Medicare and Medicaid Programs; Reapproval of the Deeming Authority of the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) for Home Health Agencies, 15331-15333 [05-5033]
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Federal Register / Vol. 70, No. 57 / Friday, March 25, 2005 / Notices
A covered entity may amend or
supplement its response at any time and
may propose voluntary compliance
through a corrective action plan at any
time. CMS may require modifications in
the terms of a proposed corrective
action plan as a prerequisite to
accepting the corrective action plan. If
a corrective action plan is accepted,
CMS will actively monitor the plan, and
the covered entity will be required to
periodically report to CMS its progress
towards compliance. If the covered
entity comes into voluntary compliance,
CMS will notify the complainant by
mail or electronically. The parties to the
complaint will be notified, as
appropriate, when the complaint is
closed.
CMS will make reasonable efforts to
secure a timely response from the
covered entity. If the covered entity fails
or refuses to provide the information
sought, an investigational subpoena may
be issued in accordance with 45 CFR
160.504 to require the attendance and
testimony of witnesses and/or the
production of any other evidence sought
in furtherance of the investigation.
After finding that a violation exists,
the Secretary will pursue other options,
such as, but not limited to, civil money
penalties.
Collection of Information Requirements
The form associated with this
complaint process entitled, ‘‘HIPAA
Non-Privacy Complaint Form’’, is
currently approved under OMB control
number 0938–0948.
Authority: Sections 1102 and 1171 through
1179 of the Social Security Act (42 U.S.C.
1302a and 1320d through 1320d–8).
Dated: December 7, 2004.
Tommy G. Thompson,
Secretary.
[FR Doc. 05–5795 Filed 3–24–05; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–2204–FN]
Medicare and Medicaid Programs;
Reapproval of the Deeming Authority
of the Joint Commission on
Accreditation of Healthcare
Organizations (JCAHO) for Home
Health Agencies
Centers for Medicare &
Medicaid Services, HHS.
ACTION: Final notice.
AGENCY:
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Jkt 205001
SUMMARY: This notice announces our
decision to approve the Joint
Commission on Accreditation of
Healthcare Organizations for continued
recognition as a national accreditation
program for home health agencies
seeking to participate in the Medicare or
Medicaid programs.
EFFECTIVE DATE: This final notice is
effective March 31, 2005 through March
31, 2008.
FOR FURTHER INFORMATION CONTACT:
Cindy Melanson, (410) 786–0310.
SUPPLEMENTARY INFORMATION:
I. Background
Under the Medicare program, eligible
beneficiaries may receive covered
services in a Home Health Agency
(HHA) provided certain requirements
are met. Sections 1861(o) and 1891 of
the Social Security Act (the Act)
establish distinct criteria for facilities
seeking designation as an HHA program.
The regulations at 42 CFR part 484
specify the conditions that an HHA
must meet in order to participate in the
Medicare program, the scope of covered
services, and the conditions for
Medicare payment for home health care.
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.
Generally, to enter into an agreement,
an HHA must first be certified by a state
survey agency as complying with the
conditions or requirements set forth in
part 484 of our regulations. Then, the
HHA is subject to regular surveys by a
state survey agency to determine
whether it continues to meet those
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 accreditation organization that
all applicable Medicare conditions are
met or exceeded, we would ‘‘deem’’
those provider entities as having met the
requirements. Accreditation by an
accreditation organization is voluntary
and is not required for Medicare
participation.
If an accreditation 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
accreditation organization applying for
approval of deeming authority under
part 488, subpart A must provide us
with reasonable assurance that the
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15331
accreditation organization requires the
accredited provider entities to meet
requirements that are at least as
stringent as the Medicare conditions.
Our regulations concerning reapproval
of accrediting organizations are set forth
at § 488.4 and § 488.8(d)(3). The
regulations at § 488.8(d)(3) require
accreditation organizations to reapply
for continued approval of deeming
authority every 6 years or sooner as we
determine. The Joint Commission on
Accreditation of Healthcare
Organizations’ (JCAHO’s) term of
approval as a recognized accreditation
program for HHAs expires March 31,
2005.
II. Deeming Applications Approval
Process
Section 1865(b)(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 an application
to complete our survey activities and
application review process. Within 60
days of receiving a completed
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 210day period, we must publish an
approval or denial of the application.
