Medicare Program; Application by the American Association of Diabetes Educators (AADE) for Continued Recognition as a National Accreditation Organization for Accrediting Entities To Furnish Outpatient Diabetes Self-Management Training, 11130-11132 [2012-4277]
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Federal Register / Vol. 77, No. 37 / Friday, February 24, 2012 / Notices
D. Speaker Declaration
On the day of the meeting, before the
end of the meeting, all primary speakers
and 5-minute speakers must provide a
brief written summary of their
comments and conclusions to the
HCPCS Public Meeting Coordinator.
Each primary speaker and 5-minute
speaker must declare in their
presentation at the meeting, as well as
in their written summary, whether they
have any financial involvement with the
manufacturers or competitors of any
items being discussed; this includes any
payment, salary, remuneration, or
benefit provided to that speaker by the
manufacturer or the manufacturer’s
representatives.
E. Written Comments From Meeting
Attendees
Written comments will be accepted
from the general public and meeting
registrants anytime up to the date of the
public meeting at which a request is
discussed. Comments must be sent to
the address listed in the ADDRESSES
section of this notice.
Meeting attendees may also submit
their written comments at the meeting.
Due to the close timing of the public
meetings, subsequent workgroup
reconsiderations, and final decisions,
we are able to consider only those
comments received in writing by the
close of the public meeting at which the
request is discussed.
srobinson on DSK4SPTVN1PROD with NOTICES
IV. Security, Building, and Parking
Guidelines
The meetings are held within the
CMS Complex which is not open to the
general public. Visitors to the complex
are required to show a valid U.S.
Government issued photo identification,
preferably a driver’s license, at the time
of entry. Participants will also be subject
to a vehicular search before access to the
complex is granted. Participants not in
possession of a valid identification or
who are in possession of prohibited
items will be denied access to the
complex. Prohibited items on Federal
property include but are not limited to,
alcoholic beverages, illegal narcotics,
explosives, firearms or other dangerous
weapons (including pocket knives),
dogs or other animals except service
animals. Once cleared for entry to the
complex participants will be directed to
parking by a security officer.
In order to ensure expedited entry
into the building it is recommended that
participants have their ID and a copy of
their written meeting registration
confirmation readily available and that
they do not bring laptops or large/bulky
items into the building. Participants are
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reminded that photography on the CMS
complex is prohibited. CMS has also
been declared a tobacco free campus
and violators are subject to legal action.
In planning arrival time, we recommend
allowing additional time to clear
security. Individuals who are not
registered in advance will not be
permitted to enter the building and will
be unable to attend the meeting. The
public may not enter the building earlier
than 45 minutes before the convening of
the meeting each day.
Guest access to the complex is limited
to the meeting area, the main lobby, and
the cafeteria. If a visitor is found outside
of those areas without proper escort
they may be escorted out of the facility.
Also be mindful that there will be an
opportunity for everyone to speak and
we request that everyone waits for the
appropriate time to present their
product or opinions. Disruptive
behavior will not be tolerated and may
result in removal from the meetings and
escort from the complex. No visitor is
allowed to attach USB cables, thumb
drives or any other equipment to any
CMS information technology (IT) system
or hardware for any purpose at anytime.
Additionally, CMS staff is prohibited
from taking such actions on behalf of a
visitor or utilizing any removable media
provided by a visitor.
We cannot assume responsibility for
coordinating the receipt, transfer,
transport, storage, set-up, safety, or
timely arrival of any personal
belongings or items used for
demonstration or to support a
presentation. Special arrangements and
approvals are required at least 2 weeks
prior to each public meeting in order to
bring pieces of equipment or medical
devices. These arrangements need to be
made with the public meeting
coordinator. It is possible that certain
requests made in advance of the public
meeting could be denied because of
unique safety, security or handling
issues related to the equipment. A
minimum of 2 weeks is required for
approvals and security procedures.
Any request not submitted at least 2
weeks in advance of the public meeting
will be denied.
