[Federal Register Volume 74, Number 38 (Friday, February 27, 2009)]
[Notices]
[Pages 8965-8967]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-3287]



[[Page 8965]]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3205-FN]


Medicare Program; Application by the American Association of 
Diabetes Educators (AADE) for Recognition as a National Accreditation 
Organization (NAO) for Accrediting Entities To Furnish Outpatient 
Diabetes Self-Management Training (DSMT)

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

ACTION: Final notice.

-----------------------------------------------------------------------

SUMMARY: This final notice announces the approval of an application 
from the American Association of Diabetes Educators (AADE) for 
recognition as a National Accreditation Organization (NAO) for 
accrediting entities that wish to furnish outpatient Diabetes Self-
Management Training (DSMT) to Medicare beneficiaries. Approval is for a 
period of 3 years.

DATES: Effective Date: This final notice is effective on March 30, 
2009.

FOR FURTHER INFORMATION CONTACT: Joan A. Moliki, (410) 786-5526. Eva 
Fung, (410) 786-7539.

SUPPLEMENTARY INFORMATION:

I. Background

    Under the Medicare program, eligible beneficiaries may receive 
outpatient Diabetes Self-Management Training (DSMT) when ordered by a 
physician (or qualified non-physician practitioner) provided certain 
requirements are met, as set out at 42 CFR 410.141. Our regulations at 
42 CFR 410.141(e)(3) require that a DSMT program be accredited by a 
National Accreditation Organization (NAO) so that it can be determined 
if the program meets the requirements set out at Sec.  410.144 when 
providing DSMT services for which Medicare payment is made.
    Under section 1865(a)(1) of the Social Security Act (the Act), the 
Secretary must find that accreditation by a NAO demonstrates that the 
standards and requirements specified by the Secretary with regard to a 
provider are met in order for the NAO to qualify for deeming authority. 
We may evaluate and recognize a nonprofit organization with 
demonstrated experience in representing the interests of individuals 
with diabetes to accredit entities to furnish training. The regulations 
pertaining to requests by a national organization to be recognized as a 
NAO for DSMT are set out at 42 CFR 410.142. Entities applying for NAO 
status must demonstrate that they apply one of the sets of quality 
standards to the DSMT programs that they accredit as set out at 42 CFR 
410.144. Our review and evaluation of the applicant organization's 
ability to maintain the standards and to apply them to accredited 
entities must provide assurance that DSMT services are able to be 
furnished consistent with federal requirements. Section 1865(a)(2) of 
the Act further requires that we consider, among other factors, with 
respect to a national accrediting body the following--
     Organization's requirements for accreditation,
     Its survey procedures,
     Its ability to provide adequate resources for conducting 
required surveys,
     Its ability to supply information for use in enforcement 
activities,
     Its monitoring procedures for provider entities found out 
of compliance with the conditions or requirements, and
     Its ability to provide us with necessary data for 
validation.
    Section 1865(a)(3)(A) of the Act requires that we publish a notice 
identifying the national accreditation body making the request within 
30 days of receipt of a completed application. The notice must describe 
the nature of the request and provide at least a 30-day public comment 
period. We have 210 days from receipt of the request to publish a 
finding of approval or denial of the application. If, after our review 
and evaluation, we determine an applicant organization meets all 
necessary requirements, any entity accredited by the organization will 
be ``deemed'' to meet the Medicare requirements.

II. Provisions of the Proposed Notice

    On October 24, 2008, we published a proposed notice in the Federal 
Register (73 FR 63483) to notify the public of American Association of 
Diabetes Educators' (AADE) request for approval of its accreditation 
program to deem entities furnishing DSMT services.

