Medicare and Medicaid Programs: Application From the American Association for Accreditation of Ambulatory Surgery Facilities, Inc. (AAAASF) for Continued Approval of Its Ambulatory Surgical Center Accreditation Program, 58253-58254 [2018-25013]
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Federal Register / Vol. 83, No. 223 / Monday, November 19, 2018 / Notices
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[FR Doc. 2018–25134 Filed 11–16–18; 8:45 am]
BILLING CODE 4163–19–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–3358–FN]
Medicare and Medicaid Programs:
Application From the American
Association for Accreditation of
Ambulatory Surgery Facilities, Inc.
(AAAASF) for Continued Approval of
Its Ambulatory Surgical Center
Accreditation Program
Centers for Medicare &
Medicaid Services, HHS.
ACTION: Notice.
AGENCY:
This final notice announces
our decision to approve the American
Association for Accreditation of
Ambulatory Surgery Facilities, Inc.
(AAAASF) for continued recognition as
a national accrediting organization for
ambulatory surgical centers (ASCs) that
wish to participate in the Medicare or
Medicaid programs.
DATES: This notice is applicable
November 27, 2018 through November
27, 2024.
FOR FURTHER INFORMATION CONTACT: Erin
McCoy, (410) 786–2337, Monda Shaver,
(410) 786–3410, or Renee Henry, (410)
786–7828.
SUPPLEMENTARY INFORMATION:
SUMMARY:
PO 00000
Frm 00032
Fmt 4703
Sfmt 4703
58253
I. Background
Under the Medicare program, eligible
beneficiaries may receive covered
services in an Ambulatory Surgical
Center (ASC) provided certain
requirements are met. Sections
1832(a)(2)(F)(i) of the Social Security
Act (the Act) establishes distinct criteria
for facilities seeking designation as an
ASC. Regulations concerning provider
agreements are at 42 CFR part 489 and
those pertaining to activities relating to
the survey and certification of facilities
are at 42 CFR part 488. The regulations
at 42 CFR part 416, specify the
conditions that an ASC must meet in
order to participate in the Medicare
program, the scope of covered services
and the conditions for Medicare
payment for ASCs.
Generally, to enter into an agreement,
an ASC must first be certified as
complying with the conditions set forth
in part 416 and recommended to the
Centers for Medicare & Medicaid
Services (CMS) for participation by a
state survey agency. Thereafter, the ASC
is subject to periodic surveys by a state
survey agency to determine whether it
continues to meet these conditions.
However, there is an alternative to
certification surveys by state agencies.
Accreditation by a nationally recognized
Medicare accreditation program
approved by CMS may substitute for
both initial and ongoing state review.
Section 1865(a)(1) of the Act provides
that, if the Secretary of the Department
of Health and Human Services finds that
accreditation of a provider entity by an
approved national accrediting
organization meets or exceeds all
applicable Medicare conditions, we may
treat the provider entity as having met
those conditions, that is, we may
‘‘deem’’ the provider entity to be in
compliance. Accreditation by an
accrediting organization is voluntary
and is not required for Medicare
participation.
Part 488, subpart A, implements the
provisions of section 1865 of the Act
and requires that a national accrediting
organization applying for approval of its
Medicare accreditation program must
provide CMS with reasonable assurance
that the accrediting organization
requires its accredited provider entities
to meet requirements that are at least as
stringent as the Medicare conditions.
Our regulations concerning the approval
of accrediting organizations are set forth
at § 488.5.
II. Application Approval Process
Section 1865(a)(3)(A) of the Act
provides a statutory timetable to ensure
that our review of applications for CMS-
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58254
Federal Register / Vol. 83, No. 223 / Monday, November 19, 2018 / Notices
khammond on DSK30JT082PROD with NOTICES
approval of an accreditation program is
conducted in a timely manner. The Act
provides us 210 days after the date of
receipt of a complete application, with
any documentation necessary to make
the determination, to complete our
survey activities and application
process. Within 60 days after receiving
a complete application, we must
publish a notice in the Federal Register
that identifies the national accrediting
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
a notice in the Federal Register
approving or denying the application.
III. Provisions of the Proposed Notice
On June 22, 2018, we published a
proposed notice in the Federal Register
(83 FR 29120) announcing the American
Association for Accreditation of
Ambulatory Surgery Facilities, Inc.
