[Federal Register: April 25, 2008 (Volume 73, Number 81)]
[Notices]
[Page 22420-22421]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25ap08-96]
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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