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

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 much education the person has around sleep testing or sleep medicine? Issue #3: what happens if a portable device indicates a high probability of sleep apnea? Is the patient to just get set up on an auto-titrating device, or does the patient need to come to the sleep lab for formal testing and titration? Is the auto-scoring feature adequate enough to determine if the patient has sleep apnea?

People who do not understand sleep apnea think all apnea is the same and can be treated the same.We have seen over the years that not all sleep apnea is the name, nor is the treatment for all sleep apnea the same, hence, the different devices now on the market that can help treat complex and central sleep apneas. Even with these devices, some apnea is so severe that oxygen and/or tracheotomy may still be necessary. If one of the issues is trying to get patients diagnosed faster, I don’t believe this will speed up the process. There can be back-logs with portable testing devices just like there can be with in-lab testing.

Patients need to be seen by a sleep specialist before and after the sleep study. The physician with the right education in sleep medicine has the knowledge to steer the patient in the appropriate direction for further work-up, whether that be a sleep study test, lab work, or psych, etc.

I am unclear how this will decrease costs to Medicare. It may even increase costs because more patients may be ordered on testing who do not need it, there will be testing that has inadequate information, and the testing will need to be repeated. Some devices will also give the wrong diagnosis. At least with in-lab testing, not only do you have the wave forms that are reviewed by the tech and the reading physician, but the patient is observed. This can provide valuable data and help lead to a more accurate diagnosis. It is imperative that the test data needs to be reviewed for accuracy. Even testing done in the labs should be required to be reviewed by the tech and physician, as is the case with accredited centers.

If the standards are kept very loose, it will be a slippery slope that lets anyone do testing without oversight. Patients may get the wrong impression that sleep apnea is not that important and may choose not get tested, or be persuaded to follow an inappropriate treatment plan. This could lead to very dissatisfied patients and poor outcomes. If home testing is to be allowed it must be done only under certain conditions and special circumstances. I am in agreement with the guidelines established by the American Academy of Sleep Medicine. Sleep apnea is an important disease that needs appropriate testing and treatment. This is done through proper protocols and guidelines. Thank you for the opportunity to voice my concerns and opinions.

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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 free-for-all and chaotic mess, with hundreds of companies jockeying to position their products, lack of standards, and more confusion and mayhem. If this does occur, I don’t think it will take anything away from the sleep medicine community; in fact, it should end up increasing awareness, and there should be even more demand for formal accredited overnight sleep centers.

I didn’t listen to Dr. Davidson’s talk, but I’m sure he would agree that CPAP is always the first line treatment option for sleep apnea. He could have been more diplomatic in making his comments, since ENTs are now a co-sponsoring member of the American Board of Sleep Medicine. What should be fostered is a renewed sense of cooperation between all five specialties. I don’t see how more home-based studies will lead to more upper airway surgeries. This should not be a turf battle. Ideally, patients with OSA should be treated in a multi-disciplinary setting, such as tumor boards. One of my future dreams is to organize or be part of such an organization, here in Manhattan.

My personal experience is that I’m much more aggressive about recommending CPAP and mandibular advancement devices with aggressive follow-up and counseling than most sleep doctors in my area. Despite this, for the minority of people who can’t tolerate CPAP or afford dental devices, I offer surgical management. I have to admit that my results could be better, but it’s much higher than the Sher’s quoted 40% success rate (which only studied the UPPP).

There’s so much confusion and misunderstanding in both camps (surgical and non-surgical, including dental). In general, very few ENTs understand or are even interested in learning how to perform hypopharyngeal surgeries, and to look at the entire airway, focusing on the soft palate only. They also focus too much on the upper airway obstruction part, and not enough on the many other comorbid sleep conditions. The medical specialists don’t routinely visualize the upper airway anatomy, and go mainly by the polysomnography results, and are relatively unaware of the different types of surgery available (besides the UPPP).

One of my greatest pleasures is giving lectures to sleep medicine fellows on surgical management of obstructive sleep apnea. I get such positive feedback from the fellows, who say that knowing something about surgery helps them manage their patients better. For some reason, the sleep doctors that I deal with on a regular basis are more realistic about CPAP use and compliance than what the journals publish. Again, we should do everything to make sure patients use their CPAPs, but over the long term, you have to admit that the overall compliance rate is poor. Even if you accept that a UPPP’s success rate is only 40%, that means that 40% of people won’t need to use CPAP (granted there will be some relapses). But for people to say that surgery should never be done without knowing the facts should reconsider their positions. Once you start addressing the entire upper airway (from the tip of the nose the vocal folds), then the success rates approach 70-80% (which is documented). Add to this that maxillo-mandibular osteotomies are about 90-95% successful, only goes to show us that the more appropriately one addresses the upper airway, the better results one gets. Although not very practical, a tracheotomy is 100% successful. Tell the patient that went from an AHI in the 50s or 60s down into the single digits that his type of surgery doesn’t work. Surgery should never be the first line option, but with proper counseling and patient selection, and with management of the appropriate anatomic areas of obstruction, many patients can have their lives changed dramatically.

Another problem is the myth that’s perpetuated by the medical community that the typical sleep apnea patient is older, snores, male, overweight, and has a big neck. Yes, this is the most likely population that’s at risk, but that’s the extreme end of the spectrum. We now know that even young, thin, non-snoring women can have significant obstructive sleep apnea. Not to mention the millions of others that miss Medicare’s cutoff by .1 and are not eligible for treatment. These people are never even considered for a sleep-breathing problem, and instead are treated for their depression, anxiety, sinus infections, acid reflux, etc. I have a forthcoming book on this very topic called, Sleep, Interrupted: A physician reveals the #1 reason why so many of us are sick and tired (http://www.westsideent.stirsite.com/page/page.cfm/sleepinterrupted ).

My feeling is that CMS shouldn’t even consider home based studies until accredited (an more importantly non-accredited) sleep labs are more standardized and give consistent results, with a certain degree of quality interpretations and patient services. In my area (NYC) there are some excellent labs, and others that are questionable. The quality of the interpretations and patient experiences are vastly different. (Also, ENTs reading polysomnographies should be looking at a lot more variables than the AHI and oxygen levels. Bare minimum, if you’re going to treat someone for obstructive sleep apnea, you should know how to properly interpret (and maybe even score) a polysomnogram.)

Standardizing the definition of the AHI (regarding hypopneas and RERAs) would be the first step. There should be some sort of standard amongst equipments as well. We’re already comparing apples to oranges. Once home studies are added, then we’re going to be comparing apple and oranges to bananas, peaches, and kiwis. I think there should be an easier way of having home studies approved for certain situations, but not completely open for anyone to order.

I will do my part and write to CMS.

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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 quality of care in the most efficient manner. As Sleep professionals and American citizens, we have a duty to provide such value to CMS and our patients. CMS has a duty to adhere to an evidence based approach.

I therefore find it stunning that the present NCD proposal engages in unjustified extrapolation from the available data. In particular, the MedCAC expressed “low to moderate” confidence that its conclusions could be generalized to the Medicare population or community based providers. The latter reflects that the bulk of the literature on HST did not occur in populations or settings reflective of Medicare beneficiaries. The NCD proposal to open use of level III and IV HST for Medicare populations, ordered by physicians with limited or no ability to assess pretest probability of disease or to appreciate the limitations of HST, with implementation of PAP by undefined means and absent definition for “benefit”, amounts to subjecting the Greatest Generation to be guinea pigs in a huge uncontrolled trial.

Much has been discussed about the above issue of increased medical and non-OSA Sleep comorbidities in the Medicare population invalidating application of existing HST data to the elderly. Let me amplify the comments of the AASM with some personal observations, which I believe need to be assessed in a comprehensive prospective community-based multicenter study before any recommendation on HST in the elderly should be considered.

First, highly disruptive periodic limb movements are much more common in the elderly, even in the absence of a restless legs complaint or perceived or observed extremity jerks. Such PLMs lead to the misdiagnosis of sleep-disordered breathing in level III and IV tests, as they induce microarousals followed by physiologic post arousal central hypopneas, central apneas, and at times occlusive events due to the influence of respiratory pattern instability on upper airway instability in individual predisposed by obesity or upper airway disease. These are not primary respiratory events, and lead to misdiagnosis by level III and IV HST. I observe this phenomenon frequently and such observations have been published (Sleep Breath. 2001 Sep;5(3):131-7). Next, when highly disruptive PLMs coexist with legitimate OSA, evaluation of reversible age-related predisposing metabolic conditions (e.g. marginal iron stores from GI disease, or B12 deficiency) and potentially medication lead to an increased likelihood of a successful subsequent CPAP titration. Finally and most significantly, harm may indeed come to the elderly patient under the proposed NCD paradigm. The literature makes it clear that long term PAP compliance is dependent on the experience of the first month of PAP use. We also know that OSA is an independent risk factor for stroke and other adverse cardiovascular events. The older patient whose OSA was diagnosed by HST and placed on autotitating PAP with poor tolerance due to undiagnosed highly disruptive PLMS will likely blame the poor tolerance on the PAP itself, and be “soured” on PAP therapy. Such a patient is less likely to agree to return for further assessment of PAP by in-lab PSG or any other means. Particularly with the elderly, you often have one chance to “get it right”. Increased morbidity and costs will ensue. CMS has a responsibility to assess research on such concerns prior to changing coverage parameters.

In failing to specify how CPAP should be initiated, or benefit defined, CMS ignores the diagnostic value of attended therapeutic polysomnography, and puts patients at risk for declarations of PAP failure and unjustified and frequently ineffective surgery. This is particularly pertinent in an elderly population. Therapeutic PSG allow for the appreciation of disruptive PLMs, disruptive bruxism, sleep seizures, complex sleep apnea (now known to be present in a significant minority of patients), atypical spindles reflecting unreported sedative-hypnotic use, and comorbid nonocclusive desaturation on PAP meeting CMS criteria for supplemental O2. Such nonocclusive desaturation occurs due to reduced O2 stores from obesity alone even in the absence of obesity-hypoventilation, COPD, kyphoscoliosis, or neuromuscular disease. Attended therapeutic PSG also allows for the efficient conversion to standard Bilevel PAP when required for tolerance or sleep hypoventilation (most patients do not have ABGs to exclude obesity-hypoventilation before a study so obesity-hypoventilation would have gone unrecognized with a HST+ autoPAP paradigm), or adaptive servo PAP for emergence of complex apnea. It allows for interface changes and real time desensitization. The long term significance of REM-dependent apnea is not yet known; pending such data prudence suggests that confirmation of PAP efficacy in REM and NREM is desirable. Further research is in progress evaluating the role of autotitrating PAP in patients diagnosed by portable monitoring. To base a management paradigm on undefined “benefit” in the absence of such data, particularly in the elderly, is unjustified.

Notwithstanding all of the above, an appropriate role for HST exists based on current data. Diagnostic accuracy depends on the pretest probability of disease combined with the operating characteristics of the test employed. HST has utility at the extremes of pretest probability of disease. The question is: will level III tests be used in a context appropriate to its limitations if payment is allowed? The answer is: you get what you pay for, and if you pay for it, it will happen. Practitioners untrained in the broad field of Sleep Medicine, unable to properly establish clinical pretest probability of disease or appreciate test limitations based on comorbidities or elderly age will use the technology in all comers. Fly by night operations pushing such studies without appropriate clinical follow-up will flourish. These operators will encourage practitioners to sign computerized summaries and submit a bill, without review of raw data. There will be increased rather than decreased costs, and misdiagnoses will be common.

Medicare’s emphasis should be on scrutinizing the quality of what it is getting for its money. CMS has a duty to make NCD decisions based on evidence based data. The nation’s elderly should not be guinea pigs in a massive uncontrolled trial.

Thank you,

Robert Aronson MD, ABSM
Medical Director, Cardinal Sleep Disorders Centers of America

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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 studies with some of them.

My comments about the proposed CMS NCD are as follows:
1. I support the use of HSTs in the practice of sleep medicine - obviously focusing on patients suspected of having sleep apnea, since that is all they are appropriate for. Nonetheless, there are a lot of sleep apnea patients to be seen. I find the flexibility HSTs offer to be useful. Not having to perform a full PSG for all patients – especially those with a high chance of having sleep apnea and no evidence of other sleep disorders – is a positive step for the field.
2. Just as with any test, using it without clinical justification and knowledge about the patient is just bad medicine. I am sure CMS does not intend this. I do not know if this decision will open this area of clinical medicine up to fraud or abuse, as some have suggested it might. I believe it depends to a large degree on how it is put into practice. There may well be fraud and abuse with the present use of full PSGs. This is not the technology’s fault; it is the fault of practitioners.
3. I agree with CMS’ focus on the outcome of a trial of PAP for 12 weeks. This needs to be fleshed out a lot more for implementation but changing the emphasis of sleep apnea care from the diagnosis to the results of treatment is to be applauded.
4. I disagree with the NCD’s discussion about the WatchPAT-100. I have used the WatchPAT-100 for several years and have found it to a useful diagnostic tool. Furthermore, this technology probably has more research behind it than any other HST that I am aware of with the possible exception of plain pulse-oximetry. My reading of the data on the watchPAT is that it is at least as accurate as other HST technology. While the watchPAT is “different” from other HSTs, in my opinion, it is a valid tool and should be allowed to be used in the same way as other HSTs.
5. I support the NCD’s change in the 2 hour rule: from 2 hours of sleep to 2 hours of recording time.

In summary, CMS’ proposed NCD on HSTs for OSA and providing CPAP is a positive step. It left many important aspects of sleep apnea medical care using HSTs unanswered. It would be useful if the final comments address some of these uncertainties. In particular, details about the 12 week PAP trial will be implemented need to be provided.

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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 difficult-to-manage patient problems in the hands of physicians that have no experience in these matters. The research to show that this approach is truly more cost effective is lacking. It could well result in a significant number of these patients being restudied at more expense and it could also result in many machines being dispensed to patients who do not use them because there is not active followup or even worse yet, having their machines taken from them because the treating physician does not have the experience to help their patients comply with treatment or with Medicare guidelines that are already in place! Please do not consider this approach - it reduces the current standard of care, puts patients at risk for missed diagnoses and/or being treated when treatment is not necessary and is fiscally irresponsible.

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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 sleep-heart program as a collaborative effort between sleep medicine and cardiology. Our clinical experience has shown that home sleep testing is beneficial particularly in the high risk populations with clinical consequences such as heart failure, hypertension, atrial arrhythmias, and other cardiovascular diseases. As a program, we strongly support outpatient testing for sleep disordered breathing (SDB) in these high risk populations. Specifically, in my prior comments to CMS, I referred to our clinical experience from a study we performed that validated a home sleep testing device against polysomnography in the heart failure population.

Thank you for addressing this complex issue with your Proposed Decision Memorandum. In reviewing the proposed memorandum, my colleagues and I support the proposal for coverage of home testing. While we agree with the recommendation of coverage for home testing, we would further recommend that (1) devices covered for home sleep testing be limited to multi-channel testing devices that have been validated against sleep laboratory polysomnography and (2) the devices generate data representative of physiological data collected from polysomnography. Given that the use of un-validated devices to clinically diagnose sleep apnea lacks sufficient evidence to meet evidence-based medicine criteria, we are not comfortable with coverage of un-validated sleep testing devices and recommend that further studies be performed to validate the efficacy of such devices.

As noted in the request letter to open the existing NCD, home testing of sleep disordered breathing is a very useful tool for physicians and their patients. Medicare coverage of validated multi-channel home testing would improve provider and patient access to appropriate diagnosis of SDB and therefore, treatment.

We respectfully request that the CMS include home testing via validated multi-channel home sleep testing devices for SDB in high risk cardiology populations in their Final Decision Memorandum for Continuous Positive Airway Pressure (CPAP) Therapy for Obstructive Sleep Apnea (OSA).

Thank you.

Sincerely,

William T. Abraham, MD, FACP, FACC, FAHA
Professor of Medicine
Chief, Division of Cardiovascular Medicine
The Ohio State University

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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 difficult-to-manage patient problems in the hands of physicians that have no experience in these matters. The research to show that this approach is truly more cost effective is lacking. It could well result in a significant number of these patients being restudied at more expense and it could also result in many machines being dispensed to patients who do not use them because there is not active followup or even worse yet, having their machines taken from them because the treating physician does not have the experience to help their patients comply with treatment or with Medicare guidelines that are already in place! Please do not consider this approach - it reduces the current standard of care, puts patients at risk for missed diagnoses and/or being treated when treatment is not necessary and is fiscally irresponsible.

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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 safe test such as portable monitoring for osa to sleep specialists is justified.

3. Related to point #2, home testing should NOT be limited to sleep labs. One of the main rationales of home testing for osa is to expand diagnosis of osa to areas/populations currently not being served by sleep labs, and limiting home testing to sleep labs would defeat this purpose.

I am against home testing for osa. With the rapidly expanding number of sleep labs, I think that most of the US is now within convenient location of a sleep lab, and I don''t see the need for a test that is inferior to in-lab polysomnography. However, now that the American Academy of Sleep Medicine has signed off on home testing, I don''t see any point in arguing further against it, and hope that you will consider my suggestions for implementing home testing.

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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 financial self-interest in recommending ENT surgery to address sleep apnea, in situations where this may be contraindicated. Non-sleep medicine physcians will view home based testing as an opportunity to increase revenue for their practice but without the expertise to interpret tests or fully understand results of testing. Sleep medicine is a complex field,with many conditions other than sleep apnea and to open up home based testing to physcians who are not sleep specialists is to undermine the specialist''s ability to ascertain which patient would benefit from testing and which patients require other sleep related assessments and treatments.

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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 by a prescription for CPAP. The idea of using a single channel screener is especially outrageous. Hardly a day passes in my clinic when we don''''t see patients who have been to some other less committed facility who have never been adequately dignosed or treated. Most of them have never seen a sleep physician or had anyone help them with their CPAP. The major problem with the treatment of sleep related breathing disorders is not that patients don''''t have access to reputable and credentialed facilities but is that the field is contaminated by so many with their own gain as the primary motivation for being in the sleep "business". Physicians whose only interest is "reading " a test or DME companies who are only interested in selling CPAP machines are not motivated to evaluate and closely follow their patients and the result is that someone pays for a sleep study and CPAP machine and the patient gets no help which is exactly why the published CPAP compliance rates are so poor. On the other hand, in a facility such as ours, compliance is much higher as I and my experienced team are in the "business" of helping patients and not just doing a test and selling equipment or performing some expensive - and often fruitless -surgical procedure. You should be focused on treatment outcomes as medicine in general is now doing. If you examine them closely I am certain you will see that dedicated sleep physicians directing comprehensive sleep programs are more successfully treating their patients. There should be nothing particularly surprising about that. Cardiologists generally treat MI''''s more successfully than GP''''s.In conclusion I would add that I strongly suspect that all parties involved in making this final decision are going to preferentially see someone like me when they have a sleep disorder.

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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 will not be well served by this approach. We should not sacrifice the safety of these individuals for an "expeditious" diagnosis which may be incorrect. This will make interpretation of the outcomes of therapy very difficult and hamper an evidence based approach to the treatment of person with sleep disorders.

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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 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 practice and patient care. Two important considerations in treating patients are to reduce medical risk and improve quality of life for our patients. I am concerned that patients will be treated with CPAP who may not actually require treatment creating an unnecessary burden of cost on the health care system that we cannot afford. Treatment decisions and medical risk assessments are best made in the hands of experienced and medically trained sleep professionals. Alternatively, other patients with sleep apnea who should be treated because of associated co-morbidities may fail therapy in the first weeks because of accommodation problems to CPAP and then not receive appropriate therapy resulting increased medical risk.

Home sleep testing has been comprehensively addressed by the AASM with the December 2007 publication of “Clinical Guidelines for the Use of Unattended Portable Monitors in the Diagnosis of Obstructive Sleep Apnea in Adult Patients.”

There are several issues that need to be considered:
1. Inclusion of Type IV devices.
2. No definition of an acceptable CPAP trial.
3. No definition of requirements for clinical evaluation that complements the home sleep test.
4. No definition of a paradigm for follow-up and long-term management, especially in patients with a negative home study test or a failed CPAP trial.
5. No definition of who is covered under this policy.
6. No requirement for patients in need of a new CPAP machine.
7. No specifics about how to treat patients who initially failed the first few weeks of treatment as a result of accommodation problems to CPAP but are at medical risk without CPAP therapy.
8. No definition of patients who have failed CPAP in the past and also had unsuccessful surgical procedures ie UPPP, LAUP with recurrent symptoms of sleep apnea.
9. No definition of individuals who have failed CPAP but then experience a significant weight increase with significant risk of developing or worsening the severity of sleep apnea.

I share the concerns outlined by the AASM and fully support its comments to CMS. I believe these issues, as well as others; can be addressed through the local coverage determination (LCD). I am willing to work with you on developing a fair and comprehensive LCD for home sleep testing; please do not hesitate to contact me at (803-251-3093) or via e-mail (jturner@sleepmed.md).

Sincerely,

Jo Anne Turner APRN BC
SleepMed
1333 Taylor St Suite 6B
Columbia, SC 29201
jturner@sleepmed.md

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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 by respective US and international societies. I lecture frequently in the US and engaged in co-research with US sleep researchers.

I am in full support of the direction taken by CMS in its recent draft NCD, specifically, suggesting coverage for CPAP therapy when the diagnosis is established with either PSG or HST, as long as such test is accompanied by clinical evaluation and perform by trained physicians.

Certain elements of the proposed NCD are problematic, specifically, the limitations imposed on one of the technologies – Watch PAT, while proposing unlimited coverage to all Type II, Type III, and certain Type IV home sleep testing devices. I request that CMS reverse its proposed decision and cover the Watch-PAT in its final decision and treat is similarly to other covered HST devices.

I have read the evidence on the Watch-PAT cited by CMS (I have also participated in the research associated with some of that evidence), and believe that it supports an opposite conclusion to that reached by CMS. The articles CMS reviewed show that the Watch-PAT is as diagnostically accurate and effective as any Type II or Type III devices with a similar or lower failure rate. This published evidence has led our practice to initiate a routine use of the Watch-PAT in our sleep program. My experience confirms that the failure rate of the Watch-PAT is very low and that using this device is easier and more suitable for patients tested outside the sleep lab than most other home sleep testing devices. Specifically, the PAT provides accurate quantification of both sleep/wake detection (which is more than most Type III devices) and sleep disordered breathing events (similarly to Type III devices). The ability of the Watch-PAT to provide valuable information on the actual sleep quality, including sleep time, sleep/wake and REM, is generally available only when patients undergo PSG, and the Watch-PAT provides the best alternative by accurately offering such information in a study performed at home. Interpretation of the Watch-PAT data is consistent and accurate as the device includes software programs that analyze the data and generate a comprehensive report for the physician and patient’s review. Since the device provides access to the entire raw data, I can perform a manual audit and adjust the interpretation report as needed, as is the case when we review PSG data.

In our practice, we test many patients reliably and effectively with the Watch-PAT. Furthermore, we have patients that cannot be tested effectively in a sleep-lab, and testing them at home with the Watch-PAT represents the best option for them. Decisions about ordering either PSG or a home test using the Watch-PAT are left to the diagnosing physicians, as they consider multiple factors when determining optimal test, just as we do with diagnostic tests for many other morbidities.

In my opinion and based on my knowledge of the evidence and my clinical experience, if CMS covers any home devices at all, it must cover the Watch-PAT as part of such decision. Again, the Watch-PAT is a very easy to use accurate and reliable home monitor for the diagnosis of sleep apnea, which has been published more than any other single alternative device! Therefore, I urge CMS to reverse its decision. Thank you for your consideration.

Sincerely yours,

Giora Pillar, MD, PhD
Associate Professor of Sleep Medicine,Technion Faculty of Medicine,Haifa, 31096, ISRAEL

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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 for those locomotive engineers whose pre-screening indicated a high probability of their having obstructive sleep apnea hypopnea syndrome (OSAHS) followed by treatment with CPAP for those diagnosed. After treatment initiation I provided follow-up care via regular phone meetings to address issues that arose so that a high adherence rate to treatment was maintained. Now, that CMS has embarked on a program to fund in- home testing I would much appreciate your considering my comments:

If CMS supports strongly the development of programs that incorporate specific well- considered guidelines then ambulatory testing will contribute positively to the care of patients with sleep problems. Used appropriately, ambulatory testing for sleep disordered breathing (SBD) may be less costly than in-home testing. Today, a large majority of people with SAHS, including patients with predominantly central SBD, remain undiagnosed or inadequately treated despite their having been diagnosed. Depending on the severity of the SAHS and the compounding medical problems of patients, the consequent morbidities, mortality and proportionate financial burden, many preventable or reduced in severity by correct diagnosis and ongoing treatment, may develop over months, years or even decades. These compounding adverse consequences of SAHS include chronic lung disease, hypertension, stroke, cognitive impairment, injuries and deaths from accidents caused by excessive sleepiness, heart failure and coronary artery disease. In the past decade, accumulating data has documented the beneficial effect of treatment with CPAP on these and other adverse consequences, including the increased mortality rate, of untreated SAHS.

Before addressing some of the challenges that I anticipate will confront a broadened in-home diagnostic testing program for SAHS, I would like to emphasize that there are no easy adequate short hand determinants of severity. Too often, payers and others consider the apnea hypopnea index (AHI) or the drops in SpO2, expressed as either the nadir or the time during the recording in which the patient’s SpO2 was below a particular level, to be the gold standards of severity measures. Unfortunately, the number of arousals, the degree of blood pressure dyscontrol during sleep and during the day also, the cognitive impairment, and excessive sleepiness and its adverse outcomes are also important measures of severity, too often ignored. Also, the severity of sleep apnea must be considered in the context of a patient’s other health problems, especially those that are exacerbated by SAHS. For example, relatively mild SAHS may pose a serious risk for someone with congestive heart failure (CHF) or severe coronary artery stenosis. All the compounding conditions that I listed in the preceding paragraph and others must be considered. Also, it is important to note that sleepiness is not always a symptom of even severe SBD. One very large population study in which the prevalence of OSAHS in a community was carefully assessed documented that only 20% of men and 50% of women with OSAHS complained of sleepiness!

I would like to comment now about some of the challenges and possible important problems that could occur as payment for in-home testing is implemented.

Patient Care Considerations
In my opinion, at present, beyond the large number of patients with SAHS who remain untested and undiagnosed, there remain important problems with treatment of patients with SAHS. While the best data suggests that use of CPAP through the entire sleep period is most effective, “compliance” standards used in published research reports are often at least four hours of use of CPAP four days per week. This is an inadequate standard. To do better, patients require substantial support and this takes the time of a knowledgeable physician or physician extender. Few physicians, in my opinion, even few thousand who are certified sleep specialists, take the time required to provide this support. In consequence patients often stop using CPAP or do not use it for a sufficient amount of time per night or nights per week. Accordingly, if more patients get testing because of the availability of ambulatory recording then how will these patients have adequate follow-up care? Plans must be made to provide effective ongoing treatment for both patients whose sleep testing is positive but also those whose testing is negative. If a workable plan is not in place then too many patients will not only not get treatment and be at risk for developing preventable consequences but they will also be discouraged about trying again.

Since some of the diagnostic devices for sleep testing require no assessment of raw data but instead generate processed data and even diagnoses (sic), any entrepreneurial but also unscrupulous person, whether knowledgeable about sleep medicine or not, can order tests and get paid for these services. Otolaryngologist and oral surgeons may bypass not only in-lab testing and CPAP titration and instead go directly from ambulatory testing to surgical treatment. For most patients surgical treatments for OSAHS are insufficiently effective and in as many as 20% exacerbate the OSAHS. Currently, most patients who undergo diagnostic work-up for SAHS are provided with the opinion of a non-surgeon about treatment options. Of course, an over-riding interest in profit may result in not only over- use of testing but over-prescribing of CPAP or other treatments. Considering these factors, if use of ambulatory testing increases substantially, there may be a dramatic increase in the overall cost of care for sleep disordered breathing. And, as I’ve noted above, the long- term costs due to inadequate or terminated treatment.

Five of the seven type IV devices that we have investigated do not measure ventilatory effort. Accordingly, patients who have predominantly non- obstructive apneas, including those with Cheyne- Stokes breathing, tested with these devices, will not be correctly diagnosed. Even worse, because most of these patients also have obstructive SBD, many patients will likely be misdiagnosed, using these devices, and then undergo treatment with CPAP. Central sleep apnea is often exacerbated by conventional CPAP treatment. Another important reason for using diagnostic devices that can distinguish central from obstructive SBD is the availability, in the past few years, of two CPAP devices, such as the ResMed Adaptive Servo-ventilation BiPAP, which are very effective for treating central SBD. Forty to sixty percent of patients who have CHF have SAHS, and most of these have predominantly non-obstructive apneas. When they are effectively treated to normalize their ventilation during sleep their CHF often improves dramatically. These patients need to be identified and treated appropriately. The five out of seven type IV devices noted above would not identify central SBD!

Using the widely used diagnostic criterion of at least five apneas/hypopneas per hour of sleep, 30% of Americans over 65 have at least mild sleep apnea. These older patients are less likely than younger patients to cooperate adequately with the demands of in-home testing and also typically require more support to maximize their use of CPAP. These same patients are also at highest risk for developing adverse consequences if they do not use effective treatment for their SBD.

Ongoing care of patients who screen positive, but also those who screen negative, for SBD is essential. CMS or its regional contractors should develop effective and enforceable guidelines that regulate the quality of ongoing care of all patients who present for sleep testing. Such guidelines must also address the issue of insufficiently educated care providers testing patients for whom screening for sleep apnea is inappropriate. Currently, responsible competent sleep medicine providers screen out these patients to prevent unnecessary testing.

The CMS recommendations issued in December 2007 do not incorporate recommendations for treatment of SBD with intra-oral devices or surgery. Evidence-based treatment guidelines and outcomes measures are needed for these treatments.

It will be critical for care providers to quantify outcomes of treatment. A system must be put in place to accomplish this essential task. Data obtained in research studies may not Adequately represent outcomes in the community because of more irregular use of CPAP in that setting.

Technology Issues
At present there are a variety of type III and IV devices. Different devices, especially those in the type IV group, measure different physiologic variables. Some, such as the SLP Sleep Strip, the Respironics RUSleeping RTS and the Snap Digital Monitor do not require interpretation by a clinician. The RUSleeping and the disposable Sleep Strip apparently require the patient to report the result to the clinician! To my knowledge these three devices have not been validated. The Sleep Strip does not distinguish obstructive from non-obstructive apneas. Type IV devices do not record sleep duration so they cannot quantify the number of ventilatory disturbances per hour but only the total number during the recording or the number per unit time regardless of the amount of time actually spent asleep. Accordingly, none of the type IV devices are able to comply with the established of CMS criteria for determining whether it will provide coverage for CPAP titration. They may substantially under-represent the severity of the sleep disordered breathing. Those that do not record both effort and air flow will fail to identify central versus obstructive SBD.

Type IV devices, which do not generate raw data that is reviewed by appropriately trained individuals, with appropriate adequate oversight by certified sleep specialists, present an unacceptable risk of abuse or misdiagnosis. There must be an appropriate balance between lowered cost of testing and improved access versus the amount of inappropriate testing and treatment and the degree of increased rate of misdiagnosis.

The cost of type IV devices varies substantially, both the prices of the actual recording devices, ranging from $30 per Sleep Strip and $69 per quarter to rent the ResMed ApneaLink to $5500 to purchase the Itamar Medical Watch-PAT 100! Similarly, the cost of disposables vary widely. Some of the more expensive devices, such as the Itamar, have been documented to diagnose sleep apnea well, but if reimbursement is uniform regardless of the quality and/or robustness of the recording device then many of those providing testing services will purchase the least expensive least adequate technology.

When in-home testing of thousands of patients was used in the NIH-sponsored Home Heart Health study, with close oversight to maximize quality, more than 80% of patients had adequate diagnostic results using a type III device. However, actual deployment of type III devices in real clinical non-research environments will likely yield adequate data in a smaller percentage of patients.

Conclusions

1. If appropriate guidelines for use of ambulatory testing to diagnose SAHS are developed and enforced then it can enable a higher percentage of patients with it and related disorders to be identified and treated.
2. The costs of testing may be decreased, as long as the guidelines minimize inappropriate testing. This includes inappropriate screening of patients for diagnostic testing and use of inappropriate devices that cannot adequately quantify the severity of the SBD and/or identify not only upper airway obstructions but also central apneas.
3. The guidelines must also define criteria for follow-up care of patients who undergo sleep diagnostic testing, whether they ambulatory testing is diagnostic of SBD or not. If adequate follow-up care is not provided then the long-term costs, due to the increased prevalence of the adverse medical consequences of inadequately treated SBD, will be prohibitive.
4. The devices approved for ambulatory testing must quantify sleep duration and measure ventilatory effort so that the severity of the rate of apneas/hypopneas is not underestimated and /or central sleep apneas missed.
5. All devices must not be approved by CMS for reimbursed ambulatory testing until they have undergone validation studies and these must be critically reviewed by independent experts and the FDA.
6. Care providers who select patients for sleep testing must have sufficient knowledge about sleep medicine. An appropriate training and certification program should be in place.
7. Dentists, oral surgeons and otolaryngologist should not be reimbursed for ambulatory sleep testing unless they have been certified to have adequate knowledge of sleep medicine, as noted in the previous recommendation.
8. Effective guidelines must recognize that the treatment of SBD must be considered in the context of the indication for treatment in specific patient groups. For example, some patients are treated to reduce sleepiness, while others are treated to reduce hypertension, heart failure, atria fibrillation, risks of stroke or myocardial infarction, cognitive impairment or other conditions.
9. CMS should encourage regional medical directors, in collaboration with sleep medicine clinicians, to develop optimal detailed specific guidelines that are compatible with CMS recommendations.
10. The guidelines for ambulatory sleep testing and reimbursement should be developed by Local Carrier Determination.

