|Highmark Medical Policy Bulletin|
|Section:||Durable Medical Equipment|
|Topic:||Devices Used for the Treatment of Obstructive Sleep Apnea in Adults|
|Effective Date:||June 30, 2014|
|Issued Date:||June 30, 2014|
|Date Last Reviewed:||02/2014|
General Policy Guidelines
Indications and Limitations of Coverage
An auto-titrating positive airway pressure (APAP)(E0601) device or a continuous positive airway pressure (CPAP)(E0601) device may be considered medically necessary for the treatment of obstructive sleep apnea (OSA) in adults and covered as durable medical equipment when the following criteria are met:
BiPAP without back-up rate (E0470)
BiPAP with back-up rate (E0471)
Intra-Oral Appliances (E0485, E0486 )
There are many different types of appliances that basically fit into one of two categories, tongue retaining appliances, and mandibular repositioning appliances. Payment may be made for one appliance. Additional appliances should be denied as not medically necessary. However, replacement of the appliance is covered in case of loss or irreparable damage or wear when necessary due to a change in the patient's condition. It will be necessary for the provider to submit medical records and/or additional documentation to determine coverage in this situation.
NOTE: CPAP has been shown to have greater effectiveness than oral appliances in general. This difference in efficacy is more pronounced for patients with severe OSA, as oral appliances have been shown to be less efficacious in patients with severe OSA than they are in patients with mild-moderate OSA. Therefore, it is particularly important that patients with severe OSA should have an initial trial of CPAP and that all reasonable attempts are made to continue treatment with CPAP, prior to the decision to switch to an oral appliance.
Nasal Expiratory Positive Airway Pressure (EPAP)
Oral Pressure Therapy (OPT)(E0600, A7002, A7047)
Payment for the rental of a Positive Airway Pressure (PAP) device
Throughout the PAP device rental period, the DME supplier should check that the member is compliant with use of the device. If the device isn’t being used as prescribed, the DME supplier should contact the patient’s physician and discuss removal of the device. If the physician agrees that removal of the machine is warranted, the supplier should remove the machine and discontinue billing for the rental. However, if the member is found to be using the PAP device as directed and is achieving the desired results, the DME supplier should contact the patient’s physician near the end of the rental period and ask the doctor to prescribe the purchase of the device.
Continued use beyond the first three months of therapy
Replacement of PAP Devices
Please refer to the following Medical Policy Bulletins for additional information:
Accessories used with a positive airway pressure (PAP) device are covered when the coverage criteria for the device are met. If the coverage criteria are not met, the accessories will be denied as not medically necessary.
A replacement cushion/pillow (A7031) is not billable when supplying an ongoing replacement of the frame with cushion/pillow (A7030). Billing for each individual component is considered unbundling of these supplies. The allowance of a replacement mask interface every month is considered an exception and documentation should support the medical necessity.
The following represents the usual maximum amount of accessories expected to be medically necessary. Replacement device is not covered if due to misuse or abuse.
Quantities of supplies greater than those described in the policy as the usual maximum amounts will be denied as not medically necessary.
Either a heated humidifier (E0562) or a non-heated humidifier (E0561) is eligible for use with a covered PAP (E0470 or E0601) device when prescribed by the treating physician to meet the needs of the individual patient.
Coverage for durable medical equipment is determined according to individual or group customer benefits.
Services that do not meet the criteria of this policy will not be considered medically necessary. A Pennsylvania participating, preferred or network provider cannot bill the member for the denied service unless: (a) the provider has given advance written notice, informing the member that the service may be deemed not medically necessary; (b) the member is provided with an estimate of the cost; and (c) the member agrees in writing to assume financial responsibility in advance of receiving the service. The signed agreement must be maintained in the provider’s records. Out of Network/Non-participating providers and providers located outside of Pennsylvania may be able to bill members if the service is denied.
Place of Service: Outpatient
Devices used for the treatment of obstructive sleep apnea in adults is typically an outpatient procedure which is only eligible for coverage as an inpatient procedure in special circumstances including, but not limited to the presence of a co-morbid condition that would require monitoring in a more controlled environment such as the inpatient setting.
Positive airway pressure (PAP) devices are indicated for use in the treatment of obstructive sleep apnea (OSA). PAP devices may improve quality of life in patients with OSA in adults. Close follow-up for PAP device usage and problems in patients with OSA by appropriately trained health care providers is indicated to establish effective utilization patterns and remediate problems if needed.
