Medicare and Medicaid Programs; Application by the Joint Commission for Deeming Authority for Psychiatric Hospitals, 65360-65362 [2010-26716]
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65360
Federal Register / Vol. 75, No. 204 / Friday, October 22, 2010 / Notices
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Æ Unsafe conditions—circumstances
that increase the probability of a patient
safety event.
Common Formats Version 1.1 is
currently limited to patient safety
reporting for acute care hospitals and is
designed to support the first stage in the
improvement cycle. Version 1.1
includes two general types of formats,
generic and event specific. The generic
Common Formats pertain to all patient
safety concerns. The three generic
formats are: Healthcare Event Reporting
Form, Patient Information Form, and
Summary of Initial Report. The eventspecific Common Formats pertain to
frequently occurring and/or serious
patient safety events. The eight eventspecific formats are: Blood or Blood
Product, Device or Medical/Surgical
Supply, Fall, Healthcare-Associated
Infection, Medication or Other
Substance, Perinatal, Pressure Ulcer,
and Surgery or Anesthesia.
As part of the Agency’s efforts to
continually refine and update the
formats, AHRQ has issued a significant
revision of the previously released
Common Format—Device or Medical/
Surgical Supply. In conjunction with
the Food and Drug Administration
(FDA) and the Office of the National
Coordinator for Health Information
Technology (ONC), AHRQ developed
the beta version of this event-specific
format to capture information about
patient safety events that are related to
HIT. Subsequently, the format was
reviewed and revised by an interagency
Federal Patient Safety Work Group
(PSWG). The enhanced format, Device
or Medical/Surgical Supply including
HIT Device, will be incorporated into
the next version of the Common
Formats (Version 1.2).
This revised format includes a
description of patient safety events and
unsafe conditions to be reported (event
description) and a sample patient safety
aggregate report and individual event
summary. The Device or Medical/
Surgical Supply including HIT Device
Common Format is available at the
Patient Safety Organization (PSO)
Privacy Protection Center (PPC) Web
site: https://www.psoppc.org/web/
patientsafety.
Commenting on Device or Medical/
Surgical Supply Including HIT Device
Common Format, Version 1.1
To allow for greater participation by
the private sector in the subsequent
development of the Common Formats,
AHRQ engaged the National Quality
Forum (NQF), a non-profit organization
focused on health care quality, to solicit
comments and advice to guide the
further refinement of the Common
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17:43 Oct 21, 2010
Jkt 223001
Formats. The NQF began this process
with feedback on AHRQ’s 0.1 Beta
release of the Common Formats. Based
upon the expert panel’s feedback,
AHRQ, in conjunction with the PSWG,
further revised and refined the Common
Formats and released Version 1.0.
The review process above was
repeated again from September 2009
through February 2010 to further refine
Common Formats Version 1.0 and
incorporate public comments prior to
finalization of the technical
specifications for electronic
implementation. These revised formats
are now available as Version 1.1.
As evidenced by the release of this
Device or Medical/Surgical Supply
including HIT Device format, AHRQ is
committed to continuing refinement of
the Common Formats. The Agency is
specifically interested in obtaining
feedback from both the private and
public sectors, particularly from those
who use the Common Formats, to guide
their improvement. Information on how
to comment and provide feedback on
the Common Formats, Version 1.1 and
the Device or Medical/Surgical Supply
including HIT Device beta version, is
available at the National Quality Forum
(NQF) Web site for Common Formats:
https://www.Quality.forum.org/projects/
commonformats.aspx.
Abuse and Mental Health Services
Administration—as well as the DoD and
the VA.
The PSWG assists AHRQ with
assuring the consistency of definitions/
formats with those of relevant
government agencies as refinement of
the Common Formats continues. To the
extent practicable, the Common Formats
are also aligned with World Health
Organization (WHO) concepts,
framework, and definitions contained in
their draft International Classification
for Patient Safety (ICPS).
The process for updating and refining
the formats will continue to be an
iterative one. More information on the
Common Formats Version 1.1 can be
obtained through AHRQ’s PSO Web site:
https://www.PSO.AHRQ.qov/.
Common Formats Development
In anticipation of the need for
Common Formats, AHRQ began their
development in 2005 by creating an
inventory of functioning private and
public sector patient safety reporting
systems. This inventory provides an
evidence base that informs construction
of the Common Formats. The inventory
now numbers 69 and includes many
systems from the private sector,
including prominent academic settings,
hospital systems, and international
reporting systems (e.g., from the United
Kingdom and the Commonwealth of
Australia). In addition, virtually all
major Federal patient safety reporting
systems are included, such as those
from the Centers for Disease Control and
Prevention (CDC), FDA, the Department
of Defense (DOD), and the Department
of Veterans Affairs (VA).