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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 for patients, thus bringing increased costs, both financial and health-related. Many patients will be funneled by special interests (eg., ENT surgeons and dentists) to undergo testing and get treated through other options in addition to CPAP (i.e., upper airway surgeries and oral appliances). Neither of these treatments has been shown to be more effective than CPAP. More importantly, these home studies will be performed by those individuals with little or no background in the evaluation and management of sleep disorders. A result of that will be a very high number of false positive diagnoses and a very high number of false negative diagnoses. Many people will treated unnecessarily due to misdiagnosis (immediatly increasing health care costs) and many other people will remain untreated and inappropriately treated (increasing health complications of individuals, again indirectly resulting in increased health care costs over the long-term).

The plan to have a short-term (i.e., 3 month review) to show benefit is a ludicrous loophole that almost anyone could bypass. In essence, this plan will ruin the proper diagnosis and management of a very important sleep disorder that is known to increase a person''s risk for other adverse health effects, including hypertension, heart attacks, cardiac arryhthmias, strokes, and diabetes. Turning our back to our nation''s citizens on this subject will result in further deterioration of our nation''s health and health care system.

To take action now and overturn this decision is the most logical next step. Then, with a well-developed oversight and review committee composed of leaders in the field of sleep medicine and experts on obstructive sleep apnea, we can develop new protocols and plans to improve upon the current system that is in place.

Thanks for your time and consideration.

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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 clinical practice and patient care.

Home sleep testing has been comprehensively addressed by the AASM with the December 2007 publication of “Clinical Guidelines for the Use of Unattended Portable Monitors in the Diagnosis of Obstructive Sleep Apnea in Adult Patients.” The AASM also sent a response to CMS that outlines several issues in the proposed NCD :
1. Inclusion of Type IV devices.
2. No definition of an acceptable CPAP trial.
3. No definition of requirements for clinical evaluation that complement the home sleep test.
4. No definition of a paradigm for follow- up and long-term management, especially in patients with a negative home study test or a failed CPAP trial.
5. No definition of who is covered under this policy.
6. No requirement for patients in need of a new CPAP machine.

I share the concerns outlined by the AASM and fully support its comment to CMS. I believe these issues, as well as others, can be addressed through the local coverage determination (LCD). As a specialist with expertise and training in sleep medicine, I am willing to work with you on developing a fair and comprehensive LCD for home sleep testing; please do not hesitate to contact me at (614-433- 2000) or via e-mail (jle@midohiosleep.com). You can also contact the AASM Senior Health Policy and Governmental Affairs Analyst, Ted Thurn, at tthurn@aasmnet.org or at (708) 492-0930

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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 Obstructive Sleep Apnea (OSA) - CAG-00093R2

Dear Acting Administrator Weems:

The Centers for Medicare and Medicaid Services (CMS) has received a request to reconsider its National Coverage Determination (NCD) for CPAP Therapy for OSA. As noted in CAG- 00093R2, physicians have historically used various methods of confirming a diagnosis of OSA for Medicare patients, either alone or in a combination of procedures and office visits. CMS has recognized that the disease is under diagnosed, for which a contributing factor may be that historically acceptable testing processes for Medicare beneficiaries can be burdensome on the beneficiaries and the physicians, can lead to significant and potentially harmful delays in treatment for afflicted patients, and are costly to beneficiaries. CMS proposes to delete selected imprecise and distinct diagnostic requirements, and seeks sound clinical evidence that may advance different methods of diagnosing OSA that yield accurate and less burdensome outcomes.

We applaud CMS for recognizing that the continuing evolution of technology in diagnostic and therapeutic equipment for the treatment of sleep disorders will lead to more accurate diagnoses and better treatment outcomes at a reduced cost to the program. We thank you for giving us the opportunity to comment on the NCD processes and to explain the functions that can potentially be performed by equipment providers and should be reviewed and measured by CMS in the context of the proposed evidence-based clinical trials.

Pacific Pulmonary Services is a large, privately-held durable medical equipment (DME) supplier of respiratory equipment. We operate in 15 states and pride ourselves on providing excellent service to approximately 50,000 Medicare patients. Although we do currently provide home-based unattended diagnostic sleep services for patients with private insurance coverage we do not expect to play a role in the clinical trials. Because of our experience with state-of-the-art home-use equipment that can be used to diagnose and treat OSA we are pleased to take this opportunity to provide our feedback concerning the proposed changes to the CMS national coverage determination for CPAP.

We believe that respiratory therapy providers can play a role in the provision of OSA diagnosis and therapy, and are pleased to be given an opportunity to educate CMS on potentially cost- saving alternatives to existing diagnostic coverage polices. We are sensitive to the perception that provider participation in diagnostic testing might yield short-term savings in diagnostic costs that are offset by the ability to induce inappropriate prescribing of sleep therapy equipment and thus increase overall expenditures by the program. Where we are able to anticipate such potential fraud and abuse concerns, we address these in the context of our commentary. We welcome the opportunity to educate CMS further if there are additional questions or concerns that we were unable to anticipate on any of the subjects addressed in these brief comments.

CMS recognizes that OSA is somewhat more prevalent than previously recognized and, left untreated, can be costly or fatal to the afflicted individual While a physician is often able to make an initial and largely accurate diagnosis of OSA based upon the patient’s description of symptoms and a simple overnight pulse oximetry test that confirms periodic episodes of elevated heart rate and oxygen desaturation that are consistent with OSA. Historically CMS has required an overnight polysomnography (PSG) test to verify medical necessity for the prescription of a CPAP.

Obtaining the overnight sleep test is both burdensome and disruptive for the elderly beneficiary, who must locate a sleep laboratory and make arrangements to spend the night in an unfamiliar setting staffed by clinical personnel who diagnose and document both the need for a CPAP and measure the appropriate pressure flow needed to correct the problem. Rural elderly patients may be forced to arrange travel to a sleep laboratory that is hours from their homes. Sleep laboratories are staffed by clinical personnel and reimbursement for the test reflects the high costs associated with the process. Thus, the diagnostic process necessitated by CMS to eliminate false OSA positives costs Medicare $529 to $820 which equates to the cost of treating a beneficiary for OSA for 4 to 9 months. And, as CMS observes, the temporal obstacles presented by the multi-faceted diagnostic process may take half a year between the tentative diagnosis and the clinical proof of diagnosis and appropriate sleep therapy, during which time the individual remains untreated. The proposed decision memo CMS would indeed be successful if Medicare were able to accurately and effectively shift OSA costs from diagnosis to treatment. We believe that CMS can do this, and that sleep therapy providers can play an active and important role in reducing the costs of diagnostic testing and improving patient outcomes.

I. CMS Should Evaluate and Encourage Supplier Participation in Home Testing.

Although no mention is made of the manner in which CMS will implement unattended home sleep testing, we believe that sleep therapy providers can and should be an important component of a viable and efficient in home diagnostic testing process. The designated Physicians Current Procedural Terminology (CPT) code 95806 (sleep study, unattended) is comprised of both a technical component (delivery of equipment and education of the patient as to in-home use) and a professional component (evaluation of the data for the purpose of diagnosis and treatment.)

We respectfully submit that it is both effective and logical for CMS to expect sleep therapy providers to facilitate the technical component of the test. The equipment is costly and a majority of smaller physician practices (e.g., rural practices) will not invest in costly equipment for the purpose of testing only a handful of their patient population and will be forced to refer patients needing testing to a sleep laboratory unless the physicians are able to rely upon sleep therapy providers to provide the equipment. Moreover, sleep therapy providers will be able to assist with patient and caregiver education in the home setting. Suffice it to say that the partnership between physicians and DME personnel has worked well in the private sector and has been successfully used as a means of containing costs while improving diagnostic testing services.

We are mindful that CMS will require assurances that supplier-facilitation will not lead to abuse, and welcome the opportunity to provide same. The technology that is used in the various in-home diagnostic testing units, including the Type IV devices, is reliable and tamper-proof. Only those persons with the appropriate software program can view or ‘read’ the data collected, and there is no means of modifying the raw data that would allow a supplier to alter the outcome of an in-home test. We propose the unalterable raw data be maintained by the DMEs as part of the patient record, providing CMS access to the data in audit situations

Finally, keeping in mind that beneficiaries are elderly and often unfamiliar or uncomfortable with technology, we applaud CMS for including Type IV devices in the Proposed Decision Memo. It has been our experience that the devices are exceedingly accurate as a front-line diagnostic tool for OSA, and are generally easier to use in an unattended home setting because there are fewer diagnostic leads to be attached to the various portions of the body. The simplicity of use leads to more reliable and accurate results, particularly among elderly or physically impaired patients.

II. Automatic Positive Air Pressure Technology Is an Important Combined Diagnostic and Therapy Modality That Deserves Consideration for Immediate Implementation by CMS.

CMS has reviewed and cited several studies that provide compelling clinical evidence that Automatic Positive Air Pressure (APAP) machines are effective in diagnosing OSA, determining therapeutic CPAP levels and as a method of treatment. We respectfully submit that many of the identified inefficiencies and treatment delays targeted by CMS in the Proposed Decision Memo could be resolved with the use of APAP as an at-home diagnostic tool with the assistance of physician and sleep therapy providers.

The cost savings and benefits of this approach are so intuitive that we suggest CMS consider the approach even before empirical data is collected. APAP technology has advanced significantly in the recent past and is one of the most efficient and accurate means of diagnosing and treating OSA. For instance, when used at home during a night of sleep, the APAP monitors each breath adjusting pressure to the patient''s need based on optimal and critical pressure levels. A memory module in the machine produces a record of apnea and hypopnea events, snoring, mask leaks and length of patient use. They are in fact the equipment used in sleep laboratories to determine optimal treatment pressure. Therefore, at the end of the suggested 12 week APAP diagnostic therapy period, the physician will have confirmed and documented the need for a CPAP, have sufficient data to prescribe the correct pressure setting, and – most importantly – the patient will have been receiving the necessary therapy in the interim.

The cost savings to Medicare are both obvious and substantial. Instead of the costs associated with one or more nights in a sleep laboratory (at a cost of $898 with titration and $643 without), CMS could reimburse providers and physicians for in-home diagnostic APAP therapy. If permitted by CMS, Sleep therapy providers would provide the APAP and bill for the technical component of the diagnostic therapy, and facilitate the direct delivery of tamper-proof reports to the physician. Supplier involvement will ensure the provision of top-quality equipment, in-home education on use and application, and the facilitation of delivery of reports directly to the physician for interpretation is consistent with existing CMS anti-fraud guidance on supplier- facilitated overnight pulse oximetry. Reimbursement for the technical portion of the diagnostic therapy could be established using a unique CPT code at an amount consistent with APAP equipment, supply and education costs (the equipment alone is approximately three times the cost of a CPAP), with a separate per-visit service code, A9279 may be appropriate, to reimburse providers for time and effort spent facilitating the transmission of tamper-proof data from the APAP’s memory device. The frequency of the supplier’s visits could be determined by the physician or by Medicare, and thus not susceptible to over-utilization by providers. Reimbursement to the physician for the professional component would be based upon the time expended to review the transmitted data, consistent with the professional components of other in-home diagnostic testing, but in any event well below the costs associated with overnight clinical staffing for a sleep laboratory.

Use of APAP diagnostic therapy will also be an excellent predictor of the beneficiary’s continued use of CPAP equipment. It is our experience that beneficiaries who do not require, are not aided by, or fail to adapt to the use of CPAP equipment exhibit non-compliance within the first three months of use. Because the APAP has a memory that records actual use by the beneficiary, providers and physicians will identify non-compliant beneficiaries promptly and seek alternate therapies for those beneficiaries who do not adapt to PAP therapy.

We respectfully submit that the use of APAP machines as a diagnostic tool has a myriad of additional benefits. For example, the process of routine re-evaluation of pressure changes in order to order CPAP adjustments (CPT 95811) could be reduced or eliminated if the APAP equipment were used to periodically evaluate a beneficiary’s treatment needs and progress.

III. Conclusion

We respectfully request that CMS consider the issues raised herein both when reviewing the proposed collection of clinical evidence and in developing the means by which any proposed National Coverage Decision will be implemented. We appreciate having the opportunity to submit these brief comments, and welcome the opportunity to meet with you to assist CMS and staff in developing and implementing changes that will facilitate prompt and accurate diagnostic testing at a cost savings to beneficiaries without compromising program integrity.

Respectfully Submitted,

/S/

Peter B. Kelly
Chief Executive Officer
Pacific Pulmonary Services

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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 the idustry who are not focused on the utmost in patient care and not focused on curing the patients sleep disorder with proper diagnosis & treatment. Please only entrust the practice of home sleep testing to those who are educated, trained, honest and ethically sound.

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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 your parent, grandparents or even children to not be fully monitored? Would you want one of these other conditions overlooked? Please consider this when you vote for passage of this "home testing."

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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.

I think that the argument that more people will be diagnosed and therefore it is for the "greater good " does not justify sub-standard diagnoses and treatment. I think that saying this is expensive treatment is not accurate given that the costs of many tests mri''s ,many cardiovascular tests are much more expensive and there is no outcry about these expenses. I think that saying the test is not accessible may have been true in the past but is no longer true as there are many sleep labs and the waiting period for a sleep study is reasonably short in many areas. I ask you to take a longer time to evaluate this. Please do not bow to the pressure of guild which does not have the greatest degree of expertise in this field. Take into consideration the opinions of the people who do have the greatest degree of expertise as well as looking the current standards in the field. Thank you for your consideration
William Wenokor,M.D.

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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 involved in both policy making and direct inspection of sleep facilities.

I have substantive concerns both about the possible decision to initiate widespread home testing and the rationale for such. Let me begin by addressing the purported rationale. First of all, with the marked increase in sleep centers in the USA has come a significant drop in the wait time for sleep studies. If you review AASM data, I believe that you will see that wait times are on average now in the 2-3 week range. This is hardly excessive and probably will improve as the field continues to mature. Contrast those numbers to e.g. our neighbor to the north or Australia. Home studies will likely be less labor intensive and less expensive. But will this translate into less costs to CMS? Dental appliances are hardly cheap and surgeries such as UPPP convey modest at best success rates.

To my mind, you will likely have an increasing total number of studies and studies often ordered by non-sleep medicine specialists. You might well also have increasing numbers of patients undergo surgery, CPAP or dental appliance therapy who completely bypass sleep medicine specialists. Perhaps this is what some would prefer, but my bias is that this will hardly benefit patients. A not insignificant number of these home studies will bear repeating due to technical problems and/or will require confirmation at a sleep center.

It is also of interest that apparently much of the push for adoption of sleep home testing (with probable bypassing of sleep medicine specialists) emanates from our colleagues in Ear Nose and Throat (ENT) surgery. My understanding is that few ENT specialists have taken the time to study and pass the Sleep Board examination (in comparison e.g. to Pulmonary/Critical Care physicians). This hardly conveys an interest in sleep medicine beyond sleep apnea. Patients with sleep apnea can be afflicted with other sleep disorders such as narcolepsy, insomnia, restless legs syndrome, obesity hypoventilation syndrome... I have also noted less of an ENT interest at our medical center in attending Staffing meetings concerning sleep medicine patients. My supposition is that ENT physicians have come to realize that their surgical techniques are often a. not rigorously studied b. ineffective and that they have less of a role to play.

I am not overtly counter to the initiation of home sleep testing. In fact, with the advent of increasingly sophisticated technology I suspect more studies will be performed at home and in a less labor intensive fashion. I would recommend that particularly if Medicare takes this major step of approving home testing, that such testing initially be performed under the aegis of AASM certified facilities. Such a trial period might allow a better understanding of the impact of this decision. It will also assure that patients being considered for such sleep testing have a thorough sleep medicine evaluation by a sleep clinician.

One might also wonder about the impact of this decision on the nascent field of sleep medicine. As you know, sleep medicine is now a recognized field just as e.g. endocrinology. A decision to open wide such testing to those who have not taken the time, interest and energy to become more globally informed about sleep medicine seems to devalue the field. I wonder if this will reduce interest in the field in those young physicians in training. Such a decision would be a shame given the remarkable growth in this field and recent myriad contributions.

Thank you very much for your attention to this note. Robert Daniel Vorona MD

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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 is imperative that there is both greater recognition of and access to appropriate sleep diagnosis and treatment. Despite the expansion of fixed sleep diagnostic facilities; there remain considerable geographic, mobility and coverage issues that significantly restrict access and appropriate therapeutic intervention. In our follow-up of 300 patients referred by cardiologists for sleep center studies, almost 30% of patients failed to keep their appointment because of issues alluded to above. In addition in patients who have had studies and therapy prescribed, long-term follow-up for continuing efficacy or for loss of effectiveness is frequently hindered by the broad array of issues involved in access. The arborization of sleep diagnostics into primary practice sites and primary and secondary hospital sites, as can be considered by the implementation of home diagnostics, can only improve cardiovascular risk management; remembering that it is very difficult to lose weight, control blood pressure, improve insulin resistance, treat various cardiac arrhythmias and favorably alter lipid profiles in the presence of undiagnosed and untreated sleep disordered breathing.

Because of our group’s interest in sleep disordered breathing and its contribution to excess morbidity and mortality in diseases in which we are expert, I have carefully followed and studied the ease and accuracy of devices of potential use for home studies. Therefore, I was surprised to see that the Watch-PAT device was not mentioned in your list. In our use and the experience of others with the Watch-PAT device, we have found it to have high accuracy when tested against PSG, high patient and technical staff acceptance (related to its ease of use, reliability, and ability to not require manual overreads), features including the delineation of REM sleep that are not available in other devices, and greatly enhances patient compliance by allowing for immediate use at the time when the patient is maximally motivated. I believe that the technology of home sleep study devices, including the Watch-PAT, has significantly evolved to the level of reliability t0 warrant coverage so that the increasingly recognized and understood benefits of appropriate sleep health can be brought to larger segments of the population, thereby contributing to the mitigation of cardiovascular disease risk.

Sincerely,
Marc R. Pritzker, M.D.
Professor of Cardiovascular Medicine and Surgery
Division of Cardiology
Department of Medicine
University of Minnesota

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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, and if they can’t come soon enough, treatment is significantly delayed, access is severely curtailed and often, treatment delayed is treatment denied.) A lot of this argument comes from our Canadian and European colleagues. The director of Saskatchewan’s sleep disorders center serving 2 million people (personal communication) told me that it took four years to get patients into his center. Likewise, in neighboring Manitoba, Meier Kryger’s lab has a 4 year waiting period. Similarly Hong Kong’s major sleep center takes 4 years to get into. So, if you don’t have enough beds to serve your population, of course you will have prolonged waiting periods. In our lab, we often find it difficult enough to get patients fully titrated with full polysomnography and we work very hard to see that that happens.

A brief look at the history and practices of our sleep disorder’s center is germaine to this issue. Our center serves a primary referral area of some 150,000 with secondary referral areas serving an estimated 225-250,000. We are the only accredited sleep center in a 100 mile radius. We started our center in 1994 with 2 beds and had a waiting period of greater than 6 months. Over a period of 10 years and with our expansion to six beds, we have been able to reduce our waiting time from evaluation to study to 2-3 weeks with the capability of getting patients in more quickly on an emergent basis. We essentially therefore do meet all local needs. We are not just a sleep study mill, which cranks out the studies with skimpy follow-up. For example, we have a full-time respiratory therapist, a PRN respiratory therapist, and a full–time clinical patient service representative that work with patients on compliance/adherence issues. Our compliance exceeds 75% compared to a national average of (I think it is less than 40%) We insist on a CPAP machine that gives data on:
a. Compliance/adherence,
b. Leak.
c. Breakthrough events.
We evaluate for mask comfort, quickly changing masks in order to prevent patients from getting frustrated and angry. We insist on a machine that gives heated humidity (evidence based from Spanish study in 2000).

If we truly are better than the national average on compliance/adherence, why not look at what we, and other centers have done that do meet local needs and see what we are doing correctly and attempt to reward and repeat such practice nationally.

We need to focus on poor patient outcomes with respect to compliance/adherence to look at why patients do not comply with CPAP, something I maintain would be hard to do without close follow-up after rigorous polysomnography evaluation. My own sense is that non-adherence to treatment originates from a variety of reasons:
a. discomfort.
B. claustrophobia.
C. body image issues (it’s not sexy)
d. fear of job loss or insurance loss or inaccessibility.

One could focus on our center and others nationally particularly with regard to reduction of morbidity/mortality. Comparisons could be relatively easy to make with centers where availability and compliance data are not as good. It would be most important to look at the cost/benefit—benefit/burden of our center vs. nationally in terms of lives saved per population treated with respect to:

a. Accidental death and injury.

b. Medical morbidity/mortality reduction.

1) Cardiovascular events (Marin study in the Lancet 2006, Wisconsin Sleep Cohort Study, and Bradley in the Sleep Heart Health Study)
2) Hypertension with obstructive sleep apnea now identified as the most common cause. This translates into reduced cost to our area from better blood pressure control, potentially with fewer medications needed. This could be studied to look at actual cost reduction.
3) Atrial fibrillation and other arrhythmias.
4) Stroke
5) Other unanswered issues such as cognitive impairment related to desaturation.

I would urge that CMS get away from circular reasoning. Let’s look at the cost of meeting local/regional needs. We could look at the cost of meeting local/regional needs by examining more rigorously, our own local cost/benefit—benefit/burden that would seem to meet the local need and get a more accurate sense of how much morbidity/mortality reduction has actually occurred vs. national averages where needs are not met. Hopefully, some hard data, actual evidence-based information with hard numbers in terms of lives saved and cost could be obtained with which to make informed decisions instead of basing an important decision on a lot of guess work. I ask you to look at us and others like us, who meet local needs for access to:
a. Establish what needs to happen for accessibility (we’ve done it locally).
b. Establish what needs to happen to get patient compliance/adherence.
c. Establish cost of accessibility of fully saturating an area with beds as we have vs. other areas.
d. Establish benefit in terms of lives saved and morbidity reduced in an area fully saturated with beds as our service area is vs. nationally.

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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 medicine. This historic approach is known to result insignificantly low compliance with CPAP therapy and ultimately a large group of patients getting sent to surgery for OSA, Surgical treatment of OSA has a reported therapeutic initial success rate of only 33-50%, with decrease in therapeutic benefit over time.Medicare''s new plan may lower up-front costs, but even this is not guaranteed. This plan will essentially decrease the number of Medicare patients appropriately diagnosed (at sleep centers) with sleep apnea and decrease the number of patients able to learn to tolerate and manage CPAP therapy. This only creates, at best, a short term decrease in health care utilization because, in the long run, this approach will increase Medicare costs by:

1. Increasing costs related to unnecessary surgery.
2. Increasing cost for treatment of medical conditions exacerbated by ineffective treatment of OSA, such as Hypertension and Congestive Heart Failure.
3. Unnecessary testing with technologies whose use is not yet defined by medical practice.

It is now well known that untreated or inappropriately treated OSA is strongly associated with increased risk for heart attack, stroke and other cardiovascular conditions, as well as diabetes, decreased alertness and associated high rates of vehicular accidents, industrial accidents, depression, decreased productivity, and job loss. Inadequate sleep evaluation and testing will cause many false negative results. This will directly compromise patient care, depriving patients of appropriate treatment. At a time when the importance of sleep to health is coming into sharp focus, with additional research data amassing on this issue each month, patient access to appropriate diagnosis and treatment of the most physiologically disruptive and dangerous of the sleep related diagnoses would be curtailed. Sleep medicine, a success story and marker of American medical care, would enter a modern dark age with the passage of this policy proposal. The new Medicare proposal for home diagnostic testing and empirical CPAP titration propose unacceptable compromises to established medical standards of appropriate diagnosis and treatment as defined in the medical literature and as defined by the practice standards of the American Academy of Sleep Medicine (AASM).

This proposal will predictably result in more negative patient outcomes; higher morbidity rates, higher rates of serious secondary disease, and decreased quality of life for patients with OSA. Moreover, negative patient outcomes will result in a higher long-term expense to all payers of health care, including taxpayers. An attended sleep study to rule out OSA currently done in a sleep center consists of 14 channels of information to show the following: EEG (You must be able to differentiate sleep from wake as well as stages of sleep.), EOC (A marker for REM sleep and sleep onset.), EMG Chin (Muscle tone as a marker for REM sleep and to identify Bruxism.), EKG (To evaluate cardiac arrhythmias associated with apnea, and to see if they are corrected with elevation of apnea.), EMG Tib (To show leg movements associated with PLMS and RLS.), Nasal/Oral Flow (To show actual breathing.), Chest and Abdominal effort (To show effort to breath. This is important in identifying Respiratory Effort Related Arousals.), SaO2 monitoring (To show oxygen desaturations and there association with apnea.), CO2 monitoring (This aids in appropriately adding CPAP pressure and Oxygen while marinating the individuals drive to breath.) To replace the current standards of testing for OSA with a 2-4 channel study as opposed to a 14 channel study is not only unfair to the patient, it would be negligence on the part of the healthcare community to administer such testing.

For these reasons, I strongly urge that this policy proposal be rejected.

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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 AASM in response to the proposals.

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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 that proposed changes eliminate the involvement of the sleep medicine professional in the diagnostic and treatment process. This could be detrimental to effective treatment for the Medicare beneficiary unless the licensed treating physician has competency in sleep medicine.

The proposed decision in moving away from polysomnography will place a greater responsibility on the licensed treating physician to document decisions in the management of the beneficiary. The ASAA makes the following recommendations in light of this fact:

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 facilitate substandard and inaccurate studies, and as a result affect people''s health in a very negative and dangerous way. This proposal is in no way a benefit to the field, and should not be passed.

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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, should be undertaken by individuals and facilities with demonstrated ability as shown through certification and accreditation pathways. More specifically, the document should require that all studies be performed under the guidance of a certfied sleep specialist and an accredited sleep center. These concerns are especially valid for critical access areas such as the one I where I now practice.

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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 accidents.
3)Other disorders including Periodic limb movement disease and sleep interuptions from other causes will be missed....ie the home studies are not really sleep studies at all.
4) The lack of supervision of these studies by a sleep trained MD will lead to siginificant overutilization of these studies and unwarrented surgical treatments for sleep apnea.....My fear is that everyone who "breaths" at night will get a home sleep study as various manufacturers of home devices, the durable medical equipment companies, the primary care MDs and the ENT mds see the enormous profit potential leading to indiscriminant testing. Inconclusion, it is my opinion that approval of home testing with not result in any cost savings, but will increase medicare costs and decrease diagnostic accuracy. Thank you for your consideration. Ira Weinstein MD

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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 practicing at the Johns Hopkins University in Baltimore MD. The opinions expressed herein represent our individual opinions and are not meant to represent those of Johns Hopkins University. We evaluate and treat over 4000 patients a year for a variety of sleep complaints at two American Academy of Sleep Medicine accredited sleep disorders centers. In addition, our group has done a variety of sleep research projects which have used various diagnostic testing devices over the past several years. Based on this experience, we feel we are well versed in both the diagnostic and evaluation of patients with sleep complaints.

We overwhelmingly agree that obstructive sleep apnea is a common disorder which is likely underdiagnosed in the US population. There are many reasons for this including a lack of awareness in both physicians and patients of the signs and symptoms of the disorder. Standard sleep center based polysomnography is the most common method to confirm the diagnosis. In the right hands, this testing procedure is usually accurate and the majority of patients benefit from correct diagnosis and treatment with CPAP. The current waiting time to get a sleep study in our laboratories is < 3 weeks – nowhere near the “assumed” waiting time of 13 weeks in your modeling paper (Obstructive Sleep Apnea-Hypopnea Syndrome: modeling different diagnostic strategies).

It is further agreed that for certain populations of patients, home sleep testing has a role. If one reviews the literature on this subject, it is clear that the patients who have been studied with both Type III and Type IV devices are highly selected. They are predominantly middle-aged men without comorbid illnesses such as COPD, CHF, morbid obesity, neuromuscular disorders, etc. They have signs and or symptoms of typical male gender based OSA: snoring, crowded upper airways, daytime sleepiness, large necks. In this highly selected population, home sleep testing likely does have a high accuracy as these patients usually have obstructive apneas with oxygen desaturation. However, this population is not the whole, or perhaps even the majority of patients that suffer from OSA. Women, the elderly (Medicare population), nonobese, patients with comorbid illnesses and patients with comorbid sleep disorders also have OSA and we know very little about the accuracy of HST in these populations.

Aside from selecting the correct population that can be accurately diagnosed with OSA using an HST device, one must also consider what qualifications are needed to examine the HST device’s output. By allowing a “licensed physician” as the only qualification, CMS is suggesting that any physician can do HST without any prior training or experience in its interpretation. We would argue that the fewer signals available to review, perhaps the more expertise required to make sense of the results. In looking out for our patients, allowing any physician to do such testing seems to make it very vulnerable to fraud and abuse. Moreover, from a cost standpoint this will likely significantly increase rather than decrease costs for sleep apnea treatment. The polysomnogram or other assessments are small costs compared to that of a life-long use of a CPAP machine. Inexperienced physicians or other providers faced with a potentially life-threatening disorder and a minimal risk treatment will likely err on the side of over-prescribing the treatment, leading to excessive, unneeded and burdensome use of treatments. This will not only significantly raise the costs of treatment it will also present an unnecessary burden on the patient potentially exacerbating the original problems that drove the patient to seek treatment.

In further review of the document, there are some specific issues we feel need to be addressed:
1. What constitutes a clinical evaluation? Could this be as simple as a questionnaire the patient fills out? Will it require a “hands-on” physical examination? Does a “licensed physician” have to perform this evaluation? If the wording is not clarified, it is possible that non-physician providers could do some type of evaluation (perhaps as simple as a questionnaire filled out in a mall), perform a HST on a patient and set the patient up on CPAP – without ever having seen a physician.
2. How will the correct CPAP level be determined? The NCD states that CPAP will be covered following a diagnostic test and that it will be limited to a 12 week period to identify those who “benefit from CPAP”. Will CMS still allow CPAP titration studies to be done in sleep centers? If CPAP is set up empirically (an arbitrary pressure is selected) but the patient does not seem to respond or “benefit” from CPAP, how is one to know if it is that the CPAP was not set correctly, if the patient was misdiagnosed by the HST or if the patient is just not tolerant of CPAP?
3. What will determine that a patient “benefits from CPAP”? A new twelve week limit has been set. Is benefit determined by number of hours the patient uses the device? If so, what is the limit? What if they sleep better – is that enough? What if their blood pressure is improved, or their glucose control is better?
4. Why are Type IV devices considered adequate but not overnight oximetry alone? The vast majority of the studies done using Type IV devices utilize oximetry alone and in fact, there is no high level evidence that suggests adding one or two more signals improve either the sensitivity or specificity of a Type IV device.
5. An AHI and an RDI are not the same. In Appendix C it is stated that an AHI or RDI ? 15 (or ? 5 with symptoms) is considered OSA. It should be pointed out that an AHI by a laboratory based PSG is not equivalent to an RDI by a HST device. They use different denominators so a patient undergoing a PSG could have a lower number of disordered breathing events to qualify for a CPAP than a patient who undergoes HST.

In conclusion, we feel that CMS has made several flawed conclusions for this NCD and should reconsider its position as it currently stands.

Sincerely,

Nancy Collop, MD
Richard Allen, PhD
Loretta Colvin, CRNP
Chris Earley, MD
Charlene Gamaldo, MD
Kim Goring, MD
David Neubauer, MD
Vsevolod Polotsky, MD, PhD

References:
Home Diagnosis of Sleep Apnea: A Systematic Review of the Literature. Chest 2003;124:1543-79

Effectiveness of Portable Monitoring Devices for Diagnosing Obstructive Sleep Apnea: Update of a Systematic Review (AHRQ, September 1, 2004: Contract # 290-02-0016)

Obstructive Sleep Apnea-Hypopnea Syndrome: modeling different diagnostic strategies (AHRQ, December 2007)

Home diagnosis of Obstructive Sleep Apnea-Hypopnea Syndrome Technology Assessment (AHRQ, August 8, 2007)

Clinical Guidelines for the Use of Unattended Portable Monitors in the Diagnosis of Obstructive Sleep Apnea in Adult Patients. J Clin Sleep Med 2007;3(7):

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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 possible tongue resection as it is currently done by most ENT''s is effective in only about 50% of cases and not in the other 50%. When it is effective, OSAS often recurs within five years. Therefore, other treatment ,CPAP or mandibular advancement device, is still eventually required.

Effective surgery, a combination of UPPP, genioglossus advancement, and myohyoid release, though about 85% effective is rarely done for whatever reason, either because it is too time consuming or requires more technical expertise than most ENT''s are willing to deal with.

In addition, if determining treatment is taken out of sleep specialists'' hands, many other factors involved htese patients'' sleep complaints will be ignored.

Please do not allow payment in the national coverage determination to go through.

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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 polysomnography and especially the elderly generation. Knowing the CMS population in our area I do not believe this will be saving insurances money. Using untrained RPSGT''s or sleep staff and accredited sleep centers is not in the best interest of the patients or insurances. As a sleep center we do screen inpatient''s on the floor with 4 channels to screen for OSA but never in the lab. Knowing that we check on these devices several times a night we still get erroneous data especially if a patient is on Oxygen therapy. I have heard all the comments on about every issue at the AASM website. If you want to provide optimal care for patients, decrease sleep lab backlogs, diagnose and treat more patients then why has CMS rulings deterred sleep labs from doing so. Most patients can be done in 1 night as a snpsg. Adjust the 2 hr sleep guideline back to 2 hours of recording time. Readvise the AHI/RDI so that more patients can be put on cpap the first night of testing. Use HMT''s devices for patient follow up. Putting on empirical CPaP is that not going to cost more for the patient, DME companies and insurances. Retesting patients for appropriate Cpap/Bipap/Auto pressures, oxygenation, central apnea and high altitude variables, complex sleep apnea, Pediatric, RLS/PLMS, seizures etc.

