[Federal Register Volume 72, Number 120 (Friday, June 22, 2007)]
[Notices]
[Pages 34469-34470]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-12046]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services


Medicare Program; Meeting of the Medicare Evidence Development & 
Coverage Advisory Committee--(MedCAC)

September 12, 2007.
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION: Notice.

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SUMMARY: This notice announces a public meeting of the Medicare 
Evidence Development and Coverage Advisory Committee (MedCAC) 
(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 consider the 
evidence on the diagnostic criteria for obstructive sleep apnea (OSA) 
in Medicare beneficiaries who may be candidates for continuous positive 
airway pressure (CPAP) therapy and alternatives to facility-based 
polysomnography (PSG) in the diagnosis of OSA, including home sleep 
testing devices and clinical diagnosis without the use of sleep 
testing.
    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, September 12, 2007 
from 7:30 a.m. until 4:30 p.m., daylight savings time (d.s.t).
    Deadline for Presentations and Comments: Send written comments and 
presentations to the address specified in the ADDRESSES section by 5 
p.m., d.s.t. on August 13, 2007. Please note that the presentation you 
submit will be final, as no further changes to the presentation will be 
accepted after submission.
    Deadline for Meeting Registration: For security reasons, 
individuals wishing to attend this meeting must register by 5 p.m., 
d.s.t. on September 5, 2007.
    Deadline for Submitting Request for 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 as specified in the FOR FURTHER 
INFORMATION CONTACT section of this notice.

ADDRESSES: Meeting Location: The meeting will be held in the main 
auditorium of the Centers for Medicare & Medicaid Services, 7500 
Security Boulevard, 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.
    Submission of 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 specified in 
the ADDRESSES section of this notice.

FOR FURTHER INFORMATION CONTACT: Michelle Atkinson, Executive Secretary 
for MedCAC, (410-786-2881; [email protected]).

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. The MCAC was subsequently rechartered as the Medicare Evidence 
Development and Coverage Advisory Committee (MedCAC).
    This notice announces the September 12, 2007 public meeting of the 
Committee.
    This meeting will inform CMS in its reconsideration of the Medicare 
National Coverage Determination (NCD) on continuous positive airway 
pressure (CPAP) therapy for OSA. We received a complete formal written 
request from the American Academy of Otolaryngology-Head and Neck 
Surgery to modify the NCD to include the use of portable multichannel 
home sleep testing devices as an alternative to facility-based 
polysomnography (PSG) in the evaluation of OSA. In addition, we 
received an incomplete request from a Medicare beneficiary, numerous 
informal requests from stakeholders, and interest from Medicare 
contractors concerning the criteria for determining the apnea-hypopnea 
index (AHI) in sleep testing. We are also aware of recently published 
research suggesting a benefit for the use of CPAP without prior sleep 
testing in selected populations (trial of CPAP).
    During this meeting, the Committee will consider evidence and hear 
presentations and public comments on the use of home sleep testing 
devices or clinical diagnosis as an alternative to facility-based PSG 
in the diagnosis or both of obstructive sleep apnea (OSA); the criteria 
for determining the AHI; the use of clinical signs, symptoms or patient 
questionnaire results to establish a diagnosis of OSA; and the 
generalizability of the evidence to the Medicare beneficiary 
population.
    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 as specified in FOR FURTHER INFORMATION 
CONTACT section of the notice and submit the following to the address 
specified in the ADDRESSES section of this notice by the date specified 
in the DATES 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

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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 
specified 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. d.s.t. on September 5, 2007.

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 11, 2007.
Barry M. Straube,
Chief Medical Officer and Director, Office of Clinical Standards and 
Quality, Centers for Medicare & Medicaid Services.
[FR Doc. E7-12046 Filed 6-21-07; 8:45 am]
BILLING CODE 4120-01-P