Conditions for Coverage and Requirements for Outpatient DSMT

    As noted above, the regulations specifying the Medicare conditions 
for coverage for outpatient DSMT are located 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 DSMT as 
specified by the Secretary.
    Under section 1865(a)(2) of the Act and our regulations at Sec.  
410.142 (CMS Process for approving NAOs) and Sec.  410.143 
(Requirements for approved accreditation organizations), we review and 
evaluate the application of national organizations to be recognized as 
NAOs for DSMT. A national organization seeking recognition as a NAO 
must demonstrate that it applies one of three sets of quality standards 
to DSMT programs: the Medicare quality standards found at 42 CFR Sec.  
410.144(a); the National Standards for Diabetes Self-Management 
Education Programs (NSDSMEP), pursuant to Sec.  410.144(b); or the 
standards of a national organization representing individuals with 
diabetes that meet or exceed Medicare standards.
    We may conduct an on-site inspection of a NAO's office and 
operations to verify information in the organization's application 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 of meetings concerning the 
accreditation process, evaluating accreditation results or the 
accreditation status decisionmaking process and interviewing the 
organization's staff.

III. Analysis of and Responses to Public Comments on the Proposed 
Notice

    We received 16 items of correspondence containing 9 different 
comments. A summary of these comments and our responses are set forth 
below.
    Comment: A few commenters supported the approval of the AADE to 
deem DSMT programs. The commenters stated that the approval of AADE 
would empower the organization to train healthcare professionals to 
educate an ailing population on diabetes self-management. They further 
stated that AADE's proposed quality standards would increase access to 
community-based DSMT programs, enable programs to conduct training in 
real-life settings, enhance behavior changes, and lead to improved 
clinical outcomes and patient satisfaction.
    Response: We thank the commenters for their comments. The goal of 
the DSMT program is to provide beneficiaries with tools to better 
manage their diabetes and to achieve good clinical and behavioral 
outcomes.
    Comment: One commenter urged CMS to ensure proper alignment of the 
AADE quality standards with CMS standards in order to assure quality 
DSMT education is delivered to beneficiaries. Another commenter 
suggested CMS use the NSDSMEP to evaluate AADE standards.

[[Page 8966]]

