[Federal Register Volume 69, Number 166 (Friday, August 27, 2004)]
[Notices]
[Page 52722]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-18632]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3136-N]


Medicare Program; Meeting of the Medicare Coverage Advisory 
Committee--September 28, 2004

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). 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 concerns the use of 
portable multichannel home sleep testing devices as an alternative to 
facility-based polysomnography in the evaluation of obstructive sleep 
apnea. 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 Tuesday, September 28, 2004 
from 7:30 a.m. until 3:30 p.m. e.s.t.
    Deadline for Presentations and Comments: Written comments must be 
received by September 10, 2004, 5 p.m., e.s.t.
    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 by September 3, 2004 (see FOR FURTHER INFORMATION CONTACT).

ADDRESSES: The meeting will be held at the Holiday Inn Inner Harbor, 
301 West Lombard Street, Baltimore, MD 21201.
    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 to Janet A. Anderson, by e-
mail at [email protected] or by mail to the Executive Secretary, 
Office of Clinical Standards and Quality, Centers for Medicare & 
Medicaid Services, 7500 Security Boulevard, MailStop C1-09-06, 
Baltimore, MD 21244.
    Website: You may access up-to-date information on this meeting at 
http://www.cms.hhs.gov/mcac/default.asp#meetings.
    Hotline: You may access up-to-date information on this meeting on 
the CMS Advisory Committee Information Hotline, 1-877-449-5659 (toll 
free) or in the Baltimore area (410) 786-9379.

FOR FURTHER INFORMATION CONTACT: Janet A. Anderson, Executive 
Secretary, by telephone at (410) 786-2700 or by e-mail at 
[email protected].

SUPPLEMENTARY INFORMATION: 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 
us about clinical issues. This notice announces a public meeting of the 
Committee.
    Meeting Topic: The Committee will discuss the evidence, hear 
presentations and public comment, and make recommendations regarding 
the use of portable multichannel home sleep testing devices as an 
alternative to facility-based polysomnography in the evaluation of 
obstructive sleep apnea (OSA). Current national coverage guidelines 
specify that only polysomnograpy done in a facility-based sleep study 
laboratory may be used to identify patients with OSA requiring 
Continuous Positive Airway Pressure (CPAP) therapy. Polysomnograpy is 
the continuous and simultaneous monitoring and recording of various 
physiological and pathophysiological parameters of sleep. It includes 
sleep staging that is defined to include a 1 to 4 lead 
electroencephalogram (EEG), and electro-oculogram (EOG), and a 
submental electromyogram (EMG). Determination of respiratory effort, 
airflow, oxygen saturation, detection of cardiac abnormalities via 
electrocardiogram (ECG), body position, and limb movements are also 
essential features of the test. Portable monitoring devices encompass a 
wide range of technologies some of which are capable of obtaining the 
same measurement parameters as standard polysomnography. However, 
devices also exist that measure only subsets of this information. For 
example, certain devices measure cardiopulmonary variables, such as 
respiratory effort, airflow, oxygen saturation, and heart rate or ECG, 
without the ability to determine sleep staging. Another category of 
devices measures only one or two variables, such as oxygen saturation 
and heart rate or ECG. Background information about this topic, 
including panel materials, is available on the Internet at http://www.cms.hhs.gov/coverage/.
    Procedure: 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 named in the FOR FURTHER 
INFORMATION CONTACT section and submit the following by the Deadline 
for Presentations and Comments date listed in the DATES section of this 
notice: a brief statement of the general nature of the evidence or 
arguments you wish to present, and the names and addresses of proposed 
participants. A written copy of your presentation must be provided to 
each Committee member before offering your public comments. Your 
presentation must address the questions asked by us to the Committee. 
If the specific questions are not addressed, your presentation will not 
be accepted. The questions will be available on our website at http://www.cms.hhs.gov/mcac/default.asp#meetings. We request that you declare 
at the meeting whether or not 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.

    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: July 27, 2004.
Sean R. Tunis,
Director, Office of Clinical Standards and Quality, Centers for 
Medicare & Medicaid Services.
[FR Doc. 04-18632 Filed 8-26-04; 8:45 am]
BILLING CODE 4120-01-P