III. Proposed Notice
On September 24, 2004, we published
a proposed notice (69 FR 57305)
announcing the JCAHO’s request for
reapproval as a deeming organization
for HHAs. In the proposed notice, we
detailed our evaluation criteria. Under
section 1865(b)(2) of the Act and our
regulations at § 488.4 (Application and
reapplication procedures for
accreditation organizations) and § 488.8
(Federal review of accreditation
organization), we conducted a review of
the JCAHO application in accordance
with the criteria specified by our
regulation, which include, but are not
limited to the following:
• An onsite administrative review of
JCAHO’s (1) corporate policies; (2)
financial and human resources available
to accomplish the proposed surveys; (3)
procedures for training, monitoring, and
evaluation of its surveyors; (4) ability to
investigate and respond appropriately to
complaints against accredited facilities;
and (5) survey review and decisionmaking process for accreditation.
• A comparison of JCAHO’s HHA
accreditation standards to our current
Medicare HHA conditions for
participation.
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Federal Register / Vol. 70, No. 57 / Friday, March 25, 2005 / Notices
• A documentation review of
JCAHO’s survey processes to:
+ Determine the composition of the
survey team, surveyor qualifications,
and the ability of JCAHO to provide
continuing surveyor training.
+ Compare JCAHO’s processes to
those of State survey agencies, including
survey frequency, and the ability to
investigate and respond appropriately to
complaints against accredited facilities.
+ Evaluate JCAHO’s procedures for
monitoring providers or suppliers found
to be out of compliance with JCAHO
program requirements. The monitoring
procedures are used only when the
JCAHO identifies noncompliance. If
noncompliance is identified through
validation reviews, the survey agency
monitors corrections as specified at
§ 488.7(d).
+ Assess JCAHO’s ability to report
deficiencies to the surveyed facilities
and respond to the facility’s plan of
correction in a timely manner.
+ Establish JCAHO’s ability to
provide us with electronic data in
ASCII-comparable code and reports
necessary for effective validation and
assessment of JCAHO’s survey process.
+ Determine the adequacy of staff and
other resources.
+ Review JCAHO’s ability to provide
adequate funding for performing
required surveys.
+ Confirm JCAHO’s policies with
respect to whether surveys are
announced or unannounced.
+ Obtain JCAHO’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.
In accordance with section
1865(b)(3)(A) of the Act, the September
24, 2004 proposed notice (69 FR 57305)
also solicited public comments
regarding whether JCAHO’s
requirements met or exceeded the
Medicare conditions of participation for
HHA. We received no public comments
in response to our proposed notice.
IV. Provisions of the Final Notice
A. Differences Between the Joint
Commission on Accreditation of
Healthcare Organizations’ and
Medicare’s Conditions and Survey
Requirements
We compared the standards contained
in JCAHO’s ‘‘Comprehensive
Accreditation Manual for Home Care’’
and its survey process in the ‘‘Request
for Continued Deeming Authority for
Home Health Agencies Handbook’’ with
the Medicare HHA conditions for
participation and our State Operations
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Manual. Our review and evaluation of
JCAHO’s deeming application, which
were conducted as described in section
III of this final notice yielded the
following:
• To comply with the requirements at
§ 484.20(a), JCAHO has agreed not to
schedule the unannounced home health
survey without written confirmation of
a successful Outcomes and Assessment
Information Set (OASIS) transmission.
• To meet the requirements at
§ 488.4(b)(3)(v), JCAHO amended its
policies and procedures to permit its
surveyors to serve as witnesses if we
take an adverse action based on
accreditation findings.
B. Term of Approval
Based on the review and observations
described in sections III and IV of this
final notice, we have determined that
JCAHO’s requirements for HHAs meet
or exceed our requirements. Therefore,
we recognize the JCAHO as a national
accreditation organization for HHAs that
request participation in the Medicare
program. Because we are planning to
revise the conditions of participation for
HHAs over the next 3 years, we believe
it is most appropriate to renew the
current deeming authority for a similar
period. As a result, we are approving
JCAHO’s program effective March 31,
2005 through March 31, 2008.
V. Collection of Information
Requirements
This final notice does not impose any
information collection and record
keeping requirements subject to the
Paperwork Reduction Act (PRA).
Consequently, it does not need to be
reviewed by the Office of Management
and Budget (OMB) under the authority
of the PRA. The requirements associated
with granting and withdrawal of
deeming authority to national
accreditation organizations, codified in
42 CFR part 488, ‘‘Survey, Certification,
and Enforcement Procedures,’’ are
currently approved by OMB under OMB
approval number 0938–0690.
