Clinical Policy: Outpatient Oxygen Use Form

CENTENE® Corporation

Clinical Policy: Outpatient Oxygen Use Reference Number: CP.MP.190 Date of Last Revision: 11/24

Coding Implications Revision Log

See Important Reminder at the end of this policy for important regulatory and legal information.

Description Oxygen therapy is the administration of oxygen at concentrations greater than that in ambient air (20.9%) with the intent of treating or preventing the symptoms and manifestations of hypoxemia.¹

Note:

• If a medically necessary, lesser cost item exists and will suit the member/enrollee's medical needs, a higher cost item will be denied.
• For criteria applicable to Medicare plans, please see MC.CP.MP.190 Outpatient Oxygen Use.

Policy/Criteria

1. It is the policy of health plans affiliated with Centene Corporation® that initial approval of oxygen concentrators and oxygen systems (for indications other than cluster headaches; for stationary oxygen systems for cluster headaches, see section VI) for members/enrollees ≥ 18 years of age are medically necessary when meeting all of the following³: A. Physician-documented severe lung disease or hypoxemia-related symptoms that might be expected to improve with oxygen therapy; B. The blood gas study or pulse oximetry measurement meets one of the following:
   1. Member/enrollee qualifies for Group I by meeting any of the following³,⁸: a. An arterial PO₂ at or below 55 mm Hg, or an arterial oxygen saturation (or pulse oximetry) at or below 88 percent taken at rest (awake), breathing room air; b. An arterial PO₂ at or below 55 mm Hg, or an arterial oxygen saturation (or pulse oximetry) at or below 88 percent, taken during sleep, for a beneficiary who demonstrates an arterial PO₂ at or above 56 mm Hg or an arterial oxygen saturation (or pulse oximetry) at or above 89 percent while awake; c. A decrease in arterial PO₂ more than 10 mm Hg, or a decrease in arterial oxygen saturation (or pulse oximetry) more than five percent from baseline saturation, taken during sleep and associated with symptoms (e.g., impairment of cognitive processes and nocturnal restlessness or insomnia) or signs (e.g., cor pulmonale, "P" pulmonale on EKG, documented pulmonary hypertension, and erythrocytosis) reasonably attributable to hypoxemia; d. An arterial PO₂ at or below 55 mm Hg or an arterial oxygen saturation (or pulse oximetry) at or below 88 percent, taken during exercise for a beneficiary who demonstrates an arterial PO₂ at or above 56 mm Hg or an arterial oxygen saturation (or pulse oximetry) at or above 89 percent during the day while at rest. In this case, oxygen is provided for during exercise if it is documented that the use of oxygen improves the hypoxemia that was demonstrated during exercise when the beneficiary was breathing room air; Page 1 of 13 CENTENE® Corporation

CLINICAL POLICY Outpatient Oxygen Use

2. Member/enrollee qualifies for Group II by meeting both of the following¹,⁸: a. An arterial PO₂ of 56 through 59 mm Hg or an arterial blood oxygen saturation of 89 percent or less at rest (awake), during sleep, or during exercise (as described under Group I criteria); b. Any of the following: i. Dependent edema suggesting congestive heart failure; ii. Pulmonary hypertension or cor pulmonale, determined by measurement of pulmonary artery pressure, gated blood pool scan, echocardiogram, or "P" pulmonale on EKG (P wave greater than 3 mm in standard leads II, III, or AVF); iii. Erythrocythemia with a hematocrit greater than 56 percent; C. The qualifying blood gas study or pulse oximetry measurement was obtained under one of the following conditions³,⁸:
   1. Performed during an inpatient hospital stay, and the reported test was the one obtained closest to, but no earlier than two days prior to the hospital discharge date;
   2. Not performed during an inpatient hospital stay, and the reported test was performed when the treating practitioner noted signs and symptoms of illness that can be relieved by oxygen treatment in the home; D. If the request is for a portable oxygen system, both of the following⁸:
   3. The member/enrollee is mobile within the home or community;
   4. The qualifying blood gas study or pulse oximetry was performed while at rest (awake) or during exercise. (If the only qualifying blood gas study or pulse oximetry measurement was performed during sleep, portable oxygen will be denied as not reasonable and necessary).

