Careers in Sleep Medicine for Psychiatrists

A reader asks:
I have a question about joining the real world as a psychiatrist and sleep physician. It seems everyone is geared toward pulm/cc guys. I think I will have some benefit with a wife in a gen med practice but only if I open up my own practice. Are there jobs out there for regular shrinks?

The number of pure sleep medicine jobs has decreased over the last several years, but there are some 100% sleep medicine jobs out there that are open to all the underlying sleep medicine specialties. You can find out about these opportunities on the AASM website, the sleep journals, and the websites of recruiting firms like locumtenens.com and MDJobsite.com.

Another possibility is starting your own sleep lab. Check out the ads in Sleep Review for companies that you can hire/partner with to assist in this process.

Another possiblity is taking a psychiatry job with a hospital that has a sleep lab and make it a condition of your employment that you can read (and get paid for) the patients you refer to the lab.

Check out the Sleep forum on the Student Doctor Network for more ideas.

Treating Resistant Insomnia

I posted this on the Medscape message boards today:
I see a lot of pts who have failed the standard hypnotics (Rozerem, Ambien, Ambien CR, Lunesta, Sonata). It's important to screen for secondary causes, including restless legs. If they haven't taken Restoril yet, that's sometimes effective. I have found chloral hydrate effective for short term use (no more than 1 month), for breaking the cycle of insomnia. I have one patient on Xyrem for insomnia (and several who take it for narcolepsy). Before prescribing xyrem, it's important to rule out obstructive sleep apnea. I'll occasionally use Seroquel for insomnia, but only if there is comorbid psychiatric illness. I'll also sometimes use neurontin, but usually only if there are also neuropathic/RLS symptoms present.

Sexual Behavior during Sleep

Current Psychiatry has an article this month on "sexsomnia":
Sexual behavior during sleep (SBS)—or “sexsomnia” ...is more than a sensational defense for a high-profile court case. Sleep physicians are finding that sexual behaviors during sleep are real and more common than previously thought. Although SBS cases sound psychological in origin, it appears that the problem lies in the brain itself.
SBS can cause great distress to its initiators and recipients but often goes unreported and untreated because of embarrassment about seeking help. Among patients who report their symptoms, many say they experienced SBS 10 to 15 years before seeking help. SBS not only disrupts sleep but can damage relationships and lead to allegations of sexual assault and rape.

I have had only one case of this in my sleep practice- a woman with masturbatory behavior during sleep. She failed all the standard treatments- benzodiazepines, tricyclic antidepressants, and anticonvulsants. Her polysomnogram and EEG were essentially negative. I ended up referring to the local university sleep center for a second opionion. She didn't keep her follow up appt with me and I have no idea what happened to her.

Insomnia Tips

5 tips on battling insomnia from Healthy Living, including:
Remove the television.

Running A Sleep Lab

A key part of running a sleep lab is keeping on top of the constantly changing regulatory environment, on both the federal and state levels. This link does a good job of describing the new federal regulations for independent diagnostic and testing facilites (IDTF's) that went into effect January 2008 (though for pre-existing IDTF's, many of the provisions do not apply until January 2009). Every February the AASM gives a course on sleep lab management that is very useful for anyone running a sleep lab.

Treating OSA improves cognitive dysfunction in Alzheimer's disease

Increases in total sleep time (TST) related to treatment of obstructive sleep apnea (OSA) with continuous positive airway pressure (CPAP) are associated with improvements in cognition in patients with Alzheimer's disease, a new study shows.
The study is summarized on Medscape.

obstructive sleep apnea and diabetes

The International Diabetes Federation reports on the close relationship between type 2 Diabetes and Obstructive Sleep Apnea:

Obstructive Sleep Apnea (OSA) is the most common form of sleep-disordered breathing, accounting for over 80% of cases.
Estimates suggest that up to 40% of people with OSA will have diabetes, but the incidence of new diabetes in people with OSA is not known.[i]
In people who have diabetes, the prevalence of OSA may be up to 23%[ii], and the prevalence of some form of sleep disordered breathing may be as high as 58%.[iii]
Overweight and obesity may play a role, but some recent studies show an association between the two conditions that is independent of overweight/ obesity.
OSA may have effects on glycemic control in people with type 2 diabetes.
OSA is associated with a range of cardiovascular complications such as hypertension, stroke and heart failure.
IDF calls on health decision makers to encourage further research into the links between the two conditions and urges healthcare professionals to adopt new clinical practices to ensure that a person with one condition is considered for the other.

More information about the relationship between diabetes and osa is available on the IDF website.

Memory dysfunction and obstructive sleep apnea

Obstuctive sleep apnea is associated with cognitive dysfunction, including memory problems.
A study reports that key brain structures involved in memory, the mammilary bodies, are shrunken in patients with Obstructive sleep apnea:
A study using high-resolution magnetic resolution imaging (MRI) scans reports that mammillary bodies — brain structures involved in memory — were 20% smaller in patients with sleep apnea than in controls.

More from Baltimore

Earlier this week preliminary data from the Sleep Heart Health Study was presented. It appears that in patients without significant preexisting cardiovascular disease, moderate to severe osa (apnea-hypopnea index of greater than 30 with events requiring a 4% desat) over a 10 year period led to only modest increases in the risk of incident coronary artery disease in men younger than 70 (about 1.35x risk), and no to minimal increased risk in older men and in women. The stroke risk however was significantly elevated in men, but not in women with an ahi of greater than 30. Sleepiness appeared to increase the risk of the development of coronary artery disease and stroke.

The implications of this large (over 6000 subjects) prospective cohort study is that osa may not increase the risk of developing cardiovascular disease (angina, coronary artery disease, congestive heart failure) as much as previously thought, though the risk of developing ischemic stroke is increased in younger men (about 2.7x).
Patients without significant cardiovascular disease should be treated if symptomatic (significant sleepiness). This study does not change the need to aggresively treat osa in patients with preexisting cardiovascular disease.

Greetings from Baltimore

Went to an interesting session today at SLEEP 2008 on portable home testing. Not much has changed over the last several months. Most Medicare carriers are still writing Local Coverage Determinations for home testing. It appears that the old code for home testing with a type 3 device (95806) is being replaced with a G code (G0399) with additional G codes for Type 2 and Type 4 devices. Trailblazer, the Medicare carrier for New Mexico and several neighboring states apparently won't cover home testing, though that decision is still under review.
Everyone is talking about home testing, but no one appears to be doing it yet to any great extent. It doesn't appear that home testing will be done to any great extent until 2009; it will take at least that long for the local Medicare carries to decide their policies regarding home testing, and more importantly, get the payment mechanisms/codes in place for home testing

SLEEP 2008

I just arrived at the SLEEP annual meeting, in Baltimore. Hope to be inspired at this meeting and post about it this week.

Congratulations to Top Sleep Technicians

Congratulations to the recipients of ADVANCE magazine's sixth annual National Sleep Achievement Awards.
The winner for Best Tech was Diana Chesnut, RRT, RPSGT.
Honorable Mention
Best Tech
Robert Parks, RPSGT Somnus Sleep Clinic, Flowood, Miss.
Roger Scott Dr. Zzzs Sleep Center Tulsa, Okla.

Sleepy

Sometimes I feel this way, after staying up too late the night before:
It's no secret our economy has reached the point that my eyelids…are drooping. Face…falling toward keyboard. Energy level…sinking fast, but cannot stop now! Must…keep…typing op-ed piece. Deadline…looming! Article due! Cannot allow…self to sleep…precious, precious sleep… until finished….

Hypnotic Prescribing Trends

A new survey finds that latency to sleep onset (rather than sleep maintenance) is what Primary care doctor's consider the most important attribute in selecting a hypnotic:
Decision Resources, a research and advisory firm focusing on pharmaceutical and health care issues, finds that a drug's effect on latency to sleep onset is the attribute that most influences the prescribing decisions of surveyed primary care physicians (PCPs) in the treatment of insomnia.
I prescribe Ambien, which is good for helping a person fall asleep, much more than Ambien CR, which is better for sleep maintenance. Ambien is also now generic and much cheaper than Ambien CR.

Pills don't cure Obstructive Sleep Apnea

The life sciences company BTG is developing a pill that will supposedly treat obstuctive sleep apnea:

BGC20-0166 is a novel combination of two marketed serotonin modulating drugs being developed for the treatment of OSA.

Various sertonergic and serotenergic/noradrenergic antidepressants, including Prozac and protriptyline, have been used to treat OSA. These medications have a mild effect on osa. They slightly improve osa by increasing upper airway tone and also possibly by decreasing REM sleep. The effects are mild and antidepressants are not considered to be an effective treatment for OSA.

I don't recommend buying stock in BTG.

