[Federal Register Volume 79, Number 225 (Friday, November 21, 2014)]
[Notices]
[Pages 69481-69482]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-27649]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3305-PN]


Medicare and Medicaid Programs: Application From the American 
Association for Accreditation of Ambulatory Surgery Facilities for 
Continued Approval of Its Accreditation Program for Organizations That 
Provide Outpatient Physical Therapy and Speech Language Pathology 
Services

AGENCY: Centers for Medicare & Medicaid Services, HHS.

ACTION: Proposed notice.

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SUMMARY: This proposed notice acknowledges the receipt of an 
application from the American Association for Accreditation of 
Ambulatory Surgery Facilities for continued recognition as a national 
accrediting organization for organizations that provide outpatient 
physical therapy and speech language pathology services that wish to 
participate in the Medicare or Medicaid programs. The statute requires 
that within 60 days of receipt of an organization's complete 
application, we publish a notice that identifies the national 
accrediting body making the request, describes the nature of the 
request, and provides at least a 30-day public comment period.

DATES: To be assured consideration, comments must be received at one of 
the addresses provided below, no later than 5 p.m. on December 22, 
2014.

ADDRESSES: In commenting, refer to file code CMS-3305-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-3305-PN, P.O. Box 8016, 
Baltimore, MD 21244-1850.
    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-3305-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.

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 outpatient physical therapy and speech 
language pathology service (OPT) provided certain requirements are met. 
Section 1861(p) of the Social Security Act (the Act) establishes 
distinct criteria for facilities seeking designation as an OPT. 
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

[[Page 69482]]

at 42 CFR part 485, subpart H specify the minimum conditions that an 
OPT must meet to participate in the Medicare program.
    Generally, to enter into an agreement, an OPT must first be 
certified by a state survey agency as complying with the conditions or 
requirements set forth in part 485, subpart H of our Medicare 
regulations. Thereafter, the OPT is subject to regular surveys by a 
state survey agency to determine whether it continues to meet these 
requirements. There is an alternative, however, to surveys by state 
agencies.
    Section 1865(a)(1) of the Act provides that, if a provider entity 
demonstrates through accreditation by a CMS-approved national 
accrediting organization that all applicable Medicare conditions are 
met or exceeded, we may deem those provider entities as having met the 
requirements. Accreditation by an accrediting organization is voluntary 
and is not required for Medicare participation.
    If an accrediting organization is recognized by the Secretary of 
the Department of Health and Human Services (the Secretary) 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 
national accrediting organization applying for approval of its 
accreditation program under part 488, subpart A, must provide CMS with 
reasonable assurance that the accrediting organization requires the 
accredited provider entities to meet requirements that are at least as 
stringent as the Medicare conditions. Our regulations concerning the 
approval of accrediting organizations are set forth at Sec.  488.4 and 
Sec.  488.8(d)(3). The regulations at Sec.  488.8(d)(3) require 
accrediting organizations to reapply for continued approval of its 
accreditation program every 6 years or sooner as determined by CMS.
    The American Association for Accreditation of Ambulatory Surgery 
Facilities (AAAASF's) current term of approval for their OPT 
accreditation program expires April 22, 2015.

II. Approval of Deeming Organizations

    Section 1865(a)(2) of the Act and our regulations at Sec.  488.8(a) 
require that our findings concerning review and approval of a national 
accrediting organization's requirements consider, among other factors, 
the applying accrediting organization'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 us 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 approval of its OPT accreditation 
program. This notice also solicits public comment on whether AAAASF's 
requirements meet or exceed the Medicare conditions of participation 
(CoPs) for OPTs.

III. Evaluation of Deeming Authority Request

    AAAASF submitted all the necessary materials to enable us to make a 
determination concerning its request for continued approval of its OPT 
accreditation program. This application was determined to be complete 
on September 29, 2014. Under Section 1865(a)(2) of the Act and our 
regulations at Sec.  488.8 (Federal review of accrediting 
organizations), 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 OPTs as compared 
with Medicare's OPT CoPs.
     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 a OPT 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.  488.7(d).
--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 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 that CMS may request (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.

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: November 5, 2014.
Marilyn Tavenner,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2014-27649 Filed 11-20-14; 8:45 am]
BILLING CODE 4120-01-P