80 FR 75866 - Medicare and Medicaid Programs: Application From the Institute for Medical Quality for Initial CMS-Approval of Its Ambulatory Surgical Center Accreditation Program

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

Federal Register Volume 80, Issue 233 (December 4, 2015)

Page Range		75866-75867
FR Document		2015-30316

This proposed notice acknowledges the receipt of an application from the Institute for Medical Quality (IMQ) for recognition as a national accrediting organization (NAO) for Ambulatory Surgical Centers (ASCs) that wish to participate in the Medicare or Medicaid programs.

Federal Register, Volume 80 Issue 233 (Friday, December 4, 2015)

[Federal Register Volume 80, Number 233 (Friday, December 4, 2015)]
[Notices]
[Pages 75866-75867]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2015-30316]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3329-PN]

Medicare and Medicaid Programs: Application From the Institute
for Medical Quality for Initial CMS-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 Institute for Medical Quality (IMQ) for
recognition as a national accrediting organization (NAO) for Ambulatory
Surgical Centers (ASCs) 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 January 4, 2016.

ADDRESSES: In commenting, please refer to file code CMS-3329-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 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-3329-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-3329-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 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: Cindy Melanson, (410) 786-0310.
Patricia Chmielewski, (410) 786-6899. 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 Web
site as soon as possible after they have been received: http://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

[[Page 75867]]

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 (NAO) that
all applicable Medicare conditions are met or exceeded, we may deem
those provider entities as having met the requirements. Accreditation
by an NAO is voluntary and is not required for Medicare participation.
If an NAO 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. A NAO applying for approval of its
accreditation program under part 488, subpart A, must provide CMS with
reasonable assurance that the NAO requires the accredited provider
entities to meet requirements that are at least as stringent as the
Medicare conditions. Our regulations concerning the approval of NAOs
are set forth at Sec. 488.5.

II. 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 a NAO's
requirements consider, among other factors, the applying NAO'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 the
Institute for Medical Quality (IMQ's) request for initial CMS-approval
of its ASC accreditation program. This notice also solicits public
comment on whether IMQ's requirements meet or exceed the Medicare
conditions for coverage (CfCs) for ASCs.

III. Evaluation of a NAO's Accreditation Program

IMQ submitted all the necessary materials to enable us to make a
determination concerning its request for initial CMS-approval of its
ASC accreditation program. This application was determined to be
complete on October 8, 2015. Under Section 1865(a)(2) of the Act and
our regulations at Sec. 488.5, our review and evaluation of IMQ will
be conducted in accordance with, but not necessarily limited to, the
following factors:
The equivalency of IMQ's standards for ASCs as compared
with Medicare's CfCsf or ASCs.
IMQ'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 IMQ's processes to those of State agencies,
including survey frequency, and the ability to investigate and respond
appropriately to complaints against accredited facilities.
++ IMQ's processes and procedures for monitoring an ASC found out
of compliance with IMQ's program requirements. These monitoring
procedures are used only when IMQ 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).
++ IMQ's capacity to report deficiencies to the surveyed facilities
and respond to the facility's plan of correction in a timely manner.
++ IMQ'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 IMQ's staff and other resources, and its
financial viability.
++ IMQ's capacity to adequately fund required surveys.
++ IMQ's policies with respect to whether surveys are announced or
unannounced, to assure that surveys are unannounced.
++ IMQ'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).

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.
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: November 18, 2015.
Andrew M. Slavitt,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2015-30316 Filed 12-3-15; 8:45 am]
BILLING CODE 4120-01-P

