Latest Review Date: December 2023

Category:  DME                                                               

POLICY:

New initiation of Oxygen therapy may be considered medically necessary for individuals with significant hypoxemia when oxygen is prescribed by a physician and evidenced by any of the following blood gas values:

1. A PaO₂ ≤ 55 mm Hg or SaO₂ ≤ 88%, taken at rest, on room air.
2. A PaO₂ ≤ 55 mm Hg or SaO₂ ≤ 88%, taken during sleep, for an individual who demonstrates a PaO₂ ≥ 56 mm Hg or SaO₂ ≥ 89% while awake.
3. A PaO₂ ≤ 55 mm Hg or SaO₂ ≤ 88%, taken during exercise, for an individual who demonstrates a PaO₂ ≥ 56 mm Hg or SaO₂ ≥ 89% during the day while at rest.
4. A decrease in PaO2 of more than 10 mm Hg or a decrease in SaO₂ of more than 5% during sleep, associated with signs or symptoms of nocturnal hypoxemia (e.g., impaired cognitive process, restlessness, insomnia).
5. A PaO₂ of 56-59 mm Hg or SaO₂ ≤ 89%, in the presence of dependent edema suggesting congestive heart failure, evidence of pulmonary hypertension or cor pulmonale, or erythrocytoses (hematocrit > 56%).

Some diseases that may require oxygen therapy include, but are not limited to, the following:

• Chronic obstructive pulmonary disease (COPD)
• Pulmonary fibrosis
• Cystic fibrosis
• Bronchiectasis
• Recurring congestive heart failure due to chronic cor-pulmonale
• Widespread pulmonary neoplasia
• Pediatric bronchopulmonary dysplasia (BPD)
• Pulmonary hypertension 
• Chronic lung disease complicated by erythrocytosis (Hematocrit > 56%)
• Persistent, but resolving hypoxemia due to respiratory infection
• Chronic severe angina with hypoxemia.
• COVID-19

For the above indications, the initiation of oxygen requires the results of a blood gas study that has been ordered and evaluated by the attending physician.  A measurement of arterial oxygen saturation obtained by ear or pulse oximetry; however, is also acceptable when ordered and evaluated by the attending physician and performed under his or her supervision or when performed by a qualified provider or supplier of laboratory services. When the arterial blood gas and the oximetry studies are both used to document the need for home oxygen therapy and the results are conflicting, the arterial blood gas study is the preferred source of documenting medical need. A DME supplier is not considered a qualified provider or supplier of laboratory services for purposes of these coverage criteria.  See additional policy guidelines below.

Oxygen therapy may be considered medically necessary for short-term use in some conditions unrelated to hypoxemia, including the following:

• Cluster headache when other treatments have failed. Cluster headache is defined by diagnostic criteria used by the International Headache Society, as at least 5 severe headache attacks with at least 1 headache per day and the headaches have the following components:
  • Individual has severe unilateral orbital, supraorbital, or temporal pain lasting at least 15 -180 minutes when untreated; and
  • The headaches must be accompanied by at least one of the following findings:
    • Ipsilateral conjunctival injection; and/or lacrimation; or
    • Ipsilateral nasal congestion; and/or rhinorrhea; or
    • Ipsilateral forehead and facial sweating; or
    • Ipsilateral miosis; or ptosis;or
    • Ipsilateral eyelid edema.
• Pediatric broncho-pulmonary dysplasia (BPD) infants who have variable oxygen needs
• Hemoglobinopathies

These indications do not require blood gas levels to meet medical criteria for coverage.

Oxygen therapy may be considered medically necessary in individuals with lung cancer who have dyspnea relieved by oxygen.  These individuals do not require blood gas levels to meet medical criteria for coverage.

Oxygen therapy is considered not medically necessary for the following conditions:

• Angina pectoris in the absence of hypoxemia
• Dyspnea without evidence of hypoxemia or cor- pulmonale
• Severe peripheral vascular disease resulting in clinically evident desaturation in one or more extremities but in the absence of systemic hypoxemia. There is no evidence that increased PO₂ will improve the oxygenation of tissues with impaired circulation.
• Terminal illnesses that do not affect the respiratory system
• Migraine headaches

POLICY GUIDELINES:

1.   There must be documentation of an arterial blood gas or arterial oxygen saturation result as ordered and evaluated by the attending physician, within 30 days of certification or recertification.

2.   The oxygen therapy must be ordered by a physician and the prescription should include the following:

• A diagnosis of the disease requiring home use of oxygen
• Oxygen concentration and flow rate
• An estimate of the frequency of use (an intermittent or leave in oxygen therapy order must include time limits and specific indications for initiating and terminating therapy
• Method of delivery
• Duration of use (e.g., 2 liters per minute, 10 minutes per hour, 12 hours per day)
• Duration of need (e.g., 6 months to lifetime).  If oxygen is prescribed on an indefinite basis, the care must be reviewed every 12 months to determine whether a medical need continues to exist

3.   Portable oxygen systems may be considered medically necessary only if the individual ambulates on a regular basis.

4.   The following components of oxygen therapy are considered not medically necessary:

• Oxygen and oxygen supplies in facilities that are expected to supply such items;
• Setup or installation of respiratory support systems;
• Preset regulators used with portable oxygen systems;
• Regulators that permit a flow rate > 8 liters per minute, as these units are not appropriate for home use, except for some individuals with terminal illness, such as pulmonary fibrosis, and a life expectancy of 6 months or less;
• A prescription for oxygen for use as needed (PRN);
• Backup or secondary oxygen systems.