Thank you
Mike Palasio
Rpsgt,RRT,

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CMS and the profession are struggling with the issue of what constitutes an adequate evaluation for obstructive sleep apnea (OSA) to permit coverage for CPAP. The tentative conclusion appears to be that a clinical history in conjunction with either a full PSG or a variety of limited home “sleep” tests (HST) may meet the need. The CMS discussion suggests broader issues related to the one under consideration. While I believe that there is a role for HST, I would like to offer some personal thoughts on these matters.

Systematic underestimation of OSA severity results in false negatives that can only be mitigated by application of a correction factor. Upper airway resistance syndrome (UARS), characterized by sleep fragmentation and sleepiness resulting from increased upper airway resistance in the absence of apnea or hypopnea, causes symptoms that are identical to and as amenable to CPAP therapy as symptoms secondary to OSA (see attached data: Weiss H, et al ). While UARS patients are not eligible for treatment under Medicare, such patients, if diagnosed by PSG, may choose to fund their treatment without Medicare support. On the other hand, HST, will, in every case, miss the diagnosis and leave the symptoms unexplained and untreated. The consequence of lack of treatment may be patient impairment and public health risk (e.g, highway crash resulting from drowsy driving). For these reasons, HST would best be applied in patients with a high pre-test probability of moderate to severe OSA, diminishing the likelihood of a false negative or ambiguous result on HST. If UARS is clinically suspected after a negative HST, confirmatory PSG is in order. For doubters, I ask the following: Would you like the pilot of a plane carrying you at 30,000 feet to nod off at the controls because of undiagnosed, untreated UARS? Would you accept as definitive a negative HST (that contains no measure of sleep or sleep fragmentation) if you were personally in charge of clearing this pilot for take-off on your next trans-Atlantic flight? How about the driver of the huge, lumbering oil truck tailgating you at 70 miles per hour on the expressway?

OSA progresses gradually and slowly over a considerable time period, and behavioral and physical deficiencies are frequently perceived by the patient as a new level of “normal”, or they are incorrectly attributed:

• to professional, social or domestic stress (which, itself, may result from OSA)
• to co-morbidity, e.g. cardiovascular (which, itself, may result from OSA)
• to increasing age.

Irritability, anxiety, and depression may be erroneously perceived as primary, rather than secondary to OSA, or vice versa. Pharmacotherapy for secondary psychiatric symptoms may obscure the etiology of symptoms actually due to OSA. OSA results in secondary sleep disorders, e.g. insomnia, inadequate sleep hygiene, dependence on hypnotics and stimulants, among others. A cursory history or one taken by a provider lacking mastery of sleep medicine is unlikely to clarify ambiguity introduced into the diagnostic process by widespread application of HST. Incorrect diagnosis and inadequate or inappropriate treatment will result in morbidity and mortality in the Medicare population. Sophisticated interpretation of historical and physical findings will supplement the limited HST data, suggesting when more comprehensive follow-up testing (which directly assesses sleep) is necessary.

The broad diversity of effective therapies (bariatric behavioral, bariatric surgical, positive pressure devices of various types [CPAP, Bilevel PAP, auto-titrating PAP], mandibular advancement devices (MAD), a wide range of soft tissue and skeletal upper airway reconstructive procedures, and tracheostomy) mandates a therapeutic plan appropriate to each individual OSA patient. Development and implementation of the plan requires a network of practitioners of different disciplines. There is need for sophisticated leadership to provide coordination and oversight for the therapeutic team in the context of a comprehensive diagnostic/therapeutic center.

Compliance with CPAP is enhanced by combining improved technology (such as downloadable compliance and respiratory monitoring) with knowledge intrinsic to the discipline of sleep medicine. Locating CPAP care within the comprehensive center provides greater control over technology provided and fosters development of a comprehensive longitudinal treatment protocol. Secondary (or additional primary) sleep disorders commonly complicate or prevent adjustment to CPAP, and these can be addressed during this period. It has been our experience that CPAP distribution by our hospital DME program allows for increased control over the nature of equipment dispersed, a higher level of interaction between the respiratory therapy support staff and medical staff, improved short and long term care, and increased CPAP compliance.

Appropriate application of surgery is best accomplished through a comprehensive testing and treatment protocol, integrating medical, surgical, and technical personnel into a cohesive team. Multi-disciplinary interaction results in a widened knowledge base and broader understanding among all providers. Surgical procedures must be followed by appropriate postoperative evaluation (including objective testing for residual OSA or UARS), and postoperative patients must be followed longitudinally over an extended time period. Residual postoperative OSA can be ruled in by HST, but residual OSA or UARS can be ruled out only by PSG. Widely applied criteria for surgical success (50% decrease in apnea-hypopnea index to an index below 20 apneas and hypopneas per hour) is archaic and inadequate based on current data indicating significant cardiovascular risk and sleepiness at lower levels of severity. Indeed, an apnea-hypopnea index of 20 would, for Medicare, trigger treatment with CPAP (even in the absence of symptoms or co-morbidity). An appropriate definition of surgical “success” must be developed. Similarly, an appropriate definition of CPAP “success” and mandibular advancement device “success” is overdue. Whereas surgical “success” does not require a measure of compliance, CPAP “success” and MAD “success” does. All will require an objective measure of effectiveness, and the challenge before us is to define that measure. Should it be PSG, HST, a different physiological measure, a behavioral measure?

The field of sleep medicine has grown mightily over the past thirty years, through documentation of a large, complex, and unique body of knowledge that, in application, directly betters the health and lives of patients. My years as a clinician, convince me that good care for OSA mandates a well- integrated, diversely trained, but highly focused team, operating under knowledgeable leadership.

Aaron E. Sher, MD

Clinical Associate Professor of Otolaryngology- Head and Neck Surgery and Clinical Associate Professor of Pediatrics, Albany Medical College (Albany, NY)
Adjunct Professor (Doctoral Faculty, Cognitive Neuroscience Subprogram, Psychology) The Graduate School and University Center, City University of New York (NYC)

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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 that both home sleep testing (HST) using Type II, III, and IV devices as well as in-lab polysomnography (PSG) are useful tools in the diagnostic evaluation of patients suspected of OSA who may benefit from CPAP. The particular patients to whom each of these diagnostic modalities should be applied, however, is a far more difficult determination. Certain individuals, including those who possess characteristics yielding a high pre-test likelihood of moderate to severe OSA, are likely to be appropriate candidates for HST. HST used without discrimination predictably results in false negatives. The apnea-hypopnea index (AHI), which is by definition the number of apneas and hypopneas per hour of sleep, is immediately reduced when HST is used and the denominator is changed to total recording time. In a database review covering seven years of PSG data generated in our lab, we calculated that about 23% of 1149 patients with actual AHI''s between 5 and 9 per hour would have generated a false negative result (AHI < 4.5) if total recording time had been used in lieu of total sleep time. Furthermore, and perhaps more importantly, patients with Upper Airway Resistance Syndrome (UARS) would be left undiagnosed/misdiagnosed given the absence of a means to identify transient arousals from sleep.

UARS, first described by Guilleminault et al. in 1993, is an entity characterized by repetitive increases in resistance to airflow within the upper airway associated with subsequent EEG arousal. These abnormalities, despite an AHI < 5, result in daytime sleepiness and an increased likelihood of hypertension (CHEST Apr 99;115(4):1127-39). CPAP is considered the most effective form of therapy for this disorder, though it has been implied that “low patient compliance may limit its practical application”. Our experience would suggest otherwise.

Our institution is an AASM-accredited comprehensive sleep disorders center, with a multidisciplinary staff including an otolaryngologist, psychologist, pulmonologist, and pediatrician, 3 three of whom are board certified certified sleep specialists, who work in conjunction with a team of trained nurse practitioners, registered respiratory therapists and registered polysomnography technicians. The center, affiliated with a hospital, is also licensed to distribute durable medical equipment. During years of experience evaluating large numbers of patients complaining of daytime sleepiness, UARS has been a diagnosis frequently encountered.

We retrospectively reviewed the data on all 93 patients, who had received CPAP therapy for a diagnosis of UARS, through the DME company affiliated with our center, between February 2005 and November 2007. The diagnosis was based on clinical symptoms of daytime sleepiness and/or poor quality sleep in conjunction with repeated episodes of airflow limitation resulting in arousal on EEG during formal overnight PSG. Each of these individuals underwent in lab CPAP titration to determine the optimal fixed level of CPAP. After CPAP was prescribed, the patients entered a protocol defining the initiation and follow up of CPAP therapy. This protocol consists of an initial 1 to 1.5 hour educational session and CPAP setup during which instructions are given to call immediately if any difficulties with therapy are experienced. Follow up thereafter is scheduled to take place at three weeks (patients are seen by both the health care provider and respiratory therapist), and then at 2 and 3 months (patients are seen by the health care provider and/or respiratory therapist). Compliance downloads are obtained at each of these visits. The timing of follow up beyond that is left to the discretion of the provider. We sought to define the clinical characteristics, PSG findings and subsequent CPAP compliance of these subjects.

The group consists of 49 men and 44 women ranging in age from 18 to 74 years (mean 44.8; (standard deviation-10.0)). The mean Epworth Sleepiness Scale Score (ESS) was 12.8 (4.6),indicating an abnormal level of daytime sleepiness, mean sleep quality, was 7.3 ( 2.2) (using a rating scale from 1-"very good sleeper" to 10-"very poor sleeper") and mean level of alertness was 6.7 ( 1.9) (using a rating scale from 1-"very alert" to 10-"can hardly stay awake").

The following table presents a comparison of pertinent polysomnographic indices on Baseline and CPAP Titration nights:

*CPAP titration was performed with goal of eliminating all respiratory related arousals during supine-REM sleep. Note: Mean transient arousal index at optimal (prescribed) pressure was 8.3 per hour (5.0)

These data demonstrate that even on the first night dealing with CPAP, when problems of adaptation might be anticipated, the sleep fragmentation and elevated time spent in Stage 1 transitional sleep characteristic of the UARS population is addressed.

The usefulness of CPAP for this group was borne out in subsequent months. 72 of 93 (77.4%) patients met insurance payor criteria to qualify for purchase of CPAP. The mean duration included on the download leading to purchase of the patient’s CPAP device was 33.7 days. CPAP was used nearly every night: the mean percent of nights used was 95.7 (5.9). Moreover, the devices were used for the bulk of the night: The mean nightly duration of CPAP use on all nights was 353.4 minutes (81.0).

This consecutive series was comprised of patients with symptoms of daytime sleepiness whose PSG data revealed an AHI &< 5 in conjunction with findings consistent with a diagnosis of UARS. The overwhelming majority of this sample subsequently adhered to CPAP therapy, objectively using the device nearly every night for almost 6 hours per night on average. CMS has unfortunately neglected to recognize UARS as a disorder that warrants treatment with CPAP, despite the relationship that has been established between this disorder and symptoms of daytime sleepiness and hypertension. CMS has proposed that CPAP be covered for those beneficiaries with OSA who benefit from CPAP during a twelve week trial period. They also clearly report in their proposal that "evidence indicates that patients who do not have true OSA (false positives) will quickly reject CPAP treatment". Our preliminary data on UARS patients would appear to contradict the latter statement. Indeed, a high level of tolerance and compliance has been demonstrated in this population of UARS patients, carefully titrated with CPAP, and intensively supported during their period of accommodation to CPAP. Applying the CMS perspective that proven tolerance and compliance implies "benefit from CPAP," our data suggest that the CMS policy not to cover CPAP for UARS be revisited. Furthermore, if CPAP for UARS were to be covered, then the negative results from an HST in a sleepy patient would mandate further testing with PSG. If CMS continues to refuse coverage of CPAP for UARS, and a negative HST is not followed by PSG, then patients with UARS will be left undiagnosed/untreated or misdiagnosed/mistreated. Without the means to establish an accurate diagnosis, even the option to cover treatment without medicare funding would be lost.

Accurately diagnosing patients with UARS and achieving CPAP compliance rates in this range requires a more comprehensive understanding of sleep disorders and an appreciation of the nuances of polysomnography that goes far beyond a simple AHI. It mandates a significant time commitment dedicated to addressing difficulties tolerating therapy and providing education regarding the disorder and its consequences. Such issues are potentially overlooked and neglected if less qualified individuals begin to use HST on an indiscriminate basis. HST clearly can play a useful role as part of our diagnostic armamentarium, however the clinical circumstances in which to use such testing is best determined by physicians who possess the level of expertise needed to promote appropriate utilization of diverse diagnostic instruments in this rapidly expanding subspecialty of medicine. Board certified sleep specialists possess this level of expertise. Therefore, if HST is ultimately determined to be a valid tool on which to base coverage for CPAP, we urge strongly that the mandated clinical evaluation be conducted by an individual with this credential.

Thank you in advance for your serious consideration.

Sincerely,
Howard S. Weiss, DO
Bill Wenzel, RRT
Paul B. Glovinsky, PhD
Aaron E. Sher, MD

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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 appropriately studied patients, I think we will see a lot of wasted expense in improperly treated individuals.

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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 with scientific problems in terms of documented accuracy of the actual equipment available and highly variable diagnostic equipment - some systems as rudimentary as snoring sound monitors or basic oximetry both of which have been shown in controlled studies to be ineffective in acurately diagnosing obstructive sleep apnea.

OSA is a serious condition with major impact on day to day functionality, general health with serious long-term health and longevity issues. It should be taken seriously and diagnosed carefully. Medicare is "jumping the gun" on current technology at the expense of the quality of care of its clients. Even worse, all other carriers use medicare as a standard and this will undermine the proper accurate diagnosis of obstructive sleep apnea. Once a consensus is reached on the optimal way to accurately diagnose sleep apnea with home diagnostic equipment then action by medicare to encourage use of this diagnostic modality will be appropriate. I studied a home diagnostic system back in the late 1980s and unfortunately issues raised then about reliability of such equipment persist today. Taking on the use of CPAP can make an enormous difference to patients subjective feeling of well being as well as long-term morbidity and mortality. Everything written about CPAP usage and compliance documents the need for accurage diagnosis and extensive patient education in order to have compliance with the use of the device. Putting patients on CPAP with unreliable basic data is not going to benefit anyone. THe concept that anyone could interpret a portable home study is laughable - would you want a pacemaker inserted based on your family practitioner''s interpretation of your Holter Monitor or would you want the cardiologist to make the final decision? Medicare is ahead of its game. Encourage the sleep community to come up with a consensus on how to accomplish validated home monitoring, set a standard and then hold us to it! It is estimated that there are many more people that require diagnosis than can be accomodated in existing sleep laboratories. This is not a territorial issue but we must promote good medicine and accurate monitoring!

H Emsellem, MD
Director,The Center for Sleep & Wake Disorders
Chevy Chase, Maryland
301-654-1575

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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 medicine. HST needs to be done by trained physicians at competent centers.

If CMS uses: 1. Evidence based and academically guided input from the AASM and 2. Implements policy to be carried out by compentent MDs then the goals of A. Good medical care and B. Cost effectiveness will be met.

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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 determining whether or not someone has OSA, CMS does not take these arousals into account. They define a hypopnea as, 'an abnormal respiratory event lasting at least 10 seconds with at least 30 percent reduction in thoracoabdominal movement or airflow as compared to baseline, and with at least 4 percent oxygen desaturation.'(1) The American Academy of Sleep Medicine recently released a manual for the Scoring of Sleep and Associated Events that alternatively defined a hypopnea as being a ¡Ý50% drop from baseline in the nasal pressure transducer flow signal lasting at least 10 seconds and associated with a ¡Ý3% desaturation or an arousal.

At September's Medicare Evidence Development & Coverage Advisory Committee, I asked that CMS redefine the criteria for CPAP reimbursement based on which definition of hypopnea was used for scoring the polysomnogram. The term Apnea Hypopnea Index (AHI) could encompass polysomnograms scored with the recommended definition of a hypopnea and the term Respiratory Disturbance Index (RDI) could be used for studies scored with the alternative definition. Both AHI and RDI would then have the same criteria for CPAP reimbursement (AHI/RDI>15 or AHI/RDI> 5 with symptoms).

Having more concrete definitions for AHI and RDI would help to standardize clinical research. More importantly, since women have more Upper Airway Resistance Syndrome (UARS) than men(2), a scoring criterion that does not take arousals into account would be discriminatory toward women who might benefit from treatment. While UARS and 'mild' OSA could possibly meet reimbursement criteria for CPAP utilizing the RDI, they would likely be missed if hypopneas associated with arousals were not allowed to be counted. Portable monitoring has the potential to exacerbate the problem. Guilleminault notes that 'studies performed without EEG and nasal cannula/pressure transducer system will miss patients with mild sleep-disordered breathing.'(3)

There has been limited research on sleep-disordered breathing in women. Much of the research used by CMS in support of portable monitoring consisted of research populations that were predominantly male. For example, in support of home oximetry, CMS annotates Guylay et al. (1993) who concluded that being at SaO2&< 90 for &< 1% of the time practically excludes clinically significant OSA. Yet, only 22 of the 98 patients were women. Moreover, this study was performed at a time when UARS was just beginning to be recognized. "It has recently been suggested that sleep fragmentation can occur without any discrete episodes of abnormal breathing. Such patients were not included in those identified as having OSA for our analysis, but if they had been, the sensitivity of counting desaturations would have decreased."(4)

In its proposed decision memo, CMS recommends that CPAP be used for severe OSA. 'In patients with mild to moderate OSA, nasal CPAP may be indicated, though conservative measuresmay be better tolerated.' The position held by CMS is not consistent with current research showing that CPAP is the most effective treatment for mild to moderate OSA(5). Women have lower AHI'S(6) and more hypersomnia associated with lower AHI's(7). As there is poor correlation between severity of AHI and severity of disease(8), under the proposed decision memo, women will have a much harder time qualifying for CPAP despite having similar symptoms and response to CPAP(9).

If CMS begins to allow all physicians to diagnose OSA through portable monitoring, it would be difficult to revoke that privelege at a later date. Gender differences in OSA are germaine to the debate, because women, who more commonly have UARS and "mild" OSA, are much more likely to be missed using portable monitoring. Because this decision could forever change the landscape of sleep medicine, CMS should include all data on UARS in its final decsion memo. The burden of proof should not be on the field of sleep medicine to prove that UARS and "mild" OSA can cause significant morbidity, but rather on CMS to prove that they do not.

-(1) National Coverage Determination Manual, 240.4.
(2) Guilleminault, C and Chowdhuri, S. Upper Airway Resistance Syndrome Is a Distinct Syndrome. Am. J. Respir. Crit. Care Med. 161: 1412-1413.
(3) Guilleminault, C et al. Chronic insomnia, premenopausal women and sleep-disordered breathing Part 2. Comparison of nondrug treatment trials in normal breathing and UARS post menopausal women complaining of chronic insomnia. Journal of Psychosomatic Research 53, 617-623.
(4) Guylay, et. al. A comparison of clinical assessment and home oximetry in the diagnosis of obstructive sleep apnea. Am Rev Respir Dis. Vol 147. 50-53, 1993.
(5) Lam B, Sam K, Mok WYW, Cheung MT, Fong DYT, Lam JCM, et al. Randomised study of three non-surgical treatments in mild to moderate obstructive sleep apnoea. Thorax. 2007 Apr;62.4:354-9.
(6) O'Connor, et al. Gender Differences in the Polysomnographic Features of Obstructive Sleep Apnea. Am. J. Respir. Crit. Care Med. 161: 1465-1472.
(7) Young T, Palta M, Dempsey J, Skatrud J, Weber S, Badr S. The occurrence of sleep-disordered breathing among middle-aged adults. NEJM 1993;328:1230-1235.
(8) Giles, T, Lasserson, T, Smith, B, et al Continuous positive airways pressure for obstructive sleep apnoea in adults. Cochrane Database Syst Rev 2006;1,CD001106
(9) Redline S, et al.: Improved outcomes after CPAP treatment in mild sleep disordered breathing. Am J Respir Crit Care Med 1998, 157:858-865.

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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. Sleep Services of America INC. (SSA) would like to provide comments specifically regarding the following proposal: CPAP coverage will be expanded to include those beneficiaries with a diagnosis of CPAP made using a combination of a clinical evaluation and unattended home sleep monitoring using a Type II, III or IV device.

SSA is not opposed to the use of a Type II for Home Study Testing (HST) in patients with a positive pretest screening and probability of severe OSA. We do not believe, however that HST is appropriate for the diagnosis of OSA in patients with significant co-morbid conditions. We also would not support it’s use as a general screening tool for OSA.

HST for the diagnosis of OSA should be performed under the auspices of a qualified comprehensive sleep medicine program. This is necessary to insure appropriate and accurate quality of care and a continuity of high quality standards. Furthermore;

1) HST for the diagnosis of OSA should be performed only in conjunction with a comprehensive clinical sleep evaluation performed or supervised by a physician board certified in sleep medicine who is qualified, knowledgeable and experienced in diagnosing and treating sleep disorders.

2) HST should be performed by an individual who is qualified, trained and experienced in performing sleep diagnostic studies as evidenced by a license or certification as recognized by the respective state licensing board.

We oppose the use of Type IV and Type III devices that the current proposal may deem acceptable for home sleep testing.

We oppose the use of Type IV and III portable monitoring devices for use in HST for the following reasons:

1) The use of an airflow sensor and oximetry alone cannot accurately diagnose OSA. The use of a Type IV device may result in a significant number of false positive results for OSA since many other medical conditions impact respiratory airflows and blood oxygen levels. This would likely lead to over prescribing of CPAP.

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) In certain circumstances, a portable monitoring device that records airflow, respiratory effort and blood oxygenation at a minimum could be sufficient for diagnosing OSA. However, based on medical evidence, the use of a Type III device that monitors only these parameters could misdiagnose patients with chronic obstructive pulmonary disease, restrictive lung disease, complex sleep apnea and central sleep apnea as having OSA. For these reasons, we oppose the use of a Type III device for HST.

3) Finally we are concerned that Type VI and III devices will miss the high prevalence of concomitant Sleep Disorders in patients with Obstructive Sleep Apnea (Sleep and Breathing 2005; 9: 50-56) which may account for over 30% of the patients tested.

Please note several items in my response were written in collaboration with some fellow National Sleep Alliance members. I respectfully submit SSA’s response as stated above.

Sincerely

John Mathias
President
Sleep Services of America
890 Airport Park Road, Suite 119
Glen Burnie, MD 21061

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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 treatment can be determined in an unsupervised setting. Will robotic surgeries soon follow or drive thru medical exams?

To eliminate the signifinace of technician assisted procedures is sending an alarming message to the health community. How can a compromised patient who is hypersomnolent be in a position to adequately ensure that home monitoring is without critical error and that misdiagnosing and/or misprescribing of therapy does not occur.

Will this committee next strive to eliminate national campaigns against the hazards of driving while sleepy or the dangerous of excessive sleepiness? Intervention required by sleep professionals to ensure adequate studies are done should be the standard of patient care promoted not eliminated to save a dollar.

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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 practice and patient care.

Home sleep testing has been comprehensively addressed by the AASM with the December 2007 publication of “Clinical Guidelines for the Use of Unattended Portable Monitors in the Diagnosis of Obstructive Sleep Apnea in Adult Patients.” The AASM also sent a response to CMS that outlines several issues in the proposed NCD :
1. Inclusion of Type IV devices.
2. No definition of an acceptable CPAP trial.
3. No definition of requirements for clinical evaluation that complement the home sleep test.
4. No definition of a paradigm for follow-up and long-term management, especially in patients with a negative home study test or a failed CPAP trial.
5. No definition of who is covered under this policy.
6. No requirement for patients in need of a new CPAP machine.

I share the concerns outlined by the AASM and fully support its comment to CMS. I believe these issues, as well as others, can be addressed through the local coverage determination (LCD). As a specialist with expertise and training in sleep medicine, I am willing to work with you on developing a fair and comprehensive LCD for home sleep testing; please do not hesitate to contact me at (insert phone number) or via e-mail (insert e-mail address). You can also contact the AASM Senior Health Policy and Governmental Affairs Analyst, Ted Thurn, at tthurn@aasmnet.org or at (708) 492-0930.

Sincerely, Anthony Masi, MD, FAASM

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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 rigorous and complete using the most current evidence available and the best interests of Medicare patients.

We recommend the final policy include this clarification.

We recommend the implementation of a new CPT code to accurately and clearly reflect stage II, i.e. a full polysomnogram in an unattended home study.

Home sleep testing may be “unattended” as there is now wireless technology that insures the data integrity of a full polysomnogram that incorporates both respiratory and neurological monitoring. These new wireless systems accurately transmit real time data from the skin sensor to the data logger. This will significantly enhance the physician’s ability to make accurate diagnostic determinations that include all facets now present in a full overnight lab study (CPT 95810).

We respectfully request CMS to hold fast to its decision as this is in the best interests of our patients and the United States Medicare program. The American Academy of Sleep Medicine (AASM) has taken on the home sleep testing issue; we do not want to see restrictions on who can order, perform or interpret home sleep testing. Proposed AASM restrictions are likely to have a built in financial bias to the established sleep labs. There will always be a need for more extensive in lab studies, but unattended home testing is the wave of the future in the digital age. Professional society endorsement effectively usurps the government of its role as an honest regulator/payer in favor of medical groups that have a direct financial interest in who is approved to render such studies. It is our position that all qualified providers have equal access to the market in order to bring the highest quality diagnostics at the most favorable cost to Medicare. Organization specific accreditation requirements advocated by the AASM are self-serving, unnecessary, and will serve as an impediment to use home testing devices for the diagnosis of OSA. Their position is nothing more than an attempt by the AASM to maintain control of the analysis portion of the study within the sleep labs and sleep technicians running their labs. CMS should not require that home sleep testing be under control of a specific professional society as this is an open and flagrant conflict of interest. Thank you for your consideration.

Sincerely,

Yosef P Krespi, MD, FACS
Robert S Lebovics MD, FACS
Professor of Otolaryngology
Former Chief, Clinical Otolaryngology
Columbia University
NIDCD, NIH Bethesda MD
Director Dept of Otolaryngology
St Lukes-Roosevelt Hospital, New York

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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 increase fraud in South Florida due to lack of controlling who administers and orders these studies. There will be many studies ordered without a valid dianosis. We need to keep quality in all areas of medicine including sleep.

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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 and warrants such a stuey. We need to keep quality in this field.

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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 American Board of Internal Medicine has recently incorporated and began board examinations and certification in Sleep Medicine. Allowing non boarded physicians to diagnose and treat sleep disorders is tantamount to allowing internists to perform surgery - it is a specialized field that requires specialized training and certification.

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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 the study-

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 reimbursement of CPAP, I disagree with the proposal from CMS to allow any physician, even without expertise in sleep medicine, to conduct such sleep studies. I have experience first hand the mismanagement of sleep apnea patients and even those without sleep apnea by unscrupulous physicians without training in sleep medicine out there trying to maximize their take home pay.

I suggest the following:

1. Allow unattended home sleep studies (Type 3 only) for the diagnosis of OSA and reimbursement of CPAP. Such sleep studies should have the following minimal characteristics:
a) Measure airflow directly via nasal cannula
b) Measure thoracic movements (respiratory effort) directly by piezoelectric or respitrace bands applied to the thorax or thorax and abdomen, or by intercostals EMG.
c) Measure pulse oximetry
d) Measure heart rate (from pulse oximetry or directly)
e) Measure sleep position
f) Ability for full disclosure of the data and for manual scoring

2. Home sleep studies should be manually scored by trained sleep technicians and the data (including raw data) reviewed by the interpreting physician who specializes in sleep medicine (Boarded).

3. Only established sleep laboratories (accredited or not), who specialize in all aspects of sleep medicine, that are headed by a clinician boarded in sleep medicine, should perform unattended home sleep studies. Home sleep studies as a side activity out of a clinician’s office should not be allowed.

4. Only patients with a high pre-test probability for OSA should undergo unattended home sleep studies. Tests such as the Berlin questionnaire or others or sleep medicine consultation can be used for such purposes. Subjects suspected of OSA but with a low pre-test probability or who are felt to have mixed pathology (comorbid periodic limb movements, upper airway resistance syndrome, REM sleep behavior disorder, insomnia, hypoventilation syndrome, seizure disorder, and narcolepsy), should undergo a full attended polysomnogram.

5. Only physicians and other clinicians (PhDs) who are board certified in sleep medicine (American Board of Sleep Medicine or the new American Board of Medical Specialties-Sleep Medicine Certification) should be allowed to analyze, interpret, and bill for home sleep studies.

6. Once the diagnosis of obstructive sleep apnea is made auto-CPAP therapy should be allowed to expedite treatment. Such therapy should only be prescribed by clinicians boarded in sleep medicine since even this new modality of therapy needs to be adjusted to the best possible range of CPAP pressures that will adequately control OSA and prevent high CPAP associated central apnea. This can be accomplished by the use of CPAP pressure prediction formulas found in the literature. I have witness clinicians not trained in sleep medicine mismanage and discourage OSA patients from using CPAP by using this effective therapy in a wide open mode (4 to 20 cm H2O).

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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 will also be in question. Furthermore, the lack of specialty and expertise of referring physicians and physicians interpreting the data will also be questionable and increase the room for error leading to misdiagnosis/underdianosis these patients as well. With all this in mind, not only will the underdiagnosed or misdiagnosed sleep apnea patient suffer, but also the lives of the people around them, i.e. the victims of drowsy/sleep drivers causing automobile accidents, spouses who also can''t sleep due to their bed partners, co-workers due to their poor work performance and friends and families due to the decreased quality of life. Lets keep the quality in this area of medicine which not only will benefit the patients, but also each and every person who comes in contact with them.

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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 familiar with the Watch-PAT100 (WP) and my sleep lab has performed over 5000 home studies with it. We have found that the WP identifies patients with OSA as accurately as polysomnography (PSG) and the other commercially available Type III home sleep testing (HST) devices we have used.

Therefore, I am writing to request that CMS not finalize its proposal to only cover the WP under Coverage with Evidence Development (CED) and instead to cover the WP for use in any patient with suspected OSA in whom it is indicated.

Two years ago, my lab evaluated the WP by comparing it to the Emblata, a Type III device we were using at the time. We found that the WP was comparable to the Emblata in diagnostic accuracy and failure rate. The diagnostic accuracy was confirmed by PSG when we brought patients into our sleep lab to titrate their CPAP. Importantly, it also dramatically improved our labs ability to start treatment with CPAP earlier because it’s data is easier to analyze and does not require manual overreading. Type II, III, and IV devices that utilize traditional channels to measure respiratory flow and effort typically require manual over-reading of their output because sophisticated accurate algorithms for those channels have not been developed. The WP has a very sophisticated algorithm which results in the devices automated reads to be so accurate that manual overreading is almost never necessary to improve diagnostic accuracy.

Use of the WP has dramatically reduced the overall cost of care for Kaiser patients because rapid diagnosis and treatment leads to reduced clinic visits, hospitalizations and emergency room visits for complications of sleep apnea.

In the two years following our evaluation, the WP has become the preferred HST device in the majority of Northern California Kaiser facilities and it has been successfully used in over 15,000 sleep studies.

I and many of my colleagues in the Northern California Permanente Medical Group consider the WP to meet the standard of care for diagnosing OSA and we are fully satisfied with its performance. We urge CMS to cover CPAP in all cases when OSA is diagnosed using the WP. Please don’t hesitate to contact me if you have any questions.

Sincerely,

Laura Butcher, MD
Medical Director
Kaiser San Jose Ambulatory Sleep Lab

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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 testing must be regulated to ensure the highest standards of patient care.

With the recent interest in and awareness of sleep disorders, the demand for sleep facilities has increased, with many labs with questionable credentials draining not only the patients, but government and private insurance companies of thousands of dollars, while patients are improperly diagnosed and treated. It is essential that the standards for these facilities be regulated so that patients are assured of competent care. An in-home sleep facility should be accredited by the American Academy of Sleep Medicine, and all interpretation, review, diagnosis and treatment should be done by a board certified sleep specialist. Testing should be administered by a Registered Sleep Technologist with reputable DME providers distributing the equipment so that patients will be assured of competent diagnosis and treatment.

Screening and follow-up of sleep patients is also at issue. It is not in the patient’s best interests to issue a CPAP machine and then provide no follow-up. This will certainly result in wasted funds and poor outcome. It is important to establish the standards now that will have an effect on the quality of care patients can expect in the future. I sincerely hope and trust that CMS will give careful consideration to these points and define the regulations that are necessary to ensure that sleep patients receive the best care possible.

Sincerely,

David Shapouri

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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 necessarily the best pathway with respect to long term outcomes, objective documentation of changes to symptoms of those individuals diagnosed with sleep apnea or the overall effects of this disease on public health. As an organization with a collective experience of over 20 years in polysomnography, unattended sleep apnea recordings and the provision of CPAP therapy, we want to thank CMS for deliberating on the various approaches to the diagnosis and clinical management of this disorder. In our response, we would like to address the following issues:

1. Patient Access:By now, there is ample documentation that obstructive sleep apnea is a major public health problem affecting at least 2-4% of the middle aged population. Research also strongly alludes to the fact that untreated sleep apnea can exacerbate other co-morbid diagnosis such as hypertension and CHF. Polysomnography, over the past decade has played a decisive role in the diagnosis and treatment of sleep apnea and uncovering the links between sleep apnea and other concurrent diagnosis. Polysomnography has also shown the need to promptly attend to the therapeutic aspects that control the symptoms once the diagnosis is made. Polysomnography has also, ironically, documented the need for greater capacity within the health care system to diagnose and treat sleep apnea. CMS needs to be applauded for recognizing the growing threat of undiagnosed sleep apnea and its effects on the overall health of individual patients and public health. Presumably, in large measure, this is the reason for this decision. As alluded to in this decision, highlighting the priority of individual case management by any available diagnostic tool (TypeI through Type IV sleep studies) or indeed physician documentation alone, is important to stem the growth of undiagnosed sleep apnea. However, while this is a great step forward, it also creates different standards for the documentation process, some of which might not actually provide the best solutions. Work still needs to be done with respect to defining the continuum of care which includes the type of diagnostic tool required and the process that documents adherence to therapy. CPAP is only one option that can reverse the symptoms of sleep apnea. Improvements in technology with respect to the delivery of positive pressure now provides for an array of therapeutic devices that can synchronize patient needs, and physiological changes with device prescriptions. Greater patient access requires a reliable, continuum of care that includes a standardized diagnostic process followed by data that documents the benefits to adherence to therapy.

