Medicare and Medicaid Programs: Application From the American Osteopathic Association/Healthcare Facilities Accreditation Program (AOA-HFAP) for Continued CMS Approval of Its Ambulatory Surgical Center Accreditation Program, 27067-27068 [2017-12193]
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Federal Register / Vol. 82, No. 112 / Tuesday, June 13, 2017 / Notices
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ATSDR–2014–0002.
Pamela I. Protzel Berman,
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[FR Doc. 2017–12161 Filed 6–12–17; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–3343–PN]
Medicare and Medicaid Programs:
Application From the American
Osteopathic Association/Healthcare
Facilities Accreditation Program
(AOA–HFAP) for Continued CMS
Approval of Its Ambulatory Surgical
Center Accreditation Program
Centers for Medicare and
Medicaid Services, HHS.
ACTION: Notice with request for
comment.
AGENCY:
This proposed notice
acknowledges the receipt of an
application from the American
Osteopathic Association/Healthcare
Facilities Accreditation Program (AOA–
HFAP) 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 13, 2017.
ADDRESSES: In commenting, please refer
to file code CMS–3343–PN. Because of
staff and resource limitations, we cannot
accept comments by facsimile (FAX)
transmission.
You may submit comments in one of
four ways (please choose only one of the
ways listed):
1. Electronically. You may submit
electronic comments on this regulation
to https://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–3343–PN, P.O. Box 8010,
Baltimore, MD 21244–8010.
nlaroche on DSK30NT082PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
14:58 Jun 12, 2017
Jkt 241001
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–3343–PN,
Mail Stop C4–26–05, 7500 Security
Boulevard, Baltimore, MD 21244–1850.
4. By hand or courier. Alternatively,
you may deliver (by hand or courier)
your written comments ONLY to the
following addresses:
a. For delivery in Washington, DC—
Centers for Medicare & Medicaid
Services, Department of Health and
Human Services, Room 445–G, Hubert
H. Humphrey Building, 200
Independence Avenue SW.,
Washington, DC 20201.
(Because access to the interior of the
Hubert H. Humphrey Building is not
readily available to persons without
Federal government identification,
commenters are encouraged to leave
their comments in the CMS drop slots
located in the main lobby of the
building. A stamp-in clock is available
for persons wishing to retain a proof of
filing by stamping in and retaining an
extra copy of the comments being filed.)
b. For delivery in Baltimore, MD—
Centers for Medicare & Medicaid
Services, Department of Health and
Human Services, 7500 Security
Boulevard, Baltimore, MD 21244–1850.
If you intend to deliver your
comments to the Baltimore address, call
telephone number (410) 786–9994 in
advance to schedule your arrival with
one of our staff members.
Comments erroneously mailed to the
addresses indicated as appropriate for
hand or courier delivery may be delayed
and received after the comment period.
For information on viewing public
comments, see the beginning of the
SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT:
Monda Shaver, (410) 786–0310, Erin
McCoy, (410) 786–2337, or Patricia
Chmielewski, (410) 786–6899.
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 Web
site as soon as possible after they have
been received: https://
www.regulations.gov. Follow the search
PO 00000
Frm 00032
Fmt 4703
Sfmt 4703
27067
instructions on that Web site to view
public comments.
Comments received timely will also
be available for public inspection as
they are received, generally beginning
approximately 3 weeks after publication
of a document, at the headquarters of
the Centers for Medicare & Medicaid
Services, 7500 Security Boulevard,
Baltimore, Maryland 21244, Monday
through Friday of each week from 8:30
a.m. to 4 p.m. To schedule an
appointment to view public comments,
phone 1–800–743–3951.
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
for approval of its accreditation program
under part 488, subpart A, must provide
CMS with reasonable assurance that the
AO requires the accredited provider
E:\FR\FM\13JNN1.SGM
13JNN1
27068
Federal Register / Vol. 82, No. 112 / Tuesday, June 13, 2017 / Notices
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
§ 488.5.
nlaroche on DSK30NT082PROD with NOTICES
II. CMS Approval of Accreditation
Organizations
Section 1865(a)(2) of the Act and our
regulations at § 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 notice of
proposed recognition is to inform the
public of the American Osteopathic
Association/Healthcare Facilities
Accreditation Program’s (AOA–HFAP’s)
request for continued CMS approval of
its ASC accreditation program. This
notice also solicits public comment on
whether AOA–HFAP’s requirements
meet or exceed the Medicare conditions
for coverage (CfCs) for ASCs.
III. Evaluation of an AO’s Accreditation
Program
AOA–HFAP 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 April
14, 2017. Under section 1865(a)(2) of the
Act and our regulations at § 488.5, our
review and evaluation of AOA–HFAP
will be conducted in accordance with,
but not necessarily limited to, the
following factors:
• The equivalency of AOA–HFAP’s
standards for ASCs as compared with
Medicare’s CfCs for ASCs.
• AOA–HFAP’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.
VerDate Sep<11>2014
14:58 Jun 12, 2017
Jkt 241001
++ The comparability of AOA–
HFAP’s processes to those of State
agencies, including survey frequency,
and the ability to investigate and
respond appropriately to complaints
against accredited facilities.
++ AOA–HFAP’s processes and
procedures for monitoring an ASC
found out of compliance with AOA–
HFAP’s program requirements. These
monitoring procedures are used only
when AOA–HFAP identifies
noncompliance. If noncompliance is
identified through validation reviews or
complaint surveys, the State survey
agency monitors corrections as specified
at § 488.9(c)(1).
