Medicare and Medicaid Programs; The Joint Commission for Continued Deeming Authority for Critical Access Hospitals, 30107-30109 [E8-10776]
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dwashington3 on PRODPC61 with NOTICES
Federal Register / Vol. 73, No. 101 / Friday, May 23, 2008 / Notices
for-profits, not-for-profit institutions;
State, Local or Tribal Governments; and
Federal Government. Number of
Respondents: 21,000; Total Annual
Responses: 10,500; Total Annual Hours:
5,248.
4. Type of Information Collection
Request: New collection; Title of
Information Collection: State Plan
Amendment template for 1915(i) State
Plan Home and Community-Based
Services (HCBS) Benefit; Use: Section
6086 of the Deficit Reduction Act
(DRA), expanded access to HCBS for the
elderly and disabled and added a new
section 1915(i) to the Social Security
Act. Under 1915(i), States can amend
their State plans to add these services.
The template includes the information
needed by CMS to determine whether
the State’s services will meet the
requirements under 1915(i). Form
Number: CMS–10259 (OMB# 0938–
NEW); Frequency: Once; Affected
Public: State, Local or Tribal
Governments; Number of Respondents:
56; Total Annual Responses: 3; Total
Annual Hours: 240.
5. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Medicaid
Disproportionate Share Hospital Annual
Reporting; Use: Section 1923(j)(i) of the
Social Security Act requires States to
submit an annual report that identifies
each disproportionate share hospital
(DSH) that received a DSH payment
under the State’s Medicaid program in
the preceding fiscal year and the
amount of DSH payments paid to that
hospital in the same year and such other
information as the Secretary determines
necessary to ensure the appropriateness
of DSH payments. The information
supplied will satisfy the requirements
under section 1923(a)(2)(D) of the Act as
well. Form Number: CMS–R–266
(OMB# 0938–0746); Frequency: Yearly;
Affected Public: State, Local or Tribal
Governments; Number of Respondents:
52; Total Annual Responses: 52; Total
Annual Hours: 1976.
6. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Use of Restraint
and Seclusion in Psychiatric Residential
Treatment Facilities (PRTFs) for
Individuals Under Age 21; Use: PRTFs
are required to report deaths, serious
injuries and attempted suicides to the
State Medicaid Agency and the
Protection and Advocacy Organization.
They are also required to provide
residents the restraint and seclusion
policy in writing, and to document in
the residents’ records all activities
involving the use of restraint and
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15:34 May 22, 2008
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seclusion. Form Number: CMS–R–306
(OMB# 0938–0833); Frequency:
Annually; Affected Public: Private
Sector: Business or other for-profits;
Number of Respondents: 500; Total
Annual Responses: 329,500; Total
Annual Hours: 501,750.
To obtain copies of the supporting
statement and any related forms for the
proposed paperwork collections
referenced above, access CMS Web Site
address at https://www.cms.hhs.gov/
PaperworkReductionActof1995, or
E-mail your request, including your
address, phone number, OMB number,
and CMS document identifier, to
Paperwork@cms.hhs.gov, or call the
Reports Clearance Office on (410) 786–
1326.
To be assured consideration,
comments and recommendations for the
proposed information collections must
be received by the OMB desk officer at
the address below, no later than 5 p.m.
on June 23, 2008: OMB Human
Resources and Housing Branch,
Attention: Carolyn Raffaelli, New
Executive Office Building, Room 10235,
Washington, DC 20503, Fax Number:
(202) 395–6974.
Dated: May 14, 2008.
Michelle Shortt,
Director, Regulations Development Group,
Office of Strategic Operations and Regulatory
Affairs.
[FR Doc. E8–11397 Filed 5–22–08; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare and Medicaid
Services
[CMS–2896–PN]
Medicare and Medicaid Programs; The
Joint Commission for Continued
Deeming Authority for Critical Access
Hospitals
Centers for Medicare and
Medicaid Services, HHS.
ACTION: Proposed notice.
AGENCY:
SUMMARY: This proposed notice with
comment period acknowledges the
receipt of a deeming application from
the Joint Commission for continued
recognition as a national accrediting
organization for critical access hospitals
(CAHs) that wish to participate in the
Medicare or Medicaid programs. Section
1865(b)(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
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30107
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 June 23, 2008.
ADDRESSES: In commenting, please refer
to file code CMS–2896–PN. Because of
staff and resource limitations, we cannot
accept comments by facsimile (FAX)
transmission.
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.regulations.gov. Follow the
instructions for ‘‘Comment of
Submission’’ and enter the filecode to
find the document accepting comments.
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–2896–
PN, P.O. Box , 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–2896–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:
a. Room 445–G, Hubert H. Humphrey
Building, 200 Independence Avenue,
SW., Washington, DC 20201.
(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.)
If you intend to deliver your
comments to the Baltimore address,
please call (410) 786–7195 in advance to
schedule your arrival with one of our
staff members.
b. 7500 Security Boulevard,
Baltimore, MD 21244–1850.