(AAAASF’s) request for continued
approval of its Medicare ASC
accreditation program. In the proposed
notice, we detailed our evaluation
criteria. Under section 1865(a)(2) of the
Act and in our regulations at § 488.5, we
conducted a review of AAAASF’s
Medicare ASC accreditation renewal
application in accordance with the
criteria specified by our regulations,
which include, but are not limited to the
following:
• An onsite administrative review of
AAAASF’s: (1) Corporate policies; (2)
financial and human resources available
to accomplish the proposed surveys; (3)
procedures for training, monitoring, and
evaluation of its ASC surveyors; (4)
ability to investigate and respond
appropriately to complaints against
accredited ASCs; and, (5) survey review
and decision-making process for
accreditation.
• The comparison of AAAASF’s
Medicare ASC accreditation program
standards to our current Medicare ASC
Conditions for Coverage (CfCs).
• A documentation review of
AAAASF’s survey process to:
++ Determine the composition of the
survey team, surveyor qualifications,
and AAAASF’s ability to provide
continuing surveyor training.
++ Compare AAAASF’s processes to
those CMS require of state survey
agencies, including periodic resurvey
and the ability to investigate and
respond appropriately to complaints
against accredited ASCs.
++ Evaluate AAAASF’s procedures for
monitoring ASCs it has found to be out
of compliance with AAAASF’s program
requirements. (This pertains only to
monitoring procedures when AAAASF
identifies non-compliance. If
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17:20 Nov 16, 2018
Jkt 247001
noncompliance is identified by a state
survey agency through a validation
survey, the state survey agency monitors
corrections as specified at § 488.9(c).)
++ Assess AAAASF’s ability to report
deficiencies to the surveyed ASC and
respond to the ASCs plan of correction
in a timely manner.
++ Establish AAAASF’s ability to
provide CMS with electronic data and
reports necessary for effective validation
and assessment of the organization’s
survey process.
++ Determine the adequacy of
AAAASF’s staff and other resources.
++ Confirm AAAASF’s ability to
provide adequate funding for
performing required surveys.
++ Confirm AAAASF’s policies with
respect to surveys being unannounced.
++ Obtain AAAASF’s agreement to
provide CMS 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 June 22,
2018 proposed notice also solicited
public comments regarding whether
AAAASF’s requirements met or
exceeded the Medicare CfCs for ASCs.
We received no comments in response
to our proposed notice.
IV. Provisions of the Final Notice
A. Differences Between AAAASF’s
Standards and Requirements for
Accreditation and Medicare Conditions
and Survey Requirements
We compared AAAASF’s ASC
accreditation program requirements and
survey process with the Medicare CfCs
at 42 CFR part 416, and the survey and
certification process requirements of
Parts 488 and 489. Our review and
evaluation of AAAASF’s ASC
application, which were conducted as
described in section III of this final
notice, yielded the following areas
where, as of the date of this notice,
AAAASF has revised its standards and
certification processes in order to meet
the requirements at:
• § 416.2, to ensure its standards
appropriately reference § 416.2 subparts
B and C;
• § 416.44(b)(1) to ensure its
standards appropriately reference Life
Safety Code requirements;
• § 416.44(b)(2) to ensure its
standards appropriately reference that
only Life Safety Code deficiencies may
request a time-limited waiver as part of
the ASC’s plan of correction;
• § 416.47(b)(4) to ensure its
standards appropriately address each
required element of § 416.47(b)(4);
PO 00000
Frm 00033
Fmt 4703
Sfmt 4703
• § 416.47(b)(5) to ensure its
standards appropriately address
§ 416.47(b)(5);
• § 416.52(a)(1) through (3) to ensure
its standards appropriately address the
requirements for a comprehensive
medical history and physical
assessment;
• § 488.5(a)(4)(i) to ensure that its
policies clearly support and convey the
unannounced nature of Medicare
deemed status surveys;
• § 488.5(a)(4)(ii) to ensure
comparability of AAAASF’s survey
process and surveyor guidance to those
required for state survey agencies
conducting federal Medicare surveys for
the same provider or supplier type;
• § 488.5(a)(4)(iii) to ensure that
copies of AAAASF’s guidelines and
instructions to surveyors appropriately
address Medicare requirements;
• § 488.5(a)(7) through (9) to ensure
its surveyors are qualified and evaluated
on performance;
• § 488.5(a)(11)(ii) to ensure accurate
survey findings are reported to CMS;
• § 488.5(a)(12) to ensure complaints
are triaged appropriately and surveyed
within the required timeframes;
• § 488.26(b) and (c) to ensure
deficiencies are cited at the appropriate
level based on manner and degree of
findings; and
• § 488.28(d) to ensure that its
policies for correction of deficiencies in
ASCs is comparable to CMS
requirements, requiring that deficiencies
normally must be corrected within 60
days.
