[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