VI. Regulatory Impact Statement
We have examined the impact of this
final notice as required by Executive
Order 12866 and the Regulatory
Flexibility Act (RFA) (Pub. L. 98–354).
Executive Order 12866 directs agencies
to assess all costs and benefits of
available regulatory alternatives and,
when regulation is necessary, to select
regulatory approaches that maximize
net benefits (including potential
economic, environmental, public health
and safety effects; distributive impacts;
and equity). The RFA requires agencies
to analyze options for regulatory relief
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for small businesses. For purposes of the
RFA, States and individuals are not
considered small entities.
Also, section 1102(b) of the Act
requires the Secretary to prepare a
regulatory impact analysis for any
notice that may have a significant
impact on the operations of a substantial
number of small rural hospitals. Such
an analysis must conform to the
provisions of section 604 of the RFA.
For purposes of section 1102(b) of the
Act, we consider a small rural hospital
as a hospital that is located outside of
a Metropolitan Statistical Area and has
fewer than 100 beds.
This final notice recognizes JCAHO as
a national accreditation organization for
HHAs that request participation in the
Medicare program. There are neither
significant costs nor savings for the
program and administrative budgets of
Medicare. Therefore, this final notice is
not a major rule as defined in Title 5,
United States Code, section 804(2) and
is not an economically significant rule
under Executive Order 12866. We have
determined, and the Secretary certifies,
that this final notice will not result in
a significant impact on a substantial
number of small entities and will not
have a significant effect on the
operations of a substantial number of
small rural hospitals. Therefore, we are
not preparing analyses for either the
RFA or section 1102(b) of the Act.
In an effort to better assure the health,
safety, and services of beneficiaries in
HHAs already certified as well as
provide relief to State budgets in this
time of tight fiscal restraints, we deem
HHAs accredited by JCAHO as meeting
our Medicare requirements. Thus, we
continue our focus on assuring the
health and safety of services by
providers and suppliers already
certified for participation in a costeffective manner.
In accordance with the provisions of
Executive Order 12866, this notice was
not reviewed by the Office of
Management and Budget. In accordance
with Executive Order 13132, we have
determined that this final notice will
not significantly affect 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’Supplemental Medical Insurance
Program)
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Federal Register / Vol. 70, No. 57 / Friday, March 25, 2005 / Notices
Dated: February 18, 2005.
Mark B. McClellan,
Administrator, Centers for Medicare &
Medicaid Services.
[FR Doc. 05–5033 Filed 3–24–05; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–2208–FN]
Medicare and Medicaid Programs;
Recognition of the American
Osteopathic Association (AOA) for
Continued Approval of Deeming
Authority for Hospitals
Centers for Medicare and
Medicaid Services, HHS.
ACTION: Final notice.
AGENCY:
SUMMARY: This notice announces the
Centers for Medicare & Medicaid
Services’ (CMS’) reapproval of the
American Osteopathic Association
(AOA) as a national accreditation
organization for hospitals that request
participation in the Medicare program.
We have determined that accreditation
of hospitals by AOA demonstrates that
all Medicare hospital conditions of
participation are met or exceeded. Thus,
CMS will continue to grant deemed
status to those hospitals accredited by
AOA.
DATES: Effective Date: This final notice
is effective March 25, 2005 through
September 25, 2009.
FOR FURTHER INFORMATION CONTACT:
Marjorie Eddinger (410) 786–0375.
SUPPLEMENTARY INFORMATION:
I. Background
A. Laws and Regulations
Under the Medicare program, eligible
beneficiaries may receive covered
services in a hospital provided certain
requirements are met. The regulations
specifying the Medicare conditions of
participation for hospitals are located in
42 CFR part 482. These conditions
implement section 1861(e) of the Social
Security Act (the Act), which specifies
services covered as hospital care and the
conditions that a hospital program must
meet in order to participate in the
Medicare program.
Regulations concerning provider
agreements are at 42 CFR part 489 and
those pertaining to the activities relating
to the survey and certification of
facilities are at 42 CFR part 488.
Generally, in order to enter into a
provider agreement, a hospital must first
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Jkt 205001
be certified by a State survey agency as
complying with the conditions or
standards set forth in the statute and
part 482 of the regulations. Then, the
hospital is subject to regular surveys by
a State survey agency to determine
whether it continues to meet Medicare
requirements. There is an alternative,
however, to surveys by State agencies.