According to the American Academy of Sleep Medicine (AASM) obstructive sleep apnea (OSA) in adults is defined as either:
The AASM classifies mild, moderate and severe OSA as:
Traditional (UCR/Fee Schedule) Guidelines
This medical policy may not apply to FEP. Medical policy is not an authorization, certification, explanation of benefits, or a contract. Benefits are determined by the Federal Employee Program.
Comprehensive / Wraparound / PPO / Major Medical Guidelines
Any reference in this bulletin to non-billable services by a network provider may not be applicable to Major Medical.
Managed Care (HMO/POS) Guidelines
Medical Policy Update
02/2001, Guidelines clarified for specific Durable Medical Equipment
DME MAC Jurisdiction A L11528
CMS Pub. 100-03, Medicare National Coverage Determinations Manual, Chapter 1, Section 240.4
Loube DI, Gay PC, Strohl KP, et al. Indications for positive airway pressure treatment of adult obstructive sleep apnea patients: a consensus statement. Chest. 1999;115(3):863-6.
Sicenica T, Kline L. For decision makers in respiratory care. RT Magazine. December 2001.
Kushida C, Littner M, Hirshkowitz M, et al. Practice parameters for the use of continuous and bilevel positive airway pressure devices to treat adult patients with sleep-related breathing disorders. Sleep. Vol. 29, No. 3, 2006.
Eckert DJ, Jordan AS, Merchia P, Malhotra A. Central sleep apnea: pathophysiology and treatment. Chest. 2007;131(2):595-607.
Ballard R, Gay P, Strollo P. Interventions to improve compliance in sleep apnea patients previously non-compliant with continuous positive airway pressure. JCSM Journal of Clinical Sleep Medicine. Vol. 3, No 7, 2007.
Morris RJ. Intermittent pneumatic compression - systems and applications. J Med Eng Technol. 2008 May-Jun;32(3):179-88.
Slovut DP, Sullivan TM. Critical limb ischemia: medical and surgical management. Vasc Med. 2008 Aug;13(3):281-91. Review.
Morgenthaler T, Aurora N, Brown T, et al. Practice parameters for the use of autotitrating continuous positive airway pressure devices for titrating pressures and treating adult patients with obstructive sleep apnea syndrome: an update for 2007. Sleep. Vol 31, No. 1, 2008.
Ruehland W, BSc (Hons), Rochford P, et al. The new AASM criteria for scoring hypopneas: impact on the apnea hypopnea index. Sleep. 2009 February 1;32(2):150-157.
Punjabi N, Nisha A. Epidemiology of sleep-disordered breathing: lessons from the sleep heart health study. Sleep Medicine Clinics. Vol. 4, Issue 1. March 2009.
Jazeela F, Klaus-Dieter L. Hypoventilation Syndromes. http://emedicine.medscape.com/article/304381. Sep 18, 2009.
Rodriguez-Roisin R, Anzueto A, Bourbeau J, Calverley P, DeGuia T. Global initiative for chronic obstructive lung disease. Pocket guide to COPD diagnosis, management and prevention. http://www.goldcopd.com/. Updated 2009.
Becker K, Wallace J. Central sleep apnea. http://emedicine.medscape.com/article/304967. Jan 22, 2010.
Kuna ST, Gurubhagavatula I, Maislin G, et al. Noninferiority of functional outcome in ambulatory management of obstructive sleep apnea. Am J Respir Crit Care Med. 2011 May 1;183(9):1238-44.
Kushida CA, Littner MR, Hirshkowitz M. et al., Practice Parameters for the Use of Continuous and Bi-level Positive Airway Pressure Devices to Treat Adult Patients With Sleep-Related Breathing Disorders: An American Academy of Sleep Medicine Report. SLEEP, Vol. 29, No. 3, 2006.
BCBSA Medical Policy Reference Manual 2.01.18
American Academy of Sleep Medicine Task Force, 1999 [R]; Chervin, 1999a [C]; Johns, 1992 [C])
Callahan C, Norman R, Taxin Z, et al. Multinight recording and analysis of continuous positive airway pressure airflow in the home for titration and management of sleep disordered breathing. Journal of Sleep. 2013 April 1;36(4):535-545.
Qaseem A, Erik C, Owens D, et al. Management of Obstructive Sleep Apnea in Adults: A Clinical Practice Guideline From the American College of Physicians. American College of Physicians. September 24, 2013.
InterQual® Level of Care Criteria 2013. Acute Care Adult. McKesson Health Solutions, LLC.
American Academy of Sleep Medicine. http://www.aasmnet.org/resources/factsheets/sleepapnea.pdf. Accessed January 9, 2014.
