SAN DIEGO-A change in the Centers for Medicare and Medicaid Services’ (CMS’) policy for national carrier determination on coverage for continuous positive airway pressure (CPAP) has created an opportunity for otolaryngologists who want to pursue incorporation of home sleep studies to diagnose obstructive sleep apnea (OSA) into their practices. But there is a limited window of opportunity if physicians wish to ensure their ability to bill for these services, said Pell Ann Wardrop, MD, of Lexington, KY, at the miniseminar, Home Sleep Studies: How Should They Fit into Your Practice?
The comprehensive session, cosponsored by the American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS) Technology Infrastructure Committee, consisted of four presentations to better prepare otolaryngologists who want to step up to the plate and incorporate home sleep studies into their diagnostic armamentaria. The presenters acquainted attendees with the advantages and drawbacks for laboratory polysomnography (PSG) versus portable monitoring; discussed the limitations of home sleep studies (HSS) with portable monitoring devices; noted how HSS limitations affect appropriate patient selection; and offered practical advice regarding sleep medicine certifications and reimbursement. Interactive audience questions provided an adjunct to the session’s content.
Drivers of CMS Policy Changes
First, Dr. Wardrop, who is Chair of the AAO-HNS Sleep Disorders Committee, summarized the CMS reassessment process regarding 240.4, a durable medical equipment ruling that governs payment for CPAP to treat OSA. Until 2005, CMS had maintained that laboratory PSG was the gold standard for diagnosis of OSA and that there was insufficient evidence to warrant home sleep testing.
Three events occurred to trigger a revisit to that ruling, said Dr. Wardrop:
- A March 2006 Institute of Medicine report titled Sleep Disorders and Sleep Deprivation: An Unmet Public Health Problem1 maintained that an estimated 50 to 70 million Americans are suffering from some type of sleep disorder, adversely affecting their health and longevity, and called for an expanded workforce and development and validation of existing and new diagnostic and therapeutic technologies.
- Also in 2006, Senn et al.2 published results of a two-week trial of CPAP for patients with high clinical probability of OSA, showing that after four months out, 94% of patients were still using their CPAP, demonstrating the efficacy of CPAP for diagnosis of OSA and reducing the need for PSG.
- CMS changed its direction and began looking at predictive results for diagnosis and treatment. At the Academy’s request, CMS began its reassessment of the 240.4 ruling in 2007, commissioning technology assessments from the Agency for Healthcare Research and Quality (AHRQ) in early 2007 and convening a Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) panel on September 12, 2007. In late December of that year, CMS issued its Proposed Decision Memo, which outlined its policy change. The official memo followed in March 2008.
CMS will now pay for an initial 12-week trial of CPAP for adult patients with an apnea-hypopnea index (AHI) or respiratory disturbance index (RDI) ≥ 15/hour or an AHI between 5 and 15 with comorbidities if the disorder has been diagnosed by one of the following: full attended PSG (Type 1) ≥ 7 channels; Type 2, full unattended PSG ≥ 7 channels; Type 3, limited channel devices (usually 4 to 7 channels); or Type 4, with 1 to 2 channels using oximetry as one of the parameters.
Dr. Wardrop and Scott Brietzke, MD, MPH, Director of Pediatric Otolaryngology and Sleep Surgery at Walter Reed Army Medical Center in Washington, DC, spoke about the American Academy of Sleep Medicine’s (AASM’s) advocacy efforts in regard to the CMS ruling change. Through issuance of its Clinical Guidelines for the Use of Unattended Portable Monitors in the Diagnosis of Obstructive Sleep Apnea in Adult Patients,3 AASM has asserted that HSS diagnostics must be preceded by a comprehensive diagnostic assessment by a board-certified physician. Of course, noted Dr. Brietzke, AASM is aggressively representing its membership, but urged his colleagues in the audience to mold the recommendations of AASM to our needs and to consider board certification in sleep medicine. That window of time, Dr. Waldrop reminded the audience, is open until 2011. The result for practitioners, said Dr. Brietzke, is not only assurance of one’s ability to bill and be reimbursed for diagnostic services, but also the ability to offer heightened efficiency of care for patients.
Not Fail-Safe
There is good agreement, on average, between unattended Type 3 sleep studies and lab PSGs on certain parameters such as RDI and lowest oxygen saturation.
