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