CMS policy requires that every
foreign national (as defined by the
Department of Homeland Security is
‘‘an individual who is a citizen of any
country other than the United States’’)
is assigned a host (in accordance with
the Department Foreign Visitor
Management Policy, Appendix C,
Guidelines for Hosts and Escorts). The
host/hosting official is required to
inform the Division of Critical
Infrastructure Protection (DCIP) at least
12 business days in advance of any visit
PO 00000
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by a foreign national. Foreign nationals
will be required to produce a valid
passport at the time of entry.
Attendees that are foreign nationals
need to identify themselves as such, and
provide the following information for
security clearance to the public meeting
coordinator by the date specified in the
DATES section of this notice:
• Visitor’s full name (as it appears on
passport).
• Gender.
• Country of origin and citizenship.
• Biographical data and related
information.
• Date of birth.
• Place of birth.
• Passport number.
• Passport issue date.
• Passport expiration date.
• Dates of visits.
• Company Name.
• Position/Title.
Dated: February 13, 2012.
Marilyn Tavenner
Acting Administrator, Centers for Medicare
& Medicaid Services.
[FR Doc. 2012–3969 Filed 2–23–12; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–3259–PN]
Medicare Program; Application by the
American Association of Diabetes
Educators (AADE) for Continued
Recognition as a National
Accreditation Organization for
Accrediting Entities To Furnish
Outpatient Diabetes Self-Management
Training
Centers for Medicare &
Medicare Services (CMS), HHS.
ACTION: Proposed notice.
AGENCY:
This proposed notice
announces the receipt of an application
from the American Association of
Diabetes Educators for continued
recognition as a national accreditation
program for accrediting entities that
wish to furnish outpatient diabetes selfmanagement training to Medicare
beneficiaries. The statute requires that
we publish a notice identifying the
national accreditation body making the
request, describing the nature of the
request, and providing at least a 30-day
public comment period.
DATES: To be assured consideration,
comments must be received at one of
the addresses provided below, no later
than 5 p.m. on March 26, 2012.
SUMMARY:
E:\FR\FM\24FEN1.SGM
24FEN1
Federal Register / Vol. 77, No. 37 / Friday, February 24, 2012 / Notices
In commenting, please refer
to file code CMS–3259–PN. Because of
staff and resource limitations, we cannot
accept comments by facsimile (Fax)
transmission.
You may submit comments in one of
four ways (please choose only one of the
ways listed):
1. Electronically. You may submit
electronic comments on this regulation
to https://www.regulations.gov. Follow
the ‘‘Submit a comment’’ instructions.
2. By regular mail. You may mail
written comments to the following
address ONLY: Centers for Medicare &
Medicaid Services, Department of
Health and Human Services, Attention:
CMS–3259–PN, P.O. Box 8016,
Baltimore, MD 21244–8016. Please
allow sufficient time for mailed
comments to be received before the
close of the comment period.
3. By express or overnight mail. You
may send written comments to the
following address ONLY: Centers for
Medicare & Medicaid Services,
Department of Health and Human
Services, Attention: CMS–3259–PN,
Mail Stop C4–26–05, 7500 Security
Boulevard, Baltimore, MD 21244–1850.
4. By hand or courier. If you prefer,
you may deliver (by hand or courier)
your written comments before the close
of the comment period to either of the
following addresses:
a. For delivery in Washington, DC—
Centers for Medicare & Medicaid
Services, Department of Health and
Human Services, Room 445–G, Hubert
H. Humphrey Building, 200
Independence Avenue SW.,
Washington, DC 20201. (Because access
to the interior of the Hubert H.
Humphrey Building is not readily
available to persons without Federal
government identification, commenters
are encouraged to leave their comments
in the CMS drop slots located in the
main lobby of the building. A stamp-in
clock is available for persons wishing to
retain a proof of filing by stamping in
and retaining an extra copy of the
comments being filed.)
b. For delivery in Baltimore, MD—
Centers for Medicare & Medicaid
Services, Department of Health and
Human Services, 7500 Security
Boulevard, Baltimore, MD 21244–1850.
