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Horizon BCBSNJ
Uniform Medical Policy ManualSection:D M E
Policy Number:047
Effective Date: 06/11/2019
Original Policy Date:04/28/2015
Last Review Date:05/12/2020
Date Published to Web: 04/28/2015
Subject:
Home Oxygen Therapy

Description:
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IMPORTANT NOTE:

The purpose of this policy is to provide general information applicable to the administration of health benefits that Horizon Blue Cross Blue Shield of New Jersey and Horizon Healthcare of New Jersey, Inc. (collectively “Horizon BCBSNJ”) insures or administers. If the member’s contract benefits differ from the medical policy, the contract prevails. Although a service, supply or procedure may be medically necessary, it may be subject to limitations and/or exclusions under a member’s benefit plan. If a service, supply or procedure is not covered and the member proceeds to obtain the service, supply or procedure, the member may be responsible for the cost. Decisions regarding treatment and treatment plans are the responsibility of the physician. This policy is not intended to direct the course of clinical care a physician provides to a member, and it does not replace a physician’s independent professional clinical judgment or duty to exercise special knowledge and skill in the treatment of Horizon BCBSNJ members. Horizon BCBSNJ is not responsible for, does not provide, and does not hold itself out as a provider of medical care. The physician remains responsible for the quality and type of health care services provided to a Horizon BCBSNJ member.

Horizon BCBSNJ medical policies do not constitute medical advice, authorization, certification, approval, explanation of benefits, offer of coverage, contract or guarantee of payment.

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Home oxygen therapy is used in the treatment of severe lung disease and hypoxia due to certain chronic pulmonary conditions or other conditions that may include hypoxia-related symptoms, as well as medical conditions that are known to clinically improve with oxygen. Home oxygen may be indicated for patients with severe lung disease that significantly impacts respiratory status leading to hypoxia.

Oxygen therapy may:
    · Decrease shortness of breath and fatigue
    · Improve sleep in some people who have sleep-related breathing disorders
    · Increase the lifespan of some people who have COPD
    · Prevent heart failure in people with severe lung disease
Oxygen is a drug and requires a prescription from a healthcare professional. Liter flow should not be indiscriminately adjusted by the patient, healthcare professional, or DME provider. Too much oxygen (too high liter flow) can be dangerous in the patient who retains carbon dioxide. Specifically, too much oxygen can lead to CO2 narcosis, defined by somnolence, confusion, lethargy, and even death. Oxygen saturation must be checked at the final liter flow.

Oxygen is supplied in three forms:
    · compressed gas,
    · liquid, or
    · concentrated form taken from the air.

Compressed oxygen gas is stored under pressure in metal cylinders. The cylinders come in many sizes. Some of the cylinders are small enough to carry around or can be placed on a small wheeled cart or in a shoulder bag or backpack.

Liquid oxygen is very cold. When released from its container, the liquid becomes gas. Liquid oxygen is delivered to the home in a large container. From this container, smaller, portable units can be filled. The advantage of liquid oxygen is that the storage units need less space than compressed or concentrated oxygen. However, since it evaporates easily, it doesn't last for a long time.

Oxygen concentrators filter out other gases in the air and store only oxygen. Oxygen concentrators come in several sizes, including portable units. These devices use room air as a source of oxygen by separating the oxygen, concentrating it (over 94%) and then storing it. Oxygen concentrators do not require oxygen refills. They are powered by electricity; therefore, the patient/caregiver should have an alternate source of power in the event of a power outage.

Humidification may be added to any type of oxygen delivery system. Humidification adds moisture to oxygen prevents drying out of the upper respiratory tract.

Oxygen is delivered to the patient through a nasal cannula, face mask, or tracheostomy.

Oxygen also can be delivered through breathing machines, such as PAP (positive airway pressure) devices or home ventilators.

Evaluating oxygen saturation:
Oxygen values may be obtained in any one of three (3) situations or in combination of these situations:
  • at rest (awake);
  • with ambulation;
  • with sleep.

In order to evaluate the patient's oxygen needs in each situation, the healthcare professional or other qualified provider of laboratory services tests the patient in each situation to determine the qualifying oxygen value.

For example, the patient may have adequate oxygen saturation at rest, but qualify for oxygen with ambulation and/or sleep. The liter flow of oxygen may vary in each of the 3 settings.

Definitions:

Arterial blood gas (ABG)—arterial blood gases are a measurement of how much oxygen and carbon dioxide are in the blood as well as the acidity (pH). Usually, blood is taken from an artery such as the radial artery in the wrist, the femoral artery in the groin or the brachial artery in the arm.

Carbon dioxide (CO2) narcosis-- a condition of confusion, tremors, convulsions, and possible coma that may occur if blood levels of carbon dioxide increase to 70 mm Hg or higher. Individuals with chronic obstructive pulmonary disease can have CO2 narcosis without these symptoms because they develop a tolerance to elevated CO2. When ventilation is sufficient to maintain a normal oxygen partial pressure in the arteries, the carbon dioxide partial pressure is generally near 40 mm Hg.

