Medicare and Medicaid Programs; Application of the American Osteopathic Association for Continued Deeming Authority for Hospitals, 44370-44371 [E9-20203]
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44370
Federal Register / Vol. 74, No. 166 / Friday, August 28, 2009 / Notices
Development, Bureau of Primary Health
Care, HRSA, at 301–594–4300.
Dated: August 24, 2009.
Mary K. Wakefield,
Administrator.
[FR Doc. E9–20818 Filed 8–27–09; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–2299–FN]
Medicare and Medicaid Programs;
Application of the American
Osteopathic Association for Continued
Deeming Authority for Hospitals
AGENCY: Centers for Medicare and
Medicaid Services (CMS), HHS.
ACTION: Final notice.
SUMMARY: This notice announces our
decision to approve the American
Osteopathic Association (AOA) for
continued recognition as a national
accreditation program for hospitals
seeking to participate in the Medicare or
Medicaid programs.
DATES: Effective Date: This final notice
is effective September 25, 2009 through
September 25, 2013.
FOR FURTHER INFORMATION CONTACT:
Lillian Williams, (410) 786–8636.
Patricia Chmielewski, (410) 786–6899.
SUPPLEMENTARY INFORMATION:
hsrobinson on DSK69SOYB1PROD with NOTICES
I. Background
Under the Medicare program, eligible
beneficiaries may receive covered
services from a hospital provided
certain requirements are met. The
regulations specifying the Medicare
conditions of participation (CoPs) for
hospitals are located at 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 located at 42 CFR part
489 and those pertaining to activities
relating to the survey and certification
of facilities are located at 42 CFR part
488.
Generally, in order to enter into a
provider agreement, a hospital must first
be certified by a State survey agency as
complying with the conditions or
requirements set forth in the statute and
part 482 of the regulations. Then, the
hospital is subject to routine State
agency surveys to determine whether it
VerDate Nov<24>2008
21:38 Aug 27, 2009
Jkt 217001
continues to meet the Medicare
requirements. There is an alternative,
however, to State compliance surveys.
Section 1865(a)(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 may ‘‘deem’’ those
provider entities as having met the
requirements.
If an accreditation organization is
recognized by the Secretary as having
standards for accreditation that meet or
exceed Medicare requirements, a
provider entity accredited by the
national accreditation organization
approved program would be deemed to
meet the Medicare conditions.
Accreditation by an accreditation
organization is voluntary and is not
required for Medicare participation.
A national accreditation organization
applying for 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 the
reapproval of accreditation
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
deeming authority every 6 years or
sooner as determined by CMS.
AOA’s term of approval as a
recognized accreditation program for
hospitals expires September 25, 2009.
II. Deeming Applications Approval
Process
Section 1865(a)(3)(A) of the Act
provides a statutory timetable to ensure
that our review of deeming applications
is conducted in a timely manner. The
Act provides us with 210 calendar days
after the date of receipt of a complete
application, with any documentation
necessary to make a determination, to
complete our survey activities and
application review. Within 60 days of
receiving a complete application, we
must publish a notice in the Federal
Register that identifies the national
accreditation organization making the
request, describes the request, and
provides no less that a 30-day public
comment period. At the end of the 210day period, we must publish an
approval or denial of the application.
III. Provisions of the Proposed Notice
and Response to Comments
On April 24, 2009, we published a
proposed notice in the Federal Register
(74 FR 18728) announcing AOA’s
PO 00000
Frm 00026
Fmt 4703
Sfmt 4703
request for reapproval as a deeming
organization for hospitals. In this notice,
we detailed the evaluation criteria.
Under section 1865(a)(2) of the Act and
our regulations at § 488.4, we conducted
a review of the AOA’s application in
accordance with the criteria specified by
our regulations, which include, but are
not limited to the following factors:
• An onsite administrative review of
AOA’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 AOA’s hospital
accreditation standards to our current
Medicare hospital CoPs.
• A documentation review of AOA’s
survey processes to:
+ Determine the composition of the
survey team, surveyor qualifications,
and AOA’s ability to provide continuing
surveyor training.
+ Compare AOA’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 AOA’s procedures for
monitoring providers or suppliers found
to be out of compliance with AOA
program requirements. The monitoring
procedures are used only when AOA
identifies noncompliance. If
noncompliance is identified through
validation reviews, the State survey
agency monitors corrections as specified
at § 488.7(d).
+ Assess AOA’s ability to report
deficiencies to the surveyed facilities
and respond to the facility’s plan of
correction in a timely manner.
+ Establish AOA’s ability to provide
us with electronic data and reports
necessary for effective validation and
assessment of AOA’s survey process.
+ Determine the adequacy of staff and
other resources.
