83 FR 29120 - 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

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services

Federal Register Volume 83, Issue 121 (June 22, 2018)

Page Range		29120-29121
FR Document		2018-13435

This proposed notice acknowledges the receipt of an application from the American Association for Accreditation of Ambulatory Surgery Facilities, Inc. for continued recognition as a national accrediting organization for Ambulatory Surgical Centers that wish to participate in the Medicare or Medicaid programs.

Federal Register, Volume 83 Issue 121 (Friday, June 22, 2018)

[Federal Register Volume 83, Number 121 (Friday, June 22, 2018)]
[Notices]
[Pages 29120-29121]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2018-13435]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3358-PN]

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 and Medicaid Services, HHS.

ACTION: Notice with request for comment.

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SUMMARY: This proposed notice acknowledges the receipt of an
application from the American Association for Accreditation of
Ambulatory Surgery Facilities, Inc. for continued recognition as a
national accrediting organization for Ambulatory Surgical Centers that
wish to participate in the Medicare or Medicaid programs.

DATES: To be assured consideration, comments must be received at one of
the addresses provided below, no later than 5 p.m. on July 23, 2018.

ADDRESSES: In commenting, refer to file code CMS-3358-PN. Because of
staff and resource limitations, we cannot accept comments by facsimile
(FAX) transmission.
Comments, including mass comment submissions, must be submitted in
one of the following three ways (please choose only one of the ways
listed):
1. Electronically. You may submit electronic comments on this
regulation to http://www.regulations.gov. Follow the ``Submit a
comment'' instructions.
2. By regular mail. You may mail written comments to the following
address ONLY: Centers for Medicare & Medicaid Services, Department of
Health and Human Services, Attention: CMS-3358-PN, P.O. Box 8010,
Baltimore, MD 21244-8010.
Please allow sufficient time for mailed comments to be received
before the close of the comment period.
3. By express or overnight mail. You may send written comments to
the following address ONLY: Centers for Medicare & Medicaid Services,
Department of Health and Human Services, Attention: CMS-3358-PN, Mail
Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
For information on viewing public comments, see the beginning of
the SUPPLEMENTARY INFORMATION section.

FOR FURTHER INFORMATION CONTACT:
Erin McCoy, (410) 786-2337.
Monda Shaver, (410) 786-3410.
Marie Vasbinder, (410) 786-8665.

SUPPLEMENTARY INFORMATION:
Inspection of Public Comments: All comments received before the
close of the comment period are available for viewing by the public,
including any personally identifiable or confidential business
information that is included in a comment. We post all comments
received before the close of the comment period on the following
website as soon as possible after they have been received: http://www.regulations.gov. Follow the search instructions on that website to
view public comments.

I. Background

Under the Medicare program, eligible beneficiaries may receive
covered services from an Ambulatory Surgical Center (ASC) provided
certain requirements are met. Section 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 by a State survey agency as complying with the conditions or
requirements set forth in part 416 of our Medicare regulations.
Thereafter, the ASC is subject to regular surveys by a State survey
agency to determine whether it continues to meet these requirements.
Section 1865(a)(1) of the Act provides that, if a provider entity
demonstrates through accreditation by a Centers for Medicare & Medicaid
Services (CMS) approved national accrediting organization (AO) that all
applicable Medicare conditions are met or exceeded, we may deem those
provider entities as having met the requirements. Accreditation by an
AO is voluntary and is not required for Medicare participation.
If an AO is recognized by the Secretary of the Department of Health
and Human Services as having standards for accreditation that meet or
exceed Medicare requirements, any provider entity accredited by the
national accrediting body's approved program may be deemed to meet the
Medicare conditions. An AO applying

[[Page 29121]]

for approval of its accreditation program under part 488, subpart A,
must provide CMS with reasonable assurance that the AO requires the
accredited provider entities to meet requirements that are at least as
stringent as the Medicare conditions. Our regulations concerning the
approval of AOs are set forth at Sec. 488.5.
The American Association for Accreditation of Ambulatory Surgery
Facilities, Inc.'s (AAAASF's) current term of approval for its ASC
program expires November 27, 2018.

II. Provisions of the Proposed Notice

A. Approval of Deeming Organizations

Section 1865(a)(2) of the Act and our regulations at Sec. 488.5
require that our findings concerning review and approval of an AO's
requirements consider, among other factors, the applying AO's
requirements for accreditation; survey procedures; resources for
conducting required surveys; capacity to furnish information for use in
enforcement activities; monitoring procedures for provider entities
found not in compliance with the conditions or requirements; and
ability to provide CMS with the necessary data for validation.
Section 1865(a)(3)(A) of the Act further 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 notice of approval or denial of the application.
The purpose of this proposed notice is to inform the public of
AAAASF's request for continued CMS-approval of its ASC accreditation
program. This notice also solicits public comment on whether AAAASF's
requirements meet or exceed the Medicare conditions for coverage (CfCs)
for ASCs.

