Education, data, and interpretation are all services which will be eliminated and impact long term compliance in the treatment of OSA. Convenience and cost savings while important considerations in health care in this case leads to poor patient ca   More...

Comment on CMS National Coverage Determination
Proposed Decision Memorandum on CPAP

As an experienced medical professional in the
field of cardiology patient management, I am
pleased to submit these comments to the CMS in
re   More...

Being a registered technician who has worked in
the field for 10+ years, I would like to comment
on why I believe the home-testing for sleep apnea
is not a good idea. So many people have periodic
limb movements, restless legs and    More...

dear sir:
i believe the rational for approving home sleep
study as diagonstic rather screening tool for
diagnosis of sleep apnea for elderly poplaion is
wrong. I disagree with it and believe will harm
our patients.therefore it s   More...

The American Academy of Sleep Medicine (AASM)
welcomes the opportunity to provide comments
regarding the Proposed Decision Memo for
Continuous Positive Airway Pressure (CPAP)
Therapy for Obstructive Sleep Apnea (OSA) (CAG-
00093   More...

I am writing in support of the recent decision of
CMS to allow unattended sleep studies in the
diagnosis and management of OSA ( obstructive
sleep apnea). I feel that the current technology
in the home based sleep study is allowing fo   More...

I think this would not be a good idea because
being a sleep tech, and working in the field, I
have seen how a unattended study would not be
beneficial to the patient. Most patients with
OSA are large and some of this stuff that is   More...

I have been practicing general ENT for
25years. Half of my practice is sleep.The bulk of
patients(truly no pun intended)walk in for
reasons other than snoring.They may appear
entirely normal until the tongue base is
assesse   More...

I am strongly opposed to the CMS decision to cover all portable
monitoring for the diagnosis and treatment of sleep apnea. This
decision arose from the misconception that there is a long wait
to get into a sleep lab and that home test   More...

I am an ABSM-certified Sleep specialist, in
practice for 22 years. I have directed an
academic center, and currently direct a Sleep
program providing care in both rural and urban
settings.

CMS describes various “stakeh   More...

The American Association of Sleep Technologists
(AAST) welcomes the opportunity to provide
comments related to the Proposed Decision Memo
for Continuous Positive Airway Pressure (CPAP)
Therapy for Obstructive Sleep Apnea (OSA) (CAG   More...

I am a board-certified pulmonary and sleep
medicine physician with extensive experience
practicing sleep medicine. The large majority of
my clinical practice is taking care of sleep
disorder patients all types, certainly including    More...

January 7, 2008

Garry Aujla
Assistant General Manager
Nashville Sleep Medicine
115 Eastpark Drive, Ste 110
Brentwood, TN 37027

Letter to CMS regarding Home Sleep Studies

The technology behind conducting home sleep<   More...

January 7, 2008

Shawn Aujla
General Manager
Nashville Sleep Medicine
115 Eastpark Drive, Ste 110
Brentwood, TN 37027

Letter to CMS regarding Home Sleep Studies

The technology behind conducting home sleep
studies   More...

If we are going ahead with home testing then in
order to keep a whole medical profession from
disolving I beleive this should only be a tool
for sleep diagnosis. There ware way too many
other diagnosed sleep disorders that come ou   More...

Stephen Phurrough, MD, MPA
Director, Coverage and Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

Regarding: Proposed Decision Memo for Continuous
Positive Airway Pressure (   More...

I am completely opposed to allowing unattended
sleep studies. The accuracy of a home sleep
studies is medial at best. The majority of
people with mild apnea\RERA would be overlooked
and the high associated arousal index untreated.    More...

Sleep Disorders should be treated by sleep
specialist who understand the pathophysiology of
the diease and the ramificatios for treatment.
Unleasing sleep treatment for proper supervision
will lead to mis diagnosis, poor treatment   More...

Caution should be exercised reagarding decisions
based on class 4 devices that only include 2
channels, particularly in the home environment.
Even when supervised by various healthcare
professionals, these devices can be problemati   More...

Please put a link to this Web page from the home
pages for Medicare, Medicaid, Centers for Medicare
and Medicaid Services, and Health and Human
Services. In all three home pages I entered the
term public comment but in none did I get a   More...

Currently all AASM accredited sleep labs adhere
to standards that ensure patient education,
follow up and treatment compliance for all
patients that have an overnight sleep study. The
patients have the resource of calling or
re   More...

I am a sleep medicine specialist, board certified
in sleep medicine and in neurology, practicing in
North Carolina. I am writing to express concern
about the Proposed Memo for CPAP Therapy for OSA,
as it proposes to cover CPAP equ   More...

Medicare unfortunately by trying to meet their
budget, is refusing to recognize sleep apnea as
fatal problem in Americans across the nation.
Increasing in car accidents, and incidents of
heart failure....
Diagnostic testing by    More...

Home testing performed by properly trained and
certified technologists and interpretted by a
qualified physician may have a place in the
broader field of sleep testing.

Overall, the most common problems will arise with
the    More...

I am currently involved in the sleep lab testing business and am just worried about the coverage of home testing for patients. What we lose in this type of testing is the hands on patient care that really determines compliance for the patients we    More...

As a veteran physician in the field of sleep medicine, having founded the first adult sleep lab and clinic at Harvard Medical School in 1978, I have long known that in-home testing, under the right circumstances, would be a very valuable and cost-   More...

Unregulated, unattended portable testing and the
use of Auto PAP is money saver for the moment
however, long term consequences will probably
cost MONEY and LIFE as compliance will most
definitely go down. Heart attacks strokes will   More...

IT IS IMPORTANT TO PROVIDE EFFICAY DATA VIA DOWNLOAD ON ALL PT'S THAT HAVE BEEN DIAGNOSED WITH SLEEP DISORDERED BREATHING AND HAVE BEEN PLACED ON AN AUTO-PAP. WE PROVIDE ALL NEW PT'S WITH AN AUTO CAPABLE PAP DEVICE FOR FUTURE TITRATING NEEDS AND   More...

As a neurologist, I am very concerned that the
fact that CMS will agree to pay for a Home Apnea
study will lead patients that actually need a
full PSG to demand the home study. I have made
clear cut clinical diagnosis of sleep apn   More...

I know this will open a huge amount of fraud
options and will increase the cost of diagnosing
sleep diasorders by Medicare. There are some
large companies that are pushing this and all
they see is $$$$$$$. Sleep medicine has come   More...

