Clinical UM Guideline

This document addresses the clinical indications for use of home oxygen therapy.

Medically Necessary:

1. Short term supplemental home oxygen therapy is medically necessary for treatment of hypoxemia-related symptoms with qualifying laboratory values (see Note below) associated with acute conditions including, but not limited to any of the following:
   1. Bronchiolitis; or
   2. Chronic obstructive pulmonary disease exacerbation; or
   3. Pneumonia.
2. Long term supplemental home oxygen therapy is medically necessary for treatment of hypoxemia-related symptoms with qualifying laboratory values (see Note below) from chronic lung conditions including, but not limited to any of the following:
   1. Bronchiectasis; or
   2. Chronic lung disease; or
   3. Chronic obstructive pulmonary disease; or
   4. Cystic fibrosis; or
   5. Diffuse interstitial lung disease; or
   6. Pulmonary hypertension; or
   7. Pulmonary neoplasm (primary or metastatic); or
   8. Recurring congestive heart failure due to chronic cor pulmonale.
3. Intermittent home oxygen therapy is considered medically necessary for the treatment of cluster headaches.
4. Supplemental home oxygen therapy is considered medically necessary during exercise when there is documentation of both of the following:
   1. Hypoxemia during exercise; and
   2. Improvement in hypoxemia and dyspnea or exercise capacity during exercise while using supplemental oxygen.
5. Supplemental home oxygen therapy is considered medically necessary during sleep in an individual with any of the following conditions:
   1. Unexplained pulmonary hypertension, cor pulmonale, edema secondary to right heart failure, or erythrocytosis and hematocrit is greater than 56%; or
   2. When obstructive sleep apnea, other nocturnal apnea, or a hypoventilation syndrome has been ruled out and there is documentation of desaturation during sleep to an SaO₂ of equal to or less than 88% for greater than 30% of the night; or
   3. When an individual with documented obstructive sleep apnea, other nocturnal apnea, or a hypoventilation syndrome experiences desaturation during sleep to a SaO₂ of equal to or less than 88% for greater than 30% of the night, which persists despite use of continuous positive airway pressure or non-invasive positive pressure ventilation devices.

Note: Hypoxemia is evidenced by any of the qualifying laboratory values obtained while breathing room (ambient) air unless contraindicated:

1. Adults:
   1. Arterial partial pressure of oxygen (PaO₂) equal to or less than 55 mm Hg or SaO₂ equal to or less than 88%; or
   2. Arterial PaO₂ of 56-59 mm Hg or SaO₂ equal to or less than 89% with any of the following conditions:
      1. Cor pulmonale; or
      2. Dependent edema secondary to right heart failure; or
      3. Erythrocytosis with hematocrit greater than 56%; or
      4. Pulmonary hypertension.
2. Infants and Children:
   1. PaO₂ of equal to or less than 60 mm Hg; or
   2. SaO₂ of equal to or less than 92%.

Not Medically Necessary: 

Home oxygen therapy is considered not medically necessary for any of the following indications, including but not limited to:

1. Severe peripheral vascular disease with clinically evident desaturation in one or more extremities in the absence of hypoxemia; or
2. Terminal illness not affecting the respiratory system; or
3. Treatment of angina pectoris or dyspnea in the absence of documented associated cor pulmonale or hypoxemia; or
4. The use of preset regulators used with portable oxygen systems.

The following codes for treatments and procedures applicable to this document 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.

When services may be Medically Necessary when criteria are met:

When services are Not Medically Necessary:
For the procedure codes listed above when criteria are not met or for situations designated in the Clinical Indications section as not medically necessary.

Home oxygen therapy administered at concentrations greater than air external to a building or device (ambient or room air) is intended to treat or prevent symptoms and manifestations of hypoxemic or non-hypoxemic medical conditions that are known to clinically improve with oxygen.

Arterial oxygen saturation of hemoglobin (SaO₂) can be measured by arterial blood gas (ABG) sampling or pulse oximetry. The healthcare practitioner orders the testing type and frequency. In adults and children (excluding premature infants), normal values of SaO₂ are 94% to 100% (NIH, 2018).