B. Evaluation of Deeming Authority Request

AAAASF submitted all the necessary materials to enable us to make a
determination concerning its request for continued CMS-approval of its
ASC accreditation program. This application was determined to be
complete on May 1, 2018. Under Section 1865(a)(2) of the Act and our
regulations at Sec. 488.5, our review and evaluation of AAAASF will be
conducted in accordance with, but not necessarily limited to, the
following factors:
The equivalency of AAAASF's standards for ASCs as compared
with Medicare's CfCs for ASCs.
AAAASF's survey process to determine the following:
++ The composition of the survey team, surveyor qualifications, and
the ability of the organization to provide continuing surveyor
training.
++ The comparability of AAAASF's processes to those of State
agencies, including survey frequency, and the ability to investigate
and respond appropriately to complaints against accredited facilities.
++ AAAASF's processes and procedures for monitoring an ASC found
out of compliance with AAAASF's program requirements. These monitoring
procedures are used only when AAAASF identifies noncompliance. If
noncompliance is identified through validation reviews or complaint
surveys, the State survey agency monitors corrections as specified at
Sec. 488.9(c)(1).
++ AAAASF's capacity to report deficiencies to the surveyed
facilities and respond to the facility's plan of correction in a timely
manner.
++ AAAASF's capacity to provide CMS with electronic data and
reports necessary for effective validation and assessment of the
organization's survey process.
++ The adequacy of AAAASF's staff and other resources, and its
financial viability.
++ AAAASF's capacity to adequately fund required surveys.
++ AAAASF's policies with respect to whether surveys are announced
or unannounced, to assure that surveys are unannounced.
++ 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 CMS may require (including corrective action
plans).

C. Notice Upon Completion of Evaluation

Upon completion of our evaluation, including evaluation of public
comments received as a result of this notice, we will publish a final
notice in the Federal Register announcing the result of our evaluation.

III. 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. Chapter 35).

IV. Response to Public Comments

Because of the large number of public comments we normally receive
on Federal Register documents, we are not able to acknowledge or
respond to them individually. We will consider all comments we receive
by the date and time specified in the DATES section of this preamble,
and, when we proceed with a subsequent document, we will respond to the
comments in the preamble to that document.
Upon completion of our evaluation, including evaluation of comments
received as a result of this notice, we will publish a final notice in
the Federal Register announcing the result of our evaluation.

Dated: May 29, 2018.
Seema Verma,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2018-13435 Filed 6-21-18; 8:45 am]
BILLING CODE P