2. Patient Adherence:The medical community needs and CMS should address in this decision or in the future the importance of having reliable data that documents the effectiveness of CPAP therapy both quantitatively and qualitatively. Unlike other types of prescriptions, the CPAP prescription is an ongoing interactive process between the patient and an essentially alien device. Published data provides some direction with respect to time used during sleep and derived benefits such as daytime sleepiness and functional status but even though adequate sleep time is defined generally, total actual sleep time and consolidated sleep are different for each individual, this needs to be taken into account in the adherence to therapy documentation process . Successful documentation of quantitative CPAP and its qualitative effects is a continual process that could require some time. The authors of this Document need to be applauded for acknowledging the need for adherence to therapy documentation within a 12 week period. But what are the objective data required. Again, much improved and innovative technology, such as electronic data cards or remote monitoring can provide standards for the documentation process within the proposed 12 week period. This needs to be addressed. For patients that have derived maximum benefits within 12 weeks, the CMS directive works very well, for those that don’t what is the alternative? The CMS preliminary decision leaves that to a somewhat arbitrary intervention and, with inexperienced clinicians, to possible failure. The long term consequences of poor adherence to the CPAP prescription and its effects on the rest of the overall patient health is still being debated and studied. The effect of the proposed CMS decision on the documentation process can at best enumerate patients with immediate effective response, however the medical community, at large, needs to define and enumerate the steps for those patients that do not meet minimum standards of CPAP adherence. In fact more than 12 weeks might be required for this process to be complete and specific recorded objective data in correlation with subjective reporting is necessary.

3. Portable unattended monitoring:What we should not lose sight of is that sleep apnea is essentially a respiratory control, or ventilatory abnormality problem that affects the upper airway. This leads to consequences in oxygenation and arousals from sleep. To document this requires specific physiological measurements that can measure this abnormality. Advances in current portable unattended monitoring, and CPAP technology can certainly provide the necessary documentation for certain types or degrees of sleep apnea, however it will not resolve or provide solutions for patients presenting with subtle forms of this disease or patients who have excessive daytime sleepiness from confusing presenting etiologies. Several studies and anecdotal physician observations support the premise that a well developed program of polysomnography, unattended portable monitoring coupled with effective long term clinical management of patients can adequately control the symptoms of patients diagnosed with severe sleep apnea. Comprehensive clinical programs with strong oversight can also maintain compliance with CPAP therapy. Mature clinical programs that produce these results have historically included physicians that are not only committed to these clinical programs, but also know the place of unattended monitoring in the total array of diagnostic tools. Requiring a twelve week time span to document the effectiveness of CPAP therapy indicates that CMS has recognized the importance of this process. However, what has not been adequately discussed is the kind of tools required that goes along with achieving 12 week results. By collectively categorizing and allowing Type 1 through Type IV devices to be used with the premise that they provide equivalent recorded data is not consistent with what each type of device can record. There is adequate technology that can directly measure objective data that verifies adherence with prescribed therapy. Portable unattended monitoring should directly measure what is required to document effective treatment or initial diagnosis, this includes at a minimum, peripheral oxygen saturation, a direct measurement of airflow, a direct measurement of respiratory effort and a direct measurement of ECG. This is a Type III device.

Several isolated, mature clinical programs that have been operating for some time now have incorporated portable unattended monitoring within the overall diagnostic and therapeutic titration process. Based on a review of all available data, a recent publication by the AASM (American Academy of Sleep Medicine) has compiled and summarized best practice standards for unattended portable monitoring.. This document has carefully laid out a clinical algorithmic process that provides for the effective utilization of these devices. While the CMS proposed decision does not provide a detailed distinction between the benefits various types of monitoring devices provide, the AASM document does do that. This document along with the proposed CMS decision can provide the proper guideline with maximum benefits for all beneficiaries.

We want to thank you for your efforts that was required to come to this decision and the opportunity to allow public comment.

Michael S. Lawee
Corporate Clinical Director-Program Development
Total Sleep
1425 Greenway Drive
Irving, TX75038

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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 medical community. This was nicely outlined in an article "Awareness Level of Obstructive Sleep Apnea Syndrome During Routine Unstructured Interviews of a Standardized Patient by Primary Care Physicians" (Sleep Vol 27, no 8, 2004). Papers such as this demonstrate that awareness and appropirate evaluation of sleep apnea patients remain an area in need of great improvement. I fear that every patient with "fatigue" who has an "abnormal oximetry" will get the government to buy them a CPAP - this pathway will clearly be very poor and very costly care.

The NCD also lists CPAP as low risk but be aware that the CANPap trial looking at using CPAP to treat patients with Cheyne-Stokes respiratory pattern was terminated early due to trend towards a higher risk of death in the CPAP treated group (Bradley et.al., NEJM, 353:2025-2033). The prevalence of this breathing pattern in the Medicare population will not be insignificant and clearly cannot easily differentiated with Type III devices and certainly cannot be identified at all with Type IV devices.

The current draft of the NCD appears to benefit patients by providing ease of access to diagnosis which I support but I am quite certain this implementaion will not improve care without the careful involvement of sleep specialsts that have a firm grounding in the pathophysiology and treatment of SDB. Indeed in it''s current form the NCD would dramatically increase CPAP presecriptions and decrease time to purchase all of which will greatly benefit HME companies but I''m afraid without the careful attention to the nuances of CPAP therapy that most of those machines will wind up as very expensive "fern misters". This likely will not improve patient care and could be VERY costly to the Medicare system.

Thank you again for your hard work on these matters.

Sincerely, David L. Dedrick, M.D.

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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 complicated population to monitor and the population with the most undiagnosed diseases is the over 65 population which is the target population you are looking to cover.Polysomnograms should be conducted only by qualified technicians who can pick up the EEG problems, restless leg movement and central apneas. All of which the portable monitoring will not be adequately able to detect.

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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 who will later interpret the study. This will result in misinterpretation of the study.

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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 aforementioned memo includes a number of proposals for the diagnosis and treatment of Obstructive Sleep Apnea including an initial limitation of CPAP coverage to 3 months except to those with who benefit from therapy, expansion of coverage to patients diagnosed with OSA using a combination of clinical evaluation and sleep monitoring using Type 2, 3, or 4 devices, elimination of the requirement for 2 hours or sleep, and elimination of the requirement that patients have at least moderate OSA as defined by an RDI of greater than 15 for coverage or at least mild OSA with symptoms. It would appear that the intent of the proposal is to expand coverage to as many patients with OSA as possible at the lowest possible cost which is certainly a valid proposition.

As clinicians specializing in Sleep Medicine for many years and having both Pulmonary and Critical Care board certifications, we have a number of concerns with this proposal. We believe it will, in the short term, result in inferior care of the patient with OSA, higher rates of noncompliance/treatment failure, and ultimately an enormous delayed cost through the explosion of uncontained obesity, pulmonary hypertension, diabetes mellitus, and hypertensive and ischemic cardiovascular disease. We agree that the proposal to limit funding for an initial 3 months has merit but that defining who achieves a benefit may be difficult. We also believe that expanding coverage to those with mild sleep apnea may be best delayed until further study defines which patients with mild OSA deteriorate over time as these patients often tend to have difficulty tolerating CPAP or oral appliances.

Our practice has evolved over the past 12-15 years from treating patients with OSA based on home attended polysomnographies or laboratory based attended studies in the setting of a pulmonary practice to more recent management of these patients in the setting of a formal sleep center. The results have been dramatic with treatment failures being common to now being quite rare. The improvement in results has clearly been related to the ability to treat these patients in a comprehensive manner with high quality type 1 studies, close sleep physician evaluation and management, and patient education. Treatment for these patients must be highly individualized and long term success depends on a proper diagnosis/diagnoses, patient access to well trained staff, and correction of comorbid diseases such as obesity. The CMS proposal would substantially expand the diagnosis and management of patients with OSA to clinicians without the training or staffing required to adequately manage these patients. These are often high needs patients who require a significant commitment of personnel to properly achieve the desired goal. Our experience clearly indicates the most cost effective long term approach to the diagnosis and treatment with patients with sleep apnea is through a comprehensive team approach as championed by the American Society of Sleep Medicine.

The expansion of diagnostic studies especially to include type 4 devices is particularly concerning as these studies cannot even define whether the patient is asleep. This will lead to the possibility of numerous false negative results. Furthermore, both type 3 and 4 devices are inadequate to diagnose central sleep apnea, complex sleep apnea, and arterial hypoxemia related to intrinsic lung disease such as COPD or pulmonary fibrosis. There are also numerous other sleep disorders which may co-exist with OSA which require treatment for the patient to be free of daytime symptoms such as PLMS with arousals, bruxism, parasomnias, and narcolepsy. Thus, many patients may not get treatment that is needed while many may receive inappropriate or inadequate treatment. It is highly likely that patients for whom a misdiagnosis is established and treatment fails will be unlikely to ever achieve proper care as they will be labeled as treatment failures or be placed on supplemental oxygen alone. The unintended consequence of CPAP failures may be an enormous expansion of the use of nocturnal oxygen reducing or eliminating the intended cost savings of the program.

Our final concern regards the long term consequences of misdiagnosed sleep disorders or inadequately treated sleep apnea. There will be many patients who needlessly suffer or die from such sleep disorders resulting in motor vehicle accidents. Additionally, the future cumulative cost of inadequately treated OSA or those with false negative studies on the failure to prevent hypertension, coronary artery disease, diabetes mellitus, and obesity will undoubtedly be enormous. Given the legal system in this country, it would not be out of the question for CMS to be held liable if patients died or were seriously injured as a result of false negative studies or misdiagnoses that could be proven in court.

It is our feeling that any decision to permit the widespread use of these limited home diagnostic studies in Medicare beneficiaries should only be made after there is clear data supporting their efficacy in populations of older patients with significant cardiac, pulmonary, and neurological comorbidities as is seen clinical practice. Patients who receive such studies should be fully informed that these studies may fail to diagnose a significant number of sleep disorders and do not represent the best test available. Furthermore, our experience clearly supports that management of patients with sleep disorders including those with obstructive sleep apnea be under the direction of a physician trained in sleep medicine whenever possible.

Respectfully,

Joseph S. Kubiak, Jr. MD
Ahmad Boota, MD
Palmetto Pulmonary & Critical Care Associates,
Greenville SC 29601

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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 requires that sleep diagnostic testing performed in a sleep diagnostic facility must be done so under strict criteria and quality standards. Furthermore, on a regional basis, some Medicare Regions require in certain states that sleep diagnostic testing in Independent Diagnostic Testing Facilities (IDTF’s) must be performed under the auspices of an AASM accredited sleep center. These strict quality standards are necessary and appropriate and these standards should continue. CMS should not deviate from these standards on any final decision by CMS for HST and coverage for CPAP and appropriate quality standards must be applied.

C) Performance of HST under a qualified, comprehensive sleep medicine program

HST for the diagnosis of OSA should be performed only under the auspices of a qualified comprehensive sleep medicine program. This is necessary to insure appropriate and accurate quality of care and a continuity of high quality standards. Furthermore;

1) HST for the diagnosis of OSA should be performed only in conjunction with a comprehensive clinical sleep evaluation. Clinical sleep evaluations must be performed or supervised by a physician board certified in sleep medicine that is qualified, knowledgeable and experienced in diagnosing and treating sleep disorders. Before CPAP is prescribed, a fully attended psg study should be required. No treatment should be prescribed based on a HST alone.

2) HST should be performed by an individual who is qualified, trained and experienced in performing sleep diagnostic studies as evidenced by a license or certification as recognized by the respective state licensing board.

D) Acceptable Portable Monitoring Devices for use in HSTCMS should 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) In certain circumstances a portable monitoring device that records airflow, respiratory effort and blood oxygenation at a minimum could be sufficient for diagnosing OSA. However, based on medical evidence, the use of a Type III device that monitors only these parameters could misdiagnose patients with chronic obstructive pulmonary disease, restrictive lung disease, complex sleep apnea and central sleep apnea as having OSA. Furthermore, the use of this type device for HST should be of significant concern to those physicians practicing at high altitude where few patients have straight forward and simple OSA. For these reasons, we do not fully support the use of a Type III device for HST.

We do not support certain aspects of CMS’ proposal to allow coverage of CPAP based upon a diagnosis by home sleep testing as long as testing is performed under the auspices of a qualified comprehensive program.

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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). As a multi-site accredited sleep center company that was founded by means of providing portable monitoring, we have a great understanding of HST advantages and disadvantages to patients and providers. While Type II, III, or IV devices may be beneficial for providing increased probability that a patient will comply with undergoing testing, it’s evidence may prove misleading without the use of a full night polysomnography, attended by a certified technologist in an accredited sleep center or laboratory. As a leading provider of diagnostic testing and treatment of sleep disorders in our community, we feel that the information we can provide you in regards to HST versus in lab polysomnograhy can be beneficial to the proposed decision memo. Our responsibility to provide patients with accurate diagnosis, treatment, and follow up care should not be benchmarked by devices that have limited proven reliability or accuracy.

The belief that HST will provide a cost effective solution is challenged with hidden expenditures to the patient, provider and sleep center. Considering the demographics and possible physical limitations of a Medicare beneficiary, expectations are lowered for receiving a clinically reliable HST without multiple retesting. This factor may result in the patient, provider, and sleep center assuming the financial impact of multiple visits to establish a reliable evaluation. The patient’s time and travel cost, the sleep center’s set up, the physician’s interpretations and provider reimbursement are effected each time a HST must be repeated with an escalating risk that the patient becomes non compliant with the process and declines further testing. The debate that providing HSTs will alleviate availability to receive diagnostic testing and treatment in a timely manner due to sleep centers backlog is hinged by receiving a readable test during the initial set up otherwise multiple visits may follow due to inaccuracy and/or reliability that would ultimately negate the HST intended benefit. The repetitive HST risk could have the reverse effect in which the patient could have been provided services sooner through testing conducted at the sleep center or laboratory.

These potential issues transition to which entities can provide HST set ups and interpretations, a matter not clearly defined in proposed decision memo for continuous positive airway pressure (CPAP) therapy for obstructive sleep Apnea (OSA) (CAG-00093R2). As an organization that operates accredited sleep centers spanning multiple states and utilizing board certified/eligible sleep physicians, we pride ourselves in providing gold standard services to our patients. We are concerned that Independent Diagnostic Testing Facilities are not clearly defined in the proposed memo as the sole entities to provide HST to eligible candidates. We are equally concerned that the NCD does not recognize any medical specialties nor facility accreditations. We have reviewed and strongly support the recommended standards and guidelines suggested by the American Academy of Sleep Medicine for Use of Unattended Portable Monitors in the Diagnosis of Obstructive Sleep Apnea in Adult Patients.

We are supportive of use of Type III HST devices as a screening tool to be utilized for the Indication for Polysomnography and Related Procedures as well as a follow up indicator of compliance for continuous positive airway pressure (CPAP) patients. We embrace HST a viable option to extend patient access and public awareness stipulating that it be conducted by board certified sleep physicians and accredited sleep centers. We thank you for the opportunity to provide comments on these matters.

Sincerely,
James C. Snider
Sleepcare Diagnostics, Inc.,

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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 hands of an experienced physician who is used to dealing with this complex problem. Portable home studies are not reliable, and some patients may falsify their studies if not attended. This will occur for a fact as I see it in my opinion. Bad idea all around. It will only exacerbatean already difficult situation.

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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 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 a sleep tech. It has been my experience that even overnight oximetries are a challange for some patients. that test has only one wire. I cannot imagine the number of unusable tests for sleep apnea due to the fact that there will be multiple wires. One last thought, how will anyone know when the patient is in fact sleeping with the equipment that is now available. I am assuming we are talking about Obstructive SLEEP Apnea

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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 7,000 sleep medicine specialists, provided a formal comment based on the evidence available at the time. The AASM stands by its comments and its commitment to evidence-based medicine.

The AASM has raised a number of concerns throughout this most recent process regarding the evidence CMS used as the base for this proposed decision. The AASM has noted that the studies cited in the proposed draft did not include the patient population covered by Medicare. Additionally, the evidence included in the proposed decision, as the AASM has also noted, is from controlled studies which were all conducted by sleep specialists in academic centers on highly selected study populations without co-morbidities who almost always had a high pre-test probability for OSA. Further, the AASM has raised the issue of high occurrences of false positive and false negatives associated with portable monitoring, especially Type IV monitors. While these concerns will not be repeated in detail within this comment, the AASM stands by its previous remarks and feel they remain relevant.

The AASM acknowledges that the proposed decision is broad. However, the AASM believes important topics are not addressed in the proposed decision:
1. Documentation of OSA and determination of severity by diagnostic testing is essential for proper management of patients with this disorder. Severity level is the best predictor of cardiovascular morbidity and predicts success with different modes of treatment, especially in those with severe disease. In-lab attended polysomnography provides the most accurate method for establishing a diagnosis of OSA and risk stratification as well as providing an opportunity to initiate CPAP in high risk individuals via a split-night protocol.
2. The proposed decision does not define an acceptable CPAP trial.
3. The proposed decision does not define the requirements for clinical evaluation that complements the HST.
4. The proposed decision does not define a paradigm for follow-up and long-term management, especially in patients with negative home study test or failed CPAP trials.
5. CMS must clarify who is covered by the NCD.
a. Does the NCD only affect beneficiaries enrolled in Medicare after implementation of the NCD?
b. Does the NCD affect all Medicare beneficiaries?
c. Does the NCD affect all Medicare beneficiaries who already utilize CPAP therapy?
6. The average life of a CPAP machine is 5 years. As such, will CMS require patients who utilize CPAP therapy to undergo an additional 12-week diagnostic period when a new machine is needed?

In the following comments the AASM addresses the medical-related topics cited 1 through 4 above as they will have an impact on patient care, and anticipate further comment from CMS on topics 5 and 6.

CMS Proposed Decision 1: We are proposing that, due to the evidence demonstrating that no combination of diagnostic procedures adequately identifies all of those beneficiaries who will benefit from CPAP, the coverage of CPAP is initially limited to a twelve week period to identify beneficiaries diagnosed with OSA as subsequently described who benefit from CPAP. CPAP is subsequently covered for those beneficiaries diagnosed with OSA who benefit from CPAP during this twelve week period.

The AASM disagrees with recommendations within this decision as stated. The proposal fails to define the measures by which any physician, especially those inexperienced and untrained in sleep medicine, would assess the benefit of therapy and also does not call for long-term management through programs that emphasize education and follow-up care. This is of particular concern due to the lack of training in sleep medicine provided to physicians in both undergraduate and postgraduate training programs, as recently documented by the Institute of Medicine.

The AASM believes that disease management by properly trained physicians board certified in sleep medicine is essential for the delivery of optimal care.
1) The AASM recommends that the diagnosis and treatment of OSA be performed under the supervision of a specialist board certified in sleep medicine.
2) Consistent with published literature, the AASM recommends that the measurement of acceptable CPAP adherence as use of CPAP for at least 4 hours of sleep for at least 70% of the days or an improvement in clinical symptoms.
3) At the end of the 12-week trial period, the AASM recommends follow-up evaluation with the board certified sleep specialist for reassessment of clinical symptoms and a review of other potential treatment options if the beneficiary is unable to meet the minimum requirement for measurement of CPAP adherence. This may include in-lab polysomnography, repeat positive pressure titration or another CPAP trial after addressing problems limiting use.

The AASM supports the requirement for documentation of a relevant clinical evaluation as an essential component of the diagnosis of OSA. The proposed decision fails to specify what constitutes a “clinical evaluation.” As such, the AASM recommends that the NCD require the following criteria be part of the required clinical evaluation:

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 unclear or even incorrect results from their tests as long as doing so benefits certain physicians and companies?

Now is not the time for Medicare to take its focus away from providing us with quality healthcare services. It is time to stand up and be counted as putting the needs of our senior citizens first.

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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 tested within a one week period so that cannot be the issue. Maybe this is brought up by physicians who are interested in making more money for themselves and really do not care about the patients and there overall outcome with this type of therapy. It is hard enough to work to get some patients compliant with CPAP/BIpap without making them come into a lab to see how things work, what they may be looking at and being able to go over the full report now generated in the labs. In the long run, if you follow the process, allowing home testing will cost Medicare more money than just doing a PSG in a lab and the outcomes with patients will be much worse.

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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 circumstances, a portable monitoring device that records airflow, respiratory effort and blood oxygenation at a minimum could be sufficient for diagnosing OSA. However, based on medical evidence, the use of a Type III device that monitors only these parameters could misdiagnose patients with chronic obstructive pulmonary disease, restrictive lung disease, complex sleep apnea and central sleep apnea as having OSA. Furthermore, the use of this type device for HST should be of significant concern to those physicians practicing at high altitude where few patients have straight forward and simple OSA. For these reasons, we do not fully support the use of a Type III device for HST.

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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 mention abnormalities in cardiac rhythm. If full laboratory based polysomnography cannot be done to a universally high standard, how is home testing going to help the situation? This is a bad idea whose time has not come.

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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 and took into consideration and will result in a better standard of care for Medicare beneficiaries.

I attended the MEDCAC meeting on September 12, 2007 and listened to Dr. Ryan talk about his research study showing that patients who underwent home testing and PAP titration showed better adherence to treatment then those undergoing the standard PSG paradigm.

In this research paper the following was written:

“To our knowledge, this is the first study to examine a combined ambulatory diagnostic and treatment algorithm without PSG in initial management of obstructive sleep apnea”.

Diagnosis and Initial Management of Obstructive Sleep Apnea without PolysomnographyA Randomized Validation Study

Alan T. Mulgrew, MB; Nurit Fox, MSc, CCRP; Najib T. Ayas, MD, MPH; and C. Frank Ryan, MB

I am writing to provide you with additional information about a research study which we conducted and completed in 2006. In this study we used an objective measure of daytime sleepiness, the psychomotor vigilance test, to determine outcomes to therapy after an initial 30 days on PAP treatment. In 1999 we began working with the father of sleep medicine, Dr. William Dement who became a believer in our unique approach after speaking to several patients who had become compliant with nasal PAP.

In an effort to validate our pathway we undertook a research study (abstract attached) to determine if our clinical model could improve the patient’s Quality of Life (QOL) while providing comparable results to previously published studies using traditional in-laboratory management. Quality of life as measured by SF-36 improved significantly for physical health, general health, vitality, social functioning, emotional and mental health subscales. Physical function trended towards improvement. Epworth scores improved from 13.21 (S.D.4.08) to 5.57 (S.D. 3.78) after treatment.

For this study, we implemented our standard clinical protocol that includes an auto-PAP titration but it is not simply a matter of providing a patient with the device and then downloading the data for compliance. We connect the auto-PAP to a portable home testing monitoring system so we can view physiological responses to therapy as indicated with a number of channels including, air flow, snoring, actigraphy, body position, thoracic and abdominal movement, oximetry and heart rate. Why don’t we just solely use the auto-PAP device and rely on the download data? We have learned that many patients do not respond well to either CPAP or auto-PAP but due to number of factors may require bi-level therapy. By taking into account pressure requirements, leak, as well as events that may occur with auto-PAP we are able to determine what the best long term therapy will be for the patient and make the necessary recommendation to the referring physician. By undertaking this disease management approach, we have been able to achieve 93% compliance on nearly 6,000 patients during the past ten years.

I believe the above information will lend additional evidence that a properly conducted in-home paradigm focusing on the diagnosis and treatment of OSA has been proven to provide superior outcomes to the existing paradigm of PSG and home care.

Thank you once again for giving the public an opportunity to voice our opinions and share their experiences and clinical research findings.

Best regards,

Robert B. Koenigsberg
President/C.E.O.

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We feel very strongly that portions of this CMS decision should be clarified. Specifically, it should be clarified:

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 to me that diagnosis is not as simple as 02 desats and AHI.If you would take the time and read the research I believe you would be better informed and this would not be an issue. I am not all that surprised as this country has fallen into a country driven by greed, in this case at the expense of our medicare population and eventually all of us. I can not see where this decision will benefit anyone with exception of a few. Has utilization really been considered? I would be interested in seeing these numbers. What will it take to reverse this decision? I know greed is powerful, can we look at the patient, co-morbidity, compliance, education, adequate diagnosis and treatment. Are any of these issues a concern. If you can answer this reasonably then maybe I can see it differently. I will be anxious to hear your comments. Sincerely, Bradley H. Weaver RCP, RPSGT.

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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 and Labs only. In addition, the studies should be scored manually by a registered polysomnography technologist and interpreted by a board certified or board eligible sleep physician. I am in support of these specific criteria to ensure the highest level of quality patient care is maintained.

Lastly, my colleagues and I strongly disagree that Auto CPAP should replace in-lab titration. The attendance of a technologist to identify the respiratory disturbances and make appropriate adjustments is crucial for long-term compliance in the patient.

Thank you for your time and consideration to this very important issue.

Sincerely,

Lynn Nichols, M.D., D, ABSM

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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 in March after a public comment period, Medicare beneficiaries could obtain home tests for sleep apnea from any physician, not only sleep specialist. This controversial proposal could prove far-reaching for Medicare beneficiaries.

Terence Davidson, an Ear, nose and Throat surgeon from the University of California-San Diego, the person who drafted the proposal to CMS, said “It’s been awkward and inconvenient and expensive to get a sleep test, and now that should be improved.”

Dr. Robert Schoumacher,MD Medical Director and I invite you to read the latest blog, “Who Should Care for our Greatest Generation’s Sleep Disorders?” at www.sleepwellandlive.wordpress.com. It has comments from a talk Dr. Davidson gave to his colleagues on the subject of sleep testing. It will explain the real motives for this decision and the implications it will have on the health and safety of our Medicare beneficiaries.

If you have any comments or questions, please do not hesitate to contact me. Thank you.

Sincerely,John Seaton

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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 directors of respiratory care departments, pulmonary rehabilitation services, sleep labs and critical care units in approximately 2,000 hospitals nationwide. Additionally, in recent years many members have established their own sleep medicine practices.

General comments: NAMDRC generally supports the proposed changes outlined in the December 14th posting by CMS on their website. We applaud the Agency’s efforts to open the door for home testing and strongly support the pathways that encourage further clinical research studies. This will help better define appropriate and optimal use of available and future technologies with sound clinical evaluation protocols that identify those patients that can be expected to benefit from CPAP therapy. This policy addresses several important issues that have long been a concern to NAMDRC:
1. We believe that a coverage policy that permits, under some circumstances, home sleep testing, cannot help but improve access to CPAP therapy for Medicare beneficiaries with obstructive sleep apnea (OSA).
2. We believe that the current “two hour rule” has the practical effect of maintaining a barrier for beneficiaries with severe OSA, and the proposed change is an improvement.
3. The establishment of a 12 week “trial period” of CPAP therapy is sound. As discussed below, however, CMS needs to make sure that the Agency and its contractors establish reasonable objective measurements to gauge compliance and clinical improvement by the beneficiary.

Specific comments and recommendations: As noted above, we support the overall approach that CMS has outlined in its proposed changes to the CPAP NCD. We do believe, however, that additional clarification and amplification of certain issues addressed in the NCD are warranted:
1. We strongly support the need to ensure the integrity of the Medicare program by coverage and payment rules that apply not only proven therapies but also recognize the need for compliance with that therapy. The establishment of a 12 week trial period is sound. Our concern is focused on the criteria that contractors might use to determine clinical benefit based on a certain degree of compliance. We urge CMS to require that Medicare coverage of CPAP devices include only devices that provide physicians with reportable data that can guide physician judgment. That data should include as a minimum-
a. Identification of the device settings
b. Specific calendar days used
c. Specific device run time for each specific day

Secondly, CMS states that “Medicare contractors may include consideration of the reports obtained via a compliance monitor as a factor in making this determination (of benefit).” Also, CMS should recognize that different patients respond differently to the same therapy, and for some patients 12 weeks might not be enough time for therapy to take effect. Some level of flexibility, based on physician review, should be permitted. This may include but should not be restricted to any of the following:
1. Patient willingness to return for 12 week review and thereafter for demonstration of objective compliance monitor check- note no specific adherence endpoint has ever been shown to clearly identify those patients that benefit from CPAP.
2. Patient reported improvement in symptoms related to CPAP treatment.
3. Improvement in physical signs, symptoms, or other clinical data that in the opinion of the treating physician supports the use of ongoing CPAP treatment. Thirdly, CMS should clarify a slight difference in its qualifying criteria for CPAP via PSG versus HST in the context of nationally covered indications. For PSG, the proposed policy states – “CPAP beyond the trial period for beneficiaries who qualified on the basis of a positive PSG is covered only in those beneficiaries who have demonstrated appropriate therapeutic use and response to the trial use of CPAP. Medicare contractors may include consideration of the reports obtained via a compliance monitor as a factor in making this determination.”For HST, the proposed policy states –“CPAP beyond the trial period for beneficiaries who qualified solely (emphasis added) on the basis of a positive home sleep test is reasonable and necessary only in those beneficiaries who have demonstrated appropriate therapeutic use and response to the trial use of CPAP. Medicare contractors may include consideration of the reports obtained via a compliance monitor as a factor in making this determination.” We are not sure if the use of the word “solely” with HST and not in the case of PSG is intentional and clarification is warranted.Fourthly, CMS’s decision to modify the “two hour rule” is based on a firm recognition that the beneficiary with severe OSA might not actually have two hours of recorded sleep because of his/her clinical condition. The proposed change closely reflects the policy adopted by Medicare contractors several years ago but was retracted upon insistence by CMS central office because it was contrary to the existing NCD.Fifthly, we are a bit confused by what appears to be a modest contradiction as CMS permits use of Type IV devices but does not permit use of overnight oximetry as a clinical determination of OSA. While we think we understand some of the rationale for this distinction, we would urge CMS to recognize only Types II and III as acceptable devices for home sleep testing. This seems especially appropriate given the low score given by the MedCAC committee members for “Type IV monitors or clinical evaluation alone.” Additionally, we invite CMS to review the very recently published guidelines from the American Academy of Sleep Medicine (Clinical guidelines for the use of unattended portable monitors in the diagnosis of obstructive sleep apnea in adult patients. J Clin Sleep Med 2007;3(7):737-747.) They stated, “At a minimum, PM must record airflow, respiratory effort, and blood oxygenation. The airflow, effort, and oximetric biosensors conventionally used for in-laboratory PSG should be used in PM.” This also allows for better consistency in scoring of the respiratory events for in-home and lab-based sleep studies.

Additional comments and recommendations:

There are three important issues where the current and proposed NCD are relatively silent but have significant impact on the delivery of CPAP therapy in a clinically appropriate and cost effective manner.

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 education, follow-up treatment, using most appropriate technologies, and orchestrating a comprehensive care plan for patients with Obstructive Sleep apnea. The problem exists in the discrepancy of centers being accredited or not. Unaccredited centers are not holding themselves to a higher standard which equates to better outcomes. I would recommend using home testing as another tool for certified sleep physicians to use in conjunction with established testing practices in a certified lab. Thank you kindly for allowing my remarks.
Bill Sides RPSGT, RRT
Northern Michigan Regional Hospital Sleep Center.

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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 combination of diagnostic procedures adequately identifies all of those beneficiaries who will benefit from CPAP, the coverage of CPAP is initially limited to a twelve week period to identify beneficiaries diagnosed with OSA as subsequently described who benefit from CPAP. CPAP is subsequently covered for those beneficiaries diagnosed with OSA who benefit from CPAP during this twelve week period.

The AAST opposes this change based on the following:

1. Diagnosis of illness and treatment of that illness are separate entities. Perhaps diagnosis and subsequent treatment should be presented in separate documents. This is further complicated by the fact that a single treatment modality may be ineffective or poorly tolerated and that a combination of multiple therapeutic interventions may be required. The time necessary to determine optimal, sustainable treatment may be substantially longer than the proposed time limit.
2. There is no definition provided in the document as to what constitutes “benefit from CPAP”.
3. There is no declaration as to how or who is responsible for determining or reporting the undefined benefit to the patient.
4. We contend that CPAP adherence will be substantially improved when follow-up and continued care is provided by qualified sleep technicians.

Proposed Decision 2: We are proposing that the use of CPAP will be covered when diagnosed using a clinical evaluation and PSG performed in a sleep laboratory. In addition, we are proposing to expand coverage of CPAP to include those beneficiaries with a diagnosis of CPAP made using a combination of clinical evaluation and unattended home sleep monitoring using a Type II, III or IV device.

1. The AAST opposes the use of Type IV devices. Single or dual channel devices do not provide sufficient data for diagnosis of OSA and would increase the likelihood of “false positive” as well as “false negative” results.
2. Sensor application or the instruction for sensor application and education on the use of the portable monitoring devices should be performed by a qualified sleep technician. We believe this will provide a higher quality recording and reduce the potential for repeat studies due to technical error.
3. The AAST recommends that the AASM clinical guideline for portable monitoring be adopted for the review, scoring and analysis of the raw data acquired during portable monitoring. Collop NA, Anderson WM, Boehlecke B et al. Clinical guidelines for the use of unattended portable monitors in the diagnosis of obstructive sleep apnea in adult patients. J Clin Sleep Med 2007;3(7):737-747.
4. The initiation of positive airway pressure (PAP) therapy should be performed in the sleep disorders center / laboratory by a qualified sleep technician to determine the appropriate PAP level and modality.
5. The term RDI is currently defined as Respiratory Disturbance Index. Changing the definition to Respiratory Distress Index, as proposed, will create confusion. Furthermore, the proposed definition of RDI is based on total sleep period time, a term that cannot be calculated with type III and type IV devices.