III.It is the policy of health plans affiliated with Centene Corporation that reauthorization of oxygen concentrators and oxygen systems for members/enrollees ≥ 18 years of age are medically necessary when meeting the following¹,⁷,⁹: A. Evaluation by the treating physician within 90 days prior to the date of recertification,

  and one of the following:
  1. Chronic hypoxemia is not expected to improve or is expected to worsen, as
     documented in an explanatory letter of medical necessity (LOMN);
  2. Treatment is for nocturnal hypoxemia in a member/enrollee who qualifies for Group I
     (as defined in criteria section I), and two oxygen requests have already been
     authorized;
  3. A new arterial blood gas (ABG) or pulse oximetry result documents that
     member/enrollees still meets the criteria in section I above (initial approval criteria),
     and one of the following:
     a. For Group I (as defined in section I), the measurement is obtained within 90 days
        of the recertification date, and by the physician or designee, or by an independent
        diagnostic testing facility (IDTF). O₂ levels obtained by DME providers do not
        qualify. Home oxygen companies are permitted to coordinate with an IDTF for
        the purpose of obtaining needed overnight oximetry saturation testing;
     b. For Group II (as defined in section I; rare cases where initial certification was for
        three months with PO₂ 56 through 59 or O₂ sat 89%), a repeat ABG or oximetry
        must be obtained within 30 days of recertification date;

B. If the request is for a portable oxygen system, both of the following⁷:

  1. The member/enrollee is mobile within the home or community;
  2. The qualifying blood gas study or pulse oximetry measurement was performed while
     at rest (awake) or during exercise. (If the only qualifying blood gas study or pulse
     oximetry measurement was performed during sleep, portable oxygen will be denied
     as not reasonable and necessary).

V. It is the policy of health plans affiliated with Centene Corporation that oxygen concentrators are not medically necessary for the following indications¹,³,⁸: A. Angina pectoris in the absence of hypoxemia; B. Breathlessness without cor pulmonale or evidence of hypoxemia; C. Severe peripheral vascular disease resulting in clinically evident desaturation in one or

  more extremities but in the absence of systemic hypoxemia;

D. Shortness of breath or dyspnea in a pediatric patient without evidence of hypoxemia; E. Terminal illnesses that do not affect the ability to breathe.¹,⁸

Background Oxygenation is the process of oxygen diffusing passively from the alveolus to the pulmonary capillary, where it binds to hemoglobin in red blood cells or dissolves into the plasma.² A low partial pressure of oxygen in the blood is termed hypoxemia. Hypoxemia can have multiple causes including hypoventilation, ventilation-perfusion (V/Q) mismatch, right-to-left shunts, Page 4 of 13 CENTENE® Corporation

CLINICAL POLICY Outpatient Oxygen Use

diffusion limitation, and reduced inspired oxygen tension. Common tests to determine if oxygenation is impaired and at risk of being insufficient include arterial oxygen saturation (SaO₂), arterial oxygen tension (PaO₂), alveolar to arterial (A-a) oxygen gradient, and the PaO₂/fraction of inspired oxygen (FiO₂) ratio.²

Indications for continuous long-term oxygen therapy (LTOT) for those with chronic lung disease include³:

• Resting arterial oxygen tension (PaO₂ less than or equal to 55 mmHg (7.32 kPa), or a pulse oxygen saturation (SpO₂) less than or equal to 88 percent;
• PaO₂ less than or equal to 59 mmHg (7.85 kPa), or an SpO₂ less than or equal to 89 percent, if there is evidence of cor pulmonale, right heart failure, or erythrocytosis (hematocrit >55 percent);
• PaO₂ of 55 mmHg (7.32 kPa) or lower, or an SpO₂ of 88 percent or lower, during exercise or sleep.