    Response: Instead of using its own set of quality standards to deem 
DSMT entities as proposed in its initial application, AADE has elected 
to adopt and abide by the NSDSMEP standards. We performed an extensive 
review of the AADE accrediting policies and procedures, and assessed 
its proposed implementation strategies for the NSDSMEP. We concluded 
that they are consistent with the NSDSMEP and meet our requirements.
    Comment: One commenter stated that the NSDSMEP requires the 
appointment of an advisory committee to promote quality and meet 
patient and community needs. The commenter noted that AADE's proposed 
policies did not address the requirement for such oversight or input. 
The commenter believed that AADE policies were therefore less stringent 
than the CMS quality improvement standard, which requires an entity to 
either have an agreement with a Quality Improvement Organization (QIO) 
to participate in a specified quality improvement project or 
demonstrate a level of achievement through a comparable project of its 
own design.
    Response: Subsequent to its decision to adopt the NSDSMEP, AADE 
revised its policies to include a patient-centered and consumer-focused 
advisory group to provide input for planning, developing, evaluating, 
and collaborating DSMT efforts to better serve the community. We 
conducted a thorough review of AADE's revised policies and determined 
that they meet applicable standards.
    Comment: Some commenters strongly objected to AADE's proposed 
standard which would have allowed non-professionals to be instructors 
on the DSMT team. They were concerned that the quality and accuracy of 
the DSMT would be significantly compromised. The commenters believed 
that the non-professional instructors could not stay current on the 
rapidly evolving treatment strategies due to their limited education 
and credentials. One commenter cited studies to demonstrate the lack of 
evidence to support the effectiveness of lay health workers in primary 
and community health care.
    Response: We fully agree with the commenters that DSMT instructors 
should have qualified credentials in order to provide quality DSMT to 
Medicare beneficiaries. With AADE's adoption of the NSDSMEP, non-
professionals will not be permitted to be a part of an accredited DSMT 
program's instructional team in an instructional capacity. Instead, 
AADE will limit their responsibilities to non-instructional and non-
technical roles, in which they will perform a variety of support 
functions to enhance patients' self-management skills. Additionally, 
AADE requires evidence, as appropriate, of current licenses, 
registration and/or certification of instructors.
    Comment: Some commenters raised concerns that AADE did not clearly 
define ``the use of non-clinical staff (such as, community health 
workers) to deliver diabetes education, with supervision by 
professional staff.'' The commenters further noted that AADE did not 
address the audit process for the training or on-going education of 
these non-professional instructors. One commenter stated that the non-
professional staff should not be authorized to provide DSMT 
independently and that their work would need to be actively supervised 
by appropriate credentialed professional staff.
    Response: As stated previously, AADE accreditation standards no 
longer permit accredited DSMT programs to include non-professionals as 
instructors on the DSMT team. AADE will require that the 
responsibilities of community health workers on the DSMT team be non-
instructional and non-technical. They will receive training and be 
directly supervised by diabetes educators in the program. We believe 
that there are merits in using non-professional staff such as community 
health workers in collaborative programs such as DSMT. With training 
and supervision as required, non-professional staff can provide social 
support to beneficiaries, facilitate access to services and enhance 
cultural competency of service delivery.
    Comment: One commenter strongly supported the requirement for a 
certified diabetes educator (CDE) on the instructional team.
    Response: With the adoption of the NSDSMEP, AADE-accredited DSMT 
entities may include instructors who are certified diabetes 
educator(s).
    Comment: One commenter stated that a physician-led team approach 
should be used to deliver cost-effective diabetes education.
    Response: The leadership role of the physician has not changed. 
Under Sec.  410.141, Outpatient DSMT, the physician or qualified non-
physician practitioner treating the beneficiary's diabetes is charged 
with evaluating the beneficiary's need for training. He or she sets out 
the comprehensive plan of care; provides guidance on plan content, the 
number of sessions, frequency, and duration of services; and provides 
follow-up as necessary. Furthermore, the DSMT entity is expected to 
periodically update the referring physician about the beneficiary's 
outcomes, goals, and educational status.
    Comment: One commenter stated that the AADE's proposed standards 
did not clarify how the accredited DSMT program would be able to meet 
beneficiaries' needs that were outside the solo instructor's scope of 
practice and expertise. In addition, the commenter stated that it was 
unclear how collaboration and linkages with other external health care 
providers of different disciplines would occur with only a solo program 
instructor.
    Response: AADE now requires programs that have solo instructors to 
establish a mechanism for ensuring that participant needs are met if 
these needs are outside the instructor's scope of practice and 
expertise.
    Comment: One commenter expressed concern that AADE's proposed 
standard 6 would have allowed DSMT to be delivered through 
telecommunication media, while the 2009 Medicare Physician Fee Schedule 
Final Rule specifically disallows payment for telehealth provision of 
services as a substitute for face-to-face DSMT service.
    Response: We agree with the commenter that the delivery of DSMT 
through telecommunication services does not meet the intent of our DSMT 
standards, which promote interactive, face-to-face and collaborative 
learning. To comply with Medicare policy on payment for telehealth 
services, AADE has removed the language on the permissibility of 
providing DSMT via telecommunication services from its Interpretive 
Guidance and notes in its policy that we do not reimburse for DSMT 
provided via telehealth.
    Comment: One commenter recommended that AADE be more explicit in 
describing the training program for volunteer auditors.
    Response: AADE revised its policies to strengthen the training 
program for volunteer auditors to ensure consistent application of the 
standards to all DSMT programs.
    Comment: One commenter requested that AADE clarify the percentage 
of programs it audits in the initial application phase as well as in 
the accreditation period.
    Response: AADE's policy on random on-site audit specifies 5 percent 
of applicants for initial accreditation, 10 percent of accredited 
programs during an accreditation cycle and 10 percent of applicants 
applying for re-accreditation.
    Comment: One commenter requested clarification of the AADE 
requirement for continuous quality improvement activities for 
accredited programs.
    Response: For continuous quality improvement activities, AADE has

