Note: Dr. Collop has an NIH Small Business Innovation Research (SBIR) Grant with CleveMed, a company that makes a wireless PSG product, which might be considered for home monitoring. The device is currently being used in the hospital, not the home.
On March 13, the Centers for Medicare and Medicaid Services (CMS) ruled that it would reimburse continuous positive airway pressure (CPAP) treatment if diagnosed with a clinical evaluation and a positive result from an unattended home monitoring device. Prior to this date, CMS covered CPAP only if sleep apnea was diagnosed in a sleep laboratory with polysomnography (PSG).
CMS examined whether patients had a change in health outcomes based on the type of sleep testing they received, and did not find a difference between home monitoring and PSG, said Terence Davidson, MD, Professor of Surgery in the Division of Otolaryngology-Head and Neck Surgery and Director of the Sleep Center at the University of California at San Diego.
The American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS) petitioned CMS in January 2007 to consider payment for CPAP diagnosed with home testing, and many academy members participated in the CMS review process during the following year.
Even as Dr. Davidson described the new ruling as an excellent decision, several questions and concerns remain, according to other experts interviewed for this article.
Immediate Implications for Patients and Physicians
Because sleep apnea is a common problem, physicians need to move toward paradigms in which they quickly, efficiently, and inexpensively diagnose and get people on treatment, said Dr. Davidson. The CMS ruling was an important first step toward doing this, he explained.
The ruling will mean better access to sleep apnea testing for patients and an alternative to undergoing PSG in a sleep center, said Pell Ann Wardrop, MD, an otolaryngologist and sleep medicine specialist at Wardrop Medical Services, PLLC, in Lexington, KY.
Additionally, some otolaryngologists who view sleep disorders as a substantial part of their practice may decide to purchase home testing devices to diagnose sleep apnea, said Dr. Davidson. Many pulmonary physicians and even sleep physicians will also incorporate this technology into their practices, he said.
Those otolaryngologists and other physicians who choose to invest in the machines will need to designate office personnel to educate patients about home testing, said Dr. Davidson. Home sleep testing is simple, but not trivial, he said. It’s not like you buy a machine and every once in a while get it out and give it to the patient.
However, purchasing home testing equipment could be premature for otolaryngologists unless they prescribe CPAP devices and see Medicare patients, said Edward Weaver, MD, MPH, Associate Professor of Otolaryngology and Chief of Sleep Surgery at the University of Washington and Harborview Medical Center in Seattle.
The new ruling does not necessarily mean that otolaryngologists who don’t currently use home monitoring are going to start using it, said Dr. Wardrop. This is partly because local carrier determinations are not going to let everyone use home testing, she explained.
For example, in Kentucky, these determinations require that only sleep centers that adhere to American Academy of Sleep Medicine (AASM) accreditation rules can offer home testing, said Dr. Wardrop.
Ruling Raises Some Concerns
Although the CMS ruling makes home testing more readily available, some sleep doctors are concerned the care patients receive will not be as good as that at a sleep center, said Dr. Wardrop. They’re worried that other specialists or general practitioners won’t use home monitoring correctly or won’t adequately follow up with CPAP care, she added.
Dr. Davidson thinks that because sleep apnea is an anatomic disorder of the upper respiratory tract, otolaryngologists should be making the initial diagnosis and offering subsequent treatment. It’s a little peculiar that it is primarily treated by neurologists, psychiatrists, and pulmonologists, he said.
Although some turf battles over testing and treatment may arise, Dr. Wardrop sees a great opportunity for cooperative care. Sleep apnea is a chronic disease and requires a chronic disease model of care, she said. It may be possible for primary care physicians and otolaryngologists to work together in the diagnosis and treatment of patients with sleep disorders. In some settings, the primary care physician may order the home testing, and in others, the otolaryngologist or other sleep specialist may take on this role, she said.
Another concern is that the ruling has left the door open as to whether durable medical equipment (DME) companies can offer sleep testing, said Dr. Wardrop.
DME centers that dispense CPAP equipment will likely be capable of providing home sleep testing as well and will contract with physicians to provide the service, explained Dr. Davidson.
There’s concern about companies trying to get into the business and taking advantage of the system, noted Nancy Collop, MD, Associate Professor of Medicine at Johns Hopkins University in Baltimore and Director of the Johns Hopkins Sleep Disorders Center.
Companies could potentially market home testing devices to non-sleep specialists, added Dr. Collop, who is also on the board of the AASM. The concern is that these companies will offer to set patients up with home monitoring, score the study, and then set them up on CPAP, while the physicians don’t have to do anything, she said.
In an ideal situation, a practitioner would know how to use the device, evaluate the test, and get the patient started on treatment, said Dr. Collop.
The CMS ruling also does not address what practitioners should do once they diagnose sleep apnea, said Dr. Collop. If ENTs are offering this type of diagnosis, then do they perform surgery or do they offer CPAP? she questioned.
