[Federal Register: August 27, 2004 (Volume 69, Number 166)]
[Notices]
[Page 52722]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27au04-53]
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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 JAnderson@cms.hhs.gov 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
JAnderson@cms.hhs.gov.
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