[Federal Register Volume 67, Number 56 (Friday, March 22, 2002)]
[Notices]
[Pages 13345-13347]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-6955]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3076-FN]


Medicare Program; Approval of the Indian Health Service (IHS) as 
a National Accreditation Organization for Accrediting American Indian 
and Alaska Native Entities To Furnish Outpatient Diabetes Self-
Management Training

AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION: Final notice.

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SUMMARY: This final notice announces the approval of the Indian Health 
Service (IHS) as a national accreditation organization for outpatient 
Diabetes Self-Management Training (DSMT) services. This notice also 
announces the decision of the IHS to adopt the National Standards for 
Diabetes Self-Management Education Programs (NSDSMEP), for purposes of 
determining that American Indian and Alaska Native (AI/AN) entities 
meet the necessary quality standards to furnish outpatient diabetes 
self-management and training services under Part B of the Medicare 
program. Therefore, diabetes self-management training (DSMT) programs 
accredited by the IHS will receive ``deemed'' status under the Medicare 
program.

EFFECTIVE DATE: This accreditation is effective on March 22, 2002, for 
a term of 6 years.

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

SUPPLEMENTARY INFORMATION:

I. Background

    Section 1861(qq) of the Social Security Act (the Act) provides us 
with the statutory authority to regulate Medicare outpatient coverage 
of diabetes self-management training (DSMT) services. The section also 
permits DSMT programs to be deemed to have met our regulatory standards 
if they are accredited by an organization that represents individuals 
with diabetes as having met standards for furnishing DSMT services. 
Section 1865 (b) of the Act specifies a process whereby we approve and 
recognize national accrediting organizations for the purpose of 
recognizing health care entities accredited by the organization to have 
met such program requirements. The regulations published in accordance 
with section 1865(b) have served as the model for our approval of 
accreditation programs.

[[Page 13346]]

    The final rule on DSMT, published on December 29, 2000 in the 
Federal Register (65 FR 251) explicitly modeled its accreditation 
organization approval process after the section 1865 approval process 
specified in 42 CFR part 488, subpart A. The final rule states that 
DSMT programs interested in participating in the Medicare program must 
meet conditions for coverage specified in our regulations at 42 CFR 
part 410, subpart H. One requirement is that entities must satisfy 
required quality standards. Currently, one way that an entity must 
satisfy the quality standards under Sec. 410.145 is to be accredited by 
a CMS-approved accrediting body. The regulations pertaining to the 
application process for national accreditation organizations for DSMT 
at Sec. 410.142(a) specify that we may approve and recognize a 
nonprofit or not-for-profit organization with demonstrated experience 
in representing the interest of individuals with diabetes to accredit 
entities to furnish training. After we approve and recognize the 
accreditation organization, it may accredit an entity to meet one of 
the sets of quality standards described in Sec. 410.144, and we will 
deem these entities to have met these standards.

II. Review Process and Findings

A. Review Process

    In evaluating an application from an accrediting organization, we 
consider the following factors under section 1865(b)(2) of the Act and 
specified for DSMT purposes at Sec. 410.142(e):
     The organization uses and enforces quality standards that 
CMS has determined meet or exceed the CMS quality standards described 
in Sec. 410.144(a), or uses the National Standards for Diabetes Self-
Management Education Programs (NSDSMEP) quality standards described in 
Sec. 410.144(b);
     The organization meets the requirements for approved 
organizations in Sec. 410.143;
     The organization is not owned or controlled by the 
entities it accredits, as defined in Sec. 413.17(b)(2) or (b)(3); and
     The organization does not accredit any entity it owns or 
controls.
    We are required by Sec. 410.142(d) to publish a proposed notice in 
the Federal Register after the receipt of a written request for 
approval from a national accreditation organization. After review of 
the national accreditation organization's application, the regulations 
require that we publish a notice of our approval or disapproval after 
we receive a complete package of information and the organization's 
deeming application.

