Swimming in the Uncertain Sea of Sleep Diagnostics – Jeff Wyscarver

The recent publication of the Centers for Medicare & Medicaid Services (CMS) proposal for the national coverage determination for CPAP, which is really about sleep diagnostics, and the subsequent publication of the American Academy of Sleep Medicine (AASM) guidelines for home sleep testing threaten to change the face of sleep medicine like nothing else since the introduction of CPAPin the 1980s. Sleep medicine in the U.S. is practiced primarily in sleep labs and sleep disorders centers, and yet these two documents allow unattended, home-based sleep testing to be used to diagnose patients with suspected OSA for the purpose of prescribing CPAP therapy. This leaves sleep professionals uncertain as to the future of sleep diagnostics and their roll in it.

To be certain, there is a greater awareness of sleep, sleep disorders and sleep apnea than ever before. There is better understanding of sleep apnea, its development and the impact of this disorder on the health of the patient. With a prevalence that may exceed ten percent in the U. S. and increased risk of heart disease, diabetes and metabolic disorder, there is no question about the need to get these patients into effective treatment regimens as quickly as possible. With the change in position on home sleep testing by both CMS and the AASM, it is clear that this method of diagnosing OSA is about to experience rapid growth.

Changes in Sleep Diagnostics

The CMS proposal and the AASM guidelines differ greatly in terms of how home sleep testing should be done. The CMS proposal allows a broad range of technologies to be employed, from portable polysomnography to very simple two or three channel devices. CMS even encourages clinicians to develop other methods outside the scope of the monitors cited in the proposal. The AASM, on the other hand, excludes based on medical evidence, Type II and Type IV monitors and leaves us with monitors with more than 7 channels that use conventional sensor technology, including respiratory inductive plethysmography, and retain data for full disclosure.

To the extent that these monitors are used in the diagnosis of OSA, there will be a reduction in the number of uncomplicated OSA patients studied in sleep labs or sleep disorders centers. These facilities will be able to study more complicated OSA patients or patients with other types of sleep disorders. As a result, the level of sophistication, both technologically and in terms of sleep medicine, will increase.

The Testing of Uncomplicated OSA Patients

Medicare and a growing number of insurance companies are requiring that sleep studies be performed in accredited facilities. At the very least, some level of documentation must be held, and this generally requires that these facilities be independent diagnostic testing facilities (IDTF). Any facility meeting these requirements can perform these tests. However, sleep labs and sleep disorders centers have well developed referral networks and may already be advertising one way or another and, therefore, may be best positioned to access this patient population. This does not guarantee that there will not be other facilities pursuing the same patients, but those that best meet the needs of the patients and the payers, will likely succeed.

There is also the possibility of contracting the setup and collection portions of home sleep studies to other groups that might even supply portable monitor technology. These other groups should be familiar with sleep testing and should follow rigorous procedures for testing in order to reduce the need for repeat studies. These groups may include home care providers with whom you already have working relationships.

Addressing an Impending Boom for Home Sleep Testing

The AASM provides clear direction for sleep professionals regarding the use of home sleep testing devices for the diagnosis of OSA. The AASM states a patient must be evaluated for OSA by a sleep specialist. Once a determination is made that the patient is likely to have OSA and does not have either medical or sleep comorbidities, the patient can be provided with a portable monitor for home sleep testing. Proper setup is important, as is patient instruction before the test. After the portable monitor is returned, the data is downloaded and the study is scored. The AASM requires that all data be retained so that artifacts can be identified and removed, and this will require a level of skill that is currently resident in sleep labs or sleep disorders centers. Titration of sleep therapy is not addressed in the most recent CMS proposal, but the AASM has suggested that they will provide guidance that calls for the use of auto-CPAP devices in determining the therapeutic pressure levels required. Aside from performing in-lab titrations or somewhat randomly suggesting pressures, the auto-CPAP approach may be the best bet for a low cost solution. Care must be taken when setting the patient up with the system and follow-up will need to be provided to ensure that the patient complies with therapy.

In summary, sleep professionals are well positioned to appropriately apply portable monitors for home sleep testing and to ensure that studies are properly set up, maintained and scored and also that CPAP, when called for, is appropriately titrated, applied and that follow-up leads to maximal compliance. Selection of portable sleep monitoring technology is of great importance. The AASM provides guidance that recommends a Type III monitor that uses sensor technology of the sort conventionally applied in sleep disorders centers and that provides complete disclosure of all recorded data. By using a comprehensive sleep therapy program including titration, setup and follow-up, sleep labs or sleep disorders centers are in an excellent competitive position to serve the needs of the growing population of sleep apnea patients. Furthermore, when home sleep testing is made part of a comprehensive program for sleep disorders management that includes awareness and the ability to address a broad range of sleep disorders, then not only will the patients be well cared for, but so will the sleep medicine profession.

Jeff Wyscarver, RPSGT
Product Manager, Sleep Diagnostics
Cardinal Health, Yorba Linda, CA

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