8, we conducted a
comparability review of the Joint Commission's CAH DPU standards to CMS
hospital standards in part 482 and appropriate provisions of part 412
in order to determine compliance with the CAH DPU requirements at Sec.
485.647.
IV. Provisions of the Final Notice
A. Differences Between the Joint Commission's CAH DPU Standards and
Requirements for Accreditation and Medicare's Conditions and Survey
Requirements
During the 180-day probationary period, we conducted a comparison
of the Joint Commission's CAH DPU accreditation standards to our
current Medicare CAH CoPs as outlined in the State Operations Manual.
We also conducted a survey observation to validate proper application
of the standards. Our review and evaluation of the Joint Commission's
CAH DPU standards yielded the following:
To meet the requirements at Sec. 482.12(b), the Joint
Commission added an element of performance (EP) to affirm that only one
individual or designee may be the chief executive officer.
To meet the requirements at Sec. 482.12(e)(2), the Joint
Commission added a new EP to require hospitals to maintain a list of
all contracted services.
To meet the requirements at Sec. 482.12(f)(2), the Joint
Commission added a new EP to require that the medical staff have
written policies and procedures for on-campus and off-campus locations
appraising emergencies, providing initial treatment, and for referring
and transferring patients.
To meet the requirements at Sec. 482.13(e)(1)(i),the
Joint Commission revised its EPs to include a definition of restraints.
To meet the requirements at Sec. 482.13(e)(1)(ii), the
Joint Commission revised its EPs to include a definition of seclusion.
To meet the requirements at Sec. 482.13(e)(5), Sec.
482.13(e)(8)(ii), Sec. 482.23(c), and Sec. 482.23(c)(2), the Joint
Commission revised its EPs to include the reference ``as specified
under Sec. 482.12(c),'' which addresses the care of the patient.
To meet the requirements at Sec. 482.13(e)(10), the Joint
Commission revised its EP to address the staff training requirements of
individuals that monitor patients in restraints and seclusion.
To meet the requirements at Sec. 482.11(e)(11), the Joint
Commission revised its EPs to require physicians and other licensed
independent practitioners authorized to order restraints and seclusion
have a working knowledge of hospital policy regarding the use of
restraint and seclusion.
To meet the requirements at Sec. 482.13(f)(2), the Joint
Commission revised its EPs to address the components of training,
education, and demonstrated knowledge on restraint and seclusion.
To meet the requirements at Sec. 482.22(c)(5)(i), the
Joint Commission revised its EP to include ``as defined in section
1861(r) of the Social Security Act,'' which contains the definition of
a physician.
To meet the requirements at Sec. 482.23(b), the Joint
Commission revised its EP to address the nurse staffing requirements,
supervisory personnel, and immediate availability of a registered nurse
for bedside care.
To meet the requirements at Sec. 482.23(c)(2), the Joint
Commission revised its EP to address the requirements related to orders
for drugs and biologicals.
To meet the requirements at Sec. 482.23(c)(2)(ii), the
Joint Commission revised its EPs to address the requirement that
hospitals have policies and procedures on who is authorized to accept
verbal orders.
To meet the requirements at Sec. 482.23(c)(3), the Joint
Commission added a new EP to require special training for staff members
administering blood transfusions.
To meet the requirements at Sec. 482.24, the Joint
Commission revised its EPs to include medical records as an essential
service.
[[Page 30586]]
To meet the requirements at Sec. 482.24(a), the Joint
Commission added a new EP that states the hospital must be able to
ensure prompt completion, filing, and retrieval of records.
To meet the requirements at 482.24(c)(1), the Joint
Commission added a new EP that requires all patient medical records
entries be timed.
To meet the requirements at 482.24(c)(1)(i), the Joint
Commission revised its EP to address ``all orders.''
To meet the requirements at Sec. 482.24(c)(1)(iii), the
Joint Commission added a new EP to address the timeframe requirement
for verbal order authentication.
To meet the requirements at Sec. 482.25, the Joint
Commission revised its EP to include a requirement that the pharmacy
must be directed by a registered pharmacist.
To meet the requirements at Sec. 482.25(b)(1), the Joint
Commission revised its EP to require a pharmacist supervise all
compounding, packing, and dispensing of drugs and biologicals.
To meet the requirements at Sec. 482.25(b)(2)(ii), the
Joint Commission revised its EP to require all controlled substances
included in Schedules II, III, IV, and V of the Comprehensive Drug
Abuse and Prevention and Control Act be locked and secure.
To meet the requirements at Sec. 482.25(b)(6), the Joint
Commission revised its EP to address the requirement, if necessary, to
report drug administration errors, adverse drug reactions and
incompatibilities to the hospital-wide quality assurance program.
To meet the requirements at Sec. 482.26(c)(1), the Joint
Commission revised its EPs to state that a radiologist is a doctor of
medicine or osteopathy.
To meet the requirements at Sec. 482.27(a), the Joint
Commission revised its EP to include a statement that hospitals must
provide laboratory services with a certified laboratory that meet the
requirements of part 493 of title 42 of the Code of Federal
Regulations.