Starting a Sleep Lab, part three

There are 3 basic types of sleep labs: hospital associated, extension of a physician practice, and independent diagnostic and testing facility (IDTF).
Assuming that a physician is not starting a sleep lab in association with a hospital, the basic choice comes down to IDTF or extension of a physician practice.
In my case, I started Somnus Sleep Clinic with some non-physician owners, so IDTF was the only option.
For a physician or physician group, either form could be appropriate. The key difference is how patients are referred to the sleep lab.

For an IDTF, the Feds mandate that most of the referrals for sleep studies come from outside physicians. Practically, what this means is that the outside physicians refer the patients directly for the sleep study. The sleep physician then sees the patient (if the patient is going to be seen by the sleep physician) after the sleep study (within 3 months will meet AASM guidelines). You need to put some type of statement on the psg order form (which should be signed by the outside referring physician) that a cpap titration will be performed if clinically appropriate- then both studies will count as ordered by the outside physician.

For a sleep lab that is an extension of a physician practice, most of the sleep study referrals (85% is a figure I've heard several times before) need to come from inside the practice. Practically, what this means is that the sleep studies need to come from either the practice's own patients and/or patients referred to the practice for a sleep evaluation (and seen by the practice prior to the sleep study). The order for the sleep study needs to come from a physician in the practice.

There are some other differences between IDTF's and physician practice sleep labs, more to come later.

Postpolio syndrome

ADVANCE magazine has an interesting article about Postpolio syndrome, focusing on respiratory disturbances:

Disordered breathing is among the most misdiagnosed and misunderstood symptoms polio survivors face later in life. Too often their breathlessness and inefficient coughs are misdiagnosed as asthma or chronic obstructive pulmonary disease. For many aging polio survivors, it largely has been up to them to initiate their care and educate their doctors on the medical literature.

One-third to one-half of polio survivors experience new or increased weakening and pain in the muscles later in life. This typically occurs 10 to 40 years after recovering from original polio. This weakening can affect the diaphragm and breathing muscles, causing such disorders as obstructive sleep apnea, central sleep apnea, pneumonia, pulmonary restriction, shallow breathing, pneumonia, and diffuse muscle twitching during sleep.

He warns that split-night sleep studies are not appropriate for polio survivors I agree with this; home testing is not appropriate either.

Polio survivors should be given portable volume-pressure ventilators to use with nasal interfaces for ventilatory assistance rather than CPAP or bilevel positive airway pressure, Dr. Bach said. Polio survivors do not benefit from the expiratory positive pressure, he said, and it detracts from the positive inspiratory pressure in assisting the inspiratory muscles.
I disagree, many do have some element of obstructive sleep apnea and benefit from BiPAP. Typically these patients do require a wide differential between the EPAP and IPAP.

A few patients still use the iron lung, a form of negative pressure ventilation. Negative pressure ventilation can predispose to or worsen obstructive sleep apnea, but is very effective in some patients with postpolio syndrome.

"Moderate" does not mean "Mild"

I was in clinic most of the day. I told 2 of the patients that their sleep studies showed "moderate sleep apnea". Both of them looked relieved and said almost exactly the same thing, "so it's not that serious?" This necessitated additional time to explain that moderate obstructive sleep apnea is indeed a significant condition that usually affects daytime functioning as well as cardiovascular health.

I'm not sure why this confusion occurred. Maybe "moderate" means something different to lay people than physicians.

I guess I should change my classification, when speaking with patients, to "mild obstructive sleep apnea", "obstructive sleep apnea," and "severe obstructive sleep apnea" to promote clarity.

The Latest on Home Testing

I want to thank everyone who's been leaving comments about home testing. Currently the situation is unclear. It seems like a new LCD is written every week. If you have questions about what is covered in your state/Medicare region, I would encourage you to contact your local Medicare carrier or your state sleep society.

If anyone out there has successfully qualified a patient for cpap using home testing and/or has successfully billed for home testing, please leave a comment and share your experience.

A reader asked the following question:

I have some questions reguarding who will or who will be required to give a sleep study at home? Can a sleep technican hook up a patient at their home, by himself? Are can only a sleep technologist hook the patient up, in there home? This just seems like a slippery slope for sleep medicine. To me at the minimal a sleep technican, but what about Nurses or Respritory Therapist? Thank you for responding.

I don't think there are any standards for the hook up. The patient can hook himself up, or he could be hooked up by a technician, nurse, or secretary. I agree with your concerns.

I will be getting a type 3 home testing device in about 2 weeks. I'll let the readers of this blog know how things work out.

Military Sleep Interventions

This month's issue of Focus Journal has an interesting article about interventions that various branches of the military use to promote alertness (PDF file).
I wish caffeinated gum was available for civilians.

Home Testing not covered in many states

The AASM just linked to a new Local Coverage Determination for the following states:
Illinois, Iowa, Kansas, Michigan, Minnesota, Missouri, Nebraska and Wisconsin.

Here is the link

http://www.aasmnet.org/Resources/PDF/WPSIC.pdf


Based on a quick read of the LCD, it appears that home testing will not be covered in the above states.

Starting a Sleep Lab, part two

Yesterday, I briefly touched upon the necessity of having patients for your sleep lab. And I am not talking about patients with restless legs or insomnia. Though I find those 2 conditions interesting and challenging to treat, they will not generate a large number of sleep studies. You can't support a million dollar sleep lab billing evaluation and management codes for insomnia!

So where will the sleep apnea patients, the bread and butter of sleep medicine come from?
If you are a pulmonlogist and part of a pulmonary group, you have a head start. If you are a psychiatrist/neurologist/non-pulm internist/FP, read on.

Most likely you will need to be part of a "network/association," and I use these words loosely and am not implying an insurance network. Let me give some examples:

1. You could run a sleep lab for a large multi-specialty group, and get referrals from the physicians in the group. If you choose this route, you will most likely get the professional fee for reading the studies, while the profit from the technical component will go to the group as a whole.

2. You could associate yourself with a hospital, perhaps formally and either be employed by the hospital or you could own the sleep lab with the hosptial as a joint venture. Alternatively you could have a less formal association with the hospital (perhaps do ER call for your primary specialty for the hospital with the understanding that sleep patients from the hospital will be directed to your private sleep lab). If you are associated with a hospital, either formally or informally, you can get referrals from other doctors/groups associated with the hospital.

3. You could sell part of your sleep lab to local physician groups (primarily IM/FP, but also cards, ENT). This strategy can work both in the initial stages of starting a sleep lab or for an established sleep lab.

disclaimer: before putting any of these ideas into practice, consult an attorney. Stark doesn't apply to sleep labs (though it does apply to DME), but anti-Kickback rules do.

ADVERTISING: You probably need to do some advertising to patients, but don't rely on this to generate a large number of sleep studies. And aim your advertising towards osa, not insomnia. More important than advertising to patients is hiring someone to promote your sleep practice to other physicians (this can be done on a part-time basis).

More later..

Starting a Sleep Lab, part one

I have had several physicians email/call/PM me recently about how to start a sleep lab, and whether it is still possible with the new CMS decision on home testing.

Regarding home testing: this will have a negative financial impact on sleep physicians, but I don't think it precludes a physician from starting a sleep lab. A lot is still up in the air, however, and the full financial implications of home testing are uncertain.

Even before the CMS decision, starting a sleep lab was a difficult process. I would encourage any physician (or technician or business person) who is interested in starting a sleep lab to attend the annual February American Academy of Sleep Medicine Management Course (see the AASM website for details).

Some things for a physician to think about in starting a sleep lab:

1. Where are the patients going to come from? If you are a pulomonologist and part of a pulmonary group, your group can probably generate enough sleep patients to sustain a sleep lab (roughly 1 sleep bed/pulmonologist). If you are a solo psychiatrist or neurologist, things are going to be tough.

2. Are you established in an area? It's easier to start a sleep lab if you are already a practicing physician in an area and a member of insurance networks.

3. Do you have a million dollars sitting around? The start-up costs for a 6 bed sleep lab are $500,000 to 1 million.

4. Who's going to manage the lab (hire/train technicians, get the lab in network/accredited, etc)? There are companies that you can work with in this regard. There are several companies that both own sleep labs and that partner with physicians and hospitals to run sleep labs- United Sleep Medicine, SleepWorks.

5. Don't even think about becoming involved in DME if you are an inexperienced physician just coming out of sleep fellowship. If you do eventually get involved in DME, make sure the situation is reviewed by a lawyer who is knowledgeable about Stark/anti-kickback rules.

More later.

State of Sleep Medicine 2008, Part one

This is the first in a series of posts in which I discuss sleep industry trends. I'll start with a familiar topic, home testing for Obstructive Sleep Apnea.