B. Term of Approval
Based on our review and observations
described in section III of this final
notice, we approve AAAASF as a
national accreditation organization for
ASCs that request participation in the
Medicare program, effective November
27, 2018 through November 27, 2024.
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).
Dated: November 7, 2018.
Seema Verma,
Administrator, Centers for Medicare &
Medicaid Services.
[FR Doc. 2018–25013 Filed 11–16–18; 8:45 am]
BILLING CODE 4120–01–P
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]]>Agencies
[Federal Register Volume 83, Number 223 (Monday, November 19, 2018)]
[Notices]
[Pages 58253-58254]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-25013]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-3358-FN]
Medicare and Medicaid Programs: Application From the American
Association for Accreditation of Ambulatory Surgery Facilities, Inc.
(AAAASF) for Continued Approval of Its Ambulatory Surgical Center
Accreditation Program
AGENCY: Centers for Medicare & Medicaid Services, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This final notice announces our decision to approve the
American Association for Accreditation of Ambulatory Surgery
Facilities, Inc. (AAAASF) for continued recognition as a national
accrediting organization for ambulatory surgical centers (ASCs) that
wish to participate in the Medicare or Medicaid programs.
DATES: This notice is applicable November 27, 2018 through November 27,
2024.
FOR FURTHER INFORMATION CONTACT: Erin McCoy, (410) 786-2337, Monda
Shaver, (410) 786-3410, or Renee Henry, (410) 786-7828.
SUPPLEMENTARY INFORMATION:
I. Background
Under the Medicare program, eligible beneficiaries may receive
covered services in an Ambulatory Surgical Center (ASC) provided
certain requirements are met. Sections 1832(a)(2)(F)(i) of the Social
Security Act (the Act) establishes distinct criteria for facilities
seeking designation as an ASC. Regulations concerning provider
agreements are at 42 CFR part 489 and those pertaining to activities
relating to the survey and certification of facilities are at 42 CFR
part 488. The regulations at 42 CFR part 416, specify the conditions
that an ASC must meet in order to participate in the Medicare program,
the scope of covered services and the conditions for Medicare payment
for ASCs.
Generally, to enter into an agreement, an ASC must first be
certified as complying with the conditions set forth in part 416 and
recommended to the Centers for Medicare & Medicaid Services (CMS) for
participation by a state survey agency. Thereafter, the ASC is subject
to periodic surveys by a state survey agency to determine whether it
continues to meet these conditions. However, there is an alternative to
certification surveys by state agencies. Accreditation by a nationally
recognized Medicare accreditation program approved by CMS may
substitute for both initial and ongoing state review.
Section 1865(a)(1) of the Act provides that, if the Secretary of
the Department of Health and Human Services finds that accreditation of
a provider entity by an approved national accrediting organization
meets or exceeds all applicable Medicare conditions, we may treat the
provider entity as having met those conditions, that is, we may
``deem'' the provider entity to be in compliance. Accreditation by an
accrediting organization is voluntary and is not required for Medicare
participation.
Part 488, subpart A, implements the provisions of section 1865 of
the Act and requires that a national accrediting organization applying
for approval of its Medicare accreditation program must provide CMS
with reasonable assurance that the accrediting organization requires
its accredited provider entities to meet requirements that are at least
as stringent as the Medicare conditions. Our regulations concerning the
approval of accrediting organizations are set forth at Sec. 488.5.
II. Application Approval Process
Section 1865(a)(3)(A) of the Act provides a statutory timetable to
ensure that our review of applications for CMS-
[[Page 58254]]
approval of an accreditation program is conducted in a timely manner.
The Act provides us 210 days after the date of receipt of a complete
application, with any documentation necessary to make the
determination, to complete our survey activities and application
process. Within 60 days after receiving a complete application, we must
publish a notice in the Federal Register that identifies the national
accrediting 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 a notice in the Federal Register
approving or denying the application.
III. Provisions of the Proposed Notice
On June 22, 2018, we published a proposed notice in the Federal
Register (83 FR 29120) announcing the American Association for
Accreditation of Ambulatory Surgery Facilities, Inc. (AAAASF's) request
for continued approval of its Medicare ASC accreditation program. In
the proposed notice, we detailed our evaluation criteria. Under section
1865(a)(2) of the Act and in our regulations at Sec. 488.5, we
conducted a review of AAAASF's Medicare ASC accreditation renewal
application in accordance with the criteria specified by our
regulations, which include, but are not limited to the following:
An onsite administrative review of AAAASF's: (1) Corporate
policies; (2) financial and human resources available to accomplish the
proposed surveys; (3) procedures for training, monitoring, and
evaluation of its ASC surveyors; (4) ability to investigate and respond
appropriately to complaints against accredited ASCs; and, (5) survey
review and decision-making process for accreditation.