+ Review AOA’s ability to provide
adequate funding for performing
required surveys.
+ Confirm AOA’s policies with
respect to whether surveys are
announced or unannounced.
+ Obtain AOA’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(a)(3)(A) of the Act, the April 24,
2009 proposed notice also solicited
public comments regarding whether
E:\FR\FM\28AUN1.SGM
28AUN1
Federal Register / Vol. 74, No. 166 / Friday, August 28, 2009 / Notices
AOA’s requirements met or exceeded
the Medicare CoPs for hospitals. We
received 28 comments in response to
our proposed notice.
All commenters expressed support for
AOA’s continued deeming authority for
hospitals. Commenters stated that
AOA’s standards are clearly written and
closely aligned with the Medicare CoPs,
and that AOA’s accreditation program
provides hospitals with a viable
alternative to other healthcare
accreditation organizations.
hsrobinson on DSK69SOYB1PROD with NOTICES
IV. Provision of the Final Notice
A. Differences Between AOA’s
Standards and Requirements for
Accreditation and Medicare’s
Conditions and Survey Requirements
We compared AOA’s hospital
accreditation requirements and survey
process with the Medicare CoPs and
survey process as outlined in the State
Operations Manual (SOM). Our review
and evaluation of AOA’s deeming
application, which were conducted as
described in section III of this final
notice, yielded the following:
• AOA revised its standards to ensure
that a medical history and physical is
completed and documented in
accordance with the requirements at
§ 482.51(b)(1).
• To meet the requirements in the
SOM Appendix A, AOA amended its
surveyor team handbook to ensure all
hospital survey teams include a
Registered Nurse.
• AOA modified its policies related to
the accreditation effective date in
accordance with the requirements at
§ 489.13.
• AOA modified its policies regarding
timeframes for sending and receiving a
plan of correction (PoC) in accordance
with section 2728 of the SOM.
• AOA revised its policies to include
timeframes for investigation of
complaints in accordance with the
requirements at section 5075.9 of the
SOM.
• AOA developed and implemented
internal monitoring procedures to
ensure its surveyors are trained and
qualified to meet the requirements at
§ 488.4(a)(4).
• AOA developed an action plan to
ensure that deemed status survey files
are complete, accurate, and consistent
with the requirements at § 488.6(a).
• AOA developed and conducted
surveyor training on the documentation
of deficiencies to ensure that all cited
deficiencies contain a regulatory
reference, a clear and detailed
description of the deficient practice, and
relevant finding.
• To meet the requirements at
§ 488.20(a) and § 488.28(a), AOA
VerDate Nov<24>2008
21:38 Aug 27, 2009
Jkt 217001
developed a policy to ensure that
facilities with condition level noncompliance on a recertification survey
submit an acceptable PoC, and receive
a follow up onsite focused survey.
• To meet the requirements at section
2005A2 of the SOM, AOA revised its
policies and developed an internal
tracking tool to ensure that facilities
with condition level non-compliance on
an initial survey receive an onsite
follow-up full survey.
• To meet the requirements at
§ 488.4(b), AOA developed and
incorporated measures to improve the
accuracy and consistency of data
submissions to CMS.
• To meet the requirements at 2700A
of the SOM, AOA revised its policies on
blackout dates.
• AOA revised its accreditation
decision letters to ensure that they are
accurate and contain all the required
elements for the CMS Regional Office to
render a decision regarding the deemed
status of an accredited hospital.
• To meet the survey process
requirements in Appendix A of the
SOM, AOA developed a policy
outlining the minimum number of
inpatient records required for review
during a certification survey.
• AOA removed all references to
mandatory consultative services from its
policies to avoid potential conflict of
interest issues.
• To verify AOA’s continued
compliance with the provisions of this
final notice, CMS will conduct a followup corporate onsite visit within one year
of the date of publication of this notice.
B. Term of Approval
Based on the review and observations
described in section III of this final
notice, we have determined that AOA’s
requirements for hospitals meet or
exceed our requirements. Therefore, we
approve AOA as a national accreditation
organization for hospitals that request
participation in the Medicare program,
effective September 25, 2009 through
September 25, 2013.
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, this regulation
PO 00000
Frm 00027
Fmt 4703
Sfmt 4703
44371
was not reviewed by the Office of
Management and Budget.
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)
(Catalog of Federal Domestic Assistance
Program No. 93.773, Medicare—Hospital
Insurance; and Program No. 93.774,
Medicare—Supplementary Medical
Insurance Program)
Dated: July 30, 2009.
Charlene Frizzera,
Acting Administrator, Centers for Medicare
& Medicaid Services.