Since February 2005, AHRQ has
coordinated the PSWG to assist AHRQ
with developing and maintaining the
Common Formats. The PSWG includes
major health agencies within the HHS–
CDC, Centers for Medicare & Medicaid
Services, FDA, Health Resources and
Services Administration, the Indian
Health Service, the National Institutes of
Health, the National Library of
Medicine, ONC, the Office of Public
Health and Science, the Substance
Medicare and Medicaid Programs;
Application by the Joint Commission
for Deeming Authority for Psychiatric
Hospitals
PO 00000
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Dated: October 12, 2010.
Carolyn M. Clancy,
Director.
[FR Doc. 2010–26667 Filed 10–21–10; 8:45 am]
BILLING CODE 4160–90–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–2326–PN]
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Proposed notice.
AGENCY:
SUMMARY This proposed notice with
comment period acknowledges the
receipt of an application from the Joint
Commission for recognition as a
national accrediting organization for
psychiatric hospitals that wish to
participate in the Medicare or Medicaid
programs. Section 1865(a)(3)(A) of the
Social Security Act requires that within
60 days of receipt of an organization’s
complete application, we publish a
notice that identifies the national
accrediting body making the request,
describes the nature of the request, and
provides 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 November 22, 2010.
ADDRESSES: In commenting, please refer
to file code CMS–2326–PN. Because of
staff and resource limitations, we cannot
accept comments by facsimile (FAX)
transmission.
E:\FR\FM\22OCN1.SGM
22OCN1
emcdonald on DSK2BSOYB1PROD with NOTICES
Federal Register / Vol. 75, No. 204 / Friday, October 22, 2010 / Notices
You may submit comments in one of
four ways (no duplicates, please):
1. Electronically. You may submit
electronic comments on specific issues
in this regulation to https://
www.cms.hhs.gov/eRulemaking. Click
on the link ‘‘Submit electronic
comments on CMS regulations with an
open comment period.’’ (Attachments
should be in Microsoft Word,
WordPerfect, or Excel; however, we
prefer Microsoft Word.)
2. By regular mail. You may mail
written comments (one original and two
copies) to the following address ONLY:
Centers for Medicare & Medicaid
Services, Department of Health and
Human Services, Attention: CMS–2326–
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 (one
original and two copies) to the following
address only: Centers for Medicare &
Medicaid Services, Department of
Health and Human Services, Attention:
CMS–2326–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 (one original
and two copies) before the close of the
comment period to one of the following
addresses. 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.
Room 445–G, Hubert H. Humphrey
Building, 200 Independence Avenue,
SW., Washington, DC 20201; or 7500
Security Boulevard, Baltimore, MD
21244–1850.
(Because access to the interior of the
HHH 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.)
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: L.
Tyler Whitaker, (410) 786–5236. Patricia
Chmielewski, (410) 786–6899.
VerDate Mar<15>2010
17:43 Oct 21, 2010
Jkt 223001
SUPPLEMENTARY INFORMATION:
Submitting Comments: We welcome
comments from the public on all issues
set forth in this proposed notice to assist
us in fully considering issues and
developing policies. You can assist us
by referencing the file code CMS–2326–
PN and the specific ‘‘issue identifier’’
that precedes the section on which you
choose to comment.
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
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.cms.hhs.gov/
eRulemaking. Click on the link
‘‘Electronic Comments on CMS
Regulations’’ 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 a psychiatric hospital
provided certain requirements are met.
Section 1861(f) of the Social Security
Act (the Act) establishes distinct criteria
for facilities seeking designation as a
psychiatric hospital. 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
482, subpart E specify, among other
things, the conditions that a psychiatric
hospital must meet in order to
participate in the Medicare program.
Generally, in order to enter into a
provider agreement with the Medicare
program, a psychiatric hospital must
first be certified by a State survey
agency as complying with the
applicable conditions or requirements
set forth in 42 CFR part 482. Thereafter,
the psychiatric hospital is subject to
regular surveys by a State survey agency
to determine whether it continues to
meet these requirements. However,
there is an alternative to surveys by
State agencies.
PO 00000
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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
provider entity accredited by the
national accrediting body’s approved
program would be deemed to meet the
Medicare conditions. A national
accrediting organization applying for
deeming authority under 42 CFR part
488, subpart A must provide us with
reasonable assurance that the
accrediting organization requires the
accredited provider entities to meet
requirements that are at least as
stringent as the Medicare conditions of
participation. The regulations at
§ 488.8(d)(3) require accrediting
organizations to reapply for continued
deeming authority every 6 years or
sooner as determined by us.
