82 FR 27067 - 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

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

Federal Register Volume 82, Issue 112 (June 13, 2017)

Page Range		27067-27068
FR Document		2017-12193

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.

Federal Register, Volume 82 Issue 112 (Tuesday, June 13, 2017)

[Federal Register Volume 82, Number 112 (Tuesday, June 13, 2017)]
[Notices]
[Pages 27067-27068]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2017-12193]

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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

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 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-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: 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 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

27068 Federal Register / Vol. 82, No. 112 / Tuesday, June 13, 2017 / Notices

entities to meet requirements that are at ++ The comparability of AOA– with a subsequent document, we will
least as stringent as the Medicare HFAP’s processes to those of State respond to the comments in the
conditions. Our regulations concerning agencies, including survey frequency, preamble to that document.
the approval of AOs are set forth at and the ability to investigate and Dated: June 7, 2017.
§ 488.5. respond appropriately to complaints Seema Verma,
against accredited facilities.
II. CMS Approval of Accreditation Administrator, Centers for Medicare &
++ AOA–HFAP’s processes and
Organizations Medicaid Services.
procedures for monitoring an ASC
Section 1865(a)(2) of the Act and our [FR Doc. 2017–12193 Filed 6–12–17; 8:45 am]
found out of compliance with AOA–
regulations at § 488.5 require that our HFAP’s program requirements. These BILLING CODE 4120–01–P
findings concerning review and monitoring procedures are used only
approval of an AO’s requirements when AOA–HFAP identifies
consider, among other factors, the DEPARTMENT OF HEALTH AND
noncompliance. If noncompliance is
applying AO’s requirements for HUMAN SERVICES
identified through validation reviews or
accreditation; survey procedures; complaint surveys, the State survey National Institutes of Health
resources for conducting required agency monitors corrections as specified
surveys; capacity to furnish information at § 488.9(c)(1). Government-Owned Inventions;
for use in enforcement activities; ++ AOA–HFAP’s capacity to report Availability for Licensing
monitoring procedures for provider deficiencies to the surveyed facilities
entities found not in compliance with and respond to the facility’s plan of AGENCY: National Institutes of Health,
the conditions or requirements; and correction in a timely manner. HHS.
ability to provide CMS with the ++ AOA–HFAP’s capacity to provide ACTION: Notice.
necessary data for validation. CMS with electronic data and reports
Section 1865(a)(3)(A) of the Act necessary for effective validation and SUMMARY: The invention listed below is
further requires that we publish, within assessment of the organization’s survey owned by an agency of the U.S.
60 days of receipt of an organization’s process. Government and is available for
complete application, a notice ++ The adequacy of AOA–HFAP’s licensing to achieve expeditious
identifying the national accrediting staff and other resources, and its commercialization of results of
body making the request, describing the financial viability. federally-funded research and
nature of the request, and providing at ++ AOA–HFAP’s capacity to development. Foreign patent
least a 30-day public comment period. adequately fund required surveys. applications are filed on selected
We have 210 days from the receipt of a ++ AOA–HFAP’s policies with inventions to extend market coverage
complete application to publish notice respect to whether surveys are for companies and may also be available
of approval or denial of the application. announced or unannounced, to assure for licensing.
The purpose of this notice of that surveys are unannounced. FOR FURTHER INFORMATION CONTACT: Dr.
proposed recognition is to inform the ++ AOA–HFAP’s agreement to Natalie Greco, 301–761–7898;
public of the American Osteopathic provide CMS with a copy of the most Natalie.Greco@nih.gov. Licensing
Association/Healthcare Facilities current accreditation survey, together information and copies of the patent
Accreditation Program’s (AOA–HFAP’s) with any other information related to applications listed below may be
request for continued CMS approval of the survey as CMS may require obtained by communicating with the
its ASC accreditation program. This (including corrective action plans). indicated licensing contact at the
notice also solicits public comment on Upon completion of our evaluation, Technology Transfer and Intellectual
whether AOA–HFAP’s requirements including evaluation of comments Property Office, National Institute of
meet or exceed the Medicare conditions received as a result of this notice, we Allergy and Infectious Diseases, 5601
for coverage (CfCs) for ASCs. will publish a final notice in the Federal Fishers Lane, Rockville, MD 20852; tel.
Register announcing the result of our 301–496–2644. A signed Confidential
III. Evaluation of an AO’s Accreditation evaluation. Disclosure Agreement will be required
Program
IV. Collection of Information to receive copies of unpublished patent
AOA–HFAP submitted all the applications.
necessary materials to enable us to make Requirements
SUPPLEMENTARY INFORMATION:
a determination concerning its request This document does not impose
Technology description follows.
for continued CMS approval of its ASC information collection requirements,
accreditation program. This application that is, reporting, recordkeeping or Human and Veterinary Cancer
was determined to be complete on April third-party disclosure requirements. Therapeutic Agent Utilizing Anthrax
14, 2017. Under section 1865(a)(2) of the Consequently, there is no need for Toxin-Based Technology
Act and our regulations at § 488.5, our review by the Office of Management and
Description of Technology
review and evaluation of AOA–HFAP Budget under the authority of the
will be conducted in accordance with, Paperwork Reduction Act of 1995 (44 Due to the disorganized nature of
but not necessarily limited to, the U.S.C. 3501 et seq.). blood vessels that run through tumors,
following factors: chemotherapeutic agents often fail to
V. Response to Public Comments
• The equivalency of AOA–HFAP’s penetrate tumors and kill cancer cells at
standards for ASCs as compared with Because of the large number of public the tumor’s center. This can lead to
nlaroche on DSK30NT082PROD with NOTICES

Medicare’s CfCs for ASCs. comments we normally receive on ineffective chemotherapeutic
• AOA–HFAP’s survey process to Federal Register documents, we are not treatments, because tumors can quickly
determine the following: able to acknowledge or respond to them grow back if the entire tumor is not
++ The composition of the survey individually. We will consider all destroyed. NIH researchers have
team, surveyor qualifications, and the comments we receive by the date and developed a therapeutic agent that
ability of the organization to provide time specified in the DATES section of solves this problem facing current
continuing surveyor training. this preamble, and, when we proceed chemotherapy treatments. By elegantly

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Document Created: 2017-06-13 00:22:15
Document Modified: 2017-06-13 00:22:15

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		Monda Shaver, (410) 786-0310, Erin McCoy, (410) 786-2337, or Patricia Chmielewski, (410) 786-6899.
FR Citation		82 FR 27067

82 FR 27067 - 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

DEPARTMENT OF HEALTH AND HUMAN SERVICESCenters for Medicare & Medicaid Services

Federal Register Volume 82, Issue 112 (June 13, 2017)

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