[Federal Register: June 23, 2006 (Volume 71, Number 121)]
[Notices]
[Page 36120-36121]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23jn06-57]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-3170-N]
Medicare Program; Meeting of the Medicare Coverage Advisory
Committee--August 30, 2006
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Notice.
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SUMMARY: This notice announces a public meeting of the Medicare
Coverage Advisory Committee (MCAC) (``Committee''). Among other things,
the Committee provides advice and recommendations about whether
scientific evidence is adequate to determine whether certain medical
items and services are reasonable and necessary under the Medicare
statute. This meeting will discuss the following issues: (1) Glycemic
control and the use of glucose monitors by which sensors automatically
monitor glucose levels in body fluids; and (2) whether and how the
frequency of outpatient glucose monitoring is related to glycemic
control and clinical outcomes in the various Medicare populations.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. App. 2, section 10(a)).
DATES: The public meeting will be held on Wednesday, August 30, 2006
from 7:30 a.m. until 4:30 p.m., e.s.t.
Deadlines: Deadline for Presentations and Comments: Send written
comments and presentations to the address listed in the ADDRESSES
section of this notice by 5 p.m., e.s.t. on July 31, 2006. [Please note
that the presentation you submit will be final, as no further changes
to the presentation can be accepted after submission.]
Deadline for Meeting Registration: For security reasons,
individuals wishing to attend this meeting must register by 5 p.m.,
e.s.t. on August 24, 2006.
Special Accommodations: Persons attending the meeting who are
hearing or visually impaired, or have a condition that requires special
assistance or accommodations, are asked to notify the Executive
Secretary (see FOR FURTHER INFORMATION CONTACT) by August 24, 2006.
ADDRESSES: Meeting Location: The meeting will be held in the main
auditorium of the Centers for Medicare & Medicaid Services, 7500
Security Blvd., Baltimore, MD 21244.
Registration: Register by contacting Maria Ellis (410-786-0309;
Maria.Ellis@cms.hhs.gov; Centers for Medicare & Medicaid Services,
OCSQ--Coverage and Analysis Group, C1-09-06, 7500 Security Boulevard,
Baltimore, MD 21244).
Presentation and Comment Submission: Submit presentation and
comments to Michelle Atkinson, Centers for Medicare & Medicaid
Services, OCSQ--Coverage and Analysis Group, C1-09-06, 7500 Security
Boulevard, Baltimore, MD 21244.
Web Site: You may access up-to-date information on this meeting at
http://www.cms.hhs.gov/FACA/02_MCAC.asp#TopOfPage.
Presentations And Comments: Interested persons may present data,
information, or views orally or in writing on issues pending before the
Committee. Please submit written comments and presentations to the
Executive Secretary at the address listed in the ADDRESSES section of
this notice.
FOR FURTHER INFORMATION CONTACT: Michelle Atkinson, Executive Secretary
for MCAC, (410-786-2881; Michelle.Atkinson@cms.hhs.gov; Centers for
Medicare & Medicaid Services, OCSQ--Coverage and Analysis Group, C1-09-
06, 7500 Security Boulevard, Baltimore, MD 21244).
SUPPLEMENTARY INFORMATION:
I. Meeting Topic
On December 14, 1998, we published a notice in the Federal Register
(63 FR 68780) to describe the Medicare Coverage Advisory Committee
(MCAC), which provides advice and recommendations to CMS about clinical
issues.
This notice announces the August 30, 2006 public meeting of the
Committee. During this meeting, the Committee will discuss evidence and
hear presentations and public comments concerning outpatient glycemic
control (as measured by glycated hemoglobin), the frequency of glucose
monitoring, and clinical outcomes in the Medicare populations.
Specifically, the Committee will review the available data on the
ability of glycemic control to blunt the progression of disease,
reverse diabetic complications, and alter morbidity and mortality in
the Medicare populations; whether the effects of glycemic control (if
any) are linear and mitigated by increased hypoglycemic risk; and
whether the frequency of
[[Page 36121]]
outpatient glucose monitoring is a determinant of glycemic control and
clinical outcomes in the Medicare populations. The role of variables
such as the type of diabetes, the therapeutic regimen employed, the age
of hyperglycemic onset, the duration of diabetes, the duration of poor
glycemic control, the level of hyperglycemia, and concomitant disease
will be discussed. The impediments to glucose monitoring and use of
monitoring data will be considered. In addition to evaluating the
available data, the Committee will identify areas in which the current
data are deficient and in which additional research is warranted.
Background information about this topic, including panel materials,
is available on the Internet at http://www.cms.hhs.gov/coverage/.
II. Meeting Procedures
This meeting is open to the public. The Committee will hear oral
presentations from the public for approximately 45 minutes. The
Committee may limit the number and duration of oral presentations to
the time available. If you wish to make formal presentations, you must
notify the Executive Secretary (see FOR FURTHER INFORMATION CONTACT)
and submit the following to the address listed in the ADDRESSES section
of this notice by the date listed in the Deadlines section of this
notice: (1) A brief statement of the general nature of the evidence or
arguments you wish to present; (2) the names and addresses of proposed
participants; and (3) a written copy of your presentation. Your
presentation should consider the questions we have posed to the
Committee and focus on the issues specific to the topic. The questions
will be available on the following Web site: http://www.cms.hhs.gov/FACA/02_MCAC.asp#TopOfPage.
We require that you declare at the meeting
whether you have any financial involvement with manufacturers of any
items or services being discussed (or with their competitors).
After the public and CMS presentations, the Committee will
deliberate openly on the topic. Interested persons may observe the
deliberations, but the Committee will not hear further comments during
this time except at the request of the chairperson. The Committee will
also allow a 15 minute unscheduled open public session for any attendee
to address issues specific to the topic. At the conclusion of the day,
the members will vote and the Committee will make its recommendation.
III. Registration Instructions
The Coverage and Analysis Group is coordinating meeting
registration. While there is no registration fee, individuals must
register to attend. Register by contacting Maria Ellis at the address
listed in the ADDRESSES section of this notice. Please provide your
name, address, organization, telephone and fax numbers, and e-mail
address.
You will receive a registration confirmation with instructions for
your arrival at the CMS complex. You will be notified if the seating
capacity has been reached.
This meeting is located on Federal property; therefore, for
security reasons, any individuals wishing to attend this meeting must
register by 5 p.m. e.s.t. on August 24, 2006.
IV. Security, Building, and Parking Guidelines
This meeting will be held in a Federal government building;
therefore, Federal security measures are applicable. In planning your
arrival time, we recommend allowing additional time to clear security.
In order to gain access to the building and grounds, individuals
must present photographic identification to the Federal Protective
Service or Guard Service personnel before being allowed entrance.
Security measures also include inspection of vehicles, inside and
out, at the entrance to the grounds. In addition, all individuals
entering the building must pass through a metal detector. All items
brought to CMS, whether personal or for the purpose of demonstration or
to support a demonstration, are subject to inspection. 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 demonstration.
Parking permits and instructions will be issued upon arrival.
Note: 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 30 to 45
minutes prior to the convening of the meeting.
All visitors must be escorted in areas other than the lower and
first floor levels in the Central Building.
Authority: 5 U.S.C. App. 2, section 10(a).
(Catalog of Federal Domestic Assistance Program No. 93.774,
Medicare--Supplementary Medical Insurance Program)
Dated: June 7, 2006.
Barry M. Straube,
Chief Medical Officer and Director, Office of Clinical Standards and
Quality, Centers for Medicare & Medicaid Services.
[FR Doc. E6-9480 Filed 6-22-06; 8:45 am]
BILLING CODE 4120-01-P