National Coverage Analysis (NCA) View Public Comments

Continuous Positive Airway Pressure (CPAP) Therapy for Obstructive Sleep Apnea (OSA)

Public Comments

Commenter Comment Information
Kaplan, Debbie Date: 01/13/2008
Comment:

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.

Meyer, RRT, RPSGT, Mary Title: Regional Manager
Organization: Aurora St. Luke''s Sleep Disorders Center
Date: 01/13/2008
Comment:

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 sleep apnea. These devices can no more tell if someone has sleep apnea vs. COPD, heart failure, pneumonia, asthma, etc. especially the device that only includes the pulse oximeter. Issue #2: who can perform the tests and interpret them? Anyone? Does it not matter how

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Slamowitz, Jean Date: 01/13/2008
Comment:

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.

slamowitz, David Title: Medical Director
Organization: The SleepWell Center
Date: 01/13/2008
Comment:

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 patients.

Park, Steven Date: 01/13/2008
Comment:

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-related breathing disorders. Despite the good intentions of certain parts of the medical community that endorses home-based sleep studies, thinking that it will increase “access” and diagnoses more people with obstructive sleep apnea, doing so has the potential of a

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Aronson, Robert Title: Medical Director
Organization: Cardinal Sleep Disorders Centers of America
Date: 01/13/2008
Comment:

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 “stakeholders” holding opposing views on methods of diagnosing and treating OSA. Clearly, most of those commenting indeed have some vested interest. Ultimately, however, the only “winners” will be those who support paradigms providing optimal value, defined as the best

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Atwood, Charles Title: Physician and associate professor of medicine
Organization: University of Pittsburgh Medical Center
Date: 01/13/2008
Comment:

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 a lot of sleep apnea patients. I also use several HST devices in my practice in both an academic hospital practice and a VA hospital. For full disclosure, I have no financial relationship with any manufacturer of these devices outside of IRB-approved research

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Plummer, MD; FAASM, Patrick Title: Otolaryngologist/Sleep Specialist
Organization: The Sleep Specialists
Date: 01/13/2008
Comment:

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 and does not take into consideration any of the possible complexities that could occur as comorbidities of obstructive sleep apnea, does not take into consideration the follow up of these patients, and places the care of these sometimes

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Abraham, William T. Title: Professor of Medicine
Organization: The Ohio State University
Date: 01/13/2008
Comment:

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 response to the Proposed Decision Memorandum for Continuous Positive Airway Pressure (CPAP) Therapy for Obstructive Sleep Apnea (OSA). I am Chief of the Division of Cardiovascular Medicine at The Ohio State University, and my colleagues and I have developed a

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wolcott, patrick Title: MD
Date: 01/13/2008
Comment:

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 and does not take into consideration any of the possible complexities that could occur as comorbidities of obstructive sleep apnea, does not take into consideration the follow up of these patients, and places the care of these sometimes

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Rack, Michael Title: MD, DABSM
Date: 01/13/2008
Comment:

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 providing a qualifying test for a product the DME company provides.

2. Any licensed physician should be able to provide home testing for osa. I am not aware of any precedent limiting a diagnostic test to a particular specialty, and I do not believe that limiting a

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Patel, Shailesh Title: Physician
Date: 01/13/2008
Comment:

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.

Kapadia, Manish Date: 01/13/2008
Comment:

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 care as long as health is concerned.

Turetsky, Rochelle Title: Sleep Medicine Physician
Organization: Gaylord Hospital
Date: 01/13/2008
Comment:

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 patients and undermines the true benefit of home-based testing, which is to improve access to HIGH QUALITY care. Physicans without formal sleep medicine training simply do not have the expertise to accurately interpret tests. Many physician''s such as ENT doctors have a

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Wells, Charles Date: 01/13/2008
Comment:

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 circumstances such as expressed in the published AASM guidelines. I am certain that you will create many more problems than you realize should you decide to allow anyone to diagnose and attempt to treat sleep disordered breathing by first ordering some home test followed

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Wagner, Mary Title: Associate Professor
Organization: University of Florida
Date: 01/13/2008
Comment:

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 expressed their intent to use this method to provide a diagnosis of OSA "expeditiously" with the plan to avoid involvement by physicians trained in sleep medicine. Many patients who are evaluated in the sleep laboratory have sleep disrorders other than OSA and

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Turner, Jo Anne Title: Nurse Practitioner
Organization: SleepMed
Date: 01/13/2008
Comment:

January 13, 2008

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

As a nurse practitioner working in an accredited sleep lab in Columbia, South Carolina with a boarded sleep medicine specialist and as a 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): Continuous Positive Airway Pressure (CPAP) Therapy

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Pillar, Giora Title: Head, Rambam Sleep Clinics
Organization: Technion - Israel Institute of Technology
Date: 01/13/2008
Comment:

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 passing the American Board of Sleep Medicine certification examination, and have a 15-year experience in practicing sleep medicine, using both PSG and HST on a regular basis. While my practice is outside the US, we follow similar practice guidelines to those established

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Biber, Michael Title: Medical Director
Organization: Neurocare Center for Sleep
Date: 01/13/2008
Comment:

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-effective adjunct to in-lab polysomnography. In fact, more than a decade ago, my colleagues and I did a pilot project for a large railroad corporation with isolated employees in remote locations. The project we developed provided in-home testing

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Kakar, M.D., M.P.H., Raj Title: Medical Director, Board-Certified Sleep Physician
Organization: The Dallas Center for Sleep Disorders
Date: 01/13/2008
Comment:

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, most importantly a significant negative impact on the health care of our citizens and a very expensive financial strain on the current Medicare system. Allowing home testing will actually increase the amount of surgeries performed and CPAP prescriptions delivered

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Eickholt, John Title: Medical Director
Organization: Neurodiagnostic Institute of Ohio
Date: 01/13/2008
Comment:

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): Continuous Positive Airway Pressure (CPAP) Therapy for Obstructive Sleep Apnea (OSA) (NCD 240.4). I am concerned that this proposal does not include defined, comprehensive policies about home sleep testing, and this omission has a negative impact on

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Kelly, Peter Title: Chief Executive Officer
Organization: Pacific Pulmonary Services
Date: 01/13/2008
Comment:

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 Human Services
Room 445-G Hubert H. Humphrey Building
200 Independence Avenue, SW
Washington, D.C. 20201

Via Electronic Transmission

Re: Proposed Decision Memo for Continuous Positive Airway Pressure (CPAP) Therapy for

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Ossivand, Sally Date: 01/13/2008
Comment:

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 sleep board certified physicians only and that patients are provided follow up consults to ensure that they are actually being treated for their disorder. Strict guidelines such as these are necessary to ensure that patients are protected from those in

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Adams, RPSGT, Karen Title: RPSGT
Organization: Premier Diagnostic Sleep Center
Date: 01/13/2008
Comment:

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 heart problems that we become aware of during the 1st night sleep study. If someone is tired all the time and does not test "positive" for sleep apnea with this home testing, this person may well go untreated. Their quality of life will suffer. Would you want

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wenokor, william Title: Psychiatrist
Date: 01/13/2008
Comment:

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 specialists in the field to oversee this process. I believe if your rules go into effect without more oversight there is great probablity that there will be a great deal of false negative results and people of need treatment will not be able to get this.

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Vorona, Robert Title: Medical Director EVMS/SNGH Sleep Disorders Center
Organization: EVMS/SNGH SDC
Date: 01/13/2008
Comment:

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 Sleep Disorders Center (long an American Academy of Sleep Medicine accredited facility) and have cared for sleep disorders patients for over 20 years. In addition, I have served in the past on the AASM National Committee for Accreditation and thus have been

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Pritzker, Marc Title: Professor of Cardiovascular Medicine and Surgery
Organization: University of Minnesota
Date: 01/13/2008
Comment:

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-recognized risk for premature vascular disease and magnifies the risk of other more commonly utilized risk factors. Given the burgeoning epidemic of obesity and its related problems and the associated magnification of risk associated with sleep disordered breathing, it

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Cale, William Title: Medical Director, Center for Sleep Medicine
Organization: Rockingham Memorial Hospital
Date: 01/13/2008
Comment:

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 screening and treatment device for something so crucial as the diagnosis and treatment of obstructive sleep apnea. The excuse has been accessibility to diagnosis, which I think is a circular argument. (If you don’t build enough of them, they can’t come,

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Stroud, Athena Title: R.PsgT.
Date: 01/13/2008
Comment:

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 and interpret a two or four channel screening study to diagnose OSA and no technical expertise or certification would be required for the technician conducting the screen. CPAP would be applied based on patient weight and height. This approach predates modern sleep

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Doghramji, Karl Title: Medical Director, Sleep Disorders Center
Organization: THomas Jefferson University
Date: 01/13/2008
Comment:

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 population and by methodologically sound studies. It is remarkable that these tests do not actually monitor sleep, yet are purported to establish the diagnosis of a syndrome that occurs exclusively during sleep. Additional concerns are summarized in the letter of the

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Grandi, Edward Title: Executive Director
Organization: American Sleep Apnea Association
Date: 01/13/2008
Comment:

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 currently diagnosed with sleep apnea to transition from private insurance to Medicare and 2) it will permit greater access to populations currently underserved by the exclusive reliance on Level I testing. (See our previous comments in 2007)

The ASAA is concerned

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Baake, Skyler Title: RPSGT, Lead Technologist
Organization: The Sleep Wellness Institute
Date: 01/13/2008
Comment:

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. The more severe cased would been seen but possibly underestimated. Compliance with the CPAP is largely successful because of intervention from sleep techs being able to work with the patient. Allowing home studies would be very degrading to the sleep field and

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Foresman, Brian Title: Sleep Medicine Specialist/Physician Informaticist
Organization: Cascade Healthcare Community
Date: 01/12/2008
Comment:

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, a lower standard of care than is generally acceptable and would promote waste through inappropriate testing by inadequately trained individuals. Specifically, testing and interpretation, whether done in a laboratory or in a home based setting,

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Weinstein, Ira Date: 01/12/2008
Comment:

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 actually measure if a pt is asleep leading to false positives and false negative tests.
2)Mild to moderate cases of sleep apnea are missed with the long term potential complications of untreated OSA including hypertension, strokes heart disease and car

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Gillespie, Marion Title: Associate Professor
Organization: Medical University of South Carolina
Date: 01/12/2008
Comment:

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.