5.   Delivery charges are considered not medically necessary.

6.   Electrical generators do not meet the definition of DME because they are not primarily medical in nature.

DESCRIPTION OF PROCEDURE OR SERVICE:

Oxygen is administered by inhalation utilizing devices that provide controlled oxygen concentrations and flow rates to the individuals.  Oxygen therapy should maintain adequate tissue and cell oxygenation while trying to avoid oxygen toxicity.  The individual’s condition is monitored to ensure that the individual is receiving the proper mixture of gases, mists and aerosols.

A individual’s oxygen level may be measured in several ways.  By drawing a sample of blood from an artery (ABG or arterial blood gas), the oxygen level in the blood, called PaO₂, can determine whether a individual requires oxygen.  Another method is to use a device called a pulse oximeter or saturation meter, which measures how saturated the blood is with oxygen (O₂ saturation or SaO₂).  These devices clip onto the finger, toe, or ear, and check the oxygen saturation of the blood by light beams.  The SaO₂ numbers are not the same as the PaO₂, but they yield similar information.

KEY POINTS:

Literature review through December 5, 2023.

PRACTICE GUIDELINES AND POSITION STATEMENTS:

The National Institute for Health and Clinical Excellence (NICE)

The National Institute for Health and Clinical Excellence (NICE)’s guideline on "Diagnosis and management of headaches in young people and adults" (2012) recommended oxygen therapy for cluster headaches; but did not mention its use for migraines.

International Headache Society Diagnostic Criteria for Cluster Headache

Diagnostic criteria used by the International Headache Society to form a definitive diagnosis of CH includes individuals who have had at least five severe to very severe unilateral headache attacks lasting 15-180 minutes when untreated. (Intensity of pain: Degree of pain usually expressed in terms of its functional consequence and scored on a verbal 5-point scale: 0 = no pain; 1 = mild pain, does not interfere with usual activities; 2 = moderate pain, inhibits but does not wholly prevent usual activities; 3 = severe pain, prevents all activities; 4 = very severe pain. It may also be expressed on a visual analogue scale.)

The headaches must be accompanied by at least one of the following findings:

1. Ipsilateral conjunctival injection and/or lacrimation; or
2. Ipsilateral nasal congestion and/or rhinorrhea; or
3. Ipsilateral eyelid edema; or
4. Ipsilateral forehead and facial sweating; or
5. Ipsilateral miosis and/or ptosis; or
6. A sense of restlessness or agitation.

U.S. Preventive Services Task Force Recommendations

Not applicable.

KEY WORDS:

Home oxygen therapy, arterial blood gas, arterial oxygen tension (PaO2), arterial oxygen saturation (SaO2), hypoxemia, cluster headache, ABG, COVID-19

APPROVED BY GOVERNING BODIES:

Not applicable

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits.  Group-specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply

FEP contracts: Special benefit consideration may apply.  Refer to member’s benefit plan.

CURRENT CODING:

HCPCS:         

REFERENCES:

1. American Association for Respiratory Care (AARC).  Clinical Practice Guideline.  Oxygen therapy in the home or alternate site health care facility-2007 revision and update.  Respiratory Care, August 2007; 52(8): 1063-1068.
2. American Association for Respiratory Care (AARC).  Clinical Practice Guideline.  Selection of an oxygen delivery device for neonatal and pediatric patients:  2002 revision and update.  Respiratory Care 2002; 47(6): 707-716.
3. American Thoracic Society.  Management of stable COPD:  Long-term oxygen therapy.  2004, www.thoracic.org/sections/copd.
4. Bailey RE.  Home oxygen therapy for treatment of patients with chronic obstructive pulmonary disease.  American Family Physician 2004; 70(5): 864-865.
5. Beck E, et al.  Management of cluster headache.  American Family Physician 2005; 71(4): 717-724.
6. Centers for Medicare and Medicaid Services (CMS).  Decision memo for home use of oxygen.  March 2006.  www.cms.hhs.gov/mcd/.
7. Croxton TL, et al.  Long-term oxygen treatment in chronic obstructive pulmonary disease: Recommendations for future research: an NHLBI Workshop Report.  American Journal Respiratory Critical Care Medicine 2006; 174: 373.
8. Doherty DE, et al.  Recommendations of the 6th long-term oxygen therapy consensus conference.  2006 Respiratory Care 51, pp. 519.
9. Eaton T, et al.  Long-term oxygen therapy improves health-related quality of life.  Respiratory Medicine 2004; 98: 285.
10. Huber G.  Oxygen therapy influences episodic cluster headache and related cutaneous brush and cold allodynia. Headache 2009; 49(1):134-6.
11. Ingenito EP.  Medical therapy for chronic obstructive pulmonary disease in 2007.  Semin Thoracic Cardiovascular Surgery 2007; 19(2): 142-150.
12. International Headache Society Diagnostic Criteria for Cluster Headache https://ichd-3.org/3-trigeminal-autonomic-cephalalgias/3-1-cluster-headache/
13. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
14. Lagatta J, Murthy K, Zaniletti I, et al. Home oxygen use and 1-year readmission among infants born preterm with bronchopulmonary dysplasia discharged from children's hospital neonatal intensive care units. J Pediatr. 2020;220:40-48.e5.
15. Lau J, et al.  Long-term oxygen therapy for severe COPD.  Agency for Healthcare Research and Quality (AHRQ).  Tufts-New England Medical Center Evidence-Based Practice Center.  June 2004.
16. National Clinical Guideline Centre. Headaches: Diagnosis and management of headaches in young people and adults. London, UK: National Institute for Health and Clinical Excellence (NICE); September 2012.
17. Nonoyama ML, et al.  Effect of oxygen on health quality of life in patients with chronic obstructive pulmonary disease with transient exertional hypoxemia.  American Journal Respiratory Critical Care Medicine 2007; 176: 343.
18. Mallory GB, Fullmer JJ, Vaughan DJ. Oxygen therapy for cystic fibrosis. Cochrane Database Syst Rev. 2005;(4):CD003884.
19. Qaseem A, et al.  Diagnosis and management of stable chronic obstructive pulmonary disease:  A clinical practice guideline from the American College of Physicians.  Annals of Internal Medicine, November 2007; 147(9): 633-638.
20. Ram SF, et al.  Ambulatory oxygen for chronic obstructive pulmonary disease.  Cochrane Database Syst Review 2002, Vol. 2: CD000238.
21. Ribeil JA, Labopin M, Stanislas A, et al. Transfusion-related adverse events are decreased in pregnant women with sickle cell disease by a change in policy from systematic transfusion to prophylactic oxygen therapy at home: A retrospective survey by the international sickle cell disease observatory. Am J Hematol. 2018;93(6):794-802.
22. Tanni SE, et al.  Influence of the oxygen delivery system on the quality of life of patients with chronic hypoxemia.  Journal Bras Pneumology 2007; 33: 161.
23. Thoracic Society of Australia and New Zealand, Fitzgerald DA, Massie RJ, Nixon GM, et al. Infants with chronic neonatal lung disease: Recommendations for the use of home oxygen therapy. Med J Aust. 2008;189(10):578-582.
24. Wilt TJ, et al.  Management of stable chronic obstructive pulmonary disease:  A systematic review for a clinical practice guideline.  Annals of Internal Medicine, November 2007; 147(9): 639-653.

POLICY HISTORY:

Medical Policy Group, April 2008 (3)

Medical Policy Administration Committee, June 2008

Available for comment May 21-June 2, 2008

Medical Policy Group, May 2008 (2)

Medical Policy Administration Committee, June 2008

Available for comment June 3-July 17, 2008

Medical Policy Group, July 2008 (2)

Medical Policy Administration Committee, August 2008

Available for comment July 25-September 8, 2008

Medical Policy Group, June 2009 (2)

Medical Policy Administration Committee, June 2009

Available for comment, June 5-July 20, 2009

Medical Policy Group, May 2011 (1) Coding update

Medical Policy Administration Committee, May 2011

Medical Policy Group, November 2012: Deleted Codes K0741 and K0742 effective 12/31/2012

Medical Policy Group, May 2013: Effective 05/1/2013: Active Policy but no longer scheduled for regular peer-literature reviews and updates.

Medical Policy Group, August 2018(6) Removed old coding from prior to 2013 and code E0445, clarified policy statement to include “every 12 months”.

Medical Policy Group, December 2018:  2019 Annual Coding Update.  Added HCPC code E0447 to the Current coding section.

Medical Policy Group, December 2019 (6): Updates to Key Points and Key Words (cluster headache, ABG). No change to policy intent.

Medical Policy Group, January 2021 (6): Updates to Key Points and Coding (E0433/E1354). No change to policy intent.

Medical Policy Group, December 2021 (6): Updates to Policy statement to include "COVID-19" as an included diagnosis. COVID-19 added to Key Words. No change to policy intent.

Medical Policy Group, January 2022 (6): Reviewed by consensus. No new published peer-reviewed literature available that would alter the coverage statement in this policy.

Medical Policy Group, December 2022 (6): Updates to Policy statement, verbiage clarification, Description, Key Points, USPSTF, Practice Guidelines and References.

Medical Policy Group, December 2023 (6): Updates to Key Points and Benefit Application.

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.