Medicare and Medicaid Programs: Approval of the Accreditation Association for Ambulatory Health Care, Inc. (AAAHC) Application for Continued Approval of Its Ambulatory Surgical Center Accreditation Program, 65676-65677 [2018-27592]
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ACTION:
Federal Register / Vol. 83, No. 245 / Friday, December 21, 2018 / Notices
I. Background
Notice of charter renewal.
This gives notice that under
the Federal Advisory Committee Act of
October 6, 1972, that the Mine Safety
and Health Research Advisory
Committee (MSHRAC), Centers for
Disease Control and Prevention,
Department of Health and Human
Services, has been renewed for a 2-year
period through November 30, 2020.
FOR FURTHER INFORMATION CONTACT:
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Officer, CDC/Mine Safety and Health
Research Advisory Committee
(MSHRAC), CDC, HHS, 626 Cochrans
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SUMMARY:
Sherri Berger,
Chief Operating Officer, Centers for Disease
Control and Prevention.
[FR Doc. 2018–27720 Filed 12–20–18; 8:45 am]
BILLING CODE 4163–19–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–3362–FN]
Medicare and Medicaid Programs:
Approval of the Accreditation
Association for Ambulatory Health
Care, Inc. (AAAHC) Application for
Continued Approval of Its Ambulatory
Surgical Center Accreditation Program
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Final notice.
AGENCY:
This final notice announces
our decision to approve the
Accreditation Association for
Ambulatory Health Care, Inc. for
continued recognition as a national
accrediting organization for ambulatory
surgical centers that wish to participate
in the Medicare or Medicaid programs.
DATES: Applicable Date: December 20,
2018 through December 20, 2024.
FOR FURTHER INFORMATION CONTACT:
Lillian Williams, (410) 786–8636,
Monda Shaver, (410) 786–3410, or
Renee Henry, (410) 786–7828.
SUPPLEMENTARY INFORMATION:
amozie on DSK3GDR082PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
00:00 Dec 21, 2018
Jkt 247001
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 or
requirements, we may deem the
provider entity as having met those
conditions or requirements.
Accreditation by an accrediting
organization is voluntary and is not
required for Medicare participation.
A national accrediting organization
applying for approval of its Medicare
accreditation program under part 488,
subpart A, 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 § 488.4.
II. Application Approval Process
Section 1865(a)(3)(A) of the Act
requires that we publish, within 60 days
of receipt of an organization’s complete
application, a notice identifying the
national accrediting body making the
PO 00000
Frm 00055
Fmt 4703
Sfmt 4703
request, describing the nature of the
request, and providing at least a 30-day
public comment period. We have 210
days from the receipt of a complete
application to publish a notice of
approval or denial of the application.
III. Provisions of the Proposed Notice
On July 26, 2018, we published a
proposed notice entitled ‘‘Application
from the Accreditation Association for
Ambulatory Health Care, Inc. (AAAHC)
for Continued Approval of its
Ambulatory Surgical Center
Accreditation Program’’ in the Federal
Register (83 FR 35486) announcing
AAAHC’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 AAAHC’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
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 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 AAAHC’s
Medicare ASC accreditation program
standards to our current Medicare ASC
conditions for coverage (CfCs).
• A documentation review of
AAAHC’s survey process to:
++ Determine the composition of the
survey team, surveyor qualifications,
and AAAHC’s ability to provide
continuing surveyor training.
++ Compare AAAHC’s processes to
those we require of state survey
agencies, including periodic resurvey
and the ability to investigate and
respond appropriately to complaints
against accredited ASCs.
++ Evaluate AAAHC’s procedures for
monitoring ASCs it has found to be out
of compliance with AAAHC’s program
requirements. (This pertains only to
monitoring procedures when AAAHC
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 § 488.9(c).)
++ Assess AAAHC’s ability to report
deficiencies to the surveyed ASC and
respond to the ASCs plan of correction
in a timely manner.
E:\FR\FM\21DEN1.SGM
21DEN1
65677
Federal Register / Vol. 83, No. 245 / Friday, December 21, 2018 / Notices
++ Establish AAAHC’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
AAAHC’s staff and other resources.
