Medicare and Medicaid Programs; Approval of the Accreditation Association for Ambulatory Health Care for Continued Deeming Authority for Ambulatory Surgical Centers, 67520-67522 [E8-27122]
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67520
Federal Register / Vol. 73, No. 221 / Friday, November 14, 2008 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–10151 and CMS–
10152]
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Centers for Medicare &
Medicaid Services.
In compliance with the requirement
of section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the
Centers for Medicare & Medicaid
Services (CMS), Department of Health
and Human Services, is publishing the
following summary of proposed
collections for public comment.
Interested persons are invited to send
comments regarding this burden
estimate or any other aspect of this
collection of information, including any
of the following subjects: (1) The
necessity and utility of the proposed
information collection for the proper
performance of the Agency’s function;
(2) the accuracy of the estimated
burden; (3) ways to enhance the quality,
utility, and clarity of the information to
be collected; and (4) the use of
automated collection techniques or
other forms of information technology to
minimize the information collection
burden.
1. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: Data Collection
for Medicare Beneficiaries Receiving
Implantable Cardioverter-defibrillator
for Primary Prevention of Sudden
Cardiac Death; Use: The Centers for
Medicare and Medicaid Services (CMS)
provides coverage for implantable
cardioverter-defibrillators (ICDs) for
secondary prevention of sudden cardiac
death based on extensive evidence
showing that use of ICDs among patients
with a certain set of physiologic
conditions are effective. Accordingly,
CMS considers coverage for ICDs
reasonable and necessary under Section
1862 (a)(1)(A) of the Social Security Act.
However, evidence for use of ICDs for
primary prevention of sudden cardiac
death is less compelling for certain
patients.
To encourage responsible and
appropriate use of ICDs, CMS issued a
Decision Memo for Implantable
Defibrillators on January 27, 2005,
indicating that ICDs will be covered for
primary prevention of sudden cardiac
death if the beneficiary is enrolled in
either an FDA-approved category B IDE
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AGENCY:
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clinical trial (42 DFR § 405.201), a trial
under the CMS Clinical Trial Policy
(NCD Manual § 310.1) or a qualifying
prospective data collection system
(either a practical clinical trial or
prospective systematic data collection,
which is sometimes referred to as a
registry). Form Number: CMS–10151
(OMB# 0938–0967); Frequency:
Reporting—Quarterly; Affected Public:
Business or other for-profit and not-forprofit institutions; Number of
Respondents: 1,217; Total Annual
Responses: 50,000; Total Annual Hours:
12,500.
2. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Data collection
for Medicare Beneficiaries Receiving
FDG Positron Emission Tomography
(PET) for Brain, Cervical, Ovarian,
Pancreatic, Small Cell Lung, and All
Other Cancers; Use: In the Decision
Memo #CAG–00181N issued on January
27, 2005, CMS determined that the
evidence is sufficient to conclude that
for Medicare beneficiaries receiving
FDG positron emission tomography
(PET) for brain, cervical, ovarian,
pancreatic, small cell lung, and
testicular cancers is reasonable and
necessary only when the provider is
participating in and patients are
enrolled in a systematic data collection
project. CMS will consider prospective
data collection systems to be qualified if
they provide assurance that specific
hypotheses are addressed and they
collect appropriate data elements. The
data collection should include baseline
patient characteristics; indications for
the PET scan; PET scan type and
characteristics; FDG PET results; results
of all other imaging studies; facility and
provider characteristics; cancer type,
grade, and stage; long-term patient
outcomes; disease management changes;
and anti-cancer treatment received.
Form Number: CMS–10152 (OMB#
0938–0968); Frequency: Reporting—On
occasion; Affected Public: Business or
other for-profit and not-for-profit
institutions; Number of Respondents:
2,000; Total Annual Responses: 50,000;
Total Annual Hours: 4,167.
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 Email 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.
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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 December 15, 2008: OMB, Office of
Information and Regulatory Affairs,
Attention: CMS Desk Officer, New
Executive Office Building, Room 10235,
Washington, DC 20503, Fax Number:
(202) 395–6974.
Dated: November 6, 2008.
Michelle Shortt,
Director, Regulations Development Group,
Office of Strategic Operations and Regulatory
Affairs.
