[Federal Register Volume 71, Number 18 (Friday, January 27, 2006)]
[Notices]
[Pages 4584-4586]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-748]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare and Medicaid Services

[CMS-2228-PN]


Medicare and Medicaid Programs; Application by the TUV Healthcare 
Specialists for Deeming Authority for Hospitals

AGENCY: Centers for Medicare and Medicaid Services, HHS.

ACTION: Proposed notice.

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SUMMARY: This proposed notice acknowledges the receipt of an 
application from the TUV Healthcare

[[Page 4585]]

Specialists for deeming authority for hospitals that wish to 
participate in the Medicare and Medicaid programs. Section 
1865(b)(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: We will consider comments if we receive them at the appropriate 
address, as provided below, no later than 5 p.m. on February 27, 2006.

ADDRESSES: In commenting, please refer to file code CMS-2228-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/regulations/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-2228-PN, P.O. Box 8018, Baltimore, MD 21244-8018.
    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-2228-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 
Yolanda Hayes at telephone number (410) 786-7195 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: Amber Wolfe, (410) 786-6773.

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-2228-PN.
    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/regulations/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 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 hospital provided certain requirements are met. 
The regulations specifying the Medicare conditions of participation 
(CoPs) for hospitals are located in 42 CFR part 482. These conditions 
implement section 1861(e) of the Social Security Act (the Act), which 
specifies services covered as hospital care and the requirements that a 
hospital must meet in order to participate in the Medicare program. 
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.
    Generally, in order to enter into an agreement with CMS, a hospital 
must first be certified by a State survey agency as complying with the 
CoPs set forth in part 482 of our regulations. Thereafter, the hospital 
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(b)(1) of the Act provides that, if a provider entity 
demonstrates through accreditation by an approved national 
accreditation organization that all applicable Medicare conditions are 
met or exceeded, we will ``deem'' those provider entities as having met 
the requirements.
    If an accreditation 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 accreditation organization applying for 
approval of deeming authority under part 488, subpart A must provide us 
with reasonable assurance that the accreditation organization requires 
the accredited provider entities to meet requirements that are at least 
as stringent as the Medicare CoPs. Accreditation by an accreditation 
organization is voluntary and is not required for Medicare 
participation.
    The Joint Commission on Accreditation of Healthcare Organizations 
(JCAHO) and the American Osteopathic Association (AOA) are currently 
the only approved national accreditation organizations for hospitals.

II. Approval of Deeming Organizations

    Section 1865(b)(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 accreditation 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

[[Page 4586]]

requirements; and ability to provide us with the necessary data for 
validation.
    Section 1865(b)(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 accreditation 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 our receipt of a completed 
application to publish approval or denial of the application.
    The purpose of this proposed notice is to inform the public of our 
consideration of the T[Uuml]V Healthcare Specialists' (T[Uuml]VHS') 
request to become a national accreditation organization for hospitals. 
This notice also solicits public comment on the ability of T[Uuml]VHS 
requirements to meet or exceed the Medicare CoPs for hospitals.

III. Evaluation of Deeming Authority Request

    On December 2, 2005, the T[Uuml]V Healthcare Specialists 
(T[Uuml]VHS) submitted all the necessary materials to enable us to make 
a determination concerning its request for approval as a deeming 
organization for hospitals. Under section 1865(b)(2) of the Act and our 
regulations at Sec.  488.8 (Federal review of accreditation 
organizations), our review and evaluation of T[Uuml]VHS will be 
conducted in accordance with, but not necessarily limited to, the 
following factors:
     The equivalency of T[Uuml]VHS' standards for hospitals as 
compared with our comparable hospital CoPs.
     T[Uuml]VHS' 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 T[Uuml]VHS' processes to those of State 
agencies, including survey frequency, and the ability to investigate 
and respond appropriately to complaints against accredited facilities.
--T[Uuml]VHS' processes and procedures for monitoring providers or 
suppliers found out of compliance with T[Uuml]VHS' program 
requirements. These monitoring procedures are used only when T[Uuml]VHS 
identifies noncompliance. If noncompliance is identified through 
validation reviews, the survey agency monitors corrections as specified 
at Sec.  488.7(d).
--T[Uuml]VHS' capacity to report deficiencies to the surveyed 
facilities and respond to the facility's plan of correction in a timely 
manner.
--T[Uuml]VHS' capacity to provide us with electronic data in ASCII 
comparable code, and reports necessary for effective validation and 
assessment of the organization's survey process.
--The adequacy of T[Uuml]VHS' staff and other resources, and its 
financial viability.
--T[Uuml]VHS' capacity to adequately fund required surveys.
--T[Uuml]VHS' policies with respect to whether surveys are announced or 
unannounced.
--T[Uuml]VHS' agreement to provide us with a copy of the most current 
ac creditation survey together with any other information related to 
the survey as we may require (including corrective action plans).

IV. 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).

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

    Because of the large number of comments we normally receive on 
Federal Register documents published for comment, 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 proposed notice.
    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 responding to the public comments and 
announcing the result of our evaluation.

VI. Executive Order 12866 Statement

    In accordance with the provisions of Executive Order 12866, this 
proposed notice was not reviewed by the Office of Management and 
Budget.

    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: January 20, 2006.
Mark B. McClellan,
Administrator, Centers for Medicare and Medicaid Services.
[FR Doc. 06-748 Filed 1-26-06; 8:45 am]
BILLING CODE 4120-01-P