Collop et al, N. Date: 01/12/2008
Comment:

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 Pressure (CPAP) Therapy For Obstructive Sleep Apnea (OSA) (240.4)

Dear Dr Phurrough,

We appreciate the opportunity to comment on NCD 240.4 regarding the use of Home Sleep Testing (HST) for OSA. The undersigned represent the sleep medicine specialists

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Margolis, M ,D., Robert Title: Diplomate, American Board of Sleep Medicine
Organization: Somnos Sleep Center
Date: 01/12/2008
Comment:

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 apnea syndrome(OSAS), will result in a large increase in ineffective surgical treatment for this disorder.

Surgical treatment of OSAS, consisting of a combination of uvulopalatopharyngoplasty(UPPP) and tonsillectomy and adenoidectomy , nasal turbinatectomy, and

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Palasio, Michael Title: Coordinator
Date: 01/12/2008
Comment:

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. However, it seems that the organizations that are so supportive of HST studies and comments documented to CMS has the whole field of sleep practioners concerned about patient care, as well as they should be. I strongly disagree that HST should take place of

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ahdoot, jonathan Title: M.D.
Date: 01/12/2008
Comment:

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 should not be approved.

Orlando, Daniel Date: 01/12/2008
Comment:

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 patient education and clinical follow up, long term follow up, and care of patients by physicians who are not trained in sleep medicine. Please take these into consideration as you are making decisions in this policy.

Sher, Aaron Title: Medical Director
Organization: St. Peter's Sleep Center
Date: 01/12/2008
Comment:

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 Einstein College of Medicine, NYC) the same year, 1977. I served on the first joint panel of the American Academy of Otolaryngology and the American Sleep Disorders Association in 1983. I served chair of the sleep disorders committee of the

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Weiss, Howard Title: Physician
Organization: St. Peter''s Sleep Center
Date: 01/12/2008
Comment:

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 diagnoses and improper treatment of patients. It is therefore with great interest that we address the recently released “Proposed Decision Memo for Continuous Positive Airway Pressure (CPAP) Therapy for Obstructive Sleep Apnea (OSA) (CAG-00093R2).

We concur

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Lynch, Jennifer Title: Sleep specialist
Organization: Ferrell-Duncan Clinic/Cox Sleep Disorders Center
Date: 01/12/2008
Comment:

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 these home tests are performed, there will be charlatans and I am afraid that the screening may be performed by non-specialists looking to make a buck if they buy the equipment, but not able to treat those folks appropriately. CPAP already has a low compliance in

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Emsellem, Helene Title: Director
Organization: The Center for Sleep & Wake Disorders
Date: 01/12/2008
Comment:

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 is currently no standard for portable home monitoring. No consensus has been established in the sleep community to determine the number of channels necessary or the types of channels necessary for accurate home diagnosis. This area of sleep medicine is frought

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Kramer, Ronald Title: M.D. Neurologist; Board Certified-Sleep Medicine
Organization: Colorado Sleep Disorders Center.
Date: 01/12/2008
Comment:

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 ENT physicians not expert in the field. After that cost of surgery, Medicare and Medicaid will then also have to pay for CPAP (or other therapy) after such failed surgery.

HST will be the future. HST needs to be used based on evidence based

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Kuhlmann, MD, D, ABSM, David Title: Medical Director, Sleep Medicine
Organization: Bothwell Regional Health Center
Date: 01/12/2008
Comment:

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 from being able to rest and replenish strength. 'Arousals from sleep usually last only a few seconds, but these brief arousals disrupt continuous sleep and prevent persons from reaching deep stages of sleep' Yet, when defining the criteria to be used for

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Galuska, Charlotte Title: RRT
Organization: Pottsville Hospital & Warne Clinic
Date: 01/12/2008
Comment:

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 to motion artifact and electrodes coming off during the test. This is a case of " pennywise and pound foolish." Please reconsider this change.
Thank You,
Charlotte Galuska

Mathias, John Title: President
Organization: Sleep Services of America, Inc.
Date: 01/12/2008
Comment:

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-00093R2). In the decision memo, CMS proposes to reconsider the 2005 national coverage determination (NCD) for CPAP therapy for OSA to allow coverage of CPAP based upon a diagnosis of OSA by home sleep testing (HST).

CMS is requesting comments by January 14, 2008.

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McCranie, Gwen Title: Neurodiagnostic Coordinator
Organization: St Mary Corwin Medical Center
Date: 01/12/2008
Comment:

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 performed in home nocturnal pulse ox study done by the patient, the margin of error is alarming.

The ulimate concern is the appropriate diagnosing and determination of therapy with optimal treatment of the disorder. This purposal suggest the patient diagosing and

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Masi, Anthony Date: 01/11/2008
Comment:

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): Continuous Positive Airway Pressure (CPAP) Therapy for Obstructive Sleep Apnea (OSA) (NCD 240.4). I am concerned that this proposal does not include defined, comprehensive policies about home sleep testing, and this omission has a negative impact on clinical

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Krespi, Yosef Title: Chairman Dept Otolaryngology
Organization: St Lukes Roosevelt Hospital NYC
Date: 01/11/2008
Comment:
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 Testing Draft NCD

Dear Doctor Phurrough:

We are writing in affirmative support of the decision of the Coverage and Analysis Groups as articulated in the proposed Decision Memo for Continuous Airway Pressure that was posted December 14, 2007. Their analysis was

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Burnaugh, Robert Title: MD, Fellow American College Chest Physicians
Organization: Southeast Lung & Critical Care Specialists, PC
Date: 01/11/2008
Comment:

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 make a diagnosis of OSA. Additionally, all licensed providers are not qualified to assess and treat OSA. Sleep specialists, pulmonologists, otolarygologists, and neurologists usually have the requisite training to safely and effectively engage OSA patients.

Sale, Gina Title: PSGT
Organization: Sotuh Miami Hospital
Date: 01/11/2008
Comment:

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 data. Technical quality of the staff is also in question as there is no one available to monitor and regulate quality and expertise. The qualification of the physician interpreting the data will also be in question leading to misdiagnosis. And lastly, it will

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Roman, Pedro Title: PSGT
Organization: South Miami Hospital / Baptist Health South Florida
Date: 01/11/2008
Comment:

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 data. The quality of the interprtation of these studies will also be questionable due to lack of physician expertise. It will also increase fraud in South Florida as their will not be anyone avilable to monitor who gets these studies and if the diagnosis is valid

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goldstein, nir Date: 01/11/2008
Comment:

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 management. Indiscriminate ordering and non-uniform interpretations of home sleep studies will encourage an explosion of tests which will be inaccurate and dramatically increase cost while endagering patients with incorrect diagnoses and inappropraie therapy. The

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Castillo, Alexis Title: RPSGT, R.N.
Organization: South Miami Hospital / Baptist Health South Florida
Date: 01/11/2008
Comment:

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. We need to keep the quality in this field of medicine.

Cabrera, Eduardo Title: RPSGT, M.D.
Organization: South Miami Hospital
Date: 01/11/2008
Comment:

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. Furthermore, the quality of the personnel and physicians interpreting the data will be questionable. We need to keep QUALITY on the scientific level of sleep medicine.

Allegra, Ludwig Date: 01/11/2008
Comment:

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 for a highly accurate assessment of the patients status and in fact likely eliminates a number of inaccuracies that are inherent with a lab based testing scenario. The lab based study by its very nature introduces two potentially significant error factors into

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Loredo, Jose S. Title: Associate Professor of Clinical Medicine
Organization: University of California San Diego, Sleep Medicine Center
Date: 01/11/2008
Comment:

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 studies (Type 2 and 3), as well as laboratory based polysomnography for clinical and research purposes for more than 20 years. While I agree with Dr. Davidson that Medicare should allow unattended home sleep studies for the diagnosis of obstructive sleep apnea and

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Holguin-Valdes, RPSGT, CRT, Ismari Title: Supervisor
Organization: South Miami Hospital
Date: 01/11/2008
Comment:

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 or misdiagnosed with the inferior quality of home testing as this modality will have less monitoing parameters. Since most of these studies will be unattended, who is to decifer artifact from real patient data? The technical quality of personnel administering the study

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Butcher, Laura Title: MD
Organization: Kaiser Permanente
Date: 01/11/2008
Comment:

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 (CPAP) Therapy for Obstructive Sleep Apnea (OSA).

I am the Director of the San Jose Ambulatory Sleep Lab and the Chair of the Northern California Ambulatory Sleep Lab Medical Directors with the Permanente Medical Group in San Jose, Ca. I am very

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Shapouri, David Title: General Manager
Organization: American Sleep Medicine, Towson, MD
Date: 01/11/2008
Comment:
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 by which patients may receive in-home sleep testing, particularly the standards that will be followed in this process. In-home testing can be the answer for patients either unable or unwilling to be tested in a sleep laboratory, but the methods, technology, and supervision of this

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Lawee, Michael S. Title: Corporate Clinical Director-Program Development
Organization: Total Sleep
Date: 01/11/2008
Comment:

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. The rate of increase in the number of patients diagnosed with sleep apnea and the documented effect of sleep apnea on public health requires greater access to diagnosis and treatment. this document encourages further debate to find the best solutions. However it is not

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Dedrick, David Title: Physician
Organization: St. Charles Medical Center
Date: 01/11/2008
Comment:

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 little if any role in screening for SDB.

