[Federal Register: September 28, 2007 (Volume 72, Number 188)]
[Notices]
[Page 55222-55224]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28se07-100]
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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