Proposed Decision 3: We are proposing to modify the criteria for a positive sleep study to remove the requirement for a minimum of two hours of continuous recorded sleep and instead recognize shorter periods of continuous recorded sleep if the total number of recorded events during that shorter period is at least the number of events that would have been required in a two hour period.

The AAST supports this change.

Proposed Decision 4: We are proposing to delete the current distinct requirements that an individual have moderate to severe OSA and that surgery is a likely alternative because these terms are not sufficiently precise.

The AAST would support this change if initial failure to adhere to CPAP therapy would not preclude future implementation of CPAP if alternative therapies alone were insufficient.

Proposed Decision 5: Due to a lack of sufficient evidence that clinical diagnosis alone or clinical diagnosis in combination with devices other than Type I, II, III, or IV adequately identify beneficiaries with OSA that will benefit from CPAP, we are proposing to expand Medicare coverage for CPAP in these instances only when provided in the context of a clinical study that meets standards set by CMS.

The AAST supports this recommendation for Coverage with Evidence Development and requests that qualified sleep technicians perform the technical application of electrodes and/or sensors and data analysis of recording.

The AAST thanks CMS for the opportunity to provide comment on the pending decision and offers its expertise in the technical aspects of sleep medicine to CMS in development of the final coverage determination document.

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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 to:

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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 ensure they understand their diagnosis, treatment options, have available resources, and sufficient follow up.

Is there a plan to prevent any and all Physicians to order a home sleep test?

Is there a plan to prevent home sleep monitors to be mailed to or set up by unlicensed personnel?

Healthcare costs will increase and co-morid conditions will worsen for sleep patients who do not receive the following: sleep education, proper follow up, and accessibility to professional sleep resources.

To ensure the continued integrity of the evidence based practice profession of sleep medicine, it is imperative for patient safety to mandate that all sleep patients be evaluated, tested as indicated, receive follow up, and have professional sleep resources available.

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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. Clinical practice according to the current draft will cause a lot of undiagnosed and misdiagnosed cases. It will be unfortunate for our patients.

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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 neuroscience professionals. The Academy has become aware of the CMS proposal to expand coverage for continuous positive airway pressure (CPAP) for obstructive sleep apnea (OSA) and wishes to provide several comments for consideration as CMS finalizes its recommendations. In the decision memo, CMS essentially proposes to implement an entirely new and untested diagnostic and treatment algorithm for sleep apnea on a national scale. The outline of this algorithm as presented in the interim rule is as follows:

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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. Imagine if 1/2 of all family physicians purchased a 3-4 portable systems? And the DME''s, let not even go there. The numbers are mind boggling. IDTF''s accepting referrals for sleep testing where clearly specified criteria are met is the only sane approach to allowing this program to be re-introduced.

2. Procedure codes and specification of services: Will CMS expect this home sleep study monitor to be delivered to the patient’s home and the patient ''hooked up'' by a qualified (?) person? Will repeat testing for botched home studies (patient self-hookups) be paid for?

My Opinion - CMS should be very specific in detailing the services expected for each procedure code. What type of personal are qualified to ''hookup'' and is it reasonable to expect an 80 year old person to self hook-up a 4 channel test at their bedside at home.

3. Reimbursement for home testing:

As an IDTF we currently bill for TC component of each sleep study we do. Medicare pays 80%. In our locality a NPSG pays $602 and PAP Titr pays $663. After 5 years in the Sleep laboratory business the only people I have seen with huge margins are Physicians (billing global and self referring) and DME''s (from CPAP sales). Any reduction in volume and or reimbursement of In-laboratory testing will adversely affect our ability to maintain our (IDTF) locations and qualified staffing (RPSGTs). CMS should consider a fair reimbursement of approximately $400-450 per home study performed. Anything below this will guarantee either unqualified personal will be hooking-up or in servicing patients or availability of IDTFs willing to do home testing will dwindle, hence we will be back at square one.

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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 the amount you claim it will cost for hometesting. We are reimbursed $36 for a medicaid patient. We have a wait list from 0-14 days. The big issue is educating the public as well as the medical community about sleep disorders. The push for home testing is going to motivate unqualified physicans to evaluate patients for sleep to help offset the physican fees cuts. When the pateint has a disorder other thatn OSA are they then going to refer their patient to a sleep specialist that is qualified to evaluate and treat? You are not improveg the quality of care to the patient. This is a money game. You really do not have the best intrest of the patient in mind. Just remember we will all be of Medicare age one day and the judgements you make know are going to effect you too. Ask your self if this is the quality of care you want for yourself or loved one. The very least you can do is mandate hometesting be done by qualified individuals and interpreted by sleep specialist. This will open the door for shotty sleep exams completed by the person that was flipping hamburgers yesterday. This is healthcare at it finest?

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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 ding me for prescribing CPAP without a good faith exam. On my yearly recheck on stable patients, I often ask them how many other people they have told to get tested. They usually answer multiple. We as a profession need to do better.

Depression can be misdiagnosed OSA. It is not coincidental that women are disporportionatly underdiagnosed with both OSA and heart disease. Untreated OSA correlates positively with, and I think, in some cases is an underlying cause of osteopenia/osteoporosis -in men as well as women. It correlates strongly with and can cause reflux and sinusitis. It should be high up in the differential of ANY patient with hypertension, heart disease,and/or stroke. By the time patients get referred to a sleep lab they can have irreversible changes in their cardiovascular and ventilitory regulatory symptoms.We should diagnose before this occurs.

The abiltiy to test and treat as per this proposal will facilitate early diagnosis. I believe it will literally save some people, improve quality of life for others, and save money.

I find CMS''s appropriate response to this extremely well written request by my Academy reaffirming. Good job and thanks,Nan Appelblatt MD,FACS

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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 me to express my opinion.
Terri Dobey MEd, RRT
Columbia, MO

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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 Legs, poor sleep hygiene,etc) are appropriately excluded from The home testing because data has not shown unmonitered home Polysomnograhy to be safe, accurate, and cost effective in these groups. There is concern that economic interests / oppportunism may likely result in inappropriate patient selection, and inadequate treatment and follow up by parties neither dedicated to nor credentialed for optimal patient care in sleep medicine.

Please consider the following in implementing the current guidelines:

1) Patients should undergo evaluation by a credentialed sleep specialist, and such evaluation should be documented in the medical record. Inclusion / exclusion criteria should be observed as outlined by the AASM guideline statement (i.e. patient selection should be appropriate)

2) Diagnostic home testing should be supervised by a dedicated (and preferable accredited) sleep center

3) All sleep studies should be interpreted by a boarded Sleep Physician, preferably in conjunction with the clinical record, in order to provide the most accurate diagnosis and treatment planning.

The resources of a dedicated sleep center with coordinated staff for education, counseling, support, and trouble shooting of all sleep medicine related health issues, is the most efficient manner for optimizing care and imroving succes and outcome.

I know that CMS intentions are towards providing optimal patient care in a cost effective manner, and I would ask that CMS consider these issues in implementing the recent guidelines.

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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 likely to order uneccesary testing. Careful history and physical examination can frequently distinguish between snoring and obstructive sleep apnea. Sleep labs are widely available and certified sleep specialists are reliable in interpeting test results.

I do not own or benefit fincancially in any way from sleep testing.

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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 the test. This is going backwards in sleep medicine to testing known to result in less than 40% compliance with CPAP therapy.

Inadequate sleep evaluation and testing will cause false results, compromise patient care and deprive patients of appropriate treatment. It is fact that untreated or inappropriately treated OSA is associated with hypertension, diabetes, stroke, myocardial infarction, industrial accidents, vehicular accidents, and depression. To those who drew up the propasal: what type of diagnostic sleep test would you want?
Sincerely,
Dale R Culver RPSGT

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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 locales such as Denver, Albuquerque, etc. Level IV devices cannot detect central apnea, Cheyne-Stokes respiration, or "Complex apnea" Also, it has been demonstrated that increasing CPAP pressures can induce and prolong these adverse events, so use of Auto-PAP would be a significant liability in this group.

I agree with many other colleagues that have posted on this issue, that the technology has improved to "diagnose" sleep apnea. The issue is that the most cost effective methods are to do the evaluation and provide treatment and follow up in a comprehensive manner. Using non-trained, non-credentialed individuals to perform the testing, generate reports, and manage care is a step backwards, and will open the door to profiteering and abuse.

In fact, the proposal to allow non-credentialed personnel to perform these tasks is contrary to LCD''s that have gone into effect as of 1/1/08, requiring RPSGT to perform PSG testing, and that within several years, Board Certification for physcians to interpret lab based PSG''s is required. It is a grave concern that testing patients in one setting would require standards and certification whereas in the home, "un-monitored" environment, there are no standards for who may perform, analyze, and manage the care. In the sleep lab, we have emergency equipment, credentialed staff, and many more physiological recording channels available, so in effect, any adverse events or poor response to PAP therapy could be addressed by changing modalities, adding supplimental oxygen, fitting a full-face vs nasal mask, etc.

If CMS wishes to be cost effective, yet open the door to judicious use of portable monitoring, then use of a mandated split night protocol, using the original 2 hr recording instead of current 2 hr sleep rule, would allow over 80% of patients to be done in 1 night. Having a trained, compassionate, and immediately available technologist to intervene, educate, and adjust PAP has been shown to increase compliance. This would decrease cost per patient by 50%, and also open up more testing slots that have been taken up because of "bring backs" due to insufficient sleep in the first portion of the test, yet clearly having sleep fragmenting respiratory events.

Portable testing could be used in the patient with minimal probability, as well as to follow up post op.

Creating a "triage" system similar to Pacificare where symptoms & co=morbidities are "ranked" to give a index of suspicion would segregate those patients of minimal probability into one path, while those with co-morbid conditions and high suspicion would get a split night in the lab.

Another issue is ioncentives for DME to obtain positive results in order to gain PAP referrals/sales.

Currently, CMS doesn''t allow a DME provider to run home oximetry to qualify for oxygen equipment. This rule should be retained for sleep equipment as well.

In closing, I support:

1. Revising the 2 hr sleep rule to the 2 hr of recording rule to qualify for CPAP in a monitored setting or using a device that records sleep vs wake.

2. Use of Level II or II (4 or more channels) of portable testing in a limited basis under supervision of qualified SLEEP TRAINED physician, and using credentialed SLEEP technologists to perform the initial pt education, hookup, download, and data summary.

3. That restrictions on who may provide portable testing be implimented in a similar fashion to home O2 screening to eliminate potential conflicts of interest with testing and equipment providers in the same or related organizations.

4. That Portables be integrated into practice models, and that lab based PSG in a monitored environment be preserved as an option when indicated due to equivocal portable results, presence of co-morbidities, poor response to therapy, or patient preference.

Thank you,

Bret Svoboda,BS,RPSGT (BRPT #106)

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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 related medical conditions. After a period of potential public comment ending Jan 14th, this ruling could become official Medicare policy on March 1, 2008.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 medicine. This historic approach is known to result in less than 40% compliance with CPAP therapy and ultimately a large group of patients getting sent to surgery for OSA, Surgical treatment of OSA has a reported therapeutic initial success rate of only 33-50%, with decrease in therapeutic benefit over time.Medicare''s new plan may lower up-front costs, but even this is not guarenteed. This plan will essentially decreasethe number of Medicare patients appropriately diagnosed (at sleep centers) with sleep apnea and decrease the number of patients able to learn to tolerate and manage CPAP therapy. This only creates, at best, a short term decrease in health care utilization because, in the long run, this approach will increase Medicare costs by: 1. Increasing costs related to unnecessary surgery. 2. Increasing cost for treatment of medical conditions exacerbated by ineffective treatment of OSA. 3. Unnecessary testing with technologies whose use is not yet defined by medical practice. It is now well known that untreated or inappropriately treated OSA is strongly associated with increased risk for heart attack, stroke and other cardiovascular conditions, as well as diabetes, decreased alertness and associated high rates of vehicular accidents, industrial accidents, depression, decreased productivity, and job loss. Inadequate sleep evaluation and testing will cause many false negative results. This will directly compromise patient care, depriving patients of appropriate treatment. At a time when the importance of sleep to health is coming into sharp focus, with additional research data amassing on this issue each month, patient access to appropriate diagnosis and treatment of the most physiologically disruptive and dangerous of the sleep related diagnoses would be curtailed. Sleep medicine, a success story and marker of American medical care, would enter a modern dark age with the passage of this policy proposal. The new Medicare proposal for home diagnostic testing and empirical CPAP titration propose uncacceptable compromises to established medical standards of appropriate diagnosis and treatment as defined in the medical literature and as defined by the practice standards of the American Academy of Sleep Medicine (AASM). This proposal will predictably result in more negative patient outcomes; higher morbidity rates, higher rates of serious secondary disease, and decreased quality of life for patients with OSA. Morever, negative patient outcomes will result in a higher long-term expense to all payers of health care, including taxpayers. For these reasons, we strongly urge that this policy proposal be rejected.

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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 as acceptable.

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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 approach predates modern sleep medicine and is known to result in less than 40% compliance with CPAP therapy.

Inadequate sleep evaluation and testing will cause many false negative results, compromise patient care and deprive patients of appropriate treatment. It is well known that untreated or inappropriately treated OSA is strongly associated with hypertension, diabetes, stroke, myocardial infarction, industrial accidents, vehicular accidents, and depression.

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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 you go the the CMS website and post a comment in support of TypeIV devices and no Pulmonolgist or Sleep Specialist involvement in the qualifationsof a patient.

Why would anyone want to decrease the quality of care that we have worked so hard to a achieve!!!

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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 sleep evaluation and testing will cause many false negative results, compromise patient care and deprive patients of appropriate treatment. It is well known that untreated or inappropriately treated OSA is strongly associated with hypertension, diabetes, stroke, myocardial infarction, industrial accidents, vehicular accidents, and depression.

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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 services to patients, includingMedicare beneficiaries. We are supportive ofmeasures that improve access to care for patients,and indeed have made patient access a key to oursuccess. Based on our experience and publishedresearch, we believe that PSG is a more reliablepredictor of OSA than any unattended study can be.This will also results in greater CPAP complianceand superior CPAP titrations (when CPAP isnecessary), but we understand that there can be arole for unattended home studies in some cases. So long as CMS is not in any way restrictingaccess to PSG, then we do not oppose the newexpanded coverage requirements for CPAP.

Nevertheless, we find the proposed decision memoconfusing in one particular respect, and note thatthis confusion appears in much of the othercommentary submitted to you in this process. Theconfusion is that the current process is aboutcoverage for CPAP, but much of the discussion isaround diagnostic tests that can be used toestablish eligibility for CPAP coverage. Theproblem is that the proposed memo does notexplicitly make a determination about the coverageof the diagnostic tests. We believe that aseparate process is necessary – either through anNCD or the physician fee schedule rule – toaddress issues surrounding coverage of the TypeII, III and IV monitoring. Without such arulemaking, we believe that there will besignificant confusion about what tests arebillable, who can furnish the tests, and theappropriate reimbursement for the test.

Considering the available CPT codes, the onlyrelevant one for HST would be 95806 (sleep study,simultaneous recording of ventilation, respiratoryeffort, ECG or heart rate, and oxygen saturation,unattended by a technologist); all other sleepstudy codes include attendance by a technologist,and therefore would not be appropriate for a studydone at home. There is no distinction within thiscode regarding HST type (II, III or IV), toaccount for the differing equipment cost of eachtest. Many contractors have determined that unattendedsleep tests are not covered by Medicare. Forexample, our Medicare carrier’s policy states,“All covered sleep studies require the presence ofa technician trained to provide a valid study andto recognize complications and take appropriateactions. Therefore, CPT code 95806, sleep studythat is unattended by a technologist, is anon-covered service.” Sleep Disorder Clinics andDiagnostic Tests, PULM-003, eff. 12/1/06, atwww.wpsmedicare.com/part_b/policy/pulm003.pdf -2006-11-28. In fact, our intermediary NationalGovernment Services, Inc. recently proposed an LCDthat also includes this policy. Draft LCD forPolysomnography and Sleep Studies (DL26428),http://www.ugsmedicare.com/providers/LCD/dl26428_draft_lcd.htm(sleep studies performed in the home are notcovered). It should be noted that these coveragedeterminations are not part of the CPAP coveragepolicies, but rather part of the polysomnographyand sleep clinic policies. It is not clear thatthe contractors will begin to cover HST uponfinalization of the CPAP NCD. And it is not clear that they should, at leastwithout further clarification from CMS. CurrentCPT coding does not account for the differenttypes of home testing. As you note in theproposed decision memo, there is a wide range ofsophistication and expense of equipment acrossthose three types of HST services. Although manycontractors do not cover 95806 under currentpolicy, it is priced under the Medicare physicianfee schedule. In Wisconsin, the fee scheduleprice is $191.95 for the global service and$116.67 for the TC only. Considering theequipment involved, this amount is too low forType II testing, and too high for Type IV testing. We submit that without more specific codes andpayment amounts, entities that furnish these testswill be incented to use the least sophisticatedtesting, which as you admit has the lowestconfidence level, and which may result in falsenegatives, false positives, and a lack of detailedinformation to determine proper CPAP pressures. Another significant problem is that it is unclearwhich entities can furnish HST services. It isimportant to clarify that IDTFs may furnish HST,to ensure that the most experienced staff remainavailable to beneficiaries for the full range ofsleep study services. As you note, CMS considersdiagnostic testing to be the appropriate coveragecategory for PSG and for multichannel home sleeptesting (HST). Diagnostic tests may only befurnished by certain entities, including IDTFs. As an IDTF sleep clinic, we are professionals insleep testing, and use technologists to performall testing, as supervised by a physician. Indeed, IDTF rules arguably require all of ourtests to be performed by a licensed technologist. See 42 CFR § 410.33(c) (any non-physicianpersonnel used by the IDTF to perform tests mustdemonstrate the basic qualifications to performthe tests in question and have training andproficiency as evidenced by licensure orcertification by the appropriate State health oreducation department). Given this rule, it is notclear to us that we will be able to furnish HSTwithin our participation requirements. There issome indication that CMS would consider home-basedtesting to be appropriately furnished by an IDTF. See 2007 Physician Fee Schedule Final Rule, 71 FR69624, 69700 (12/1/06) (discussing site of servicefor IDTF tests, and mentioning that abeneficiary’s home could be a site). However, itis not clear to us whether CMS would consider HSTto be appropriately furnished by an IDTF (assumingit is covered at all). If HST may not befurnished by IDTFs, then the testing will not beavailable from the one group of sleep testproviders that is solely focused on and mostexperienced in this area. CMS should clarify thatIDTFs may appropriately furnish HST. Thank you for the opportunity to submit thesecomments.

Regards,

The Sleep Wellness Institute, Inc.

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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 reviewed the results of a home base sleep study done by a unqualified individual and the diagnostic recording was horrible. I could not read anything due to popping, artifact, muscle artifact, etc... Now, let''s talk about treatment of sleep apnea. We can not allow unqualified indiviual to practice CPAP (continuous Positive Airway Pressure Therapy). It take a well qualified individual to fit a patient with the proper mask, explain the procedure and patiently treat patients with sleep apnea. Patients are claustrophobic, weiry about CPAP, and needless to say not cooperative some of the time, so we need professional people to perform diagnostic sleep recording and therapeutic CPAP Titrations. Please do not open the door for money hungry people to enter the sleep medicine profession. Also, this will lower everyone''s standard as a AASM Accredited Sleep Disorder Center. An AASM accrdited sleep disorder center does not only perform quality diagnostic sleep study and Therapeutic CPAP Titration, we look at all aspects of sleep disorders while diagnostic recordings are being performed. Also, an AASM accredited sleep disorder center follows up with all patients, demand perfect customer service from DME providers, annual education to the public and most of all the patients have someone to contact if they are having problems with CPAP. I do not object to home sleep studies, but if this is approved the AASM Accredited Sleep Center should be responsible for providing this service. This will assure that the patients'' well being or welfare is in the right hands.

Thank you for your time and consideratoin!

Sincerely,

Fredrick Bowman

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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 many of them I have talked with to get the help they need. The ability to home monitor would allow us to help those patients in a rural area who are in desperate need of sleep testing and CPAP therapy.

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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 Centers for Medicare and Medicaid Services (CMS) that argued that the current policy is inhibiting the diagnosis of obstructive sleep apnea (OSA) because the nation’s 692 sleep labs are simply too full.

Dr. Davidson claims that 95-99% of people with OSA can be diagnosed in the home and has prompted CMS to reassess its decision to require beneficiaries receiving continuous positive airway pressure (CPAP) to be diagnosed in a lab using polysomnography.

During Dr. Davidson’s presentation in New York, he had some interesting opinions and comments and also seemed to have some conflicts of interest and an astounding degree of arrogance towards the Sleep Medicine and Pulmonary Medicine professions.

Although he has claimed to have no conflicts of interest, Dr. Davidson is on the Medical Advisory Board of Directors of ResMed, Inc. as a paid consultant. ResMed and their auto titration CPAP units stand to benefit substantially from gaining Medicare’s approval of in-home, unattended testing.

He has staggering disrespect for Pulmonologists, some of whom are also on ResMed’s Board, saying that “Sleep apnea is a disease of the upper respiratory tract, which doesn’t have much to do with the lungs.” He added that Pulmonologists view the upper respiratory tract as nothing more than a “nuisance” that stands between them and “something they can recognize.” Adding, “We’ve all seen them pass by large neoplasms just to do their bronchoscopy,” Dr. Davidson went on to say that “Sleep apnea is ours for the taking.”

This is a very interesting statement considering a research study published in the January 5, 2008 edition of the British Medical Journal. Several recent meta-analyses and literature reviews found inconsistent benefits and high rates of adverse effects from upper airway surgery, which is growing in popularity as first-line therapy by ENTs in the treatment of obstructive sleep apnea. (1) According to Akram Khan, MD, of the University of Florida in Jacksonville, “An ideal patient for upper airway surgery is someone who is young, e.g. less than 40, is not very heavy (body mass index less than 32), and has an apnea-hypopnea index less than 40.” He continued “If these patients are chosen for surgery their response rate is likely going to be much higher.” (2) This is a MUCH different population, however, than the Medicare population currently under consideration.

And while Dr. Davidson demonstrates arrogrance toward patients and sleep technicians, he has a very healthy respect for the dollars that find their way into his pockets. In noting that his lab uses SNAP machines only if their 4 Emblettas (Res Med product) are already being used, Dr. Davidson says the SNAP technology is perfectly fine, but that he has a problem with the money going to “the guys in Chicago” rather than to Dr. Davidson, himself.

A 2004 study published in Chest on the SNAP device demonstrated that the SNAP study accurately assessed the true severity in only 11 of 31 cases when compared to in-lab polysomnography. The SNAP study also overestimated the severity of sleep apnea in 13 of the 31 patients. In 8 of those 13 patients, the SNAP study diagnosed sleep apnea when the patient had a normal polysomnographic finding. (3) Furthermore, SNAP’s technology is “proprietary.” Once a SNAP study is completed, the results are sent to their facility (Chicago) which uses proprietary technology to analyze the results of the study. The ordering physician cannot review the raw data of the SNAP study to determine if the analysis from the SNAP technology was accurate.

Dr. Davidson also describes the amount of time he devotes to reading a portable test. During his presentation, he describes the results of a portable test: “This individual, the apnea hypopnea index is now 14 and the O2 saturation events are 14. So this is a valid test. I mean, this is frankly all that you need to look at. This is a 20 second, no 10 second read. This is the report it put out. The guy’s got a AHI (apnea hypopnea index) of 14 and I think that that is sufficiently diagnostic.”

I agree that Dr. Davidson’s methods will increase utilization among our seniors when it comes to getting tested, but at what cost? It is estimated that over 50 percent of adults aged 65 and older report some sleep disruption, while about 20 percent suffer from chronic insomnia. OSA, a major cause of daytime drowsiness, occurs in an estimated 20-60 percent of older people, depending on the definition used and the specific population being studied.

People are living longer with more co-morbid and psychiatric conditions. The higher burden of illness and the number of medications used to treat these conditions plays an important role in the quality and quantity of sleep in older adults. In approaching sleep complaints in our Medicare patients, it is essential that practitioners recognize the multidimensional mechanisms by which illness impacts sleep. Equally important, a balanced management approach that includes optimizing the underlying illness, adjusting medications using cognitive-behavioral approaches, and using judicious hypnotic therapy seems justified based on the current evidence. (4)

As to Dr. Davidson’s assertion that the current policy for our Medicare population is inhibiting the diagnosis of OSA because the nation’s sleep labs are simply too full, recent data from the American Academy of Sleep Medicine states that the availability of sleep laboratories across the United States based on a 2001 study of 2001 data estimates that 427 PSG were performed per year per 100,000 population. (5) Since 2001, the number of sleep laboratories accredited by the AASM has more than doubled to 1,169, with 129 applications having been received in just the first three months of 2007, alone.

In a 2004 AASM survey, there was an average wait of about three weeks for a sleep study or sleep consultation. An independent survey in 2004 by Shariq estimated there were more than 2,500 accredited and non-accredited sleep laboratories in the US with an average wait time for a PSG between two and three weeks. (6) A 2005 survey of US sleep centers by Wachovia Securities found that in the prior year there was a 27% increase in sleep laboratory bed capacity and a decrease in wait times to 3.9 weeks. A survey of accredited sleep laboratories completed by the AASM in April, 2007 indicated that the wait time for a PSG has been reduced to a median of 12 days, and that the wait time for a sleep consultation has falled to a median of 14 days. (7)

Incredibly, Dr. Davidson has gone on record with all of these statements and other stunning comments about the field of Sleep Medicine. You can listen to a CD Rom of his presentation at the 2004 Annual Meeting of the American Academy of Otolaryngology - Head and Neck Surgery Foundation in New York. Due to copyright laws, you will need to purchase it by clicking on the following link: http://www.siattend.com/Conference.aspx?cid=172&aid=12 and select “MiniSeminar” from the Individual Sessions section. The title of the presentation is “Thinking of Opening Your Own Sleep Lab?” (tracks 6-10). The cost is $16 plus shipping.

In closing, our current Medicare population is the men and women who left to fight a World War and then came home to build our great nation and make it what it is today. They are the volunteers who donate their time and energies to organizations throughout our communities. They are role models and mentors for our kids. They contribute to our economy and enrich our lives. They truly are the greatest generation. The health and safety of our senior citizens is at stake. We should not compromise their care for the sake of expediency. They deserve nothing but the best care given by the most qualified people.

Source references:

1. British Medical Journal: Elshaug A., et al “Upper Airway Surgery Should Not be First Line Treatment for Obstructive Sleep Apnea in Adults,” BMJ 2008; 336:44-45.
2. Surgery Disparaged as First-line Treatment for Sleep Apnea http://www.medpagetoday.com/PrimaryCare/SleepDisorders/tb/7845.
3. Evaluation of the Accuracy of SNAP Technology Sleep Sonography in Detecting Obstructive Sleep Apnea in Adults Compared to Standard Polysomnography* Timothy N. Lesching, MD; Carol Carlisle, RN; Ana Marte, BA; Alice Bonitati, MD, FCCP, and Richard P. Millman, MD, FCCP.
4. Comorbidities: Psychiatric, Medical, Medications, and Substances. Sleep Medicine Clinics, Volume 1, Issue 2, Pages 231-245, S. BARCZI.
5. J Clin Sleep Med 2005; 1:23-26.
6. Sleep 2005; 28: 145-6.
7. Letter to CMS regarding its national coverage decision on CPAP therapy for OSA. American Academy of Sleep Medicine, 04/11/2007.

Mark Stoiber, President
The Sleep Wellness Institute

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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 ALL COMPLY, BUT NEITHER DO ALL DIABETICS FOLLOW AN ADA DIET OR TAKE THEIR PRESCRIBED MEDS.IT IS THE ROLE OF THE DME/MD TO ENCOURAGE COMPLIANCE. THE DATA REVEALS A WIDE EXPANSE OF INFORMATION. THE PT''S WITH POSSIBLE COMPLEX SLEEP APNEA/CENTRAL SLEEP APNEA WOULD BE EASY TO DISTINGUISH AND REFERRED TO A LAB FOR FURTHER TESTING. TO THE PROPERLY TRAINED OR EXPERIENCED RT SLEEP DISORDERED BREATHING CAN BE EASILY SCREENED EVEN WITH AN OVERNOC P-OX.IN MY EXPERIENCNE U.A.R.S. CAN EASILY BE RECOGNIZED. SAW TOOTHED PATTERNED SATS WITHOUT SIGNIFICANT DESATURATIONS ARE A PRIMARY EXAMPLE. CLASS IV DEVICES THAT INCLUDE NASAL FLOW WITH OXIMETRY WILL BE ADEQUATE FOR THE MAJORITY OF PATIENTS. A POSITIVE RESPONSE TO A FEW SIMPLE QUESTIONS BY THE PT''S MD IS ALL THAT IS NECESSARY TO PROCEED WITH A CLASS IV OVERNOC SCREENING DEVICE. THE CURRENT LABS SHOULD NOT BE AFFECTED IN THE LONG TERM AS THEY WILL HAVE A SIGNIFICANT INCREASE IN REFERRALS TO DIAGNOSE AND TITRATE FOR COMPLEX/CENTRAL SLEEP APNEA WHICH WILL BE EASILY REVEALED WITH THE DATA FROM A DOWNLOAD. WIRELESS MONITORING IS ANOTHER OPTION. THIS PROVIDES REAL TIME COMPLIANCE AND EFFICAY DATA AND CAN BE VIEWED BY ANY AUTHORIZED PERSON. I ECOURAGE YOU TO CONTACT ME TO DISCUSS THIS IF YOU WISH AS I COULD CONTINUE ON FOR AWHILE AND HAVE MUCH EXPERIENCE EVALUATING SCREENING DEVICES AND PAP DOWNLOADS. IN THE PAST 6 MONTHS ALONE I HAVE COMPLETED APPROXIMATELY 1,000. I WAS INCHARGE OF THE INITIAL BETA TESTING FOR THE RESMED WIRELESS RESTRAXX TECHNOLOGY FOR BAYCARE HOMECARE AND AM IN THE PROCESS OF EVALUATING RESPIRONICS ENCORE ANYWHERE MODEM TYPE PAP MONITORING SYSTEM. IN CLOSING I APPLAUD YOUR FORWARD THINKING RESPONSE TO THE SLEEP DISORDERED BREATHING EPIDEMIC THAT WE ALL FACE IN TODAYS WORLD.

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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 support CMS’ position that diagnostic testing to be the appropriate coverage category for PSG and multichannel HST. On a national basis, CMS currently requires that sleep diagnostic testing performed in a sleep diagnostic facility must be done so under strict criteria and quality standards. Furthermore, on a regional basis, some Medicare Regions require in certain states that sleep diagnostic testing in Independent Diagnostic Testing Facilities (IDTF’s) must be performed under the auspices of an AASM accredited sleep center. We feel that these strict quality standards are necessary and appropriate and these standards should continue. CMS should not deviate from these standards on any final decision by CMS for HST and coverage for CPAP and appropriate quality standards must be applied.

C) Performance of HST under a qualified, comprehensive sleep medicine program

HST for the diagnosis of OSA should be performed only under the auspices of a qualified comprehensive sleep medicine program. We feel this is necessary to insure appropriate and accurate quality of care and a continuity of high quality standards. Furthermore;

1) HST for the diagnosis of OSA should be performed only in conjunction with a comprehensive clinical sleep evaluation. Clinical sleep evaluations must be performed or supervised by a physician board certified in sleep medicine that is qualified, knowledgeable and experienced in diagnosing and treating sleep disorders.

2) HST should be performed by an individual who is qualified, trained and experienced in performing sleep diagnostic studies as evidenced by a license or certification as recognized by the respective state licensing board.

D) Acceptable Portable Monitoring Devices for use in HST

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 circumstances, a portable monitoring device that records airflow, respiratory effort and blood oxygenation at a minimum could be sufficient for diagnosing OSA. However, based on medical evidence, the use of a Type III device that monitors only these parameters could misdiagnose patients with chronic obstructive pulmonary disease, restrictive lung disease, complex sleep apnea and central sleep apnea as having OSA. Furthermore, the use of this type device for HST should be of significant concern to those physicians practicing at high altitude where few patients have straight forward and simple OSA. For these reasons, we do not fully support the use of a Type III device for HST.

We support certain aspects of CMS’ proposal to allow coverage of CPAP based upon a diagnosis by home sleep testing as long as testing is performed under the auspices of a qualified comprehensive program. In that regard we respectfully submit our responses as stated above.

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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 for your considerations,

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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 in the sleep lab, the medicare population is least likely to benefit from home testing. These patients tend to be more anxious about testing, sleep poorly in general, get up often at night, have more central than obstructive apneas and hypopneas, and tend to be "technophobs". Placing even a few sensors on these patients and sending them home is likely to increase their anxiety, further disrupt sleep, and likely aggravate falls. In the lab, there are techs to help the them and answer their questions, which reduces anxiety and reduces risk. Missed or incorrect diagnoses will result from home studies that do not evaluate EEG or type of respiration. Elderly patients have more central apnea which needs to be identifiable from any sleep study. Clinicians who say their experience with portable testing is good neglect to mention that Medicare patients are not the majority of their patients and they don''t know what diagnoses they are missing in limited channel studies. In CA where many labs do home monitoring, I''ve been told that about 1/3 of the patients need repeat testing due to data loss. In fact a review of cases in a lab in CA where half of all the patients had home studies, showed that 3 out of 4 patients with portable monitoring needed to have the tests repeated. In two cases, it was assumed that the continuing symptoms meant that the data wasn''t reliable. From my perspective, it appeared that it was just too easy for the physicians to say let''s repeat the test rather than spending time with the patient to look for and treat other causes. Research studies that use portable monitoring in elderly, have a motivated population and highly trained technicians that go out to the patients'' home to do hook-ups and even in this perfect situation there is still data loss. If CMS allows portable monitoring, without scientific evidence to support a decision, I would strongly hope that they will at least require level 2 studies and require that it be done through an accredited sleep program or board certified sleep specialist. Without an EEG, there is no way to compute an AHI and without monitoring legs, a diagnosis of periodic limb movements which is very common in elderly, would be missed, wasting both time and money. Limiting testing to accredited programs or sleep specialist, would provide the best outcomes and treatment for the patients, as numerous studies have shown that the use of specialists are the most cost effective option and provide the best patient outcomes. I think that there is a role for home monitoring, however we do not have the data to support an educated decision about its role at this time.

