02-6955. 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.

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, [phone].

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.

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 § 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 § 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 § 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 § 410.142(e):

• The organization uses and enforces quality standards that CMS has determined meet or exceed the CMS quality standards described in § 410.144(a), or uses the National Standards for Diabetes Self-Management Education Programs (NSDSMEP) quality standards described in § 410.144(b);
• The organization meets the requirements for approved organizations in § 410.143;
• The organization is not owned or controlled by the entities it accredits, as defined in § 413.17(b)(2) or (b)(3); and
• The organization does not accredit any entity it owns or controls.

We are required by § 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 § 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 § 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 § 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 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 § 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.