II. Approval of Deeming Organizations
Section 1865(a)(2) of the Act and our
regulations at § 488.8(a) require that our
findings concerning review and
approval of a national accrediting
organization’s requirements consider,
among other factors, the applying
accrediting organization’s requirements
for accreditation; survey procedures;
resources for conducting required
surveys; capacity to furnish information
for use in enforcement activities;
monitoring procedures for provider
entities found not in compliance with
the conditions or requirements; and the
ability to provide us with the necessary
data for validation.
Section 1865(a)(3)(A) of the Act
further 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.
We have 210 days from the receipt of a
complete application to publish notice
of approval or denial of the application.
The purpose of this proposed notice
is to inform the public of the Joint
Commission’s request for deeming
authority for psychiatric hospitals. This
notice also solicits public comment on
whether the Joint Commission’s
requirements meet or exceed the
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Federal Register / Vol. 75, No. 204 / Friday, October 22, 2010 / Notices
emcdonald on DSK2BSOYB1PROD with NOTICES
Medicare conditions for participation
for psychiatric hospitals.
the survey as we may require (including
corrective action plans).
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
III. Evaluation of Deeming Authority
Request
The Joint Commission submitted all
the necessary materials to enable us to
make a determination concerning its
request for approval as a deeming
organization for psychiatric hospitals.
This application was determined to be
complete on September 3, 2010. Under
section 1865(a)(2) of the Act and § 488.8
(Federal review of accrediting
organizations), our review and
evaluation of the Joint Commission will
be conducted in accordance with, but
not necessarily limited to, the following
factors:
• The equivalency of the Joint
Commission’s standards for a
psychiatric hospital as compared with
CMS’ psychiatric hospital conditions of
participation.
• The Joint Commission’s survey
process to determine the following:
+ The composition of the survey
team, surveyor qualifications, and the
ability of the organization to provide
continuing surveyor training.
+ The comparability of the Joint
Commission’s processes to those of
State agencies, including survey
frequency, and the ability to investigate
and respond appropriately to
complaints against accredited facilities.
+ The Joint Commission’s processes
and procedures for monitoring
psychiatric hospitals found out of
compliance with the Joint Commission’s
program requirements. These
monitoring procedures are used only
when the Joint Commission identifies
noncompliance. If noncompliance is
identified through validation reviews,
the State survey agency monitors
corrections as specified at § 488.7(d).
+ The Joint Commission’s capacity to
report deficiencies to the surveyed
facilities and respond to the facility’s
plan of correction in a timely manner.
+ The Joint Commission’s capacity to
provide us with electronic data and
reports necessary for effective validation
and assessment of the organization’s
survey process.
+ The adequacy of the Joint
Commission’s staff and other resources,
and its financial viability.
+ The Joint Commission’s capacity to
adequately fund required surveys.
+ The Joint Commission’s policies
with respect to whether surveys are
announced or unannounced, to assure
that surveys are unannounced.
+ The Joint Commission’s agreement
to provide us with a copy of the most
current accreditation survey together
with any other information related to
IV. Response to Public Comments and
Notice Upon Completion of Evaluation
Food and Drug Administration
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17:43 Oct 21, 2010
Jkt 223001
Because of the large number of public
comments we normally receive on
Federal Register documents, we are not
able to acknowledge or respond to them
individually. We will consider all
comments we receive by the date and
time specified in the DATES section of
this preamble, and, when we proceed
with a subsequent document, we will
respond to the comments in the
preamble to that document.
Upon completion of our evaluation,
including evaluation of comments
received as a result of this notice, we
will publish a final notice in the Federal
Register announcing the result of our
evaluation.
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
Paperwork Reduction Act of 1995 (44
U.S.C. 35).
VI. Regulatory Impact Statement
In accordance with the provisions of
Executive Order 12866, the Office of
Management and Budget did not review
this proposed notice.
In accordance with Executive Order
13132, we have determined that this
proposed notice would not have a
significant effect on the rights of States,
local or Tribal governments.
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—Supplementary Medical
Insurance Program)
Dated: October 14, 2010.
Donald M. Berwick,
Administrator, Centers for Medicare &
Medicaid Services.