Prescribed oxygen flow rates may vary throughout the day with activity or sleep or during acute exacerbations of disease. For patients with nocturnal oxygen desaturation, clinical evaluation for sleep-disordered breathing utilizing polysomnography is often appropriate.³

The American Association for Respiratory Care According to the American Association for Respiratory Care LTOT in the home or alternate site health care facility is normally indicated for the treatment of hypoxemia and has been shown to have a significant positive impact on hypoxemic patients with chronic obstructive pulmonary disease (COPD). LTOT has also been shown to reduce hospitalizations and lengths of stay. Laboratory indications for LTOT include documented hypoxemia in adults, children, and infants older than 28 days as evidenced by PaO₂ ≤ 55 mm Hg or SaO₂ ≤ 88% in subjects breathing room air or PaO₂ of 56 to 59 mm Hg or SaO₂ or SpO₂ ≤ 89% in association with specific clinical conditions such as cor pulmonale, congestive heart failure, or erythrocythemia with hematocrit >

56. Some patients may not demonstrate a need for oxygen therapy at rest but will be hypoxemic during ambulation, sleep, or exercise. Oxygen therapy is indicated during these specific activities when the SaO₂ is demonstrated to fall to ≤ 88%. The initial need for LTOT is determined by measurement of inadequate arterial blood oxygen tensions and/or saturations and/or the presence of clinical indicators. Ongoing evaluation or reassessment of arterial blood gas tensions and/or saturations by invasive or noninvasive methods may be indicated whenever there is a change in clinical status that may be cardiopulmonary related.¹

The American Thoracic Society Per the American Thoracic Society Clinical Practice Guidelines for Home Oxygen Therapy (HOT) in Adults, HOT is recommended for the following:⁴

• For patients with severe resting hypoxemia, the prescription of LTOT to improve survival is supported by historical trials in patients with COPD;
• The expert panel strongly recommends prescribing oxygen for patients with interstitial lung disease (ILD) with severe resting hypoxemia;
• Existing evidence and panel consensus suggest not prescribing LTOT for patients with COPD with moderate resting hypoxemia; Page 5 of 13 CENTENE® Corporation

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• This review confirmed scarce and inconclusive data to support the prescription of oxygen in patients who have normoxia at rest but desaturate (sometimes markedly) with exertion;
• Emerging evidence suggests that ambulatory oxygen therapy may improve health-related quality of life in patients with ILD in the short term but long-term data is needed;
• The panel unanimously agreed that liquid oxygen (LOX) should be offered to active patients on high-flow oxygen;
• Finally, the minimal standard of care for all patients receiving home oxygen therapy must include education and training related to their oxygen equipment, oxygen safety, and self- management.

The American Thoracic Society Clinical Practice Guidelines for Home Oxygen Therapy in Children states that, despite widespread use of home oxygen therapy (HOT) in children for various lung and pulmonary vascular diseases, there is a striking paucity of data regarding its implementation, efficacy, monitoring, and discontinuation. With limited evidence, the panel provides recommendations based on expert opinion and experiences associated with patient- important outcomes, which will aid clinicians in the management of complex pediatric patients requiring HOT.⁵

HOT for children is recommended for the following situations³:

• Cystic fibrosis complicated by severe chronic hypoxemia (strong recommendation, very low-quality evidence);
• Cystic fibrosis patients who have both mild chronic hypoxemia and dyspnea on exertion (conditional recommendation, very low-quality evidence);
• Bronchopulmonary dysplasia complicated by chronic hypoxemia (strong recommendation, very low-quality evidence);
• Sleep-disordered breathing complicated by severe nocturnal hypoxemia in those who cannot tolerate positive airway pressure therapy or are awaiting surgical treatment of sleep-disordered breathing (conditional recommendation, very low-quality evidence);
• Sickle cell disease complicated by severe chronic hypoxemia (conditional recommendation, very low-quality evidence);
• Pulmonary hypertension without congenital heart disease complicated by chronic hypoxemia (strong recommendation, very low-quality evidence);
• Interstitial lung disease complicated by severe chronic hypoxemia (strong recommendation, very low-quality evidence);
• Interstitial lung disease patients who have mild chronic hypoxemia and either dyspnea on exertion or desaturation during sleep or exertion (conditional recommendation, very low- quality evidence);
• Pulmonary hypertension with congenital heart disease complicated by chronic hypoxemia but not until there has been consultation with a pediatric pulmonologist or cardiologist who has expertise in the management of pulmonary hypertension in this clinical setting, regardless of previous reparative or palliative congenital heart surgery (strong recommendation, very low-quality evidence).