Morgenthaler TI, Aurora RN, Brown T, et al. Practice parameters for the use of auto-titrating continuous positive airway pressure devices for titrating pressures and treating adult patients with obstructive sleep apnea syndrome: an update for 2007. An American Academy of Sleep Medicine (AASM) report. Sleep. 2008;31(1):141-7.
American Academy of Sleep Medicine (AASM). AASM clarifies hyponea scoring criteria. http://www.aasmnet.org/articles.aspx?id=4203. Accessed January 29, 2014.
Berry RB, Budhiraja R, Gottlieb DJ, et al. Rules for scoring respiratory events in sleep: update of the 2007 AASM Manual for the Scoring of Sleep and Associated Events. Deliberations of the sleep apnea definitions task force of the American Academy of Sleep Medicine. J Clin Sleep Med. 2012;8(5):597. Up-to-date. http://www.uptodate.com/contents/sleep-related-breathing-disorders-in-adults-definitions/abstract/3?utdPopup=true. Accessed January 30, 2014.
Kushida CA, Chedlak, A, Berry RB, et al. Clinical guidelines for the manual titration of positive airway pressure in patients with obstructive sleep apnea positive airway pressure Titration Task Force of the American Academy of Sleep Medicine. Journal of Clinical Sleep Medicine. 2008;(4)2.
Callahan C, Norman R, Taxin Z, et al. Multinight recording and analysis of continuous positive airway pressure airflow in the home for titration and management of sleep disordered breathing. Journal of Sleep. 2013 April 1;36(4):535–545.
Epstein LJ, Kristo D, Strollo PJ, et al. Clinical guideline for the evaluation, management and long-term care of obstructive sleep apnea in adults. Adult obstructive sleep apnea task force of the American Academy of Sleep Medicine. Journal of Clinical Sleep Medicine. 2009:5(3).
Morgenthaler, TI Kapen S, Lee-Chiong T, et al. Practice parameters for the medical therapy of obstructive sleep apnea. Standards-of-Practice Committee of the American Academy of Sleep Medicine. SLEEP. 2006 1031;29:8. http://www.aasmnet.org/Resources/PracticeParameters/PP_MedicalTherapyOSA.pdf. Accessed January 11, 2014.
American Academy of Dental Sleep Medicine (AADSM). http://www.aadsm.org/oralappliances.aspx. Accessed February 6, 2104.
American Association of Sleep Technologist. Positive airway pressure acclimation and desensitization. Updated July 2012. http://www.aastweb.org/Resources/Guidelines/PAPacclimation.pdf. Accessed February 6, 2014.
Rosen CL, Auckley D, Benca R, et al. A multisite randomized trial of portable sleep studies and positive airway pressure autotitration versus laboratory-based polysomnography for the diagnosis and treatment of obstructive sleep apnea: the HomePAP study. Sleep. 2012;35(6):757-67.
Skomro RP, Gjevre J, Reid J, et al. Outcomes of home-based diagnosis and treatment of obstructive sleep apnea. Chest. 2010;138(2):257-63.
Centers for Medicare and Medicaid Services (CMS). National coverage determination for continuous positive airway pressure (CPAP) therapy for obstructive sleep apnea (OSA);240.4. http://www.cms.hhs.gov/manuals/downloads/ncd103c1_Part4.pdf. Accessed January 29, 2014.
Strohl, KP. Sleep related breathing disorders in adults: Definitions. Up-to-date.
Parthasarathy S. Complex sleep apnea. Up-to-date. http://www.uptodate.com/contents/complex-sleep-apnea?source=preview&anchor=H18678839&selectedTitle=1~150#H18678839. Accessed January 11, 2014.
Cistulli PA. Oral appliances in the treatment of obstructive sleep apnea in adults. Up-to-Date.
Farid-Moayer M, Siegel LC, Black J. Oral pressure therapy for treatment of obstructive sleep apnea: clinical feasibility. Nat Sci Sleep. 2013;5:53-59.
Vorona RD, Ware JC, Sinacori JT, et al. Treatment of obstructive sleep apnea syndrome (OSAS) with a chinstrap. J Clin Sleep Med. 2007 December 15;3(7):729-730.
Malhotra A, Bogan RK, Farid-Moayer M, et al. Oral pressure therapy improves obstructive sleep apnea. Am Thor J. http://www.atsjournals.org/doi/abs/10.1164/ajrccm-conference.2012.185.1_MeetingAbstracts.A6810?prevSearch=A6810&searchHistoryKey. Accessed February 3, 2014.
