Medicare and Medicaid Programs; Application by the Indian Health Service (IHS) for Continued Recognition as a National Accreditation Organization for Accrediting American Indian and Alaska Native Entities To Furnish Outpatient Diabetes Self-Management Training, 55222-55224 [E7-18470]
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55222
Federal Register / Vol. 72, No. 188 / Friday, September 28, 2007 / Notices
jlentini on PROD1PC65 with NOTICES
complies with sections 1902(a)(10) and
1902(a)(30) of the Act by limiting
payment of medical assistance to
payment of medical costs for
individuals who lack sufficient income
and resources to meet the cost of care;
and
• Whether the State has provided
adequate documentation to demonstrate
that the State’s rate methodology is
consistent with the requirements of
section 1902(a)(30) of the Act;
specifically whether the rates paid to
service providers are consistent with
efficiency, economy, and quality of care.
Section 1116 of the Act and Federal
regulations at 42 CFR Part 430, establish
Department procedures that provide an
administrative hearing for
reconsideration of a disapproval of a
State plan or plan amendment. CMS is
required to publish a copy of the notice
to a State Medicaid agency that informs
the agency of the time and place of the
hearing, and the issues to be considered.
If we subsequently notify the agency of
additional issues that will be considered
at the hearing, we will also publish that
notice.
Any individual or group that wants to
participate in the hearing as a party
must petition the presiding officer
within 15 days after publication of this
notice, in accordance with the
requirements contained at 42 CFR
430.76(b)(2). Any interested person or
organization that wants to participate as
amicus curiae must petition the
presiding officer before the hearing
begins in accordance with the
requirements contained at 42 CFR
430.76(c). If the hearing is later
rescheduled, the presiding officer will
notify all participants.
The notice to Pennsylvania
announcing an administrative hearing to
reconsider the disapproval of its SPA
reads as follows:
Ms. Estelle B. Richman,
Secretary of Public Welfare, Commonwealth
of Pennsylvania, Department of Public
Welfare, Office of Medical Assistance
Programs, Bureau of Policy, Budget and
Planning,
P.O. Box 8046,
Harrisburg, PA 17105.
Dear Ms. Richman:
I am responding to your request for
reconsideration of the decision to disapprove
Pennsylvania State plan amendment (SPA)
06–007, which was submitted on September
27, 2006, and disapproved on June 29, 2007.
Under this SPA, the State requested the
addition of targeted case management
services for first-time, low-income expectant
mothers who have, or are at risk of having,
a high incidence of medical or social
problems. The Centers for Medicare &
Medicaid Services (CMS) disapproved the
SPA because CMS found that it violated the
VerDate Aug<31>2005
17:12 Sep 27, 2007
Jkt 211001
statute for reasons set forth in the
disapproval letter.
The CMS made a Request for Additional
Information on December 22, 2006, to which
the State responded on April 2, 2007. The
information provided confirmed that the
targeted case management services proposed
in SPA 06–007 are currently provided to
first-time expectant mothers without charge
through State grant funding and private
funds.
Section 1902(a)(10) of the Social Security
Act (the Act) requires that States make
available medical assistance, which is
defined at section 1905(a) of the Act, and is
limited to payment of medical costs for
‘‘individuals whose income and resources are
insufficient to meet all of such costs.’’ The
term ‘‘medical assistance’’ fundamentally
excludes payment for medical services that
are free to the general public, since where a
service is provided without charge the
individual is not in the circumstance of
having insufficient income or resources to
meet the cost of care. Hence, such services
do not meet the definition of ‘‘medical
assistance.’’
In addition, section 1902(a)(30) of the Act
requires States to have methods and
procedures in place to assure that payments
are consistent with efficiency, economy, and
quality of care. CMS did not find that
Medicaid payments for case management for
first-time expectant mothers were consistent
with this requirement when these same
services are available to non-Medicaid
enrollees without charge. Furthermore, the
State failed to provide documentation
requested by CMS demonstrating that the rate
methodology used to determine payments to
service providers was consistent with section
1902(a)(30). The State failed to provide
documentation of the various cost elements
used to determine a fee-schedule amount or
to submit provider surveys conducted by the
State to determine whether its proposed
indirect cost rate should be applied to direct
costs to calculate the final fee paid to
providers.