Cluster headache-- a type of headache. It is one-sided head pain that may involve tearing of the eyes and a stuffy nose. Attacks occur regularly for 1 week to 1 year. The attacks are separated by pain-free periods that last at least 1 month or longer.

Dyspnea-– shortness of breath.

Hypoxia-— low levels of oxygen in the blood.

Oxygen concentrator-- a machine that plugs in to an electrical outlet and takes room air, passes it through the filtering system in the machine and converts it to more pure oxygen. Room air is circulated through the machine filtering system and changes from regular room air (21% oxygen) to approximately 95% oxygen.

Pulse oximetry-- a procedure used to measure the oxygen level (or oxygen saturation) in the blood. It is considered to be a noninvasive, painless, general indicator of oxygen delivery to the peripheral tissues (such as the finger, earlobe, or nose).


Policy:
(NOTE: For Medicare Advantage, Medicaid and FIDE-SNP, please refer to the Coverage Sections below for coverage guidance.)

A. Home oxygen therapy is considered medically necessary when all of the following conditions are met:

      1. The treating physician has prescribed oxygen therapy for a member who has a severe lung disease or hypoxia-related symptoms that are known to clinically improve with oxygen therapy; and
        2. The member's arterial blood gas study or pulse oximetry meets either criteria Group I or Group II; and
    Criteria (Group I) for oxygen therapy are met in any of the following conditions:
    Member Tested (while awake) on Room Air at RestMember Tested During ExerciseMember Tested During Sleep
    • Oxygen saturation at or below 88%; or
    • Arterial Partial Pressure (ABG) of Oxygen (PO2) at or below 55 mm Hg.
    If ABG is at or above 56 mm Hg or an oxygen saturation at or above 89% on room air while at rest, additional documentation must show both of the following:

    a. ABG results during ambulation and without oxygen below 55 mm Hg or an oxygen saturation at or below 88%;


      And

    b. Documented improvement of hypoxemia during ambulation with oxygen.
    If ABG is at or above 56 mm Hg or an oxygen saturation at or above 89% while awake, additional testing must show either:

    a. ABG at or below 55 mm Hg, or an oxygen saturation at or below 88%, for at least 5 minutes taken during sleep;

      Or

    b. Decrease in ABG of more than 10 mm Hg, or a decrease in oxygen saturation more than 5% for at least 5 minutes taken during sleep associated with symptoms and signs reasonably attributable to hypoxia.
    Criteria (Group II) for oxygen therapy are met in any of the following conditions:
    • Oxygen saturation of 89%; or
    • ABG of 56-59 mm Hg;
      And

      a. Dependent edema suggesting congestive heart failure, or

      b. Pulmonary hypertension or cor pulmonale, determined by measurement of pulmonary artery pressure, gated blood pool scan, echocardiogram, or "P" pulmonale on electrocardiography (EKG) (P wave greater than 3 mm in standard leads II, III, or AVF); or

      c. Erythrocythemia with a hematocrit above 56%.

    • Oxygen saturation of 89%; or
    • ABG of 56-59 mm Hg;
      And

      a. Dependent edema suggesting congestive heart failure, or

      b. 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); or

      c. Erythrocythemia with a hematocrit above 56%.

    During sleep for at least 5 minutes:
    • Oxygen saturation of 89%; or
    • ABG of 56-59 mm Hg;
      And

      a. Dependent edema suggesting congestive heart failure, or

      b. 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); or

      c. Erythrocythemia with a hematocrit above 56%.

    Group III
    Arterial PO2 levels at or above 60 mm Hg or oxygen saturations at or above 90 percent. For these members, medical need for oxygen is not established.
        3. The qualifying blood gas study or pulse oximetry was obtained under either of the following conditions:
            a. If the qualifying arterial blood gas study or pulse oximetry is performed during an inpatient hospital stay, the reported test must be the one obtained closest to, but no earlier than 2 days prior to the hospital discharge date, or
            b. If the qualifying arterial blood gas study or pulse oximetry is not performed during an inpatient hospital stay, the reported test must be performed while the member is in a chronic stable state – i.e., not during a period of acute illness or an exacerbation of their underlying disease.
          For purposes of this policy, either an arterial blood gas or pulse oximetry* result measuring oxygen saturation is acceptable.

          *Pulse oximetry readings are accurate to +/-4%.

    B. Oxygen following immediate post-hospital stay for short term needs:
      The member may require oxygen following a hospital stay for acute diagnoses such as:
      • Pneumonia
      • Pulmonary Embolism
      • Bronchitis

      Lab values must be documented to support the medical necessity for short term oxygen use after discharge from the hospital.