[FR Doc. 2010–26716 Filed 10–21–10; 8:45 am]
BILLING CODE 4120–01–P
PO 00000
Frm 00071
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[Docket No. FDA–2010–N–0001]
Oncologic Drugs Advisory Committee;
Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Oncologic Drugs
Advisory Committee
General Function of the Committee:
To provide advice and
recommendations to the Agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on December 1, 2010, from 8 a.m.
to 5 p.m.
Location: FDA White Oak Campus,
Bldg 31, the Great Room, White Oak
Conference Center (rm. 1503), 10903
New Hampshire Ave., Silver Spring, MD
20993–0002. Information regarding
special accommodations due to a
disability, visitor parking, and
transportation may be accessed at:
https://www.fda.gov/
AdvisoryCommittees/default.htm; under
the heading ‘‘Resources for You’’, click
on ‘‘White Oak Conference Center
Parking and Transportation Information
for FDA Advisory Committee Meetings’’.
Contact Person: Nicole Vesely, Center
for Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, rm. 2417,
Silver Spring, MD 20993–0002, 301–
796–9001, FAX: 301–847–8533, e-mail:
Nicole.vesely@fda.hhs.gov, or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington, DC area), code 301–451–
2542. Please call the Information Line
for up-to-date information on this
meeting. A notice in the Federal
Register about last minute modifications
that impact a previously announced
advisory committee meeting cannot
always be published quickly enough to
provide timely notice. Therefore, you
should always check the Agency’s Web
site and call the appropriate advisory
committee hot line/phone line to learn
about possible modifications before
coming to the meeting.
Agenda: On December 1, 2010, the
committee will discuss supplemental
new drug applications (sNDAs) 021–
319/S–024, trade name AVODART
(dutasteride) Soft Gelatin Capsules,
E:\FR\FM\22OCN1.SGM
22OCN1
Agencies
[Federal Register Volume 75, Number 204 (Friday, October 22, 2010)]
[Notices]
[Pages 65360-65362]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-26716]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-2326-PN]
Medicare and Medicaid Programs; Application by the Joint
Commission for Deeming Authority for Psychiatric Hospitals
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Proposed notice.
-----------------------------------------------------------------------
SUMMARY This proposed notice with comment period acknowledges the
receipt of an application from the Joint Commission for recognition as
a national accrediting organization for psychiatric hospitals that wish
to participate in the Medicare or Medicaid programs. Section
1865(a)(3)(A) of the Social Security Act requires that within 60 days
of receipt of an organization's complete application, we publish a
notice that identifies the national accrediting body making the
request, describes the nature of the request, and provides 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 November 22,
2010.
ADDRESSES: In commenting, please refer to file code CMS-2326-PN.
Because of staff and resource limitations, we cannot accept comments by
facsimile (FAX) transmission.
[[Page 65361]]
You may submit comments in one of four ways (no duplicates,
please):
1. Electronically. You may submit electronic comments on specific
issues in this regulation to https://www.cms.hhs.gov/eRulemaking. Click
on the link ``Submit electronic comments on CMS regulations with an
open comment period.'' (Attachments should be in Microsoft Word,
WordPerfect, or Excel; however, we prefer Microsoft Word.)
2. By regular mail. You may mail written comments (one original and
two copies) to the following address ONLY: Centers for Medicare &
Medicaid Services, Department of Health and Human Services, Attention:
CMS-2326-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 (one
original and two copies) to the following address only: Centers for
Medicare & Medicaid Services, Department of Health and Human Services,
Attention: CMS-2326-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 (one original and two copies) before the
close of the comment period to one of the following addresses. 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. Room 445-G, Hubert H. Humphrey Building,
200 Independence Avenue, SW., Washington, DC 20201; or 7500 Security
Boulevard, Baltimore, MD 21244-1850.
(Because access to the interior of the HHH 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.)
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: L. Tyler Whitaker, (410) 786-5236.
Patricia Chmielewski, (410) 786-6899.
SUPPLEMENTARY INFORMATION:
Submitting Comments: We welcome comments from the public on all
issues set forth in this proposed notice to assist us in fully
considering issues and developing policies. You can assist us by
referencing the file code CMS-2326-PN and the specific ``issue
identifier'' that precedes the section on which you choose to comment.
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 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.cms.hhs.gov/eRulemaking. Click on the link ``Electronic Comments on
CMS Regulations'' 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 a psychiatric hospital provided certain
requirements are met. Section 1861(f) of the Social Security Act (the
Act) establishes distinct criteria for facilities seeking designation
as a psychiatric hospital. 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 482, subpart E specify, among other things,
the conditions that a psychiatric hospital must meet in order to
participate in the Medicare program.