Based on the above, and after consultation
with the Secretary of the Department of
Health and Human Services as required
under Federal regulations at 42 CFR
430.15(c)(2), CMS disapproved Pennsylvania
Medicaid SPA 06–007.
The issues to be decided at the hearing are
• Whether Pennsylvania has demonstrated
that its SPA 06–007 complies with sections
1902(a)(10) and 1902(a)(30) of the Act by
limiting payment of medical assistance to
payment of medical costs for individuals
who lack sufficient income and resources to
meet the cost of care; and
• Whether the State has provided adequate
documentation to demonstrate that the
State’s rate methodology is consistent with
the requirements of section 1902(a)(30) of the
Act; specifically whether the rates paid to
service providers are consistent with
efficiency, economy, and quality of care.
I am scheduling a hearing on your request
for reconsideration to be held on November
16, 2007, at Suite 216, The Public Ledger
Building, 150 S. Independence Mall West,
Conference Room 241, the Pennsylvania
Room, Philadelphia, PA 19106, to reconsider
PO 00000
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Fmt 4703
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the decision to disapprove SPA 06–007. If
this date is not acceptable, we would be glad
to set another date that is mutually agreeable
to the parties. The hearing will be governed
by the procedures prescribed by Federal
regulations at 42 CFR Part 430.
I am designating Ms. Kathleen ScullyHayes as the presiding officer. If these
arrangements present any problems, please
contact the presiding officer at (410) 786–
2055. In order to facilitate any
communication which may be necessary
between the parties to the hearing, please
notify the presiding officer to indicate
acceptability of the hearing date that has
been scheduled and provide names of the
individuals who will represent the State at
the hearing.
Sincerely,
Kerry Weems,
Acting Administrator.
Section 1116 of the Social Security
Act (42 U.S.C. 1316; 42 CFR 430.18)
(Catalog of Federal Domestic Assistance
Program No. 13.714, Medicaid Assistance
Program.)
Kerry Weems,
Acting Administrator, Centers for Medicare
& Medicaid Services.
[FR Doc. E7–19141 Filed 9–27–07; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare and Medicaid
Services
[CMS–3186–PN]
Medicare and Medicaid Programs;
Application by the Indian Health
Service (IHS) for Continued
Recognition as a National
Accreditation Organization for
Accrediting American Indian and
Alaska Native Entities To Furnish
Outpatient Diabetes Self-Management
Training
Centers for Medicare and
Medicaid Services, HHS.
ACTION: Proposed notice.
AGENCY:
SUMMARY: This proposed notice
announces the receipt of an application
from the Indian Health Service for
continued recognition as a national
accreditation organization for
accrediting American Indian and Alaska
Native entities that wish to furnish
outpatient diabetes self-management
training to Medicare beneficiaries. This
notice also announces 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. October 29, 2007.
E:\FR\FM\28SEN1.SGM
28SEN1
Federal Register / Vol. 72, No. 188 / Friday, September 28, 2007 / Notices
In commenting, please refer
to file code CMS–3186–PN. Because of
staff and resource limitations, we cannot
accept comments by facsimile (FAX)
transmission.
You may submit comments in one of
four ways (no duplicates, please):
1. Electronically. You may submit
electronic comments on specific issues
in this regulation to https://
www.cms.hhs.gov/eRulemaking. Click
on the link ‘‘Submit electronic
comments on CMS regulations with an
open comment period.’’ (Attachments
should be in Microsoft Word,
WordPerfect, or Excel; however, we
prefer Microsoft Word.)