If you intend to deliver your comments
to the Baltimore address, please call
telephone number (410) 786–9994 in
advance to schedule your arrival with
one of our staff members.
Comments mailed to the addresses
indicated as appropriate for hand or
courier delivery may be delayed and
received after the comment period.
FOR FURTHER INFORMATION CONTACT:
Jacqueline Leach, (410) 786–4282.
srobinson on DSK4SPTVN1PROD with NOTICES
ADDRESSES:
VerDate Mar<15>2010
18:34 Feb 23, 2012
Jkt 226001
Kristin Shifflett, (410) 786–4133. Maria
Hammel, (410) 786–1775.
SUPPLEMENTARY INFORMATION: Inspection
of Public Comments: All comments
received before the close of the
comment period are available for
viewing by the public, including any
personally identifiable or confidential
business information that is included in
a comment. We post all comments
received before the close of the
comment period on the following Web
site as soon as possible after they have
been received: https://www.regulations.
gov. Follow the search instructions on
that Web site to view public comments.
Comments received timely will also
be available for public inspection as
they are received, generally beginning
approximately 3 weeks after publication
of a document, at the headquarters of
the Centers for Medicare & Medicaid
Services, 7500 Security Boulevard,
Baltimore, Maryland 21244, Monday
through Friday of each week from 8:30
a.m. to 4 p.m. To schedule an
appointment to view public comments,
phone 1–800–743–3951.
I. Background
Under the Medicare program, eligible
beneficiaries may receive outpatient
Diabetes Self-Management Training
(DSMT) when ordered by the physician
(or qualified non-physician practitioner)
treating the beneficiary’s diabetes,
provided certain requirements are met.
Pursuant to our regulations at 42 CFR
410.141(e)(3), we use national
accrediting organizations to assess
whether provider entities meet
Medicare requirements when providing
services for which Medicare payment is
made. If a provider entity is accredited
by an approved accrediting
organization, it is ‘‘deemed’’ to meet
applicable Medicare requirements.
Under section 1865(a)(1)(B) of the
Social Security Act (the Act), a national
accreditation organization must have an
agreement in effect with the Secretary
and meet the standards and
requirements specified by the Secretary
in 42 CFR part 410, subpart H, to qualify
for deeming authority. The regulations
pertaining to application procedures for
national accreditation organizations for
DSMT are specified at § 410.142 (CMS
process for approving national
accreditation organizations).
A national accreditation organization
applying for deeming authority must
provide us with reasonable assurance
that the accrediting organization
requires accredited entities to meet
requirements that are at least as
stringent as our requirements.
We may approve and recognize a
nonprofit organization with
PO 00000
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Sfmt 4703
11131
demonstrated experience in
representing the interests of individuals
with diabetes to accredit entities to
furnish training. The accreditation
organization, after being approved and
recognized by us, may accredit an entity
to meet one of the sets of quality
standards in § 410.144 (Quality
standards for deemed entities).
Section 1865(a)(2) of the Act further
requires that we review the applying
accreditation organization’s
requirements for accreditation, as
follows:
• Survey procedures.
• Ability to provide adequate
resources for conducting required
surveys.
• Ability to supply information for
use in enforcement activities.
• Monitoring procedures for
providers found out of compliance with
the conditions or requirements.
• Ability to provide us with necessary
data for validation.
We then examine the national
accreditation organization’s
accreditation requirements to determine
if they meet or exceed the Medicare
conditions as we would have applied
them. 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 we recognize an
accreditation organization in this
manner, any entity accredited by the
national accreditation body’s CMSapproved program for that service will
be ‘‘deemed’’ to meet the Medicare
conditions for coverage.