Federal Register / Vol. 80, No. 233 / Friday, December 4, 2015 / Notices 75867

conditions that an ASC must meet in We have 210 days from the receipt of a unannounced, to assure that surveys are
order to participate in the Medicare complete application to publish notice unannounced.
program, the scope of covered services, of approval or denial of the application. ++ IMQ’s agreement to provide CMS
and the conditions for Medicare The purpose of this proposed notice with a copy of the most current
payment for ASCs. is to inform the public of the Institute accreditation survey together with any
Generally, to enter into an agreement, for Medical Quality (IMQ’s) request for other information related to the survey
an ASC must first be certified by a State initial CMS-approval of its ASC as CMS may require (including
survey agency as complying with the accreditation program. This notice also corrective action plans).
conditions or requirements set forth in solicits public comment on whether
part 416 of our Medicare regulations. IV. Collection of Information
IMQ’s requirements meet or exceed the
Thereafter, the ASC is subject to regular Requirements
Medicare conditions for coverage (CfCs)
surveys by a State survey agency to for ASCs. This document does not impose
determine whether it continues to meet information collection requirements,
these requirements. III. Evaluation of a NAO’s that is, reporting, recordkeeping or
Section 1865(a)(1) of the Act provides Accreditation Program third-party disclosure requirements.
that, if a provider entity demonstrates IMQ submitted all the necessary Consequently, there is no need for
through accreditation by a Centers for materials to enable us to make a review by the Office of Management and
Medicare & Medicaid Services (CMS) determination concerning its request for Budget under the authority of the
approved national accrediting initial CMS-approval of its ASC Paperwork Reduction Act of 1995 (44
organization (NAO) that all applicable accreditation program. This application U.S.C. 3501 et seq.).
Medicare conditions are met or was determined to be complete on
exceeded, we may deem those provider V. Response to Public Comments
October 8, 2015. Under Section
entities as having met the requirements. 1865(a)(2) of the Act and our regulations Because of the large number of public
Accreditation by an NAO is voluntary at § 488.5, our review and evaluation of comments we normally receive on
and is not required for Medicare IMQ will be conducted in accordance Federal Register documents, we are not
participation. with, but not necessarily limited to, the able to acknowledge or respond to them
If an NAO is recognized by the following factors: individually. We will consider all
Secretary of the Department of Health • The equivalency of IMQ’s standards comments we receive by the date and
and Human Services as having for ASCs as compared with Medicare’s time specified in the DATES section of
standards for accreditation that meet or CfCsf or ASCs. this preamble, and, when we proceed
exceed Medicare requirements, any • IMQ’s survey process to determine with a subsequent document, we will
provider entity accredited by the the following: respond to the comments in the
national accrediting body’s approved ++ The composition of the survey preamble to that document.
program may be deemed to meet the team, surveyor qualifications, and the Upon completion of our evaluation,
Medicare conditions. A NAO applying ability of the organization to provide including evaluation of comments
for approval of its accreditation program continuing surveyor training. received as a result of this notice, we
under part 488, subpart A, must provide ++ The comparability of IMQ’s will publish a final notice in the Federal
CMS with reasonable assurance that the processes to those of State agencies, Register announcing the result of our
NAO requires the accredited provider including survey frequency, and the evaluation.
entities to meet requirements that are at ability to investigate and respond Dated: November 18, 2015.
least as stringent as the Medicare appropriately to complaints against Andrew M. Slavitt,
conditions. Our regulations concerning accredited facilities. Acting Administrator, Centers for Medicare
the approval of NAOs are set forth at ++ IMQ’s processes and procedures & Medicaid Services.
§ 488.5. for monitoring an ASC found out of
[FR Doc. 2015–30316 Filed 12–3–15; 8:45 am]
compliance with IMQ’s program
II. Approval of Deeming Organizations BILLING CODE 4120–01–P
requirements. These monitoring
Section 1865(a)(2) of the Act and our procedures are used only when IMQ
regulations at § 488.5 require that our identifies noncompliance. If
findings concerning review and DEPARTMENT OF HEALTH AND
noncompliance is identified through HUMAN SERVICES
approval of a NAO’s requirements validation reviews or complaint
consider, among other factors, the surveys, the State survey agency Food and Drug Administration
applying NAO’s requirements for monitors corrections as specified at
accreditation; survey procedures; § 488.9(c)(1). [Docket No. FDA–2015–N–4399]
resources for conducting required ++ IMQ’s capacity to report
surveys; capacity to furnish information Determination That OPHTHAINE
deficiencies to the surveyed facilities
for use in enforcement activities; (proparacaine hydrochloride) Solution
and respond to the facility’s plan of
monitoring procedures for provider and Other Drug Products Were Not
correction in a timely manner.
entities found not in compliance with ++ IMQ’s capacity to provide CMS Withdrawn From Sale for Reasons of
the conditions or requirements; and with electronic data and reports Safety or Effectiveness
ability to provide CMS with the necessary for effective validation and AGENCY: Food and Drug Administration,
necessary data for validation.
asabaliauskas on DSK5VPTVN1PROD with NOTICES

assessment of the organization’s survey HHS.
Section 1865(a)(3)(A) of the Act process. ACTION: Notice.
further requires that we publish, within ++ The adequacy of IMQ’s staff and
60 days of receipt of an organization’s other resources, and its financial SUMMARY: The Food and Drug
complete application, a notice viability. Administration (FDA or Agency) has
identifying the national accrediting ++ IMQ’s capacity to adequately fund determined that the drug products listed
body making the request, describing the required surveys. in this document were not withdrawn
nature of the request, and providing at ++ IMQ’s policies with respect to from sale for reasons of safety or
least a 30-day public comment period. whether surveys are announced or effectiveness. This determination means

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Document Created: 2015-12-14 13:52:38
Document Modified: 2015-12-14 13:52:38

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		Cindy Melanson, (410) 786-0310. Patricia Chmielewski, (410) 786-6899. Marie Vasbinder, (410) 786-8665.
FR Citation		80 FR 75866

80 FR 75866 - Medicare and Medicaid Programs: Application From the Institute for Medical Quality for Initial CMS-Approval of Its Ambulatory Surgical Center Accreditation Program

DEPARTMENT OF HEALTH AND HUMAN SERVICESCenters for Medicare & Medicaid Services

Federal Register Volume 80, Issue 233 (December 4, 2015)

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