This policy addresses the use of home overnight oximetry, which may be used to measure the nocturnal oxygen saturation in the blood of patients with known or suspected sleep apnea,  lung, and other ventilatory or cardiac disorders.

This policy also addresses the use of home spirometry, a method that may be used to provide measurement of respiratory function, including forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC). 

Note: For information regarding the use of home oxygen therapy, please see:

• Home Oxygen Therapy (CG-DME-18)

Medically Necessary:

Home overnight pulse oximetry is considered medically necessary for the following:

1. Use as an overnight screening test for sleep apnea, only where nocturnal hypoxemia is suspected to be a causative factor in any of the following conditions:
   • Unexplained right heart failure; or
   • Unexplained polycythemia; or
   • Unexplained pulmonary hypertension; or 
   • Cardiac arrhythmias occurring only during sleep (or increased during sleep).

Note: In these cases, evidence of nocturnal hypoxemia may then prompt polysomnography to potentially identify sleep apnea as a cause for the hypoxemia.

 

or

2. Use as an overnight screening test in patients with suspected nocturnal hypoxemia due to a condition unrelated to sleep apnea (e.g., chronic pulmonary disease with daytime hypoxemia but not meeting criteria for continuous oxygen therapy (see Home Oxygen Therapy [CG-DME-18]), or in the presence of any of the conditions listed in the four bullets in number 1 above when daytime hypoxemia, sufficient to explain the condition, has not been demonstrated).

Investigational/Not Medically Necessary:

Home overnight pulse oximetry is considered investigational/not medically necessary for use as the sole diagnostic test for sleep apnea syndrome in lieu of polysomnography or for routine screening for sleep apnea in the absence of any of the above conditions.

Home overnight pulse oximetry (and home pulse oximetry in general) is considered investigational/not medically necessary for use in the home for asthma management.

Home spirometry for monitoring of pulmonary function is considered investigational/not medically necessary for any indication.
 

The evidence assessing the quality of spirometric data collected at home includes one randomized controlled trial.  This study showed a high patient non-compliance rate. In addition, individual differences were wide in that, even under ideal conditions, home spirometry provides an incomplete, and therefore potentially biased, picture of long-term changes in pulmonary function. 

A 2006 National Heart, Lung and Blood Institute/World Health Organization Global Asthma Initiative Report concluded that pulse oximetry is not an appropriate method of monitoring patients with asthma. The report explained that, during asthma exacerbations, the degree of hypoxemia may not accurately reflect the underlying degree of ventilation-perfusion mismatch.

As a screening tool for the diagnosis of sleep apnea, overnight oximetry sensitivity and specificity remain controversial and deserve further clarification through controlled studies. Technical limitations, limited user knowledge, and the lack of consensus on interpretation of data all play a role in diminishing the value of pulse oximetry as a diagnostic tool.  Pulse oximetry will also not identify patients suffering from Upper Airway Resistance Syndrome. 

The use of home overnight pulse oximetry may be considered appropriate to detect nocturnal oxygen desaturation in certain conditions unrelated to sleep apnea where nocturnal hypoxemia is suspected.   

Pulse oximetry is a method by which arterial oxygen saturation, the amount of oxygen dissolved in the blood, may be measured.  A pulse oximeter is a small device that is usually placed on the patient's finger, earlobe, toe or nose. It functions by passing a specific wavelength of light through a part of the body and then measuring the amount of light that has been absorbed by the body.  The degree of light absorption provides an indication of the oxygen saturation of the blood.  Data from these types of devices is usually presented on a digital screen that constantly displays arterial saturation. It is important to note that pulse oximetry should not be relied upon as a stand-alone device for measurement of pulmonary function.  Because it does not assess ventilation, over reliance on pulse oximetry may delay detection of clinically significant hypoxemia.

