[Federal Register Volume 72, Number 188 (Friday, September 28, 2007)]
[Notices]
[Pages 55222-55224]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-18470]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare and Medicaid Services

[CMS-3186-PN]


Medicare and Medicaid Programs; Application by the Indian Health 
Service (IHS) for Continued Recognition as a National Accreditation 
Organization for Accrediting American Indian and Alaska Native Entities 
To Furnish Outpatient Diabetes Self-Management Training

AGENCY: Centers for Medicare and Medicaid Services, HHS.

ACTION: Proposed notice.

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SUMMARY: This proposed notice announces the receipt of an application 
from the Indian Health Service for continued recognition as a national 
accreditation organization for accrediting American Indian and Alaska 
Native entities that wish to furnish outpatient diabetes self-
management training to Medicare beneficiaries. This notice also 
announces 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. October 29, 2007.

[[Page 55223]]


ADDRESSES: In commenting, please refer to file code CMS-3186-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-3186-PN, P.O. Box 3014, Baltimore, MD 21244-1850.
    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-3186-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 information on viewing public comments, see the beginning of 
the SUPPLEMENTARY INFORMATION section.

FOR FURTHER INFORMATION CONTACT: Eva Fung, (410) 786-7539.

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-3186-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.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

    Under the Medicare program, eligible beneficiaries may receive 
outpatient diabetes self-management training when ordered by the 
physician or qualified nonphysician practitioner treating the 
beneficiary's diabetes, provided certain requirements are met. We 
sometimes use national accreditation organizations to determine whether 
a provider entity meets the Medicare requirements that are necessary in 
order for an entity to provide a service covered by Medicare.
    Section 1865(b)(1) of the Social Security Act (the Act), provides 
that a national accreditation organization must have an agreement in 
effect with the Secretary and meet the standards and requirements as 
specified in 42 CFR part 410, subpart H. The regulations pertaining to 
application procedures for national accreditation organizations for 
diabetes self-management training services are specified in 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 it requires 
accredited entities to meet requirements that are at least as stringent 
as those set forth by CMS. Nonprofit or not-for-profit organizations 
with demonstrated experience in representing the interests of 
individuals with diabetes are eligible to request recognition as a 
national accreditation organization. The national accreditation 
organization, after being approved and recognized by CMS, evaluates the 
entity to determine if it meets one of the sets of quality standards as 
specified in Sec.  410.144 (Quality standards for deemed entities). If 
the national accreditation organization finds that the entity meets or 
exceeds applicable requirements, the Secretary shall deem the entity as 
meeting the Medicare requirements.
    Section 1865(b)(2) of the Act requires that the Secretary's 
findings relative to approving a national accreditation organization as 
a deeming authority consider the organization's requirements for 
accreditation, its survey procedures, its ability to provide adequate 
resources for conducting required surveys and its ability to supply 
information for use in enforcement activities, its monitoring 
procedures for entities found out of compliance with the conditions or 
requirements, and its ability to provide the Secretary with necessary 
data for validation. The Secretary evaluates 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 the Secretary 
publish within 60 days of receipt of a completed application, 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. In addition, the Secretary has 210 days from 
receipt of the request to publish a finding of approval or denial of 
the application. If the Secretary recognizes an accreditation 
organization in this manner, once an entity that furnishes diabetes 
training is accredited by a national accreditation organization, it can 
be ``deemed'' to meet the Medicare conditions of coverage for diabetes 
self-management training.

II. Provisions of the Proposed Notice

    [If you choose to comment on issues in this section, please include 
the caption ``PROVISIONS OF THE PROPOSED NOTICE'' at the beginning of 
your comments.]

[[Page 55224]]

    The purpose of this notice is to notify the public of the Indian 
Health Service's (IHS's) request for the approval for continued 
recognition as a national accrediting organization for accreditation of 
American Indian and Alaska Native entities to furnish outpatient 
diabetes self-management training services. The IHS proposes to 
continue to adopt the National Standards for Diabetes Self-Management 
Education as its quality standards. This notice also solicits public 
comments on the ability of the IHS to develop and apply its standards 
to entities furnishing outpatient diabetes self-management training 
services.

Outpatient Diabetes Self-Management Training Services

    The regulations specifying the Medicare conditions for coverage for 
outpatient diabetes self-management training services are specified 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(b)(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 specified in Sec.  410.142(b), and we review the ongoing 
responsibilities of an approved accreditation organization.
    We may visit the prospective organization's offices to verify 
information in the organization's reapplication package, including, but 
not limited to, review of documents, and interviews with the 
organization's staff. We may conduct onsite inspection of a national 
accreditation organization's operations and office to verify 
information 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 from meetings 
concerning the accreditation process, evaluating accreditation results 
or the accreditation status decision making process, and interviewing 
the organization's staff.

Notice Upon Completion of Evaluation

    Upon completion of our evaluation, including consideration of 
public 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. 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, 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. 93.778, Medical 
Assistance Program) (Catalog of Federal Domestic Assistance Program 
No. 93.773, Medicare--Hospital Insurance; and Program No. 93.774, 
Medicare--Supplementary Medical Insurance Program)

    Dated: September 6, 2007.
Kerry Weems,
Acting Administrator, Centers for Medicare & Medicare Services.
[FR Doc. E7-18470 Filed 9-27-07; 8:45 am]
BILLING CODE 4120-01-P