If CPAP is used, physicians need to consider whether it should be autotritrating or empiric and whether it should be started immediately or if patients need to go to a sleep center for a CPAP study, she said.
Moreover, the CMS ruling states that after three months of CPAP, physicians should make sure patients are benefiting from treatment; however, what criteria should be used to measure this benefit-for example, improvement in blood pressure or lack of sleepiness-are not mentioned, said Dr. Collop.
Deciding Between At-Home Testing and In-Lab PSG
When deciding what form of sleep testing is best for their patients, otolaryngologists need to be aware of a number of factors, said the experts interviewed for this article.
For example, the suspected sleep disorder essentially determines whether patients should undergo home monitoring or in-lab PSG.
Specifically, only individuals with a high risk of moderate to severe sleep apnea are candidates for home sleep monitoring, said Dr. Collop, who is the lead author of the AASM’s clinical guidelines for using portable monitors to diagnose obstructive sleep apnea (J Clin Sleep Med 2007;3(7):737-747).
Patients who likely have mild forms of sleep apnea or interruptions in sleep architecture but no drops in oxygen during the night need testing in a sleep lab, added Dr. Collop.
Additionally, patients who have sleep abnormalities that do not appear to be sleep apnea should receive an in-lab PSG, said Dr. Davidson. For example, patients with symptoms of narcolepsy or parasomnias require testing that provides better information than that available through home monitoring, he said.
PSG is better at diagnosing a variety of sleep problems because it measures brain waves, explained Dr. Davidson. So when you have things that involve nightmares or dreams or sleep stage abnormalities, the PSG is only thing that is going to pick that up, he said.
Other suspected sleep disorders that commonly warrant testing in a sleep lab include obesity hypoventilation syndrome, upper airway resistance syndrome and limb movement disorders, said Dr. Weaver.
Finally, those with negative home monitoring results might warrant in-lab testing if a sleep disorder is still suspected or if technical problems arose with home testing, said Dr. Weaver.
Cognitive Impairments and Comorbidities
Individuals suspected of having sleep apnea but who are cognitively impaired may require in-lab testing so an attendant can monitor and adjust monitors as needed, said Dr. Davidson.
In addition, patients with suspected sleep apnea but with significant comorbidities are best tested in a sleep lab, said Dr. Weaver. These include serious cardiovascular, pulmonary, or neurological disease or any other condition that might affect sleep testing quality or complicate the sleep apnea, he explained.
Those with significant cardiac disease or pulmonary problems are generally not good candidates for home testing because if blood oxygen drops, the machine cannot detect whether it is due to sleep apnea or there other underlying conditions, explained Dr. Wardrop.
Also of consideration are the diagnostic capabilities of home testing and PSG for sleep apnea. Overall, the literature indicates both approaches provide equally good diagnostic data and test results, said Dr. Davidson.
For example, a recent randomized, controlled, open-label study of 68 patients with a high probability of obstructive sleep apnea found that PSG has no advantage over home testing in making a diagnosis (Ann Intern Med 2007;146(3):157-66).
However, home monitoring can be conducted over several nights, which could potentially provide more reliable results than PSG, noted Dr. Weaver. Home monitoring also reduces unnecessary measurements for routine sleep apnea, he said.
A potential drawback of home monitoring is that it may underestimate the severity of sleep apnea, said Dr. Weaver. Additionally, because a technician isn’t on hand to monitor whether lines become unhooked, home testing can result in unusable data or data loss, he said. Moreover, standardizing the quality of testing is difficult and some scoring algorithms may be inadequate, he added.
Whatever the diagnostic capabilities of the tests or the recommendations of the physician are, patients may prefer home monitoring to diagnose suspected sleep apnea, noted Dr. Davidson.
Senior citizens, for example, are less likely to opt for PSG, one reason often being that they don’t like to drive at night, he said. Older people don’t sleep as well and would rather test at home in their own bed, he added. As many as 50% of older patients don’t go to PSG when recommended to do so by their physicians, he explained.
Patients may also not want to undergo testing in a sleep center because they need to take care of their children or an elderly parent, are not close to a center, or simply do not like the idea of sleeping away from home, said Dr. Wardrop.
Costs and Reimbursement
Costs and reimbursement are other factors otolaryngologists need to be aware of when considering sleep testing for their patients.
Up-front costs of PSG are high compared with home testing, said Dr. Davidson. The initial cost of PSG equipment is around $50,000, and it requires renting office space and hiring a technician for every two beds. Technician salaries are generally $40,000 to $50,000 a year, he said.
In contrast, home sleep test machines cost $5000 to $7000. Normally, a nurse or medical assistant can teach patients to use the machine, so hiring new staff is not necessary, said Dr. Davidson. Each test also requires disposables such as nasal cannulae and batteries, which are other costs to consider, he said.
