E8-2803. Medicare Program: Approval of Application by the Indian Health Service (IHS) for Continued Recognition as a National Accreditation Organization That Accredits American Indian and Alaska Native (AI/AN) Entities To Furnish Outpatient Diabetes ...

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 the purpose of determining that entities meet the necessary quality standards to furnish outpatient diabetes self-management training services under Part B of the Medicare program. Therefore, American Indian and Alaska Native diabetes self-management training (DSMT) programs accredited by the IHS will receive deemed status under the Medicare program for purposes of this benefit.

EFFECTIVE DATE:

This approval of IHS as a national accreditation organization is effective on February 22, 2008.

FOR FURTHER INFORMATION CONTACT:

Eva Fung, [phone].

SUPPLEMENTARY INFORMATION:

I. Background

To participate in the Medicare program, diabetes self-management training (DSMT) programs 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. An entity seeking approval as a DSMT supplier must meet the requirements found at § 410.144 as determined by an organization that meets the standards found at § 410.142. These organizations are referred to as national accreditation organizations (NAOs).

II. Review Process

In evaluating an application from an accrediting organization, we consider the following factors under section 1865(b)(2) of the Social Security Act (the Act):

• Accreditation requirements.
• Survey procedures.
• Ability to provide adequate resources for conducting required surveys and to supply information for use in enforcement activities.
• Monitoring procedures.
• Ability to provide us with the necessary data for validation.

After the receipt of a written request to become a NAO or to renew status as a NAO, a proposed notice is published in the Federal Register, with a 30 day public comment period. After review of the NAO's application, we are required to publish a final notice of approval or denial no later than 210 days after the date of receipt of a complete application package from the organization requesting to become a NAO.

III. Analysis of and Responses to Public Comments

We received a complete application from the IHS on July 11, 2007. On September 28, 2007, we published a proposed notice in the Federal Register (72 FR 55222-55224) announcing the application from the IHS for continued approval as a NAO for accrediting of American Indian (AI) and Alaska Native (AN) entities that wish to furnish outpatient DSMT to Medicare beneficiaries.

We note that no public comments were received on our proposed notice.

IV. Provisions of the Final Notice

On March 22, 2002, we approved the IHS as a NAO for a term of 6 years to accredit AI/AN entities that provide diabetes self-management training (67 FR 13345). We recognize that the IHS has a solid record of experience in past decades in representing the interest of individuals with diabetes. The AI/AN population has one of the highest rates of diabetes in the world and the prevalence of diabetes is substantially 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, to develop standards-of-care policies for diabetes, to disseminate comprehensive information about diabetes, and to advocate for the AI/AN population. The IHS has played a leadership role in the development of diabetic care surveillance and data collection in the AI/AN diabetes programs. It monitors the quality of the AI/AN diabetes education service through its National Diabetes Program, 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.

A special Task Force consisting of the American Diabetes Association, the American Association of Diabetes Educators, the American Dietetic Association, the Veteran's Health Service, the National Certification Board for Diabetes Educators, the Centers for Disease Control and Prevention, the Department of Veterans Affairs, the Diabetes Research and Training Centers, the Indian Health Service, and the National Certification Board for Diabetes Educators was convened on March 31, 2006 and again on September 19, 2006 as part of the process to update the National Standards for Diabetes Self-Management Education Programs (NSDSMEP). The revised standards were approved on March 25, 2007 and were published in the June 2007 issue of Diabetes Care. (Volume 30, Number 6.) Prior to revision, the Task Force reviewed the standards for their appropriateness, relevancy, scientific basis, specificity, and ability to be implemented in multiple settings. The current NSDSMEP standards (7th Edition) were effectuated in June 2007 and reflect the changing approaches in diabetes training and education.

Our findings indicate that the IHS continues to meet our criteria as “a nonprofit organization with demonstrated experience in representing the interests of individuals with diabetes” to accredit entities to furnish training as specified in § 410.142(a) and continues to meet all applicable requirements in § 410.140 through § 410.146.

The Iowa Foundation for Medicare Care (IFMC) is under contract (#GS-35F-5831 H/HHSM 500-2006-0015IG) to CMS to validate the DSMT accreditation policies of NAOs including IHS. IFMC surveyed a sample of IHS accredited facilities. Based on these reviews, we have determined that the IHS deeming authority has been exercised in compliance with published requirements and have approved IHS' continued recognition as a NAO, effective for 6 years, beginning February 22, 2008.

V. Collection of Information Requirements

This document does not impose information collection and recordkeeping requirements. Consequently, it need not be reviewed by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. 35).

Authority: Sections 1865 of the Social Security Act (42 U.S.C. 1395bb).

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

Dated: December 6, 2007.

Kerry Weems,

Acting Administrator, Centers for Medicare & Medicaid Services.

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