++ Confirm AAAHC’s ability to
provide adequate funding for
performing required surveys.
++ Confirm AAAHC’s policies with
respect to surveys being unannounced.
++ Obtain AAAHC’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 July 26,
2018 proposed notice also solicited
public comments regarding whether
AAAHC’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 AAAHC’s
Standards and Requirements for
Accreditation and Medicare Conditions
and Survey Requirements
We compared AAAHC’s ASC
accreditation program requirements and
survey process with the Medicare CfCs
at part 416, and the survey and
certification process requirements of
parts 488 and 489. Our review and
evaluation of AAAHC’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,
AAAHC has revised its standards and
certification processes in order to meet
the requirements at:
• § 416.44(b)(1), to ensure its
standards appropriately reference Life
Safety Code requirements;
• § 416.44(c), to ensure its standards
appropriately reference Life Safety Code
requirements;
• § 416.44(c)(1)(iv), to ensure its
standards appropriately reference Life
Safety Code requirements;
• § 488.5(a)(4)(ii), to ensure
comparability of AAAHC’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)(iv), to ensure all
identified areas of non-compliance are
clearly documented and cited
appropriately in the final survey report.
• § 488.5(a)(7) through (9), to ensure
its surveyors are appropriately qualified,
trained and maintain competence
during extended periods of time without
conducting a survey;
• § 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;
• § 488.18(a), to ensure that the
findings are documented and written
within the principles of documentation.
• § 488.26(b), 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.
• § 489.13(c), to ensure that all
accreditation requirements have been
met before granting accreditation and
making a recommendation for
participation or continued participation
in the Medicare program 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 AAAHC as a
national accreditation organization for
ASCs that request participation in the
Medicare program, effective December
20, 2018 through December 20, 2024.
V. Collection of Information
Requirements
This document does not impose
information collection requirements,
that is, reporting, recordkeeping or
third-party disclosure requirements.
Consequently, there is no need for
review by the Office of Management and
Budget under the authority of the
Paperwork Reduction Act of 1995 (44
U.S.C. 3501 et seq.).
Dated: December 14, 2018.
Seema Verma,
Administrator, Centers for Medicare &
Medicaid Services.
[FR Doc. 2018–27592 Filed 12–20–18; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Comment Request
Proposed Projects:
Title: Head Start Program Information
Report.
OMB No.: 0970–0427.
Description: The Office of Head Start
within the Administration for Children
and Families, United States Department
of Health and Human Services, is
proposing to renew, with changes,
authority to collect information using
the Head Start Program Information
Report (PIR), monthly enrollment,
contacts, and center locations. All
information is collected electronically
through the Head Start Enterprise
System (HSES). The PIR provides
information about Head Start and Early
Head Start services received by the
children and families enrolled in Head
Start programs. The information
collected in the PIR is used to inform
the public about these programs, to
make periodic reports to Congress about
the status of children in Head Start
programs as required by the Head Start
Act, and to assist the administration and
training/technical assistance of Head
Start programs. Other program data is
used to track enrollment, contact the
program, provide a locator for parents to
find a nearby program, and for
oversight.
Respondents: Head Start and Early
Head Start program grant recipients.
ANNUAL BURDEN ESTIMATES
Number of
respondents
amozie on DSK3GDR082PROD with NOTICES1
Instrument
Head Start Program Information Report ..........................................................
Grantee Monthly Enrollment Reporting ...........................................................
Contacts, Center Locations .............................................................................
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Number of
responses per
respondent
3,449
2,066
3,449
E:\FR\FM\21DEN1.SGM
1
12
1
21DEN1
Average
burden hours
per response
4
0.05
0.25
Total burden
hours
13,796
1,240
862
]]>Agencies
[Federal Register Volume 83, Number 245 (Friday, December 21, 2018)]
[Notices]
[Pages 65676-65677]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-27592]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-3362-FN]
Medicare and Medicaid Programs: Approval of the Accreditation
Association for Ambulatory Health Care, Inc. (AAAHC) Application for
Continued Approval of Its Ambulatory Surgical Center Accreditation
Program
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Final notice.
