[Federal Register Volume 83, Number 210 (Tuesday, October 30, 2018)]
[Notices]
[Pages 54591-54593]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-23611]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-3369-PN]
Medicare and Medicaid Programs: Application From the American
Association for Accreditation of Ambulatory Surgery Facilities, Inc.
(AAAASF) for Continued CMS-Approval of Its Outpatient Physical Therapy
and Speech Language Pathology Services Accreditation Program
AGENCY: Centers for Medicare and Medicaid Services (CMS), 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. (AAAASF) for continued recognition
as a national accrediting organization (AO) for clinics, rehabilitation
agencies, or public health agencies that furnish outpatient physical
therapy and speech language pathology services 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 November 29,
2018.
[[Page 54592]]
ADDRESSES: In commenting, please refer to file code CMS-3369-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-3369-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-3369-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, or Renee Henry, (410) 786-7828.
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 section 1861(p) of the Medicare statute, eligible
beneficiaries may receive outpatient physical therapy and speech
language pathology (OPT) services from a provider of services, a
clinic, rehabilitation agency, a public health agency, or others,
provided certain requirements are met. Section 1832(a)(2)(C) of the
Social Security Act (the Act) permits payment for OPT services.
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
485 subpart H specify the conditions that a clinic, rehabilitation
agency or public health agency (``OPT providers'') must meet in order
to participate in the Medicare program, the scope of covered services,
and the conditions for Medicare payment for OPT providers.
Generally, to enter into an agreement, an OPT provider must first
be certified by a State survey agency as complying with the conditions
of participation set forth in part 485, subpart H of our Medicare
regulations. Thereafter, the OPT provider 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 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.
AAAASF's current term of approval for its OPT provider
accreditation program expires April 4, 2019.
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 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 OPT provider
accreditation program. This proposed notice also solicits public
comment on whether AAAASF's requirements meet or exceed the Medicare
conditions of participation (CoPs) for OPT providers.
III. Evaluation of an AO's Accreditation Program
AAAASF submitted all the necessary materials to enable us to make a
determination concerning its request for continued CMS-approval of its
OPT provider accreditation program. This application was determined to
be complete on September 6, 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 OPT providers as
compared with Medicare's CoPs for OPT providers.
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 OPT provider
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.
[[Page 54593]]
++ 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).
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 proposed notice, we will publish a final
notice in the Federal Register announcing the result of our evaluation.
Dated: October 19, 2018.
Seema Verma,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2018-23611 Filed 10-29-18; 8:45 am]
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