Comments mailed to the addresses
indicated as appropriate for hand or
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30108
Federal Register / Vol. 73, No. 101 / Friday, May 23, 2008 / Notices
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:
Cindy Melanson, (410) 786–0310.
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
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.
dwashington3 on PRODPC61 with NOTICES
I. Background
Under the Medicare program, eligible
beneficiaries may receive covered
services in a 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. 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
485, subpart F specify the conditions
that a CAH must meet in order to
participate in the Medicare program,
and the scope of covered services. The
conditions for Medicare payment for
CAHs are set out at § 413.70.
Generally, in order to enter into a
provider agreement with the Medicare
program, a CAH must first be certified
by a State survey agency as complying
with the conditions or requirements set
forth in part 482 and part 485, subpart
F of CMS regulations. Thereafter, the
CAH 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.
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15:34 May 22, 2008
Jkt 214001
Section 1865(b)(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, CMS shall 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 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.
Our regulations concerning the
reapproval of accrediting organizations
are set forth at §§ 488.4 and 488.8(d)(3).
The regulations at § 488.8(d)(3) require
accrediting organizations to reapply for
continued deeming authority every 6
years or sooner as determined by CMS.
The Joint Commission’s term of
approval as a recognized accreditation
program for CAHs expires November 21,
2008.
II. Approval of Deeming Organizations
Section 1865(b)(2) of the Act and our
regulations at § 488.8(a) require that our
findings concerning review and
reapproval 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 ability to provide
CMS with the necessary data for
validation.
Section 1865(b)(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.
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The purpose of this proposed notice
is to inform the public of the Joint
Commission’s request for continued
deeming authority for CAHs. This notice
also solicits public comment on whether
the Joint Commission’s requirements
meet or exceed the Medicare conditions
for participation for CAHs.
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 reapproval as a deeming
organization for CAHs. This application
was determined to be complete on
March 28, 2008. Under section
1865(b)(2) of the Act and our regulations
at § 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 CAH as
compared with CMS’ CAH 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 CAHs
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
or complaint surveys, 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 in
ASCII comparable code, 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.
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Federal Register / Vol. 73, No. 101 / Friday, May 23, 2008 / Notices
—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 (September
1993, Regulatory Planning and Review,
the Regulatory Flexibility Act (RFA)
(September 19, 1980, Pub. L. 96–354)),
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.
dwashington3 on PRODPC61 with NOTICES
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: May 1, 2008.
Kerry Weems,
Acting Administrator, Centers for Medicare
& Medicaid Services.
[FR Doc. E8–10776 Filed 5–22–08; 8:45 am]
BILLING CODE 4120–01–P
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Jkt 214001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare and Medicaid
Services
[CMS–2224–N]
RIN 0938–ZA98
Medicare, Medicaid, and CLIA
Programs; Continuing Approval of
AABB (Formerly the American
Association of Blood Banks as a CLIA
Accreditation Organization
Centers for Medicare and
Medicaid Services (CMS), HHS.
ACTION: Notice.
AGENCY:
SUMMARY: In this notice, we reapprove
and grant AABB (formerly known as the
American Association of Blood Banks)
deeming authority as an accrediting
organization for clinical laboratories
under the Clinical Laboratory
Improvement Amendments of 1988
(CLIA) program. This deeming authority
is granted to AABB for the Blood Bank
and Transfusion Service (BB/TS)
accreditation program and the
Immunohematology Reference
Laboratory (IRL) Program.
DATES: Effective Date: This notice is
effective from May 23, 2008 to May 23,
2014.
FOR FURTHER INFORMATION CONTACT:
Daralyn Hassan, (410) 786–9360.
SUPPLEMENTARY INFORMATION:
I. Background and Legislative
Authority
On October 31, 1988, the Congress
enacted the Clinical Laboratory
Improvement Amendments of 1988
(CLIA), Public Law 100–578. CLIA
replaced in its entirety, section 353(e)(2)
of the Public Health Service Act, as
enacted by the Clinical Laboratory
Improvement Act of 1967. We issued a
final rule implementing the
accreditation provisions of CLIA on July
31, 1992 (57 FR 33992). Under the CLIA
program, CMS may grant deeming
authority to an accreditation
organization that accredits clinical
laboratories if the organization meets
certain requirements. An organization’s
requirements for accredited laboratories
must be equal to, or more stringent than,
the applicable CLIA program
requirements in 42 CFR part 493
(Laboratory Requirements). The
regulations in subpart E (Accreditation
by a Private, Nonprofit Accreditation
Organization or Exemption Under an
Approved State Laboratory Program)
specify the requirements an
accreditation organization must meet to
be an approved accreditation
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30109
organization. We approve an
accreditation organization for a period
not to exceed 6 years.
In general, the approved accreditation
organization must:
• Use inspectors qualified to evaluate
laboratory performance and agree to
inspect laboratories at the frequency
determined by CMS.
• Apply standards and criteria that
are equal to, or more stringent than,
those condition-level requirements
established by CMS.