Federal Register / Vol. 83, No. 121 / Friday, June 22, 2018 / Notices 29121

for approval of its accreditation program • AAAASF’s survey process to IV. Response to Public Comments
under part 488, subpart A, must provide determine the following:
CMS with reasonable assurance that the ++ The composition of the survey Because of the large number of public
AO requires the accredited provider team, surveyor qualifications, and the comments we normally receive on
entities to meet requirements that are at ability of the organization to provide Federal Register documents, we are not
least as stringent as the Medicare continuing surveyor training. able to acknowledge or respond to them
conditions. Our regulations concerning ++ The comparability of AAAASF’s individually. We will consider all
the approval of AOs are set forth at processes to those of State agencies, comments we receive by the date and
§ 488.5. including survey frequency, and the time specified in the DATES section of
The American Association for ability to investigate and respond this preamble, and, when we proceed
Accreditation of Ambulatory Surgery appropriately to complaints against with a subsequent document, we will
Facilities, Inc.’s (AAAASF’s) current accredited facilities. respond to the comments in the
term of approval for its ASC program ++ AAAASF’s processes and preamble to that document.
expires November 27, 2018. procedures for monitoring an ASC Upon completion of our evaluation,
II. Provisions of the Proposed Notice found out of compliance with including evaluation of comments
AAAASF’s program requirements. received as a result of this notice, we
A. Approval of Deeming Organizations These monitoring procedures are used will publish a final notice in the Federal
Section 1865(a)(2) of the Act and our only when AAAASF identifies Register announcing the result of our
regulations at § 488.5 require that our noncompliance. If noncompliance is evaluation.
findings concerning review and identified through validation reviews or Dated: May 29, 2018.
approval of an AO’s requirements complaint surveys, the State survey Seema Verma,
consider, among other factors, the agency monitors corrections as specified Administrator, Centers for Medicare &
applying AO’s requirements for at § 488.9(c)(1). Medicaid Services.
accreditation; survey procedures; ++ AAAASF’s capacity to report [FR Doc. 2018–13435 Filed 6–21–18; 8:45 am]
resources for conducting required deficiencies to the surveyed facilities BILLING CODE P
surveys; capacity to furnish information and respond to the facility’s plan of
for use in enforcement activities; correction in a timely manner.
monitoring procedures for provider ++ AAAASF’s capacity to provide DEPARTMENT OF HEALTH AND
entities found not in compliance with CMS with electronic data and reports HUMAN SERVICES
the conditions or requirements; and necessary for effective validation and
ability to provide CMS with the assessment of the organization’s survey Centers for Medicare & Medicaid
necessary data for validation. process. Services
Section 1865(a)(3)(A) of the Act ++ The adequacy of AAAASF’s staff
further requires that we publish, within and other resources, and its financial [CMS–7050–N2]
60 days of receipt of an organization’s viability.
complete application, a notice ++ AAAASF’s capacity to adequately Medicare & Medicaid Programs, and
identifying the national accrediting Other Program Initiatives, and
fund required surveys.
body making the request, describing the Priorities; Meeting of the Advisory
++ AAAASF’s policies with respect to
nature of the request, and providing at Panel on Outreach and Education
whether surveys are announced or
least a 30-day public comment period. (APOE), June 20, 2018
unannounced, to assure that surveys are
We have 210 days from the receipt of a
unannounced.
complete application to publish notice AGENCY: Centers for Medicare &
of approval or denial of the application. ++ AAAASF’s agreement to provide
CMS with a copy of the most current Medicaid Services (CMS), HHS.
The purpose of this proposed notice
is to inform the public of AAAASF’s accreditation survey together with any ACTION: Cancellation of meeting.
request for continued CMS-approval of other information related to the survey
its ASC accreditation program. This as CMS may require (including SUMMARY: On June 1, 2018, we
notice also solicits public comment on corrective action plans). published a Federal Register notice (83
whether AAAASF’s requirements meet C. Notice Upon Completion of FR 25461) announcing a new meeting of
or exceed the Medicare conditions for Evaluation the Advisory Panel on Outreach and
coverage (CfCs) for ASCs. Education (APOE) (the Panel), which
Upon completion of our evaluation, was scheduled for Wednesday, June 20,
B. Evaluation of Deeming Authority including evaluation of public 2018. This notice announces the
Request comments received as a result of this cancellation of the June 20, 2018
AAAASF submitted all the necessary notice, we will publish a final notice in meeting.
materials to enable us to make a the Federal Register announcing the
determination concerning its request for result of our evaluation. FOR FURTHER INFORMATION CONTACT:
continued CMS-approval of its ASC Lynne Johnson, Acting Designated
III. Collection of Information Federal Official, Office of
accreditation program. This application Requirements
was determined to be complete on May Communications, CMS, 7500 Security
1, 2018. Under Section 1865(a)(2) of the This document does not impose Boulevard, Mail Stop S1–05–06,
Act and our regulations at § 488.5, our information collection requirements, Baltimore, MD 21244, 410–786–0897,
daltland on DSKBBV9HB2PROD with NOTICES

review and evaluation of AAAASF will that is, reporting, recordkeeping or email Lynne.Johnson@cms.hhs.gov.
be conducted in accordance with, but third-party disclosure requirements. Additional information about the APOE
not necessarily limited to, the following Consequently, there is no need for is available on the internet at: http://
factors: review by the Office of Management and www.cms.gov/Regulations-and-
• The equivalency of AAAASF’s Budget under the authority of the Guidance/Guidance/FACA/APOE.html.
standards for ASCs as compared with Paperwork Reduction Act of 1995 (44 Press inquiries are handled through the
Medicare’s CfCs for ASCs. U.S.C. Chapter 35). CMS Press Office at (202) 690–6145.

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Document Created: 2018-11-06 09:50:57
Document Modified: 2018-11-06 09:50:57

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice with request for comment.
Dates		To be assured consideration, comments must be received at one of
Contact		Erin McCoy, (410) 786-2337.
FR Citation		83 FR 29120

83 FR 29120 - 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

DEPARTMENT OF HEALTH AND HUMAN SERVICESCenters for Medicare & Medicaid Services

Federal Register Volume 83, Issue 121 (June 22, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services