2. By regular mail. You may mail
written comments (one original and two
copies) to the following address ONLY:
Centers for Medicare & Medicaid
Services, Department of Health and
Human Services, Attention: CMS–3186–
PN, P.O. Box 3014, Baltimore, MD
21244–1850.
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 (one
original and two copies) to the following
address ONLY: Centers for Medicare &
Medicaid Services, Department of
Health and Human Services, Attention:
CMS–3186–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 (one original
and two copies) before the close of the
comment period to one of the following
addresses. 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.
Room 445–G, Hubert H. Humphrey
Building, 200 Independence Avenue,
SW., Washington, DC 20201; or 7500
Security Boulevard, Baltimore, MD
21244–1850.
(Because access to the interior of the
HHH 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.)
Comments mailed to the addresses
indicated as appropriate for hand or
courier delivery may be delayed and
received after the comment period.
jlentini on PROD1PC65 with NOTICES
ADDRESSES:
VerDate Aug<31>2005
17:12 Sep 27, 2007
Jkt 211001
For information on viewing public
comments, see the beginning of the
SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT: Eva
Fung, (410) 786–7539.
SUPPLEMENTARY INFORMATION:
Submitting Comments: We welcome
comments from the public on all issues
set forth in this proposed notice to assist
us in fully considering issues and
developing policies. You can assist us
by referencing the file code CMS–3186–
PN and the specific ‘‘issue identifier’’
that precedes the section on which you
choose to comment.
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.cms.hhs.gov/
eRulemaking. Click on the link
‘‘Electronic Comments on CMS
Regulations’’ 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 when
ordered by the physician or qualified
nonphysician practitioner treating the
beneficiary’s diabetes, provided certain
requirements are met. We sometimes
use national accreditation organizations
to determine whether a provider entity
meets the Medicare requirements that
are necessary in order for an entity to
provide a service covered by Medicare.
Section 1865(b)(1) of the Social
Security Act (the Act), provides that a
national accreditation organization must
have an agreement in effect with the
Secretary and meet the standards and
requirements as specified in 42 CFR part
410, subpart H. The regulations
pertaining to application procedures for
national accreditation organizations for
diabetes self-management training
services are specified in § 410.142 (CMS
process for approving national
accreditation organizations).
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55223
A national accreditation organization
applying for deeming authority must
provide us with reasonable assurance
that it requires accredited entities to
meet requirements that are at least as
stringent as those set forth by CMS.
Nonprofit or not-for-profit organizations
with demonstrated experience in
representing the interests of individuals
with diabetes are eligible to request
recognition as a national accreditation
organization. The national accreditation
organization, after being approved and
recognized by CMS, evaluates the entity
to determine if it meets one of the sets
of quality standards as specified in
§ 410.144 (Quality standards for deemed
entities). If the national accreditation
organization finds that the entity meets
or exceeds applicable requirements, the
Secretary shall deem the entity as
meeting the Medicare requirements.
Section 1865(b)(2) of the Act requires
that the Secretary’s findings relative to
approving a national accreditation
organization as a deeming authority
consider the organization’s
requirements for accreditation, its
survey procedures, its ability to provide
adequate resources for conducting
required surveys and its ability to
supply information for use in
enforcement activities, its monitoring
procedures for entities found out of
compliance with the conditions or
requirements, and its ability to provide
the Secretary with necessary data for
validation. The Secretary evaluates 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(b)(3)(A) of the Act
requires that the Secretary publish
within 60 days of receipt of a completed
application, 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. In addition, the
Secretary has 210 days from receipt of
the request to publish a finding of
approval or denial of the application. If
the Secretary recognizes an
accreditation organization in this
manner, once an entity that furnishes
diabetes training is accredited by a
national accreditation organization, it
can be ‘‘deemed’’ to meet the Medicare
conditions of coverage for diabetes selfmanagement training.
II. Provisions of the Proposed Notice
[If you choose to comment on issues
in this section, please include the
caption ‘‘PROVISIONS OF THE
PROPOSED NOTICE’’ at the beginning
of your comments.]