I am very concerned that the NCD uses an open "clincal evaluation" in combination with objective measurement (Type I-IV). I am impressed in my own practice to see how little understanding there is of SDB in the general

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Rickel, Roger Title: Director of Cardio - Pulmnonar Svc
Organization: Kettering Medical Center
Date: 01/11/2008
Comment:

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 testing quality is much better in a full service lab overnight study. These studies much be continously monitored by a registered sleep tech who knows the variables involved and many neuro and pulmonary issues that surround this complicated diagnosis.The most

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Balachandran, MD, DABSM, Diwakar Title: Assisatant Professor
Organization: Univestiy of Texas MD Anderson Cancer Center
Date: 01/11/2008
Comment:

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, and unscrupolous vendors and clinicians taking advantage ofa public which deserve access to the best available care.

Rios, Ralph Title: Assistant Vice President
Organization: South Miami Hospital
Date: 01/11/2008
Comment:

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 setting. Test components such as sleep staging, heart rate monitors, REM sleep evaluation, restless leg syndrome are absent. Most importantly, these are unattended studies. As a result, many forms of testing error may be introduced, without the knowledge of the person

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Kubiak, Joseph Date: 01/11/2008
Comment:

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 in response to CMS recent Proposed Decision Memo for Continuous Positive Airway Pressure (CPAP) Therapy for Obstructive Sleep Apnea (OSA) dated December 14, 2007. Commentary regarding the contents of this memo is sought by CMS and is included herein.

As you know, the

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fraley, r. denise Title: Senior Vice President of Operations and Bus. Dev
Organization: SleepWorks Sleep Centers of Excellence
Date: 01/11/2008
Comment:

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 appropriate for use as a general screening tool for OSA.

B) Application of Quality Standards for HST

CMS’ position that diagnostic testing to be the appropriate coverage category for PSG and multichannel HST. On a national basis, CMS currently

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Snider, James Organization: Sleepcare Diagnostics, Inc.,
Date: 01/11/2008
Comment:

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
Jean Stiller, MA
Ross Brechner, MD, MS, MPH

Our organization, Sleepcare Diagnostics Inc., would like to take the opportunity to provide comment on Proposed Decision Memo for Continuous Positive Airway Pressure (CPAP) Therapy for Obstructive Sleep Apnea (OSA) (CAG-00093R2).

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Illuzzi, Angelo Title: Medical Director
Organization: DuBois Regional Medical Center
Date: 01/11/2008
Comment:

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 probably causes numerous misdiagnoses and situations of under and overtreatment. Sleep patients are often difficult to diagnose and to treat, and elderly sleep patients are some of the most difficult to treat. They require accurate diagnosis and expert care at the

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Iseler, Mary Title: Patient Care Coordinator
Organization: American Sleep Medicine/Louisville Sleep Disorders Center
Date: 01/11/2008
Comment:

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 apnea. Many patients need extensive support after their diagnosis, during their adjustment to treatment. I am concerned if testing is not done by entities experienced in sleep disorders (sleep labs, doctors who are Diplomates in sleep medicine, etc.) many

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  • Middleton MEd, Marianne Title: RRT,RPSGT; Clinical Coordinator
    Organization: Lawrence Memorial Hospital
    Date: 01/11/2008
    Comment:

    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 lead to worse heart and sleep problems for the patient. The AASM has already set proper guidelines for sleep testing. These should be followed for any sleep test. Also, Medicare has already determined that home testing is not as affective as testing that is attended by

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    Chediak, MD, Alex Organization: American Academy of Sleep Medicine
    Date: 01/11/2008
    Comment:

    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-00093R2).

    Home sleep testing (HST) was first considered by the Centers for Medicare & Medicaid Services (CMS) in 1989, and subsequently in 1995, 2001, 2005 and 2007. Each time the issue was addressed by CMS, the AASM, as the professional society representing almost

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    Gardner, Stephen Date: 01/11/2008
    Comment:

    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 understand all facets of the proposal, but I can detect a poorly thought-out, perhaps even self-serving idea when I see it. Small wonder all of the home care companies think it''s a good idea. But it clearly is not. Must we stand by and watch as people get

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    Bibbee, Ronald Title: Office Manager
    Organization: Independent Diagnostic Testing Faciltiy
    Date: 01/11/2008
    Comment:

    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 have tested that need CPAP or BIPAP. Again it seems changes are being made to programs that do not need changed and the only one that suffers is the patient themselves. What is so wrong with PSG at a lab? We have had no issues with getting patients

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    Workman, Linda Title: VP of Medical Services
    Date: 01/11/2008
    Comment:

    This is being considered for all of the wrong reasons. The reason that we have specialist is to have specific knowledge in one area. Would you send your diabetic child to a cardioligist? I would send mine to an Endocronologist. The same as if I would want to send my child with sleep problems to a board certified sleep doctor rather than someone in it for the money.

    crissinger, dana Date: 01/11/2008
    Comment:

    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 oximetry alone cannot accurately diagnose OSA. The use of a type IV device would result in a significant number of false –positive results for OSA since many other medical conditions impact respiratory airflows and blood oxygen levels.

    2) We realize that in certain

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    Schmitz, Mecca Title: Polysomnographer
    Organization: AMERICAN SLEEP MEDICINE
    Date: 01/11/2008
    Comment:

    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.

    Smith, Sharon Title: Billing Specialist
    Organization: AMERICAN SLEEP MEDICINE
    Date: 01/11/2008
    Comment:

    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 compliance with this diagnosis.

    Johnston RRT RPSGT, Sharon Date: 01/11/2008
    Comment:

    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 supervision by a physician with education in sleep medicine.

    Strobel, Richard Date: 01/11/2008
    Comment:

    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 trained and not board certified. Now, imagine throwing into this mix results from 4 channel sleep screening instruments that do not monitor the sleep state and cannot assess for sleep fragmentation from subtle respiratory events, movements or parasomnias, not to

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    Koenigsberg, Robert Title: C.E.O.
    Organization: SleepQuest, Inc.
    Date: 01/11/2008
    Comment:

    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 21224-1850

    Dear Dr. Phurrough,

    I am in support of the decision of the Coverage and Analysis Group as articulated in the proposed Decision Memo for Continuous Airway Pressure that was posted December 14, 2007. The analysis was exhaustive; evidence based

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    Hall, Thomas Title: President
    Organization: AASM
    Date: 01/11/2008
    Comment:

    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

    Brickner-York, Jennifer Organization: SleepCare
    Date: 01/11/2008
    Comment:

    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 of Sleep Medicine accredited sleep centers and labs.

  • Only pulmonologists or ABSM physicians should be qualified to read portable tests.

  • Outcomes must be reported to prove such testing and treatment (i.e. - positive pressure therapy or

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  • Weaver, Bradley Title: Director
    Organization: Sleep Network of WV
    Date: 01/11/2008
    Comment:

    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 patients with Obstructive Sleep Apnea then approving this testing method. Having worked in medicine for many years and particularly sleep medicine I have had the opportunity to see many patients with OSA as well as many other co-morbidities. It is clear

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    Boling, Karrie Title: Manager/Admin
    Organization: Summit Sleep Services
    Date: 01/11/2008
    Comment:

    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 accredited sleep disorder center and strongly support the quality initiatives from the American Academy of Sleep Medicine.

    Therefore, this letter is in support for any level of approval for portable home monitoring to be strictly administered by AASM accredited Centers

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    Seaton, John Title: Supervisor/Coordinator
    Organization: Methodist LeBonheur Healthcare Systems
    Date: 01/11/2008
    Comment:

    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 provider and have had the privilege of diagnosing and treating Medicare patients for the last several years. I am writing to you about the recent proposal from CMS to consider portable testing for sleep apnea.

    Under the proposal, which likely will become final

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    lui, karen Title: Associate
    Organization: NAMDRC
    Date: 01/11/2008
    Comment:

    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 Care, welcomes the opportunity to comment on proposed changes to the national coverage determination for continuous positive airway pressure (CPAP) and also appreciated a chance to comment at the MedCAC meeting on September 12, 2007. NAMDRC members serve as medical

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    Sides, Bill Title: Supervisor
    Organization: Northern Michigan Regional Hospital
    Date: 01/11/2008
    Comment:

    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 established by the American Academy of Sleep Medicine will result in poorer outcomes for patients. Our compliance rate for CPAP use is near 80%. This comes from a sleep specialist evaluation, qualified technologists, following established policies, extensive

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    Atkinson, Jon Title: President
    Organization: American Association of Sleep Technologists
    Date: 01/11/2008
    Comment:

    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-0093R2)

    The AAST has concerns from our unique technologic perspective. These are annotated in the comments concerning the proposed changes below.

    CMS Proposed Decision 1: We are proposing that, due to the evidence demonstrating that no

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    Porte, Phillip Organization: Sleep Manufacturers Alliance
    Date: 01/11/2008
    Comment:

    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 by CMS December 14th, 2007. The SMA is composed of industry leaders (Cardinal Health, Covidien, DeVilbiss, Embla, Fisher Paykel Healthcare, Pro-Tech, ResMed and Respironics) whose collective mission is to represent manufacturers of sleep products that are committed

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    Grayson, CMIS, CMOM, Debbie Title: Clinical Director
    Organization: Premier Sleep Diagnostic Center
    Date: 01/11/2008
    Comment:
    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 health. They will be non-compliant to c-pap due to lack of education. These patients need to be seen in a controlled environment in order to receive the optimal care they both need and deserve. The current home monitoring systems available have as much as a 40%

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    Beauchamp, Robby Title: Sleep Disorders Program Coordinator
    Organization: Tampa General Hospital
    Date: 01/11/2008
    Comment:

    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 returning to the sleep lab at anytime during normal business hours for any sleep related problems. With those standards and resources we are able to have a 60-70% treatment compliance. As licensed healthcare providers we have a responsibility to our patients. We need to

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    Chiang, Ambrose Title: Associate Clinical Professor of Medicine
    Organization: Duke University Medical Center
    Date: 01/11/2008
    Comment:

    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 be used for diagnosis of sleep apnea. In our experience, type 4 device should be used as a "screening tool", but not a test for definitive diagnosis. I would urge Medicare to move on with further change ONLY when good clinical evidences support the change.