++ AOA–HFAP’s capacity to report
deficiencies to the surveyed facilities
and respond to the facility’s plan of
correction in a timely manner.
++ AOA–HFAP’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 AOA–HFAP’s
staff and other resources, and its
financial viability.
++ AOA–HFAP’s capacity to
adequately fund required surveys.
++ AOA–HFAP’s policies with
respect to whether surveys are
announced or unannounced, to assure
that surveys are unannounced.
++ AOA–HFAP’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).
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.
IV. 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.).
V. 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
PO 00000
Frm 00033
Fmt 4703
Sfmt 4703
with a subsequent document, we will
respond to the comments in the
preamble to that document.
Dated: June 7, 2017.
Seema Verma,
Administrator, Centers for Medicare &
Medicaid Services.
[FR Doc. 2017–12193 Filed 6–12–17; 8:45 am]
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[Federal Register Volume 82, Number 112 (Tuesday, June 13, 2017)]
[Notices]
[Pages 27067-27068]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-12193]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-3343-PN]
Medicare and Medicaid Programs: Application From the American
Osteopathic Association/Healthcare Facilities Accreditation Program
(AOA-HFAP) for Continued CMS Approval of Its Ambulatory Surgical Center
Accreditation Program
AGENCY: Centers for Medicare and Medicaid Services, HHS.
ACTION: Notice with request for comment.
-----------------------------------------------------------------------
SUMMARY: This proposed notice acknowledges the receipt of an
application from the American Osteopathic Association/Healthcare
Facilities Accreditation Program (AOA-HFAP) 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 13, 2017.
ADDRESSES: In commenting, please refer to file code CMS-3343-PN.
Because of staff and resource limitations, we cannot accept comments by
facsimile (FAX) transmission.
You may submit comments in one of four ways (please choose only one
of the ways listed):
1. Electronically. You may submit electronic comments on this
regulation to https://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-3343-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-3343-PN, Mail
Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
4. By hand or courier. Alternatively, you may deliver (by hand or
courier) your written comments ONLY to the following addresses:
a. For delivery in Washington, DC--Centers for Medicare & Medicaid
Services, Department of Health and Human Services, Room 445-G, Hubert
H. Humphrey Building, 200 Independence Avenue SW., Washington, DC
20201.
(Because access to the interior of the Hubert H. Humphrey Building
is not readily available to persons without Federal government
identification, commenters are encouraged to leave their comments in
the CMS drop slots located in the main lobby of the building. A stamp-
in clock is available for persons wishing to retain a proof of filing
by stamping in and retaining an extra copy of the comments being
filed.)
b. For delivery in Baltimore, MD--Centers for Medicare & Medicaid
Services, Department of Health and Human Services, 7500 Security
Boulevard, Baltimore, MD 21244-1850.
If you intend to deliver your comments to the Baltimore address,
call telephone number (410) 786-9994 in advance to schedule your
arrival with one of our staff members.
Comments erroneously mailed to the addresses indicated as
appropriate for hand or courier delivery may be delayed and received
after the comment period.
For information on viewing public comments, see the beginning of
the SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT: Monda Shaver, (410) 786-0310, Erin
McCoy, (410) 786-2337, or Patricia Chmielewski, (410) 786-6899.
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 Web
site as soon as possible after they have been received: https://www.regulations.gov. Follow the search instructions on that Web site to
view public comments.
Comments received timely will also be available for public
inspection as they are received, generally beginning approximately 3
weeks after publication of a document, at the headquarters of the
Centers for Medicare & Medicaid Services, 7500 Security Boulevard,
Baltimore, Maryland 21244, Monday through Friday of each week from 8:30
a.m. to 4 p.m. To schedule an appointment to view public comments,
phone 1-800-743-3951.
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 for approval of its accreditation
program under part 488, subpart A, must provide CMS with reasonable
assurance that the AO requires the accredited provider
[[Page 27068]]
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.
II. CMS Approval of Accreditation 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 notice of proposed recognition is to inform the
public of the American Osteopathic Association/Healthcare Facilities
Accreditation Program's (AOA-HFAP's) request for continued CMS approval
of its ASC accreditation program. This notice also solicits public
comment on whether AOA-HFAP's requirements meet or exceed the Medicare
conditions for coverage (CfCs) for ASCs.
III. Evaluation of an AO's Accreditation Program
AOA-HFAP 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 April 14, 2017. Under section 1865(a)(2) of the Act and our
regulations at Sec. 488.5, our review and evaluation of AOA-HFAP will
be conducted in accordance with, but not necessarily limited to, the
following factors:
The equivalency of AOA-HFAP's standards for ASCs as
compared with Medicare's CfCs for ASCs.
AOA-HFAP'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 AOA-HFAP's processes to those of State
agencies, including survey frequency, and the ability to investigate
and respond appropriately to complaints against accredited facilities.
++ AOA-HFAP's processes and procedures for monitoring an ASC found
out of compliance with AOA-HFAP's program requirements. These
monitoring procedures are used only when AOA-HFAP 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).
++ AOA-HFAP's capacity to report deficiencies to the surveyed
facilities and respond to the facility's plan of correction in a timely
manner.
++ AOA-HFAP'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 AOA-HFAP's staff and other resources, and its
financial viability.
++ AOA-HFAP's capacity to adequately fund required surveys.
++ AOA-HFAP's policies with respect to whether surveys are
announced or unannounced, to assure that surveys are unannounced.
++ AOA-HFAP'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).
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.
IV. 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.).
V. 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.
Dated: June 7, 2017.
Seema Verma,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2017-12193 Filed 6-12-17; 8:45 am]
BILLING CODE 4120-01-P