HOME TESTING- WHERE ARE WE 3 WEEKS AFTER THE BIG DECISION:

3 weeks ago, CMS approved home testing for OSA on a national level. Currently the Medicare Regions are implementing the national decision via Local Coverage Determinations (LCD), which are not expected to veer too far from the National Coverage Determination (NCD). Specifically, either Type 3 (at least 4 channels) or Type 4 devices with 3 channels (not all Type 4 devices have 3 channels) will be acceptable for diagnosing OSA and qualifying the patient for CPAP. Certain type 3 devices have been, and will continue to remain elgible for reimbursement by Medicare under the following CPT code:

CPT code 95806 (unattended sleep study) by definition involves the absence of a technologist. Unattended sleep studies must meet the CPT definition in order to bill CPT code 95806.95806SLEEP STUDY, SIMULTANEOUS RECORDING OF VENTILATION, RESPIRATORY EFFORT, ECG OR HEART RATE, AND OXYGEN SATURATION, UNATTENDED BY A TECHNOLOGIST.

The Medicare reimbursement for 95806 is slightly over $200 (for the combined technical and professional component of billing).

Commercial insurers are expected to follow Medicare's lead in the upcoming months. Aetna is following Medicare's NCD closely.

American Academy of Sleep Medicine accredited sleep centers/labs that offer home testing will need to use Type 3 devices to stay within AASM guidelines.

At least for now, there has been no change in the coverage for in-lab polysomnography (Medicare and all major insurers cover standard polysomnography and do not require portable testing to be done). CPAP titration studies also remain covered. An in-lab CPAP titration study is not required to prescribe CPAP. In the long-term, it is possible that insurers will try to cut down on the number of the more expensive in-lab studies done.

UNCERTAINTIES IN HOME TESTING:
To what extent will home testing replace in-lab studies? Will primary care doctors move into the sleep apnea business and start to offer home testing? To what extent will home auto-cpap titrations (there is no reimbursement for performing this type of study) replace standard in-lab cpap titrations? Will primary care doctors in rural areas try to treat osa without the involvement of a sleep lab by doing portable testing followed by home auto-cpap titrations?

A FINAL QUESTION TO THINK ABOUT:
Will Auto CPAP replaced fixed-pressure CPAP???? Rather that performing a titration study (either in a lab or at home), will it become standard practice just to prescribe an auto-cpap machine set with a range of 4-20 for permanent use, and then perhaps narrow the pressure range over time???? This would be the most economical strategy for insurance companies, and I think that this is where the sleep industry is headed over the next 5-10 years. I don't think that this is the best strategy for patient care, however.

Symphony of Destruction

Sleep Review Magazine has a Podcast series on portable monitoring. The series starts off with a talk by Mary Susan Esther, MD, President-elect of the AASM. Dr. Esther's talk is followed by that of Dr. Chediak, current AASM President. In the coming days, talks will be added by industry representatives.

Local Coverage Decision for Home Testing for OSA

The local coverage decisions that will implement Medicare coverage for home testing are starting to come out. The following "Future LCD" appears to cover Indiana, New Jersey, New York, and Kentucky:
The diagnosis of sleep apnea may be made using the following modalities:
polysomnography (PSG) performed in a sleep laboratory; or
unattended home sleep monitoring device of Type II; or
unattended home sleep monitoring device of Type III; or
unattended home sleep monitoring device of Type IV, measuring at least three channels (CAG-00093R2)

CPT code 95806 (unattended sleep study) by definition involves the absence of a technologist. Unattended sleep studies must meet the CPT definition in order to bill CPT code 95806.
95806
SLEEP STUDY, SIMULTANEOUS RECORDING OF VENTILATION, RESPIRATORY EFFORT, ECG OR HEART RATE, AND OXYGEN SATURATION, UNATTENDED BY A TECHNOLOGIST

I expect LCD's covering other regions to be similar. The bottom line is that Type 4 devices can be used to diagnose osa and obtain coverage for cpap, but there is no reimbursement for the actual study. The reimbursement for a type 3 study (95806) is about $200.

Get 8 hours of sleep to lose weight

I have previously posted on the relationship between sleep deprivation and weight gain.

Carnie Wison agrees with me:

"Ever since I had my daughter, my focus is not on me; it's on her," says Wilson, who is currently a size 16. "For the past two-and-a-half years, I haven't slept. I am convinced there has to be a link between sleep deprivation and a slower metabolism ... the past year, my workouts have been lazy. I've been snacking on the wrong foods and not drinking enough water."

eHealthTech

The billing for my outpatient sleep practice as well as for Somnus Sleep Clinic (sleep studies) is done by eHealthTech. eHealthTech is stationed in MS, but handles medical billing and physician practice management across the country. I highly recommend eHealthTech to sleep physicians and sleep labs.

Confessions of a sleeping-pill junkie

MSNBC reports on an Ambien junkie (via Kevin MD):
Right off I had trouble adjusting to my new schedule. The workdays went by slowly and the evenings all too quickly, and by the time I got into bed, it was often midnight or later. Knowing I could get only six hours of sleep at the most, I would start to panic. Worrying about not sleeping kept me from sleeping, and by the time my alarm clock sounded, I was lucky if I’d gotten four hours.
So by the time I turned to the sleep aid Ambien for relief, I was desperate — and primed to become an addict.
And I started abusing it almost immediately: I ignored the prolific warnings on the package, called multiple doctors to get it, mixed it with alcohol and took more than the prescribed amount. The makers of this drug never intended it to be used in any of those ways. And neither did I.

Type 4 Devices for Home Testing for OSA

I received the press release below via email. The two main type 4 devices that meet CMS criteria for home testing for OSA are the Itamar Watch-PAT100 and the Resmed ApneaLink (with the optional oximeter). Neither device is acceptable by the AASM for accredited sleep centers. The AASM has approved certain type 3 devices for accredited sleep centers.
Press Release

Hold until 18:00 (13 March, 2008)

"Watch-PAT100 included as an accepted ambulatory device for Medicare and Medicaid beneficiaries"

Itamar Medical Inc. is pleased to report that the Centers for Medicare and Medicaid Services (CMS) has released today its final National Coverage Decision (NCD) where it has decided to cover the Watch-PAT 100 for home diagnosis of obstructive sleep apnea. This decision will make the Watch-PAT available to Medicare beneficiaries nationwide.

"Today's decision will mean that Medicare beneficiaries in the United States will have access to one of the most accurate, convenient, and cost-effective home sleep testing diagnostic device for sleep apnea," said Itamar Medical Inc. CEO Israel Schreiber. "Medicare now joins the Department of Veterans Affairs, Kaiser Permanente, and other organizations and physicians nationwide in recognizing the usefulness and benefits of Watch-PAT in the diagnosis of sleep apnea."

"The Watch-PAT is already a widely used home sleep testing device, and this coverage decision means that all Medicare beneficiaries suspected of having obstructive sleep apnea will have access to a device that was designed to provide uniquely convenient and comfortable use with proven accurate and reliable performance," said Gary Sagiv, Itamar Medical Inc's Vice President.

Another Update on Home Testing for OSA

Several weeks ago I posted that regional Medicare carriers in many states decided not to cover home testing. Apparently those decisions are not in effect and the new national decision takes precedence:
That's because CMS has not yet released its final decision on whether to cover at-home based sleep tests. The decision, expected March 13, will likely favor the proposal. Until then, local coverage policy cannot be updated, said Dr. Hughes."Until the rules change, the rules are what they are," he said.
So basically, the new CMS decision overrides any pre-existing rules, but now that there has been a national decision, local coverage policy can be updated (at least that's my understanding, it's a confusing issue).

Aetna Follows CMS Policy on Home Testing

Please see my earlier posts today about CMS approving home testing for OSA.

Aetna's Policy is very similar to Medicare's:

Aetna considers the diagnosis and treatment of obstructive airway disease medically necessary according to the criteria outlined below.
Diagnosis
Aetna considers any of the following diagnostic techniques medically necessary for members with symptoms suggestive of OSA:
Full-channel nocturnal polysomnography (NPSG) (Type I device) performed in a healthcare facility;
Unattended home sleep monitoring using a Type II, III, or IV device.
Split-night study NPSG in which the final portion of the NPSG is used to titrate continuous positive airway pressure (CPAP);
Note: On occasion, an additional full-night CPAP titration NPSG may be necessary if the split-night study did not allow for the abolishment of the vast majority of obstructive respiratory events or prescribed CPAP treatment does not control clinical symptoms.
Limited-channel NPSG for members with a high pretest probability of OSA (as suggested by the simultaneous presence of snoring, excessive daytime sleepiness, obesity, and observed apneas or nocturnal choking or gasping);
Video-EEG-NPSG (NPSG with video monitoring of body positions and extended EEG channels) to assist with the diagnosis of paroxysmal arousals or other sleep disruptions that are thought to be seizure related when the initial clinical evaluation and results of a standard EEG are inconclusive.
Thank you to my colleague in Ohio for sending me the link to Aetna's policy.

