[Federal Register Volume 72, Number 101 (Friday, May 25, 2007)]
[Notices]
[Pages 29325-29326]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 07-2454]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-3181-PN]
Medicare Program; Application by the American Diabetes
Association (ADA) for Continued Recognition as a National Accreditation
Program for Accrediting Entities To Furnish Outpatient Diabetes Self-
Management Training
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Proposed notice.
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SUMMARY: This proposed notice announces the receipt of an application
from the American Diabetes Association (ADA) for continued recognition
as a national accreditation program for accrediting entities that wish
to furnish outpatient diabetes self-management training to Medicare
beneficiaries. Section 1865(b)(3) of the Social Security Act (the Act)
requires that we 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: Comment Date: To be assured consideration, comments must be
received at one of the addresses provided below, no later than 5 p.m.
on June 25, 2007.
ADDRESSES: In commenting, please refer to file code CMS-3181-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-3181-PN, P.O. Box 8017, Baltimore, MD 21244-8017.
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-3181-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. 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: Room 445-G, Hubert H. Humphrey Building,
200 Independence Avenue, SW., Washington, DC 20201; or 7500 Security
Boulevard, Baltimore, MD 21244-1850.
(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.)
Comments mailed to the addresses indicated as appropriate for hand
or courier delivery may be delayed and received after the comment
period.
FOR FURTHER INFORMATION CONTACT: Joan A. Brooks, (410) 786-5526.
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 the issues. You can assist us by referencing the file code
CMS-3181-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 electronic
comments received before the close of the comment period on its public
Web site as soon as possible after they have been received: http://www.cms.hhs.gov/eRulemaking. Click on the link ``Electronic Comments on
CMS Regulations'' 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
[If you choose to comment on issues in this section, please include
the caption ``Background'' at the beginning of your comments.]
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
[[Page 29326]]
beneficiary's diabetes, provided certain requirements are met. We
sometimes use national accreditation organizations to assess whether
provider entities meet Medicare requirements when providing services
for which Medicare payment is made.
Under section 1865(b)(1) of 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 part 410, subpart H to qualify for deeming authority. The
regulations pertaining to application procedures for national
accreditation organizations for diabetes self-management training
services are specified at Sec. 410.142 (CMS process for approving
national accreditation organizations).
A national accreditation organization applying for deeming
authority must provide us with reasonable assurance that the
accrediting organization requires accredited entities to meet
requirements that are at least as stringent as CMS's 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 CMS,
may accredit an entity to meet one of the sets of quality standards in
Sec. 410.144 (Quality standards for deemed entities).
Section 1865 (b)(2) of the Act further requires that we review the
applying accreditation organization's requirements for accreditation,
as follows:
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(b)(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. Purpose
The purpose of this notice is to notify the public of the American
Diabetes Association's (ADA'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 ADA to develop and apply its standards to entities
furnishing outpatient diabetes self-management training services that
meet or exceed the Medicare conditions for coverage.
III. Outpatient Diabetes Self-Management Training Services Conditions
for Coverage and Requirements
The regulations specifying the Medicare conditions for coverage for
outpatient diabetes self-management training services are located in 42
CFR part 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(b)(2) of the Act and our regulations 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 for 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 decision
making process, and interviewing the organization's staff.
IV. Notice Upon Completion of Our 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 Register announcing the result of our evaluation.
V. Responses 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.
In accordance with the provisions of Executive Order 12866, the
Office of Management and Budget did not review this notice.
Authority: Section 1865 of the Social Security Act (42 U.S.C.
1395bb).
(Catalog of Federal Domestic Assistance Program No. 93.773 Medicare-
Hospital Insurance Program; and No. 93.774, Medicare-Supplementary
Medical Insurance Program)
Dated: May 11, 2007.
Leslie V. Norwalk,
Acting Administrator, Centers for Medicare & Medicare Services.
[FR Doc. 07-2454 Filed 5-24-07; 8:45 am]
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