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Home sleep testing for Medicare patients.

Significant advances have been made in the detection and treatment of obstructive sleep apnea, but it remains a significant public health concern among men and women. While the gold standard for diagnosing OSA is in-lab polysomnography, home screening has quickly become an efficient and cost-effective way to monitor patients.

In March, the Centers for Medicare and Medicaid Services issued its final coverage decision for ambulatory sleep testing. The policy now states that home sleep tests can be used by a Medicare patient's physician to diagnose OSA. CMS also said that ambulatory testing shows improved health outcomes in Medicare recipients with OSA who receive appropriate treatment.

CMS determined the following ambulatory tests are "reasonable and necessary" for diagnosing or monitoring OSA in Medicare and Medicaid beneficiaries:

A Type II or Type III sleep testing device is covered when used to aid the diagnosis of OSA in patients with clinical signs and symptoms indicative of OSA if performed unattended in or out of a sleep facility or attended in a sleep lab facility.

A Type IV sleep testing device that measures three or more channels, one of which is airflow, is covered when used to aid the diagnosis of OSA in patients who have signs and symptoms indicative of OSA if performed unattended in or out of a sleep facility or attended in a sleep lab facility.

A sleep testing device measuring three or more channels that include actigraphy, oximetry and peripheral artery tone (PAT) is covered when used to aid the diagnosis of OSA in patients who have signs and symptoms indicative of OSA if performed unattended in or out of a sleep facility or attended in a sleep lab facility.

With these approved coverage rules in mind, let's review the three types of home sleep tests and how they can help more efficiently diagnose older patients with sleep apnea.

Type II Monitors

Type II portable monitors for home sleep testing can perform full polysomnography outside of a sleep laboratory. Generally, they only differ from PSG (Type I devices) in that a sleep technologist need not be present to administer the test. Also referred to as comprehensive portable devices, Type II monitors are required to have a minimum of seven channels, including EEG, EOG, ECG (heart rate), EMG, airflow, respiratory effort and oxygen saturation.

Unlike many of their in-lab counterparts, portable Type II monitors have quickly become wireless, combining the head-box, telemetry, amplifiers and transducers in one unit. Without the wires of traditional systems, these monitors give patients better freedom of movement during diagnostic periods.

Type III Monitors

Type III sleep testing devices do not record signals required to determine sleep disruption or sleep stages. These monitors must have a minimum of four channels, including two respiratory movement/airflow, ECG and oxygen saturation. Some devices may have other channels to monitor snoring, detect light or determine body position.

Most of the pocket-sized portable monitors fall into this category. And despite stringent reimbursement guidelines, there are a number of Type III monitors available that go above and beyond CMS requirements. For starters, wireless devices allow patients to move about more freely, giving clinicians a better idea of their normal breathing patterns during testing.

One of the newest Type III devices can work with a continuous positive airway pressure device and simultaneously measure respiratory inductive plethysmography. It also provides measurements for SpO2, pulse, airflow and body position. All of these features allow the device to diagnose sleep apnea and monitor the effectiveness of treatment.

Some of these monitors give sleep technologists the option to customize data reports, as well as manually score sleep studies. Additionally, Windows[R]-based software allows RPSGTs to easily integrate home reports into their in-lab systems.

Type IV Monitors

Finally, Type IV portable sleep monitors have at least three channels. Type IV devices are also referred to as continuous single or dual bioparameter monitors. They record one or two variables, and their channels usually include airflow and arterial oxygen saturation.

As of January 1, the durable medical equipment Medicare administrative contractors (DME MACs) released new local coverage determinations that revised criteria for Type IV devices. A DME MAC letter to physicians stated that Type IV monitors must provide direct calculation of an apnea-hypopnea index (AHI) or respiratory disturbance index (RDI) as a result of measuring airflow of thoracoabdominal movement.

About two years ago, one manufacturer developed a monitor worn on the forehead that can story up to four nights of sleep data. A February 2008 study from the New York University Sleep Disorders Center found that this device failed to correctly diagnose OSA in less than 3 percent of the patients studied. When compared to traditional PSG, the device was shown to provide acceptable and accurate OSA indices for in-home monitoring.

Currently, only one device indirectly calculates AHI/RDI, and that is a wrist-worn PAT monitor. PAT is a physiological signal that reflects the changes in the autonomic nervous system that stemming from respiratory disturbances during sleep. The monitor's algorithm analyzes the wearer's PAT signal to identify apneic events.

RELATED ARTICLE: Mail-in Diagnostic Systems Provide Completely Unassisted In-Home Testing

The Food & Drug Administration has in the past cleared in-home sleep apnea diagnostics that can be delivered directly to a patient's front door for unattended, self-administered use.

One of these testing devices includes a bedside console and three sensors that the patient can apply to his or herself before sleeping. Instructions and voice prompts tell the patient how to apply the sensors and set up the device, which can be used for up to three nights of testing. It collects sleep data, including apneas, hypopneas, snoring, blood oxygen saturation, pulse rate and respiratory effort.

The mail-in device differs from in-lab and portable polysomnography because it does not include extra tests that are not required for diagnosis of sleep apnea. These tests include EEC, EOG, EKG and EMG. By not including these channels, the test is less complex and more cost-efficient than standard PSG.

Following three nights of home testing, the patient can ship the device back in its original packaging to its manufacturer. The manufacturer then downloads the sleep data and provides the patient's physician with a comprehensive report for diagnosis.


Stephanie Richardson is a freelance medical writer based in Philadelphia.
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Author:Richardson, Stephanie
Publication:FOCUS: Journal for Respiratory Care & Sleep Medicine
Date:May 1, 2009
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