II. Provisions of the Proposed Notice
The purpose of this notice is to notify
the public of the American Association
of Diabetes Educators’ (AADE) request
for the Secretary’s approval of its
accreditation program for outpatient
DSMT services. The AADE submitted
all the necessary materials to enable us
to make a determination concerning its
request for re-approval as a deeming
organization for DSMTs. AADE was
initially accredited on March 27, 2009,
for a period of 3 years. This application
was determined to be complete on
January 13, 2012. This notice also
solicits public comments on the ability
of the AADE to continue to develop
standards that meet or exceed the
Medicare conditions for coverage, and
apply them to entities furnishing
outpatient DSMT.
E:\FR\FM\24FEN1.SGM
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11132
Federal Register / Vol. 77, No. 37 / Friday, February 24, 2012 / Notices
Conditions for Coverage and
Requirements for Outpatient Diabetes
Self-Management Training Services
The regulations specifying the
Medicare conditions for coverage for
outpatient diabetes self-management
training services 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 services
specified by the Secretary.
Under section 1865(a)(2) of the Act
and our regulations at § 410.142 (CMS
process for approving national
accreditation organizations) and
§ 410.143 (Requirements for approved
accreditation organizations), we review
and evaluate a national accreditation
organization based on (but not
necessarily limited to) the criteria set
forth in § 410.142(b).
We may conduct on-site inspections
of a national accreditation
organization’s operations and office 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 decision making
process, and interviewing the
organization’s staff.
Notice Upon Completion of Evaluation
Upon completion of our evaluation,
including evaluation of comments
received as a result of this notice, we
will publish a notice in the Federal
Register announcing the result of our
evaluation.
III. 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.
srobinson on DSK4SPTVN1PROD with NOTICES
IV. Response to Comments
Because of the large number of public
comments we normally receive on
Federal Register documents, we are not
able to acknowledge or respond to them
individually. We will consider all
comments we receive by the date and
time specified in the DATES section of
this preamble, and, when we proceed
with a subsequent document, we will
respond to the comments in the
preamble to that document.
VerDate Mar<15>2010
18:34 Feb 23, 2012
Jkt 226001
(Catalog of Federal Domestic Assistance
Program No. 93.773 Medicare-Hospital
Insurance Program; and No. 93.774,
Medicare-Supplementary Medical Insurance
Program)
Dated: February 10, 2012.
Marilyn Tavenner,
Acting CMS Administrator, Centers for
Medicare & Medicaid Services.
[FR Doc. 2012–4277 Filed 2–23–12; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0145]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Improving Food
Safety and Defense Capacity of the
State and Local Level: Review of State
and Local Capacities
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the Agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal Agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
a survey entitled ‘‘Improving Food
Safety and Defense Capacity of the State
and Local Level: Review of State and
Local Capacities.’’ The data collection
will obtain knowledge of State and local
capacities including food safety defense
staffing and expertise, laboratory
capacities, and information systems to
support food and feed safety and
defense.
SUMMARY:
Submit either electronic or
written comments on the collection of
information by April 24, 2012.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
DATES:
PO 00000
Frm 00070
Fmt 4703
Sfmt 4703
Ila S. Mizrachi, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr.,
P150–400B, Rockville, MD 20850,
301–796–7726,
Ila.Mizrachi@fda.hhs.gov.
Under the
PRA (44 U.S.C. 3501–3520), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
SUPPLEMENTARY INFORMATION:
Improving Food Safety and Defense
Capacity at the State and Local Level:
Review of State and Local Capacities—
(OMB Control Number 0910—New)
The Food Safety Modernization Act
(FSMA) (Pub. L. 111–353) states that a
review must be conducted to assess the
State and local capacities to show needs
for enhancement in the areas or staffing
levels, laboratory capacities, and
information technology systems. This
mandate is referenced again in FSMA
section 110 stating that a review of
current food safety and food defense
capabilities must be presented to
Congress no later than 2 years after the
date of enactment (enactment date
January 4, 2011). In order to facilitate
this review, this team must distribute a
E:\FR\FM\24FEN1.SGM
24FEN1
]]>Agencies
[Federal Register Volume 77, Number 37 (Friday, February 24, 2012)]
[Notices]
[Pages 11130-11132]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-4277]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-3259-PN]
Medicare Program; Application by the American Association of
Diabetes Educators (AADE) for Continued Recognition as a National
Accreditation Organization for Accrediting Entities To Furnish
Outpatient Diabetes Self-Management Training
AGENCY: Centers for Medicare & Medicare Services (CMS), HHS.
