[Federal Register: October 24, 2008 (Volume 73, Number 207)]
[Notices]
[Page 63483-63485]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24oc08-85]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-3205-PN]
Medicare Program; Application by the American Association of
Diabetes Educators (AADE) for Recognition as a National Accreditation
Organization for Accrediting Entities To Furnish Outpatient Diabetes
Self-Management Training
AGENCY: Centers for Medicare & Medicare Services (CMS), HHS.
ACTION: Proposed notice.
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SUMMARY: This proposed notice announces the receipt of an application
from the American Association of Diabetes Educators (AADE) for
recognition as a national accreditation program for accrediting
entities that wish to furnish outpatient diabetes self-management
training to Medicare beneficiaries. The statute requires that the
Secretary publish a notice identifying the national accreditation body
making the request, describing the nature of the request, and providing
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 November 24, 2008.
ADDRESSES: In commenting, please refer to file code CMS-3205-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 specific
issues in 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-3205-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-3205-PN, Mail
Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
[[Page 63484]]
4. By hand or courier. If you prefer, you may deliver (by hand or
courier) your written comments (one original) 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 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. 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: Joan A. Moliki, (410) 786-5526.
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
outpatient diabetes self-management training when ordered by the
physician (or qualified non-physician practitioner) treating the
beneficiary's diabetes, provided certain requirements are met. We
sometimes use national accrediting organizations to determine whether
an entity meets some or all of the Medicare requirements when providing
services for which Medicare payment is made.
Under section 1865(a)(1) of the Social Security Act (the Act), a
national accreditation organization must have an agreement in effect
with the Secretary and meet the standards and requirements specified by
the Secretary in 42 CFR 410, subpart H to qualify for deeming
authority. The regulations pertaining to application procedures for
national accreditation organizations for diabetes self-management
training are specified at Sec. 410.142 (CMS process for approving
national accreditation organizations). One of the regulations requires
national accreditation organizations applying for deeming authority to
provide us with reasonable assurance that the accrediting organization
requires accredited entities to meet requirements that are at least as
stringent as our requirements.
We may approve and recognize a nonprofit or not-for-profit
organization with demonstrated experience in representing the interests
of individuals with diabetes to accredit entities to furnish training.
The accreditation organization, after being approved and recognized by
us, may accredit an entity to meet one of the sets of quality standards
in Sec. 410.144 (Quality standards for deemed entities).
Section 1865(a)(2) of the Act further requires that we review the
applying accreditation organization as follows:
The organization's requirements for accreditation,
Survey procedures,
Ability to provide adequate resources for conducting
required surveys,
Ability to supply information for use in enforcement
activities,
Monitoring procedures for providers found out of
compliance with the conditions or requirements, and
Ability to provide us with necessary data for validation.
We then examine the national accreditation organization's
accreditation requirements to determine if they meet or exceed the
Medicare conditions as we would have applied them. Section
1865(a)(3)(A) of the Act requires that we publish a notice identifying
the national accreditation body making the request within 30 days of
receipt of a completed application. The notice must describe the nature
of the request and provide at least a 30-day public comment period. We
have 210 days from receipt of the request to publish a finding of
approval or denial of the application. If we recognize an accreditation
organization in this manner, any entity accredited by the national
accreditation body's CMS-approved program for that service will be
``deemed'' to meet the Medicare conditions for coverage.
II. Provisions of the Proposed Notice
The purpose of this notice is to notify the public of the American
Association of Diabetes Educators (AADE's) request for the Secretary's
approval of its accreditation program for outpatient diabetes self-
management training services. This notice also solicits public comments
on the ability of the AADE to develop standards that meet or exceed the
Medicare conditions for coverage, and apply them to entities furnishing
outpatient diabetes self-management training.
Conditions for Coverage and Requirements for Outpatient Diabetes Self-
Management Training Services
The regulations specifying the Medicare conditions for coverage for
outpatient diabetes self-management training services are located in 42
CFR parts 410, subpart H. These conditions implement section 1861(qq)
of the Act, which provides for Medicare Part B coverage of outpatient
diabetes self-management training services specified by the Secretary.
Under section 1865(a)(2) of the Act and our regulations at Sec.
410.142 (CMS process for approving national accreditation
organizations) and Sec. 410.143 (Requirements for approved
accreditation organizations), we review and evaluate a national
accreditation organization based on (but not necessarily limited to)
the criteria set forth in Sec. 410.142(b).
We may conduct on-site inspections of a national accreditation
organization's operations and office to verify information in the
organization's application and assess the organization's compliance
with its own policies and procedures. The onsite inspection may
include, but is not limited to, reviewing documents, auditing
documentation of meetings concerning the accreditation process,
evaluating accreditation results or the accreditation status
decisionmaking process, and interviewing the organization's staff.
Notice Upon Completion of Evaluation
Upon completion of our evaluation, including evaluation of comments
received as a result of this notice, we will publish a notice in the
Federal
[[Page 63485]]
Register announcing the result of our evaluation.
III. 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. Chapter 35)
IV. Response to 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.
In accordance with the provisions of Executive Order 12866, this
regulation was not reviewed by the Office of Management and Budget.
(Catalog of Federal Domestic Assistance Program No. 93.773,
Medicare-Hospital Insurance Program; and No. 93.774, Medicare-
Supplementary Medical Insurance Program)
Dated: October 9, 2008.
Kerry Weems,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. E8-25195 Filed 10-23-08; 8:45 am]
BILLING CODE 4120-01-P