For the diagnosis of cluster headache, oxygen inhalation (100%) delivered at a rate of 7 to 10L/min. for 15 minutes through a loose-fitting facemask is considered a safe and effective first-line treatment for acute attacks. High-flow oxygen has been shown to abort the headache within several minutes.

Oxygen equipment alternatives include three types of systems to provide home oxygen:

• Compressed oxygen (tanks);
• Liquid oxygen;
• Oxygen concentrators.

With all of these systems, oxygen is inhaled through a mask or more commonly, a nasal cannula. Oxygen conserving devices can be used with compressed or liquid oxygen. The most popular oxygen conserving devices are demand inspiratory flow systems. These devices use a sensor to detect when inspiration begins and deliver oxygen only during inspiration, thus conserving oxygen during exhalation.

There has been recent interest in how multiple factors, including skin pigmentation, can impact the accuracy of pulse oximeter readings and potentially result in overreliance on pulse oximeter levels and suboptimal treatment management of individuals whose oxygen levels are below normal. The Australian Government Department of Health and Aged Care Therapeutic Goods Administration produced a Medical Device Safety Update regarding the limitations of pulse oximeters and the effect of skin pigmentation in 2022. Pulse oximeter devices work by shining light through the skin. Oxygen transporters in blood reflect light differently depending on how much oxygen they contain. The accuracy of the measurement has been known to be affected by many factors, including skin pigmentation. Other factors include correct fitting of the device, peripheral blood flow, nail coatings, tattoos and dyes, and maintenance and cleaning of the devices.

The Australian safety update noted recent cohort studies and systematic reviews indicating the potential for pulse oximeter readings that may over-estimate oxygen saturation levels in people with darker skin pigmentation (Bickler, 2005; Cabanas, 2022; Feiner, 2007; Sjoding, 2020; Valbuena, 2022). These inaccuracies are greater at lower levels of oxygenation and are more frequently reported in persons with darker skin pigmentation. They also occur at saturation levels where key decisions are often made around supplemental home oxygen therapy (at SaO₂ levels of 88-94%) with measures that are 3-4 percentage points above the actual oxygen saturation determined by ABG analysis. The authors propose that the effect in persons with intermediate skin tones may be in between that of darker and fairer skin tones. Investigators also acknowledged disparities in the accuracy of different pulse oximeter devices. The safety report concluded that home use of pulse oximeters is safer and more effective when done as part of coordinated medical management of the individual’s total condition with consideration of all clinical factors when recommending treatment. Clinicians are reminded that pulse oximeter devices may not accurately detect hypoxemia in persons with darker skin tones where oxygen saturations levels may be overestimated. At the present time, there is insufficient available evidence to make recommendations about any specific pulse oximeter devices (Australian Therapeutic Goods Administration, 2022).

On June 21, 2022 the U.S. Food and Drug Administration (FDA) issued an FDA Safety Communication about Pulse Oximeter Accuracy and Limitations, in which the following was noted:

The FDA continues to evaluate all available information pertaining to factors that may affect pulse oximeter accuracy and performance. Because of ongoing concerns that these products may be less accurate in individuals with darker skin pigmentations, the FDA is planning to convene a public meeting of the Medical Devices Advisory Committee later this year to discuss the available evidence about the accuracy of pulse oximeters, recommendations for patients and health care providers, the amount and type of data that should be provided by manufacturers to assess pulse oximeter accuracy, and to guide other regulatory actions as needed. Further details concerning the agenda, timing, and location of the Advisory Committee meeting will be announced in the coming weeks.

The FDA recommendations provided below have not changed. The FDA will continue to keep the public informed as significant new information or recommendations become available.

• Follow your health care provider’s recommendations about when and how often to check your oxygen levels.
• Be aware that multiple factors can affect the accuracy of a pulse oximeter reading, such as poor circulation, skin pigmentation, skin thickness, skin temperature, current tobacco use, and use of fingernail polish. To get the best reading from a pulse oximeter:
  • Follow the manufacturer’s instructions for use;
  • When placing the oximeter on your finger, make sure your hand is warm, relaxed, and held below the level of the heart. Remove any fingernail polish on that finger;
  • Sit still and do not move the part of your body where the pulse oximeter is located;
  • Wait a few seconds until the reading stops changing and displays one steady number.
• Write down your oxygen levels with the date and time of the reading so you can easily track changes and report these to your health care provider (FDA, 2022).