Additionally, the expert panel unanimously agreed that optimal implementation of the above HOT recommendations consists of all of the following⁵:

• Oxygen therapy to maintain an oxygen saturation as measured by pulse oximetry in an acceptable range according to age and respiratory condition outlined in the full guideline document;
• Use of oxygen equipment that is of the appropriate size, developmental stage, and flow rate to function properly;
• Oxygen therapy monitoring by pulse oximetry in the home. Page 6 of 13 CENTENE® Corporation

CLINICAL POLICY Outpatient Oxygen Use

Coding Implications This clinical policy references Current Procedural Terminology (CPT®). CPT® is a registered trademark of the American Medical Association. All CPT codes and descriptions are copyrighted 2023, American Medical Association. All rights reserved. CPT codes and CPT descriptions are from the current manuals and those included herein are not intended to be all-inclusive and are included for informational purposes only. Codes referenced in this clinical policy are for informational purposes only. Inclusion or exclusion of any codes does not guarantee coverage. Providers should reference the most up-to-date sources of professional coding guidance prior to the submission of claims for reimbursement of covered services.

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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. AARC; 2007. https://www.aarc.org/wp-content/uploads/2014/08/08.07.1063.pdf. Published August 2007. Accessed September 23, 2024.
2. Theodore AC. Measures of oxygenation and mechanisms of hypoxemia. UpToDate. www.uptodate.com. Published August 15, 2023. Accessed September 23, 2024.
3. Carter R, Nwasuruba C. Long-term supplemental oxygen therapy. UpToDate. www.uptodate.com. Published July 10, 2023. Accessed September 23, 2024.
4. 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 [published correction appears in Am J Respir Crit Care Med. 2021 Apr 15;203(8):1045 to 1046]. Am J Respir Crit Care Med. 2020;202(10):e121 to e141. doi:10.1164/rccm.202009-3085ST
5. Hayes D Jr, Wilson KC, Krivchenia K, et al. Home Oxygen Therapy for Children. An Official American Thoracic Society Clinical Practice Guideline. Am J Respir Crit Care Med. 2019;199(3):e5 to e23. doi:10.1164/rccm.201812-2276ST
6. Nagler J. Continuous delivery systems for the acute care of infants, children, and adults. UpToDate. www.uptodate.com. Published July 19, 2023Accessed September 23, 2024. Page 10 of 13

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7. Local coverage determination: Oxygen and oxygen equipment (L33797). Centers for Medicare and Medicaid Services. http://www.cms.hhs.gov/mcd/search.asp. Published October 01, 2015 (revised April 01, 2023). Accessed September 23, 2024.
8. National coverage determination: home use of oxygen (240.2). Centers for Medicare and Medicaid Services. http://www.cms.hhs.gov/mcd/search.asp. Published October 27, 1993 (revised September 27, 2021). Accessed September 23, 2024.
9. Spece LJ, Epler EM, Duan K, et al. Reassessment of Home Oxygen Prescription after Hospitalization for Chronic Obstructive Pulmonary Disease. A Potential Target for Deimplementation. Ann Am Thorac Soc. 2021;18(3):426 to 432. doi:10.1513/AnnalsATS.202004-3640C
10. American Headache Society, American Migraine Foundation. Our Joint Statement on Oxygen Therapy for Cluster Headache. https://americanheadachesociety.org/news/ahs-amf- statement-oxygen-therapy/. Accessed September 23, 2024.
11. Headache Classification Committee of the International Headache Society (IHS) The International Classification of Headache Disorders, 3rd edition. Cephalalgia. 2018;38(1):1 to 211. doi:10.1177/0333102417738202
12. Robbins MS, Starling AJ, Pringsheim TM, Becker WJ, Schwedt TJ. Treatment of Cluster Headache: The American Headache Society Evidence-Based Guidelines. Headache. 2016;56(7):1093 to 1106. doi:10.1111/head.12866
13. National Institute for Health and Care Excellence. Headaches in over 12s: diagnosis and management. Clinical guideline [CG150]. https://www.nice.org.uk/guidance/cg150/chapter/Key-priorities-for-implementation. Published September 19, 2012 (Updated December 17, 2021). Accessed September 24, 2024.
14. Omoj Odihi Malu, Bailei J, Matthew Kendall Hawks. Cluster Headache: Rapid Evidence Review. American Family Physician. 2022;105(1):24-32. Accessed September 24, 2024. https://www.aafp.org/pubs/afp/issues/2022/0100/p24.html?~text=Cluster%20headache%20 consists%20of%20attacks