The Key Line in the CMS decision

Please see my post earlier today for the full CMS decision on Home Testing.

I found this line interesting:

unattended home sleep monitoring device of Type IV, measuring at least three channels

I only have a basic understanding of the main Type 4 device on the market, the Resmed ApneaLink. My understanding is that it utilizes a nasal pressure transducer. I just googled it and came up with this site:

http://www.resmed.com/en-us/products/clinical_systems/apnealink/apnealink.html?menu=products

It looks like there is an optional oximeter available, that adds 2 channels (pulse and oximetry) to the nasal pressure transducer channel, giving the required 3 channels.

Are most doctors who are currently using the Resmed ApneaLink also using the optional oximeter??? If anyone has some info about this device, please leave a comment. Thanks.

CMS Approves Home Testing for Obstructive Sleep Apnea

Decision Summary
We received a request to reconsider the 2005 National Coverage Determination (NCD) for CPAP Therapy for OSA (CAG-00093R) to allow coverage of CPAP based upon a diagnosis of OSA by home sleep testing (HST). After considering public comments and additional information, we are making the following changes to the NCD for CPAP. The revised indications and limitations NCD are noted in Appendix B.
Coverage of CPAP is initially limited to a 12 week period for beneficiaries diagnosed with OSA as subsequently described. CPAP is subsequently covered for those beneficiaries diagnosed with OSA whose OSA improved as a result of CPAP during this 12 week period.We remind the reader that Durable Medical Equipment, Prothetics, Orthotics, and Supplies (DMEPOS) suppliers are required to provide beneficiaries with necessary information and instructions on how to use Medicare-covered items safely and effectively. 42 CFR 424.57(c)(12). Failure to meet this standard may result in revocation of the DMEPOS supplier’s billing privileges. 42 CFR 424.57(d).
CPAP for adults is covered when diagnosed using a clinical evaluation and a positive:
polysomnography (PSG) performed in a sleep laboratory; or
unattended home sleep monitoring device of Type II; or
unattended home sleep monitoring device of Type III; or
unattended home sleep monitoring device of Type IV, measuring at least three channels
We remind the reader that, in general, pursuant to 42 CFR 410.32(a) diagnostic tests that are not ordered by the beneficiary’s treating physician are not considered reasonable and necessary. Pursuant to 42 CFR 410.32(b) diagnostic tests payable under the physician fee schedule that are furnished without the required level of supervision by a physician are not reasonable and necessary.
A positive test for OSA is established if either of the following criterion using the Apnea-Hypopnea Index (AHI) or Respiratory Distress Index (RDI) are met:
AHI or RDI greater than or equal to 15 events per hour, or
AHI or RDI greater than or equal to 5 and less than or equal to 14 events per hour with documented symptoms of excessive daytime sleepiness, impaired cognition, mood disorders or insomnia, or documented hypertension, ischemic heart disease, or history of stroke. The AHI is equal to the average number of episodes of apnea and hypopnea per hour. The RDI is equal to the average number of respiratory disturbances per hour.
If the AHI or RDI is calculated based on less than two hours of continuous recorded sleep, the total number of recorded events to calculate the AHI or RDI during sleep testing is at least the number of events that would have been required in a two hour period.
We are deleting the distinct requirements that an individual have moderate to severe OSA and that surgery is a likely alternative.
I wish to thank my colleague in Ohio for sending this to me.

Behavioral Sleep Medicine- Who Should Practice It?

I would like to thank Dr. Perlis for his thougtful response to my Saturday March 1 post. Since not everyone reads the comments, I think that Dr. Perlis's reply deserves its own post and am reprinting it below:

===========> Michael Perlis Reply RE: Michael Rack, MD Post #1169The Threat FROM Psychologists===========>
It is interesting that Dr. Rack phrased the subject to his email this way. I think many people who specialize in Behavioral Sleep Medicine would see this differently, i.e., be concerned about recent initiatives by the AASM as a THREAT TO the continued participation of Psychologists in Sleep Medicine.
MR: Has anyone read the editorial in this month's issue of JCSM by Michael Perlis, Phd? In this editorial about behavioral sleep medicine/CBT-insomnia, Dr. Perlis advocates for the requirement that all accredited sleep disorders centers be required to "have a provider on staff (full time or part time) who is BSM "boarded" or board eligible. ===========>

This was indeed one of many recommendations. There are two issues here. First, it is a fact that most accredited Sleep Disorders Centers (SDCs) do not have people who specialize in the assessment and tx of insomnia. Second, it is a fact that the people who are "boarded" in BSM specialize in the assessment and tx of insomnia and are the only Sleep Medicine clinicians with any certification to conduct CBT-I. So it follows that fully accredited SDCs
Given that the need to provide treatment for all sleep DXs Incl. insomnia
Given the desire to provide the highest standard of care possible
should have BSM "boarded" or board eligible on staff.

MR: I am a DABSM and also certified in sleep medicine by the ABIM. I have also passed the AASM behavioral sleep medicine certification exam, and so I periodically receive emails from Dr. Perlis regarding the issue of who can provide behavioral sleep medicine services (I am also a member of the behavioral sleep medicine committee, but I will not reveal those confidential discussions). There is a growing movement among psychologists who are upset because they are not eligible for the new physician sleep boards to require accredited sleep centers to have BSM-certified individuals (primarily psychologists) on staff.===========>
While there is a contingent of PhD clinicians that are indeed upset about not being eligible for the ABMS exam, this is not the main issue for BSM clinicians. In fact, this issue is old news. The BSM exam was designed and established by the original AASM Presidential Committee for BSM (of which I was a member) precisely to fill the void left by the closure of the ABMS to PhD clinicians. Note: Unlike the new Sleep Medicine Exam… The BSM exam is (and should continue to be) open to PhDs and MDsThe current debate is whether to extend the credentialing process to MA level clinicians (NPs, PAs, etc.). The commentary written by Dr. Smith and I airs out the issues related to this movement and how this might be achieved in a manner that guarantees the highest standards of care be maintained. Finally, please note that one of the recommendations made in our JCSM Commentary is that both BSM and ABMS certified individuals should supervise MA level clinicians.
MR: I encourage all sleep physicians to write the AASM Board of Directors and support the position that physician board certification in sleep medicine qualifies the physician to practice all aspects of sleep medicine, including behavioral sleep medicine. ===========>
There is no question that the certification in sleep medicine does indeed proffer the right for all such certified individuals to practice BSM. The real questions are
1. Do most MDs certified in sleep medicine feel themselves qualified to practice and/or supervise CBT-I and other BSM interventions ?
2. Do most MDs want to practice in this arena ? I think the answer to both questions would be an emphatic “No!”. Perhaps the best analogy, as I understand this, is that MD degree and license is sufficient to for any MD to conduct any form of medicine. So any MD, for example, can conduct assessments and treatment for sleep disorders. The question here, again, is should they ? Are they really qualified? Will they provide the best possible treatment? Like Dr. Rack – I also encourage you to engage these issues and, whatever your opinion, share them with the BSM section leaders and the AASM BOD.
MR: In addition, consider attending the Insomnia Section meeting at Sleep 2008. The Insomnia Section has become a center for psychologists who support Dr. Perlis's position.===========> Please do attend. Although if your expecting this to be a Perlis Supporter Che-Guevara-type meeting… you’ll likely be very disappointed. Sincerely Michael Perlis

Restless Legs Syndrome and Cardiovascular Disease

Dr. Poceta at Sleep Expert recently posted about the link between Restless Legs and Heart Attacks. It seems that restless legs syndrome isn't just an abnormal sensory/motor experience, it also has adverse health consequences:
In a recent blog post,
I reviewed a new study that showed an increased risk of heart disease in patients with restless legs syndrome (RLS). This study and others suggest that RLS, like sleep apnea, is more than just an unpleasant sleep disorder; such that RLS actually raises the chances of having a serious medical condition.
RLS is more than a feeling—patients with RLS have poor sleep and also have periodic limb movements (PLM's) during sleep.
PLM's are the repetitive movements of the foot, leg, and thigh that happen mostly during sleep in patients with RLS.
A recent study sheds some light on how and why RLS could lead to heart attacks—by raising blood pressure during the PLM's.
The study is published in the medical journal Clinical Neurophysiology in mid 2007.
I encourage you to read the full post at Sleep Expert, a revolutionhealth blog.