[FR Doc. E8–27061 Filed 11–13–08; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–2897–FN]
Medicare and Medicaid Programs;
Approval of the Accreditation
Association for Ambulatory Health
Care for Continued Deeming Authority
for Ambulatory Surgical Centers
Centers for Medicare &
Medicaid Services, (CMS), HHS.
ACTION: Final notice.
AGENCY:
SUMMARY: This notice announces our
decision to approve the Accreditation
Association for Ambulatory Health Care
(AAAHC) for continued recognition as a
national accreditation program for
ambulatory surgical centers (ASCs)
seeking to participate in the Medicare or
Medicaid programs.
DATES: Effective Date: This final notice
is effective December 20, 2008 through
December 20, 2012.
FOR FURTHER INFORMATION CONTACT:
Aviva Walker-Sicard, (410)–786–8648.
Patricia Chmielewski (410)–786–6899.
SUPPLEMENTARY INFORMATION:
I. Background
Under the Medicare program, eligible
beneficiaries may receive selected
covered services in an ASC provided
certain requirements are met. Sections
1832(a)(2)(f)(i) of the Social Security Act
(the Act) authorizes the Secretary to
establish distinct criteria for facilities
seeking designation as an ASC. Under
this authority, the minimum
requirements that an ASC must meet to
participate in Medicare are set forth in
regulations at 42 CFR part 416 which
determines the basis and scope of ASC
covered services, and the conditions for
E:\FR\FM\14NON1.SGM
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Federal Register / Vol. 73, No. 221 / Friday, November 14, 2008 / Notices
jlentini on PROD1PC65 with NOTICES
Medicare payment for facility services.
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 ASC must first be certified by a State
survey agency as complying with
conditions or requirements set forth in
part 416 of our regulations. Then, the
ASC 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(a)(1) of the Act (as
redesignated under section 125(b) of the
Medicare Improvements for Patients and
Providers Act of 2008 (MIPPA) (Pub. L.
110–275)) 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
Medicare requirements. (We note that
section 125 of MIPPA redesignated
subsections (b) through (e) of section
1865 of the Act as (a) through (d),
respectively.) 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, a
provider entity accredited by the
national accrediting body’s approved
program may 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 § 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 AAAHC’s current term
of approval as a recognized
accreditation program for ASCs expires
December 20, 2008.
II. Deeming Applications Approval
Process
Section 1865(a)(3)(A) of the Act
(formerly section 1865(b)(3)(A) of the
Act) provides a statutory timetable to
ensure that our review of deeming
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16:29 Nov 13, 2008
Jkt 217001
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 30day 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
In the June 27, 2008 Federal Register
(73 FR 36520), we published a proposed
notice announcing the AAAHC’s request
for reapproval as a deeming
organization for ASCs. In the proposed
notice, we detailed our evaluation
criteria. Under section 1865(a)(2) of the
Act (formerly section 1865(b)(2) of the
Act) and our regulations at § 488.4
(Application and reapplication
procedures for accreditation
organizations), we conducted a review
of the AAAHC application in
accordance with the criteria specified by
our regulation, which include, but are
not limited to the following:
• An onsite administrative review of
AAAHC’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 AAAHC’s ASC
accreditation standards to our current
Medicare ASC conditions for coverage.
• A documentation review of
AAAHC’s survey processes to—
++ Determine the composition of the
survey team, survey or qualifications,
and the ability of AAAHC to provide
continuing surveyor training;
++ Compare AAAHC’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 AAAHC’s procedures for
monitoring providers or suppliers found
to be out of compliance with AAAHC
program requirements. The monitoring
procedures are used only when AAAHC
identifies noncompliance. If
noncompliance is identified through
validation reviews, the State survey
agency monitors corrections as specified
at § 488.7(d);
++ Assess AAAHC’s ability to report
deficiencies to a surveyed facility and
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67521
respond to the facility’s plan of
correction in a timely manner;
++ Establish AAAHC’s ability to
provide us with electronic data and
reports necessary for effective validation
and assessment of AAAHC’s survey
process;
++ Determine the adequacy of staff
and other resources;
++ Review AAAHC’s ability to
provide adequate funding for
performing required surveys;
++ Confirm AAAHC’s policies with
respect to whether surveys are
announced or unannounced; and,
++ Obtain AAAHC’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 (formerly
1865(b)(3)(A) of the Act), the June 27,
2008 proposed notice, also solicited
public comments regarding whether
AAAHC’s requirements met or exceeded
the Medicare conditions of coverage for
ASCs. We received no public comments
in response to our proposed notice.