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    Kuechenmeister, Katie Organization: American Academy of Neurology Professional Association
    Date: 01/11/2008
    Comment:

    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 Pressure (CPAP) Therapy for Obstructive Sleep Apnea (OSA) (CAG-00093R2)

    Dear Acting Administrator Weems:

    The American Academy of Neurology Professional Association ("Academy") is a national medical specialty society representing more than 20,000 neurologists and

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    brezchnev, leonid Date: 01/11/2008
    Comment:
    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 "sweat-shops" are staffed by under paid, ill-trained, out of the street people, who provide less than adequate service to their patients. These corrupt "physicians" and their hunchmen investors only seek their personal wealth and it is them who have tainted our

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    Holland, Charles Title: Vice President
    Organization: Total Sleep Management,Inc
    Date: 01/11/2008
    Comment:

    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 Physicians, all Physicians, DME''s, Home Health?

    My opinion - the only group that should be allowed to perform these home studies is IDTFs. There will be too much incentive for physicians to send home a Sleep monitor on every other patient they see each day.

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    Stone, Lorrie Date: 01/11/2008
    Comment:

    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 be the best thing for the patient. Medicare needs to do something about the sky rocketing cost of medications and the out of pocket expense for our senoirs. We do primarly medicare patients in our facility and we are reimbursed about $500. Sounds kind of like

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    Appelblatt, Nan Title: MD
    Organization: Sacramento Ear, Nose, and Throat Medical and Surgical Group Inc.,
    Date: 01/10/2008
    Comment:

    I have been practicing general ENT for 25 years. 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 assessed. I read most of the PSGs. When a patient relates their bed partner (as we say in CA) has undiagnosed OSA, they are usually right. I may order a study sight unseen, then see them after the home CPAP trial. I have kiddingly (I hope) told them the medical board may

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    Dobey MEd, RRT, Terri Date: 01/10/2008
    Comment:

    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 should be provided only by credentialled polysomnography technologists NOT by persons affiliated in any way with a home medical equipment company. This would include physicians who have an interest in home medical equipment companies as well.

    Thank you for allowing

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    Salah, Jack Title: MD, Diplomate American Board of Sleep Medicine,
    Organization: ACCP, ABSM
    Date: 01/10/2008
    Comment:

    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 overusage of this modality, and for quality issues regarding clinical diagnosis and care.

    In the Committee''s statement, patients with CoMorbid Medical conditions (significant Cardiac disease, COPD, etc) and those with CoMorbid Sleep conditions (Insomnia, Restless

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    Klapper, Phillip Date: 01/10/2008
    Comment:

    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 revenue for physicians and equipment suppliers. Primary care physicians in paticular would tend to rely on testing done by their office rather than making appropriate referrals to specialists who are better qualified to make clinical judgements and are less

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    Culver, Dale Title: RPSGT
    Date: 01/10/2008
    Comment:

    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 obstructive sleep apnea (OSA).

    This proposal allows for treating sleep apnea that is being diagnosed with no documentation of sleep.

    It allows any physician to order two-four channel studies and no technical expertise is required for conducting

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    Svoboda, Bret Date: 01/10/2008
    Comment:

    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 retirement or disability status. The probability of co-morbid conditions is greater with this population than others. The presence of underlying cardio-pulmonary issues can lead to misdiagnosis, maltreatment, and poor response to CPAP, especially in high-altitude

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    Scrima, Lawrence Title: President (elected 2007-)
    Organization: Colorado Sleep Society
    Date: 01/10/2008
    Comment:

    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 (2004-2007), L. Scrima, PhD, D,ABSM, President (2007-), Colorado Sleep Society

    On December 14 of 2007, Medicare officials submitted a recommendation that will limit patient access to medical care for the diagnosis and treatment of obstructive sleep apnea (OSA) and

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    Thomasson, Chris Title: Director
    Organization: BMH - Sleep Disorders Center
    Date: 01/10/2008
    Comment:

    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 be tempted to skew information from the home studies just so they could sell CPAP units as well. What would keep dishonest physicians from turning into DME service directly from their offices. I think home studies are going to be trouble and should not be viewed

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    Fox, Anne Date: 01/10/2008
    Comment:

    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 allows for treating sleep apnea that is being diagnosed with no documentation of sleep.

    The proposal as written allows any physician to order two-four channel studies and no technical expertise is required for the technician conducting the screen. This

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    Breen, Kathi Title: Sleep Counselor
    Organization: National Jewish Medical and Research Center
    Date: 01/10/2008
    Comment:

    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, accurate diagnosis, treatment and education are essential. Quality of life is at stake here; it''s not about money. Asking our Medicare population to participate in "do it yourself" healthcare is unconscionable. Shame on you.

    Barford, Robert Date: 01/10/2008
    Comment:

    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 problematic and results questionable at times. In the home environment, some patients may not be operational issues may may not be overtly obvious. At best this can result in a wasted ''''study'''' or potentially decisions based on erroneous data.

    Blatt, Ginger Title: Coordinator of Sleep Center
    Organization: Baptist Hospial
    Date: 01/10/2008
    Comment:

    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 a long way to correct and avoid downfalls. If we let this bill pass, we are in-for a rude awakening.

    We had a company (Instant Diagnostic Systems)come into town and told billers and coders how to vote on this issue. That company wrote, Make sure that

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    Krupski, Theresa Date: 01/10/2008
    Comment:

    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 physician to order two-four channel studies and no technical expertise is required for the technician conducting the screen. This approach predates modern sleep medicine and is known to result in less than 40% compliance with CPAP therapy.

    Inadequate

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    Baake, Ron Title: CEO
    Organization: The Sleep Wellness Institute, Inc.
    Date: 01/10/2008
    Comment:

    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 (CPAP)
    Therapy for Obstructive Sleep Apnea (OSA)
    (CAG-00093R2)

    Dear Dr. Phurrough,

    The Sleep Wellness Institute, Inc. is anindependent diagnostic testing facility (IDTF)which furnishes attended polysomnography (PSG)diagnostic

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    Bowman, Fredrick Title: Clinical Manager
    Organization: Midsouth Sleep Diagnostics DBA American Sleep Medicine
    Date: 01/10/2008
    Comment:

    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 home studies done by unqualified people. This is not the first time home studies have been put into play. Personal business owners send people off the streets to conduct home studies that have 1 or 2 weeks training and call it a quality sleep study. Also, I have

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    Davis, Gary Title: Cardiopulmonary Director
    Organization: Stuttgart Regional Medical Center
    Date: 01/10/2008
    Comment:

    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 varied reasons could benefit from this approach. Currently in our rural area, our hospital based sleep lab closed when our pulmonologist left for a larger hospital. Currently our patients must travel over an hour to have the NPSG performed. This has discouraged

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    Stoiber, Mark Title: President
    Organization: The Sleep Wellness Institute, Inc.
    Date: 01/10/2008
    Comment:

    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 Diego, was invited to give a “mini seminar” entitled “Thinking of Opening a Sleep Lab?” Dr. Davidson could also be called the “father” of the current attempt to get Medicare to approve unattended home testing for sleep apnea. It was his Jan. 29, 2004 letter to the

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    BISHOP, MIKE Title: Clinical Specialist
    Organization: BayCare HomeCare
    Date: 01/10/2008
    Comment:

    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 COMMUNICATE WITH MD''S WHEN DOWNLOADS REVEAL ELEVATED EVENTS THAT REQUIRE ADDITIONAL CHANGES AND CONFIRMATION OF EFFICACY.

    WE REQUEST FROM EVERY NEW PAP PT THAT THEY SEND THEIR DATA CARD FOR DOWNLOAD AFTER THE FIRST 30 DAYS OF USE. NOT

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    Clark RPSGT, Kimi Date: 01/09/2008
    Comment:

    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 probability of moderate to severe OSA. We do not feel that HST is appropriate for the diagnosis of OSA in patients with significant co-morbid conditions nor do we feel it is appropriate for use as a general screening tool for OSA.

    B) Application of Quality Standards for HST

    We

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    Marteney, Rebecca Date: 01/09/2008
    Comment:

    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 because they have issues that prevent them from going to a lab especially in rural areas.
    I believe there should be a 12 week trial period in which the Respiratory Therapist assesses compliance and effectiveness of the therapy.
    Thank you

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    Arand, Donna Date: 01/09/2008
    Comment:

    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 testing would be easier for older patients and more cost effective. A formal survey in 2005 showed that there was an average 3 week wait for sleep studies across the country and that number has decreased to less than 2 weeks at present. From my experience

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    Killmer, Edward Organization: SomnoMedics LLC
    Date: 01/09/2008
    Comment:

    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 York, Terence Davidson, an Otolaryngologist (ENT) and Dean of Continuing Education at the University of California, San Diego, was invited to give a “mini seminar” entitled “Thinking of Opening a Sleep Lab?” Dr. Davidson could also be called the “father” of the

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    Rendon, Isabel Date: 01/09/2008
    Comment:

    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 Physician treatment will be incorrect. It''s sad that the Sleep prosposal is a step back in Sleep instead of moving forward to help the patient with the best possible treatment that is available. You will have a lot of unqualified people making decisions on the

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    konstantinova, nina Title: medical director
    Organization: hamden sleep disorders center
    Date: 01/09/2008
    Comment:

    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 nation as a whole is essentially a myth. There is no evidence to suggest that a change in the NCD policy for portable monitoring will have a significant effect on patient access. There is strong consensus that published studies up to 2004 have not provided evidence

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    Hammond, Jeffrey Date: 01/09/2008
    Comment:

    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 treatment is an unacceptable standard for patient care.

