[Federal Register Volume 72, Number 207 (Friday, October 26, 2007)]
[Notices]
[Pages 60856-60857]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-20495]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3181-FN]


Medicare Program: Approval of Application by the American 
Diabetes Association (ADA) for Continued Recognition as a National 
Accreditation Organization That Accredits 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 American 
Diabetes Association (ADA) as a national accreditation organization for 
the purpose of determining that an entity meets the necessary quality 
standards to furnish outpatient diabetes self-management training 
services under Part B of the Medicare program.

[[Page 60857]]

Therefore, diabetes self-management training (DSMT) programs accredited 
by the ADA will receive deemed status under the Medicare program.

DATES: Effective Date: This accreditation is effective on October 27, 
2007.

FOR FURTHER INFORMATION CONTACT: Joan A. Brooks, (410) 786-5526.

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. Currently, one way of 
satisfying the quality standards under Sec.  410.145 is to be approved 
by an approved accrediting body. The regulations pertaining to the 
application procedures for national accreditation organizations for 
DSMT are at Sec.  410.142. 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.

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.
    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 the information and the organization's 
deeming application.

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

    We received a complete application from the American Diabetes 
Association (ADA) on March 3, 2007. On May 25, 2007, we published a 
proposed notice in the Federal Register, (72 FR 29325) announcing the 
application of the ADA for continued approval as an accreditation 
organization for diabetes self-management training programs.
    Comment: We received one comment on our proposed notice, which was 
supportive of the ADA's application. Although the comment supported 
ADA, the commenter expressed concern that some of ADA's accrediting 
requirements do not reflect the current state of health care practice 
for many DSMT programs. Specifically, the commenter expressed concern 
about the requirements pertaining to data collection, documentation, 
location requirements, and fees. The commenter stated that 
accreditation requirements can be burdensome for small DSMT practices 
that may operate outside of a large hospital-based setting. The 
commenter further specified that some large hospitals' DSMT programs 
have closed in recent years, due to a variety of factors that include 
the burdensome administrative requirements of accreditation combined 
with overall low reimbursement for DSMT services.
    Response: Although reimbursement issues are not within the scope of 
this final notice, we recognize these are issues of concern. Some 
reimbursement issues associated with DMST are--
     Entities' failure to meet the required number of 
participants for group training;
     Entities' failure to meet the requirement for both a 
registered dietician (RD) and a registered nurse (RN) on the training 
team; and
     Entities' failure to bill correctly.
    Recent revisions made to the National Standards for Diabetes Self-
Management Education Programs (NSDSMEP) include: 1) a reduction in the 
number of participants required for group training (from 15 to 10); and 
2) a change in the instructional requirements that DSMT programs must 
meet. Previously, a DSMT entity was required to have both a RD and a RN 
conduct training. The recent revisions to the NSDSMEP changed this 
requirement. An entity may now have either a RD or a RN conduct 
training. This revision should help to alleviate some of the 
administrative burdens faced by entities when administering the DSMT 
benefit. Additionally, we have revised Chapter 18 of the CMS Claims 
Processing Manual, and Chapter 15 of the CMS Benefits Policy Manual to 
clarify the instructions for filing specific claims. Our findings 
indicate that the ADA continues to use one of the sets of quality 
standards described in Sec.  410.144. It also continues to meet the CMS 
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 Sec.  410.142(a).
    The ADA began its Education Recognition Program (ERP) in 1986. At 
that time they formally recognized diabetes self-management education 
programs that meet the NSDSMEP. These standards, created by the 
National Diabetes Advisory Board (NDAB), were designed to promote 
quality diabetes self-management education nationwide for every person 
with diabetes.
    A Task Force consisting of the ADA, 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 update process. The revised 
standards were approved on March 25, 2007 and was published in the June 
2007 issue of Diabetes Care, Volume 30, Number 6. 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.
    We reviewed ADA's materials and the findings presented by the Iowa 
Foundation for Medicare Care (IFMC, Contract GS-35F-5831 H/
HHDM 500-2006-0015IG), which was under contract with CMS to validate 
ADA's accreditation policies. IFMC surveyed a sample of ADA's 
accredited facilities. Based on these reviews, we have determined that 
the ADA's deeming authority has been exercised in compliance with Sec.  
410.142. Therefore, ADA's continued recognition as a national 
accrediting organization is approved and is effective for 6 years, 
beginning October 27, 2007.

    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: September 6, 2007.
Kerry Weems,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. E7-20495 Filed 10-25-07; 8:45 am]
BILLING CODE 4120-01-P