From our medical director:

I am writing in response to the recently
published CMS national coverage determination
proposal for portable polysomnography testing,
appropriate therapies and follow up care. I
oversee an AASM acc   More...

January 10, 2008

Fredrick Bowman, Clinical Manager
American Sleep Medicine
1669 Kirby Parkway Suite 110
Memphis, Tn 38120

To whom it may concern;

I have been in sleep medicine for 14 years
and I have seen hom   More...

I am a practicing clinical neurologist who is
medical director of two
small Sleep Disorders Centers (one AASM
Certified for 16 years, the
other just newly started). I care for general
neurological patients, as
well as slee   More...

As a Respiratory therapist for 32 years, I cannot
endorse your decision to consider at home sleep
testing for our elderly a/o a disabled
population. With all of the disease states that
can be linked to untreated sleep apnea, accura   More...

I am very concerned and suprised that the
government will allow unattended home sleep
studies. This is a 30 year step backwards in the
diagnosis and treatment of sleep apnea syndrome
and other sleep disorders. Certain sleep
d   More...

For the last 20 years that I have been in the
field of sleep medicine, dramatic changes have
occurred. From new ways of treating patients to
an increase in un-ethical money hungry physicians
who set up so called sleep labs. These "   More...

We feel very strongly that portions of this CMS
decision should be clarified. Specifically, it
should be clarified:
• Portable testing needs to be done in
conjunction with a comprehensive sleep program
through American Academy    More...

The decision is difficult to understand since on
page 1 #2 seems to conflict with page 2, #5.
The latter states that coverage for CPAP will be
expanded ONLY in the context of a clinical
research study because is states that it is   More...

Seems like the issue is not portable monitoring
(PM)per se, but unattended monitoring that is the
key. CMS has approved unattended PM it appears.
It would seem that the Medicare benificiaries are
the very patients who would likely    More...

The current CMS proposal will remove the role of
the sleep medicine physician in the care of
patients with sleep apnea and have the diagnosis
be made and treated by corporate entrepreneurs
with little if no interest in the quality of t   More...

The proposed CMS regulations regarding the
diagnosis and treatment of OSA will require
modification to be clinically applicable in a
manner consistent with sound medical evidence.
Specifically, Type IV devices are insufficient to    More...

The idea of Medicare considering home unattended sleep studies is very surprising to me. I’ve worked in a sleep center for the last 14 years and understand the continuous work that is required throughout testing to obtain a good quality stud   More...

1/11/08

RE: CAG #00093R2

Dear Drs. Phurrough, Jacques, and Brechner

I appreciate the opportunity to submit comments
on the proposed National Coverage Determination
(NCD) for Continuous Positive Airway Pressure
(CPA   More...

Having scored thousands of sleep records over the
past 20 years, I can positively state that
without examining the neurophysiologic component
of sleep, scoring respiratory events becomes
largely a matter of guesswork. When only li   More...

I am in opposition to this ruling. I feel that
home sleep studies will be unsafe for patients,
they won't be accurate and will increase fraud
rate in South Florida and the rest of the US.
There will be no control over it. Furth   More...

Portable Monitoring in Sleep Medicine

Generally, I share the opinion of Dr. Barbara
Phillips, past president of the American Academy
of Sleep Disorders, about the worthlessness of
portable monitoring, interposing a less rigorous   More...

Paul Capodilupo BS, RRT
Manager of Cardiopulmonary Services
OSF, Saint Francis Hospital
Escanaba, MI. 49829

906-786-5707 ext 5304

I have read with interest the proposed changes to
the rules for reimbursing CPAP therapy.    More...

The use of Portable units can be beneficial to
some people who can't get to a sleep facility
such as nursing home patients however with no
sleep state documented, the sleep test could not
give an accurate AHI.Fraud for falsely NOT   More...

Thanks for opening Pandora Box I thought CMS
close it in the 90s. You (CMS) cut O2
reimbursements but now I can order a whole lot of
these home unit and be of and running $$$$$.

I oppose home sleep studies becuase I consider
them to be inadequate and unsafe for the
patients. It will also increase the fraud rate
in South Florida as there will be no control of
who is administering the study or referring. W   More...

I am an academic sleep specialist at Duke
University Medical Center. I fully support the
position and recommendation of American Academy
of Sleep Medicine. The current draft is not
evidence-based and the type 4 device should not    More...

My concern deals with patient care. Medicare has
done research in the past that shows that sleep
studies done in sleep centers have significantly
better quality than in-home tests. Also,
patients who have sleep studies done at sl   More...

I would like the change to also include a
guideline for patients with severe oxygen
desaturations due to sleep apnea. This would
include the ability to perform a split night
earlier due to these guidelines.

Portable or home sleep apnea testing will be a
good and usefull tool to help identify
individuals with a high likelyhood of moderate to
severe sleep apnea. However, this technology must
be controlled and administered by knowledgeab   More...

A)  Appropriateness of Home Sleep Testing (HST)

Our organization is not opposed to the use of HST.  We feel that HST is appropriate for the diagnosis of OSA in patients with high pretest prob   More...

Home monitoring potential for fraud and abuse.
QUESTIONS:
Definition of licnesed treating physiian?
Diagnosis and treat over the Internet?
Out of the Country?

What is a clinical evaluation?
a questionnaire?
over the intern   More...

January 12, 2008

Steve E. Phurrough, MD, MPA
Director, Coverage and Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244


RE: NCD for Continuous Positive Airway Pres   More...

HST will be a significant step backwards for your
beneficiaries and will result in many false
positives and negatives. Your beneficiaries
deserve the "gold standard" of care. I urge you
not to approve HST until further trials pro   More...

We do not support the use of certain portable
monitoring devices as acceptable for home sleep
testing.

1) Type IV portable monitoring devices are
not acceptable for use in HST. The use of an
airflow sensor and oxi   More...

This is a reckless and negligent proposal. If you
are in any sense an advocate for quality patient
care, you must reject the currently proposed
Medicare policy regarding home diagnostic testing
and empirical CPAP titration for obst   More...

December 26, 2007

To: CMS

From: Terence M. Davidson, MD

Re: Proposed Coverage Decision Memorandum for
CPAP (CPAP) Therapy for Obstructive Sleep Apnea
(OSA) (CAG-00093R2)


As a head and neck surgeon with in   More...