ACTION: Proposed notice.
-----------------------------------------------------------------------
SUMMARY: This proposed notice announces the receipt of an application
from the American Association of Diabetes Educators for continued
recognition as a national accreditation program for accrediting
entities that wish to furnish outpatient diabetes self-management
training to Medicare beneficiaries. The statute requires that we
publish a notice identifying the national accreditation body making the
request, describing the nature of the request, and providing at least a
30-day public comment period.
DATES: To be assured consideration, comments must be received at one of
the addresses provided below, no later than 5 p.m. on March 26, 2012.
[[Page 11131]]
ADDRESSES: In commenting, please refer to file code CMS-3259-PN.
Because of staff and resource limitations, we cannot accept comments by
facsimile (Fax) transmission.
You may submit comments in one of four ways (please choose only one
of the ways listed):
1. Electronically. You may submit electronic comments on this
regulation to https://www.regulations.gov. Follow the ``Submit a
comment'' instructions.
2. By regular mail. You may mail written comments to the following
address ONLY: Centers for Medicare & Medicaid Services, Department of
Health and Human Services, Attention: CMS-3259-PN, P.O. Box 8016,
Baltimore, MD 21244-8016. Please allow sufficient time for mailed
comments to be received before the close of the comment period.
3. By express or overnight mail. You may send written comments to
the following address ONLY: Centers for Medicare & Medicaid Services,
Department of Health and Human Services, Attention: CMS-3259-PN, Mail
Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
4. By hand or courier. If you prefer, you may deliver (by hand or
courier) your written comments before the close of the comment period
to either of the following addresses:
a. For delivery in Washington, DC--Centers for Medicare & Medicaid
Services, Department of Health and Human Services, Room 445-G, Hubert
H. Humphrey Building, 200 Independence Avenue SW., Washington, DC
20201. (Because access to the interior of the Hubert H. Humphrey
Building is not readily available to persons without Federal government
identification, commenters are encouraged to leave their comments in
the CMS drop slots located in the main lobby of the building. A stamp-
in clock is available for persons wishing to retain a proof of filing
by stamping in and retaining an extra copy of the comments being
filed.)
b. For delivery in Baltimore, MD--Centers for Medicare & Medicaid
Services, Department of Health and Human Services, 7500 Security
Boulevard, Baltimore, MD 21244-1850. If you intend to deliver your
comments to the Baltimore address, please call telephone number (410)
786-9994 in advance to schedule your arrival with one of our staff
members.
Comments mailed to the addresses indicated as appropriate for hand
or courier delivery may be delayed and received after the comment
period.
FOR FURTHER INFORMATION CONTACT: Jacqueline Leach, (410) 786-4282.
Kristin Shifflett, (410) 786-4133. Maria Hammel, (410) 786-1775.
SUPPLEMENTARY INFORMATION: Inspection of Public Comments: All comments
received before the close of the comment period are available for
viewing by the public, including any personally identifiable or
confidential business information that is included in a comment. We
post all comments received before the close of the comment period on
the following Web site as soon as possible after they have been
received: https://www.regulations.gov. Follow the search instructions on
that Web site to view public comments.
Comments received timely will also be available for public
inspection as they are received, generally beginning approximately 3
weeks after publication of a document, at the headquarters of the
Centers for Medicare & Medicaid Services, 7500 Security Boulevard,
Baltimore, Maryland 21244, Monday through Friday of each week from 8:30
a.m. to 4 p.m. To schedule an appointment to view public comments,
phone 1-800-743-3951.