Home Spirometry is a method by which measurements of pulmonary function and lung volumes are taken. The measurements taken by this method include forced vital capacity (FVC), which is the maximum volume of air that can be exhaled (expired/breathing out and  FEV-1, which is the volume of air forcefully exhaled during the first second after a full breath and normally accounts for greater than 75% of the forced vital capacity. Home spirometry monitoring devices have been primarily investigated among lung or heart-lung transplant recipients as a technique to provide early diagnosis of infection and rejection. While spirometry alone may not identify a specific diagnosis, it can differentiate between obstructive and restrictive lung disorders and home based spirometry use has been investigated for the ongoing determination of the severity in conditions such as chronic obstructive pulmonary disease, bronchitis, emphysema, asthma and cystic fibrosis.

Forced Expired Volume in One Second (FEV₁): the volume expired in the first second of maximal expiration after a maximal inspiration and a useful measure of how quickly full lungs can be emptied

Hypoxemia: insufficient oxygenation of the blood

Pulse Oximetry: non-invasive method of monitoring the percentage of hemoglobin (Hb) which is saturated with oxygen

Sleep apnea: a disorder characterized by brief interruptions of breathing during sleep

Spirometry: the study of air volume and flow rate within the lungs; spirometry is frequently used to evaluate lung function in people with obstructive or restrictive lung diseases such as asthma or cystic fibrosis

Vital Capacity (VC): the maximum volume of air that can be exhaled or inspired during either a forced (FVC) or a slow (VC) maneuver

The following codes for treatments and procedures applicable to this policy are included below for informational purposes.  Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy.  Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

Home Overnight Pulse Oximetry
When services may be Medically Necessary when criteria are met in the home setting:

CPT

ICD-9 Diagnosis

When services are Investigational/Not Medically Necessary, in the home setting:
For the procedure and diagnosis codes listed above when criteria are not met, for all other diagnoses not listed, or when the code describes a procedure indicated in the Policy section as investigational/not medically necessary.

Home Spirometry
When services are Investigational/Not Medically Necessary:

CPT

HCPCS

ICD-9 Diagnosis

Peer Reviewed Publications:

1. Chowienczyk PJ, Parkin DH, et al. Do asthmatic patients correctly record home spirometry measurements? BMJ. 1994: 309(6969):1618.
2. Finkelstein J, Cabrera MR, Hripcsak G. Internet-based home asthma telemonitoring. Chest. 2000;117(1):34-38.
3. Flemons WW, Littner MR, et al.    Home diagnosis of sleep apnea:  a systematic review of the literature.  An evidence review cosponsored by the American Academy of Sleep Medicine, the American College of Chest Physicians, and the America Thoracic Society.  Chest. 2003; 124(4):1535-1542. 
4. Fussell KM, Ayo DS, Branca P, et al. Assessing need for long-term oxygen therapy: a comparison of conventional evaluation and measures of ambulatory oximetry monitoring. Respir Care. 2003; 48(2):115-119.
5. Martinez MW, Rodysill KJ, Morgenthaler TI. Use of ambulatory overnight oximetry to investigate sleep apnea in a general internal medicine practice. Mayo Clin Proc. 2005; 80(4):455-462.
6. Mullan B, Snyder M, Lindgren B, et al. Home monitoring for lung transplant candidates. Prog Transplant. 2003;13(3):176-182.
7. Netzer N, Eliasson AH, et al. Overnight pulse oximetry for sleep-disordered breathing in adults. Chest. 2001; 120(2):625-633.
8. Pilling J, Cutata M. Ambulatory oximetry monitoring in patients with severe COPD. Chest 1999; 116(2);314-321.
9. Series F, Marc I, et al. Utility of nocturnal home oximetry for case finding in patients with suspected sleep apnea hypopnea syndrome. Ann Intern Med. 1993; 119(6): 449-453.
10. Series F, Kimoff RJ, Morrison D, et al. Prospective evaluation of nocturnal oximetry for detection of sleep-related breathing disturbances in patients with chronic heart failure. Chest. 2005; 127(5):1507-1514.
11. Snow V, Lascher S, et al. The evidence base for management of acute exacerbations of COPD. Clinical practice guideline, part 1. Chest. 2001; 119(4):1185-1189.
12. Wensley DC, Silverman M.  The quality of home spirometry in school children with asthma. Thorax. 2001; 56(3):164-165.
13. Wiltshire N, Kendrick, Catterall JR. Home oximetry studies for diagnosis of sleep apnea/hypopnea syndrome. Chest. 2001; 120(2):384-389.