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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 current attempt to get Medicare to approve unattended home testing for sleep apnea. It was his Jan. 29, 2004 letter to the Centers for Medicare and Medicaid Services (CMS) that argued that the current policy is inhibiting the diagnosis of obstructive sleep apnea (OSA) because the nation’s 692 sleep labs are simply too full.

Dr. Davidson claims that 95-99% of people with OSA can be diagnosed in the home and has prompted CMS to reassess its decision to require beneficiaries receiving continuous positive airway pressure (CPAP) to be diagnosed in a lab using polysomnography.

During Dr. Davidson’s presentation in New York, he had some interesting opinions and comments and also seemed to have some conflicts of interest and an astounding degree of arrogance towards the Sleep Medicine and Pulmonary Medicine professions.

Although he has claimed to have no conflicts of interest, Dr. Davidson is on the Medical Advisory Board of Directors of ResMed, Inc. as a paid consultant. ResMed and their auto titration CPAP units stand to benefit substantially from gaining Medicare’s approval of in-home, unattended testing.

He has staggering disrespect for Pulmonologists, some of whom are also on ResMed’s Board, saying that “Sleep apnea is a disease of the upper respiratory tract, which doesn’t have much to do with the lungs.” He added that Pulmonologists view the upper respiratory tract as nothing more than a “nuisance” that stands between them and “something they can recognize.” Adding, “We’ve all seen them pass by large neoplasms just to do their bronchoscopy,” Dr. Davidson went on to say that “Sleep apnea is ours for the taking.”

This is a very interesting statement considering a research study published in the January 5, 2008 edition of the British Medical Journal. Several recent meta-analyses and literature reviews found inconsistent benefits and high rates of adverse effects from upper airway surgery, which is growing in popularity as first-line therapy by ENTs in the treatment of obstructive sleep apnea. (1) According to Akram Khan, MD, of the University of Florida in Jacksonville, “An ideal patient for upper airway surgery is someone who is young, e.g. less than 40, is not very heavy (body mass index less than 32), and has an apnea-hypopnea index less than 40.” He continued “If these patients are chosen for surgery their response rate is likely going to be much higher.” (2) This is a MUCH different population, however, than the Medicare population currently under consideration.

And while Dr. Davidson demonstrates arrogrance toward patients and sleep technicians, he has a very healthy respect for the dollars that find their way into his pockets. In noting that his lab uses SNAP machines only if their 4 Emblettas (Res Med product) are already being used, Dr. Davidson says the SNAP technology is perfectly fine, but that he has a problem with the money going to “the guys in Chicago” rather than to Dr. Davidson, himself.

A 2004 study published in Chest on the SNAP device demonstrated that the SNAP study accurately assessed the true severity in only 11 of 31 cases when compared to in-lab polysomnography. The SNAP study also overestimated the severity of sleep apnea in 13 of the 31 patients. In 8 of those 13 patients, the SNAP study diagnosed sleep apnea when the patient had a normal polysomnographic finding. (3) Furthermore, SNAP’s technology is “proprietary.” Once a SNAP study is completed, the results are sent to their facility which uses proprietary technology to analyze the results of the study. The ordering physician cannot review the raw data of the SNAP study to determine if the analysis from the SNAP technology was accurate.

Dr. Davidson also describes the amount of time he devotes to reading a portable testing. During his presentation, he describes the results of a portable test: “This individual, the apnea hypopnea index is now 14 and the O2 saturation events are 14. So this is a valid test. I mean, this is frankly all that you need to look at. This is a 20 second, no 10 second read. This is the report it put out. The guy’s got a AHI (apnea hypopnea index) of 14 and I think that that is sufficiently diagnostic.”

I agree that Dr. Davidson’s methods will increase utilization among our seniors when it comes to getting tested, but at what cost? It is estimated that over 50 percent of adults aged 65 and older report some sleep disruption, while about 20 percent suffer from chronic insomnia. OSA, a major cause of daytime drowsiness, occurs in an estimated 20-60 percent of older people, depending on the definition used and the specific population being studied.

People are living longer with more co-morbid and psychiatric conditions. The higher burden of illness and the number of medications used to treat these conditions plays an important role in the quality and quantity of sleep in older adults. In approaching sleep complaints in our Medicare patients, it is essential that practitioners recognize the multidimensional mechanisms by which illness impacts sleep. Equally important, a balanced management approach that includes optimizing the underlying illness, adjusting medications using cognitive-behavioral approaches, and using judicious hypnotic therapy seems justified based on the current evidence. (4)

As to Dr. Davidson’s assertion that the current policy for our Medicare population is inhibiting the diagnosis of OSA because the nation’s sleep labs are simply too full, recent data from the American Academy of Sleep Medicine states that the availability of sleep laboratories across the United States based on a 2001 study of 2001 data estimates that 427 PSG were performed per year per 100,000 population. (5) Since 2001, the number of sleep laboratories accredited by the AASM has more than doubled to 1,169, with 129 applications having been received in just the first three months of 2007, alone.

In a 2004 AASM survey, there was an average wait of about three weeks for a sleep study or sleep consultation. An independent survey in 2004 by Shariq estimated there were more than 2,500 accredited and non-accredited sleep laboratories in the US with an average wait time for a PSG between two and three weeks. (6) A 2005 survey of US sleep centers by Wachovia Securities found that in the prior year there was a 27% increase in sleep laboratory bed capacity and a decrease in wait times to 3.9 weeks. A survey of accredited sleep laboratories completed by the AASM in April, 2007 indicated that the wait time for a PSG has been reduced to a median of 12 days, and that the wait time for a sleep consultation has falled to a median of 14 days. (7)Incredibly, Dr. Davidson has gone on record with all of these statements and other stunning comments about the field of Sleep Medicine. You can listen to a CD Rom of his presentation at the 2004 Annual Meeting of the American Academy of Otolaryngology - Head and Neck Surgery Foundation in New York. Due to copyright laws, you will need to purchase it by clicking on the following link: http://www.siattend.com/Conference.aspx?cid=172&aid=12 and select “MiniSeminar” from the Individual Sessions section. The title of the presentation is “Thinking of Opening Your Own Sleep Lab?” (tracks 6-10). The cost is $16 plus shipping.

In closing, our current Medicare population is the men and women who left to fight a World War and then came home to build our great nation and make it what it is today. They are the volunteers who donate their time and energies to organizations throughout our communities. They are role models and mentors for our kids. They contribute to our economy and enrich our lives. They truly are the greatest generation. The health and safety of our senior citizens is at stake. We should not compromise their care for the sake of expediency. They deserve nothing but the best care given by the most qualified people.

Source references:

British Medical Journal: Elshaug A., et al “Upper Airway Surgery Should Not be First Line Treatment for Obstructive Sleep Apnea in Adults,” BMJ 2008; 336:44-45. Surgery Disparaged as First-line Treatment for Sleep Apnea http://www.medpagetoday.com/PrimaryCare/SleepDisorders/tb/7845. Evaluation of the Accuracy of SNAP Technology Sleep Sonography in Detecting Obstructive Sleep Apnea in Adults Compared to Standard Polysomnography* Timothy N. Lesching, MD; Carol Carlisle, RN; Ana Marte, BA; Alice Bonitati, MD, FCCP, and Richard P. Millman, MD, FCCP. Comorbidities: Psychiatric, Medical, Medications, and Substances. Sleep Medicine Clinics, Volume 1, Issue 2, Pages 231-245, S. BARCZI. J Clin Sleep Med 2005; 1:23-26. Sleep 2005; 28: 145-6. Letter to CMS regarding its national coverage decision on CPAP therapy forOSA. American Academy of Sleep Medicine, 04/11/2007. Mark Stoiber, President

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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 treatment of a patient. Their treatment needs to be closely monitored by qualified, certified people. In the long run more money will be spent because of the wrong treatment decision by an unqualified person. Its a sad situation.

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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 in support of portable monitoring for the diagnosis of OSA. Two recent studies provide some evidence in support of portable monitoring in highly selected cases managed intensively in academic sleep centers, but more research is needed, especially with regard to economic as well as clinical outcomes. 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. Wide use of portable monitoring by physicians and surgeons not trained in its use or in the comprehensive management of patients with sleep disorders will likely result in adverse patient outcomes. There is credible evidence that patients managed for OSA at accredited sleep centers have better outcomes. The AASM-sponsored multicenter trial of portable monitoring that is about to commence will provide highly useful data on both clinical and economic outcomes.

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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 in understanding differential diagnois of a broad array of symptoms. Patient within the Medicare population often suffer from other comorbid sleep disorders such as central sleep apnea, periodic limb movement disorder, insomnia, parasomnias, or narcolepsy. Patient''s can avoid a potential for misdiagnosis when seen by an experience sleep practioner.

In addition, there is little data on the use of Portable Monitoring (PM) in the pediatric and older (>65 years of age) populations. Most studies have been done in middle-aged adults; I would suspect that little or no studies have been done concerning PM and patients with significant comorbid medical conditions that may degrade the accuracy of PM, including moderate to severe pulmonary disease, neuromuscular disease, or CHF. The highest probably of these conditions are found within the Medicare population.

Patient education regarding the nature of testing,good sleep hygiene, and application of treatment (PAP) will maximize data quality, patient safety and satisfaction, and a greater chance of compliance. This component is critical to fostering positive outcomes when dealing with OSA patients and Cpap compliance. It appears that under the proposal as written this aspect of patient education will be overlooked. Of note, all the research used to support PM by CMS was done by certified technicians who followed detailed protocols. An extremely important component to producing quality data and positivie outcomes for patients are PROFESSIONALLY TRAINED TECHICIANS. Is medicare going to set standards on who can instruct or hookup a patient for PM?

There is a place for PM, but the Medicare population seems to be the worst demographic to apply it too. Doesn''t it seem to make more sense to incorporate PM within the younger less medically complex population. The new Medicare proposed recommendations for home diagnostic test and Auto PAP are an unacceptable compromise to necessary standards towards appropriate diagnosis and treatment. Quite frankly it is irresponsible and near sighted and it is this type of proposal that is the reason that the United States healthcare system remains 37th in overall preformance and 72 in overall health in the world.

Thank you for your time.
Jeffrey R. Hammond RPSGT, RRT, BS
Rocky Mountain Pulmonary Sleep Lab and Research

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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 appliances and OSA. I endorse the home testing as a way of reducing costs, but ask you to please consider oral appliances as part of the treatment options with home testing to verify effectiveness.
Thank you,
Thomas R Kuhn DDS
2383 California St, San francisco CA 94115, 415/921-2448

from: Journal "SLEEP" of the AMERICAN ACADAMY of SLEEP MEDICINE Practice Parameters

Full Article with Additional research at end.
http://www.journalsleep.org/Articles/290215.pdf

Summary:

Practice Parameters for the Treatment of Snoring and Obstructive Sleep Apnea with Oral Appliances: An Update for 2005

An American Academy of Sleep Medicine Report

Clete A. Kushida, MD, PhD1; Timothy I. Morgenthaler, MD2; Michael R. Littner, MD3; Cathy A. Alessi, MD4; Dennis Bailey, DDS5; Jack Coleman, Jr., MD6; Leah Friedman, PhD7; Max Hirshkowitz, PhD8; Sheldon Kapen, MD9; Milton Kramer, MD10; Teofilo Lee-Chiong, MD11; Judith Owens, MD12; Jeffrey P. Pancer, DDS13

1Stanford University Center of Excellence for Sleep Disorders, Stanford, CA; 2Mayo Sleep Disorders Center, Mayo Clinic, Rochester, MN; 3VA Greater Los Angeles Healthcare System and David Geffen School of Medicine at UCLA, Sepulveda, CA; 4UCLA/Greater Los Angeles Healthcare System, Sepulveda, CA; 5Englewood, Colorado; 6Middle Tennessee ENT, Murfreesboro, TN; 7Stanford University School of Medicine, Stanford, CA; 8Baylor College of Medicine and VA Medical Center, Houston, TX; 9VA Medical Center and Wayne State University, Detroit, MI; 10Maimonides Medical Center, Psychiatry Department, Brooklyn, NY and New York University School of Medicine, New York, NY; 11National Jewish Medical and Research Center, Sleep Clinic, Denver, CO; 12Department of Pediatrics, Rhode Island Hospital, Providence, RI; 13Toronto, Ontario, CN

Practice Parameters for Oral Appliances—AASM Practice Parameters

PRACTICE PARAMETERS

Summary: These practice parameters are an update of the previously published recommendations regarding use of oral appliances in the treatment of snoring and Obstructive Sleep Apnea (OSA).

Oral appliances (OAs) are indicated for use in patients with mild to moderate OSA who prefer them to continuous positive airway pressure (CPAP) therapy, or who do not respond to, are not appropriate candidates for, or who fail treatment attempts with CPAP. Until there is higher quality evidence to suggest efficacy, CPAP is indicated whenever possible for patients with severe OSA before considering OAs. Oral appliances should be fitted byqualified dental personnel who are trained and experienced in the overall care of oral health, the temporomandibular joint, dental occlusion and associated oral structures. Follow-up polysomnography or an attended cardiorespiratory (Type 3) sleep study is needed to verify efficacy, and may be needed when symptoms of OSA worsen or recur. Patients with OSA who are treated with oral appliances should return for follow-up office visits with the dental specialist at regular intervals to monitor patient adherence, evaluate device deterioration or maladjustment, and to evaluate the health of the oral structures and integrity of the occlusion. Regular follow up is also needed to assess the patient for signs and symptoms of worsening OSA. Research to define patient characteristics more clearly for OA acceptance, success, and adherence is needed.

Keywords: Practice parameters; practice guidelines, standards of practice, snoring, obstructive sleep apnea syndrome, oral appliances, dental devices

Citation: Kushida CA; Morgenthaler TI; Littner MR et al. Practice parameters for the treatment of snoring and obstructive sleep apnea with oral appliances: An Update for 2005. SLEEP 2006;29(2): 240-243.

Full Article: Additional research at end.http://www.journalsleep.org/Articles/290215.pdf

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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 Academy of Sleep Medicine.
2. Review, interpretation, and treatment by sleep boarded physicians only.
3. In person consults as well as follow ups with the patient at 48 hours, 30 days and 6 months from the date of the test.
4. Appointments at the sleep center as needed for non compliant patients.Patient care needs to be the highest priority and the above controls will give it the greatest chance of success while minimizing abuse.

I trust that you will make the right decision - for the patient.

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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 attended polysomnography in a laboratory setting is the gold standard test to diagnose obstructive sleep apnea, and should be used whenever possible. Other devices, including home study devices, are not able to reliably detect mild OSA, upper airway resistance syndrome, central and complex sleep apnea syndromes, and other sleep disorders which can greatly complicate treatment. In the event that a patient is unable to obtain a Type I sleep study due to medical or geographic challenges, a Type 3 device, with 4-7 channels used in the home, is a reasonable option, if ordered and interpreted by a board-certified sleep specialist. A type 4 device, which is basically a pulse oximeter, is certainly unable to reliably distinguish OSA from other causes of hypoxemia, and is often riddled with artifact.

As sleep laboratory testing is growing to accommodate growing need, and studies have shown that most patients are able to have a laboratory based sleep study within 3 weeks, this type of testing is certainly available within a reasonable amount of time for most patients.

Even the Proposed Memo describes the drawbacks to using home sleep testing for the Medicare beneficiary population. "Medicare beneficiaries are older than the studied subjects (the median average age was approximately 50 years in the analyzed studies), and may more often have conditions other than OSAHS that affect sleep...These conditions may be misdianosed as OSAHS by sleep monitors that do not record channels necessary for the differential diagnosis from OSAHS." Studies have documented that "middle-aged people (50 years old) with symptoms and signs suggestive of OSAHS are tested in the home setting, approximately 10 percent of those with OSAHS are expected to remain undiagnosed; approximately 15 percent of those without OSAHS receive false-positive diagnoses. For older adults (70 years old) the expected number of misclassificaitons is larger..." The errors in diagnosis expected from home testing would likely result in greater health and economic cost overall.

Furthermore, a national survey published in 2006 found that patients who were evaluated and treated by board certified sleep specialists had superior outcomes. This is to be expected, as a sleep specialist can comprehensively evaluate the patient, screen for other sleep disorders, educate the patient on the testing process, the diagnosis, and treatment options, and provide the long-term support needed to enable patients to use CPAP.

If the medicare National Coverage Determination does allow coverage of CPAP based on a diagnosis of OSA by home sleep testing, using any type of device and interpreted by any physician, with or without credentials in sleep medicine, I believe the result will be greatly compromised care for medicare beneficiaries, and increased financial costs in the long run as more patients are misdiagnosed and are not given the necessary support by physicians with expertise in the field.

Thank you for considering my comments.

Sincerely,

Nancy Behrens, M.D.
Board Certified, Sleep Medicine
Board Certified, Neurology

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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 therapists, I am pleased to submit comments on the Centers for Medicare and Medicaid Services’ (CMS) proposed Decision Memo regarding the diagnosis of patients with Obstructive Sleep Apnea (OSA) requiring Continuous Positive Airway Pressure (CPAP) therapy. CMS is proposing to expand CPAP coverage beyond the current polysomnography (PSG) testing in a facility-based sleep study laboratory to include among other changes, clinical evaluation and home sleep testing using Type II, III or IV devices.

The AARC commends CMS on the thoroughness of its review in determining whether expansion of the current national coverage determination (NCD 240.4) is warranted. We note that a variety of evidence was considered, including external and internal technology assessments, analysis by the Medicare Coverage Advisory Committee (MedCAC), evidenced-based guidelines, professional society position statements, and public comments. With respect to AARC’s position statement, we are disappointed that comments submitted in April 2007 on proposed changes at that time were not taken into consideration in revising CMS’ current position. Therefore, some of the concerns we expressed in earlier comments are reiterated below.

Home Testing

Comment: The AARC has concerns about expanding CPAP coverage to include home sleep testing and is opposed, in particular, to the proposed coverage of Type IV devices to be used in unattended home sleep monitoring.

When CMS first considered the inclusion of home sleep tests in 2005, it determined at that time there was insufficient evidence to conclude that use of multi-channel sleep testing with a minimum of 7 monitored channels (Type II devices) was reasonable and necessary in the diagnosis of OSA. Two years later, however, CMS acknowledges that the body of evidence pertinent to the use of HST devices for the diagnosis of OSA is more robust subsequent to is earlier review and is supported by more favorable Medicare Coverage Advisory Committee (MedCAC) scores in 2007 when compared to the Committee’s 2004 scores. Yet, in its own internal technology assessment, CMS acknowledges that they reviewed the Agency for Healthcare Research and Quality’s assessment on home testing for OSA and found no additional evidence on HST for Types II, III and IV devices. Thus, CMS’ proposed decision to expand CPAP coverage to include home sleep testing using Type II, III and IV devices appears to be based on rather limited data.

In reviewing CMS’ discussion of the evidence on the ability of various diagnostic strategies to correctly identify patients with OSA and exclude patients who do not have OSA, we note the MedCAC’s confidence level for clinical evaluation combined with Type IV HST devices received the lowest score (“less than moderate), while Type II and Type III devices received evaluations of “strong moderate” and “moderate”, respectively. Similarly, the external technology assessment conducted by AHRQ concluded that the ability of Type IV monitors to predict the Apnea-Hypopnea Index (AHI) suggestive of OSAHS appears to be better in studies conducted in specialized sleep units. It also noted that Medicare beneficiaries are older than those patients in the studies and that some Type III and Type IV monitors “may yield more false positives among Medicare beneficiaries, compared to what was observed in the assessed studies.” Finally, the AHRQ stated that its assessment of the types of HST devices per se was based on limited data.

Type IV devices have the fewest number of monitoring channels and also the lowest diagnostic specificity in the medical literature. Any device that has a reduced number of electrodes may misdiagnose a patient’s co-morbidities. Moreover, in the hands of untrained personnel this could be a significant liability for the patient and healthcare entity providing the service. We believe the use of Type IV devices will result in greater false positives and thus require additional testing at a cost to both the patient and Medicare. We also concur with current medical evidence suggesting that Type IV devices with the utilization of oximetry and at least one other airflow parameter are not recommended for use in diagnosing sleep apnea.

Recommendation:

The AARC strongly recommends that CMS reconsider its current position and remove Type IV HST devices from those considered appropriate for unattended home sleep monitoring if, in its final analysis, CMS expands CPAP coverage to include home sleep studies.

Comment: If CMS finalizes its proposed policy to include HST devices for home sleep monitoring, the AARC is concerned that there will be a proliferation of entities such as durable medical equipment suppliers and home health agencies, among others, that may choose to enter the sleep study arena because it offers an additional revenue stream. Quality standards, including personnel qualifications of those deemed competent to conduct the testing, are needed to ensure patient safety.The AARC believes that the inclusion of non-facility health care suppliers or providers such as durable medical equipment (DME) companies and home health agencies (HHAs) into the home sleep testing arena could raise important patient safety and quality issues, not to mention utilization concerns, unless there is some type of quality assurance standards that such entities must meet in order qualify for coverage.As stated in our April 2007 comments, the AARC recommends that any new device introduced into the home for sleep testing should meet minimum testing criteria. For example, central apnea versus obstructive apnea requires more physiologic data than pulse oximetry and flow. Inaccurate or poorly executed testing can result in false positives or false negatives. Without appropriate data a misdiagnosis may result. Sleep testing in the home also raises unique issues that must be considered. The sleep set-up will most likely be performed at night in the patient’s home. For patient safety reasons, the personnel performing these tests should be credentialed or licensed and a background check should be performed prior to their providing the service, if the employer does not already require such a background check prior to employment.While we recognize that DME suppliers and HHAs have to meet certain standards and conditions to participate in the Medicare program in general, we feel strongly that CMS should put in place specific standards regarding home sleep testing and proper use of HST devices by qualified personnel in order to protect the Medicare beneficiary and prevent over-utilization. Although certain DME quality standards are in place currently, they do not address this issue.

Recommendation: Assuming CMS finalizes its current proposed decision memorandum to include home sleep testing, the AARC recommends that CMS establish mandatory standards for health care entities that will provide unattended home sleep testing to ensure that Medicare beneficiaries receive the appropriate care. This is an important consideration that should be part of the national coverage determination and not left to the regional contractors to interpret.

Facility-Based Testing: Accreditation and Personnel Qualifications

Comment:

In our April 2007 comments, we raised concerns that CMS was not requiring polysomnography (PSG) facility-based testing to be carried out in an accredited sleep-testing laboratory. The AARC has urged that CMS require that facility-based sleep testing be provided in accredited facilities. However, should CMS implement this requirement, we strongly recommend that no one accrediting entity be given a monopoly in this area.

Within the last few years, there has been an unprecedented increase in the number of business entities entering into the sleep disorder arena. We believe the current structure of payment and reimbursement for diagnostic sleep testing has spurred this tremendous growth. For example, there is nothing to prevent these sleep businesses from billing themselves as a “sleep laboratory” or “sleep facility” or “sleep center” and marketing themselves as such. Without the need for facilities to be accredited, there is no assurance that the testing is being properly performed, that the proper equipment is available and calibrated correctly, and that the personnel performing the services have verifiable competency.

Recommendation: The AARC once again strongly recommends that CMS revise the current language in its NCD to mandate that polysomnograpy testing must be performed in “an accredited facility-based sleep study laboratory.” Since several accrediting bodies exist now and there is potential for more in future, we urge CMS to be flexible in developing its policy, rather than singling out a single entity. For example, the Joint Commission on Accreditation accredits sleep labs and facilities under its Ambulatory Care standards. The American Academy of Sleep Medicine is also an accrediting body, and we expect other entities may emerge as nationally recognized accrediting entities in the future if CMS finalizes its proposed decision memorandum.

Comment: The AARC continues to advocate that sleep facilities, centers, labs and entities be staffed with personnel who are qualified to prepare the patient, set up the testing equipment, and run the polysomnogram while monitoring the patient’s clinical status.With the presumed expanded Medicare coverage for home sleep testing, it continues to be of utmost importance that qualified health care practitioners be designated by CMS as individuals who have the education and competency documentation to provide these services. However, the designation of qualified personnel must not be so restrictive that it excludes health care professionals such as respiratory therapists from continuing to perform sleep diagnostics including administering polysomnograms. Sleep diagnostics and therapeutics have been an integral component of the respiratory therapy scope of practice for decades. All respiratory therapists are graduates of the Commission on Accreditation of Allied Health Programs (CAAHEP) accredited respiratory therapy education programs. These accredited education programs must include extensive education in all aspects of sleep disorders and testing. Moreover, the mandated valid competency examination for respiratory therapy credentials includes questions covering sleep therapeutics and diagnostics. Respiratory therapists are highly qualified to perform all aspects of sleep testing, diagnostics and therapeutics, and must be permitted to continue to do so.

Recommendation:

The AARC, in conjunction with the Association of Polysomnography Technologists, has developed a clinical practice guideline on polysomnograpy that contains the levels and qualifications of personnel who may perform polysomnography. We urge CMS to specifically list the personnel who are acceptable under Medicare to perform these services as part of its national policy, rather than leaving interpretation up to the regional contractors, by revising the current language as follows:“Polysomnography must be performed by qualified personnel, such as registered polysomnographic technologists, licensed and certified respiratory therapists, specially-trained nurses or other health professionals who have been competency tested by nationally recognized accreditation entities and under the supervision and oversight of a board certified physician holding a sleep specialty credential.”

SUMMARY

The AARC believes that additional work is needed by CMS before a final decision memorandum can be issued. While CMS notes that the scope of the reconsideration includes all aspects of the NCD, to date, CMS has not addressed the issue of requiring facility-based sleep laboratories to be accredited nor has CMS discussed patient safety issues regarding the need for quality standards and the types of qualified personnel who may perform sleep test studies, especially those conducted in the home. We have provided specific recommendations to address these issues and would hope that in the next reiteration of this policy that CMS will offer its analysis of these areas of concern. We appreciate the opportunity to provide comments on the expansion of CPAP therapy for OSP and appreciate your consideration of our recommendations.

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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 therapists, I am pleased to submit comments on the Centers for Medicare and Medicaid Services’ (CMS) proposed Decision Memo regarding the diagnosis of patients with Obstructive Sleep Apnea (OSA) requiring Continuous Positive Airway Pressure (CPAP) therapy. CMS is proposing to expand CPAP coverage beyond the current polysomnography (PSG) testing in a facility-based sleep study laboratory to include among other changes, clinical evaluation and home sleep testing using Type II, III or IV devices.

The AARC commends CMS on the thoroughness of its review in determining whether expansion of the current national coverage determination (NCD 240.4) is warranted. We note that a variety of evidence was considered, including external and internal technology assessments, analysis by the Medicare Coverage Advisory Committee (MedCAC), evidenced-based guidelines, professional society position statements, and public comments. With respect to AARC’s position statement, we are disappointed that comments submitted in April 2007 on proposed changes at that time were not taken into consideration in revising CMS’ current position. Therefore, some of the concerns we expressed in earlier comments are reiterated below.

Home Testing

Comment: The AARC has concerns about expanding CPAP coverage to include home sleep testing and is opposed, in particular, to the proposed coverage of Type IV devices to be used in unattended home sleep monitoring.

When CMS first considered the inclusion of home sleep tests in 2005, it determined at that time there was insufficient evidence to conclude that use of multi-channel sleep testing with a minimum of 7 monitored channels (Type II devices) was reasonable and necessary in the diagnosis of OSA. Two years later, however, CMS acknowledges that the body of evidence pertinent to the use of HST devices for the diagnosis of OSA is more robust subsequent to is earlier review and is supported by more favorable Medicare Coverage Advisory Committee (MedCAC) scores in 2007 when compared to the Committee’s 2004 scores. Yet, in its own internal technology assessment, CMS acknowledges that they reviewed the Agency for Healthcare Research and Quality’s assessment on home testing for OSA and found no additional evidence on HST for Types II, III and IV devices. Thus, CMS’ proposed decision to expand CPAP coverage to include home sleep testing using Type II, III and IV devices appears to be based on rather limited data.

In reviewing CMS’ discussion of the evidence on the ability of various diagnostic strategies to correctly identify patients with OSA and exclude patients who do not have OSA, we note the MedCAC’s confidence level for clinical evaluation combined with Type IV HST devices received the lowest score (“less than moderate), while Type II and Type III devices received evaluations of “strong moderate” and “moderate”, respectively. Similarly, the external technology assessment conducted by AHRQ concluded that the ability of Type IV monitors to predict the Apnea-Hypopnea Index (AHI) suggestive of OSAHS appears to be better in studies conducted in specialized sleep units. It also noted that Medicare beneficiaries are older than those patients in the studies and that some Type III and Type IV monitors “may yield more false positives among Medicare beneficiaries, compared to what was observed in the assessed studies.” Finally, the AHRQ stated that its assessment of the types of HST devices per se was based on limited data.

Type IV devices have the fewest number of monitoring channels and also the lowest diagnostic specificity in the medical literature. Any device that has a reduced number of electrodes may misdiagnose a patient’s co-morbidities. Moreover, in the hands of untrained personnel this could be a significant liability for the patient and healthcare entity providing the service. We believe the use of Type IV devices will result in greater false positives and thus require additional testing at a cost to both the patient and Medicare. We also concur with current medical evidence suggesting that Type IV devices with the utilization of oximetry and at least one other airflow parameter are not recommended for use in diagnosing sleep apnea.

Recommendation:

The AARC strongly recommends that CMS reconsider its current position and remove Type IV HST devices from those considered appropriate for unattended home sleep monitoring if, in its final analysis, CMS expands CPAP coverage to include home sleep studies.Comment: If CMS finalizes its proposed policy to include HST devices for home sleep monitoring, the AARC is concerned that there will be a proliferation of entities such as durable medical equipment suppliers and home health agencies, among others, that may choose to enter the sleep study arena because it offers an additional revenue stream. Quality standards, including personnel qualifications of those deemed competent to conduct the testing, are needed to ensure patient safety.The AARC believes that the inclusion of non-facility health care suppliers or providers such as durable medical equipment (DME) companies and home health agencies (HHAs) into the home sleep testing arena could raise important patient safety and quality issues, not to mention utilization concerns, unless there is some type of quality assurance standards that such entities must meet in order qualify for coverage.As stated in our April 2007 comments, the AARC recommends that any new device introduced into the home for sleep testing should meet minimum testing criteria. For example, central apnea versus obstructive apnea requires more physiologic data than pulse oximetry and flow. Inaccurate or poorly executed testing can result in false positives or false negatives. Without appropriate data a misdiagnosis may result. Sleep testing in the home also raises unique issues that must be considered. The sleep set-up will most likely be performed at night in the patient’s home. For patient safety reasons, the personnel performing these tests should be credentialed or licensed and a background check should be performed prior to their providing the service, if the employer does not already require such a background check prior to employment.While we recognize that DME suppliers and HHAs have to meet certain standards and conditions to participate in the Medicare program in general, we feel strongly that CMS should put in place specific standards regarding home sleep testing and proper use of HST devices by qualified personnel in order to protect the Medicare beneficiary and prevent over-utilization. Although certain DME quality standards are in place currently, they do not address this issue.

Recommendation:

Assuming CMS finalizes its current proposed decision memorandum to include home sleep testing, the AARC recommends that CMS establish mandatory standards for health care entities that will provide unattended home sleep testing to ensure that Medicare beneficiaries receive the appropriate care. This is an important consideration that should be part of the national coverage determination and not left to the regional contractors to interpret.

Facility-Based Testing: Accreditation and Personnel Qualifications< p>Comment:

In our April 2007 comments, we raised concerns that CMS was not requiring polysomnography (PSG) facility-based testing to be carried out in an accredited sleep-testing laboratory. The AARC has urged that CMS require that facility-based sleep testing be provided in accredited facilities. However, should CMS implement this requirement, we strongly recommend that no one accrediting entity be given a monopoly in this area.

Within the last few years, there has been an unprecedented increase in the number of business entities entering into the sleep disorder arena. We believe the current structure of payment and reimbursement for diagnostic sleep testing has spurred this tremendous growth. For example, there is nothing to prevent these sleep businesses from billing themselves as a “sleep laboratory” or “sleep facility” or “sleep center” and marketing themselves as such. Without the need for facilities to be accredited, there is no assurance that the testing is being properly performed, that the proper equipment is available and calibrated correctly, and that the personnel performing the services have verifiable competency.Recommendation:The AARC once again strongly recommends that CMS revise the current language in its NCD to mandate that polysomnograpy testing must be performed in “an accredited facility-based sleep study laboratory.” Since several accrediting bodies exist now and there is potential for more in future, we urge CMS to be flexible in developing its policy, rather than singling out a single entity. For example, the Joint Commission on Accreditation accredits sleep labs and facilities under its Ambulatory Care standards. The American Academy of Sleep Medicine is also an accrediting body, and we expect other entities may emerge as nationally recognized accrediting entities in the future if CMS finalizes its proposed decision memorandum.