I am writing to recommend that unattended home
sleep monitoring be approved for CPAP coverage.
As a practicing RRT who also managed the sleep
center at our facilty, I can say that many of our
patients who could not undergo NPSG for   More...

I feel that Medicare is not responding to the
needs of their insureds by not recognizing sleep
apnea testing. There are approximately 18
million Americans that suffer from this problem.
This could mean the demise of several
ind   More...

First I completely agree that home testing is
acceptable for many patients with suspect sleep
disordered breathing (SDB) but that so far only
type I,II and III devices seem appropriate and
would advocate that type IV devices have l   More...

January 10, 2008



Ms. Francina Spencer
Centers for Medicare and Medicaid Services
Room C1-12-13 Central Building
Mail Stop: C1 -09-06
7500 Security Blvd.
Baltimore, MD 21244-1850

Re: Proposed    More...

I would like to comment on the proposal for at
home apnea testing...

As a sleep professional it has been in my
experience that cheap at home monitoring devices
of limited information can only lead to
misdiagnosis, and possib   More...

I support the expansion of in-home diagnostic testing to diagnose obstructive sleep apnea on patients that have been screened by a sleep specialist prior to the test being ordered and/or conducted.  Further, the testing shou   More...

WILL DME PROVIDERS BE ABLE TO SUPPLY THE TYPE
II,III OR IV SLEEP APNEA TESTING EQUIPMENT TO A
PHYSICIAN REFERRED CLIENT, AND, WITH QUALIFYING
RESULTS AND RX FROM THE PHYSICIAN, BE ABLE TO
PROVIDE THE CPAP AND SUPPLIES?

WILL   More...

We urge CMS to reconsider the changes being
proposed in the nature of polysomnographic
testing as a prelude to the utilization of CPAP
for OSAS. The accuracy of these tests has yet
not been definitively demonstrated in this
po   More...

I am against as I feel home testing will be used
by persons not educated in sleep medicine, will
not pick up other important clinical information,
and provides no method to detect fraud as to who
is actually being tested. This may   More...

As a practicing sleep medicine specialist in (insert state) and member of the American Academy of Sleep Medicine (AASM), I am writing in regards to the recent draft proposal issued by the Centers for Medicare & Medicaid Services (CMS): Continu   More...

I strongly disagree with medicare's proposal to
allow for CPAP therapy based on home monitoring
provided by portable diagnostic equipment.
Although I recognize the need for increased
availability of sleep diagnostic testing there   More...

HST has a place in diagnosing certain patients
but the CMS proposal is irresponsible as
proposed. It would be prudent for CMS to take
smaller steps and evaluate the results as less
drastic changes are made over a period of years -   More...

If Medicare approves home studies, we will have a
huge problem on our hands. There are
opportunistic people who only see $$ and do not
have the objective of conducting sleep studies to
diagnose, treat and cure sleep disorders. Al   More...

Available data do not indicate that portable
monitoring is more cost effective than laboratory
polysomnography, especially taking into account
technical failures, as well as false negative and
false positive results from portable m   More...

With regard to diagnostic testing and interpretation as outlined with the proposed wording, there are some changes that would be needed to assure the delivery of quality care to these individuals. As written, this would allow, and in fact promote,   More...

As a Sleep Medicine professional, I strongly
urge rejection of the proposed Medicare policy
regarding home diagnostic testing and empirical
CPAP titration for obstructive sleep apnea
(OSA).

First of all, this proposal allow   More...

A) Appropriateness of Home Sleep Testing (HST)

in patients with high pretest probability of
moderate to severe OSA. HST is not appropriate
for the diagnosis of OSA in patients with
significant co-morbid conditions nor it is <   More...

To whom it may concern,
It is my observation that as sleep medicine is
still a growing field, extreme caution should be
used in allowing health care providers to utilize
home testing as adequate to prescribe CPAP therapy.

It is    More...

December 20, 2007

Steve Phurrough, MD
Director, Coverage and Analysis Group
Center for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore, Maryland 21244-1850

Re: Comment Period-Home Sleep Testing Draft   More...

I am a technical director in a sleep center and have seen the benefits of having cpap titration preformed by trained technicians. What happens to the patient we have to coach to wear the mask? What happens when they become very anxious? What happe   More...

I disagree with unattended sleep studies. I
worked in a sleep lab and know how important the
basic hookup is and the need to pay attention to
all channels throughout the night. I'm sure there
will be many useless test received due   More...

I am writing to express my deep concern over the
CMS proposal to permit unattended in-home testing
for sleep apnea. This proposal appears to place
expediency ahead of quality care for our seniors,
myself included. I don't claim to u   More...

Although home sleep testing and/or unattended
testing can be a useful tool in sleep medicine
for the inpatient or the much
exaggerated "patient in wait", we need to make
sure that we do not do a diservice to the many in
an atte   More...

I believe that allow diagnosis of OSA from home
equipment is a big mistake. Sleep studies are
very fluid and to be done correctly the element
of human observation, documentation and
intervention should always be available. Ther   More...

CMS' proposed change to allow for portable home
testing is another classic, disturbing example of
poorly conceived policy. It is misleadingly guised
to the public as an 'increased access' campaign
when, in reality, the primary objec   More...

I applaud the decision to allow home testing. I
believe it will improve access and reduce the
cost of diagnosing sleep-disordered breathing. It
may also allow less costly follow-up of patients
to ensure optimal outcomes.

As a practicing sleep specialist, I have grave
concerns about home testing for sleep apnea.
Sleep related breathing disorders are a group of
complex often life threatening conditions that
require special expertise and careful manag   More...

The American Sleep Apnea Association (ASAA)
supports the proposed decision to permit Level II,
III, and possibly IV devices in the diagnosis and
management of obstructive sleep apnea because 1)
it will be less costly for people current   More...

I would like to say that I am deeply disturbed by
this proposal that is coming through. My
concerns are for the well-being of the patients
involved. I believe that patients will not get
the treatment necessary to improve their he   More...

I believe that the use of home testing devices in
the detection and treatment of OSA does a
disservice to the patient. Education, data, and
interpretation are all services which will be
eliminated and impact long term compliance in the   More...

I really think if this is aggressively used it
will fail based on the economics. There will be
enough bad outcomes to inhibit widespread use.

