CMS Decision on Home Testing

Released 3/3/09

Decision Summary
CMS finds that the evidence is sufficient to determine that the results of the sleep tests identified below can be used by a beneficiary’s treating physician to diagnose OSA, that the use of such sleep testing technologies demonstrates improved health outcomes in Medicare beneficiaries who have OSA and receive the appropriate treatment, and that these tests are thus reasonable and necessary under section 1862(a)(1)(A) of the Social Security Act.
Therefore:
Type I Polysomnography (PSG) is covered when used to aid the diagnosis of obstructive sleep apnea (OSA) in beneficiaries who have clinical signs and symptoms indicative of OSA if performed attended in a sleep lab facility.
A Type II or a Type III sleep testing device is covered when used to aid the diagnosis of obstructive sleep apnea (OSA) in beneficiaries who have clinical signs and symptoms indicative of OSA if performed unattended in or out of a sleep lab facility or attended in a sleep lab facility.
A Type IV sleep testing device measuring three or more channels, one of which is airflow, is covered when used to aid the diagnosis of obstructive sleep apnea (OSA) in beneficiaries who have signs and symptoms indicative of OSA if performed unattended in or out of a sleep lab facility or attended in a sleep lab facility.
A sleep testing device measuring three or more channels that include actigraphy, oximetry, and peripheral arterial tone is covered when used to aid the diagnosis of obstructive sleep apnea (OSA) in beneficiaries who have signs and symptoms indicative of OSA if performed unattended in or out of a sleep lab facility or attended in a sleep lab facility.

DME Companies Left Out of Home Testing

It appears that Durable Medical Equipment companies have been left out of home testing by most of the regional Medicare carriers.
Here is part of the Local Coverage Determination for Positive Airway Pressure (PAP) Devices for the Treatment of Obstructive Sleep Apnea (L11518) for Cigna Government Services:

No aspect of an HST, including but not limited to delivery and/or pickup of the device, may be performed by a DME supplier. This prohibition does not extend to the results of studies conducted by hospitals certified to do such tests.

The LCD also states:

The test must be ordered by the beneficiary’s treating physician and conducted by an entity that qualifies as a Medicare provider of sleep tests and is in compliance with all applicable state regulatory requirements.

I interpret this section is not allowing individual doctors to perform home testing in the area covered by Cigna Government Services. It seems that home testing must be performed by a sleep center/sleep lab.

Home Testing Reimbursement Announced

The AASM reports that Trailblazer, the Medicare carrier for Texas and surrounding states (not Mississippi) has decided reimbursement rates for home testing for OSA:

G0399: Home Sleep Testing, Type III portable monitor; minimum 4 channels - $125.00 - $85 is recognized for the Professional Component - $35 is recognized for the Technical Component

With a low reimbursement like this, home testing is not going to quickly become widespread.

Somnus Sleep Clinic is trying out its Type III home testing device tonight. I should be able to let you know next week how it worked out.

Type 3 Home Testing Device

At Somnus Sleep Clinic, we finally obtained a type 3 home testing device, the SleepTrek 3:

SleepTrek3, a 6-channel Home Sleep Screener, is a small lightweight physiological data recorder specifically designed to assist the clinician in the diagnosis of sleep-disordered breathing. SleepTrek3, Type III Sleep Screener, uses sensors to record oxygen saturation, pulse rate, airflow, snoring, respiratory effort and body position. The screener is designed to be used in a supervised (hospital/institutional) or unsupervised (home) environment. It is capable of recording 12+ hours of patient data using a single 3.6-volt Lithium battery and a CompactFlashCard.

The SleepTrek 3 has been available for several months. Our holdup in getting it was that we were waiting for the software that would allow it to be fully integrated with the Grass Twin PSG system.
We plan to test it over the next week, I'll let you know how it turns out.

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

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.

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 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.

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.

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.

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.

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.

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.