Bronchiectasis: A condition characterized by the loss of smooth muscle and elasticity of segments of the bronchial tubes.

Bronchiolitis: An inflammation of the bronchioles, the smallest air passages of the lungs, usually caused by a virus.

Cor pulmonale: Abnormal enlargement of the right side of the heart as a result of disease of the lungs or the pulmonary blood vessels.

Hypoxemic: An oxygen deficiency in arterial blood.

Peer Reviewed Publications:

1. Bailey RE. Home oxygen therapy for treatment of patients with chronic obstructive pulmonary disease. Am Fam Physician. 2004; 70(5):864-865.
2. Beck E, Sieber WJ, Trejo R. Management of cluster headache. Am Fam Physician. 2005; 71(4):717-724.
3. Bickler PE, Feiner JR, Severinghaus JW. Effects of skin pigmentation on pulse oximeter accuracy at low saturation. Anesthes. 2005; 102(4):715-719.
4. Cabanas AM, Fuentes-Guajardo M, Latorre K, et al. Skin pigmentation influence on pulse oximetry accuracy: A systematic review and bibliometric analysis. Sensors (Basel). 2022; 22(9):3402.
5. Cohen AS, Burns B, Goadsby PJ. High-flow oxygen for treatment of cluster headache: a randomized trial. JAMA. 2009; 302(22):2451-2457.
6. Feiner JR, Severinghaus JW, Bickler PE, et al. Dark skin decreases the accuracy of pulse oximeters at low oxygen saturation: the effects of oximeter probe type and gender. Anesthesia & Analgesia. 2007; 105(6):S18-S23.
7. Halstead S, Roosevelt G, Deakyne S, Bajaj L. Discharged on supplemental oxygen from an emergency department in patients with bronchiolitis. Pediatrics. 2012; 129(3):e605-e610.
8. Long-Term Oxygen Treatment Trial Research Group, Albert RK, Au DH, Blackford AL, et al. A randomized trial of long-term oxygen for COPD with moderate desaturation. N Engl J Med. 2016; 375(17):1617-1627.
9. Louie A, Feiner JR, Bickler PE, et al. Four types of pulse oximeters accurately detect hypoxia during low perfusion and motion. Anesthes. 2018; 128:520-530.
10. MacLean JE, Fitzgerald DA. A rational approach to home oxygen use in infants and children. Pediatric Respir Rev. 2006; 7(3): 215-222.
11. Matharu M, Silver N. Cluster headache. Clin Evid (Online). 2008; pii: 1212.
12. Moy ML, Harrington KF, Sternberg AL, et al. LOTT Research Group. Characteristics at the time of oxygen initiation associated with its adherence: Findings from the COPD Long-term Oxygen Treatment Trial. Respir Med. 2019; 149:52-58.
13. Roffe C, Nevatte T, Sim J, et al; Stroke Oxygen Study Investigators and the Stroke Oxygen Study Collaborative Group. Effect of routine low-dose oxygen supplementation on death and disability in adults with acute stroke: The stroke oxygen study randomized clinical trial. JAMA. 2017; 318(12):1125-1135.
14. Sjoding MW, Dickson RP, Iwashyna TJ, et al. Racial bias in pulse oximetry measurement. N Engl J Med. 2020; 383:2477-2478.
15. Tie SW, Hall GL, Peter S, et al. Home oxygen for children with acute bronchiolitis. Arch Dis Child. 2009; 94(8):641-643.
16. Uronis HE, Currow DC, McCrory DC, et al. Oxygen for relief of dyspnea in mildly- or non-hypoxemic patients with cancer: a systematic review and meta-analysis. Br J Cancer. 2008; 98(2):294-299.
17. Valbuena VSM, Barbaro RP, Claar D, et al. Racial bias in pulse oximetry measurement among patients about to undergo extracorporeal membrane oxygenation in 2019-2020: A retrospective cohort study. Chest. 2022; 161(4):971-978.
18. Whitehead-Clarke T. More on racial bias in pulse oximetry measurement. N Engl J Med. 2021; 384:1278.
19. Wilt TJ, Niewoehner D, MacDonald R, Kane RL. Management of stable chronic obstructive pulmonary disease: a systematic review for a clinical practice guideline. Ann Intern Med. 2007; 147(9):639-653.