B. Review Findings

    We received a complete application from the Indian Health Service 
(IHS) on September 5, 2001. On October 26, 2001, we published a 
proposed notice in the Federal Register (66 FR 54262) announcing the 
application of the IHS for approval as an accreditation organization 
for American Indian/Alaska Natives (AI/AN) diabetes self-management 
training programs. We reviewed the application, and our findings 
indicated that the IHS meets the CMS criteria as ``a nonprofit 
organization with demonstrated experience in representing the interests 
of individuals with diabetes'' to accredit entities to furnish training 
in Sec. 410.142(a).
    We recognize that the IHS has a solid record of well-balanced 
experience in representing the interest of individuals with diabetes in 
the past decades. The AI/AN population has the highest rate of diabetes 
in the world and the prevalence of diabetes is 350 percent higher than 
in the general U.S. population. Recognizing the size of the AI/AN 
population affected by diabetes, the Congress, since 1979, has funded 
the IHS-administered National Diabetes Program to promote collaborative 
strategies to combat diabetes, develop standards-of-care policies for 
diabetes, disseminate comprehensive information about diabetes, and 
advocate for the AI/AN population in the health field. The IHS has 
played a leadership role in the development of diabetic care 
surveillance and data collection in the AI/AN diabetes program. The IHS 
monitors the quality of the AI/AN diabetic education service through 
the established system and network of the IHS National Diabetes 
Program, the IHS Area Consultants, the IHS Model Diabetes Program, the 
Special Diabetes Grant Programs and the IHS Integrated Diabetes 
Education and Clinical Standards Recognition Program for AI/AN 
Communities. Additionally, the IHS works in partnership with the IHS 
Model Diabetes Programs to tailor educational materials, treatment 
programs, nutrition counseling and physical activities to accommodate 
cultural, physical and geographical needs.
    We recognize that the traditional definition of ``nonprofit 
organization'' used by HHS in other contexts generally does not cover 
governmental entities. However, we have determined that the IHS 
possesses the indicia of nonprofit status because among other things, 
it is not formed for commercial or profit-making purposes; it does not 
have shares or shareholders, and it serves charitable purposes. All the 
health care services, including DSMT services, are furnished to the AI/
AN population free of charge, and The Indian Health Care Improvement 
Act requires Medicare and Medicaid reimbursements be allocated back to 
the facilities to make improvements in the programs and maintain 
compliance with the applicable conditions and requirements.
    We do not anticipate a conflict of interest in the deeming of AI/AN 
DSMT entities by IHS. The Indian Self-Determination and Education 
Assistance Act (ISDEAA) (25 U.S.C. 450f) authorizes the IHS to contract 
or compact with tribes for independent administration and operation of 
health services and programs in their communities. Under ISDEAA and the 
Public Health Service Act (42 U.S.C. section 254c-3(c)), the tribes may 
administer the diabetes programs funds independently from the IHS, and 
the agency serves in a consultative role regarding best practices. The 
IHS provides technical assistance to tribes on an as needed basis and 
has limited authority to sanction or assume a tribal health program. We 
therefore believe that IHS's deeming authority will be exercised in 
compliance with Sec. 410.142(e) (regarding relationships with owned or 
controlled entities).
    In the best interests of the AI/AN population, which has been 
affected by diabetes in alarming proportions, we have exercised our 
flexibility and discretion to approve the IHS application to accredit 
AI/AN DSMT programs. Our decision is based on the consideration of the 
unique relationship between the IHS National Diabetes Program, the 
Tribal Diabetes Program and the Special Diabetes Grant Program, as well 
as the distinct IHS funding structure that does not exist in other 
types of health care systems.
    During the term of approval as an accrediting organization, IHS 
will: (1) Enforce the NSDSMEP for its deemed entities; (2) comply with 
the requirements for approved accreditation organizations under 
Sec. 410.143; (3) continue to refrain from exercising administrative 
authority over the IHS Model Diabetes Programs, Tribal Model Diabetes 
Programs and the 1997 BBA Diabetes Grant Programs; and (4) continue to 
retain its consultative role regarding best diabetes practices.

III. Analysis of and Responses to Public Comments and Provisions of 
the Final Notice

    During the 30-day comment period, we received one comment in 
support of the IHS application. We reviewed the application and 
determined that IHS has

[[Page 13347]]

demonstrated experience in representing the interests of individuals 
with diabetes and is therefore qualified to accredit entities to 
furnish training. The IHS is adopting the NSDSMEP quality standards as 
permitted by the statute. Therefore, we have approved the IHS' 
application as an accreditation organization for diabetes self-
management training programs under Sec. 410.142(d) for a term of 6 
years. The IHS is the second accreditation organization that we have 
approved for accrediting diabetes self-management training programs.
    In accordance with the provisions of Executive Order 12866, this 
notice was not reviewed by the Office of Management and Budget.

    Authority: Sections 1861(qq), 1871 of the Social Security Act 
(42 U.S.C. 1395(qq), 1395bb.

(Catalog of Federal Domestic Program No. 93.773, Medicare-Hospital 
Insurance Program; and No. 93.774, Medicare-Supplementary Medical 
Insurance Program)

    Dated: February 3, 2002.
Thomas A. Scully,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 02-6955 Filed 3-21-02; 8:45 am]
BILLING CODE 4120-01-P