[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:
The equivalency of DNVHC's standards for a hospital as
compared with CMS' hospital conditions of participation.
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
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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