IV. Provisions of the Final Notice
A. Differences Between the AAAHC’s
Standards and Requirements for
Accreditation and Medicare’s
Conditions and Survey Requirements
We compared the standards contained
in AAAHC’s accreditation requirements
for ASCs and its survey process in
AAAHC’s application for renewal of
deeming authority for ASCs with the
Medicare ASC conditions for coverage
and our State Operations Manual
(SOM). Our review and evaluation of
AAAHC’s deeming application, which
were conducted as described in section
III. of this final notice, yielded the
following:
• To meet the requirements at
§ 416.41, AAAHC added language to its
standards to ensure that the governing
body will provide contracted services in
a safe and effective manner.
• To meet the requirements at
§ 416.42, AAAHC modified its standards
to require surgical procedures be
performed only by qualified physicians
in a safe manner.
• AAAHC modified its standards to
ensure the administration of anesthesia
meets the requirements at § 416.42.
• To meet the requirements at
§ 416.44(a)(3), AAAHC amended its
standards to ensure that ASC’s establish
programs for identifying and preventing
infections, maintain sanitary
environments, and report the results to
appropriate authorities.
E:\FR\FM\14NON1.SGM
14NON1
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67522
Federal Register / Vol. 73, No. 221 / Friday, November 14, 2008 / Notices
• To meet the requirements at
§ 416.44, AAAHC updated the
requirements on its Physical
Environment Checklist (PEC) and
modified its policies to clearly reflect
that life safety code (LSC) waivers may
only be granted by a CMS regional
office.
• To meet the requirements at
§ 416.44(d), AAAHC revised its
standards to require that ASCs train
personnel in the use of all types of
emergency equipment, not just
cardiopulmonary and cardiac
emergency equipment.
• To meet the requirements at
§ 416.45(b), AAAHC revised its
standards to require that the scope of
procedures performed in the ASC be
periodically reviewed and amended as
appropriate.
• To meet the requirements at
§ 416.46(a), AAAHC revised its
standards to require a registered nurse
be available for emergency treatment
whenever there is a patient in the ASC.
• To meet the requirements at
§ 416.47(b), AAAHC revised its survey
procedures to ensure that surveyors use
a random selection of medical records
for review during an onsite survey.
• To meet the requirements at
§ 488.4(a)(4), AAAHC revised its
policies related to surveyor
credentialing and privileging to ensure
that surveyor’s were appropriately
privileged, credentialed and trained.
• AAAHC modified its surveyor
training program to strengthen the
Physical Environment and Life Safety
Code training to ensure that surveyors
thoroughly understand Physical
Environment and Life Safety Code and
can translate the teachings into practice
on survey.
• CMS will conduct a survey
observation, in 1 year, to validate the
implementation of AAAHC’s revised
surveyor training program for Physical
Environment and Life Safety Code and
assess the competency of the surveyor’s
ability to conduct Physical Environment
and Life Safety Code surveys in
accordance with Medicare
requirements.
• AAAHC amended its policies and
procedures to address any real or
perceived conflict of interest issues
between AAAHC’s accreditation
activities and AAAHC’s consultative
services.
• To meet the requirements at
§ 488.4(a)(6) AAAHC amended its
policies and procedures for complaints
to comply with the Medicare
requirements in Chapter 5 of the SOM.
• AAAHC revised its accreditation
decision letters to ensure they are
accurate and contain all of the required
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16:29 Nov 13, 2008
Jkt 217001
elements necessary for the CMS
Regional Office to render a decision
regarding deemed status of a provider.
• AAAHC modified its policies
regarding condition-level
noncompliance identified during an
initial certification survey for
participation in Medicare in accordance
with section 2005A of the SOM.