[[Page 8967]]

specific policies and procedures in place that require accredited 
programs to have a systematic process for implementing a continuous 
quality improvement process and plan, that is, programs are required to 
develop projects of their own design, and to specify the outcome 
measures they are currently tracking, providing a rationale for 
selecting the outcome measures. Furthermore, AADE also requires an 
accredited program to undertake quality improvement activities 
annually.
    Comment: One commenter stated that AADE's proposed re-accreditation 
methodology that would perform random checks on providers' professional 
licenses, certificates and continuing education, would be inadequate, 
since the staffing turnover in DSMT programs is high. Random credential 
validation could pose a potential quality assurance problem.
    Response: We agree with the commenter that an accrediting 
organization should comprehensively validate professional licenses, 
certificates and continuing education in the re-accreditation phases to 
ensure DSMT programs provide quality care by qualified staff. AADE's 
reaccreditation methodology now requires programs to notify the AADE of 
any change in staff status, and to maintain documentation of current 
verification of professional licenses, certificates and continuing 
education for inspection during the re-accreditation process.
    Comment: One commenter recommended that AADE adopt NSDSMEP standard 
10, requiring the DSMT entity to measure the effectiveness of 
the education process and determine opportunities for improvement using 
a written continuous quality improvement plan that describes and 
documents a systematic review of the entity's process and outcome data.
    Response: As stated earlier, AADE is adopting the NSDSMEP in its 
entirety, including standard 10.
    Comment: A commenter expressed concerns that AADE standards would 
require its accredited programs to use the AADE7TM self-care 
behaviors and continuum of outcomes framework. This could create a 
potential conflict of interest if AADE-approved entities were required 
to purchase the AADE7TM framework as a condition of 
accreditation.
    Response: We do not believe there is a conflict of interest if a 
prospective program makes the business decision to be accredited by the 
AADE and purchase the AADE7TM to enhance its data collection 
and quality improvement practices. Also, AADE allows its accredited 
programs the option to use other data collection tools. DSMT programs 
also have the option of seeking accreditation by either of the other 
NAOs for DSMT: the American Diabetes Association or the Indian Health 
Service (accrediting American Indian and Alaska Native programs).
    Comment: One commenter suggested that in addition to granting 
deeming authority to NAOs, CMS should expand outreach efforts to 
increase access to DSMT programs by educating beneficiaries, 
physicians, and qualified non-physician practitioners (for example, 
nurse practitioners, physician assistants) to enhance their 
understanding of the DSMT referral process.
    Response: This is beyond the scope of this final notice. However, 
educating more professionals about how to care for persons with 
diabetes, and educating more persons with diabetes about self-care is 
an area that we consider to be beneficial. Currently, there are a 
number of studies being conducted by our Quality Improvement 
Organizations. We expect to build on the lessons from these studies to 
further reduce disparities between health care received by minority 
populations and to be able to measure improvements as evidenced by 
these studies. It is anticipated that the studies will provide an 
opportunity to learn the most appropriate treatment modalities for a 
variety of serious health concerns, including diabetes, that are 
prevalent in our society.

IV. Provisions of the Final Notice

    AADE's application to become a NAO for purposes of DSMT as 
authorized under Section 1861 (qq) of the Act is approved for a period 
of three (3) years and becomes effective 30 days after publication of 
this final notice. This approval is subject to renewal subsequent to 
the receipt of an application from the AADE and subject to review, 
evaluation and approval of its program.

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. Chapter 35).

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

    Dated: February 6, 2009.
Charlene Frizzera,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. E9-3287 Filed 2-26-09; 8:45 am]
BILLING CODE 4120-01-P