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[Federal Register Volume 76, Number 93 (Friday, May 13, 2011)]
[Notices]
[Pages 28040-28042]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-11705]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare and Medicaid Services

[CMS-2375-PN]

Medicare and Medicaid Programs; Application by the Joint 
Commission for Continued Deeming Authority for Critical Access 
Hospitals

AGENCY: Centers for Medicare and Medicaid Services (CMS), HHS.

ACTION: Proposed Notice.

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SUMMARY: This proposed notice with comment period acknowledges the 
receipt of an application from the Joint Commission for continued 
recognition as a national accrediting organization for critical access 
hospitals (CAHs) that wish to participate in the Medicare or Medicaid 
programs. Section 1865(a)(3)(A) of the Social Security Act 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 June 13, 2011.

ADDRESSES: In commenting, please refer to file code CMS-2375-PN. 
Because of staff and resource limitations, we cannot accept comments by 
facsimile (FAX) transmission.
    You may submit comments in one of four ways (no duplicates, 
please):
    1. Electronically. You may submit electronic comments on specific 
issues in this regulation to http://www.cms.hhs.gov/eRulemaking. Click 
on the link ``Submit electronic comments on CMS regulations with an 
open comment period.'' (Attachments should be in Microsoft Word, 
WordPerfect, or Excel; however, we prefer Microsoft Word.)
    2. By regular mail. You may mail written comments (one original and 
two copies) to the following address ONLY:

Centers for Medicare & Medicaid Services, Department of Health and 
Human Services, Attention: CMS-2375-PN, P.O. Box 8016, Baltimore, MD 
21244-8016.

    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 (one 
original and two copies) to the following address ONLY: Centers for 
Medicare & Medicaid Services, Department of Health and Human Services, 
Attention: CMS-2375-PN, Mail Stop C4-26-05, 7500 Security Boulevard, 
Baltimore, MD 21244-1850.
    4. By hand or courier. If you prefer, you may deliver (by hand or 
courier) your written comments (one original and two copies) before the 
close of the comment period to one of the following addresses. If you 
intend to deliver your comments to the Baltimore address, please call 
telephone number (410) 786-9994 in advance to schedule your arrival 
with one of our staff members.
    Room 445-G, Hubert H. Humphrey Building, 200 Independence Avenue, 
SW., Washington, DC 20201; or 7500 Security Boulevard, Baltimore, MD 
21244-1850.
    (Because access to the interior of the HHH 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.)
    Comments 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: L. Tyler Whitaker, (410) 786-5236. 
Patricia Chmielewski, (410) 786-6899.

SUPPLEMENTARY INFORMATION:
    Submitting Comments: We welcome comments from the public on all 
issues set forth in this proposed notice to assist us in fully 
considering issues and developing policies. You can assist us by 
referencing the file code CMS-2375-PN and the specific ``issue 
identifier'' that precedes the section on which you choose to comment.
    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.cms.hhs.gov/eRulemaking. Click on the link ``Electronic Comments on 
CMS Regulations'' on that Web site to view public comments.
    Comments received timely will also be available for public 
inspection as

[[Page 28041]]

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 in a critical access hospital (CAH) provided certain 
requirements are met. Sections 1820(c)(2)(B) and 1861(mm) of the Social 
Security Act (the Act) establish distinct criteria for facilities 
seeking designation as a CAH. 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 F specify the 
conditions that a CAH must meet in order to participate in the Medicare 
program, and the scope of covered services. The conditions for Medicare 
payment for CAHs are set forth at Sec.  413.70.
    Generally, in order to enter into a provider agreement with the 
Medicare program, a CAH must first be certified by a State survey 
agency as complying with the conditions or requirements set forth in 
part 485, subpart F. Thereafter, the CAH 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 an approved national accrediting 
organization that all applicable Medicare conditions are met or 
exceeded, we will 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 as 
having standards for accreditation that meet or exceed Medicare 
requirements, any provider entity accredited by the national 
accrediting body's approved program would be deemed to meet the 
Medicare conditions. A national accrediting organization applying for 
deeming authority under part 488, subpart A must provide us 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. The regulations concerning the 
reapproval 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 deeming authority 
every six years or sooner as determined by us.
    The Joint Commission's term of approval as a recognized 
accreditation program for CAHs expires November 21, 2011.

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 reapproval 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 the 
Joint Commission's request for continued deeming authority for CAHs. 
This notice also solicits public comment on whether the Joint 
Commission's requirements meet or exceed the Medicare conditions for 
participation for CAHs.

III. Evaluation of Deeming Authority Request

    The Joint Commission submitted all the necessary materials to 
enable us to make a determination concerning its request for reapproval 
as a deeming organization for CAHs. This application was determined to 
be complete April 1, 2011. 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 the Joint Commission will 
be conducted in accordance with, but not necessarily limited to, the 
following factors:
     The equivalency of the Joint Commission's standards for a 
CAH as compared with CMS' CAH conditions of participation.
     The Joint Commission'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 the Joint Commission's processes to those 
of State agencies, including survey frequency, and the ability to 
investigate and respond appropriately to complaints against accredited 
facilities.
    ++ The Joint Commission's processes and procedures for monitoring 
CAHs found out of compliance with the Joint Commission's program 
requirements. These monitoring procedures are used only when the Joint 
Commission identifies noncompliance. If noncompliance is identified 
through validation reviews, the State survey agency monitors 
corrections as specified at Sec.  488.7(d).
    ++ The Joint Commission's capacity to report deficiencies to the 
surveyed facilities and respond to the facility's plan of correction in 
a timely manner.
    ++ The Joint Commission's capacity to provide us with electronic 
data and reports necessary for effective validation and assessment of 
the organization's survey process.
    ++ The adequacy of the Joint Commission's staff and other 
resources, and its financial viability.
    ++ The Joint Commission's capacity to adequately fund required 
surveys.
    ++ The Joint Commission's policies with respect to whether surveys 
are announced or unannounced, to assure that surveys are unannounced.
    ++ The Joint Commission's agreement to provide us with a copy of 
the most current accreditation survey together with any other 
information related to the survey as we may require (including 
corrective action plans).

IV. Response to Public Comments and Notice Upon Completion of 
Evaluation

    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.

[[Page 28042]]

V. Collection of Information Requirements

    This document does not impose information collection and 
recordkeeping requirements. Consequently, it need not be reviewed by 
the Office of Management and Budget under the authority of the 
Paperwork Reduction Act of 1995 (44 U.S.C. 35).

VI. Regulatory Impact Statement

    In accordance with the provisions of Executive Order 12866, the 
Office of Management and Budget did not review this proposed notice.
    In accordance with Executive Order 13132, we have determined that 
this proposed notice would not have a significant effect on the rights 
of States, local or tribal governments.

    Authority: Section 1865 of the Social Security Act (42 U.S.C. 
1395bb).

(Catalog of Federal Domestic Assistance Program No. 93.778, Medical 
Assistance Program; No. 93.773 Medicare--Hospital Insurance Program; 
and No. 93.774, Medicare--Supplementary Medical Insurance Program)

    Dated: May 4, 2011.
Donald M. Berwick,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2011-11705 Filed 5-12-11; 8:45 am]
BILLING CODE 4120-01-P
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