Insurance companies normally cover PSG with proper authorization, whereas some companies cover home sleep testing, added Dr. Davidson. In the best markets, reimbursement is $2000 for PSG and $500 for home testing, while in tighter markets, these figures are generally $1000 and $250, respectively, he said. As people ask for home tests, more and more insurers will cover it, he said.
Coverage depends on the region of the country the patient is in and on the insurer, said Dr. Wardrop.
CMS reimbursement for PSG is about $1000, noted Dr. Collop, whereas reimbursement for home monitoring is anticipated to be about $250.
CMS reimbursement for home testing remains a gray area, said Dr. Wardrop. The CMS ruling states that it will pay for CPAP based on a home testing diagnosis; however, the ruling does not say it will pay for home testing, she explained.
It’s only assumed that CMS will pay for it, she said, adding that billing codes still need to be established. We’re gone ahead and have sent in claims to see what CMS will do, she said. It may require an appeal. For type III home testing, we have been told that CMS will likely pay about $200 for the technical and professional component combined, she added.
Another unknown is whether CMS will reimburse for interval home testing during staged surgery for sleep apnea, said Dr. Weaver.
One factor that may affect reimbursement at some point is that some practitioners are asking CMS to cover only those physicians who can read the raw data generated by home testing, said Dr. Weaver. Others are pushing for only sleep physicians certified by the American Board of Medical Specialties to be eligible for reimbursement, he said, adding that this requirement is not in the CMS ruling.
Although reimbursement may take some time to work out, Dr. Wardrop noted that private insurers will most likely follow the current CMS ruling and cover CPAP diagnosed with home testing. I believe insurers will follow, but with specific variations, she said. For instance, the Kentucky local carrier determinations went a little further than CMS in specifying that home monitoring should follow AASM guidelines, she explained.
Deciding on the Type of Home Testing
If otolaryngologists opt to acquire home monitoring devices to diagnose sleep apnea, they will have to investigate various available models to decide which ones will work for them, said Dr. Collop. No studies have compared one instrument with another to determine which is the most accurate, and each device has its limitations, she said.
Dr. Davidson has used most brands of home testing during his years of practice and finds that all work quite well. There aren’t Cadillac or fly-by-night products, he said.
The CMS ruling covers three types of home testing devices. The first is Type II, which has a minimum of seven channels, including electroencephalogram (EEG), electro-oculogram (EOG), electromyogram (EMG), electrocardiogram (ECG)-heart rate, airflow, oxygen saturation, and sleep staging, which allows for apnea-hypopnea index (AHI) calculation.
Type III monitors are covered and have a minimum of four channels, including two measuring ventilation or airflow, and the others measuring heart rate or ECG, and oxygen saturation.
Last, CMS covers Type IV devices that measure three or more parameters. The CMS ruling suggests these devices should have a minimum of three parameters but doesn’t tell you what those parameters are, noted Dr. Collop.
When trying to decide on a home testing device, physicians should also refer to AASM guidelines, said Dr. Collop. The guidelines state that at a minimum, home testing or portable monitoring (PM) must record airflow, respiratory effort, and blood oxygenation. The airflow, effort, and oximetric biosensors conventionally used for in-laboratory PSG should be used in PM.
The device also needs to display raw data with the capability of manual scoring or editing of automated scoring by a qualified sleep technician. Furthermore, experienced sleep technicians should be available to show patients how to use the home monitoring equipment, the guidelines state.
Although she does not recommend one brand over another, Dr. Wardrop notes that of the many options available for home monitoring, the Embletta (Embla Systems, Broomfield, CO) meets all the criteria of the AASM practice parameters. The company’s Web site states that it is compliant with CMS recommendations.
Watch-PAT 100 (Itamar Medical, Israel) and ARES (Advanced Brain Monitoring, Inc., Carlsbad, CA) use technology that is not currently recommended by the AASM but that may be useful in certain clinical situations, said Dr. Wardrop.
Whatever system you use, if you become comfortable with it and what the machine is measuring, you’re probably fine, Dr. Wardrop said.
In addition to choosing the appropriate device, the AASM guidelines recommend that home testing should only be performed under the guidance of an AASM-accredited sleep medicine program and in conjunction with a comprehensive sleep evaluation. Testing should be supervised by someone who is board certified in sleep medicine or who fulfills the eligibility criteria for the sleep medicine certification examination.
Finally, physicians need to schedule a follow-up visit to review test results with their patients, the guidelines state.
The Bottom Line
Even though it may take some time to address all the questions and concerns about the CMS ruling and reimbursement and for otolaryngologists to decide whether to offer home testing and what monitoring devices to use, ultimately, the decision is good for our patients and good for resource management, concluded Dr. Davidson.
For the full CMS ruling, go to CMS’s Web site at www.cms.hhs.gov/mcd/viewdecisionmemo.asp?from2=viewdecisionmemo.asp&id=204& .
©2008 The Triological Society