Comment:

The AARC continues to advocate that sleep facilities, centers, labs and entities be staffed with personnel who are qualified to prepare the patient, set up the testing equipment, and run the polysomnogram while monitoring the patient’s clinical status.With the presumed expanded Medicare coverage for home sleep testing, it continues to be of utmost importance that qualified health care practitioners be designated by CMS as individuals who have the education and competency documentation to provide these services. However, the designation of qualified personnel must not be so restrictive that it excludes health care professionals such as respiratory therapists from continuing to perform sleep diagnostics including administering polysomnograms. Sleep diagnostics and therapeutics have been an integral component of the respiratory therapy scope of practice for decades. All respiratory therapists are graduates of the Commission on Accreditation of Allied Health Programs (CAAHEP) accredited respiratory therapy education programs. These accredited education programs must include extensive education in all aspects of sleep disorders and testing. Moreover, the mandated valid competency examination for respiratory therapy credentials includes questions covering sleep therapeutics and diagnostics. Respiratory therapists are highly qualified to perform all aspects of sleep testing, diagnostics and therapeutics, and must be permitted to continue to do so.

Recommendation:

The AARC, in conjunction with the Association of Polysomnography Technologists, has developed a clinical practice guideline on polysomnograpy that contains the levels and qualifications of personnel who may perform polysomnography. We urge CMS to specifically list the personnel who are acceptable under Medicare to perform these services as part of its national policy, rather than leaving interpretation up to the regional contractors, by revising the current language as follows:“Polysomnography must be performed by qualified personnel, such as registered polysomnographic technologists, licensed and certified respiratory therapists, specially-trained nurses or other health professionals who have been competency tested by nationally recognized accreditation entities and under the supervision and oversight of a board certified physician holding a sleep specialty credential.”

SUMMARY
The AARC believes that additional work is needed by CMS before a final decision memorandum can be issued. While CMS notes that the scope of the reconsideration includes all aspects of the NCD, to date, CMS has not addressed the issue of requiring facility-based sleep laboratories to be accredited nor has CMS discussed patient safety issues regarding the need for quality standards and the types of qualified personnel who may perform sleep test studies, especially those conducted in the home. We have provided specific recommendations to address these issues and would hope that in the next reiteration of this policy that CMS will offer its analysis of these areas of concern. We appreciate the opportunity to provide comments on the expansion of CPAP therapy for OSP and appreciate your consideration of our recommendations.
Sincerely,

Toni Rodriquez, Ed.D, RRT
President

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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 assess CPAP effectiveness. This will be problematic with the advent of home studies. Some home study devices will be simple enough for untrained physicians to utilize. It can easily take 3 months before an untrained physicians makes an assessment that the implementation of CPAP in a particular patient is not going well. It is possible that requesting the assistance of a physician trained in sleep and familar with the devices/interfaces available would occur after the trial period is over. I suggest a trial of 6 months. This will provide less trained physicians the time to give CPAP a trial and then if the trial presents problems, request the assistance of a specialist.

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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 not available. Based on personal experience, I suspect that proposed home testing will prove problematic in many unanticipated ways, with many tests being completely worthless due to a multitude of potential complications. Ultimate costs to CMS may actually increase as quality patient care declines. Sleep medicine specialists seem to be left out entirely on this one... quite unfortunate.

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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 procedures and the need for compliance is stressed time and again. The information is much to consume and even though it is repeated several times the patients, they do not retain it easily. This is the generations of fix it fast with a pill and anything more aggressive than this has to be stressed if we hope to have compliant patients. During home testing will there be some QUALIFIED person there to see the problems occurring that will follow the patient out of the lab and into the home when they are all alone and don’t have the knowledge to express what is occurring that will make them give up wearing CPAP? I think not. I treat all of my patients as I would want my family members treated. I am honest and listen to what they have to say, I try to ease their fears and explain the importance of treating OSA and the possible results of Not wearing it. I am not alone in my efforts here in Kansas. Most of the sleep techs I know do the same thing. It has been proven that the repetitive talks and checking back with the patient often especially in the first few weeks of wearing CPAP compliance can be increased from less than fifty percent to more than eighty percent. I hope that the people making the final decision on this issue will keep in mind that they or their family member may need CPAP. If you take the business from the labs and put it in the hands of God knows who. You will run the risk of eliminating smaller labs that cannot survive with out these patients. This means the people who have the knowledge to help overcome the obstacles that CPAP wearers face will not be around for a resource later when they have moved on from lack of work. Where will the patients be then and how costly will the home testing eventually become? Cindy Birdsong RRT/RPSGT president of Kansas Association of Sleep Professionals

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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:

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 diagnositic studies as a standard of care. It will cheapen the data and result in overtreatment and added cost to try to correct the errors in evaluation and treatment.

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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 healthcare, which translates to poorer health and increased costs for Medicare.

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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 disordered breathing is not present, particularly when the clinical evaluation is not impressive. Many studies have to be repeated because of technical difficulties, or at least action has to be taken based on limited data at times. But...in my opinion the diagnostic step (ambulatory or in-house PSG), while perhaps necessary for insurance purposes, is not what will guarantee a successful outcome. Without adequate follow up by a physician knowledgeable on sleep disorders, a large number of patients will not benefit, and the diagnostic step will simply become an exercise in futility. In addition, not all in life is sleep apnea. I see a large number of patients with many issues affecting their sleep and their wake function, not just sleep apnea. The physician must have time, knowledge and interest to deal with these individuals. I believe that it can be predicted that if ambulatory monitoring is used by "non experts": diagnoses will be frequently incorrect, follow up will be deficient, the number of oropharyngeal surgeries of questionable value will increase, dental appliances will be used innapropriately, the compliance with CPAP will suffer, the medical supplies stores will become the "consultants to patients" (with the attendant conflict of interest) and the quality of care will therefore suffer. I have strived for access and for less expensive care for patients with OSAS and other sleep disorders. But access has to be for more than initial visits and laboratory studies, it is equally important for follow up.

Let me bring up an example regarding testing. Evaluating a sprirogram appears simple, but how many physicians are comfortable with its interpretation? How many can verify that the study was performed following the ATS guidelines and that the "numbers" can be trusted? How many tell patients that they have "restriction" when obstruction is the answer, or vice-versa (I see this quite often in my clinical practice). Based on this - How much did the patient benefit from the test (spirometry)? The same can be expected from ambulatory monitoring if CMS approves all types of ambulatory monitors (including simple oximetry) for anyone and everyone to use. While I do not always agree with the AASM (for example their position on the MSLT and even the so called nosology), I must admit that the guidelines on ambulatory monitoring that they have proposed are logical and practical. They will prevent "the free-for-all". I am free of conflict of interest, my days as a practicing physician are coming to an end.
Respectfully:
Francisco Perez-Guerra MD FCCP
Professor of Medicine
Texas A and M Health Science Center, School of Medicine
Medical Director
Scott and White Sleep Disorders Center

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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 network of sleep disorder centers, has been providing sleep diagnostic services to individuals in excess of 10 years. In its network of 38 sleep disorder centers in 11 states, Sleepworks performs over 19,000 sleep diagnostic tests annually. Our organization remains committed to working with hospitals, physicians and other related healthcare professionals in providing quality sleep diagnostics and therapeutic care to those individuals affected by obstructive sleep apnea and other sleep disorders.

The prevalence of obstructive sleep apnea (OSA) and associated complications impact the lives of millions of individuals annually. Undiagnosed and/or untreated OSA can lead to other co-morbid conditions, accidents associated with untreated OSA or even death. To adequately and accurately diagnose OSA it is imperative the diagnosis and care is performed under the auspices of a comprehensive qualified sleep program. This insures that each individual will be clinically evaluated by a qualified sleep specialist, diagnostic testing is performed in a qualified sleep facility, diagnostic devices appropriately capture and record necessary physiologic data, and the sleep specialist can prescribe and monitor therapy and care.

On December 14, 2007 CMS released it 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). Briefly, CMS proposed;

1. The coverage of CPAP is initially limited to a twelve week period to identify beneficiaries diagnosed with OSA as subsequently described who benefit from CPAP. CPAP is subsequently covered for those beneficiaries with OSA who benefit from the CPAP.
2. CPAP coverage will be expanded to include those beneficiaries with a diagnosis of CPAP made using a combination of a clinical evaluation and unattended home sleep monitoring using a Type II, III or IV device.
3. Modify the criteria for a positive sleep study to remove the requirement for a minimum two hours of continuous recorded sleep and instead recognize shorter periods of continuous recorded sleep if the total number of recorded events during that shorter period is at least the number of events that would have been required in a two hour period.
4. Delete the current requirements that an individual have moderate to severe OSA and that surgery is a likely alternative because these terms are not sufficiently precise. Due to a lack of sufficient evidence that clinical diagnosis alone or clinical diagnosis in combination with devices other than Type I, II, III, or IV adequately identify beneficiaries with OSA that will benefit from CPAP, CMS proposes to expand Medicare coverage for CPAP in these instances only when provided in the context of a clinical study when that study meets strict standards as defined by CMS.

CMS is requesting comments by January 14, 2008. SleepWorks, LLC would like to provide the following comments on the proposed determination as published by CMS on December 14, 2007.

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 support CMS’ position that diagnostic testing to be the appropriate coverage category for PSG and multichannel HST. On a national basis, CMS currently requires that sleep diagnostic testing performed in a sleep diagnostic facility must be done so under strict criteria and quality standards. Furthermore, on a regional basis, some Medicare Regions require in certain states that sleep diagnostic testing in Independent Diagnostic Testing Facilities (IDTF’s) must be performed under the auspices of an AASM accredited sleep center. We feel that these strict quality standards are necessary and appropriate and these standards should continue. CMS should not deviate from these standards on any final decision by CMS for HST and coverage for CPAP and appropriate quality standards must be applied.

C) Performance of HST under a qualified, comprehensive sleep medicine program

HST for the diagnosis of OSA should be performed only under the auspices of a qualified comprehensive sleep medicine program. We feel this is necessary to insure appropriate and accurate quality of care and a continuity of high quality standards. Furthermore;

D) Acceptable Portable Monitoring Devices for use in HST

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

We support certain aspects of CMS’ proposal to allow coverage of CPAP based upon a diagnosis by home sleep testing as long as testing is performed under the auspices of a qualified comprehensive program. In that regard we respectfully submit our responses as stated above.

Respectfully Submitted,

Larry A. Webb, CEO
On behalf of SleepWorks, LLC

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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 for sleep disorders.

Home sleep testing facilities should have the following –

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 that produce the portable equipment.

On the other hand, peer reviewed research published by disinterested investigators concludes that portable monitoring for diagnosing sleep disorders in an inferior mode of treatment. It has proven to be inaccurate, and misleading, especially in the hands of untrained technicians. (1) A study by Liesching, et al (Chest, 2004;125:886-890.), concludes that there is an approximately 65% error rate in classification of sleep apnea in patients with portable monitoring. These errors include both under and over-diagnosis. Those patients who are under-diagnosed run the risk of mortality and morbidity associated with untreated OSA. Additionally, patients are faced with the added cost and inconvenience of obtaining additional (in-lab) sleep studies to obtain a correct diagnoses. Conversely, patients who are over-diagnosed incur the unnecessary expense and burden of improperly prescribed CPAP or worse, the expense and risk of unnecessary surgery.

In addition to clinical excellence, patient comfort level is higher with attended in-lab PSG’s. Gagnadoux, et. al.(Chest 2002;121;753-758), in a randomized crossover trial, provides clear evidence that impatient monitored PSG’s are not only technically superior to unattended home studies, but that contrary to popular belief, the majority of patients prefer inpatient studies over home studies. This is likely to contribute to better quality sleep and ultimately better compliance.

Finally, allowing for portable PSG’s will work at cross purposes with the 2008 OIG work plan. The 2008 work plan targets sleep labs, and the over use of sleep studies. According to the OIG, Medicare reimbursement for polysomnography increased from $62 million in 2001 to $170 million in 2004. To allow companies to provide inferior portable testing that is ordered and read by non-certified practitioners will open the floodgates for abuse with no discernable benefit to the program or to patients. . This will lead to the same problems that we have with medical imaging. PSG’s should only be ordered and delivered under the supervision of properly qualified practitioners and technicians.

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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 patient gets lost in the system, or is not followed up with board certified specialist in Sleep Medicine, the compliance rate will fall dramatically. It is my concern that this form of testing will be administered by untrained or minimally trained personnel. The patient''s knowledge in their diagnosis and continued support with an accredited sleep center is vital for the best treatment and follow up available. As a clinical coordinator and Registered Polysomnography Sleep Technologist, the interaction that we have in the sleep lab with our patients is vital for their continued treatment of their sleep disorder. It is my professional opinion that home sleep testing should be only done in an accredited sleep faciltiy with board certified sleep specialists interpreting and most importantly following up with the patient. Thank you very much.

Diane Mooney,RPSGT

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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 following:

Full Accreditation from the American Acadamy of Sleep Medicine. Review, intereption, treatment from boarded physicians only. In person follow up with patients at 48 hours, 30 days and six months from the date of testing. Facility sponsored patient support meetings on an ongoing basis.

If not properly monitored, then you have sleep facilities getting paid, the DME selling a CPAP machine and getting paid; but the patient does not get better.

This process should not become a revenue stream open to potential fraud, so put home sleep testing into the hands of trained, educated and ethical people,

Sincerely,

Douglas Shaffer
General Manager, American Sleep Medicne, Webster Texas.

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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 studies, and the use of an "autopap" devise, where one could use the "autopap" CPAP devise to determine and track the clinical benefit of providing the optimal level of centimeters of water pressure that is best for the patient. All autopap devises have built in memory cards to track compliance and the level of centimeters of water pressure used over the course of the night the patient utilizes the device. As a sleep technologist knows, there have been CPAP compliance issues with most patients not using the device after 4 months. The DME cost and the fact that there are issues surrounding CPAP compliance makes the argument for a different model use for the implementation CPAP therapy for those that suffer from OSA.

There would be better compliance with this type of sleep system delivery for the patients, and the cost would be significantly less overall in health care dollars spent. If a break even analysis is warranted, I would be happy to provide this in the cost analysis for making a determination.

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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 consider the time and expense that polysomnographic technicians have put forth to educate themselves to become certified technologists. Think about the physicians and others who have gone to great expense to develop traditional sleep medicine practices to treat the entire patient and to develop sleep labs that are like hotels instead of hospitals. The medicare reimbursement for a full night study is not but 200 dollars or so more than the 500 dollars that apparently will be charged for a home study. Also think about the fact that a charge may go in for the home study and the patient was unable to figure out how to do it. lots of our patients are uneducated, have hearing impairments, sight impairments and severe memory impairments. I do think that it should be available as a last resort if the patient can not be studied in a laboratory but this should be pointed out specifically and reasons for not using laboratory studies must be stipulated by the ordering physician. Once you open pandoras box, you have a hard time cutting back. If sleep specialists and laboratories are available, this must be the first choice. It is part of a sleep centers duties also to make sure their patients maintain CPAP compliance. Thank you for your consideration

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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 quality, accredited sleep testing centers and help patients to go through the process and stay in compliance with their CPAP treatment know how difficult this process is. we have to spend hours on the phone with our patients and the DME companies in order to ensure patient compliance with CPAP treatment. This care has no CPT code attached to it and we do not get paid for it. But without such high level of care patients end up not using their CPAP machines because of million reasons.

Now through in the home based testing units. Opportunistic unit providers will have a field day and make money but the patients will lose the help they need to get from accredited sleep centers. ENT physicians will end up doing more surgeries and make more money but the patients do not get better. Certified sleep physicians will make their decisions based on inadequate data, bill for their services but the patients do not get better.Physicians with no sleep background will be offered units by DME companies as kickbacks and bill for the service but the patient does not get better. Medicare will pay for the home unit use but patients do not benefit from it.

Home units, unless there are used ONLY by accredited sleep centers and certified sleep physicians, will not work.

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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 diagnosed and treated. 60% of the millions of Medicare patients who suffer with sleep apnea will be left untreated with C-pap - a non-invasive therapy known to improve quality and length of life. You may think that this does not affect you directly, however, if you examine the statistics on automobile accidents, the financial and personal cost of hypertension, congestive heart failure, myocardial infarction and cerebral vascular accidents, the small money potentially associated with lower upfront cost looks to be the 20 shekels paid to Judas.

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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 strides need to be taken to insure knowledgeable, responsible, patient-care orientated facilities are entrusted with the performance of home testing for sleep disorders and not just anyone who can afford the equipment.

Centers that offer home sleep testing should have the following:

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 knowledgeable, responsible, patient care orientated facilities are entrusted with the performance of home testing for sleep disorders.

Home sleep testing facilities should have the following –

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 knowledgeable, responsible, patient care orientated facilities are entrusted with the performance of home testing for sleep disorders.

Home sleep testing facilities should have the following –

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 disorders.

Home sleep testing facilities should have the following –

• Full accreditation from the American Academy of Sleep Medicine.
• Review, interpretation, treatment from sleep boarded physicians only.
• In person follow up consults with patients at 48 hours, 30 days and six months from date of testing.
• Appointments at the sleep center as needed for non compliant patients.
• Quarterly facility sponsored patient support group meetings on an ongoing basis.

We must protect the patients from opportunistic people who only see dollar signs and do not have the objective of conducting sleep studies to diagnose, treat and cure sleep disorders.

If not - than you have the sleep facility getting paid, the DME selling a CPAP machine and getting paid; but the patient does not get better.

Please do not let this happen. You must put home sleep testing into the hands of trained, educated and ethical people.

I know CMS holds the welfare of their patients above all other considerations and will do the right thing when setting their standards of care.

Thank you for your time and attention to this letter.

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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 following a patient’s clinical responses is significant enough basis of evidence to warrant CPAP payment to a DME company seems to suggest giving money away without warrant. Also, the application and instruction of the unattended study equipment to the patient by potentially unqualified individuals is simply absurd. Many of these Medicare recipients could not follow the directions to use an overnight pulse oximeter to check blood oxygen levels not to mention the greater complexity of these multichannel devices used in unattended study environment. What about CPAP/Bilevel compliance? Has any consideration been given to checking compliance on an ongoing basis. This would implore DME companies to help assure ongoing compliance as a means to reimbursement. After all should Medicare pay for equipment if it isn’t being used? To suggest some type of surface changes begs to ask the tougher questions that should be well thought in advance of implementation of such a proposal. Please reconsider your proposal and leave this sleep specialty to attended studies in a facility based environment. If they must be completed on an unattended basis, please take the advice of the American Academy of Sleep Medicine and assure quality home studies via a credentialing process for such organizations desiring to provide this type of service to Medicare patients. Please understand that what your committee suggests has HUGE potential impact to commercial insurance payors. Patients deserve excellent care. I feel that attended studies in a facility based environment deliver this level of excellence. Thank you for all of your hard work on this important topic!

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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 Head and Neck is a quick test to justify surgical intervention which is not the goal standard of treatment. The Head and Neck surgeons know that they can remove a patient''s uvula, but that does not address and treat the OSA. Many times the cause of OSA is below the oropharyns and can not be surgically addressed. Again the gold standard is CPAP. Which then could not be started until all the surgical healing process is done. In addition to this any carving out of this process opens the door for fraud and abuse.

Over the years we have had to retest patients who went through the extensive surgical procedure to "correct" their OSA. The sound of their snoring might not be as loud or heard but their OSA still exists. These patients are not being followed by the surgeons post surgically with a full sleep testing for quality results. Instead we get them months to years later with the same complaint of being tired and decreased work productivity from being tired and falling asleep while working. Along with those issues that have not been resolved your comorbid conditions are increasing. Now we are doing a full PSG test and it confirms they still have OSA and now need CPAP.

So what cost savings was accomplished? Absolutely NONE. CMS must realize that their cost savings is in treatment compliance with CPAP. By testing patients that are fully monitored and titrated more accurately we can achieve better outcomes and with out pain. There is however the most important component of all this and that is CPAP compliance.

Compliant CPAP users lower their comorbid risks and that is where the real cost savings is for any insurance carrier. The professional organizations of the AASM, ATS and ACCP have worked over the years to bring this high level of quality sleep medicine to date. These professional organizations know that quality testing and compliant CPAP therapy is the real cost savers for insurance carriers. Testing Centers who are AASM accredited also are very conscious for fraud and abuse issues as this is part of our accrediation process. For CMS to come in and carve out this would only further show that CMS really does not want quality of care as they say they do, but an inexpensive diagnostice evaluation that does not give an accurate picture of the patient''s over all health issues. If CMS is really pushing the P4P they should know that their cost savings is in compliance with CPAP therapy not in diagnostic testing. The cost savings are in decreasing hospitalizations of patients with cardiovasular conditions, less drug therapy for hypertension and cardiac arrhythmias, and in the area of diabetes and better control of their diabetes. The reasearch and articles support this unlike the surgical intervention.

It is up to CMS to show us do they really want P4P or just inexpensive inconclusive care that will cost us all more down the road.

Cc: Congressman Fred Upton

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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 (AASM), entitled: “Clinical Guidelines for the use of Unattended Portable Monitors in the Diagnosis of Obstructive Sleep Apnea in Adult Patients”. The AASM article states that portable monitoring does have a place in the diagnosis of OSA, but only if ordered and approved by AASM, as “accredited comprehensive sleep medicine programs under the direction of Board Certified Sleep Specialists.”

For medical professionals who have been following the decade-long debate about the validity of home sleep apnea diagnosis, the AASM’s sudden approval of home testing, and the stipulation that only a sleep accredited professional can manage it, is alarming. Now, after years of relentless opposition to portable home sleep testing, the AASM proposes that only AASM accredited professionals be permitted to monitor the portable procedure.

The AASM wants to become the sole administrator and regulator of a technology (home testing) that until a month ago they adamantly opposed. Their proposal is tantamount to allowing only Board Certified Pulmonologists to diagnose and treat asthma or COPD, or only Board Certified ENT physicians to diagnose ear infections.

In his 2004 letter to CMS, William C. Dement, MD, PhD, the “father of sleep apnea testing,” wrote: “Multi-channel home testing and auto-CPAP titration will allow primary care practitioners, cardiologists, ear nose and throat (ENT) surgeons, and other healthcare providers to rapidly and accurately diagnose and begin therapy, thus helping to alleviate the enormous lack of access that Medicare patients experience in the treatment of this condition.”

The Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) addressed the issue of limiting sleep apnea testing to a group of “accredited” physicians during its meeting on September 12 2007. The idea was soundly rejected. There will always be a need for sleep specialists and PSG labs to diagnose and treat patients with complicated sleep problems or severe co-morbid conditions. However, there is nothing esoteric about uncomplicated OSA patients that could not be handled competently by a well informed internist, family physician, anesthesiologist or ENT physician.

It is our duty as health care professionals to diagnose and treat patients afflicted with sleep apnea. I am sure CMS had this in mind when it made its long-deliberated decision on home testing. We are serious about diagnosing and treating the people in the United States who have undiagnosed OSA and are suffering each day the medical consequences and costs of not being treated. Portable home testing is an essential tool in this endeavor.

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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 poor quality that is being delivered by many facilities. Home testing needs to be approved with proper restrictions on who is qualified to perform the testing, diagnosis and treatment.

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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 therapy), due to their insurance coverage guidelines. This policy change is not only timely, but also necessary in a costly healthcare system with significant health disparities. Simply put, Medicare patients who require PAP therapy to manage their OSA should have adequate access to care and I believe the expanded coverage will allow that.

OSA is highly comorbid with cardiovascular disease, type II diabetes, depression, obesity, hypertension, and motor vehicle accidents (Nieto et al., 2000; Logan et al., 2001; Enburg et al., 2007; Moore et al., 2001; Hoffstein & Mateika, 1994; Gami et al., 2005; Reichmuth et al., 2005; Ambrosetti et al., 2006; Fritscher et a., 2007; Sassani et al., 2004). Since all of these conditions are facing parallel epidemics with the aging U.S. population, there is a public health need to effectively address OSA in clinical settings. I fully support the incorporation of home sleep tests in the expanded coverage for CPAP therapy, as it will have substantial benefit for all key players involved.

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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 tests, follow up of patient and false positive/negative results.

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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 these places often leaves patients mistreated or undertreated, even if they do have OSA. Many of them don''t, but have other important sleep disorders that go ignored. We serious people in the field are left to often pick up the pieces, but only after much of your money has been spent on worthless testing or treatment has been undertaken.

Now come home studies. You must realize that, just because careful studies done at good sleep facilities have validated the accuracy of a piece of equipment, it doesn''t mean that the equipment will be used properly or according to any standard. There is no doubt in my mind, at least, the much of the home studies done will be worthless, for many reasons. One reason is that unless some kind of clinical context is provided, and someone who knows sleep can interpret all the information, important diagnoses will be ignored, missed, or not treated. Also, it may sound nice to be able to establish nasal CPAP and do all this testing at home, but it takes very skilled people to accomplish this, and those people are more commonly found in sleep centers and not in home care companies. (unfortunately)

It is for this reason that the American Academy of Sleep Medicine has advocated that home testing and treatment be at least done under the supervision of a sleep specialist with credentials and, preferably, be a service offered as part of accredited sleep centers. My fear is that if lots of trash studies are funded, the future backlash result will be the severe curtailing of necessary testing and a demeaning of the field.

Thanks for your consideration.

Leon Sweer, MD FCCP DABSMPenn State

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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 encouragement or adjustments needed to achieve a succesful titration. Also I am concerned with wheter this would open the door for increased fruad. I see a future open to the following scenatio: An individual has insurance, but their family member does not. This family member has suspected OSA, but due to lack of insurance the family member cannot afford the test or the CPAP. What will prevent the insured individual from going to the PCP getting an order for a home sleep study, go through the education of the hook up, then coming home having their relative sleep over and hook them up for the test. Then turn it back in the following morning. Then getting a CPAP unit for that family member. How will the CMS monitor this potential fraud? Don''t we currently have a problem with DME and fraud issues? Thank you for your time and hard work on this issue.

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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 increased number of false negative results. There are many more sleep disorders than sleep apnea: these limited devices cannot accurately measure the range of pathologies that can occur during sleep. CMS is encourage to consider limiting payment for these tests to providers qualified in sleep medicine.

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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 established regulations/accreditations as to who can read/interpret studies.

The patient population that would most benefit from HST (symptomatic individuals suspected of having OSA without cormorbid medical conditions and in the abscence of any other cormorbid sleep disorders) typically do not fall under the Medicare umbrella.

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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% range, meaning that 10% of OSA patients will be missed, thus not being adequately treated.As a neurologist, I am concerned about many other sleep disorders, as well as OSA. I feel that if unattended sleep studies are done outside a sleep center and/or with incomplete monitoring, there is a significant risk of missing other diseases. When testing a patient who is suspected of having OSA, it is not enough to look just for that entity. Many patients have a dual diagnosis and the second diagnosis will be missed when incomplete, suboptimal studies are performed. Second diagnoses often include PLMS, arousals due to pain, psychiatric disorders causing impaired sleep. These will often be missed without a complete polysomnogramAlthough an individual patient may have risk factors for OSA, the sleep evaluation is not merely a search for OSA, but a search for whatever disturbs a person''s sleep. By limiting the discussion to OSA only, it presumes the other disease entities don''t require testing and evaluation.Since patients are not treated by a sleep disorders specialist in many cases, if the patient simply stops CPAP because of persistent daytime sleepiness, I know from experience that the primary care physician will simply not think to look for additional causes of daytime sleepiness, such as PLMS.By allowing unattended, partial studies and therefore limiting the use of complete, attended polysomnography, individual patients will suffer as a result of incomplete diagnoses and treatment plans. This will no doubt be abused by the insurance industry who will require the cheaper test be done and thus the more complex patients will not be adequately diagnosed and treated.Anyone who thinks this is not true, hasn''t worked in clinical practice and is not aware of how the insurance companies operate.
David W. Brandes, MS, MD, FAAN
Asst. Clinical Professor, UCLA
Director, Northridge Hospital Sleep Evaluation Center
Director, Rest Analysis

Question Reference #071231-000001

- Product Level 1: Medicare
Product Level 2: Coverage
Product Level 3: Medicare Coverage Database
Date Created: 12/31/2007 12:51 AM Last Updated: 01/02/2008 07:48 AM Status: Solved

[-001:002922:23089-]

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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 or maybe someone taught in a clinical environment on how to interpret the results but not trained in sleep medicine. We all know who is the best choice.

A PSG can be problematic due to artifact that occurs over the course of the sleep study. Ask an RPSGT how many times you might have to enter the room to correct artifact or a lead that has been pulled off (remember Type II HST monitors) or simply re-positioning the patients hand because it has the the hand with the POX on it is under the pillow and effecting the readings. I could go on but you get the picture.

There are other sleep disorders that HST won''t detect such as, RLS and PLMD. I guess they get an HST and a PSG. What a savings. What about the patient that is 64" tall and 280 lbs but don''t have moderate to severe OSA? There are those that meet the profile to suggest OSA but they may have an RDI of 2 and still have EDS.

In the CMS paper under IX. Conclusion it mentions the study meet additional standards. In those standards it talks about research studies. This seems confusing to me when it seems the whole debate is about CMS paying for HST. So where does the research come in?

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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 subsequent therapy that follows. (This is akin to letting a person take a urine cup home to gather the sample.)

2) Or, by creating false "apneas" while awake during HST, to obtain CPAP equipment for sale on the black market (Which would grow exponentially as the field is thrown wide open.)

3) As well as fraud for falsely NOT being diagnosed, by those CMS beneficiaries who may wind up with a hardship if diagnosed (eg. Truck drivers or bus drivers, etc.) All they need to do is but "REMAIN AWAKE" and the test reports NO Apnea, or likelihood of such.

These are a few of the ways that the system CMS is proposing to reimburse can readily and easily be "worked."

Unfortunately, with no sleep state documented, the HST is blind to the very core of the diagnosis. I feel that this is, in effect, CMS forcing physicians to commit fraud by using a diagnostic code that recognizes the difference in sleep state, but forces the utilization of technology that does not document it. At least the AASM guidelines covered this scenario.

Dr. Phurrough must guarantee the American taxpayer that CMS has recognized the very real possiblity of easy fraud in this proposed system, and it must layout structures, processes and safeguards to fend off what could be the wholesale bloodletting of the American taxpayer.

The true nature of CPAP "compliance" must include sleep data gathering, not just hours of use at pressure. Questions probing the nature of the patient''s sleep, and being able and willing to recognize the appropriate issues that may indicate secondary sleep disorders and how to deal with them. It is as if CMS does not wish to avail the CMS beneficiaries of proper sleep medical care.

It is paramount that every questioning taxpayer know that CMS has attempted to structure and formalize a system that affords medical oversight and control to be maintained by entities knowledgeable and properly trained in the field of Sleep Medicine. Otherwise, it is as if they are throwing the CMS beneficiaries to the wolves."

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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 the costs rise for Medicare, I anticipate the appearance of restrictive regulations that will make more difficult for patients with bonafied needs to receive the equipment

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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 can be there to help with all situations during the night for the patient.

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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 great value to the study by documenting and describing events that help with the interpretation. How will we ever diagnose positional osa? There are multiple times that a technologist needs to reattch a wire or nasal transducer secondary to it falling off! Will we repeat those studies? What will the cost be? Frustration of the patient? How can I truly explain the importance of treating OSA, when I can not be 100% sure of the data?

At the very least a qualifed personal should interpret the questionable results!

In the end I will probably end up treating frustrated patients, repeat mutliple studies and cost the system more $$$$!

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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 on this cash cow. If you think this will control spending, think again! I have already heard of DME''s purchasing home testing equipment in anticipation for this ruling with $$$ dancing in their heads. I implore you to tighten and severely regulate who will be able to perform this service. Strict guidelines also need to be in place that describe which patient should not have a home study.

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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 representative segments of the general population to support the effectiveness or accuracy of portable monitoring.

The use of portable home testing equipment, which can not differentiate between the types of apneas, and the use of auto adjusting CPAP, will not improve the conditions of patients having complex sleep disorder breathing, such as Cheyne Stoke respiration. Patients suffering from co-morbid cardiovascular disease are most at risk.

More importantly, there is some data suggesting that patient compliance with therapy is greatly improved when the patient undergoes traditional CPAP titration and education provided by a sleep specialist. The interaction, education and support provided by sleep physicians and sleep technologists can be key to the successful treatment of sleep disordered breathing.

CMS must be aware that by approval of the use of such a wide range of equipment types, even by persons who may be licensed medical professionals but are untrained and non- credentialed in sleep, is opening a Pandora’s Box. This would do a disservice to the patients that should benefit from treatment of a serious health issue.

I urge you to narrow your focus on the types of allowable testing equipment and treatments as well as the professionals who would be qualified to provide such services.

Respectfully,

Henry L. Johns RPSGT, CRT, CPFT

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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 patient will have the surgery and it will not correct their problem. Then they will have to have another study to provide another diagnosis, ultimately resulting in CPAP usage in the first place.

2)The PSG is not recognized as the "Gold" standard. Then why have we subtly recognized it as such the last 30 years? CMS says that the PSG "may be compromised by many factors such as inter-reader variability, the use of different test instruments, night to night variablility in a given patient, and patient ability to sleep in a non-home setting." All of these issues can stand true with a home test except for one. Sleeping in the home. I would estimate, in my experience, that 70% of patient''s with excessive daytime sleepiness do not follow good sleep hygiene practices. That is, the TV being on, the dogs jumping on and off the bed, staying up until 2 a.m. when you have to get up at six, drinking a six-pack right before bed, etc. Even though the lab in not home, it creates the proper environment for sleep, thus resulting in an increased opportunity for a proper diagnosis. Again, proper diagnosis is the key.

3)CMS allowing this contradicts its ruling that was just released as a final rule in October. That ruling stated that a Medicare patient in a sleep lab MUST be monitored by a RSPGT. If CMS was so interested in its patients diagnosis that it required sleep labs to have a PSG monitored ONLY by a registered tech, how on earth can CMS rule 2 months later that its OK to let a patient have a home study that is unmonitered? That makes absolutely no sense.