• To meet the Medicare requirements
at § 488.20(a) and § 488.28(a), AAAHC
developed a policy regarding CMS
requirements for submission of a plan of
correction by the ASC and the
completion of an onsite follow-up
survey to determine compliance with
the Medicare conditions for coverage
(CFCs) after citing condition level
noncompliance during a recertification
survey.
• AAAHC modified its policies
regarding timeframes for sending and
receiving a required plan of correction
in accordance with section 2728 of the
SOM.
• To meet the Medicare requirements
related to unannounced surveys at
2700A of the SOM, AAAHC expanded
its survey window in which
organizations could receive an
accreditation survey for deemed status.
• AAAHC modified the language
related to deferred decisions and early
survey option in its accreditation
handbook to provide clarification and
consistency between its policies and the
Medicare requirements.
• AAAHC amended its policies
regarding subsequent revisions of its
Accreditation Handbook and surveyor
tools to ensure all documents are
consistent in language and reflect CMS’s
requested changes.
B. Term of Approval
Based on the review and observations
described in section III. of this final
notice, we have determined that
AAAHC’s requirements for ASCs meet
or exceed our requirements. Therefore,
we approve AAAHC as a national
accreditation organization for ASCs that
request participation in the Medicare
program, effective December 20, 2008
through December 20, 2012.
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. Chapter 35).
Authority: Section 1865 of the Social
Security Act (42 U.S.C. 1395bb).
PO 00000
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Fmt 4703
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(Catalog of Federal Domestic Assistance
Program No. 93.773, Medicare—Hospital
Insurance; Program No. 93.774, Medicare—
Supplementary Medical Insurance Program;
and Catalog of Federal Domestic Assistance
Program No. 93.778, Medical Assistance
Program)
Dated: October 2, 2008.
Kerry Weems,
Acting Administrator, Centers for Medicare
& Medicaid Services.
[FR Doc. E8–27122 Filed 11–13–08; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–2898–FN]
Medicare and Medicaid Programs;
Approval of the Joint Commission for
Continued Deeming Authority for
Ambulatory Surgical Centers
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Final notice.
AGENCY:
SUMMARY: This notice announces our
decision to approve the Joint
Commission for continued recognition
as a national accreditation program for
ambulatory surgical centers (ASCs)
seeking to participate in the Medicare or
Medicaid programs.
DATES: Effective Date: This final notice
is effective December 20, 2008, through
December 20, 2014.
FOR FURTHER INFORMATION CONTACT:
Laura Weber, (410) 786–0227. Patricia
Chmielewski (410) 786–6899.
SUPPLEMENTARY INFORMATION:
I. Background
Under the Medicare program, eligible
beneficiaries may receive selected
covered services in an ASC provided
certain requirements are met. Sections
1832(a)(2)(f)(i) of the Social Security Act
(the Act) authorizes the Secretary to
establish distinct criteria for facilities
seeking designation as an ASC. Under
this authority, the minimum
requirements that an ASC must meet to
participate in Medicare are set forth in
regulations at 42 CFR part 416, which
determine the basis and scope of ASC
covered services, and the conditions for
Medicare payment for facility services.
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 ASC must first be certified by a State
E:\FR\FM\14NON1.SGM
14NON1
]]>Agencies
[Federal Register Volume 73, Number 221 (Friday, November 14, 2008)]
[Notices]
[Pages 67520-67522]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-27122]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-2897-FN]
Medicare and Medicaid Programs; Approval of the Accreditation
Association for Ambulatory Health Care for Continued Deeming Authority
for Ambulatory Surgical Centers
AGENCY: Centers for Medicare & Medicaid Services, (CMS), HHS.
ACTION: Final notice.
-----------------------------------------------------------------------
SUMMARY: This notice announces our decision to approve the
Accreditation Association for Ambulatory Health Care (AAAHC) for
continued recognition as a national accreditation program for
ambulatory surgical centers (ASCs) seeking to participate in the
Medicare or Medicaid programs.
DATES: Effective Date: This final notice is effective December 20, 2008
through December 20, 2012.
FOR FURTHER INFORMATION CONTACT: Aviva Walker-Sicard, (410)-786-8648.
Patricia Chmielewski (410)-786-6899.