I. Background
Under the Medicare program, eligible beneficiaries may receive
outpatient Diabetes Self-Management Training (DSMT) when ordered by the
physician (or qualified non-physician practitioner) treating the
beneficiary's diabetes, provided certain requirements are met. Pursuant
to our regulations at 42 CFR 410.141(e)(3), we use national accrediting
organizations to assess whether provider entities meet Medicare
requirements when providing services for which Medicare payment is
made. If a provider entity is accredited by an approved accrediting
organization, it is ``deemed'' to meet applicable Medicare
requirements.
Under section 1865(a)(1)(B) of the Social Security Act (the Act), a
national accreditation organization must have an agreement in effect
with the Secretary and meet the standards and requirements specified by
the Secretary in 42 CFR part 410, subpart H, to qualify for deeming
authority. The regulations pertaining to application procedures for
national accreditation organizations for DSMT are specified at Sec.
410.142 (CMS process for approving national accreditation
organizations).
A national accreditation organization applying for deeming
authority must provide us with reasonable assurance that the
accrediting organization requires accredited entities to meet
requirements that are at least as stringent as our requirements.
We may approve and recognize a nonprofit organization with
demonstrated experience in representing the interests of individuals
with diabetes to accredit entities to furnish training. The
accreditation organization, after being approved and recognized by us,
may accredit an entity to meet one of the sets of quality standards in
Sec. 410.144 (Quality standards for deemed entities).
Section 1865(a)(2) of the Act further requires that we review the
applying accreditation organization's requirements for accreditation,
as follows:
Survey procedures.
Ability to provide adequate resources for conducting
required surveys.
Ability to supply information for use in enforcement
activities.
Monitoring procedures for providers found out of
compliance with the conditions or requirements.
Ability to provide us with necessary data for validation.
We then examine the national accreditation organization's
accreditation requirements to determine if they meet or exceed the
Medicare conditions as we would have applied them. 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 we recognize an accreditation
organization in this manner, any entity accredited by the national
accreditation body's CMS-approved program for that service will be
``deemed'' to meet the Medicare conditions for coverage.
II. Provisions of the Proposed Notice
The purpose of this notice is to notify the public of the American
Association of Diabetes Educators' (AADE) request for the Secretary's
approval of its accreditation program for outpatient DSMT services. The
AADE submitted all the necessary materials to enable us to make a
determination concerning its request for re-approval as a deeming
organization for DSMTs. AADE was initially accredited on March 27,
2009, for a period of 3 years. This application was determined to be
complete on January 13, 2012. This notice also solicits public comments
on the ability of the AADE to continue to develop standards that meet
or exceed the Medicare conditions for coverage, and apply them to
entities furnishing outpatient DSMT.
[[Page 11132]]
Conditions for Coverage and Requirements for Outpatient Diabetes Self-
Management Training Services
The regulations specifying the Medicare conditions for coverage for
outpatient diabetes self-management training services 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 services specified by the Secretary.
Under section 1865(a)(2) of the Act and our regulations at Sec.
410.142 (CMS process for approving national accreditation
organizations) and Sec. 410.143 (Requirements for approved
accreditation organizations), we review and evaluate a national
accreditation organization based on (but not necessarily limited to)
the criteria set forth in Sec. 410.142(b).
We may conduct on-site inspections of a national accreditation
organization's operations and office 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 decision
making process, and interviewing the organization's staff.
Notice Upon Completion of Evaluation
Upon completion of our evaluation, including evaluation of comments
received as a result of this notice, we will publish a notice in the
Federal Register announcing the result of our evaluation.
III. 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.
IV. Response to Comments
Because of the large number of public comments we normally receive
on Federal Register documents, we are not able to acknowledge or
respond to them individually. We will consider all comments we receive
by the date and time specified in the DATES section of this preamble,
and, when we proceed with a subsequent document, we will respond to the
comments in the preamble to that document.
(Catalog of Federal Domestic Assistance Program No. 93.773 Medicare-
Hospital Insurance Program; and No. 93.774, Medicare-Supplementary
Medical Insurance Program)
Dated: February 10, 2012.
Marilyn Tavenner,
Acting CMS Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2012-4277 Filed 2-23-12; 8:45 am]
BILLING CODE 4120-01-P