-----------------------------------------------------------------------
SUMMARY: This final notice announces our decision to approve the
Accreditation Association for Ambulatory Health Care, Inc. for
continued recognition as a national accrediting organization for
ambulatory surgical centers that wish to participate in the Medicare or
Medicaid programs.
DATES: Applicable Date: December 20, 2018 through December 20, 2024.
FOR FURTHER INFORMATION CONTACT: Lillian Williams, (410) 786-8636,
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 or requirements, we
may deem the provider entity as having met those conditions or
requirements. Accreditation by an accrediting organization is voluntary
and is not required for Medicare participation.
A national accrediting organization applying for approval of its
Medicare accreditation program under part 488, subpart A, 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. 488.4.
II. Application Approval Process
Section 1865(a)(3)(A) of the Act requires that we publish, within
60 days of receipt of an organization's complete application, a notice
identifying the national accrediting body making the request,
describing the nature of the request, and providing at least a 30-day
public comment period. We have 210 days from the receipt of a complete
application to publish a notice of approval or denial of the
application.
III. Provisions of the Proposed Notice
On July 26, 2018, we published a proposed notice entitled
``Application from the Accreditation Association for Ambulatory Health
Care, Inc. (AAAHC) for Continued Approval of its Ambulatory Surgical
Center Accreditation Program'' in the Federal Register (83 FR 35486)
announcing AAAHC'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 AAAHC'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 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 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 AAAHC's Medicare ASC accreditation
program standards to our current Medicare ASC conditions for coverage
(CfCs).
A documentation review of AAAHC's survey process to:
++ Determine the composition of the survey team, surveyor
qualifications, and AAAHC's ability to provide continuing surveyor
training.
++ Compare AAAHC's processes to those we require of state survey
agencies, including periodic resurvey and the ability to investigate
and respond appropriately to complaints against accredited ASCs.
++ Evaluate AAAHC's procedures for monitoring ASCs it has found to
be out of compliance with AAAHC's program requirements. (This pertains
only to monitoring procedures when AAAHC 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 AAAHC's ability to report deficiencies to the surveyed
ASC and respond to the ASCs plan of correction in a timely manner.
[[Page 65677]]
++ Establish AAAHC'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 AAAHC's staff and other resources.
++ Confirm AAAHC's ability to provide adequate funding for
performing required surveys.
++ Confirm AAAHC's policies with respect to surveys being
unannounced.
++ Obtain AAAHC'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 July 26,
2018 proposed notice also solicited public comments regarding whether
AAAHC'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 AAAHC's Standards and Requirements for
Accreditation and Medicare Conditions and Survey Requirements
We compared AAAHC's ASC accreditation program requirements and
survey process with the Medicare CfCs at part 416, and the survey and
certification process requirements of parts 488 and 489. Our review and
evaluation of AAAHC'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, AAAHC has revised its
standards and certification processes in order to meet the requirements
at:
Sec. 416.44(b)(1), to ensure its standards appropriately
reference Life Safety Code requirements;
Sec. 416.44(c), to ensure its standards appropriately
reference Life Safety Code requirements;
Sec. 416.44(c)(1)(iv), to ensure its standards
appropriately reference Life Safety Code requirements;
Sec. 488.5(a)(4)(ii), to ensure comparability of AAAHC'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)(iv), to ensure all identified areas of
non-compliance are clearly documented and cited appropriately in the
final survey report.
Sec. 488.5(a)(7) through (9), to ensure its surveyors are
appropriately qualified, trained and maintain competence during
extended periods of time without conducting a survey;
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. 488.18(a), to ensure that the findings are
documented and written within the principles of documentation.
Sec. 488.26(b), 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.
Sec. 489.13(c), to ensure that all accreditation
requirements have been met before granting accreditation and making a
recommendation for participation or continued participation in the
Medicare program 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 AAAHC as a national accreditation
organization for ASCs that request participation in the Medicare
program, effective December 20, 2018 through December 20, 2024.
V. Collection of Information Requirements
This document does not impose information collection requirements,
that is, reporting, recordkeeping or third-party disclosure
requirements. Consequently, there is no need for review by the Office
of Management and Budget under the authority of the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.).
Dated: December 14, 2018.
Seema Verma,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2018-27592 Filed 12-20-18; 8:45 am]
BILLING CODE 4120-01-P
