[Federal Register Volume 75, Number 142 (Monday, July 26, 2010)]
[Notices]
[Pages 43531-43532]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-18371]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-2336-PN]


Medicare and Medicaid Programs; Application by Det Norske Veritas 
Healthcare for Deeming Authority for Critical Access Hospitals (CAHs)

AGENCY: Centers for Medicare & 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 Det Norske Veritas Healthcare (DNVHC) 
for 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 August 25, 2010.

ADDRESSES: In commenting, please refer to file code CMS-2336-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 instructions under 
the ``More Search Options'' tab.
    2. By regular mail. You may mail written comments to the following 
address only:

Centers for Medicare & Medicaid Services, Department of Health and 
Human Services, Attention: CMS-2336-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-2336-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: Lillian Williams, (410) 786-8636. 
Patricia Chmielewski, (410) 786-6899.

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, 
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 from 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 in 42 CFR part 489 and those pertaining to 
activities relating to the survey and certification of facilities are 
in 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. The scope of covered services and 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 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.

[[Page 43532]]

    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 of our rules 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 
re-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 deeming authority 
every 6 years or sooner, as determined by CMS.

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 re-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 CAH deeming authority. This notice also solicits 
public comment on whether DNVHC's requirements meet or exceed the 
Medicare CAH conditions of participation (CoPs).

III. Evaluation of Deeming Authority Request

    DNVHC submitted all the necessary materials to enable us to make a 
determination concerning its request for approval as an accreditation 
organization for CAHs. This application was determined to be complete 
on June 3, 2010. 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 a CAH 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 CAHs 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, 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.
     + NVHC'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

    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.

III. Collection of Information Requirements 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: July 14, 2010.
Marilyn Tavenner,
Principal Deputy Administrator and Chief Operating Officer, Centers for 
Medicare & Medicaid Services.
[FR Doc. 2010-18371 Filed 7-23-10; 8:45 am]
BILLING CODE 4120-01-P