[Federal Register Volume 71, Number 121 (Friday, June 23, 2006)]
[Notices]
[Pages 36120-36121]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-9480]


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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; 
[email protected]; 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; [email protected]; 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