[Federal Register Volume 77, Number 57 (Friday, March 23, 2012)]
[Notices]
[Pages 17070-17072]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-6856]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3258-PN]


Medicare and Medicaid Programs; Application From Det Norske 
Veritas Healthcare (DNVHC) for Continued Approval of Its Hospital 
Accreditation Program

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 an application from Det Norske Veritas Healthcare (DNVHC) 
for continued recognition as a national accrediting organization for 
hospitals 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 April 23, 2012.

ADDRESSES: In commenting, please refer to file code CMS-3258-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 (one original and 
two copies) to the following address ONLY: Centers for Medicare & 
Medicaid Services, Department of Health and Human Services, Attention: 
CMS-3258-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-3258-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 before the close of the comment period 
to either of 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, please call telephone number (410) 
786-7195 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: Barbara Easterling (410) 786-0482, 
Patricia Chmielewski, (410) 786-6899, or Cindy Melanson, (410) 786-
0310.

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,

[[Page 17071]]

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 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 part 488. The regulations at 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. Thereafter, the 
hospital is subject to regular surveys by a State survey agency to 
determine whether it continues to meet these requirements. However, 
there is an alternative 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 have met the 
Medicare conditions. A national accrediting organization applying for 
approval of its accreditation program 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.  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 us.
    DNVHC's current term of approval for their hospital accreditation 
program expires September 26, 2012.

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 
DNVHC's request for continued approval of its hospital accreditation 
program. This notice also solicits public comment on whether DNVHC's 
requirements meet or exceed the Medicare conditions for participation 
for hospitals.

III. Evaluation of Deeming Authority Request

    DNVHC submitted all the necessary materials to enable us to make a 
determination concerning its request for continued approval of its 
hospital accreditation program. This application was determined to be 
complete on January 27, 2012. Section 1865(a)(3)(A) of the Social 
Security Act (the Act), requires that within 60 days of receipt of an 
organization's complete application to be a CMS-approved accrediting 
organization, 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. 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 DNVHC will be conducted in accordance with, but not 
necessarily limited to, the following factors:
    <bullet> The equivalency of DNVHC's standards for a hospital as 
compared with CMS' hospital conditions of participation.
    <bullet> DNVHC'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 DNVHC's processes to those of State 
agencies, including survey frequency, and the ability to investigate 
and respond appropriately to complaints against accredited facilities.
    + DNVHC's processes and procedures for monitoring a hospital found 
out of compliance with DNVHC's program requirements. These monitoring 
procedures are used only when DNVHC 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).
    + DNVHC's capacity to report deficiencies to the surveyed 
facilities and respond to the facility's plan of correction in a timely 
manner.
    + DNVHC'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 DNVHC's staff and other resources, and its 
financial viability.
    + DNVHC's capacity to adequately fund required surveys.
    + DNVHC's policies with respect to whether surveys are announced or 
unannounced, to assure that surveys are unannounced.
    + DNVHC'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. 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

    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

[[Page 17072]]

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.

    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: March 13, 2012.
Marilyn Tavenner,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2012-6856 Filed 3-22-12; 8:45 am]
BILLING CODE 4120-01-P