E:\FR\FM\28SEN1.SGM
28SEN1
55224
Federal Register / Vol. 72, No. 188 / Friday, September 28, 2007 / Notices
The purpose of this notice is to notify
the public of the Indian Health Service’s
(IHS’s) request for the approval for
continued recognition as a national
accrediting organization for
accreditation of American Indian and
Alaska Native entities to furnish
outpatient diabetes self-management
training services. The IHS proposes to
continue to adopt the National
Standards for Diabetes Self-Management
Education as its quality standards. This
notice also solicits public comments on
the ability of the IHS to develop and
apply its standards to entities furnishing
outpatient diabetes self-management
training services.
Outpatient Diabetes Self-Management
Training Services
jlentini on PROD1PC65 with NOTICES
The regulations specifying the
Medicare conditions for coverage for
outpatient diabetes self-management
training services are specified 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 diabetes selfmanagement training services specified
by the Secretary.
Under section 1865(b)(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
specified in § 410.142(b), and we review
the ongoing responsibilities of an
approved accreditation organization.
We may visit the prospective
organization’s offices to verify
information in the organization’s
reapplication package, including, but
not limited to, review of documents,
and interviews with the organization’s
staff. We may conduct onsite inspection
of a national accreditation
organization’s operations and office to
verify information 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 from 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 consideration of public
comments received as a result of this
notice, we will publish a final notice in
VerDate Aug<31>2005
17:12 Sep 27, 2007
Jkt 211001
the Federal Register announcing the
result of our evaluation.
III. 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.
In accordance with the provisions of
Executive Order 12866, the Office of
Management and Budget did not review
this notice.
Authority: Section 1865 of the Social
Security Act (42 U.S.C. 1395bb).
(Catalog of Federal Domestic Assistance
Program No. 93.778, Medical Assistance
Program) (Catalog of Federal Domestic
Assistance Program No. 93.773, Medicare—
Hospital Insurance; and Program No. 93.774,
Medicare—Supplementary Medical
Insurance Program)
Dated: September 6, 2007.
Kerry Weems,
Acting Administrator, Centers for Medicare
& Medicare Services.
[FR Doc. E7–18470 Filed 9–27–07; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–1378–N]
Medicare Program; Medicare Provider
Feedback Group Town Hall Meeting—
October 16, 2007
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Notice of meeting.
AGENCY:
SUMMARY: This notice announces the
annual Medicare Provider Feedback
Group (MPFG) Town Hall meeting. This
meeting is open to all Medicare fee-forservice (FFS) providers and suppliers
that participate in the Medicare
program, including physicians,
hospitals, home health agencies, other
third-party billers and other interested
parties, to present their individual
views and opinions on selected FFS
Medicare topics. In addition, we will be
soliciting input on how we can improve
communications to better serve the
Medicare providers and suppliers. The
meeting agenda and discussion
materials will be available by October
12, 2007. The public can access these
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Fmt 4703
Sfmt 4703
materials at https://www.cms.hhs.gov/
center/provider.asp.
The feedback provided during this
meeting will assist us as we evaluate
FFS Medicare policy, operational issues
and CMS’ provider and supplier
communication activities. The meeting
is open to the public, but attendance is
limited to space available. Registered
participants from the meeting will be
included in the Medicare Provider
Feedback Group and may be contacted
throughout the year for follow-up
meetings to solicit additional opinions
and clarify any issues that may arise
from the October 16, 2007 meeting.
DATES: Meeting Date: The Town Hall
meeting announced in this notice will
be held on Tuesday, October 16, 2007,
from 2 p.m. to 4 p.m. e.s.t.
ADDRESSES: The Town Hall meeting will
be held in the main auditorium of the
central building of the Centers for
Medicare & Medicaid Services, 7500
Security Boulevard, Baltimore, MD
21244.
