Initial Public Comments for NCA for Continuous Positive Airway Pressure (CPAP) Therapy for Obstructive Sleep Apnea (CAG -00093R) Public Comment Period (April 8, 2004 – May 8, 2004) Comment #1: Submitter: Asela M. Cuervo, Senior Vice President Organization: American Association for Homecare (AAHomecare) Date: May 7, 2004 5:57 PM Comment: The America Association for Homecare (AAHomecare) submits the following comments on the Centers for Medicare and Medicaid ServicesÆ (CMSÆ) reconsideration of the national coverage decision (NCD) on the use of continuous positive airway pressure (CPAP) devices for the treatment of obstructive sleep apnea (OSA) in adults. Currently, the NCD states that only a polysomnogram performed in a facility-based sleep study laboratory may be used to identify patients with OSA who will require CPAP. In response to a request from Dr. Terence M. Davidson, CMS has opened the NCD for reconsideration on whether CMS should permit the use of portable multi-channel sleep testing devices in the home site of service as an alternative to facility based polysomnography for the appropriate patient populations. AAHomecare represents member companies in every line of service within the homecare community. Our members include home health agencies, and suppliers and manufacturers of durable medical equipment (DME) services and supplies and assistive and rehabilitative technologies. We support a revision to the current NCD to permit the use of portable multi-channel sleep testing devices in the home site of service as an alternative to facility based polysomnography for the evaluation of OSA. Many private sector payers currently recognize the use of home sleep studies for the diagnosis of OSA because this technology is reliable and affordable. Moreover, it has been widely acknowledged by the medical community that a lack of access to facility based polysomnography presents a barrier to treatment for individuals with OSA. The Medicare program should follow the private sectorÆs lead in recognizing home sleep studies for the evaluation of OSA to improve the availability of sleep testing for patients with OSA. Background Sleep apnea is a disorder characterized by periods of apneas and hypopneas (breathing cessation and reduced breathing respectively). Obstructive sleep apnea is a common form of sleep apnea characterized by the partial or complete collapse of the upper airway during sleep. Symptoms of OSA include daytime sleepiness, fatigue, headaches, and cognitive impairment. OSA can lead to serious health risks for the individual, including for example, hypertension. OSA is commonly diagnosed by measuring the number of apneas and hypopneas during a defined period of sleep (the AHI index) and/or measuring the rate of oxygen desaturation during sleep in conjunction with the presence of other symptoms such as daytime sleepiness or hypertension. While there are a number of treatment options for OSA, including surgery, the most prevalent form of therapy involves the use of a CPAP device. The CPAP forces a flow of air through the airways using a noninvasive nasal interface. The device maintains the airflow at a fixed pressure, forcing the airway to remain open. Since 1987, CMS has covered the use of CPAP devices for patients with ômoderate or severe OSA for whom surgery is a likely alternative.ö The NCD CMS issued in 1987 was consistent with the consensus opinion on the diagnostic criteria for OSA at that time. In 2001, CMS revised the NCD for the use of CPAP for the treatment of OSA to reflect current diagnostic criteria for OSA. Medicare will cover and pay for CPAP for the treatment of adults with OSA who meet the following diagnostic criteria: ò AHI > 15 events per hour, or ò AHI > 5 and < 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 NCD defines an apnea as the ôcessation of airflow for at least ten seconds.ö A hypopnea is defined as an ôabnormal respiratory event lasting at least 10 seconds with at least a 30% reduction in thoracoabdominal movement or airflow as compared to baseline, and with at least a 4% oxygen desaturation.ö OSA is typically diagnosed via a laboratory based, attended sleep study (polysomnography) that measures at the least, sleep time through sleep staging and respiration. The Medicare NCD specifically states that the polysomnography used to diagnose OSA must be performed in a ôfacility- based sleep study laboratory, and not in a home or mobile facility.