Government Agency, Medical Society, and other Authoritative Publications:

1. Ameer F, Carson KV, Usmani ZA, Smith BJ. Ambulatory oxygen for people with chronic obstructive pulmonary disease who are not hypoxemic at rest. Cochrane Database Syst Rev. 2014; (6):CD000238.
2. Australian Government Department of Health and Aged Care Therapeutic Goods Administration (TGA). Medical Devices Safety Update. Limitations of pulse oximeters and the effect of skin pigmentation. January 7, 2022. Available at: https://www.tga.gov.au/news/safety-updates/limitations-pulse-oximeters-and-effect-skin-pigmentation. Accessed on May 9, 2024.
3. Badesch DB, Abman SH, Simonneau G, et al. Medical therapy for pulmonary arterial hypertension: updated American College of Chest Physicians evidence-based clinical practice guidelines. Chest. 2007; 131(6):1917-1928.
4. Balfour-Lynn IM, Field DJ, Gringras P, et al. British Thoracic Society (BTS) guidelines for home oxygen in children. Thorax. 2009; 64(2):ii1-26.
5. Bradley JM, O'Neill B. Short-term ambulatory oxygen for chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2005; (4):CD004356.
6. Centers for Medicare and Medicaid Services (CMS). National Coverage Determinations. Home use of oxygen. NCD #240.2. Effective September 7, 2021. Available at: https://www.cms.gov/medicare-coverage-database/search.aspx. Accessed on May 9, 2024.
7. Cranston JM, Crockett AJ, Currow D. Oxygen therapy for dyspnea in adults. Cochrane Database Syst Rev. 2008; (3):CD004769.
8. Cranston JM, Crockett AJ, Moss JR, Alpers JH. Domiciliary oxygen for chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2005; (4):CD001744.
9. Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease (Updated 2024). Available at: https://goldcopd.org/2024-gold-report/. Accessed on May 9, 2024.
10. Headache Classification Committee of the International Headache Society (IHS). The International Classification of Headache Disorders, 3rd edition (beta version). Cephalalgia. 2013; 33:629.
11. Jacobs SS, Krishnan JA, Lederer DJ, et al. Home oxygen therapy for adults with chronic lung disease. An official American Thoracic Society Clinical Practice Guideline. Am J Respir Crit Care Med. 2020; 202(10):e121-e141.
12. Jacobs SS, Lederer DJ, Garvey CM, et al. American Thoracic Society (ATS) Workshop Report: Optimizing Home Oxygen Therapy. Ann Am Thorac Soc. 2018; l 15(12):1369-1381.
13. National Institutes of Health (NIH). MedLinePlus. Blood gases. Updated July 31, 2022. Available at: http://www.nlm.nih.gov/medlineplus/ency/article/003855.htm. Accessed on May 9, 2024.
14. Qaseem A, Wilt TJ, Weinberger SE, et al. Diagnosis and management of stable chronic obstructive pulmonary disease: a clinical practice guideline update from the American College of Physicians, American College of Chest Physicians, American Thoracic Society, and European Respiratory Society. Ann Intern Med. 2011; 155(3):179-191.  
15. Wedzicha JA, Miravitlles M, Hurst JR, et al. Management of COPD exacerbations: a European Respiratory Society/American Thoracic Society guideline. Eur Respir J. 2017; 49(3):pii 1600791.
16. U.S. Food and Drug Administration (FDA). Pulse Oximeter Accuracy and Limitations: FDA Safety Communication. November 1, 2022. Available at: https://www.fda.gov/media/162709/download. Accessed on May 13, 2024.

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