To meet the requirements at Sec. 482.27(a)(1), the Joint
Commission added a new EP requiring laboratory services be available 24
hours a day.
To meet the requirements at Sec. 482.27(a)(4), the Joint
Commission added a new EP to require the medical staff and pathologist
establish which tissue specimens require macroscopic and microscopic
examinations.
To meet the requirements at Sec. 482.27(b), the Joint
Commission added new EPs associated with potentially infectious blood
and blood components.
To meet the requirements at Sec. 482.27(b)(5)(ii), the
Joint Commission revised its EP to include the requirement that the
plan to transfer medical records must be ``fully funded.''
To meet the requirements at Sec. 482.27(b)(6)(ii), the
Joint Commission revised its EPs to include the statement that if the
hospital administered potentially HIV or HCV infectious blood or blood
components and the physician is unavailable or declines to make the
notification, the hospital must make reasonable attempts to give this
notification to the patient, legal guardian, or relative.
To meet the requirements at Sec. 482.28(a)(1)(iii), the
Joint Commission revised its EP to include that the full time director
of food and dietetic services be qualified by experience or training.
To meet the requirements at Sec. 482.43, the Joint
Commission added a new EP to require hospitals have a discharge
planning process that applies to all patients.
To meet the requirements at Sec. 482.43(b)(2), the Joint
Commission added a new EP to require RNs, social workers or other
appropriately qualified personnel develop, or supervise the development
of the evaluation.
To meet the requirements at Sec. 482.43(b)(6), the Joint
Commission added a new EP to require the inclusion of a discharge
planning evaluation in the medical record for use in establishing an
appropriate discharge plan. The Joint Commission also requires the
hospital to discuss the results of the discharge plan with the patient
or individual acting on behalf of the patient.
To meet the requirements at Sec. 482.43(c), the Joint
Commission added new EPs to address the discharge planning
requirements.
To meet the requirements at Sec. 482.51(b)(1)(ii), the
Joint Commission revised its EPs to include a requirement for an update
within 24 hours after admission or registration when the medical
history and physical examination are completed within 30 days before
admission or registration.
To meet the requirements at Sec. 482.52(a)(5), the Joint
Commission revised its EPs to include ``as defined in Sec.
410.69(c),'' which provides the definition of an anesthesiologist
assistant.
To meet the requirements at Sec. 482.52(b)(3), the Joint
Commission added a new EP to address the requirements of the
postanesthesia evaluation.
To meet the requirements at Sec. 482.53(a)(1), the Joint
Commission added a new EP to identify the nuclear medicine services
that must be supervised and administered by a doctor of medicine or
osteopathy qualified in nuclear medicine.
To meet the requirements at Sec. 482.53(b)(1), the Joint
Commission added a new EP to state that the ``in-house preparation'' of
radiopharmaceuticals must be under the supervision of an
``appropriately trained registered pharmacist or a doctor of medicine
or osteopathy.''
To meet the requirements at Sec. 482.55(a)(1), the Joint
Commission added a new EP that requires a qualified member of the
medical staff direct emergency services.
To meet the requirements at Sec. 482.55(a)(3), the Joint
Commission added an EP to clarify that the policies and procedures
governing medical care provided in the emergency department are
established by and are a continuing responsibility of the medical
staff.
To meet the requirements at Sec. 482.55(b)(1), the Joint
Commission added a new EP to require a qualified member of the medical
staff supervise emergency services.
To meet the requirements at Sec. 482.57(a)(1), the Joint
Commission added a new EP to address the requirement that there must be
a director of respiratory services who is a doctor of medicine or
osteopathy.
To meet the requirements at Sec. 482.57(b)(3), the Joint
Commission added new EPs to state respiratory services are provided
only on and in accordance with, the orders of a doctor of medicine or
osteopathy.
B. Term of Approval
Based on the review and observations, we have determined that the
Joint Commission's accreditation standards for CAHs meet or exceed our
requirements. Therefore, we approve the Joint Commission as a national
accreditation organization for CAHs that request participation in the
Medicare program, effective November 21, 2008 through November 21,
2011. Under Sec. 488.8(f)(4), notice was given to the Joint Commission
on October 24, 2008 (73 FR 63480) and this notice, although not
required by our regulations is being published as a public service for
informational purposes.
V. Collection of Information Requirements
This document does not impose information collection and
recordkeeping requirements. Consequently, it need not be reviewed by
the Office of Management and Budget under the authority of the
[[Page 30587]]
Paperwork Reduction Act of 1995 (44 U.S.C. 35).
Authority: Section 1865 of the Social Security Act (42 U.S.C.
1395bb).
(Catalog of Federal Domestic Assistance Program No. 93.778, Medical
Assistance Program; No. 93.773 Medicare--Hospital Insurance Program;
and No. 93.774, Medicare--Supplemental Medical Insurance Program)
Dated: May 7, 2009.
Charlene Frizzera,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. E9-14778 Filed 6-25-09; 8:45 am]
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