The Growing Threat from Psychologists

I recently posted the following in the American Academy of Sleep Medicine discussion forums. There is a growing movement among sleep psychologists to limit the ability of sleep physicians to practice the full aspect of sleep medicing. Specifically, some sleep psychologists are trying to make it a condition of sleep center accreditation that the sleep center has a practioner certified in behavioral sleep medicine (which is an AASM certificate examination) on staff. The AASM behavioral sleep medicine certification is primarily for psychologists, though some MD's, including myself, have taken and passed the exam.

Has anyone read the editorial in this month's issue of JCSM (The Feb issue of the Journal of Clinical Sleep Medicine) by Michael Perlis, PhD?
In this editorial about behavioral sleep medicine/CBT-insomnia, Dr. Perlis advocates for the requirement that all accreditied sleep disorders centers be required to "have a provider on staff (full time or part time) who is BSM "boarded" or board elgible.
I am a DABSM and also certified in sleep medicine by the ABIM. I have also passed the AASM behavioral sleep medicine certification exam, and so I periodically receive emails from Dr. Perlis regarding the issue of who can provide behavioral sleep medicine services (I am also a member of the behavioral sleep medicine committee, but I will not reveal those confidential discussions).
There is a growing movement among psychologists who are upset because they are not elgible for the new physician sleep boards to require accredited sleep centers to have BSM-certified individuals (primarily psychologists) on staff.
I encourage all sleep physicians to write the AASM Board of Directors and support the position that physician board certification in sleep medicine qualifies the physician to practice all aspects of sleep medicine, including behavioral sleep medicine. In addition, consider attending the Insomnia Section meeting at Sleep 2008. The Insomnia Section has become a center for psychologists who support Dr. Perlis's position.

Sleep psychologists are trying to force sleep disorders centers to hire them on staff, using AASM accreditation as the enforcement mechanism. Most sleep physicians, including myself, would have no problem with referring CBT-I (cognitive behavioral therapy for insomnia) cases out to qualified psychologists. We board-certified sleep physicians should not, however, be force to hire psychologists, nor be limited in our ability to practice the full spectrum of sleep medicine, including, if we choose, behavioral sleep medicine.

Obtaining Coverage for CPAP and CPAP titrations

Medicare and some insurance companies have strict criteria about covering the purchase of a CPAP machine for a patient. Here is my response to a question on the AASM discussion forums about getting CPAP and CPAP titrations covered for patients who have OSA/Upper airway resistance, but don't meet their insurance company's criteria for CPAP:

My understanding is that the MEdicare criteria (4% desat, etc), are for the coverage of the cpap machine. The actually cpap titration is covered if the attending feels it is medically necessary. So if the AHI (using 4% desat criteria for hypopneas) is less than 5, one approach would be to do a cpap titration-covered by Medicare- and then try to get a DME company to sell the pt a used, discounted cpap machine.

This approach also works with other insurance companies- usually diagnostic testing/titration is covered by a different department within the insurance company than DME. Though it may seem illogical, even insurance companies that have strict criteria for cpap machines will usually approve cpap titrations (at least in the state of Mississippi).

Update on Home Testing for OSA

Sleep Well and Live reports that home testing for OSA will not be covered in many states:

Effective April 1, 2008: “For a study to be reported as a polysomnogram, sleep must be recorded and staged and must be attended. Sleep studies should be performed in a hospital, sleep laboratory or by an Independent Diagnostic Testing Facility that is supervised by a physician (MD/DO) trained in analyzing and interpreting the recordings and should be attended by a trained technologist. Sleep studies performed in the home are not covered.”

The LCD affects the following primary geographic jurisdictions: American Samoa, California, Connecticut, Delaware, Guam, Hawaii, Kentucky, Illinois, Indiana, Maine, Marina Islands, Massachusetts, Michigan, Nevada New Hampshire, New Jersey, New York (with the exception of Queens County), Ohio, Vermont, Virginia, West Virginia, and Wisconsin.

The decline of physician-practice sleep labs

There are 3 basic business structures of sleep labs:
1. hospital-owned
2. independent diagnostic and testing facility (IDTF's)
3. extension of a physician practice

At the AASM Sleep Management course I went to in February, it was reported that business structure 3 comprised less than 5% of sleep labs. The differences between the 3 business structures can be complex, and I plan to talk about this more in future posts. To briefly illustrate the complexity, I will just mention at this time that physicians are often part-owners of IDTF's and hospital associated sleep labs. Physicians sometimes fully own an IDTF.

In my brief career in sleep medicine, the decline of stucture #3 has been a disturbing trend. Sleep Review Magazine reports on how a new interpretation of an old Florida law has led to severe restriction on this type of lab:

In responding to a request from Jacksonville Heart Center (Jax Heart), the State of Florida Board of Medicine finds that physicians of physician-owned labs must directly supervise sleep studies.
In its request, Jax Heart, a group practice comprised of 17 cardiovascular physicians, proposed to establish an eight-bed sleep center as part of its medical practice. The request stated, in part, “.... For sleep studies performed after normal business hours, a Jax Heart physician would be on-call and immediately available by phone."
.....the main issue with the request submitted by Jax Heart was whether the sleep center’s services were being conducted under the “direct supervision” of Jax Heart.
The State of Florida Board of Medicine stated, “If the Sleep Center does provide services under the direct supervision of Jax Heart, the Petitioner’s proposed arrangement does not constitute a ‘referral’ that is precluded by Section 458.053(5), Florida Statutes.
“We found that the law dictated that patients needing a sleep study would be supervised differently depending upon whether the lab was owned by a physician group rather than an IDTF/Hospital,” said Masters.
Ultimately, the Board found that Jax Heart would not be providing services under the “direct supervision” (meaning supervision by a physician who is present in the office suite and immediately available to provide assistance and direction throughout the time services are being performed), and that Jax Heart’s proposed referral of patients to its sleep center is precluded by Section 458.053(5), Florida Statutes.
“It is also important to note that the declaratory statement did not say that physicians are not able to own their own lab—rather that they must provide direct supervision for patient care in a sleep center,” Masters said. “Secondly, the Board reinforced that physician-owned sleep labs must only treat their patients in the sleep center. This provision would not change even if the Direct Supervision requirement was changed to be an exception.”
Read the entire decision here.
Basically, the state of Florida is requiring sleep labs that are an extension of a physician practice to have a physician present whenever sleep studies are run. This is a poorly written article; as I pointed out above, a physician can own all or part of an IDTF. There is a definite distinction between a physician-owned sleep lab and a sleep lab that is an extension of a physician practice.

My Last Comment about Home Testing for OSA

This is my last comment about home testing for OSA, until CMS makes its final decision in March. I have previously extensively discussed the AASM's task force report on home testing, and its role in bringing about home testing for obstructive sleep apnea (click on the Home Testing or Portable Home Testing label below for more details).

Nic Butkov, the RPSGT guru, discusses another development that paved the way to home testing in this month's issue of SLEEP REVIEW:
It has been suggested by some that the new scoring manual is paving the way for portable, limited channel sleep studies and automated scoring. The manual does, in fact, present the respiratory scoring parameters apart from the rest of the polysomnogram, without discussing the relevance of viewing respiratory patterns within the context of the patient's sleep/wake physiology. The only reference to other PSG channels is made by the brief mention of arousal, as a possible scoring criterion for the alternative hypopnea definition and as a criterion for the optional scoring of RERAs. The lack of discussion regarding other PSG parameters creates the impression that respiratory events can be evaluated based solely on respiratory tracings and oximetry, without viewing the polysomnogram as a whole. This is unfortunate because without correlating respiratory patterns with the patient's physiological state, and evaluating their effects upon that state, the interpretation of respiratory events becomes largely a matter of guesswork.
So in addition to the Task Force report, the new American Academy of Sleep Medicine Scoring Manual also played a role in bringing about CMS approval of home testing for qualifying a patient for cpap therapy. Although the AASM claims it is going to work with regional Mediare carriers to limit home testing to board certified sleep specialists (wouldn't it be funny if some carriers excluded diplomates of the American Board of Sleep Medicine but instead required passing the new American Board of Internal Medicine test?), it is my opinion that most Medicare carriers will not limit the specialties that can perform home testing. The AASM has made its bed and now has to lie in it.