Insurance companies could easily payout more in
the end and with unhappy subscribers. It'   More...

I find it amusing that CMS ruled that attended
sleep studies could not be performed in a
hotel/motel setting starting January 1, 2008, yet
CMS is considering unattended studies for
diagnosing obstructive apnea in a patient's
h   More...

I am concerned with the coverage of unattend
studies as we seem to get a lot of studies back
even from overnight oximeters with so much
artifact it is hard to determine exactly what was
happening. Patients have a hard time hooking    More...

Nanette Hajj
General Manager
Midsouth Sleep Diagnostic Center ,Inc
1669 Kirby Pkwy Suite 110
Memphis,TN 38120

Please help us treat patients right.

Letter to CMS regarding Home Sleep Studies

As a center manager and    More...

I support you decision/proposal to allow home
sleep studies. I do a lot of Sleep Apnea home
studies and treatment. Thomas d. Hall DDS

I do not support the proposal for portable
monitoring for diagnosing OSA as it is currently
written. The new Medicare proposed
recommendations for accepting type 4 devices for
diagnosis of OSA and using Auto PAP as a
treatmen   More...

Unattended home sleep monitoring should be under
the auspices of an accredited sleep center by the
American Academy of Sleep Medicine and evaluation
for determining whether patients will benefit or
qualify for a home based sleep st   More...

There are 3 modifications that I would recommend:
1. These studies have not been evaluated in the
pediatric population. Thus, home studies should
NOT be used in this population until more
published data is available.
2. Thes   More...

I am a registered polysmnographic technologist
(RPSGT) and in the past seven years I have
trained with some of the brightest sleep
certified doctors in the field. I also was
unfortunate to work with doctors that acquired
their   More...

This is obviously a debatable issue that can be
argued back and forth. To me it seems that CMS
is more interested in listening to the ENT's of
the world, because the folks at the AASM have not
been talking enough. Therefore, I w   More...

Home sleep studies would be of use for PCP to use
to screen for OSA. Positives would need to be
confirmed and followed up in a facility center.
In our facility we find that 12 weeks followup on
CPAP is not adequate. One or two w   More...

I oppose the decision to allow home sleep
studies due to the fact that quality will be
compromised immensely in all areas of sleep
medicine. Sleep Apnea is a very serious and
debilitating disease which will go
underdiagnosed o   More...

There is no denying that portable home sleep
studies can be instrumental in diagnosing OSA.
There are many questions that must be determined
before CMS opens a huge can of worms:

1. Who can perform these studies? IDTF's, Sleep    More...

Has anyone taken into consideration the number of
repeat/invalid studies that will be done? I am a
sleep tech and I took home a unit to try it out
and I woke up with the pulse oximeter off. Your
SAO2 is a major determining factor i   More...

Evidence provided on portable monitors have been
on patients approximately 50 years of age, a
group that is younger than the average member of
the Medicare population. Medicare patients may
have additional health concerns that coul   More...

I could not think of a more wasteful and poorly
thought out scheme than to allow for home testing
for sleep disordered breathing, let alone
allowing it to be performed by non sleep
physicians. This would be ripe for abuse, and
   More...

Dear Friends:

I am writing regarding the proposal to allow home
sleep testing. As the Patient Care Coordinator
at a sleep facility I have some concerns
regarding this proposal.

• I counsel patients daily who have sleep <   More...

It is my opinion that CMS has approached this
review in a fair and reasonable manner up to this
point. However, I am concerned that in the draft
release of this coverage determination that more
specific requirements of who will pe   More...

Dear Sirs;

I am writing to oppose the use of unregulated,
unattended, portable monitoring for the diagnosis
and treatment of sleep disordered breathing.

Over the past few years the topic of portable
monitoring has been a c   More...

It is my firm belief that opening up portable sleep study testing to and and all providers will result in a hugh increase in usage for Medicare and Medicaid, at greatly increased cost, rather than a financial savings. It takes a great deal of expe   More...

I feel there is a strong possibility for abuse by
DME's or individuals that purchase Type IV
devices and AutoCPAPs and bill themselves
as "sleep specialists"
I would hope that HST would still have the
requirement of supervisio   More...

As both a Register Polysomnographer and a Registered Respiratory Therapist, I am concerned with the "dumbing down" of our professions. I have in the past 10 yrs. seen "fly-by-night" labs open up that hire anyone off the street without any medical    More...

There are a variety of valid reasons to allow
home studies. The recommendations given by AASM
should be the criteria adopted to determine which
setting a study should be performed. My comment
is that ALL forms of studies be done th   More...

I just read a comment on Home OSA testing by an
HME supplier.
His comment "Sadly it would be too easy for a DME
to manipulate the study in order to bill for the
equipment." This type of statement is ludicrous
and in my opini   More...

As a board-certified sleep medicine physician and
a public health professional, I do not support
the current plan to allow home testing to
diagnose obstructive sleep apnea. There are far-
reaching ramifications of this decision, mo   More...

I Oppose home sleep testing, which has no
standard, Its just proposed to solve the problem
of long waiting period for testing, however Don't
forget that its a Medicine, changes someone's
life and should never consider substandard   More...

I am against the proposal for home testing for
Dx. of OSA. This proposal is counter to current
medical literature as discussed by the AASM
response.

By considering portable monitoring for
identification of OSAS, you will be opening the
doors for every physician practice who wants to
pad their back pockets with another revenue
stream. I guarantee, most of these physicians
w   More...

Pacific Pulmonary Services
88 Rowland Way, Suite 300
Novato, CA 94945

January 13, 2008

Acting Administrator Kerry N. Weems
Centers for Medicare an Medicaid Services
U.S. Department of Health and Huma   More...

The In Home Unattended Sleep Study devices are of course being utilized today with positive outcomes.  The most efficient process would be; Upon Physician's orders, DME companies are dispensing these devices, teaching the pa   More...

The following is so so very important....

Who Should Care for our “Greatest Generation’s”
Sleep Disorders?


At the 2004 Annual Meeting of the American
Academy of Otolaryngology - Head and Neck
Surgery Foundation in New   More...

While I agree that home sleep testing is the
future of the sleep medicine, I am concerned
about the rush to do it now. Through our own
research of the home testing equipment, it is
apparent that work still needs to be done in
   More...