Section 1865(b)(1) of the Act permits
hospitals accredited by the AOA to be
exempt from routine surveys by State
survey agencies to determine
compliance with Medicare conditions of
participation. Accreditation by an
accreditation organization is voluntary
and is not required for Medicare
participation. Section 1865(b)(1) of the
Act provides that, if a provider
demonstrates through accreditation that
all applicable conditions are met or
exceed the Medicare conditions, we
shall ‘‘deem’’ the hospital as having met
the health and safety requirements.
Our regulations concerning
reapproval of accrediting organizations
are set forth at § 488.4 and § 488.8(d)(3).
The regulations at § 488.8(d)(3) require
reapplication at least every 6 years and
permit us to determine the required
materials from those enumerated in
§ 488.4 and the deadline to reapply for
continued approval of deeming
authority.
II. Approval of Deeming Organizations
Section 1865(b)(2) of the Act further
requires that our findings concerning
review of national accrediting
organizations consider, among other
factors, the accreditation organization’s
requirements for accreditation, its
survey procedures, its ability to provide
adequate resources for conducting
required surveys and ability to supply
information for use in enforcement
activities, its monitoring procedures for
provider entities found out of
compliance with the conditions or
requirements, and its ability to provide
us with 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 of the
national accreditation body’s
application, identifying the national
accreditation body making the request,
describing the nature of the request, and
providing at least a 30-day public
comment period. Subsequently, we have
210 days from the receipt of the request
to publish approval or denial of the
application.
The purpose of this notice is to notify
the public of our decision to approve
AOA’s request for continuation of its
deeming authority. This decision is
based on our finding that the AOA’s
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15333
separate accreditation program for
hospital care meets or exceeds the
Medicare hospital conditions of
participation.
III. Proposed Notice
On September 24, 2004, we published
a proposed notice in the Federal
Register (69 FR 57308) announcing
AOA’s request for reapproval as a
deeming organization for hospitals. In
the notice, we detailed the evaluation
criteria. As set forth under section
1865(b)(2) of the Act and our regulations
at § 488.8(d)(3)(i), our review and
evaluation of the AOA application
included the following:
1. An on-site administrative review of
the corporate policies, resources to
accomplish the accreditation surveys,
program and surveyor evaluation and
monitoring, AOA’s ability to investigate
and respond appropriately to
complaints against accredited facilities,
and the survey review and decisionmaking process for accreditation.
2. A determination of the equivalency
of AOA’s standards for a hospital to our
comparable hospital conditions of
participation.
3. A review through documentation
and on-site observation of AOA’s survey
processes to determine the following:
• The comparability of AOA’s
processes to those of State agencies,
including survey frequency and whether
surveys are announced or unannounced.
• The adequacy of the guidance and
instructions and survey forms AOA
provides to surveyors.
• AOA’s procedures for monitoring
providers or suppliers found to be out
of compliance with program
requirements. (These procedures are
used only when AOA identifies
noncompliance.)
4. AOA’s procedures for responding
to complaints and for coordinating these
activities with appropriate licensing
bodies and ombudsmen programs.
5. AOA’s policies and procedures for
identifying potential fraud and abuse
and its coordination with, or reporting
to, CMS.
6. AOA’s survey team, the content
and frequency of the in-service training
provided, the evaluation systems used
to assess the performance of surveyors,
and potential conflict-of-interest
policies and procedures.
7. AOA’s data management system
and reports used to assess its surveys
and accreditation decisions, and its
ability to provide us with electronic
data and new statistical validation
information including the number,
accreditation status, and resurvey cycle
for facilities; the number, types, and
resolution times for follow up when
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]]>Agencies
[Federal Register Volume 70, Number 57 (Friday, March 25, 2005)]
[Notices]
[Pages 15331-15333]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-5033]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-2204-FN]
Medicare and Medicaid Programs; Reapproval of the Deeming
Authority of the Joint Commission on Accreditation of Healthcare
Organizations (JCAHO) for Home Health Agencies
AGENCY: Centers for Medicare & Medicaid Services, HHS.
ACTION: Final notice.