Respiratory Therapists Try to Take over Polysomnography in California

I previously posted on the attempt of respiratory therapists to take control over polysomnography in California.
The process is moving forward. As reported by Sleep Review Magazine,
Introduced by State Sen Jeff Denham (R-Merced), the “Polysomnographic Technologist Act” Senate Bill 1125 aims to prevent criminal abuse and ensure proper medical diagnosis, as well as ensure a standard of training and accountability for the profession.
"Hundreds and possibly thousands of unlicensed technicians are working with patients in vulnerable circumstances where most have not had a criminal background check and competency testing is optional. Failure to perform competently and protect the consumer holds little or no consequence for unlicensed personnel," said Stephanie Nunez, executive officer for the Respiratory Care Board of California.
The actual text of the bill is here. Some key parts of the bill:
"Board" means the Respiratory Care Board of California.

b) The failure of an employer to provide documents as required bythis section is punishable by an administrative fine not to exceedfifteen thousand dollars ($15,000) per violation. This penalty shallbe in addition to, and not in lieu of, any other civil or criminalremedies. 3818. The board shall issue, deny, suspend, place probationaryterms upon, and revoke licenses to practice polysomnography andpolysomnography-related respiratory care services.
The board shall determine the hours of credit tobe granted for the passage of particular examinations. 3819.5. The board may require successful completion of one ormore professional courses offered by the board, the AmericanAssociation for Respiratory Care, the California Society forRespiratory Care, or the National Board for Respiratory Care in anyor all of the following circumstances: (a) As part of continuing education. (b) Prior to initial licensure.
As I interpret it, this California bill would give respiratory therapists, through their board, the power to license sleep lab technicians and fine labs that hire technicians not licensed by their board. This law is a slap in the face to the majority of sleep technicians who are not respiratory therapists.

The Failure of the AASM Leadership

The Feb 15 issue of the Journal of Clinical Sleep Medicine has an editorial on "Why CMS Approved Home Sleep Testing for CPAP Coverage", by Dr. Chediak, President of the American Academy of Sleep Medicine. The editorial is a glaring whitewash of AASM's role in this debacle. A sample statement from this editorial is: "While there was variance in the degree of conviction, in general, the AASM, ACCP, and ATS testified against the indiscriminate use of HST" (HST= home sleep testing).
Dr. Chediak makes no mention of the AASM Task Force Report on Portable Monitors in the Diagnosis of Obstructive Sleep Apnea. This report, which came out in the middle of the CMS decision making process, basically came out in favor of home testing (when performed by sleep physicians in AASM-accredited sleep centers). After the task force report came out, the perception among CMS officials and the public was that the AASM had approved of home testing. After this task report came out, how could CMS not approve of home testing?
----------------------------------------
Valid arguements can be made in favor of HST. However for the AASM to initially come out against HST and then months later publish a task force report that was widely viewed as being an endorsement of HST is an incredible lack of leadership on the part of the AASM's Board of Directors.
I think that every member of the AASM Board of Directors who voted to approve the Task Force Report should resign.

The life of a sleep doctor

I have answered 20 questions about the life of a sleep physician for the Student Doctor Network.
Here is a sample question and answer:
What is the best way to prepare for this specialty?
Sleep medicine is a one year fellowship after a psychiatry, neurology, ENT, family practice, pediatrics, or internal medicine residency. The best way to prepare is to do one or two sleep medicine elective months during residency. Sleep medicine is becoming a more competitive fellowship, and it is hard for someone who has only completed an internal medicine residency to get- general internists are competing with pulmonary specialists for slots. If a resident is trying to go straight from internal medicine residency to sleep fellowship (rather than doing a pulmonary fellowship first), some sleep research during residency would be helpful.
Read more here.

Treatment of Posttraumatic Sleep Disturbances

Sleep disturbance is common after head injury. Here is part of an article I wrote on posttraumatic sleep disturbance:

Patients with narcolepsy secondary to a head injury or posttraumatic hypersomnia often require stimulant medication such as methylphenidate or amphetamines in doses similar to those for idiopathic narcolepsy-cataplexy syndrome. Modafinil may be the medication of first intention; it has fewer side-effects overall than the other stimulants. The dosage is usually 300 to 400 mg, administered in 2 divided doses in the morning and at lunch time. Modafinil, however, activates hypothalamic regions and does not act directly through dopaminergic or noradrenergic pathways; and patients with severe head trauma who complain of intellectual slowness may benefit more from amphetamine-like medications. These medications will have a general “activating” effect that is not solely devoted to sleepiness. Of course, any coexistent sleep pathology or neurologic disease requires independent management. The potential beneficial effects of naps have not been studied; they should probably be restricted to less than 30 minutes to avoid significant sleep inertia effects. They should be taken when the patient feels sleepiest but not within 4 or 5 hours of habitual nocturnal sleep time.
Cases of sleep apnea resulting from a head injury are treated in the usual manner with continuous or bilevel positive airway pressure therapy. Sometimes the spontaneous/timed mode of bilevel positive airway pressure therapy is necessary for central sleep apnea and mixed obstructive/central sleep apnea. Adaptive-servo ventilation has recently become available to treat central and mixed sleep apnea, but experience in non-heart failure patients is limited. Treatment of sleep apnea should be conducted by a sleep disorders specialist. Posttraumatic organic insomnia has generally proven difficult to treat. Patients respond rather poorly to the benzodiazepine hypnotics employed to help initiate and maintain sleep. Cognitive behavioral therapy, including stimulus control, sleep restriction, cognitive restructuring, sleep hygiene education, and fatigue management, can improve nocturnal sleep quality as well as reduce daytime fatigue (Ouellet and Morin 2007

You can read more at Medlink Neurology

Cell Phones and Sleep

A new study suggests that mobile phones interfere with sleep:
By Geoffrey Lean, Environment Editor
Published: 20 January 2008
Radiation from mobile phones delays and reduces sleep, and causes headaches and confusion, according to a new study.
The research, sponsored by the mobile phone companies themselves, shows that using the handsets before bed causes people to take longer to reach the deeper stages of sleep and to spend less time in them, interfering with the body's ability to repair damage suffered during the day.
The scientists studied 35 men and 36 women aged between 18 and 45. Some were exposed to radiation that exactly mimicked what is received when using mobile phones; others were placed in precisely the same conditions, but given only "sham" exposure, receiving no radiation at all.
The people who had received the radiation took longer to enter the first of the deeper stages of sleep, and spent less time in the deepest one. The scientists concluded: "The study indicates that during laboratory exposure to 884 MHz wireless signals components of sleep believed to be important for recovery from daily wear and tear are adversely affected."
The embarrassed Mobile Manufacturers Forum played down the results, insisting – at apparent variance with this published conclusion – that its "results were inconclusive" and that "the researchers did not claim that exposure caused sleep disturbance".
But Professor Bengt Arnetz, who led the study, says: "We did find an effect from mobile phones from exposure scenarios that were realistic. This suggests that they have measurable effects on the brain."

My Official Comment on Home Testing

Although several posts ago I stated that I was not going to comment on home testing for osa at the official CMS comment site, I changed my mind. Here is what I posted a few minutes ago:

Comment: I am against home testing for osa, but if home testing is to be implemented, allow me to make the following suggestions:
1. DME companies should not be allowed to provide home testing, due to the conflict of interest in providing a qualifying test for a product the DME company provides.
2. Any licensed physician should be able to provide home testing for osa. I am not aware of any precedent limiting a diagnostic test to a particular specialty, and I do not believe that limiting a 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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Resmed Consultant Behind Home Testing Movement

Sleep Well and Live has an interesting post today about the movement for home osa testing and its originator:
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.

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.
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.
I encourage you to read the full post.

osa home testing hits the mainstream media

This is the first news article I've seen about home testing for osa outside of an industry publication:
Last month, the American Academy of Sleep Medicine, which represents sleep centers, changed its position to say home tests can help certain high-risk patients - but should be administered by sleep specialists.Medicare's proposal wouldn't limit which doctors offer home tests. The American Academy of Otolaryngology, head-and-neck surgeons, requested the change.
There are some inaccuracies in the article, like this statement:
In fact, Medicare concluded a sleep-lab test isn't perfect, either - and thus proposed that all patients get a 12-week trial of CPAP treatment. Only if their doctors certify they're being helped would treatment continue.