The comparison of AAAASF's Medicare ASC accreditation
program standards to our current Medicare ASC Conditions for Coverage
(CfCs).
A documentation review of AAAASF's survey process to:
++ Determine the composition of the survey team, surveyor
qualifications, and AAAASF's ability to provide continuing surveyor
training.
++ Compare AAAASF's processes to those CMS require of state survey
agencies, including periodic resurvey and the ability to investigate
and respond appropriately to complaints against accredited ASCs.
++ Evaluate AAAASF's procedures for monitoring ASCs it has found to
be out of compliance with AAAASF's program requirements. (This pertains
only to monitoring procedures when AAAASF identifies non-compliance. If
noncompliance is identified by a state survey agency through a
validation survey, the state survey agency monitors corrections as
specified at Sec. 488.9(c).)
++ Assess AAAASF's ability to report deficiencies to the surveyed
ASC and respond to the ASCs plan of correction in a timely manner.
++ Establish AAAASF's ability to provide CMS with electronic data
and reports necessary for effective validation and assessment of the
organization's survey process.
++ Determine the adequacy of AAAASF's staff and other resources.
++ Confirm AAAASF's ability to provide adequate funding for
performing required surveys.
++ Confirm AAAASF's policies with respect to surveys being
unannounced.
++ Obtain AAAASF's agreement to provide CMS 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 June 22,
2018 proposed notice also solicited public comments regarding whether
AAAASF's requirements met or exceeded the Medicare CfCs for ASCs. We
received no comments in response to our proposed notice.
IV. Provisions of the Final Notice
A. Differences Between AAAASF's Standards and Requirements for
Accreditation and Medicare Conditions and Survey Requirements
We compared AAAASF's ASC accreditation program requirements and
survey process with the Medicare CfCs at 42 CFR part 416, and the
survey and certification process requirements of Parts 488 and 489. Our
review and evaluation of AAAASF's ASC application, which were conducted
as described in section III of this final notice, yielded the following
areas where, as of the date of this notice, AAAASF has revised its
standards and certification processes in order to meet the requirements
at:
Sec. 416.2, to ensure its standards appropriately
reference Sec. 416.2 subparts B and C;
Sec. 416.44(b)(1) to ensure its standards appropriately
reference Life Safety Code requirements;
Sec. 416.44(b)(2) to ensure its standards appropriately
reference that only Life Safety Code deficiencies may request a time-
limited waiver as part of the ASC's plan of correction;
Sec. 416.47(b)(4) to ensure its standards appropriately
address each required element of Sec. 416.47(b)(4);
Sec. 416.47(b)(5) to ensure its standards appropriately
address Sec. 416.47(b)(5);
Sec. 416.52(a)(1) through (3) to ensure its standards
appropriately address the requirements for a comprehensive medical
history and physical assessment;
Sec. 488.5(a)(4)(i) to ensure that its policies clearly
support and convey the unannounced nature of Medicare deemed status
surveys;
Sec. 488.5(a)(4)(ii) to ensure comparability of AAAASF's
survey process and surveyor guidance to those required for state survey
agencies conducting federal Medicare surveys for the same provider or
supplier type;
Sec. 488.5(a)(4)(iii) to ensure that copies of AAAASF's
guidelines and instructions to surveyors appropriately address Medicare
requirements;
Sec. 488.5(a)(7) through (9) to ensure its surveyors are
qualified and evaluated on performance;
Sec. 488.5(a)(11)(ii) to ensure accurate survey findings
are reported to CMS;
Sec. 488.5(a)(12) to ensure complaints are triaged
appropriately and surveyed within the required timeframes;
Sec. 488.26(b) and (c) to ensure deficiencies are cited
at the appropriate level based on manner and degree of findings; and
Sec. 488.28(d) to ensure that its policies for correction
of deficiencies in ASCs is comparable to CMS requirements, requiring
that deficiencies normally must be corrected within 60 days.
B. Term of Approval
Based on our review and observations described in section III of
this final notice, we approve AAAASF as a national accreditation
organization for ASCs that request participation in the Medicare
program, effective November 27, 2018 through November 27, 2024.
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).
Dated: November 7, 2018.
Seema Verma,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2018-25013 Filed 11-16-18; 8:45 am]
BILLING CODE 4120-01-P