Generally, in order to enter into a provider agreement with the
Medicare program, a psychiatric hospital must first be certified by a
State survey agency as complying with the applicable conditions or
requirements set forth in 42 CFR part 482. Thereafter, the psychiatric
hospital is subject to regular surveys by a State survey agency to
determine whether it continues to meet these requirements. However,
there is an alternative 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 provider entity accredited by the national
accrediting body's approved program would be deemed to meet the
Medicare conditions. A national accrediting organization applying for
deeming authority under 42 CFR part 488, subpart A must provide us with
reasonable assurance that the accrediting organization requires the
accredited provider entities to meet requirements that are at least as
stringent as the Medicare conditions of participation. The regulations
at Sec. 488.8(d)(3) require accrediting organizations to reapply for
continued deeming authority every 6 years or sooner as determined by
us.
II. Approval of Deeming Organizations
Section 1865(a)(2) of the Act and our regulations at Sec. 488.8(a)
require that our findings concerning review and approval of a national
accrediting organization's requirements consider, among other factors,
the applying accrediting organization's requirements for accreditation;
survey procedures; resources for conducting required surveys; capacity
to furnish information for use in enforcement activities; monitoring
procedures for provider entities found not in compliance with the
conditions or requirements; and the ability to provide us with the
necessary data for validation.
Section 1865(a)(3)(A) of the Act further 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. We have 210 days from the receipt of a complete
application to publish notice of approval or denial of the application.
The purpose of this proposed notice is to inform the public of the
Joint Commission's request for deeming authority for psychiatric
hospitals. This notice also solicits public comment on whether the
Joint Commission's requirements meet or exceed the
[[Page 65362]]
Medicare conditions for participation for psychiatric hospitals.
III. Evaluation of Deeming Authority Request
The Joint Commission submitted all the necessary materials to
enable us to make a determination concerning its request for approval
as a deeming organization for psychiatric hospitals. This application
was determined to be complete on September 3, 2010. Under section
1865(a)(2) of the Act and Sec. 488.8 (Federal review of accrediting
organizations), our review and evaluation of the Joint Commission will
be conducted in accordance with, but not necessarily limited to, the
following factors:
The equivalency of the Joint Commission's standards for a
psychiatric hospital as compared with CMS' psychiatric hospital
conditions of participation.
The Joint Commission's survey process to determine the
following:
+ The composition of the survey team, surveyor qualifications, and
the ability of the organization to provide continuing surveyor
training.
+ The comparability of the Joint Commission's processes to those of
State agencies, including survey frequency, and the ability to
investigate and respond appropriately to complaints against accredited
facilities.
+ The Joint Commission's processes and procedures for monitoring
psychiatric hospitals found out of compliance with the Joint
Commission's program requirements. These monitoring procedures are used
only when the Joint Commission identifies noncompliance. If
noncompliance is identified through validation reviews, the State
survey agency monitors corrections as specified at Sec. 488.7(d).
+ The Joint Commission's capacity to report deficiencies to the
surveyed facilities and respond to the facility's plan of correction in
a timely manner.
+ The Joint Commission's capacity to provide us with electronic
data and reports necessary for effective validation and assessment of
the organization's survey process.
+ The adequacy of the Joint Commission's staff and other resources,
and its financial viability.
+ The Joint Commission's capacity to adequately fund required
surveys.
+ The Joint Commission's policies with respect to whether surveys
are announced or unannounced, to assure that surveys are unannounced.
+ The Joint Commission's agreement to provide us with a copy of the
most current accreditation survey together with any other information
related to the survey as we may require (including corrective action
plans).
IV. Response to Public Comments and Notice Upon Completion of
Evaluation
Because of the large number of public comments we normally receive
on Federal Register documents, we are not able to acknowledge or
respond to them individually. We will consider all comments we receive
by the date and time specified in the DATES section of this preamble,
and, when we proceed with a subsequent document, we will respond to the
comments in the preamble to that document.
Upon completion of our evaluation, including evaluation of comments
received as a result of this notice, we will publish a final notice in
the Federal Register announcing the result of our evaluation.
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
Paperwork Reduction Act of 1995 (44 U.S.C. 35).
VI. Regulatory Impact Statement
In accordance with the provisions of Executive Order 12866, the
Office of Management and Budget did not review this proposed notice.
In accordance with Executive Order 13132, we have determined that
this proposed notice would not have a significant effect on the rights
of States, local or Tribal governments.
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--Supplementary Medical Insurance
Program)
Dated: October 14, 2010.
Donald M. Berwick,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2010-26716 Filed 10-21-10; 8:45 am]
BILLING CODE 4120-01-P