    Assessment, treatment, and diagnosis of sleep disorders or sleep related breathing disorders needs to be evaluated by a professional who has sufficient training in the field. A sleep specialist is properly trained

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    DOE, MARILYN Title: CRTT, PRESIDENT
    Organization: SLEEP WELL, INC.
    Date: 01/09/2008
    Comment:

    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 DME PROVIDERS NEED A NEW PROVIDER NUMBER TO CONDUCT THE TESTING OR WILL THAT FALL UNDER OUR CURRENT DMEPOS PROVIDER NUMBER?

    Kuhn, Dr Thomas Title: Dentist
    Organization: Drs Kuhn, jacobsen, & Cui Dental Office
    Date: 01/09/2008
    Comment:

    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 Sleep Apnea. Dental appliance can be at least as effective in many of these cases with greater compliance and less cost than CPAP. BELOW is a SUMMARY of PRACTICE PARAMETERS of the AASM American Academy of Sleep Medicine & supporting research regarding Oral

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    King, Drew Title: General Manager
    Organization: American Sleep Medicine - Jacksonville, FL
    Date: 01/09/2008
    Comment:

    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 order to properly diagnose sleep disorders with it. However, if the decision is to approve home sleep testing now, then I feel that the following need to be the minimum requirements of those in charge of the process:

    1. Full accreditation with the American

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    Genenbacher, Teresa Date: 01/09/2008
    Comment:

    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. There will be an increase in false negatives and positives.

    Behrens, Nancy Title: Physician
    Organization: Presbyterian Sleep Medicine, Novant Health
    Date: 01/09/2008
    Comment:

    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 equipment for Medicare beneficiaries who are diagnosed with obstructive sleep apnea (OSA)using basically any home sleep testing device by any physician, regardless of whether they have training which would enable them to manage these patients.

    Type I, full

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    DeMayo, Brenda Title: Administrative Coordinator
    Organization: American Association for Respiratory Care (AARC)
    Date: 01/09/2008
    Comment:
    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 Decision Memo for Continuous Positive Airway Pressure (CPAP) Therapy for Obstructive Sleep Apnea (OSA) (CAG-00093R2)

    Dear Ms. Spencer:

    On behalf of the American Association for Respiratory Care (AARC), a professional association representing over 45,000 respiratory

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    Rodriguez, Toni Title: President
    Organization: American Association for Respiratory Care (AARC)
    Date: 01/09/2008
    Comment:
    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 Decision Memo for Continuous Positive Airway Pressure (CPAP) Therapy for Obstructive Sleep Apnea (OSA) (CAG-00093R2)

    Dear Ms. Spencer:

    On behalf of the American Association for Respiratory Care (AARC), a professional association representing over 45,000 respiratory

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    roca, dominic Date: 01/09/2008
    Comment:

    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 patient is a sleep unless EEG is being recorded. That seems to mandate at least a type two device or a type 3 device with EEG. It also seems to exclude type 4 devices and type 3 devices without EEG.

    2. The first proposal manadates a 12 week trial to

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    Brown, Terry Title: Dr
    Organization: Sleep Medicine Associates
    Date: 01/09/2008
    Comment:
    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 require repeat study in the sleep lab since older persons may be less able to complete the home unattended studies error free. With a 25% restudy rate in many PM studies, odds are good Medicare will go broke paying for these as well as the subsequent in lab

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    Knight, David Date: 01/08/2008
    Comment:

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

    gibson, russ Date: 01/08/2008
    Comment:

    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 objective is cost savings. The AASM has demonstrated statistics showing quality and timely access for those in need of sleep specialty services and testing. In addition, well designed studies showing significant costs savings when employing home testing are simply

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    Birdsong, Cindy Title: RRT/RPSGT President of KASP
    Organization: Kansas Association of Sleep Professionals
    Date: 01/08/2008
    Comment:

    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 ultimately occur as a result of untreated sleep apnea. Not all will fail; some will make the adjustments easily and wear their CPAPs. Most of the patients I see through the two places I do sleep studies this would not be the case. The patients hand is held and

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    Fernkas, Laura Title: Physicians Relations
    Organization: American Sleep Medicine
    Date: 01/08/2008
    Comment:

    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. All home sleep testing facilities must have the following:

  • Full accreditation from the American Academy of leep Medicine.
  • Review, interpretation, treatment from sleep boarded physicians only.
  • In person follow up consults with patients at 48 hours, 30

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  • Murphy, Everett Organization: Consultants in Pulmonary Medicine, P.A.
    Date: 01/08/2008
    Comment:

    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 reflect what is happening at the home site. Unfortunately the data is not accurate and has over estimated the needs for the patient causing over treatment of patients leading to noncompliance. As a result, I am reluctant to buy into the unobserved outpatient sleep

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    ramos, al Title: president
    Organization: alra
    Date: 01/08/2008
    Comment:

    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 patient to recieve a cpap machine. all unattented cpap self titration machines should not be excepted by doctors as the optimal cpap pressure to set a cpap machine for a patient.

    Christensen, Sean Title: President
    Organization: Idaho Diagnostic Sleep Center
    Date: 01/08/2008
    Comment:

    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 sleep centers have more resources to help them with compliance once they are on CPAP equipment, thus improving their overall health. Basically, Medicare won''t be saving money by lowering standards for sleep testing, because patients will be receiving poorer

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    Perez-Guerra, Francisco Title: Please see above after my signature
    Organization: Scott and White Clinic
    Date: 01/08/2008
    Comment:

    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 very consistent with OSAS. However, it can be argued that if the clinical picture leaves no doubdt about the diagnosis, what is needed is treatment and not an ambulatory study. They are also useful in reassuring patients and doctors alike that sleep

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    Webb, Larry Title: CEO
    Organization: SleepWorks, LLC
    Date: 01/08/2008
    Comment:

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

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

    Re: SleepWorks response to CMS Proposed Decision Memo for Continuous Positive Airway Pressure (CPAP) Therapy for Obstructive Sleep Apnea (OSA) (CAG-00093R2) dated December 14, 2007

    Dear Dr. Phurrough,

    Sleepworks, LLC, a

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    Hajj, Nanette Date: 01/08/2008
    Comment:

    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 a patient myself I can tell you first hand that technology behind conducting home sleep studies is improving but we still lack knowledgeable, responsible, patient care orientated facilities that can be entrusted with the performance of home testing

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    Bateman, Jill Date: 01/08/2008
    Comment:

    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 link to this page.

    Leeds, William Title: D.O., D-ABSM
    Organization: Pulmonary & Sleep Associates
    Date: 01/08/2008
    Comment:

    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 endeavor to short circuit an evidence based approach to sleep medicine based on sound principles of good clinical practice. Those studies that support the use of portable polysomnography are invariably authored by investigators having financial ties to the companies

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    Mooney, Diane Title: Clinical Coordinator
    Organization: American Sleep Medicine
    Date: 01/08/2008
    Comment:

    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 treatment for obstructive sleep apnea. It is very important to have a board certified sleep specialist and an accredited sleep center involved in this treatment and diagnosis. Compliance is the most important part of the treatment with CPAP. If the

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    Shaffer, Douglas Title: General Manager
    Organization: American Sleep Medicine- Clear Lake
    Date: 01/08/2008
    Comment:

    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 use of home studies so now a larger worry is to make sure that knowledgeable, responsible, patient care oriented facilities are entrusted with the performance of home testing for testing sleep disorders.

    Home sleep testing facilities should have the

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    Bergquist, Donna Date: 01/08/2008
    Comment:

    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 respiratory techs and Sleep physicians is an important part of this and should not be ignored.

    day, jennifer Date: 01/08/2008
    Comment:

    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 individuals via car accidents or incidents of heart failure. I believe this needs to be immediately addressed by CMS. Thank you

    Port, Kristina Title: President,
    Organization: Port-Able Services LLC
    Date: 01/08/2008
    Comment:

    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. CPAP is NOT the only therapeutic intervention for treatment of OSA and a physician should include any and all treatment options for the patient if a polysomnogram study was done.

    The most efficient use of health care dollars would allow portable home sleep

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    Blanchard, Bertha Organization: Southern Neuroscience Center, PA
    Date: 01/07/2008
    Comment:

    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 apnea. After the patient had the PSG, they were found to be having nocturnal seizures which actually led to apneic episodes. I have also seen patients have oxygen desaturations into the 50''s, also have sleep apnea, but need additional oxygen supplementation. Also

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    Zadeh, Row Title: Administrator
    Organization: American Sleep Medicine
    Date: 01/07/2008
    Comment:

    Home testing of sleep disorders is a bad idea. It may make economical sense but makes no clinical sense. It only opens the doors for money hungry equipment vendors and greedy unqualified individuals to make a buck when preciously not able to do so.

    Sleep testing industry is filled with illegitimate players, kick backs and other bad practices that we fight all the time. This will add another element to the chaotic environment. Do not do this.

    Those of us who are operating a high

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    broyles, kathleen Date: 01/07/2008
    Comment:

    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 the patient’s care.