SUPPLEMENTARY INFORMATION:
I. Background
Under the Medicare program, eligible beneficiaries may receive
selected covered services in an ASC provided certain requirements are
met. Sections 1832(a)(2)(f)(i) of the Social Security Act (the Act)
authorizes the Secretary to establish distinct criteria for facilities
seeking designation as an ASC. Under this authority, the minimum
requirements that an ASC must meet to participate in Medicare are set
forth in regulations at 42 CFR part 416 which determines the basis and
scope of ASC covered services, and the conditions for
[[Page 67521]]
Medicare payment for facility services. 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 ASC must first be
certified by a State survey agency as complying with conditions or
requirements set forth in part 416 of our regulations. Then, the ASC 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(a)(1) of the Act (as redesignated under section 125(b)
of the Medicare Improvements for Patients and Providers Act of 2008
(MIPPA) (Pub. L. 110-275)) 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 Medicare requirements. (We note that section 125 of MIPPA
redesignated subsections (b) through (e) of section 1865 of the Act as
(a) through (d), respectively.) 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, a provider entity accredited by the national accrediting
body's approved program may 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 AAAHC's current term of
approval as a recognized accreditation program for ASCs expires
December 20, 2008.
II. Deeming Applications Approval Process
Section 1865(a)(3)(A) of the Act (formerly 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. Provisions of the Proposed Notice
In the June 27, 2008 Federal Register (73 FR 36520), we published a
proposed notice announcing the AAAHC's request for reapproval as a
deeming organization for ASCs. In the proposed notice, we detailed our
evaluation criteria. Under section 1865(a)(2) of the Act (formerly
section 1865(b)(2) of the Act) and our regulations at Sec. 488.4
(Application and reapplication procedures for accreditation
organizations), we conducted a review of the AAAHC application in
accordance with the criteria specified by our regulation, which
include, but are not limited to the following:
An onsite administrative review of AAAHC'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 AAAHC's ASC accreditation standards to our
current Medicare ASC conditions for coverage.
A documentation review of AAAHC's survey processes to--
++ Determine the composition of the survey team, survey or
qualifications, and the ability of AAAHC to provide continuing surveyor
training;
++ Compare AAAHC'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 AAAHC's procedures for monitoring providers or
suppliers found to be out of compliance with AAAHC program
requirements. The monitoring procedures are used only when AAAHC
identifies noncompliance. If noncompliance is identified through
validation reviews, the State survey agency monitors corrections as
specified at Sec. 488.7(d);
++ Assess AAAHC's ability to report deficiencies to a surveyed
facility and respond to the facility's plan of correction in a timely
manner;
++ Establish AAAHC's ability to provide us with electronic data and
reports necessary for effective validation and assessment of AAAHC's
survey process;
++ Determine the adequacy of staff and other resources;
++ Review AAAHC's ability to provide adequate funding for
performing required surveys;
++ Confirm AAAHC's policies with respect to whether surveys are
announced or unannounced; and,
++ Obtain AAAHC'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 (formerly
1865(b)(3)(A) of the Act), the June 27, 2008 proposed notice, also
solicited public comments regarding whether AAAHC's requirements met or
exceeded the Medicare conditions of coverage for ASCs. We received no
public comments in response to our proposed notice.
IV. Provisions of the Final Notice
A. Differences Between the AAAHC's Standards and Requirements for
Accreditation and Medicare's Conditions and Survey Requirements
We compared the standards contained in AAAHC's accreditation
requirements for ASCs and its survey process in AAAHC's application for
renewal of deeming authority for ASCs with the Medicare ASC conditions
for coverage and our State Operations Manual (SOM). Our review and
evaluation of AAAHC's deeming application, which were conducted as
described in section III. of this final notice, yielded the following:
To meet the requirements at Sec. 416.41, AAAHC added
language to its standards to ensure that the governing body will
provide contracted services in a safe and effective manner.
To meet the requirements at Sec. 416.42, AAAHC modified
its standards to require surgical procedures be performed only by
qualified physicians in a safe manner.
AAAHC modified its standards to ensure the administration
of anesthesia meets the requirements at Sec. 416.42.