Although portable at-home sleep testing can be an
effective alternative to formal sleep lab testing
for sleep apnea I fear that establishing
insurance payments for such testing may quickly
result in immediate abuse as a new form of   More...

I am infavor of being able to do in home studies.

January 12, 2008

Steve E. Phurrough, M.D.
Director, Coverage Analysis Group
Centers for Medicare & Medicaid Services
Office of Clinical Standards & Quality
7500 Security Boulevard
Mail Stop C1-09-06
Baltimore, MD 21224-185   More...

I completely support AASM in they comments:
Available data indicate that laboratory
polysomnography is widely available in the United
States and that the widely quoted opinion that
there are inadequate numbers of facilities in the <   More...

I'm concerned that you do not have an accurate
definition of RDI.

RDI, first of all, stands for Respiratory
Disturbance Index (not Distress).

Second, and most important, the RDI does not stand
for apneas plus hypopneas.    More...

Medicare needs to listen to the American Academy
of Sleep Medicine (AASM) on this issue.

If Medicare doesn't, Medicare and Medicaid will
see a tremendous rise in the cost of surgery that
will be done inappropriately, mainly by    More...

January 11, 2008

Steve Phurrough, MD
Director, Coverage and Analysis Group
Center for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore, Maryland 21244-1850

Re: Comment Period-Home Sleep   More...

As a Sleep Medicine professional, I strongly urge
rejection of the proposed Medicare policy
regarding home diagnostic testing and empirical
CPAP titration for obstructive sleep apnea (OSA).

The proposal as written allows any ph   More...

Steve Phurrough, MD, MPA
Director, Coverage and Analysis Group
Centers for Medicare & Medicaid Services
U.S. Department of Health and Human Services


January 11, 2008


Dear Dr. Phurrough,

This letter is i   More...

The following was also submitted via email.
Thank you.

January 7, 2008

Kerry Weems, Acting Administrator
Centers for Medicare and Medicaid Services

RE: CMS Proposed Decision Memo for Continuous
Positive Airway Pres   More...

In the Proposed Decision Memo for Continuous
Positive Airway Pressure (CPAP) Therapy for
Obstructive Sleep Apnea (OSA), the Center for
Medicare and Medicaid Services (CMS) states that
arousals from sleep are what prevents the body    More...

I am a dentist in San Francisco with 20 years experience treating
snoring and mild to moderate sleep apnea with dental
appliances. This modality was not even considered in the new
proposed guidelines for home testing and treatment of S   More...

Letter to CMS regarding Home Sleep Studies

The technology behind conducting home sleep studies is improving. From our trials of various manufacturers’ equipment in our sleep center we feel there is much work still to be done. Howev   More...

Steve E. Phurrough, MD, MPA
Director, Coverage and Analysis Group
Centers for Medicare & Medicaid Services

Dear Dr. Phurrough,

I was very surprised to see the extent to which the proposed coverage policy went.   More...

RESPONSE TO CMS PRELIMINARY DECISION ON CPAP
COVERAGE


The CMS announcement regarding the preliminary
decision on changes for coverage of CPAP, and
the role of unattended portable monitoring is
certainly welcome. Th   More...

Allowing for reimbursement of unattended,
portable monitoring in the treatment and diagnosis
of sleep disorders will result in preventable risk
to patients and unnecessary expense to the health
care system. This is a misguided en   More...

In addition to the obvious reasons against having
inadequately trained, any “licensed physician”
manage sleep patients with unattended home
monitoring, the “negative domino effect” this
ruling will have on care of patients is
e   More...

12.30.07

Steve Phurrough, MD
Director, Coverage and Analysis Group
Center for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore, Maryland 21244-1850

I writing to oppose the home sleep    More...

When I first heard of the HST being asked to be included for coverage under CMS I had some immediate questions. How a HST could accurately collect the data and still come up with results that are dependable and verifiable? A Type II monitors have    More...

Dear Sirs:

I am a board certified sleep medicine physician
who has been caring for patients with sleep
disorders for more than 10 years. In our
institution we have been performing high quality
multichannel home sleep studie   More...

1-11-08

RE: CAG-00093R2

Comments: Proposed Decision Memo for Continuous
Positive Airway Pressure (CPAP) Therapy for
Obstructive Sleep Apnea (OSA

NAMDRC, the National Association for Medical
Direction of Respiratory   More...

I do not necessarily oppose home testing as a
much improved screen for sleep apnea, but I do
oppose this being done without sleep specialist
supervision. I also feel that a full study should
be performed for the titration. When the   More...

Home testing without any control of who is
qualified to do the testing will open another
source of income for unscrupulous home care
companies and medical providers. There has to be a
mechanism to restrict it to the people who are
   More...

The CMS is to be commended for its preliminary
decision to cover CPAP based on clinical
evaluation and testing with either I, II, III, or
IV devices. CMS has established that there is
sufficient evidence that home diagnosis is as <   More...

To allow portable sleep apnea testing to be done
in the hands of non-sleep specialists, largely
otorhinolaryngologists(ENT's), who are frustrated
with not receiving enough referrals for surgical
treatment of obstructive sleep apne   More...

This is in response to Home sleep studies studies, and new related CPAP payment issues. I am a Respiratory Therapist and I owne a DME company that only suplies CPAP/ BIPAP I believe there are so many patients that have OSA and go without a polysom   More...

As a practicing sleep medicine specialist in
Missoure and member of the American Academy of
Sleep Medicine (AASM), I am writing in regards to
the recent draft proposal issued by the Centers
for Medicare & Medicaid Services (CMS): <   More...

Dear Colleagues,

On December 14, the Centers for Medicare and
Medicaid Services ( CMS) released it’s Proposed
Decision Memo for Continuous Positive Airway
Pressure (CPAP) Therapy for Obstructive Sleep
Apnea (OSA). (CAG-00093   More...

I have been in the field of sleep disorders
testing for 20 years. I am in favor of home
testing as long as there are guidelines
established for its proper use, scoring and
interpretation by a Board Certified Sleep
Specialist.    More...

To Whom it may concern:

In review of the purposal for home monitoring
and therapy of sleep apnea, there should be
great concern for the competency of these
procedure when performed in the home. As
experienced with the now p   More...

Dear CMS,

I am a registered Respiratory Therapist working
in sleep medicine. I am concerned about sleep
studies being performed in the home setting.
Often while working in the lab our patient
require reassurance and coaching   More...