Written Questions or Statements: Any
interested party may send written
comments electronically. We will give
consideration to feedback received on
the topics discussed at the Town Hall
meeting, but written responses will not
be provided. We will accept and take
into consideration written feedback,
questions, or other statements about the
town hall meeting and agenda topics
before the meeting, and up until October
26, 2007. Send written feedback,
questions, or other statements to Colette
Shatto at MFG@cms.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
Colette Shatto, 410–786–6932. You may
also send inquires about this meeting by
MFG@cms.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
CMS has held three Medicare
Provider Feedback Group Town Hall
Meetings beginning in 2005. The
purpose of these meetings is to capture
individual provider and supplier
feedback on relevant FFS Medicare
policy and operational issues. As a
result, we are able to further advance
our efforts to strengthen the Medicare
program and enhance our relationship
with providers and suppliers. The Town
Hall meetings also provide a venue to
allow us to continue a process of
communicating with individual
providers and suppliers through the
following year.
II. Meeting Format
The meeting will begin with an
overview of the goals and objectives of
the MPFG efforts to gather feedback
E:\FR\FM\28SEN1.SGM
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]]>Agencies
[Federal Register Volume 72, Number 188 (Friday, September 28, 2007)]
[Notices]
[Pages 55222-55224]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-18470]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare and Medicaid Services
[CMS-3186-PN]
Medicare and Medicaid Programs; Application by the Indian Health
Service (IHS) for Continued Recognition as a National Accreditation
Organization for Accrediting American Indian and Alaska Native Entities
To Furnish Outpatient Diabetes Self-Management Training
AGENCY: Centers for Medicare and Medicaid Services, HHS.
ACTION: Proposed notice.
-----------------------------------------------------------------------
SUMMARY: This proposed notice announces the receipt of an application
from the Indian Health Service for continued recognition as a national
accreditation organization for accrediting American Indian and Alaska
Native entities that wish to furnish outpatient diabetes self-
management training to Medicare beneficiaries. This notice also
announces 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. October 29, 2007.
[[Page 55223]]
ADDRESSES: In commenting, please refer to file code CMS-3186-PN.
Because of staff and resource limitations, we cannot accept comments by
facsimile (FAX) transmission.
You may submit comments in one of four ways (no duplicates,
please):
1. Electronically. You may submit electronic comments on specific
issues in this regulation to https://www.cms.hhs.gov/eRulemaking. Click
on the link ``Submit electronic comments on CMS regulations with an
open comment period.'' (Attachments should be in Microsoft Word,
WordPerfect, or Excel; however, we prefer Microsoft Word.)
2. By regular mail. You may mail written comments (one original and
two copies) to the following address ONLY: Centers for Medicare &
Medicaid Services, Department of Health and Human Services, Attention:
CMS-3186-PN, P.O. Box 3014, Baltimore, MD 21244-1850.
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 (one
original and two copies) to the following address ONLY: Centers for
Medicare & Medicaid Services, Department of Health and Human Services,
Attention: CMS-3186-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 (one original and two copies) before the
close of the comment period to one of the following addresses. 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. Room 445-G, Hubert H. Humphrey Building,
200 Independence Avenue, SW., Washington, DC 20201; or 7500 Security
Boulevard, Baltimore, MD 21244-1850.
(Because access to the interior of the HHH 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.)
Comments mailed to the addresses indicated as appropriate for hand
or courier delivery may be delayed and received after the comment
period.
For information on viewing public comments, see the beginning of
the SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT: Eva Fung, (410) 786-7539.
SUPPLEMENTARY INFORMATION:
Submitting Comments: We welcome comments from the public on all
issues set forth in this proposed notice to assist us in fully
considering issues and developing policies. You can assist us by
referencing the file code CMS-3186-PN and the specific ``issue
identifier'' that precedes the section on which you choose to comment.
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.cms.hhs.gov/eRulemaking. Click on the link ``Electronic Comments on
CMS Regulations'' 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 when ordered by the
physician or qualified nonphysician practitioner treating the
beneficiary's diabetes, provided certain requirements are met. We
sometimes use national accreditation organizations to determine whether
a provider entity meets the Medicare requirements that are necessary in
order for an entity to provide a service covered by Medicare.