    Recent research has documented the important contribution of sleep apnea to automobile accidents, cardiovascular and cerebral illness. The current proposal will result in less than 40% of patients with sleep apnea being appropriately

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    Ritchie, Shawna Title: National Director of Clinical Services
    Organization: American Sleep Medicine
    Date: 01/07/2008
    Comment:

    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 behind conducting home sleep studies is improving, our trials of various manufacturers’ equipment in our center still tells me there is a lot of work that still needs to be done. If Medicare is going to approve the use of home studies, the bigger issue is that

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    Aujla, Shawn Title: General Manager
    Organization: Nashville Sleep Medicine
    Date: 01/07/2008
    Comment:

    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 is improving. From our trials of various manufacturers’ equipment in our sleep center we feel there is much work still to be done. However, Medicare is going to approve the use of home studies so now a bigger worry is to make sure that

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    Aujla, Garry Title: Assistant General Manager
    Organization: Nashville Sleep Medicine
    Date: 01/07/2008
    Comment:

    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 studies is improving. From our trials of various manufacturers’ equipment in our sleep center we feel there is much work still to be done. However, Medicare is going to approve the use of home studies so now a bigger worry is to make sure that

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    Lauch, Jerry Title: Manager
    Organization: Louisville Sleep Disorders Center
    Date: 01/07/2008
    Comment:

    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. However, Medicare is going to approve the use of home studies so now a bigger worry is to make sure that knowledgeable, responsible, patient care orientated facilities are entrusted with the performance of home testing for sleep

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    Meska, Michael Date: 01/07/2008
    Comment:

    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 test from the facility based (attended) compared to that of the home testing (unattended). Do sleep labs simply fade away or do they perform “unattended” sleep studies in their facility…..sort of like renting a room at a hotel. Additionally, the thought that merely

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    Piasecki, Mari Title: Business Manager
    Organization: Michiana Regional Sleep Disorders Center
    Date: 01/07/2008
    Comment:

    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 Fellows are trying to carve out a portion of a quality of care delivery system. When a patient is tested for OSA we are looking at potentially many other health issues that the patients may have going on besides OSA. You must realize the sole focus and goal of

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    Mair, MD, FAAP, FACS, Eric Title: Sleep Disorders Committee Member, AAO-HNS
    Organization: Charlotte EENT
    Date: 01/05/2008
    Comment:

    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 accurate and reliable as the in-patient based PSG. It was a bold decision, thoughtfully made, with emphasis on patient benefit and advanced medicine.

    This CMS decision was followed by publication of a position paper by the American Academy of Sleep Medicine

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    McCoy, Cynthia Date: 01/05/2008
    Comment:

    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. Careful consideration should also be given to the types of devices used and who is performing the setup of these devices. I am not in favor of Type 4 devices being approved. I agree with CMS statement that facility testing is no longer the gold standard due to the

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    Patel, Minal Title: MPH Candidate, Health Behavior & Health Education
    Organization: University of Michigan School of Public Health
    Date: 01/04/2008
    Comment:

    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. They are reliable and valid diagnostic tools that successfully triage patients to appropriate therapeutic solutions. Through my experiences, I have seen a large number of Medicare patients face many challenges in receiving adequate treatment for OSA (PAP

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    Wolfla, Lyman Title: Retired
    Date: 01/04/2008
    Comment:

    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 are correct. This testing should be done both on a time basis, and with a change in the patient such as weight loss, or the change of medication.

    HOLMES, SCOTT Date: 01/03/2008
    Comment:

    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 could complicate or cause a misdiagnosis. Patients with COPD, CHF, parkinsons etc… will be subjected to great risks and the end results will be poor compliance, and an increase in surgeries that have been proven to not be the best treatments.

    FOLEY, SARAH Date: 01/03/2008
    Comment:

    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 monitoring. There is a great likelihood of repeat testing and possible in lab testing for confirmation.

    ABELL, DAWN Title: PSGT
    Organization: AMERICAN SLEEP MEDICINE
    Date: 01/03/2008
    Comment:

    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 care. It will ultimately drive up utilization, decrease compliance and increase costs.

    Turner, Debra Date: 01/03/2008
    Comment:

    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 this leaves too much room for untrained persons to do a very important medical test. Sleep disorders should be looked upon so lightly as do do "at home testing"

    McKinley, Mary Title: Director
    Organization: Minneapolis Community and Technical College
    Date: 01/03/2008
    Comment:

    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 any of the other sleep disorders, a home study is worthless.

    Burton, Shelia Date: 01/03/2008
    Comment:

    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 study. The thought of a patient being held responsible for proper equipment maintenance and the chances of equipment malfunction during the night are reasons enough to decline the decision. Additional reasoning would take me to possible altering of

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    Sweer, Leon Title: Associate Professor of Medicine
    Organization: Penn State/Milton S. Hershey Medical Center
    Date: 01/03/2008
    Comment:

    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 frightening prospect that may cause a general degredation of the field.

    Already all over the country, physicians and other health professionals are opening sleep labs of very poor technical quality and little or no supervision. The garbage that often comes out of

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    McKenzie, Meaghan Date: 01/02/2008
    Comment:

    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 when working with adjusting to the CPAP machine. It is crucial that the patient be able to switch mask during the study if they cannot tolerate the first mask they have chosen for the study. With a home based study patient would not recieve the reassurance and

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    Saskin, Paul Date: 01/02/2008
    Comment:

    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 service providers. The limitations of home based recording mandate that the results be interpreted by physicians qualified in sleep medicine. To have any physician able to attempt to read these tests without appropriate background and training will almost guarantee an

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    Garrison, Michael Organization: somniTech Inc.
    Date: 01/02/2008
    Comment:

    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 attempt to improve accessability and lower cost for a few.

    Having the ability to differentiate the types of sleep disordered breathing is crucial in any HST device. Strict criteria for scoring and interpreting data should be implemented. There should be

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    Carter, Joyce Title: Co-Clinical Coordinator
    Organization: American Sleep Medicine
    Date: 01/02/2008
    Comment:

    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 being diagnosed, by those patients who may wind up with a hardship if diagnosed (eg. Truck drivers or bus drivers, etc.) All they need to do is "REMAIN AWAKE" and the test reports NO Apnea, or likelihood of such.

    Brandes, David Title: Asst. Clinical Professor
    Organization: UCLA
    Date: 01/02/2008
    Comment:

    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 sleep disorder patients.

    The risk of trying to identify and treat OSA patients without a complete polysomnogram is the risk of missing other diagnoses. Also, some OSA cases will also be missed, since the sensitivity of the non-polysomnographic testing is in the 90%

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    Line, Desmond, RPSGT Title: RPSGT
    Date: 01/01/2008
    Comment:

    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 seven channels. EEG, EOG and EMG are part of the seven. Certainly CMS doesn’t expect the patient to apply these leads for the HST

    Who is interpreting these results; a DME representative, a physician board certified in sleep medicine

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    Parikh, MD, Pranav Title: Medical Director, Sleep Laboratory
    Organization: Hannibal Regional Hospital
    Date: 01/01/2008
    Comment:

    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, "Just put the CPAP in the closet for 3 months, and then they will let me cut you to cure you."

    And fraud on the CMS beneficiary''s regard:

    1) Fraud for falsely being diagnosed by those CMS beneficiaries who use the HST equipment on non-CMS beneficiaries, and the

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    Zaldivar, George Title: MD
    Organization: George L. Zaldivar, M.D, Ltd
    Date: 01/01/2008
    Comment:

    Dear Sirs/Madam: Sleep Medicine is more than Sleep Apnea. Given that reliable home studies cost almost as much as laboratory studies, I anticipate a huge expense for Medicare if such studies are approved to be done without supporting evidence of its possible need. I also envision a huge surge in the ordering of CPAP equipment by health care personnel without adequate follow up. Overall, I anticipate a bonanza for DME providers without material improvement of the comunal sleep health. As

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    Allred, Jeremy Title: Supervisor of Sleep Lab, CRT/RPSGT
    Organization: Serenity Sleep Lab
    Date: 12/31/2007
    Comment:

    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 put on them for home use can come off and they not know it during the home test. This would make for a retest needed and more cost involved for supplies and patients comeing back in to get the machine. Sleep studies should be done by someone who is trained and

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    Linarez, MD, E. Title: Sleep Physician
    Date: 12/29/2007
    Comment:

    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 testing model. It is not well thought out and it will simply be more costly to medicare in the end given the explosion of studies that will conducted improperly by companies looking to increase thier bottom line.

    A Technologist's presence adds

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    Shrivastava, D,ABSM, MD, Deepak Title: Medical Director SJGH Sleep Center
    Organization: San Joaquin County Health Care Services
    Date: 12/28/2007
    Comment:

    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 is inexact at this time and exposes the patient to significant risk.

    Jones, Kelly Title: Sleep Lab Coordinator/ RPSGT, RRT
    Organization: Hospital
    Date: 12/28/2007
    Comment:

    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 credential or education and are able to apply oxygen and CPAP without any knowledge of possible adverse reactions....now we are being insulted again with the threat of any and all Medical professions, DME''s, or anyone else who is inclined to jump

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    Johns RPSGT, CRT, CPFT, Henry Title: Sleep Center Director
    Organization: Pulmonary & Sleep Associates
    Date: 12/28/2007
    Comment:

    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 continuous issue. The evidence used to promote portable monitoring has been provided by the manufactures of those devices and is based on limited study of a limited number of carefully selected subjects. There have been no large, independent studies on

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    Swint, Trey Title: RRT, RPSGT
    Organization: Wadley Regional Health Systems
    Date: 12/27/2007
    Comment:

    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.

    Holmes, Theresa Title: Registered Polysomnographic Technician
    Organization: American Sleep Medicine
    Date: 12/27/2007
    Comment:

    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 in diagnosing OSA. This would have been an invalid study. At the very least there should be a qualified tech monitoring the study live at home.