[FR Doc. E9–20203 Filed 8–27–09; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–7016–N]
Medicare Program; Request for
Nominations for the Advisory Panel on
Medicare Education
AGENCY: Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Notice.
SUMMARY: This notice requests
nominations for individuals to serve on
the Advisory Panel on Medicare
Education (the Panel) to fill current
vacancies and vacancies that will
become available in 2009. The Panel
advises and makes recommendations to
the Secretary of Health and Human
Services and the Administrator of the
Centers for Medicare & Medicaid
Services on the effectiveness of
consumer education strategies
concerning the Medicare program.
DATES: Deadline for Nominations by
Regular Mail: Monday, September 14,
2009 at 5 p.m., eastern daylight time
(e.d.t.).
Deadline for Nominations by
Electronic Mail: Monday, September 14,
2009 at 5 p.m., e.d.t.
ADDRESSES: Regular Mail: Dwayne E.
Campbell, Office of External Affairs,
Centers for Medicare & Medicaid
Services, 7500 Security Boulevard, S1–
05–14, Baltimore, MD 21244–1850.
Electronic Mail:
Dwayne.Campbell@cms.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
Dwayne E. Campbell, Health Insurance
Specialist, Division of Forum and
Conference Development, (410) 786–
0291. Please refer to the CMS Advisory
Committees Information Line (1–877–
E:\FR\FM\28AUN1.SGM
28AUN1
Agencies
[Federal Register Volume 74, Number 166 (Friday, August 28, 2009)]
[Notices]
[Pages 44370-44371]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-20203]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-2299-FN]
Medicare and Medicaid Programs; Application of the American
Osteopathic Association for Continued Deeming Authority for Hospitals
AGENCY: Centers for Medicare and Medicaid Services (CMS), HHS.
ACTION: Final notice.
-----------------------------------------------------------------------
SUMMARY: This notice announces our decision to approve the American
Osteopathic Association (AOA) for continued recognition as a national
accreditation program for hospitals seeking to participate in the
Medicare or Medicaid programs.
DATES: Effective Date: This final notice is effective September 25,
2009 through September 25, 2013.
FOR FURTHER INFORMATION CONTACT: Lillian Williams, (410) 786-8636.
Patricia Chmielewski, (410) 786-6899.
SUPPLEMENTARY INFORMATION:
I. Background
Under the Medicare program, eligible beneficiaries may receive
covered services from a hospital provided certain requirements are met.
The regulations specifying the Medicare conditions of participation
(CoPs) for hospitals are located at 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 located at 42 CFR
part 489 and those pertaining to activities relating to the survey and
certification of facilities are located at 42 CFR part 488.
Generally, in order to enter into a provider agreement, a hospital
must first be certified by a State survey agency as complying with the
conditions or requirements set forth in the statute and part 482 of the
regulations. Then, the hospital is subject to routine State agency
surveys to determine whether it continues to meet the Medicare
requirements. There is an alternative, however, to State compliance
surveys.
Section 1865(a)(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 may ``deem'' those provider entities as having met
the requirements.
If an accreditation organization is recognized by the Secretary as
having standards for accreditation that meet or exceed Medicare
requirements, a provider entity accredited by the national
accreditation organization approved program would be deemed to meet the
Medicare conditions. Accreditation by an accreditation organization is
voluntary and is not required for Medicare participation.
A national accreditation organization applying for 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 the reapproval of accreditation
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 deeming authority every 6 years or sooner as
determined by CMS.
AOA's term of approval as a recognized accreditation program for
hospitals expires September 25, 2009.
II. Deeming Applications Approval Process
Section 1865(a)(3)(A) of the Act provides a statutory timetable to
ensure that our review of deeming applications is conducted in a timely
manner. The Act provides us with 210 calendar days after the date of
receipt of a complete application, with any documentation necessary to
make a determination, to complete our survey activities and application
review. Within 60 days of receiving a complete application, we must
publish a notice in the Federal Register that identifies the national
accreditation organization making the request, describes the request,
and provides no less that 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. Provisions of the Proposed Notice and Response to Comments
On April 24, 2009, we published a proposed notice in the Federal
Register (74 FR 18728) announcing AOA's request for reapproval as a
deeming organization for hospitals. In this notice, we detailed the
evaluation criteria. Under section 1865(a)(2) of the Act and our
regulations at Sec. 488.4, we conducted a review of the AOA's
application in accordance with the criteria specified by our
regulations, which include, but are not limited to the following
factors:
An onsite administrative review of AOA'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 AOA's hospital accreditation standards to
our current Medicare hospital CoPs.
A documentation review of AOA's survey processes to:
+ Determine the composition of the survey team, surveyor
qualifications, and AOA's ability to provide continuing surveyor
training.