To meet the requirements at Sec. 416.44(a)(3), AAAHC
amended its standards to ensure that ASC's establish programs for
identifying and preventing infections, maintain sanitary environments,
and report the results to appropriate authorities.
[[Page 67522]]
To meet the requirements at Sec. 416.44, AAAHC updated
the requirements on its Physical Environment Checklist (PEC) and
modified its policies to clearly reflect that life safety code (LSC)
waivers may only be granted by a CMS regional office.
To meet the requirements at Sec. 416.44(d), AAAHC revised
its standards to require that ASCs train personnel in the use of all
types of emergency equipment, not just cardiopulmonary and cardiac
emergency equipment.
To meet the requirements at Sec. 416.45(b), AAAHC revised
its standards to require that the scope of procedures performed in the
ASC be periodically reviewed and amended as appropriate.
To meet the requirements at Sec. 416.46(a), AAAHC revised
its standards to require a registered nurse be available for emergency
treatment whenever there is a patient in the ASC.
To meet the requirements at Sec. 416.47(b), AAAHC revised
its survey procedures to ensure that surveyors use a random selection
of medical records for review during an onsite survey.
To meet the requirements at Sec. 488.4(a)(4), AAAHC
revised its policies related to surveyor credentialing and privileging
to ensure that surveyor's were appropriately privileged, credentialed
and trained.
AAAHC modified its surveyor training program to strengthen
the Physical Environment and Life Safety Code training to ensure that
surveyors thoroughly understand Physical Environment and Life Safety
Code and can translate the teachings into practice on survey.
CMS will conduct a survey observation, in 1 year, to
validate the implementation of AAAHC's revised surveyor training
program for Physical Environment and Life Safety Code and assess the
competency of the surveyor's ability to conduct Physical Environment
and Life Safety Code surveys in accordance with Medicare requirements.
AAAHC amended its policies and procedures to address any
real or perceived conflict of interest issues between AAAHC's
accreditation activities and AAAHC's consultative services.
To meet the requirements at Sec. 488.4(a)(6) AAAHC
amended its policies and procedures for complaints to comply with the
Medicare requirements in Chapter 5 of the SOM.
AAAHC revised its accreditation decision letters to ensure
they are accurate and contain all of the required elements necessary
for the CMS Regional Office to render a decision regarding deemed
status of a provider.
AAAHC modified its policies regarding condition-level
noncompliance identified during an initial certification survey for
participation in Medicare in accordance with section 2005A of the SOM.
To meet the Medicare requirements at Sec. 488.20(a) and
Sec. 488.28(a), AAAHC developed a policy regarding CMS requirements
for submission of a plan of correction by the ASC and the completion of
an onsite follow-up survey to determine compliance with the Medicare
conditions for coverage (CFCs) after citing condition level
noncompliance during a recertification survey.
AAAHC modified its policies regarding timeframes for
sending and receiving a required plan of correction in accordance with
section 2728 of the SOM.
To meet the Medicare requirements related to unannounced
surveys at 2700A of the SOM, AAAHC expanded its survey window in which
organizations could receive an accreditation survey for deemed status.
AAAHC modified the language related to deferred decisions
and early survey option in its accreditation handbook to provide
clarification and consistency between its policies and the Medicare
requirements.
AAAHC amended its policies regarding subsequent revisions
of its Accreditation Handbook and surveyor tools to ensure all
documents are consistent in language and reflect CMS's requested
changes.
B. Term of Approval
Based on the review and observations described in section III. of
this final notice, we have determined that AAAHC's requirements for
ASCs meet or exceed our requirements. Therefore, we approve AAAHC as a
national accreditation organization for ASCs that request participation
in the Medicare program, effective December 20, 2008 through December
20, 2012.
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. Chapter 35).
Authority: Section 1865 of the Social Security Act (42 U.S.C.
1395bb).
(Catalog of Federal Domestic Assistance Program No. 93.773,
Medicare--Hospital Insurance; Program No. 93.774, Medicare--
Supplementary Medical Insurance Program; and Catalog of Federal
Domestic Assistance Program No. 93.778, Medical Assistance Program)
Dated: October 2, 2008.
Kerry Weems,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. E8-27122 Filed 11-13-08; 8:45 am]
BILLING CODE 4120-01-P