ö CMS is reconsidering this portion of the NCD to allow the use of portable multi-channel sleep testing in the home site of service as an alternative to facility based polysomnography. Comments It is widely acknowledged within the medical community that timely access to facility based polysomnography is a hurdle to treatment for patients with undiagnosed OSA. In the Wisconsin sleep cohort study, for example, 93% of women and 82% of men with moderate OSA did not receive a diagnosis. As CMS recognized in the decision memorandum for the NCD on the use of CPAP to treat OSA, the clinical literature establishes that sleep apnea is a risk factor for hypertension and cardiovascular comordbidity. CMSÆ decision memorandum references a number of randomized controlled trials that evaluated the use of CPAP for the treatment of OSA. These studies showed that individuals on CPAP devices had improved outcomes compared to those who received other therapy. Untreated OSA results in a number of more serious health risks including hypertension as well as other behavioral and cognitive symptoms that can be reduced or avoided with appropriate treatment. The current NCD for CPAP limits coverage for CPAP to those cases where the OSA was diagnosed during a facility based polysomnography, expressly excluding the use of portable multi-channel home sleep testing for the diagnosis of OSA. This policy is short sighted in light of the documented lack of timely access to facility based polysomnography and the serious health consequences of undiagnosed OSA. In contrast, the private sector, recognizing the importance of timely treatment for OSA, has adopted the use of portable multi-channel sleep studies in the home site of service as an effective alternative to facility based polysomnography. This policy allows payers to reduce both the costs associated with facility based studies and patient care inasmuch as individuals with OSA who are treated with CPAP have better health outcomes. We are aware of one such program developed by a private sector health maintenance organization in response to backlogs of as much as four months for facility based sleep testing. The program has resulted in savings for the insurer, and its enrollees receive treatment within 30 days. We urge CMS to carefully consider the evidence in favor of adopting this alternative to facility based polysomnography. The available technology is reliable, effective and addresses the lack of timely availability to facility based studies for individuals with undiagnosed OSA. Conclusion Based on the foregoing, we reiterate our recommendation that CMS revise the current NCD for CPAP to include portable, multi-channel sleep testing in the home site opf service as an alternative to facility based polysomnography for the appropriate patient populations. We appreciate the opportunity to submit these comments and remain available to discuss them with you at your convenience. Please feel free to contact me if you have any questions, or if we can be of further assistance. OSA Diagnosis Bibliography Peppard P, Young T, Palta M,Skatrud J, Perspective Study of the Association Between Sleep-Disordered Breathing and Hypertension, New England Journal of Medicine 2000; May 11; 342 (19): 1378-1384. Pack, Allan I., M.D., Sleep-Disordered Breathing, Access Is the Issue, American Journal of Respiratory and Critical Care Medicine 2004; 169: 666-667. Bahammam et al., Health Care Utilization in Males with Obstructive Sleep Apnea, SLEEP 1999; 22(6): 740-747. Ip, Mary S.M. et al., Endothelial Function in Obstructive Sleep Apnea and Response to Treatment, American Journal of Respiratory and Critical Care Medicine 2004; 169: 348û353 Pelletier-Fleury, N., Meslier, M. et al., Economic arguments for the immediate management of moderate-to severe obstructive sleep apnoea syndrome, European Respiratory Journal 2004; 23: 53▒ 60. Shamsuzzaman, Abu S.M. et al, Obstructive Sleep Apnea: Implications for Cardiac and Vascular Disease, Journal of American Medical Association, October 8, 2003; 290(14): 1906-1914. Comment #2: Submitter: Anthony Yonkers Organization: Otolaryngology Date: May 4, 2004 11:28 AM Comment: I agree with the letter sent to you by Dr. Terry Davidson regarding the cost effectiveness of the portable sleep testing devices that can be taken home with the patient. Comment #3: Submitter: Bob Ricker Organization: Rex Healthcare Date: May 3, 2004 8:38 AM Comment: The process of monitoring & managing OSA patients should be completed in an accredited Sleep Laboratory or Sleep Disorders Center. Patients monitored at home can not receive the real time interface with professionals to receive a quality study. It was only 6-8 years ago that the home study polysomnography abuse was laid to rest, please to not give credence to this study and dilute the value of the Sleep Disorders profession once again. Comment #4: Submitter: Buddy Marshall Organization: Baptist Health Sleep Center Date: Apr 30, 2004 11:37 AM Comment: The use of portable multi-channel sleep testing devices is not well defined. Does this mean an attended or unattended study? What parameters will be monitored? Although a cardio-respiratory sleep study may be adequate for identifying clear- cut OSA, it will not provide the information required to identify various sleep disorders such as PLMD, arousal disorders, UARS, and parasomnias. Therefore, if a patient with sleep- related symptoms is negative for OSA based on a multi-channel sleep test, he or she would need further polysomnographic testing.