[Federal Register: February 27, 2009 (Volume 74, Number 38)]
[Notices]
[Page 8965-8967]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27fe09-90]
[[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