• Assure that laboratories accredited
by the accreditation organization
continually meet these standards and
criteria.
• Provide us with the name of any
laboratory that has had its accreditation
denied, suspended, withdrawn, limited,
or revoked within 30 days of the action
taken.
• Notify us at least 30 days before
implementing any proposed changes in
its standards.
• If we withdraw our approval, notify
the accredited laboratories of the
withdrawal within 10 days of the
withdrawal.
CLIA requires that we perform an
annual evaluation of approved
accreditation organizations by
inspecting a representative sample of
laboratories accredited by an approved
accreditation organization as well as by
any other means that we determine to be
appropriate.
II. Notice of Approval of AABB as an
Accreditation Organization
In this notice, we approve AABB as
an organization that may accredit
laboratories for purposes of establishing
their compliance with CLIA
requirements. We have examined the
AABB application and all subsequent
submissions to determine equivalency
with our requirements under subpart E
of part 493 that an accreditation
organization must meet to be approved
under CLIA. We have determined that
AABB complies with the applicable
CLIA requirements and grant AABB
approval as an accreditation
organization under subpart E, as for the
period stated in the ‘‘Effective Date’’
section of this notice for the following
specialty and subspecialty areas:
• Microbiology, including
Bacteriology, Virology.
• Diagnostic Immunology, including
Syphilis Serology, General Immunology.
• Chemistry, including Routine
Chemistry, Urinalysis, Toxicology.
• Hematology.
• Immunohematology, including
ABO Group and Rh Group, Antibody
Detection, Antibody Identification,
Compatibility Testing.
E:\FR\FM\23MYN1.SGM
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Agencies
[Federal Register Volume 73, Number 101 (Friday, May 23, 2008)]
[Notices]
[Pages 30107-30109]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-10776]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare and Medicaid Services
[CMS-2896-PN]
Medicare and Medicaid Programs; The Joint Commission for
Continued Deeming Authority for Critical Access Hospitals
AGENCY: Centers for Medicare and Medicaid Services, HHS.
ACTION: Proposed notice.
-----------------------------------------------------------------------
SUMMARY: This proposed notice with comment period acknowledges the
receipt of a deeming application from the Joint Commission for
continued recognition as a national accrediting organization for
critical access hospitals (CAHs) that wish to participate in the
Medicare or Medicaid programs. Section 1865(b)(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 June 23, 2008.
ADDRESSES: In commenting, please refer to file code CMS-2896-PN.
Because of staff and resource limitations, we cannot accept comments by
facsimile (FAX) transmission.
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.regulations.gov. Follow the
instructions for ``Comment of Submission'' and enter the filecode to
find the document accepting comments.
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-2896-PN, P.O. Box , 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-2896-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:
a. Room 445-G, Hubert H. Humphrey Building, 200 Independence
Avenue, SW., Washington, DC 20201.
(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.)
If you intend to deliver your comments to the Baltimore address,
please call (410) 786-7195 in advance to schedule your arrival with one
of our staff members.
b. 7500 Security Boulevard, Baltimore, MD 21244-1850.
Comments mailed to the addresses indicated as appropriate for hand
or
[[Page 30108]]
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: Cindy Melanson, (410) 786-0310.
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 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 in a 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. 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 485, subpart F specify the conditions that a CAH must meet
in order to participate in the Medicare program, and the scope of
covered services. The conditions for Medicare payment for CAHs are set
out at Sec. 413.70.
Generally, in order to enter into a provider agreement with the
Medicare program, a CAH must first be certified by a State survey
agency as complying with the conditions or requirements set forth in
part 482 and part 485, subpart F of CMS regulations. Thereafter, the
CAH 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(b)(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, CMS shall 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 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. Our regulations concerning the
reapproval of accrediting organizations are set forth at Sec. Sec.
488.4 and 488.8(d)(3). 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 CMS.
The Joint Commission's term of approval as a recognized
accreditation program for CAHs expires November 21, 2008.
II. Approval of Deeming Organizations
Section 1865(b)(2) of the Act and our regulations at Sec. 488.8(a)
require that our findings concerning review and reapproval 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 ability to provide
CMS with the necessary data for validation.
Section 1865(b)(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 continued deeming authority for CAHs.
This notice also solicits public comment on whether the Joint
Commission's requirements meet or exceed the Medicare conditions for
participation for CAHs.
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 reapproval
as a deeming organization for CAHs. This application was determined to
be complete on March 28, 2008. Under section 1865(b)(2) of the Act and
our regulations at 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
CAH as compared with CMS' CAH 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 CAHs
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 or complaint surveys, 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 in
ASCII comparable code, 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.
[[Page 30109]]
--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
(September 1993, Regulatory Planning and Review, the Regulatory
Flexibility Act (RFA) (September 19, 1980, Pub. L. 96-354)), 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: May 1, 2008.
Kerry Weems,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. E8-10776 Filed 5-22-08; 8:45 am]
BILLING CODE 4120-01-P