Why I am not commenting (officially) on Home Testing

On the AASM discussion forum (open to members only), some have been advocating that sleep physicians comment on the CMS (Medicare) website either 1) in oppostion to home testing for osa or 2) to request that home testing be limited to certain devices or to AASM accredited sleep labs. I posted this on the AASM discussion forum a few minutes ago:

I am not going to comment on the CMS website comment section because:
1. Home testing is inevitable. How can a sleep physician argue against home testing when industry publications, such as Sleep Review Magazine, have "AASM Approves Home Sleep Testing to Detect Sleep Apnea" as one of their headlines.
2. Some have argued that sleep physicians should try to limit home testing to type 3 devices, as opposed to type 4. This would make very little economic difference to sleep centers. Frankly, if home testing is going to be a reality, I would like the freedom to pick the device that I, as a sleep professional, felt was most appropriate for the situation. For example, home oximetry could be useful for triaging patients to psg vs split-night study. Here is a study from the JCSM that supports the use of the ApneaLink, a single channel recording device: http://www.aasmnet.org/jcsm/Articles/030409.pdf
3. Some have argued that home testing should be limited to AASM-accredited labs. As an accreditation site visitor for nearly a year, it is my understanding that AASM accreditation was always meant to be voluntary, and that the AASM's position was that it did not promote accreditation status as being necessary for insurance reimbursement. The AASM is not a government agency! I don't think that the AASM should have the power to determine which sleep labs are elgible for government (Medicare) reimbursement. Michael Rack, MD

sleep and diabetes

The evidence continues to grow linking poor sleep to diabetes:
WASHINGTON (Dec. 31) - When Shakespeare called sleep the "chief nourisher of life's feast," he may have been well ahead of his time, medically at least. Researchers at the University of Chicago Medical Center report that disrupting sleep damages the body's ability to regulate blood sugar levels, potentially raising the risk of developing type 2 diabetes.More than 18 million Americans have diabetes and the most common form is type 2, in which the body either becomes resistant to insulin or doesn't produce enough of it to regulate sugar in the bloodstream.In a small experiment, researchers led by Dr. Esra Tasali, an assistant professor of medicine, found that disrupting the deepest sleep periods of volunteers rapidly resulted in reduction in their ability to regulate blood-sugar levels.The findings are reported in Monday's online edition of Proceedings of the National Academy of Sciences.The researchers studied the sleep patterns of nine volunteers, five men and four women, all of normal weight, in good health and aged 20 to 31.Normal sleep is divided into several stages, with the so-called slow-wave sleep considered the deepest.Whenever the volunteers went into slow-wave sleep the researchers made noise — enough to disturb the sleep though not to fully awaken them.After just three days the ability of the volunteers to regulate blood sugar was reduced by 25 percent, the researchers reported.Earlier studies have indicated that lack of sleep can reduce the ability to regulate sugar, and this report adds evidence that poor sleep quality is also a diabetes risk."This decrease in slow-wave sleep resembles the changes in sleep patterns caused by 40 years of aging," Tasali said in a statement. Young adults spend 80 to 100 minutes per night in slow-wave sleep, while people over age 60 generally have less than 20 minutes. "In this experiment," she said, "we gave people in their 20s the sleep of those in their 60s.""Since reduced amounts of deep sleep are typical of aging and of common obesity-related sleep disorders, such as obstructive sleep apnea, these results suggest that strategies to improve sleep quality, as well as quantity, may help to prevent or delay the onset of type 2 diabetes in populations at risk," said co-author Dr. Eve Van Cauter, a professor of medicine.

Nasal Orexin for Sleepiness

Wired.com reports on an experimental orexin nasal spray that combats sleepiness. Orexin deficiency is the main cause of narcolepsy with cataplexy. This sounds like a promising treatment for narcolepsy and idiopathic hypersomnia. I do not think this would be an appropriate treatment for voluntary sleep deprivation (except perhaps in the military):
Darpa-funded scientists might have found a drug that will eliminate sleepiness.
A nasal spray containing a naturally occurring brain hormone called orexin A reversed the effects of sleep deprivation in monkeys, allowing them to perform like well-rested monkeys on cognitive tests. The discovery's first application will probably be in treatment of the severe sleep disorder narcolepsy.
"It reduces sleepiness without causing edginess."
Orexin A is a promising candidate to become a "sleep replacement" drug. For decades, stimulants have been used to combat sleepiness, but they can be addictive and often have side effects, including raising blood pressure or causing mood swings.
The monkeys were deprived of sleep for 30 to 36 hours and then given either orexin A or a saline placebo before taking standard cognitive tests. The monkeys given orexin A in a nasal spray scored about the same as alert monkeys, while the saline-control group was severely impaired.
The study, published in the Dec. 26 edition of The Journal of Neuroscience, found orexin A not only restored monkeys' cognitive abilities but made their brains look "awake" in PET scans.
Siegel said that orexin A is unique in that it only had an impact on sleepy monkeys, not alert ones, and that it is "specific in reversing the effects of sleepiness" without other impacts on the brain.
Such a product could be widely desired by the more than 70 percent of Americans who the National Sleep Foundation estimates get less than the generally recommended eight hours of sleep per night
The research follows the discovery by Siegel that the absence of orexin A appears to cause narcolepsy. That finding pointed to a major role for the peptide's absence in causing sleepiness. It stood to reason that if the deficit of orexin A makes people sleepy, adding it back into the brain would reduce the effects, said Siegel.
"What we've been doing so far is increasing arousal without dealing with the underlying problem," he said. "If the underlying deficit is a loss of orexin, and it clearly is, then the best treatment would be orexin."
Dr. Michael Twery, director of the National Center on Sleep Disorders Research, said that while research into drugs for sleepiness is "very interesting," he cautioned that the long-term consequences of not sleeping were not well-known.
Both Twery and Siegel noted that it is unclear whether or not treating the brain chemistry behind sleepiness would alleviate the other problems associated with sleep deprivation.
"New research indicates that not getting enough sleep is associated with increased risk of cardiovascular disease and metabolic disorders," said Twery.
Still, Siegel said that Americans already recognize that sleepiness is a problem and have long treated it with a variety of stimulants.
"We have to realize that we are already living in a society where we are already self-medicating with caffeine," he said.
He also said that modafinil, which is marketed as Provigil by Cephalon and Alertec in Canada, has become widely used by healthy individuals for managing sleepiness.
"We have these other precedents, and it's not clear that you can't use orexin A temporarily to reduce sleep," said Siegel. "On the other hand, you'd have to be a fool to advocate taking this and reducing sleep as much as possible."
Sleep advocates probably won't have to worry about orexin A reaching drugstore shelves for many years. Any commercial treatment using the substance would need approval from the Food and Drug Administration, which can take more than a decade.

Home Testing Comments

Interested in commenting on home testing for OSA? Here is the link:

http://www.cms.hhs.gov/mcd/viewpubliccomments.asp?nca_id=204&rangebegin=12_14_2007&rangeend=01_13_2008

Or you can just read the comments others have made to CMS.

AASM Holiday Sleep Tips

AASM Issues Holiday Sleep Tips (via Sleep Review)
Rest of Sleep Review quote deleted, due to their request
Chediak offers these suggestions for better sleep during the holiday season:
• Take time to relax, and ensure time to wind down before bed.• Keep a regular sleep schedule. Maintain a regular bedtime and wake-up time. Other regular rituals, such as a warm bath, a light snack or a few minutes of reading, also may help.• Plan ahead for holiday activities. Set aside time earlier in the day to wrap gifts, decorate the house, plan your holiday menu, and do similar tasks. To stay on track, write these “appointments” in a daily planner.• Drowsy drivers should pull off to a rest area and take a short nap, preferably 15 to 20 minutes in length.• Do not eat heavy meals right before bedtime. This might cause heartburn or discomfort, which can disturb sleep.• Love eggnog? Avoid too much alcoholic eggnog or coffee at evening holiday parties. Alcohol and caffeine can inhibit normal sleep patterns.

IDTF's can no longer perform sleep studies in hotels

Sleep Review reports that:
Hotels/Motels Not Appropriate for Sleep Studies, CMS Says
New regulatory standards for independent diagnostic testing facilities released by CMS last month are scheduled to take effect January 1, 2008.
Among the standards is one that rules out the use of hotels and motels for performing sleep studies.
For more info, see here.
I believe that this ruling only applies to IDTF's. As an AASM accreditation site visitor, I have inspected a university-owned sleep lab that was based in a hotel. It was a nice operation. I don't agree with this CMS decision, though it will affect only a few sleep labs.

More on home testing for sleep apnea

Sleep Review Magazine reports on home testing for osa:
Last week, home testing took a step closer to becoming a covered benefit under CMS....
deleted upon request of Sleep Review Magazine.
reimbursement criteriaRead the entire announcement by clicking here.

Portable Monitoring Webinar

From the American Academy of Sleep Medicine website:

Get an in-depth overview of the new guidelines for portable monitoring and answers to frequently asked questions by registering for Portable Monitoring Discussion Forum.
AASM Portable Monitoring Task Force chair Nancy Collop, MD, will lead this 60-minute Webinar on December 18, 2007, at 12 p.m. CST. Please note that registrants must submit questions in advance to rrosenberg@aasmnet.org. The deadline to submit questions has been extended to 5 p.m. CST, December 14, 2007.
Log on to www.aasmnet.org/SleepEdSeries.aspx to register for Portable Monitoring Discussion Forum.
The new guideline will be published in the December issue of the Journal of Clinical Sleep Medicine; visit www.aasmnet.org/PortableMonitoring.aspx for comprehensive information.