-----------------------------------------------------------------------
SUMMARY: This notice announces our decision to approve the Joint
Commission on Accreditation of Healthcare Organizations for continued
recognition as a national accreditation program for home health
agencies seeking to participate in the Medicare or Medicaid programs.
EFFECTIVE DATE: This final notice is effective March 31, 2005 through
March 31, 2008.
FOR FURTHER INFORMATION CONTACT: Cindy Melanson, (410) 786-0310.
SUPPLEMENTARY INFORMATION:
I. Background
Under the Medicare program, eligible beneficiaries may receive
covered services in a Home Health Agency (HHA) provided certain
requirements are met. Sections 1861(o) and 1891 of the Social Security
Act (the Act) establish distinct criteria for facilities seeking
designation as an HHA program. The regulations at 42 CFR part 484
specify the conditions that an HHA must meet in order to participate in
the Medicare program, the scope of covered services, and the conditions
for Medicare payment for home health care. 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.
Generally, to enter into an agreement, an HHA must first be
certified by a state survey agency as complying with the conditions or
requirements set forth in part 484 of our regulations. Then, the HHA is
subject to regular surveys by a state survey agency to determine
whether it continues to meet those 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
accreditation organization that all applicable Medicare conditions are
met or exceeded, we would ``deem'' those provider entities as having
met the requirements. Accreditation by an accreditation organization is
voluntary and is not required for Medicare participation.
If an accreditation 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 accreditation organization applying for
approval of deeming authority under part 488, subpart A must provide us
with reasonable assurance that the accreditation organization requires
the accredited provider entities to meet requirements that are at least
as stringent as the Medicare conditions. Our regulations concerning
reapproval of accrediting organizations are set forth at Sec. 488.4
and Sec. 488.8(d)(3). The regulations at Sec. 488.8(d)(3) require
accreditation organizations to reapply for continued approval of
deeming authority every 6 years or sooner as we determine. The Joint
Commission on Accreditation of Healthcare Organizations' (JCAHO's) term
of approval as a recognized accreditation program for HHAs expires
March 31, 2005.
II. Deeming Applications Approval Process
Section 1865(b)(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 an application to complete our survey activities and
application review process. Within 60 days of receiving a completed
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.
III. Proposed Notice
On September 24, 2004, we published a proposed notice (69 FR 57305)
announcing the JCAHO's request for reapproval as a deeming organization
for HHAs. In the proposed notice, we detailed our evaluation criteria.
Under section 1865(b)(2) of the Act and our regulations at Sec. 488.4
(Application and reapplication procedures for accreditation
organizations) and Sec. 488.8 (Federal review of accreditation
organization), we conducted a review of the JCAHO application in
accordance with the criteria specified by our regulation, which
include, but are not limited to the following:
An onsite administrative review of JCAHO's (1) corporate
policies; (2) financial and human resources available to accomplish the
proposed surveys; (3) procedures for training, monitoring, and
evaluation of its surveyors; (4) ability to investigate and respond
appropriately to complaints against accredited facilities; and (5)
survey review and decision-making process for accreditation.
A comparison of JCAHO's HHA accreditation standards to our
current Medicare HHA conditions for participation.
[[Page 15332]]
A documentation review of JCAHO's survey processes to:
+ Determine the composition of the survey team, surveyor
qualifications, and the ability of JCAHO to provide continuing surveyor
training.
+ Compare JCAHO's processes to those of State survey agencies,
including survey frequency, and the ability to investigate and respond
appropriately to complaints against accredited facilities.
+ Evaluate JCAHO's procedures for monitoring providers or suppliers
found to be out of compliance with JCAHO program requirements. The
monitoring procedures are used only when the JCAHO identifies
noncompliance. If noncompliance is identified through validation
reviews, the survey agency monitors corrections as specified at Sec.
488.7(d).
+ Assess JCAHO's ability to report deficiencies to the surveyed
facilities and respond to the facility's plan of correction in a timely
manner.
+ Establish JCAHO's ability to provide us with electronic data in
ASCII-comparable code and reports necessary for effective validation
and assessment of JCAHO's survey process.
+ Determine the adequacy of staff and other resources.
+ Review JCAHO's ability to provide adequate funding for performing
required surveys.
+ Confirm JCAHO's policies with respect to whether surveys are
announced or unannounced.
+ Obtain JCAHO'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.
In accordance with section 1865(b)(3)(A) of the Act, the September
24, 2004 proposed notice (69 FR 57305) also solicited public comments
regarding whether JCAHO's requirements met or exceeded the Medicare
conditions of participation for HHA. We received no public comments in
response to our proposed notice.