How is Medicare going to prevent insurance fraud
with Home Testing for Sleep Apnea? If a insured
patient with an uninsured family member gets a
home test, and let the uninsured family member
wear it. Then they let them wear the A   More...

There is so much more to sleep than simple sleep
apnea. A home test will show only simple
obstructive sleep apnea. If there is anything
else involved i.e. CPAP intolerance, narcolepsy,
complex sleep apnea, central sleep apnea, or   More...

Please note publication by the American Academy
of Sleep Medicine of new guidelines on use of
unattended portable sleep monitors in the
diagosis of OSA in adult patients on December 15,
2007 in the Journal of Clinical Sleep Medicin   More...

My concern is for the quality of the testing. If
home care comapanies do the testing and benifit
from the CPAP contract that results, how ethical
is that? I think the quality will suffer and CPAP
will be the next Valium.

While the proposed decision is undoubtedly well
intended, it really is sending the medical
(sleep) community in a bit of a tizzy.
Unintended consequences exist such as; the
difference in use of methodology to "score" the
sleep   More...

There are a number of concerns regarding the
proposed decision to allow home sleep testing.
These are issues and questions I have concerning
the proposed decision:
Issue #1: allowing the use of Type IV devices to
screen for sle   More...

I am afraid that unless there is strict
guidelines for interpretation and follow up for
the patients that have to use this type of
testing, many patients will be missed diagnosed
and not have the proper follow up. This could
le   More...

There are 2 modifications that I feel should made
to your proposed change regarding home sleep
studies to diagnose OSA.
1. These studies should be interpreted only by
individuals trained in sleep medicine. I have
seen home car   More...

Letter to the CMS regarding home sleep studies

I have worked in a sleep center 15 years and there have been many changes in the field of sleep medicine. Home sleep studies can be a very important part for the diagnosis and continued trea   More...

I am a board certified sleep specialist, and
have over 20 years experience with both home
testing and in-lab testing for sleep apnea. At
the current time, about 40% of our sleep tests
are done at home and 60% are laboratory based.   More...

My experience with outpatient studies has not
been good. My only experience is with auto
CPAP. Initially I was enthused thinking it
would better assimulate real life experience
outside the hospital environment and better
refle   More...

It is very scary that CPAP titration is not
required if the diagnosis is confirmed with full
PSG or HST. There is no evidence to support this.

There are a lot of limitations for HST and this
might result in misdiagnosis and tre   More...

I agree that home testing in certain population
would be effective and increase availability. I
do have question on who would administer this
testing (to avoid over utilization and self
revenue generating)(pandora's box). DME ki   More...

As a sleep specialist, I am very concerned about the use of certain
portable monitoring devices, especially in the Medicare population.
Also concerning is the validity of Type IV portable monitoring
devices. Other concerns include pa   More...

Home sleep testing should only be entrusted to fully accredited sleep centers that are knowledgeable, responsible and patient care orientated. These home sleep testing facilities should also ensure that studies are reviewed and interpreted by slee   More...

Dear sirs - I am quite concerned that your review
of this matter did not include my recent peer
reviewed paper "Obstructive Sleep Apnea (OSA) in
Primary Care - Evidence Based Practice, published
in the Journal of the Board of Family Pr   More...

In response to the CMS proposed actions on HST
and OSA treatment with CPAP:

As a sleep and respiratory specialist for 12
years I do agree with some colleagues that in the
right circumstances that HST could be
beneficial.    More...

While the at home testing could be a
valuable "screening" tool, it is necessary to go
to a sleep lab for clinical documentation of
adequate CPAP titration. This "proof" is the only
way to document that the patient had actual
re   More...

There will be a real possibility of fraud with
the decision of CMS to allow home testing.

Claude Albertario, RPSGT of www.somn.us has very
eloquently described the possibility of fraud.


"Fraud on the clinican's part, "J   More...

My comment on the following blog, “Who Should Care for our
Greatest Generation’s Sleep Disorders?” at
www.sleepwellandlive.wordpress.com.

I am an otolaryngologist and member of the AASM, and my
practice is primarily sleep-relate   More...

I am a practicing sleep medicine specialist in NY. I am concerned that current CMS proposal does not include defined and comprehensive policies about home sleep testing and this may cause negative impact on clinical practice and patient care.

I am pleased to see that expanded coverage for
CPAP therapy with a diagnosis from a home sleep
test is being considered for Medicare patients. I
have worked in clinical sleep for 4 years,
administering over a 1,000 home sleep tests. T   More...

In mountainous communities, Medicare should
allow "at home" sleep studies, by mobile
companies that can provide fully attended sleep
studies at patient homes, if the patient lives
2000 feet or more, in elevation, above that of
   More...

I have extensive experience with ambulatory
monitors as I have used them in our HMO patients
for several years. They are useful and seem to
expedite the diagnostic evaluation. They are
most useful when the clinical evaluation is ve   More...

what will be the qualification requirements of
the individual(s) providing the HST? Will anyone
be able to do it or will there be restrictions?

Dear CMS,
I am writing in response to the 30 day comment
period about diagnostice in home testing for
OSA. CMS must look at this as an over all
quality of care issue. What is being done here
is the Head and Neck Surgery Fellow   More...

Dear Sir / Madam,

I am commenting on this proposed NCD as a
physician and a researcher in the field of sleep
medicine. I completed my fellowship in the
Brigham and Women''s hospital, Harvard Medical
School, including pass   More...

I am an ENT physician/surgeon and a sleep specialist (board certified in both specialties) and frankly I am ashamed to count the drafting physician of this proposal (Terence Davidson) as a fellow ENT colleague. This (his) proposal is short sighted   More...

Although CPAP has been used extensively for the
treatment of Obstructive Sleep Apnea (OSA), as a
registered sleep technologist, there have been
many technological advances for the treatment of
OSA that have come to the marketplace. CPA   More...

January 11, 2008

RE: (CAG-00093R2)

The Sleep Manufacturers Alliance (SMA) welcomes
the opportunity to comment on proposed changes
to the National Coverage Determination for CPAP
therapy for Obstructive Sleep Apnea posted   More...

Dear Sirs:

I am writing in support of the proposal to expand
diagnostic and therapeutic testing for sleep
disordered breathing to include home studies.
Sleep disordered breathing constitutes a large
and largely under-recogn   More...