Preliminary Approval for Home Testing for OSA

Home testing for OSA preliminarly approved: http://www.cms.hhs.gov/mcd/viewdraftdecisionmemo.asp?from2=viewdraftdecisionmemo.asp&id=204&

Not only were type 2 (unattended polysomnogram) and type 3 devices (four channel) approved, but unexpectedly type 4 (1 or 2 channel) devices were also approved.

I am glad that I sold off my shares of Sleep Holdings Inc last week. I wish I would have bought Respironics instead of Resmed on Friday- Respironics makes the superior pulse oximeter (type 4 device)- the 920 M series.

Organized Medicine Endorses Home Testing

I've previously blogged in depth about the American Academy of Sleep Medicine endorsing home testing for the diagnosis of obstructive sleep apnea. Now the American Board of Internal Medicine has also (implicitly) endorsed it:

The ability to interpret results of polysomnography multiple sleep latency testing, maintenance of wakefulness testing, actigraphy, and portable monitoring related to sleep disorders.The ability to interpret results of polysomnography multiple sleep latency testing, maintenance of wakefulness testing, actigraphy, and portable monitoring related to sleep disorders.
From the ABIM website, training and procedural requirements for sleep medicine certification

The preliminary decision from the Center for Medicare Services regarding home testing for osa is expected today.

Sleep Lab Busted by Medicare

Sleep Review magazine reports that HMS Diagnostics Inc was recently busted by CMS (Medicare) for having uncertified technicians run sleep studies on Medicare patients:
Sleep Lab Medicare Claims Under Investigation
According to the release, the US Attorney's Office seems to be suggesting that any CPT 98510 or CPT 98511 study not actually performed by a credentialed technician cannot be billed. The fact that the credentialed technician is on site and supervising apparently is not a factor, HMS Diagnostics stated in the release.
Rest of quote from Sleep Review article deleted, due to their request
“If what CMS is saying is true, then the amount of money that would be owed to Medicare by the industry is phenomenal,” says Goodman. “The liability potential on an industry such as ours with Medicare could be a very big number.”
This is a disturbing development. The requirement for tech certification is virtually unknown in the sleep community. On the AASM message boards, we were recently discussing a new CMS regulation that All studies are to be done by a certified polysomnographer by January 1, 2008 in Arkansas, Louisiana, Eastern Missouri, New Mexico, and Oklahoma and by October 1, 2008 in Rhode Island; and the consensus was that uncertified technicians were ok for the time being in most other states. Most sleep labs have a combination of certified and uncertified techs, and I agree with the article that if CMS is going to enforce this newly discovered regulation, the amount of money owed would be phenomenal.

More on Portable Home Testing and Auto-CPAP

In response to a reader who emailed regarding my predictions of cpap vs. auto-cpap useage:

I don't think that APAP will entirely replace CPAP, but its marketshare will increase somewhat. This will be good for Respironics/RESmed, and bad for the durable medical equipment companies (DME's are reimbursed the same for cpap/auto-cpap machines and therefore there is a higher profit margin on the regular cpap machines for the DME companies). APAP will be prescribed in certain rural areas of the country by some primary care docs. After diagnosing a patient with portable home testing, they will tend to prescribe an auto-cpap machine rather than refer their patients to a sleep lab for a cpap titration. This will have little economic effect on the primary care doc, they will do this to maintain control of the process and maintain their independence from sleep labs. Some primary care docs, especially family practitioners in rural areas, take pride in being able to handle most problems themselves rather than referring to specialists.

Don't Blame the Turkey

Feel sleepy after a big Thanksgiving meal? Contrary to popular thinking, it's not the turkey's fault.
While there is an amino acid in turkey that induces sleepiness, experts say it's much more likely the reason you're tired after having Thanksgiving dinner is a combination of simple factors: you ate and drank too much and didn't sleep enough.
So don't blame the turkey.
"The poor turkeys have enough problems on Thanksgiving," said Dr. Carol Ash of Somerset Medical Center's Sleep for Life Center in Hillsborough, New Jersey.
The reason turkey gets blamed for making people sleepy is because it contains tryptophan, an amino acid that produces the brain chemical serotonin, which promotes calm and sleepiness. But as part of a big dinner, the tryptophan has a hard time reaching the brain.
Even if it did, "you'd have to ingest quite a number of turkeys" for it to have an effect, she said.
If the tiredness has anything to do with dinner, Ash said, it would be because of carbohydrates, which studies show are more likely to make people sleepy. And even that would only be a small factor, she said.
There's the travel, working longer days to get things done and lack of sleep, along with the carbs and alcohol, she said.
Overeating also contributes to feeling tired at Thanksgiving, said Joan Salge Blake, a registered dietitian and nutrition professor at Boston University.
"You're just eating a whole heck of a lot of foods and are stuffed," said Salge Blake.
On top of that, she added, you're "often just sitting around afterward, watching football."
From Cnn.com
Bottom line: if you are sleepy after thanksgiving dinner, it is probably due to a combination of over-eating, alcohol, sleep deprivation, and excessive carbohydrates. It's not due to the tryptophan in turkeys.

Duloxetine may improve sleep in patients with diabetic neuropathy

Clinical Psychiatry News reports on a poster presentation suggesting that duloxetine improves sleep in in patients with diabetic neuropathy:
WASHINGTON – Not only does duloxetine appear to reduce the severity of pain, especially during the night, but it may also help patients with diabetic peripheral neuropathy get a better night's sleep, according to a poster presentation at the annual meeting of the American Pain Society.
After 12 weeks of treatment, patients on 60 mg of duloxetine once or twice daily had improvements in average daily pain severity, night pain severity, and pain-related sleep interference, wrote Dr. David A. Fishbain, professor of psychiatry and behavioral sciences at the University of Miami, and his colleagues at Eli Lilly, maker of duloxetine (Cymbalta).
Although causality cannot be demonstrated between duloxetine and better sleep, the findings suggest that improvements in pain will be associated with less interference in sleep, the authors wrote.
The researchers pooled data from three double-blind, placebo-controlled trials of duloxetine in patients with diabetic peripheral neuropathic pain (DPNP). In the first study, 457 patients were randomized to receive 20 mg of duloxetine once daily, 60 mg of duloxetine once or twice daily, or placebo. In studies two and three, 334 and 348 patients, respectively, were randomized to receive 60 mg of duloxetine once daily, 60 mg of duloxetine twice daily, or placebo. Although the primary efficacy measure for the studies was the reduction in the weekly mean of the 24-hour average pain score, secondary end points included average daily night pain severity (measured on an 11-point Likert scale) and the Brief Pain Inventory sleep interference item.
Patients were included in the trials if they were 18 years or older with pain because of bilateral peripheral neuropathy caused by type 1 or type 2 diabetes mellitus. Pain had to have begun in the feet with relatively symmetric onset. Diagnosis was confirmed by a score of at least three on the Michigan Neuropathy Screening Instrument. Daily pain had to be present for at least 6 months. Patients also had to have at least a 4 on the 24-hour average pain severity (11-point Likert) scale and stable glycemic control. Notably, patients with a current or recent (within the last year) diagnosis of major depressive disorder as defined by the DSM-IV were excluded from the studies.
The researchers identified a subset of nonsomnolent patients by excluding those who reported treatment-emergent somnolence or who were on concomitant sedating medications. Treatment-emergent somnolence included reports of daytime sleepiness, drowsiness, being drowsy upon awakening, excessive daytime sleepiness, a feeling of residual sleepiness, groggy, groggy and sluggish, groggy on awakening, hard to awaken, less alert on rising, sleepiness, sleepy, and somnolence.
In all three studies, 339 patients received placebo. Of these, 307 met the criteria for the nonsomnolent subset. A total of 685 patients received 60 mg or 120 mg per day of duloxetine in all three studies. Of these, 607 met the criteria for the nonsomnolent subset. Patients in the nonsomnolent/nonsedating subgroup who were on duloxetine showed improvements in daily average pain and night pain severity, compared with those on placebo. The improvements started as early as 1 week and were maintained for 12 weeks. At 12 weeks, subset patients on 60 mg of duloxetine once and twice daily had improvements in daily average pain severity of 47% and 50%, compared with 29% for those on placebo.
Also at 12 weeks, subset patients on 60 mg of duloxetine once and twice daily had improvements in night pain severity of 47% and 51%, respectively, compared with 34% for those on placebo.
Most of the SSRI's and dual reuptake antidepressants can cause insomnia when used to treat major depressive disorder. This study suggests that by improving pain, duloxetine (which increases synaptic levels of serotonin and norepinephrine by inhibiting their reuptake) improves sleep in non-depressed patients with diabetic neuropathy. One limitation to this study is that patients who developed somnolence were excluded from analysis.