Section 1865(b)(1) of the Social Security Act (the Act), provides
that a national accreditation organization must have an agreement in
effect with the Secretary and meet the standards and requirements as
specified in 42 CFR part 410, subpart H. The regulations pertaining to
application procedures for national accreditation organizations for
diabetes self-management training services are specified in 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 it requires
accredited entities to meet requirements that are at least as stringent
as those set forth by CMS. Nonprofit or not-for-profit organizations
with demonstrated experience in representing the interests of
individuals with diabetes are eligible to request recognition as a
national accreditation organization. The national accreditation
organization, after being approved and recognized by CMS, evaluates the
entity to determine if it meets one of the sets of quality standards as
specified in Sec. 410.144 (Quality standards for deemed entities). If
the national accreditation organization finds that the entity meets or
exceeds applicable requirements, the Secretary shall deem the entity as
meeting the Medicare requirements.
Section 1865(b)(2) of the Act requires that the Secretary's
findings relative to approving a national accreditation organization as
a deeming authority consider the organization's requirements for
accreditation, its survey procedures, its ability to provide adequate
resources for conducting required surveys and its ability to supply
information for use in enforcement activities, its monitoring
procedures for entities found out of compliance with the conditions or
requirements, and its ability to provide the Secretary with necessary
data for validation. The Secretary evaluates 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(b)(3)(A) of the Act requires that the Secretary
publish within 60 days of receipt of a completed application, 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. In addition, the Secretary has 210 days from
receipt of the request to publish a finding of approval or denial of
the application. If the Secretary recognizes an accreditation
organization in this manner, once an entity that furnishes diabetes
training is accredited by a national accreditation organization, it can
be ``deemed'' to meet the Medicare conditions of coverage for diabetes
self-management training.
II. Provisions of the Proposed Notice
[If you choose to comment on issues in this section, please include
the caption ``PROVISIONS OF THE PROPOSED NOTICE'' at the beginning of
your comments.]
[[Page 55224]]
The purpose of this notice is to notify the public of the Indian
Health Service's (IHS's) request for the approval for continued
recognition as a national accrediting organization for accreditation of
American Indian and Alaska Native entities to furnish outpatient
diabetes self-management training services. The IHS proposes to
continue to adopt the National Standards for Diabetes Self-Management
Education as its quality standards. This notice also solicits public
comments on the ability of the IHS to develop and apply its standards
to entities furnishing outpatient diabetes self-management training
services.
Outpatient Diabetes Self-Management Training Services
The regulations specifying the Medicare conditions for coverage for
outpatient diabetes self-management training services are specified 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 diabetes self-management training services specified by the
Secretary.
Under section 1865(b)(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 specified in Sec. 410.142(b), and we review the ongoing
responsibilities of an approved accreditation organization.
We may visit the prospective organization's offices to verify
information in the organization's reapplication package, including, but
not limited to, review of documents, and interviews with the
organization's staff. We may conduct onsite inspection of a national
accreditation organization's operations and office to verify
information 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 from 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 consideration of
public comments received as a result of this notice, we will publish a
final notice in the Federal Register announcing the result of our
evaluation.
III. 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.
In accordance with the provisions of Executive Order 12866, the
Office of Management and Budget did not review this notice.
Authority: Section 1865 of the Social Security Act (42 U.S.C.
1395bb).
(Catalog of Federal Domestic Assistance Program No. 93.778, Medical
Assistance Program) (Catalog of Federal Domestic Assistance Program
No. 93.773, Medicare--Hospital Insurance; and Program No. 93.774,
Medicare--Supplementary Medical Insurance Program)
Dated: September 6, 2007.
Kerry Weems,
Acting Administrator, Centers for Medicare & Medicare Services.
[FR Doc. E7-18470 Filed 9-27-07; 8:45 am]
BILLING CODE 4120-01-P