I am against home testing for osa, but if home
testing is to be implemented, allow me to make
the following suggestions:

1. DME companies should not be allowed to
provide home testing, due to the conflict of
interest in pro   More...

I practice a single speciality-Sleep medicine-in
a community setting as a board certified sleep
specialist and medical director of an AASM
accredited sleep center. Like Dr. Mulgrew's
center in Canada we have on staff a full time <   More...

attented at home sleep studies (95810 and 95811)
are ok by me as long as the are preformed by
qualified techs. any study that is not attened
and has less then 10 monitored channels is not a
good study and should not qualify a patien   More...

I think that this proposal is not in the best
interest of the patient. It sounds like it will
save the insurance companies money. It seems
that Sleep Medicine treatment is taking a a turn
for the worst. Without a certified Sleep    More...

Home screening for OSAS and more spercifically
Sleep Related Disordered Breathing seems
feasible with a Level 2 or 3 device. A full
polysomnography is still the gold standard and
physicians should have the right to still order
t   More...

I am strongly opposed to the CMS decision to
vover all protable monitoring fo the diagnosis
and treatment of sleep apnea. There is no need
for this since we can get sleep disorder patients
in for a test within the week and the tes   More...

Home sleep studies inherently reduce quality in
the evaluation of patients with these
debilitating conditions. As is well known, home
tests significantly limit the extent of the
evaluation possible within a professional care
se   More...

January 7, 2008

Shawna L. Ritchie, RPSGT
National Director of Clinical Services
American Sleep Medicine
1102 Anderson Road
Georgetown, Kentucky 40324

Letter regarding Home Sleep Studies

Although the technology behi   More...

1. I find the third change to contradict the 2nd
change. In the third change there is a reference
to sleep. Specifically...recognize shorter
periods of continuous recorded sleep.... It would
seem difficult to determine whether a pa   More...

January 10, 2008



Ms. Francina Spencer
Centers for Medicare and Medicaid Services
Room C1-12-13 Central Building
Mail Stop: C1 -09-06
7500 Security Blvd.
Baltimore, MD 21244-1850

Re: Proposed    More...

I oppose to home sleep studies because they are
of poor quality and unsafe for the patients.
The quality of the data will be in question as
there will be no one available to determine
whether the data is artifact or real patient <   More...

I am very concerned about physicians making
dignoses based on single-channel screening
devices (type IV), since it is relatively easy
for patients to purposely create false positive
test results using these technologies.

Als   More...

Though the recent AASM guidelines for home Sleep
Apnea diagnostic testing have merit and are
consistent with current technology, I and other
Sleep clinicians, are very concerned about the
potential for abuse and inappropirate overu   More...

I oppose to home sleep studies as these studies
are of inferior quality and will be unsafe for
the patients due to the decreased number of
monitoring parameters and ability to determine
whether data is artifactual or real patient <   More...

There is a potential for tremendous abuse of this
technology by home care providers as well as less
than scrupulous entrepreneurs who will view this
as a means of co-opting primary care physicians
into their network of sleep servic   More...

Let the fraud begin. You are opening the gates to
a new era of poor care at what will prove to be a
staggering cost to CMS. This ruling was wanted by
the equipment manufactures to sell machines.
Special intrest wins again!

I feel it is important to state that a lot of
companies and facilities interested in doing the
HST are DME company's and other facilities. I am
an educator in sleep medicine and sleep technology
here at my sleep center and the local    More...

I believe that the people initiating this see dollar signs and the patients are the one that are going to have to suffer. Research has proven that there is not a long wait to get in for a sleep study throughout the United States.

Colorado Sleep Society's (80 members: MD, DO,
DDS, PhD, RPSGT & Sleep Technicians) Consensus
Response on Date: 1-08-08, To:

MEDICARE PLANS FOR CHANGING PATIENT CARE - SLEEP
APNEA

J. F. Pagel MD, D,BSM, President (2004-   More...

In my experience, the most cost effective
approach is do a split study PSG, using the
first half to diagnose OSA and if present the
second half to titrate the CPAP. Home studies
vary widely in diagnostic accuracy. Only 50% of
p   More...

My name is John Seaton and I am Supervisor of
the LeBonheur Pediatric Sleep Disorders Center
in Memphis, Tn. This is a sleep disorders center
accredited by the American Academy of Sleep
Medicine. We are also a contracted Medicare    More...

I have been running polysomnograms for ten years, so my "HANDS ON" I believe my experience should be extremly useful in this topic. Most people who are diagnosed with OSA (obstructive sleep apnea)do not fair positively initially with CPAP. It is v   More...

The technology behind conducting home sleep
studies is improving. From our trials of various
manufacturer's equipment in our sleep center, we
feel there is mulch work still to be done.
However, medicare is going to approve the u   More...

I do realize that PSG is an expensive test. It
is gold standard for diagnosis of sleep apnea.
I have seen patients who received CPAP from
their relatives and using it. They still come to
see me because they are not improving. Diagno   More...

January 11, 2008

David Shapouri
General Manager
American Sleep Medicine
660 Kenilworth Drive, Suite 203
Towson, MD 21204

RE: In-Home Sleep Studies

I am writing to express my concern for the
process   More...

I am an otolaryngologist, and have enjoyed a thirty year history in sleep medicine. I became a diplomate in Otolaryngology and was named otolaryngological consultant to the first accredited sleep/wake center in the US (Montefiore Hospital, Albert    More...

The proposed changes for coverage of portable
sleep studies are welcome on one hand, however
not free of potential hazards on the other. It
should also be linked with who can order Portable
studies. The science of portable studies    More...

As clinical supervisor of an accredited sleep
disorders center, I am writing in regards to
allowing portable sleep testing. I contend that
patients who do not receive care under
established practice parameters and safe guards
e   More...

One wonders how this discussion would have
developed if CPAP devices were distributed
independently of the DME industry. If there were
no profit to be made from CPAP, would the DME
industry have expressed so much concern for early    More...

I am not in favor of the home testing proposal
from CMS as it currently stands. The proposal
will allow an increase in access to diagnostic
testing in the absence of adequate standards and
will result in substandard care for patien   More...

I am against home testing for the diagnosis of
OSA. This proposal seems to reverse the trend of
CMS to provide adequate standards for diagnostic
testing.