    Herndon, Cody Title: Director
    Organization: Ellis County Sleep Center
    Date: 12/27/2007
    Comment:

    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 will speak as well as I can on their behalf.

    1) Research indicates that and ENT that performs a surgery specifically for OSA has only a 20% success rate. Therefore, CMS'' notion that surgery is a viable option will only increase Medicare spending. The

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    nelson, william Date: 12/27/2007
    Comment:

    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 kick-backs to medical directors, consultants who by the way will also be referral sources will be worse than it is now. Who will review findings of the portable monitoring for compliance, artifact, efficacy? Where would these individuals learn the skills to

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    Haake, George Title: Director
    Organization: Midwest Center for Sleep Medicine
    Date: 12/27/2007
    Comment:

    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''s hard enough to get successful outcomes above 80%. It will certainly be less with this model.

    Think about how vocal things will become when patients with bad outcomes have to proceed already disgusted by their failed progress thus far with a

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    England, Hudson Title: RPSGT
    Organization: Star Valley Medical Center Sleep Lab
    Date: 12/27/2007
    Comment:

    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 - this is in the best interst of our PATIENTS!

    To change from an evidence facility-based PSG diagnosis and therapy titration by experienced qualified credentialed sleep professionals to a type IV diagnostic device with APAP by any PCP is a huge, drastic

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    Hagbloom, Robert Title: Technical Coordinator
    Organization: University of Michigan Sleep Disorders Laboratories
    Date: 12/26/2007
    Comment:

    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 home.

    Davidson, Terence Title: Professor
    Organization: Univeristy of California, San Diego School of Medicine
    Date: 12/26/2007
    Comment:

    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 interest and practice in sleep medicine, I submit the following comments in favor of the above proposed decision.

    This is an incredible document and the first I have ever read wherein a party without self interest other than the general health of the US seniors has

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    grzymkowski, paul Date: 12/26/2007
    Comment:

    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 treatment of OSA. Convenience and cost savings while important considerations in health care are in this case throwing the baby out with the bath water.

    Levine, Steven Title: medical director
    Date: 12/26/2007
    Comment:

    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 enormous. I currently observe, even in the setting of current suboptimal regulations, the influence inadequately trained physicians and programs have on the care of patients in the community. So called “word of mouth” has a tremendous impact in this particular unique

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    Sims, Ronald Date: 12/25/2007
    Comment:

    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 diagnosis of OSA patients? Given the concern that CMS has demonstrated regarding physicians who self-refer to diagnostic testing facilities or to outpatient surgical centers, should CMS not take steps to prevent for-profit DME companies from trolling for

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    Bregman, Richard Title: Medical Director
    Organization: Saint Francis Hospital Sleep Disorders Center
    Date: 12/24/2007
    Comment:
    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 disorders can only be diagnosed and accurately be given recommendation as to therapy with an in lab sleep study. With this ruling any office whether a family practice physician, an otolaryngologist or anyone else can order a sleep study and sign a computer printout as if

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    Freudman, Jonathan Date: 12/24/2007
    Comment:
    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 NCD

    Dear Doctor Phurrough:

    I am in support of the decision of the Coverage and Analysis Groups as articulated in the proposed Decision Memo for Continuous Airway Pressure that was posted December 14, 2007.The analysis was

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    Vardi, Dan Title: MD
    Date: 12/24/2007
    Comment:

    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 careful review of the results together with a comprehensive sleep evaluation can bring to an adequate diagnosis and therapy (the same is true for a full night polysomnography that is getting out of hand as far as deteriorating quality and a big push for business

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    Ramachandran, Siva Date: 12/23/2007
    Comment:

    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 CPAP coordinator- a certified respiratory therapist as well a chief technologist a RSPGT in addition to our polysomnographers. Our initial evaluation and subsequent follow up are close to 100%- our CPAP coordinator initiates mask changes in the center as

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    Ayers, Ellen Title: Branch Manager
    Organization: somniTech, Inc.
    Date: 12/22/2007
    Comment:

    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 out of a professional staffed sleep study that would be overlooked and pt.''s misdiagnosed. I feel there would be a rise in incompetent, financial driven companies/personel and bottom line the pt.''s would suffer and insurance would pay a higher price for a lesser

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    Butkov, Nic Title: Education Coordinator
    Organization: Rogue Valley Sleep Center
    Date: 12/22/2007
    Comment:

    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 limited data are available, scoring rules must also be made sufficiently narrow. Consequently, the process becomes oversimplified, with reproducible, but often meaningless results. Normal variants of sleep physiology and common artifacts may be misinterpreted as

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    Cohen, Michael Title: MD
    Date: 12/22/2007
    Comment:

    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 interne? tat Walmart? Who does is the 12 week evalaution? DME company? questionnaire over the internet?

    Henriquez, Aurelio Date: 12/22/2007
    Comment:

    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 training out of a “Cracker Jack box.” In retrospect, I am glad to have worked with doctors who spent their careers innovating the field and providing “good medicine,” to the public. From Hans Berger to Peter Mcgregor, we have made a profession where we provide

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    Weingartner, Jason Title: RPSGT
    Date: 12/21/2007
    Comment:

    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.

    I have had patients a school bus driver comes to mind who suffered from UARS and needed CPAP. Would these home tests be able to pick that up?

    If not, the public is placed at risk by home testing and those who would approve such a decision.

    Bernard, Lori Title: Clinical Coordinator
    Organization: Nebraska Sleep Lab LLC
    Date: 12/21/2007
    Comment:

    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 withthe unskilled, working for the poorly trained who are not motivated to provide long term patient care and who have no interest - clinically or financially - in providing positive patient outcomes. This will lead to all the obvious and predictable

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    Clark, Steven Title: Registerd Polysomnographic Technologist
    Organization: OSF St Mary Medical Center
    Date: 12/21/2007
    Comment:

    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 knowledgeable sleep professionals and must have the capability of full data disclosure. Automated scoring and report generation without the ability to view, edit, and confirm validity of the raw data must not be allowed.

    Lauterbach, Gary Date: 12/21/2007
    Comment:

    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. I can understand the lobbying efforts that have gone on over the years to allow more access to CPAP, and other modalities. Sleep diagnosis should be maintained within the sleep professionals hands. I have a grave concern that large Home Health Care

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    Spector, BS, RRT, RPSGT, Jim Title: Instructor, Clinician
    Organization: Texas State University, Health Sciences Department
    Date: 12/21/2007
    Comment:

    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 restrictions and caveats are also implemented.

    Home sleep testing should be carefully regulated. There are clear problems with conflicts by DME dealers and physicians and dental offices providing sleep studies and CPAP or oral appliances. The results of portable studies

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    McNutt, Brad Title: Supervisor Respiratory Care/ Sleep
    Organization: St Joseph''s Hospital
    Date: 12/21/2007
    Comment:

    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.

    Jamerson, Byron Title: Director of Sleep Disorders Services
    Organization: The Sleep Center at ECM East
    Date: 12/21/2007
    Comment:

    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 perform the evaluations were not made.

    If evaluations performed by physicians who are not trained in sleep medicine are allowed then you will not be serving your patient''s needs adequately. Yes, I agree that OSA can be adequately diagnosed by portable

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    Johnson, Kathy Date: 12/21/2007
    Comment:

    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 expertise to collect and interpret the information contained in a full PSG study. When the amount of information is reduced it will take greater expertise to "fill in the blanks" and come up with an accurate diagnosis and treatment plan.

    It

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    mahajan, devinder Title: M.D.
    Date: 12/20/2007
    Comment:

    Home testing without any control of who isqualified to do the testing will open anothersource of income for unscrupulous home carecompanies and medical providers. There has to be amechanism to restrict it to the people who arequalified . Test should be done through accreditedsleep lab.

    Haupt, Randall Title: Director, Sleep Disorders Center
    Organization: Jennie Stuart Medical Center
    Date: 12/20/2007
    Comment:

    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 studies should reside with a physician that is board certified in sleep medicine by the American Board of Sleep Medicine or the American Board of Internal Medicine with sleep medicine as a specialty.

    I concur that the minimum 2 hours of total sleep time

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    Scully, Robert Title: CMO
    Organization: Health Alliance Medical Plans
    Date: 12/20/2007
    Comment:

    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 patients use CPAP as prescribed and sleep titration in a certified lab is important.I therefore disagree with the proposed decision.

    McKenzie, Michael Title: CEO
    Organization: Progressive Sleep Diagnostics
    Date: 12/20/2007
    Comment:

    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 Auto CPAP at home, and this will lead to fraud/abuse of the already drained Medcare system. This is one reason why an attended sleep study should be the only available option. Home testing will work only if there is a universal healthcare system in place.

    Joy, Paul Title: Director
    Organization: Ridgeview Home Medical Equipment
    Date: 12/20/2007
    Comment:

    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 opinion displays a level of ingnorance that perpetuates the total misconseption that all HME providers are dishonest.I would ask that you disregard this statement as it has nothing to do with home/portable OSA testing. I do however agree that all forms of testing be done only

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    Joy, Paul Title: DIrector
    Organization: Ridgeview Home Medical Equipment
    Date: 12/20/2007
    Comment:

    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 through an ACCREDITED sleep center, scored by a RPSGT and interpreted by a ABSM only! There would be inherent gate keepers, monitoring and documentation assuring compliance.

    Weingartner, Jason Title: RPSGT
    Date: 12/19/2007
    Comment:

    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 application of unmonitored tests.

    This only opens the door to more fraud/misuse/failure to occur in sleep-disordered testing and the lowering of CPAP compliance by patients.

