[Federal Register Volume 73, Number 81 (Friday, April 25, 2008)]
[Notices]
[Pages 22420-22421]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-8266]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare and Medicaid Services

[CMS-2895-PN]


Medicare and Medicaid Programs; The Det Norske Veritas 
Healthcare, Inc (DNV) for Deeming Authority for Hospitals

AGENCY: Centers for Medicare and Medicaid Services, HHS.

ACTION: Proposed Notice.

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SUMMARY: This proposed notice with comment period acknowledges the 
receipt of a deeming application from Det Norske Veritas Healthcare 
(DNV) for recognition as a national accrediting organization for 
hospitals that wish to participate in the Medicare or 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: To be assured consideration, comments must be received at one of 
the addresses provided below, no later than 5 p.m. on May 27, 2008.

ADDRESSES: In commenting, please refer to file code CMS-2895-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-2895-PN, P.O. Box ----, 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 (one 
original and two copies) to the following address ONLY: Centers for 
Medicare & Medicaid Services, Department of Health and Human Services, 
Attention: CMS-2895-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: a. Room 
445-G, Hubert H. Humphrey Building, 200 Independence Avenue, SW., 
Washington, DC 20201.
    (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.)
    b. 7500 Security Boulevard, Baltimore, MD 21244-1850.
    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.
    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: 
Cindy Melanson, (410) 786-0310.
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-2895-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.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 in a hospital provided certain requirements are met. 
Section 1861(e) of the Social Security Act (the Act), establishes 
distinct criteria for facilities seeking designation as a hospital. 
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 
482 specify the conditions that a hospital must meet in order to 
participate in the Medicare program, the scope of covered services and 
the conditions for Medicare payment for hospitals.
    Generally, in order to enter into an agreement, a hospital must 
first be certified by a State survey agency as complying with the 
conditions or requirements set forth in part 482 of our CMS 
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 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

[[Page 22421]]

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. Our regulations concerning the 
approval of accrediting organizations are set forth at Sec. Sec.  488.4 
and 488.8(d)(3). The regulations at Sec.  488.8(d)(3) require 
accrediting organizations to reapply for continued deeming authority 
every 6 years or sooner as determined by us.

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 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(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 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 
DNV's request for deeming authority for hospitals. This notice also 
solicits public comment on whether DNV's requirements meet or exceed 
the Medicare conditions of participation for hospitals.

III. Evaluation of Deeming Authority Request

    DNV submitted all the necessary materials to enable us to make a 
determination concerning its request for approval as a deeming 
organization for hospitals. This application was determined to be 
complete on March 12, 2008. Under Section 1865(b)(2) of the Act and our 
regulations at Sec.  488.8 (Federal review of accrediting 
organizations), our review and evaluation of DNV will be conducted in 
accordance with, but not necessarily limited to, the following factors:
     The equivalency of DNV's standards for a hospital as 
compared with Medicare's hospital conditions of participation.
     DNV'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 DNV's processes to those of State agencies, 
including survey frequency, and the ability to investigate and respond 
appropriately to complaints against accredited facilities.
--DNV's processes and procedures for monitoring a hospital found out of 
compliance with DNV's program requirements. These monitoring procedures 
are used only when DNV 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).
--DNV's capacity to report deficiencies to the surveyed facilities and 
respond to the facility's plan of correction in a timely manner.
--DNV's 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 DNV's staff and other resources, and its financial 
viability.
--DNV's capacity to adequately fund required surveys.
--DNV's policies with respect to whether surveys are announced or 
unannounced, to assure that surveys are unannounced.
--DNV'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.

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: April 11, 2008.
Kerry Weems,
Acting Administrator, Centers for Medicare & Medicaid Services.
 [FR Doc. E8-8266 Filed 4-24-08; 8:45 am]
BILLING CODE 4120-01-P