IV. Provisions of the Final Notice
A. Differences Between the Joint Commission on Accreditation of
Healthcare Organizations' and Medicare's Conditions and Survey
Requirements
We compared the standards contained in JCAHO's ``Comprehensive
Accreditation Manual for Home Care'' and its survey process in the
``Request for Continued Deeming Authority for Home Health Agencies
Handbook'' with the Medicare HHA conditions for participation and our
State Operations Manual. Our review and evaluation of JCAHO's deeming
application, which were conducted as described in section III of this
final notice yielded the following:
To comply with the requirements at Sec. 484.20(a), JCAHO
has agreed not to schedule the unannounced home health survey without
written confirmation of a successful Outcomes and Assessment
Information Set (OASIS) transmission.
To meet the requirements at Sec. 488.4(b)(3)(v), JCAHO
amended its policies and procedures to permit its surveyors to serve as
witnesses if we take an adverse action based on accreditation findings.
B. Term of Approval
Based on the review and observations described in sections III and
IV of this final notice, we have determined that JCAHO's requirements
for HHAs meet or exceed our requirements. Therefore, we recognize the
JCAHO as a national accreditation organization for HHAs that request
participation in the Medicare program. Because we are planning to
revise the conditions of participation for HHAs over the next 3 years,
we believe it is most appropriate to renew the current deeming
authority for a similar period. As a result, we are approving JCAHO's
program effective March 31, 2005 through March 31, 2008.
V. Collection of Information Requirements
This final notice does not impose any information collection and
record keeping requirements subject to the Paperwork Reduction Act
(PRA). Consequently, it does not need to be reviewed by the Office of
Management and Budget (OMB) under the authority of the PRA. The
requirements associated with granting and withdrawal of deeming
authority to national accreditation organizations, codified in 42 CFR
part 488, ``Survey, Certification, and Enforcement Procedures,'' are
currently approved by OMB under OMB approval number 0938-0690.
VI. Regulatory Impact Statement
We have examined the impact of this final notice as required by
Executive Order 12866 and the Regulatory Flexibility Act (RFA) (Pub. L.
98-354). Executive Order 12866 directs agencies to assess all costs and
benefits of available regulatory alternatives and, when regulation is
necessary, to select regulatory approaches that maximize net benefits
(including potential economic, environmental, public health and safety
effects; distributive impacts; and equity). The RFA requires agencies
to analyze options for regulatory relief for small businesses. For
purposes of the RFA, States and individuals are not considered small
entities.
Also, section 1102(b) of the Act requires the Secretary to prepare
a regulatory impact analysis for any notice that may have a significant
impact on the operations of a substantial number of small rural
hospitals. Such an analysis must conform to the provisions of section
604 of the RFA. For purposes of section 1102(b) of the Act, we consider
a small rural hospital as a hospital that is located outside of a
Metropolitan Statistical Area and has fewer than 100 beds.
This final notice recognizes JCAHO as a national accreditation
organization for HHAs that request participation in the Medicare
program. There are neither significant costs nor savings for the
program and administrative budgets of Medicare. Therefore, this final
notice is not a major rule as defined in Title 5, United States Code,
section 804(2) and is not an economically significant rule under
Executive Order 12866. We have determined, and the Secretary certifies,
that this final notice will not result in a significant impact on a
substantial number of small entities and will not have a significant
effect on the operations of a substantial number of small rural
hospitals. Therefore, we are not preparing analyses for either the RFA
or section 1102(b) of the Act.
In an effort to better assure the health, safety, and services of
beneficiaries in HHAs already certified as well as provide relief to
State budgets in this time of tight fiscal restraints, we deem HHAs
accredited by JCAHO as meeting our Medicare requirements. Thus, we
continue our focus on assuring the health and safety of services by
providers and suppliers already certified for participation in a cost-
effective manner.
In accordance with the provisions of Executive Order 12866, this
notice was not reviewed by the Office of Management and Budget. In
accordance with Executive Order 13132, we have determined that this
final notice will not significantly affect 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'Supplemental Medical Insurance Program)
[[Page 15333]]
Dated: February 18, 2005.
Mark B. McClellan,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 05-5033 Filed 3-24-05; 8:45 am]
BILLING CODE 4120-01-P