    It''s time for CMS to step up and clarify rules and regulations and

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    shah, MD, Hemang Title: MD
    Organization: Tidewater Neurologists
    Date: 12/19/2007
    Comment:

    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. Diagnosis of sleep apnea is easy but titrating patients on CPAP and working with them so they keep on using CPAP is art of medicine. I have been repeating attended studies on patients who had home testing at Naval Hospital. Allowing poorly trained medical professinals

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    Freeman, Zachary Title: Registered Polysomnographic Technologist
    Date: 12/19/2007
    Comment:

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

    It is also my observation that because somethingmay be good enough to verify sleep apnea treatmentis indicated, this does not mean that what is goodenough for these purposes is to a persons fulladvantage. With the number of sleep disorders thatexist, and with the

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    Zarnke, JoAnn Date: 12/19/2007
    Comment:

    Why do you need any test at all? just look at how fat they are, and perhaps test only the in-betweeners. Your other commentators are in the the pay for testing. They won''t tell you that it''s not necessary.

    Cox, M.D., Robert Date: 12/19/2007
    Comment:

    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 prove equal outcome to the current procedure.

    Deneau, Kornelia Title: Clinical Coordinator RPSGT.
    Organization: Hospital Based
    Date: 12/19/2007
    Comment:

    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 possible harmful health risks...

    Polysomnography is more that just CPAP, it is the gathering of numerous and pertinent informations that paint a picture in the total SLEEP and possible health of patients...

    We can not draw conclusions of a patient

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    heidi, Connolly Title: Director of Pediatric Sleep Medicine Services
    Organization: University of Rochester/Golisano Children''s Hospital
    Date: 12/19/2007
    Comment:

    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. These studies must be interpreted by a physician with sleep medicine expertise - i.e. board certified either by the American Board of Medical Specialties in Sleep Medicine or board certified by the American Board of Sleep Medicine. Without this kind of

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    Yurcheshen, Michael Title: Assistant Professor of Neurology
    Organization: University of Rochester School of Medicine and Dentistry
    Date: 12/19/2007
    Comment:

    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. Home studies should be reviewed by physicians trained in sleep medicine.

    2. A negative home study in a patient with a clinical history suggestive of OSA or daytime sleepiness should be followed up by an in lab PSG. In the words of your report:"The diagnosis of OSA is

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    Modrak, MD, Joe Title: Medical Director
    Organization: Sleep Disorders Center of the Finger Lakes
    Date: 12/19/2007
    Comment:

    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 care companies tout their home studies that are essentially computer generated report that oftentimes is inaccurate. Home studies should be reviewed by physicians trained in sleep medicine.

    2. A negative home study in a patient with a clinical history

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    Duffy, Brendan Date: 12/19/2007
    Comment:

    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 be an avenue for state mandated or job mandated tests to be done by persons other than the patient in order to maintain their commercial driving or other duties that require vigilence. It allows an unsafe public practice to be funded.

    Scalise, Louie Title: Clinical Director
    Date: 12/19/2007
    Comment:

    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 college. I also have tought continuing education for both Respiratory Therapist and Registered Polysomnographic Technologist. When teaching these groups I have noticed that RT''s have very little knowledge how to analyze signals from the HST approved devices

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    Gable, Katherine Title: Technical Director, CRT, RPSGT
    Date: 12/18/2007
    Comment:

    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 happen with that patient that has centrals? This is at least 70% of the cpap study that we preform. It''s sad that these patients will fall through the cracks and cost us more due to a car accidents, strokes and rehab because they could not tolerate

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    Ryan, Pam Date: 12/18/2007
    Comment:

    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.

    Also, I worry about the incorrect or over-use of home testing, as I fear that many more patients will fail at CPAP under the new rules. We often get only "one shot" at accomplishing proper treatment of OSA with CPAP. After that, the patient may simply say, "I tried

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    Pagel, James Date: 12/18/2007
    Comment:

    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 Practice 2007. 20(4)392-8."

    I would also like to point out that the evaluation and treatment of OSA that you are proposing: DME 4-channel screen > empirical C-pap therapy administered by a health care provider untrained in sleep medicine is in

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    Warner, Scott Title: sleep specialist
    Date: 12/18/2007
    Comment:

    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 Proposed Decision Memo for Continuous Positive Airway Pressure (CPAP) Therapy for Obstructive Sleep Apnea (OSA) (CAG-00. 093R2). At MedCAC on home-testing in obstructive sleep apnea on September 12th, 2007, other than the AASM president, Dr. Chediak, there was only

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    Perry, Michael Title: Clinical Director
    Organization: Ohio Sleep Disorders Centers
    Date: 12/18/2007
    Comment:

    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?

    Thompson, Lowery Title: Physician
    Organization: Neurology Consultants
    Date: 12/18/2007
    Comment:

    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 selection of patients for unattended monitoring. There is significant potential for harm to patients if unattended monitoring is used non-selectively. Thank you

    Patz, David Title: M.D.
    Organization: St. Mary''s Hospital Sleep Lab
    Date: 12/18/2007
    Comment:

    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 the nearest sleep lab. Otherwise, if they travel down to the sleep lab, the study may underestimate severity. See: Patz et al, The Effect of Altitude on Obstructive Sleep Apnea, CHEST, Dec. 2006, p1744-1750

    Pane, Michael Title: Manager, Neurodiagnostics and Sleep Lab
    Organization: Robert packer Hospital
    Date: 12/18/2007
    Comment:

    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 relief from symptoms, hence preventing law suits against physicians and homecare companies, if the patient fails to comply and has an accident. While a significant increase in the amount of sleep studies being performed is a real possibility, the treatment and "$" spent

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    Sebastian RPSGT, Troy Date: 12/18/2007
    Comment:

    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 vital in their a person''''s success to be in an accredited sleep center in adapting to nCPAP.

    Turpin, Don Date: 12/18/2007
    Comment:

    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 lab-based testing that cannot be accounted for with home based testing. For instance, the parameters monitored during traditional polysomnography are more complete, and therefore create a more reliable diagnosis than home-testing could possibly do. Home-testing

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    Cash, Jim Date: 12/18/2007
    Comment:

    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 $$$$$.

    Savage, James Organization: Bay Medical
    Date: 12/18/2007
    Comment:

    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!

    HEY, MD, DABSM, JOHN Title: Medical Director
    Organization: Sleep Disorders Center-Greenwood Leflore Hospital
    Date: 12/17/2007
    Comment:

    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 weeks is optimum and if the patient is seen at this time, one year later 95% are compliant and helped. There should be mandatory training in home sleep CPAP set up and fitting for the DME companies and their RRT or RN that sets up the CPAP and fits the mask. For

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    Kasso, David Title: RCP, RPSGT, Manager
    Organization: Premier Diagnostics, Inc. "Accredited with the AASM"
    Date: 12/17/2007
    Comment:

    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 will attempt to manage a patient''s sleep disorder when they have no business doing so. I have met these physicians, who most didn''t even know what an "AHI" was. Medicare billing will increase significantly, as any patient who sneezes funny will get ordered a sleep

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    Morse, Aaron Title: Medical Director
    Organization: Central Coast Sleep Disorders Center
    Date: 12/17/2007
    Comment:

    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. There are few physicians in the country who have comparable experience with home studies.

    While home testing definitely has value in selected circumstances, it is very important that the pre test probability of sleep apnea and the follow up of patients

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    Capodilupo, Paul Date: 12/17/2007
    Comment:

    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. I have been involved with sleep labs for nearly 20 years. First as a night shift RRT whose responsibility it was to make sure the ink pens did not become tangled, to my current position overseeing a two-bed lab in a rural Michigan

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    Clark, Lance Title: Clinical Coordinator
    Organization: CardioHealth Sleep Inc
    Date: 12/17/2007
    Comment:

    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.

    Brown, Terry Title: Dr
    Organization: St. Joseph Memorial Hospital
    Date: 12/17/2007
    Comment:

    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 all uncertain as to whether sleep evaluation and combinations of studies II, III, and IV will detect all the medicare cases. I think if one looks at number 5 and not number 2 or if one looks at both of them it is not clear that CMS intends to allow NCD for

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    Stewart, Tim Title: Contract Specialist
    Organization: Sheldon Medical Supply
    Date: 12/17/2007
    Comment:

    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'' when waiting for an available bed in a sleep diagnostic center. Home sleep studies offer an added option to reduce the scheduling burden, resulting in a test being conducted more promptly.

    Sleeping in one''s home environment is much more

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    haigh, rachel Title: Manager of Sleep Lab/Respiratory Care
    Organization: Avera St Lukes
    Date: 12/17/2007
    Comment:

    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 things up at home and I am afraid unattend sleep studies may result in many false findings.

    Nadrous, Hassan Date: 12/16/2007
    Comment:

    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 treatment as well as in billions of dollars waste on CPAP machines.

    In a time when there is a major fear about the future of medicare financial situation, I think it is very wise to be very careful on the decision to implement the usage of home study

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    Kight, John Date: 12/16/2007
    Comment:

    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 patient how to use the device safely and effectively, retreiving and downloading the device, and providing the ordering Physician with the results. If the patient is identified as having OSA, the Physician then orders an AutoPAP to titrate the patient's Continuous PAP

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    Krakow, MD, Barry Title: Medical Director
    Organization: Maimonides Sleep Arts & Sciences, Ltd.
    Date: 12/15/2007
    Comment:

    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. RDI stands for apneas plus hypopneas plus RERAs. The latter term is also known as flow limitation or UARS. If you need clarification, check the nosology (ICSD-2) of the American Academy of Sleep Medicine.

    Last, because of this misuse of the

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    McLaughlin, Mercedes Date: 12/15/2007
    Comment:

    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 Medicine (link to draft document: http://www.aasmnet.org/jcsm/AcceptedPapers/PMProof.pdf). Thank you.