Government Agency, Medical Society, and Other Authoritative Publications:

1. Allen J, Zwerdling R, Ehrenkranz R, Gaultier C, Geggel R, Greenough A, et al.; American Thoracic  Society. Statement on the care of the child with chronic lung disease of infancy and childhood. Am J Respir Crit Care Med. 2003; 168(3):356-96. Available at:
   http://www.thoracic.org/sections/publications/statements/ pages/respiratory-disease-pediatric/childcare.html. Accessed on February 26, 2007. 
2. American Academy of Pediatrics. Committee on Fetus and Newborn. Apnea, sudden infant death syndrome, and home monitoring. Pediatrics. 2003; 111(4 Pt 1):914-917. Available at: http://aappolicy.aappublications.org/cgi/content/full/pediatrics;111/4/914. Accessed on February 26, 2007. 
3. American Association for Respiratory Care. Clinical Practice Guideline. Pulse oximetry. No date provided. Available at: http://www.rcjournal.com/cpgs/pulsecpg.html. Accessed on February 26, 2007. 
4. American Association for Respiratory Care. Clinical Practice Guideline. Spirometry, 1996 update. Respir Care. 1996; 41(7): 629-636. Available at: http://www.rcjournal.com/cpgs/spirupdatecpg.html. Accessed on February 26, 2007. 
5. Centers for Medicare and Medicaid Services. National Coverage Determination Home Use of Oxygen. NCD #240.2. Effective October 27, 1993. Available at: http://www.cms.hhs.gov/mcd/index_list.asp?list_type=ncd. Accessed on February 26, 2007. 
6. Chesson AL Jr, Berry RB, Pack A; American Academy of Sleep Medicine; American Thoracic Society; American College of Chest Physicians. Practice parameters for the use of portable monitoring devices in the investigation of suspected obstructive sleep apnea in adults. Sleep. 2003; 26(7):907-913.
7. Hayes Inc. Hayes Medical Technology Directory.  Home Sleep Studies for Diagnosis of Obstructive Sleep Apnea in Adults. Hayes, Inc. April 2003.  Search updated February 22, 2006.
8. Global Initiative for Asthma (GINA), National Heart, Lung and Blood Institute (NHLBI). Global strategy for asthma management and prevention. Available at: http://www.guideline.gov/summary/summary.aspx?doc_id=10170. Accessed on February 26, 2007.

1. National Library of Medicine. Medical Encyclopedia. Asthma. Available at: http://www.nlm.nih.gov/medlineplus/ency/article/000141.htm. Accessed on February 26, 2007.  
2. National Library of Medicine. Medical Encyclopedia. Spirometry. Available at: http://www.nlm.nih.gov/medlineplus/ency/imagepages/1142.htm. Accessed on February 26, 2007.

Ambulatory Spirometry
Home Spirometry
Pulmonary Function, Home Monitoring
Pulmonary Function Tests
Pulse Oximetry
Spirometry, Home or Ambulatory
 

Federal and State law, as well as contract language, including definitions and specific contract provisions/exclusions, take precedence over Medical Policy and must be considered first in determining eligibility for coverage. The member's contract benefits in effect on the date that services are rendered must be used. Medical Policy, which addresses medical efficacy, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving, and we reserve the right to review and update Medical Policy periodically. No part of this publication may be reproduced, stored in a retrieval system or transmitted, in any form or by an means, electronic, mechanical, photocopying, or otherwise, without permission from the health plan.

©CPT Only - American Medical Association