-M. Boyd Gillespie, MD
The advantages of home sleep testing for patients are obvious, said M. Boyd Gillespie, MD, Associate Professor of Otolaryngology-Head and Neck Surgery at Medical University of South Carolina. The testing can be done in a natural sleep environment instead of a laboratory setting; the testing is potentially less expensive [unless repeat testing is required due to poor data]; most portable monitoring is simpler than lab PSG; and because of its portability, there is increased patient access to diagnostics.
Most home sleep monitoring is accomplished with Type 3 devices, which typically measure airflow, oxygen saturation, pulse oximetry, pulse rate, and respiratory effort. Some devices also measure sleep position, whereas others employ actigraphy.
Scott Brietzke, MD, urged his colleagues to mold the recommendations of AASM to our needs and to consider board certification in sleep medicine.Dr. Gillespie then summarized some of the literature addressing the concerns about reliability of HSS. The Sleep Heart Health Study4 showed that scoring variability in laboratory versus home monitoring with Type 3 devices was not significantly different. In fact, he said, pointing to results of an examination of scoring variability between sleep lab technologists,5 the potential for scoring variability also exists with the so-called gold standard of PSG. There is good agreement, on average, between unattended Type 3 sleep studies and lab PSGs on certain parameters such as RDI and lowest oxygen saturation, he noted.
Because Type 3 studies can be slightly less sensitive on average than lab PSG, a negative result in a symptomatic patient should be repeated in the lab.
Who Are the Best Candidates?
Peter D. O’Connor, MD, OD, of the Department of Otolaryngology-Head and Neck Surgery, Sleep Medicine and Surgery at Brooke Army Medical Center in San Antonio, TX, spent some time in his presentation advising participants on careful patient selection. As the AASM notes in its Clinical Guidelines decision tree, the most appropriate use of HSS is in patients who have a high pretest probability of moderate to severe OSA. If patients have signs or symptoms of co-morbid disorders, it’s best to order lab PSG.
Dr. O’Connor noted that as of September 2009, 87 different HSS devices-primarily Type 3 and 4-were listed on the FDA Web site. It’s important to understand what the test provides, to whom you can apply it, whether the device has been validated, whether it has limitations, and whether you can utilize it within the parameters set by CMS, he said.
Dr. Brietzke wrapped up the session, noting other advantages of incorporating OSA diagnosis into one’s practice. He and his colleagues at Walter Reed Army Medical Center are very focused on sleep apnea, screening for and treating it often. Using simple tools, such as the sleep history or sleep diary,6 can help identify common problems and other comorbid conditions. For instance, using the simple mnemonic URGE (Urge to move; Rest makes it worse; Gets better with movement; Evening only) can help physicians identify and treat the high prevalence of restless legs syndrome. Dr. Brietzke reiterated the advice of his fellow panelists, all of whom are board-certified in sleep medicine, to consider certification by the American Board of Otolaryngology which is a member of the American Board of Medical Specialties’ conjoint board of Sleep Medicine. Otolaryngologists willing to take up the challenge of board certification can then ensure that they can optimize the new CMS ruling, retaining and following their patients over time. This increased continuity of care, they said, is good for the doctor and good for the patient.
References
- Institute of Medicine. Sleep Disorders and Sleep Deprivation: An Unmet Public Health Problem, March 2006. Available from the IOM Web site at http://www.iom.edu/Reports/2006/Sleep-Disorders-and-Sleep-Deprivation-An-Unmet-Public-Health-Problem.aspx .
- Senn O, Brack T, Russi EW, Bloch KE. A continuous positive airway pressure trial as a novel approach to the diagnosis of the obstructive sleep apnea syndrome. Chest 2006;129:67-75.
- Collop NA, Anderson WM, Boehlecke B, Claman D, et al. Clinical guidelines for the use of unattended portable monitors in the diagnosis of obstructive sleep apnea in adult patients. J Clin Sleep Med 2007;3:737-47.
- Iber C, Redline S, Kaplan Gilpin AM, Quan SF, et al. Polysomnography performed in the unattended home versus the attended laboratory setting-Sleep Heart Health Study methodology. Sleep 2004;27:536.
- Collop NA. Scoring variability between polysomnography technologists in different sleep laboratories. Sleep Med 2002;3:43-47.
- Davidson TM. Sleep medicine for surgeons. Laryngoscope 2008;118:915-31.
©2009 The Triological Society