[Federal Register Volume 79, Number 124 (Friday, June 27, 2014)]
[Notices]
[Pages 36521-36522]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-15100]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3301-PN]


Medicare and Medicaid Programs; Application From Det Norske 
Veritas Healthcare for Continued CMS-Approval of Its Critical Access 
Hospital Accreditation Program

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 Det Norske Veritas Healthcare (DNVHC) for continued 
recognition as a national accrediting organization for critical access 
hospitals (CAHs) 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 July 28, 2014.

ADDRESSES: In commenting, please refer to file code CMS-3301-PN. 
Because of staff and resource limitations, we cannot accept comments by 
facsimile (FAX) transmission.
    You may submit comments in one of four ways:
    1. Electronically. You may submit electronic comments on specific 
issues in 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-3301-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 to 
the following address ONLY: Centers for Medicare & Medicaid Services, 
Department of Health and Human Services, Attention: CMS-3301-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 comments 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.)
    Comments erroneously mailed to the addresses indicated as 
appropriate for hand or courier delivery may be delayed and received 
after the comment period.
    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.
    For information on viewing public comments, see the beginning of 
the SUPPLEMENTARY INFORMATION section.

FOR FURTHER INFORMATION CONTACT: Barbara Easterling, (410) 786-0482, 
Cindy Melanson, (410) 786-0310, Patricia Chmielewski, (410) 786-6899, 
or Lillian Williams, (410) 786-8636.

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. Referencing the file code 
CMS-3301-PN and the specific ``issue identifier'' that precedes the 
section on which you choose to comment will assist us in fully 
considering issues and developing policies.
    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 Critical Access Hospital (CAH) provided certain 
requirements are met by the CAH. Section 1820(e) and 1861(mm) of the 
Social Security Act (the Act), establishes 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 to participate in the 
Medicare program, the scope of covered services, and the conditions for 
Medicare payment for CAHs.
    Generally, to enter into an agreement, 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 of our CMS regulations. 
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 
approval of its accreditation program under part 488, subpart A, must 
provide us with reasonable assurance that the

[[Page 36522]]

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 an accrediting organization to 
reapply for continued approval of its accreditation program every 6 
years or as determined by CMS. Det Norske Veritas Healthcare's (DNVHC) 
current term of approval for its CAH accreditation program expires 
December 23, 2014.

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 CMS approval of its CAH accreditation 
program. This notice also solicits public comment on whether DNVHC's 
requirements meet or exceed the Medicare conditions of participation 
(CoPs) for CAHs.

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 CAH 
accreditation program. This application was determined to be complete 
on May 2, 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 DNVHC will be conducted in accordance with, 
but not necessarily limited to, the following factors:
     The equivalency of DNVHC's standards for CAHs as compared 
with CMS' CAH CoPs.
     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 CAH 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 CMS 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 CMS with a copy of the most current 
accreditation survey together with any other information related to the 
survey as CMS 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 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.

    Dated: June 18, 2014.
Marilyn Tavenner,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2014-15100 Filed 6-26-14; 8:45 am]
BILLING CODE 4120-01-P