4)Duke University conducted a study that showed ample difference in CPAP compliance in patients that had a home study with no titration as opposed to those who had an inpatient study. They tested the effect of laboratory CPAP exposure and technologist support in a retrospective chart review of 98 veterans with obstructive sleep apnea to determine whether patients who received standard laboratory CPAP titration complied better with CPAP than did patients who received no laboratory CPAP titration. Fifty patients underwent standard technician-attended polysomnography (PSG) with CPAP titration, and 48 patients underwent unattended PSG with no laboratory trial of CPAP (first CPAP exposure was at home). Objective CPAP compliance measures were obtained from CPAP units at follow-up visits. Attended-PSG patients wore CPAP significantly longer per night on average (5.0 hours vs 3.9 hours) and tended to wear CPAP on more nights (76.5% vs 64.2%) compared with unattended-PSG patients. These findings suggest that patients'' sleep laboratory experience with CPAP and the support and education provided by sleep technologists are important factors in facilitating CPAP compliance.

In conclusion, I feel there is a place for home testing. It should be considered for preliminary screening or done away with all together. A PAT is cooralative to OSA but it cannot monitor sleep patterns, if and when a patient is asleep, what stage of sleep they are in, if the patient has narcolepsy, periodic leg movements, etc. When a patient is being screened at a physicians office, they don''t hand the patient the cup and tell them to bring it back. The patient is monitored, as well they should be. Sleep patient''s should be monitored as well. All in all, if CMS passes this ruling they will see an increase in payout due to misdiagnosis. If our government wants to save money, quit cutting Medicare benificiaries'' benefits and stop paying billions of dollars for a war. Or, better yet, tax people on their income that make over $80,000 a year. Don''t take away the benefits of our elderly.

Sincerely, Cody Herndon

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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 evaluate this information? Would computerized evaluation be sufficient, Nurse, Physician, Registered Sleep Technologist.....? In the end this should be about patients but unfortunately all parties, ALL PARTIES are more interested in either remaining relevant, getting their share, or the (who will benefit most) manufacturers. One of the CPAP manufacturers mentioned in your data was purchased last week in anticipation of of your March ruling. (A CPAP IN EVERY HOME)CMS had better be prepared because fraud will be rampant, all revenue interested parties will skirt the edges. Easy money will influence good honest people to make poor decisions. There was an advertisement from a manufacturer that stated THE WALLS ARE COMING DOWN how prophetic.

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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 traditional sleep evaluation process.

If this has any chance of success it needs to be implemented well by accredited sleep labs using proven technologies.

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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 irresponsible change. At the very least - a drastic change like this should be first tested in a small CMS region or state to evaluate the results!

CMS - Please consider the impact these drastic changes may have on our patients. If you are convienced that the drastic changes in your proposal are necessary - then at least test their validity in a small patient population and work out the problems before it becomes a NCD!

It is the only prudent and responsible way to to evalute such drastic changes! Thank You

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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 reviewed the literature of OSA with attention to diagnosis and treatment. The conclusions are insightful.

1. No combination of diagnostic procedures adequately identifies all of those beneficiaries who have OSA and will benefit from CPAP. I think this is true and we the sleep community must reassess our entire approach to OSA patients.
2. The proposed 12 week trial is an excellent policy.
3. PSG is not a gold standard for the diagnosis of OSA and should not be confused with such. This is true and it is an important statement.
4. Language and policy nurturing and supporting clinical research is a novel policy and will help clinicians interested in meaningful clinical research. This is particularly true for research which is not readily fundable by industry or government granting agencies.
5. Nurturing clinical research focused on out comes is an important focus.
6. Expanding coverage of CPAP to those beneficiaries with a diagnosis of OSA (miswritten on page 2 line 2 as CPAP) made using a combination of a clinical evaluation and unattended home sleep monitoring using a Type II, III or IV device, is a good policy for all patients and a particularly excellent policy for seniors who do not like or will not drive at night or will not sleep away from home and therefore will not undergo PSG testing, almost regardless of consequences. Furthermore, adoption of this policy should increase the number of OSA patients diagnosed, reduce the expense for diagnosis and improve the health of the nation.

cc: David Nielsen, MD

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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 field of medicine, given the somewhat atypical and unconventional form of the most commonly used therapy for Obstructive Sleep Apneas Syndrome, namely CPAP. Patients that will likely gain little or no response or in fact have a negative experience with the workup and therapy of Obstructive Sleep Apnea Syndrome, which will undoubtedly be the case under these new regulations, will set off a tremendous negative awareness or desire for further therapy. It is not uncommon, referred patients and negatively biased acquaintances, that have been evaluated at other centers, not optimally trained in sleep medicine, were suboptimally cared for. As such, given their negative experience (clinically and financially), which has undoubtedly been relayed to their friends and family members subsequently require a tremendous amount of encouragement/coaxing, either by other family members or health professionals, to pursue much needed albeit, delayed appropriate workup. With this subset of patients (and acquaintances), we are starting behind the so called “eight ball”, given their newly formed negative attitude, in convincing them to allow appropriate workup and treatment of this potentially life threatening disease. These patients, and the impact their “wake” of negative comments having on other patients, make them extremely difficult to manage effectively. This negative “domino effect” effect is greatly under appreciated, and is extremely important and will further impair bonafide sleep physicians to offer appropriate care that they wish and have been trained to deliver.

Sleep medicine is unique, and unlike managing, for example hypertension, where suboptimal care or patient non compliance with recommended therapy, essentially impacts the patient alone, mismanagement of Sleep Disorders, including Obstructive Sleep Apnea Syndrome, has a huge impact on public safety. Sleepy motor vehicle drivers, including automobile, school bus and truck drivers; sleepy pilots and nuclear power plant operators; air traffic controllers to name a few segments of society, being managed in a suboptimal fashion, which will undoubtedly take place in the setting of this current decision, and will place the public in harms way. Trained physicians and centers in the field of sleep medicine, managing these patients, will minimize these risks.

Home monitoring, in the setting of appropriately trained personal, physicians and technicians, does offer some advantages though extending the management of sleep patients to any “licensed physician” who undoubtedly lacks the adequate knowledge and finesse to mange these patients will have a tremendous negative impact on their health, quality of life and public safety.

I ask you to reconsider your ruling. Please take advantage of organizations currently in place, like the American Academy of Sleep Medicine, whose role is to educate and oversee physicians and centers, assuring that their knowledge base is current, ensuring optimally cared for patients. Please act before it is too late, as I am certain, in a matter of years, this decision will be looked upon unfavorably. Unfortunately, in the interim, the impact that this ruling will have had on millions of patients, both directly and indirectly, will be enormous and irreparable.

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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 customers? Are we going to see television ads urging people to have a convenient home test for OSA, somewhat akin to trial lawyers on television who urge us to come in for a free consultation if we''ve ever been injured?

The same thought applies to preventing physicians with little sleep training from setting up apnea testing mills. Also, given that CMS is spending money on quality of care incentives for physicians, would it not be more consistent to require some level of qualification in sleep medicine to labs and physicians for home apnea testing? (CMS currently requires that a neurologist, orthopedist, or physiatrist certify the medical necessity of a motorized wheelchair.)

The main reason that so many people with OSA are undiagnosed is not lack of access, but rather lack of awareness about the importance of sleep and reluctance to use CPAP among those who have heard about it. Patients often tolerate snoring and daytime somnolence for years (even decades) before seeking medical care for these problems. CMS could make a real improvement in public health by funding a campaign to inform the public about OSA and by funding a quality of care incentive for physcians to actually take a sleep history (this is rarely done by most primary care providers).

The recent CMS proposal states that no single diagnostic test predicts which patients will comply with CPAP. Although this is correct, a similar statement could be made about every other medical problem we treat. Is there a diagnostic test that predicts which patients with pulmonary embolism will comply with warfarin therapy? Does an MRI predict better than a CT which stroke patients will comply with physical therapy? How is that type of consideration relevant to the question of whether a type III apnea screener should be used by an untrained health care provider to diagnose OSA?

CMS is correct to be concerned that compliance with CPAP is often not achieved. The best remedy for that problem would be to mandate that diagnosis and treatment of OSA be conducted by sleep centers that have proven their quality by becoming accredited.

I would like to echo others'' comments that, to date, there is very little experience regarding reliability of type III or IV apnea tests performed NOT by well trained sleep techs and sleep specialist physicians. The study CMS ought to conduct (before proposing to open home apnea screening to anybody regardless of their qualifications) would be one that compared diagnostic accuracy between type I polysomnograms performed at accredited sleep centers versus type III apnea screening studies interpreted by untrained general practitioners. Given that there are essentially ZERO sleep professionals who think that a type IV device is the best method for diagnosis of OSA, why is CMS interested in paying for such a test? Is the CMS interest in type IV devices not a result of advocacy from groups that stand to increase their income?

CMS should GIVE MORE WEIGHT to the testimony from the three professional groups that have by far done the most to advance the treatment of sleep patients: the American Academy of Sleep Medicine, the American College of Chest Physicians, and the Sleep Research Society. CMS should GIVE LESS WEIGHT to testimony from physicians who are paid by the companies that stand to profit from home apnea screening.

Of course, CMS should give great weight to well-designed scientific medical studies regarding the diagnosis of sleep apnea, but (as stated above) there are no studies available that address the scenario that CMS proposes to create by allowing home apnea screening by poorly trained persons to take the place of Type I studies in accredited sleep centers. At the very least, CMS should pospone a final decision until such studies become available.

CMS should also look into the scenario in which a home apnea test performed by an untrained entity yields a falsely negative result. That is, what is to happen to the patient who is told, erroneously, that he does not have OSA based on a poorly performed type III apnea screening test? That patient will have increased risk of cardiac and cerebrovascular disease, motor vehicle accident, depression, and impaired work productivity due to untreated sleep apnea. Is this outcome better than the scenario in which that patient waited a month to have a properly performed comprehensive sleep evaluation by an accredited sleep center?

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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 thorough; evidence based and took into consideration the best interests of Medicare beneficiaries.

I respectfully suggest that the final policy include clarification on a few points:
a.) The requirement for documenting a clinical response to CPAP is in addition to the requirement for testing by PSG or a Level II, III, or IV home study.
b) That home sleep testing may be “unattended”.

I would also suggest clarification and possible revision regarding Level IV studies. As the NCD states “Type IV devices measure one or two parameters (e.g. , oxygen saturation or airflow). Thus some might consider a device that only provides oxygen saturation to be a type IV device. However, since the NCD appropriately points out that the evidence does not support the utility of pulse oximetry alone in the diagnosis of OSA, there is the potential for confusion. I would suggest making it clear in the decision summary that for the purposes of this NCD a pulse oximetry alone does not constitute a type IV device. Alternatively, type IV devices could be shifted into the Coverage with Evidence portion of the decision.

I urge CMS to hold fast to its decision even if there is pushback from the sleep labs. Given the public position that the American Academy of Sleep Medicine (AASM) has taken on the home sleep testing issue, it is highly likely that during this comment period the AASM will lobby to have the NCD include restrictions on who can order, perform or interpret home sleep testing.

1) Sleep testing (HST or PSG) should be ordered in patients who have signs and symptoms of OSA or a previously confirmed diagnosis in whom response to treatment needs to be assessed. There is no clinical reason why ordering a sleep test requires evaluation in an AASM accredited center or by Board Certified/Board eligible Sleep Medicine physicians. Current Medicare policy has no such requirements prior to ordering PSG and there is no evidence that indicates a need for this requirement for HST which is less invasive, and less expensive.

2) Sleep tests should be interpreted by those who are qualified to do so. However, this is the default mode for all diagnostics that require interpretation. Medicare covers a wide range of diagnostic services that require far more clinical acumen than interpreting a home sleep test- without specific credentialing requirements of the physician reader.

3) The technical quality of home sleep testing can be assured in a variety of ways that are already addressed by the Medicare program and the FDA. It is reasonable to limit home sleep testing to devices that are FDA cleared and measure parameters needed to provide an AHI. Medicare regulations regarding IDTFs (Independent Diagnostic Testing Facilities) have generic requirements pertaining to quality of equipment and qualifications of personnel. Micromanaging advocated by the AASM pertaining to sensor placement ignores advancements made in sensor technology and innovative approaches to assist patients in performing a successful home study. Organization specific accreditation requirements advocated by the AASM are self serving, unnecessary, and will serve as an impediment to use of HST for the efficient diagnosis of OSA.

4) The AASM position that HST devices must display raw data and allow for manual scoring is another specious argument. If the device and the software have been FDA approved as well as clinically validated vs. PSG and the results published in several peer reviewed journals, raw data is not needed. This position is nothing more than an attempt by the AASM to maintain control of the analysis portion of the study within the sleep labs and sleep technicians running their labs

CMS should not require that home sleep testing be under control of a specific professional society. Thank you for your consideration of these issues.

Sincerely,

Jon Freudman, MD
Tel 415 456 1652
jon@freudman.com

On behalf of Sleep Solutions Inc.

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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 ventures).

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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 well as doing CPAP desensitization in the center and all patients have access to multidisciplinary CPAP clinics with close collaboration with DME providers. In difficult patients-frail, elderly with psychiatric comorbidities- center coordinators do home visits with close liaison with their caregivers. All patients on CPAP are tracked with objective compliance data and this is maintained as a database in the center. Our CPAP compliance is consistently above 80% (Over 500 patients).

Rescue CPAP in a vulnerable population: Does intense services in an AASM accredited sleep center matter?

Siva Ramachandran, MD., Dip ABSM, Matthew Pham and Maureen Weiss, CRT and Anil Verma MD.

Sleep Wellness Center of Pottstown, Pottstown, Philadelphia

INTRODUCTION
Nasal CPAP is effective in treating OSAS although resistance and intolerance to it pose limitations to its use. Studies have indicated that early CPAP use, as early as 3 days- identifies long term adherence to CPAP therapy. Predictors of long tem CPAP usage in this population remain unclear. We sought to determine the impact of a goal driven protocol on long term CPAP compliance in patients with OSAS

METHODS
We studied 55 (36 males and 19 females) consecutive patients in an AASM accredited center with OSAS whose CPAP compliance was < 4 hours at their 1 month follow up visit. All subjects were evaluated and counseled by a board certified sleep specialist and a certified respiratory therapist and were educated about OSA. CPAP desensitization and mask fittings were conducted if indicated and patients had access to specialized CPAP clinic. All patients were offered follow up with their downloadable compliance card.

RESULTS
Of the 55 patients (mean age 55.7± 13.7 years, BMI 34.5± 7.8, ESS 12±5 AHI 25± 18 and PSQI 10±4) 34 patients (61%) were compliant and were followed up for 6 months. CPAP compliance improved from 138.6 ± 52.0 minutes to 259.0± 103.5 minutes (p&< 0.001) in those 34 patients and more patients availed of mask changes and desensitization in the compliant group (p=0.006). Older age was related to increasing compliance (r=0.38; p=0.02) and in a multivariate stepwise model including age, gender, BMI, AHI, ESS, PSQI, CPAP pressure, mask changes and desensitization, older age was the most important predictor of compliance (p=0.009).

CONCLUSION
Access to specialized services with close follow up in an AASM accredited center improves long term CPAP compliance in patients with high risk of CPAP failure. Patients in the older age group are particularly responsive to multimodal CPAP rescue services and are a model for development in sleep centers.

We strongly urge CMS to consider the impact of AASM accreditation on long term patient care,research and education especially in the elderly.12 week follow up must be cordinated by credentialled sleep physicans with collaborative care (with physicians, DME providers) to ensure optimal treatment for patients with OSAS. Thank you for allowing me to comment

Siva Ramachandran MD

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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 outcome. Sleep is an infantile field of medicine and it would be ashame to take type of turn when we are only at the beginning of understanding how much sleep disorders effect the health of many. Those who are educated in sleep (MD''s/RPSGT/A-step graduates/Respiratory Therapists)are best to screen and set up home studies and not have it left to anyone in the public, if these home studies are to be approved.

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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 pathological events, while abnormal respiratory patterns that do not fit the classic OSA model may be overlooked. The problem is compounded when the studies are performed and scored by individuals with minimal training in sleep.

I respectfully urge CMS to consider the consequences of allowing unrestricted use of portable recording devices with limited channel capabilities for the diagnosis and treatment assessment of obstructive sleep apnea. I believe this will further degrade the current trend of inappropriate CPAP titrations and poor compliance. Please let the professionals do what they do best.

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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 accurate diagnostic services to the public for the past 30 years. The American Academy of Sleep Medicine (AASM) and various insurance companies have acknowledged polysomnograhy as the gold standard and have demanded that sleep laboratories obtain “AASM accreditation” in order to obtain payment. It is hard to understand CMS position on portable monitoring studies and the lack of knowledge about our field and most importantly the risks to the public. In closing, we should change medicine in general by allowing podiatrists to perform bariatric surgery.

Sincerey,
Sleeptech0904@hotmail.com

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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 problems.

Uncommon problems will arise as some come to understand the utility of providing fraudulent outcomes, either positive or negative to those with a need for a ''certain outcome''. Others will take the test for a possibly positive truck driver or railroad engineer or pilot or air traffic controller. The potential for fraud and abuse is too high.

What I find most disturbing is that the very patient population you represent are the ones who are the least likely to be good candidates for home testing. Medicare patients rarely present to my lab with out a variety of co-morbidities, making them the most problematic to test and to treat. A large number of the studies we perform are on patients who are already sporting hundreds of thousands of (Medicare) dollars worth of cardiac care and who''s status requires all our available skill and training. The studies and research abound warning of who is not an acceptible candidate for home testing. They describe the vast majority of Medicare patients.Your own disclaimers will proscibe most Medicare recipients from qualifying for home testing. To even contemplate allowing these most fragile and problematic populations to fall into the hands of the unskilled is a travesty.

If cost is an issue, find another way to save dollars. Refuse to pay the outlandish fees charged by the makers and suppliers of nPAPs and masks.

If patient care, positive patient outcomes and saving dollars is your priority then control the machinery costs and require sleep labs and sleep doctors to provide long term care to patients. The factory labs and the factory doctors will quickly move on.

If you honestly believe testing has gained primacy over care then require that long term care be one of the criteria for reimbursing the test. Throwing patients to the wolves is not the solution. It''s bad medicine and it''s bad business.

The most vulnerable will pay the price.

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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 companies will engage in very aggressive marketing to the PCP community, and the growth in CPAP will be astronomical with a very significant drop in compliance. We may be talking about a large net increase in costs to CMS with the patient unable to be titrated effectively, to be able to use the CPAP device with positive results. Twelve weeks does not represent success in my opinion, but it is a good start.

Home health care companies, must not be responsible for CPAP compliance without the oversight of a boarded sleep professional. Many, many patients have their CPAP sitting at home collecting dust because of the lack of patient support, a great in-service, and sleep physician management.

Home PSG monitoring is sometimes the only option because of patient health considerations. It should also be noted that long delays for getting into a sleep laboratory are greatly overstated.

Heart failure, stroke, diabetes, and other co- morbidities are quoted as being extremely high with patients having OSA. We have been quoted rates of over 50% with all of these conditions. How would anyone be able to discriminate patients? With complex sleep issues such as, central sleep apnea, Cheyne-Stokes respirations, PLMD, insomnia, and seizures, home testing could mask significant issues. If we want to control Hemoglobin A1C, Homocysteine, Hypertension, C- reactive protein, etc. we must make sure we understand patient conditions with more information than a home screen.

I fear CMS will explode their sleep budget, and have less total patients effectively treated than the present time.

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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 can be easily manipulated in the DME''s favor, thus generating more CPAP referrals for the DME. Also, DME dealers can easily set up "portable sleep monitoring companies" which would appear to be legally separate entities, but, in fact, are set up specifically to generate CPAP referrals. I have seen this very thing happen with private insurance companies, and it constitutes abuse of the system.

Physician offices and Nursing agencies have also been known to set up similar services to abuse the system.

It is far too easy to see potential abuse made possible by the new regulations.

I propose that additional restrictions be included in he regulations which would require the necessary expertise and independence needed to stop potential abuse.

Portable studies should be performed and monitored by Sleep Centers using only properly trained Sleep Technologists and Boarded Sleep Physicians to perform and interpret "type II, II, and IV" portable monitoring.

We have significant abuse now. Without proper regulation, supervision and expertise, the abuse will grow exponentially.

Please do not allow, Nursing Agencies, DME''s and Physician Offices monopolize this necessary, but potentially abused method of testing. Instead, create similar regulations and accreditation standards which are equivalent to those imposed on sleep laboratories.

Thank you for your consideration.

Jim Spector, BS, RRT, RPSGT

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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 methods - but what if the portable test is negative? What about the patient''s sleep complaint then? Only a trained sleep physician can appropriately manage these cases and, I believe, should be making the decision regarding the appropriate method of diagnosis (i.e. portable vs. lab study).

I also strongly oppose the inclusion of type IV studies in the draft policy. These devices monitor far too few parameters to accurately diagnose OSA or any other sleep disorder.

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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 is my prediction that patients who undergo home testing with a reduced amount of information will frequently require repeat studies, either at home or in the sleep lab, so now Medicare will be paying for two studies instead of one. Many patients will simply be misdiagnosed while believing that they had accurate testing performed. They will remain undiagnosed and continue to utilize medical services at a greater rate than if they had been accurately diagnosed.

Although there are specific patient populations which might benefit from home testing, including those who are home-bound or those who might need screening studies, these studies need to be ordered for specific reasons, performed by trained personnel and interpreted by specialists.

Therefore, I would cast my vote in opposition to reimbursement for home sleep testing as the decisions stands now.

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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 be lifted as a qualifier to begin CPAP treatment when the individual meets criteria based on a derived apnea/hypopnea index that would equal the minimum requirement set by CMS.

I cannot stress enough how paramount it is that home sleep testing be regulated by accredited sleep centers and certified sleep specialists when determining the course of diagnosing and treating patients with obstructive sleep apnea. I am also in agreement that portable monitoring be used to assess those individuals as at risk for OSA candidates for surgery. As JCAHO establishes a safety guideline goal for 2008 for anesthesia for the screening of sleep apnea, portable monitoring will be instrumental in assisting those anesthesiologists and surgeons with pre-surgical screening for patients suspected with OSA.

Sincerely,

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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 through an accredited sleep center, scored by a RPSGT and finally interpreted by a ABSM!

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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 implement clear guidelines with respect to lab-based testing not delve into the home-testing frontier.

Sincerely,
Jason Weingartner, RPSGT

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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 to diagnose sleep apnea by an unmonitored test and prescribe CPAP with less than optimal setting will creat more tratment failures. This in turn will lead to general belief of CPAP being unsucessful. This in turn will work against patients because they will not be treated with one of miracle treatment of medicine, leading them to develop cardiovascular complications and making insurance companies spend more money at the end for same patients. Lifetime cost of CPAP therapy is approximate $3500.00 and two sleep studies is approximate $1800.00 .this gives a gaunrantee that we have most accurate diagnosis and best CPAP setting for patients. Leading to sucessful outcomefutue cost savings. I do not agree with current proposal of undermining one of the best and cheapest treatment of medicine.

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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 lack of awareness in the areaof sleep medicine (in both the patient and healthcare community), it dose not take greatimagination to perceive the numbers of people thatcould quite easily be under diagnosed or just aswell misdiagnosed should this form of testing notbe administered by credentialed specialists in thesleep community.

In conclusion it is my position that alleconomical, marketablness of services, and allperspective and benefit of home testing be setfirmly behind ensuring that the management andtreatment of any suspected or possible sleepdisorders be put in the hands of professionals ofthat specialty.

Thank you very much for the time of those who readthis posting.

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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 based on the limited data of some airflow and pulse oximeter. In my personal experience if not the correct type, and correct placement can lead to terribly erroneous information...
Due to the fact that there is also more than one type of sleep apnea, and the proposed recording devices and auto titration devices cannot conclude which type of apneas the patients may be having.

Patients with COPD, CHF, parkinsons etc.... the MEDICARE patients 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.

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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 oversight, computer generated numbers without careful review will be mis-applied.
3. Negative home studies are inadquate to exclude clinically significant sleep apnea. Thus, patients with symptoms but a negative home study should undergo a monitored (in-lab) sleep study.

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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 extremely complex, reflecting the need to consider a very large number of variables and options as one proceeds from the initial clinical suspicion of the disease to its successful treatment with CPAP or another modality." Diagnosis and management of this condition should not be left to untrained individuals.

The studies referenced in your report regarding home monitoring were performed by sleep medicine specialists; their results should not be generalized to cover studies carried out and reviewed by those without sleep training.

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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 suggestive of OSA or daytime sleepiness should be followed up by an in lab PSG.

Without these 2 caveats, home studies will be performed and interpreted by individuals with no training in sleep medicine and patients will not receive appropriate treatment. All of the studies looking at home study efficacy were performed by sleep medicine specialists, so there results should not be generalized to cover studies carried out and reviewed by those without sleep training.

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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 none the less signals from a PSG. Many times I have spoken with physicians not formally trained in sleep medicine and technology that simply read reports and do not review data on their own. Relying on the word of DME specialist to simply, "the patient meets the purposed criteria." Sleep medicine is still very young and to this day our eyes are being opened to things first we didn''t realize before. I find it to be a big mistake to take so many steps backwards and leave diagnosing up to professional not formally trained in that area. I have read that false positives may come about and I feel this may get a little out of hand being in the hands of formally trained individuals and facilities. Right now as it stands alot of our patients are receiving large amounts of supplies that they do not need from DME companies and we on a daily basis ask the the DME comp[anies not to supply extra hoses, cushions, filters, etc unless we request the patient needs them. I strongly feel that diagnostic testing should be in the hands of specifically trained and educated accredited facilities and Registered Polysomnographic Technologist.

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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 cpap without help. Maybe they would have needed bipap or vpap sv. Please reconsider! That patient that falls thur could be yours or could injure yours.

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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 that and it didn''t work at all," despite anyone''s best efforts to convince the patient that a different mask, or humidity, etc. might make a huge difference in their tolerance of the therapy.

I applaud the proposed repeal of the 2-hour rule, as I feel it has only penalized the most severe patients, making it harder for them to qualify for rapid treatment in a split-night fashion.

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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 current wide-spread use in rural areas of the mountain west. I include the following data for comment:

Mortality rates derived from Colorado Hospital Quality web-site – 2006 data. This is a review of 16 Southwest Colorado hospitals – some are currently not reporting data.

CHF mortality Colorado - Mean 2.3 Hospitals using 4 channel screens and non-sleep trained physicians for OSA diagnosis > empirical c-pap treatment

Mean 12.0(Range 9-15)(n=2) Hospitals with sleep laboratories but without a trained sleep medicine physician reading psg’s Mean 5.2(range 4.9-5.5)(n=2) Hospitals without an accredited sleep laboratory but with a board certified sleep medicine physician reading psg studies Mean 3.0(range 2.5-4.0)(n=3) Hospitals with board certified labs, techs and physicians reading psg studies Mean 2.15(range 2.1-2.3)(n=3). Similar trends exist for MI and CVA mortality, however, only a limited number of sites report this data. The presence of an accredited sleep laboratory and trained sleep medicine physician is one hospital variable associated improvement in hospital mortality rates. Your proposal would mark the return to a pre-sleep medicine protocol for treatment of OSA in which patients would be far less likely to receive optimal care. The cost in morbidity and mortality of such a change will be enormous. Sincerely, JF Pagel MD

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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 one other sleep physician there not sponsored by industry. The medical industry reported that there were significant problems with lab-based polysomnograms because of cost, convenience, and access. Their solution is to allow widespread usage of home-based testing.

Reality

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 in treating OSA side affects, (Diabetes, HTN, CAD, Obesity, MVA''s, stroke....) is by far more expensive in the long term. All long haul truck driver should also be required to at least use an at home screener to check for OSA before renewal of their license. OSA and its side affects can be controlled if we take interest in what we can do to treat it. The use of at home “screening” devices is a giant step in the right direction, but by no means can it be the last step.

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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 also removes the structure, protocols, and quality controls found in lab-based testing, such as artifact recognition and correction. What will happen if the home-testing device malfunctions during the night? There will be noone there to correct it. Certainly, home-testing has it''s place; certain medical and/or psychiatric conditions prevent patients from being lab-tested. These patients would be excellent candidates for home testing - when lab-testing is inappropriate. This has the likely potential of actually costing CMS more (which as we know the bottom line is driving this). As more and more botched and inconclusive home-tests are performed, this may drive up the numbers having to return for lab based testing. The problem with the entire field of sleep medicine is that it is largely unregulated, which has allowed too many people with too much money and not enough conscience to start sleep labs (focused solely on profit). The result is poor outcomes, questionable diagnosis, and patient dissatisfaction. The broad spectrum approval home-based testing is yet another step in the deregulation of this field. Now, every "Tom, Dick, and Harry" will be home-testing patients. Many of these home-testing companies will know nothing about sleep medicine, they will be focused solely on profit. Who does this benefit? Certainly not the patients (which should, after all, be the reason we do what we do). Another disturbing fact is that this push for home-testing is largely being advocated by ENTs. Here''s why: the ENTs wish to home-test their patients, and perform surgery. That is all they know; it''s all they do. So we''ll see a dramatic increase in the number of sleep apnea surgeries performed on uneducated patients. Patients who do not realize that there are other, more effective, treatment options. Right now, the apnea-related surgeries are grossly ineffective for all but the most mild of patients. Most patients that opt for surgery ultimately require CPAP or some other additional form of therapy. No, this is an attmept by ENTs to operate outside the system, to the detrement of their patients. Without some form of regulation, home-testing will actually turn back the clock on advancing the field of sleep medicine. Only accredited sleep labs/centers should be reimbursed for this technology. After all, if the field is deregulated, and everyone can perform testing, what will accreditation mean, anyway?

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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 followup, the CPAP should have a compliance card that also shows time used each night, AHI and mask leaks and possibly auto-pap. After confirmation of success, then a simpler machine could be substituted. Requiring accreditation of the sleep facility would greatly improve the terrible national record of compliance and use by patients. Many insurance companies already require this, why not CMS? JPH

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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 study by their doctor, who stands to add revenue to his/her practice. Is this the new direction of Medicare? Loosely driven sleep care is the only outcome I see. Sleep studies should only be allowed in Accredited sleep disorder centers, done by the professionals who have devoted their careers to doing so. A decision to allow portable monitoring is only going to benefit the MD''s, the manufacturers of the portable devices, and maybe some patients. There is not a documented lack of access to sleep centers now, and Medicare should think twice before it bankrupts itself by allowing access to revenue by unqualified physicians, who seek only to find an easier way to pay their mortgages. I speak the truth, and you know it. Please don''t dumb-down sleep medicine. I would''nt see a urologist for my sore foot. Now go on and do the right thing.

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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 treated with CPAP be done by a physician with knowledge and experience in the treatment of this disease.

To "throw the doors open" to everyone (physician or non-physician) who can afford the minimal investment required to to home testing will not be in patients'' interest. It is certain to result in unnecessary testing,misinterpretation, and poor or non-existent patient management. It is also imperative that patients have access to a sleep lab and board certified sleep specialist when necessary.

I would suggest that the use of ambulatory home diagnostic testing for sleep apnea be limited to existing sleep laboratories that can provide either service as well as expert clinical evaluation. In this way, the highest possible level of service and improved access can be achieved.

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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 setting.

My Thoughts:

A BALANCE BETWEEN TOO MUCH AND TOO LITTLE

Over the past few years I have disagreed with territorial feuds over the rights to sleep services between the AARC, AASM, and the Society of Neurodiagnostic Technicians. I do not feel one diagnostic test is worthy of its own society (and all associated dues and fees that go along with it) If all labs are forced to follow recently released AASM guidelines it would make access to sleep services even more restrictive.

We have tried hard to make our lab accessible to as many patients as possible by allowing all physicians to order a sleep study without having to be funneled through a specialist office. Our highly qualified board certified sleep specialist does however provide a written interpretation and recommendation after the test is complete. We have chosen not to become an "accredited lab" to help contain unneccessary cost. The AASM guidelines for staging and scoring a sleep study are so grotesquely cumbersome that it would take an experienced technician over one to two hours to stage and score a single study. This is usually unneccessary, especially when the unquantified diagnosis of sleep apnea is fairly obvious.

Now on the other hand, I feel our full service hospital based lab is very effective at diagnosing and treating sleep apnea. This setting is especially beneficial to the patient with severe OSA with difficult titration needs.

Conclusion:
I would disagree that a level 4 home study (Oximetry and or HR) would adequately diagnoseOSA. We currently use overnight oximetry to support the clinical suspicion.

A level 2 or 3 home study may have a place for diagnosis and screening.

A CPAP or BiPAP titration should still be performed in a monitored hospital based setting.

Sometimes it does seem a bit rediculous to have MCA paying upwards of $2000.00 for the justification of a device which cost under $300.

Thank you for providing me withthe opportunity to express my thoughts and opinion.

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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 CPAP in a regular clinical (non-research) setting.

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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 comforting than in a ''sterile'' lab setting. There is more adherence to normal sleep routines, resulting in more reliable data.

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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 testing for OSA.

There are a lot of limitations for HST and that will result in loss of billions of dollars due to those limitations:1- The vast majority of patients who will have HST will be sent to full PSG. 2- HST does not address sleep stages,periodc leg movements, and the possiblity of complex sleep disorders and that means again the full PSG will be ordered. 3- In huge number of patients using the HST devices will be a problem and that will result in ordering full PSG.

Now this should not be implemented otherwise we will cause harm to our patients and big financial burden on the medicare in a time when we need to save every penny.Sincerely,H F Nadrous, MD FCCP

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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 therapeutic pressure. To help insure compliance from the patient, The DME company sholuld provide support in monitoring the patients on CPAP therapy and providing this information to the Physician on a regular basis. The Healthcare community has available viable systems and technologies to identify and treat OSA with positive outcomes.

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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 term RDI and no doubt for other reasons, CMS continues to deny coverage to patients with high RDIs but AHIs less than 5.

Why is this point not addressed in your memo, or in a roundabout way, are you trying to address the point with your concerns about "moderate to severe sleep apnea." If so, you could be a lot clearer by using terms such as RERAs, flow limitation, or UARS, which by the way have been in use in the field of sleep medicine nearly a quarter century.

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