Mikkelson ME, Christie JD, Lanken PN, et al. The adult respiratory distress syndrome cognitive outcomes study: long-term neuropsychological function in survivors of acute lung injury. Am J Respir Crit Care Med. 2012 Jun 15;185(12):1307-15.
Farid-Moayer M, Siegel LC, Black J. A feasibility evaluation of oral pressure therapy for the treatment of obstructive sleep apnea. http://tar.sagepub.com/content/7/1/3.abstract. Accessed February 3, 2014.
Miller DP, Li H, Emmett A. et al. Cluster analysis using data from a survey of patients with asthma: identification of asthma subgroups with history of exacerbations. Am J Respir Crit Care Med. 2012;185:A6810.
Schwab RJ, Kim C, Siegel LC, et al. Mechanism of action of a novel device using oral pressure therapy (OPT) for the treatment of OSA. Am J Respir Crit Care Med. 2012;185:A6811.
Patel SR, Malhotra A, Siegel LC, et al. Predicting response to oral pressure therapy for obstructive sleep apnea. Am J Respir Crit Care Med. 2013;187:A3752.
Colrain IM, Black J, Siegel LC. A multi-center evaluation of oral pressure therapy for the treatment of obstructive sleep apnea. Sleep Medicine. 2013;14:830-837.
Ktynger MH, Berry RB, Massie CA. Long-term use of a nasal expiratory positive airway pressure (EPAP) device as a treatment for obstructive sleep apnea (OSA). J Clin Sleep Med. 2011;7(5);449-53B.
Berry RB, Kryger MH, Massie CA. A novel nasal expiratory positive airway pressure (EPAP) device for the treatment of obstructive sleep apnea: a randomized controlled trial. Sleep. 2011;34(4);479-85. http://www.ncbi.nlm.nih.gov/pubmed/21461326. Accessed February 6, 2014.
Dave NB, Brown LK. Initiation of positive airway pressure therapy for obstructive sleep apnea in adults. Up-to-date. http://www.uptodate.com/contents/initiation-of-positive-airway-pressure-therapy-for-obstructive-sleep-apnea-in-adults?source=search_result&search=Auto+adjusting+positive+airway+pressure&selectedTitle=1%7E150#H5. Accessed February 6, 2104.
Kryger MH, Malhotra A. Management of obstructive sleep apnea in adults. Up-to-date.
Spencer J, Patel M, Mehta N et al. Special consideration regarding the assessment and management of patients being treated with mandibular advancement oral appliance therapy for snoring and obstructive sleep apnea. Cranio. 2013;31(1):10-3.
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Procedure Code Attachments
ICD-9 Diagnosis Codes
Covered Diagnosis Codes
For Procedure Code E0601
Non-Covered Diagnosis Codes
For Procedure Code E0471
ICD-10 Diagnosis Codes
Covered Diagnosis Codes
For Procedure Code E0601
Non-Covered Diagnosis Codes
For Procedure Code E0471
Positive Airway Pressure (PAP) devices:
Auto-titrating Positive Airway Pressure (APAP)
Continuous Positive Airway Pressure (CPAP)
Bi-level Positive Airway Pressure (BiPAP)
Apnea/hypopnea index (AHI)
The apnea hypopnea index (AHI) is the total number of apneas and hypopneas per hour of sleep. The AHI is most commonly calculated per hour of total sleep. However, an AHI is occasionally calculated per hour of non-REM sleep, per hour of REM sleep, or per hour of sleep in a certain position to provide insight into the sleep stage dependency or sleep position dependency of the sleep related breathing disorder. The AHI is the primary metric used to report polysomnography results.
Respiratory disturbance index (RDI)
The respiratory disturbance index (RDI) is the total number of events (e.g., apneas, hypopneas, and RERAs) per hour of sleep. The RDI is generally larger than the AHI, because the RDI includes the frequency of RERAs, while the AHI does not.
Respiratory effort related arousals (RERAs)
Respiratory effort related arousals (RERAs) exist when there is a sequence of breaths that lasts at least 10 seconds, characterized by increasing respiratory effort or flattening of the nasal pressure waveform followed by an arousal from sleep, which does not meet the criteria for an apnea or hypopnea. RERAs are often accompanied by a terminal snort or an abrupt change in respiratory measures.
RERAs (>5 events per hour) associated with daytime sleepiness were previously called upper airway resistance syndrome (UARS), which was considered a subtype of obstructive sleep apnea (OSA). These patients have abnormal sleep and cardiorespiratory changes typically found in OSA. Patients previously diagnosed with UARS are now considered to have OSA.
Negative Pressure Device
Oral pressure therapy device (e.g., Winx system)