+ Compare AOA'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 AOA's procedures for monitoring providers or suppliers
found to be out of compliance with AOA program requirements. The
monitoring procedures are used only when AOA identifies noncompliance.
If noncompliance is identified through validation reviews, the State
survey agency monitors corrections as specified at Sec. 488.7(d).
+ Assess AOA's ability to report deficiencies to the surveyed
facilities and respond to the facility's plan of correction in a timely
manner.
+ Establish AOA's ability to provide us with electronic data and
reports necessary for effective validation and assessment of AOA's
survey process.
+ Determine the adequacy of staff and other resources.
+ Review AOA's ability to provide adequate funding for performing
required surveys.
+ Confirm AOA's policies with respect to whether surveys are
announced or unannounced.
+ Obtain AOA'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(a)(3)(A) of the Act, the April 24,
2009 proposed notice also solicited public comments regarding whether
[[Page 44371]]
AOA's requirements met or exceeded the Medicare CoPs for hospitals. We
received 28 comments in response to our proposed notice.
All commenters expressed support for AOA's continued deeming
authority for hospitals. Commenters stated that AOA's standards are
clearly written and closely aligned with the Medicare CoPs, and that
AOA's accreditation program provides hospitals with a viable
alternative to other healthcare accreditation organizations.
IV. Provision of the Final Notice
A. Differences Between AOA's Standards and Requirements for
Accreditation and Medicare's Conditions and Survey Requirements
We compared AOA's hospital accreditation requirements and survey
process with the Medicare CoPs and survey process as outlined in the
State Operations Manual (SOM). Our review and evaluation of AOA's
deeming application, which were conducted as described in section III
of this final notice, yielded the following:
AOA revised its standards to ensure that a medical history
and physical is completed and documented in accordance with the
requirements at Sec. 482.51(b)(1).
To meet the requirements in the SOM Appendix A, AOA
amended its surveyor team handbook to ensure all hospital survey teams
include a Registered Nurse.
AOA modified its policies related to the accreditation
effective date in accordance with the requirements at Sec. 489.13.
AOA modified its policies regarding timeframes for sending
and receiving a plan of correction (PoC) in accordance with section
2728 of the SOM.
AOA revised its policies to include timeframes for
investigation of complaints in accordance with the requirements at
section 5075.9 of the SOM.
AOA developed and implemented internal monitoring
procedures to ensure its surveyors are trained and qualified to meet
the requirements at Sec. 488.4(a)(4).
AOA developed an action plan to ensure that deemed status
survey files are complete, accurate, and consistent with the
requirements at Sec. 488.6(a).
AOA developed and conducted surveyor training on the
documentation of deficiencies to ensure that all cited deficiencies
contain a regulatory reference, a clear and detailed description of the
deficient practice, and relevant finding.
To meet the requirements at Sec. 488.20(a) and Sec.
488.28(a), AOA developed a policy to ensure that facilities with
condition level non-compliance on a recertification survey submit an
acceptable PoC, and receive a follow up onsite focused survey.
To meet the requirements at section 2005A2 of the SOM, AOA
revised its policies and developed an internal tracking tool to ensure
that facilities with condition level non-compliance on an initial
survey receive an onsite follow-up full survey.
To meet the requirements at Sec. 488.4(b), AOA developed
and incorporated measures to improve the accuracy and consistency of
data submissions to CMS.
To meet the requirements at 2700A of the SOM, AOA revised
its policies on blackout dates.
AOA revised its accreditation decision letters to ensure
that they are accurate and contain all the required elements for the
CMS Regional Office to render a decision regarding the deemed status of
an accredited hospital.
To meet the survey process requirements in Appendix A of
the SOM, AOA developed a policy outlining the minimum number of
inpatient records required for review during a certification survey.
AOA removed all references to mandatory consultative
services from its policies to avoid potential conflict of interest
issues.
To verify AOA's continued compliance with the provisions
of this final notice, CMS will conduct a follow-up corporate onsite
visit within one year of the date of publication of this notice.
B. Term of Approval
Based on the review and observations described in section III of
this final notice, we have determined that AOA's requirements for
hospitals meet or exceed our requirements. Therefore, we approve AOA as
a national accreditation organization for hospitals that request
participation in the Medicare program, effective September 25, 2009
through September 25, 2013.
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, this
regulation was not reviewed by the Office of Management and Budget.
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)
(Catalog of Federal Domestic Assistance Program No. 93.773,
Medicare--Hospital Insurance; and Program No. 93.774, Medicare--
Supplementary Medical Insurance Program)
Dated: July 30, 2009.
Charlene Frizzera,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. E9-20203 Filed 8-27-09; 8:45 am]
BILLING CODE 4120-01-P