I believe that Medicare will pay more money out
due to repeat testing and inaccurate studies and
patient's will not get the care that they need
and deserve if you open this up for everyone.
There has to be a standard for complianc   More...

Subject: Proposed Decision Memo for
Continuous Positive Airway Pressure (CPAP)
Therapy for Obstructive Sleep Apnea (OSA) (CAG-
00093R2)

Dear, Steve Phurrough, MD, MPA
Louis Jacques, MD
Francina Spencer   More...

To the committee,

As a clinician, researcher, and instructor in
respiratory care for over 25 years. I do see a
need for home sleep testing due to the backlogs in
sleep clinics for inpatient testing as long as
certain restriction   More...

Home diagnostic sleep studies, which are patterned after the control standards of a typical sleep lab environment, provide for ease of scheduling and the comfort of routine sleep.

Many patients must wait to be added to 'the schedule' w   More...

At the 2004 Annual Meeting of the American Academy
of Otolaryngology - Head and Neck Surgery
Foundation in New York, Terence Davidson, an
Otolaryngologist (ENT) and Dean of Continuing
Education at the University of California, San
D   More...

In our lab we offer free screening for OSA.
We've had many peolpe that are not able to place
the cannula on themselves (after instruciotn and
demonstration)and press the button to start a
recording, and you expect home testing to   More...

I have evaluated polysomnography reports from
many laboratories. Many are poorly written,
contain little useful information, and are
obviously not reviewed carefully by the
responsible sleep specialist, many of whom are
poorly   More...

The proposal as written states that since OSA is
so common, the diagnosis should be based on
clinical suspicion followed by screening, with
continuous positive airway pressure (CPAP)
applied empirically. Physicians would order    More...

As a RPSGT with over 24 yrs of experience, I
feel that allowing unrestricted use of portable
testing is not in the best interest of the
Medicare patient population. This group is
being covered by Medicare because of either
ret   More...

While the policy addresses CPAP therapy, it
seems to me to open the door for the payment of
home testing ordered by anyone. As a sleep
specialist and pulmonary/critical care physician
for over 15 years, this strikes me as a
fr   More...

I think home testing is a big step in the wrong
direction. Remember, the complaints of Excessive
Daytime Somnolence come from the arousals that an
individual has. Keeping the airway patent is only
the first step.

I work in a Sleep Center, and feel like if you
open the door to home testing that every DME
company will try to run as a substitute sleep
lab. Patients will not receive the quality of
care and no follow up. These companies would b   More...

Unattended monitoring using Type III devices are
probably useful in diagnosing OSAS in selected
patients. Type IV monitors are probably less
accurate. I would hope that there would be some
effort to encourage the very careful selec   More...

To permit non-sleep medicine specialist doctors
to administer and interpret home based
polysomnography tests is to provide unqualified
individuals with the opportunity to diagnose and
treat patients. This is a disservice to patient   More...

January 13, 2008



Dear Dr. Steve Phurrough, Dr. Louis Jacques,
Francine Spencer, Jean Stiller MA, and Dr. Ross
Brechner:

As a nurse pra   More...

I own a small two bed sleep lab in SW Kansas,we
see patients all the time that would not have
done well at all had they been tested at home. I
do not beleive that at home portable testing is
even remotely adequate. I belevie that t   More...

I feel the approval of unattended, home testing
devices will be a disaster. This is essentially
taking a complicated, science based medical
test, and creating a "do-it-yourself" diagnosis
kit. There are many facets and benefits to    More...

The portable monitoring will be useful and not
abused only with strict monitoring by a sleep
specialist (as defined by the AASM).
Ordering this study by any medical practitioner
will bring on deregulation and over testing.
Only a   More...

Dear Sir or Madam: I am writing this post to
convey my thoughts about the possible CMS decision
on home sleep study testing. I am currently the
medical director at the Eastern Virginia Medical
School/Sentara Norfolk General Hospital Sl   More...

I have concern about that the new proposal for
ambulatory diagnosis of obstructive sleep apnea
will result in suboptimal care for many persons
with sleep related breathing disorders. Several
nationally recognized physicians have e   More...

Steve E. Phurrough, MD, MPA

Director, Coverage and Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

Dear Dr. Phurrough,

This letter is in regards to the Propose   More...

Thank you for giving me this opportunity to comment on what I believe is a disgrace to the health care system. It is hard for me to understand why CMS has taken the correct steps in setting the STANDARD for IDTF's in diagnosing and treating patie   More...

January 7, 2008
https://www.cms.hhs.gov/mcd/viewdraftdeci
sionmemo

Steve Phurrough, MD, MPA
Director, Coverage and Analysis Group
Centers for Medicare & Medicaid Services
U.S. Department of Health and Human Services

   More...

I'd like to further add to my comments that I
would be extremely disappointed were home testing
to be approved would all patients be tested
for PLMS, UARS, RERAs, etc. that are just as
debilitating in the quality of sleep as OSA.   More...

I'm amazed by the proposed decision to allow for
home testing. The standards/practices I've seen
across the industry in my many levels of
experience show that rigorous standards of
monitoring tests need to be in place not the <   More...

I am a sleep medicine physician who would like to
express my concerns with the potential approval
for home sleep apnea tests. I have worke with
home studies in the past and my experiences were
as follows: 1) the tests do not actua   More...

The issue of how to appropriately apply
particular diagnostic tests in the evaluation of
sleep disordered breathing is one of
considerable complexity; and if done in an
imprudent manner is likely to result in
inaccurate diagnos   More...

I have for 20 years directed a large and busy
AASM accredited sleep center in Central Georgia.
I am adamantly opposed to the idea of
unrestricted home testing. I do, however, believe
home testing is acceptable under certain
circ   More...

Dear Sirs,
It seems to me that the new guidelines for
diagnosing and treating sleep apnea are
sub-standard. You have not looked to standards
in the field for home monitoring and monitoring of
cpap. You have not looked to the   More...

I am an ENT physician/surgeon and a sleep specialist (board certified in both specialties) and frankly I am ashamed to count the drafting physician of this proposal (Terence Davidson) as a fellow ENT colleague. This (his) proposal is short sighted   More...

For patients that are screened by their physician, I support in home CPAP testing for patients who have not yet used CPAP. Even more important, I think that patients using CPAP should have access to home testing to assure that the pressure setting   More...