      The need for oxygen after discharge from the hospital may resolve with limited or short term use, (i.e., 30 days). Documentation to support the medical necessity for ongoing oxygen therapy beyond thirty (30) days post-discharge should include documentation pertaining to oxygen saturation. (Also see policy statement G below.)

    C. Oxygen for Cluster Headache:
      Pulse oximetry or arterial blood gas studies are not required to determine medical necessity for treatment of cluster headache with oxygen.

      Treatment of acute attacks of cluster headache with inhalation of 100% oxygen via face mask with a flow rate of at least 7 L/min over 15 min alone or along with the administration of triptans is considered medically necessary.

    D. Oxygen in conjunction with PAP:
      Oxygen use with PAP devices requires the following be met for initial set up:

      Medical necessity for both the oxygen and oxygen equipment and positive airway presssure (PAP) devices for the treatment of obstructive sleep apnea must be met. (Please refer to a separate policy on 'Diagnosis and Medical Management of Obstructive Sleep Apnea Syndrome' Policy #002 in the Medicine Section) and,

      To determine the medical necessity for oxygen therapy for a member with obstructive sleep apnea, the member must be in a “chronic stable state” (not during a period of an acute illness or an exacerbation of their underlying disease) and meets either of the following:
      • A qualifying oxygen saturation test must be done during a titration polysomnographic study (either split night or stand-alone).
        The titration polysomnography (PSG) is one in which all of the following criteria are met:
        1. The titration is conducted over a minimum of two (2) hours; and
        2. During titration:
          a. the AHI/RDI is reduced to less than or equal to an average of ten (10) events per hour; or
          b. if the initial AHI/RDI was less than an average of ten (10) events per hour, the titration demonstrates further reduction in the AHI/RDI; and
        3. Nighttime oximetry conducted for the purpose for oxygen reimbursement qualification is performed after optimal PAP settings have been determined and the member is using the PAP device at those settings; and
        4. The nighttime oximetry conducted during the PSG demonstrates an oxygen saturation ≤ 88% for 5 minutes total, measured on pulse oximetry (which need not be continuous).
        OR
      • A qualifying oxygen saturation test may occur after the member has been prescribed PAP therapy and has ongoing hypoxia.
        • The nighttime oximetry conducted while on optimal PAP therapy demonstrates an oxygen saturation <88% for 5 minutes total, measured on pulse oximetry, which need not be continuous.
        • The use of home oxygen therapy as the sole treatment for sleep apnea, including obstructive sleep apnea (OSA) is not considered medically necessary.

    E. Oxygen for member comfort in terminal care:
      Terminal care is defined as the management of members during the last few days or weeks or even months of life.

      When oxygen for terminal care is a covered benefit under the member's contract, the member does not need to demonstrate hypoxemia or oxygen saturation.

    F. Oxygen as alternative therapy:
      The peer-reviewed medical literature does not support routine use of oxygen without evidence of desaturation (e.g. Alzheimer’s disease, cancer, etc.).

    G. Continued Oxygen Use:
      Ongoing use of oxygen therapy is considered medically necessary when:
      • the member's oxygen saturation level, (measured either by pulse oximetry or arterial blood gas) is within the criteria described in either Group I or Group II (see above) values, and
      • documentation in the member's clinical record indicates adherence to the prescribed oxygen therapy.
    H. Retesting Policy:
      Retesting for oxygen re-qualification can be done by:
      • Qualified provider/supplier of laboratory services, or
      • DME provider of oxygen and oxygen equipment.

      Short Term-Acute Diagnoses (e.g. pneumonia, bronchitis, etc.):
      • If continued oxygen therapy is ordered after 3 months of initial therapy, a repeat arterial blood gas study or pulse oximetry reading is considered medically necessary to evaluate if the member continues to meet the criteria in either Group I or Group II.

      Long Term-Chronic Diagnoses (e.g. COPD, CHF, etc.):
      • A repeat arterial blood gas study or pulse oximetry reading is considered medically necessary 12 months after oxygen therapy is initiated and annually thereafter.
      • Oxygen in conjunction with PAP therapy:
        Continued oxygen therapy with PAP, requires the member be tested annually using overnight pulse oximetry on PAP therapy alone and without supplemental oxygen bleed into PAP.

    I. Portable Oxygen Systems: Canisters and Portable Oxygen Concentrator
      A portable oxygen system is considered medically necessary when the member is mobile within the home and the qualifying blood gas study/oxygen saturation was performed while at rest (awake) or during exercise. If the only qualifying blood gas study/oxygen saturation was performed during sleep, portable oxygen is not considered medically necessary.

      Use of portable oxygen systems is defined as:
      1. Non-portable oxygen concentrators (E1390) and portable oxygen canisters
      2. Portable oxygen concentrators (E1392) that are capable of delivering 85% or greater oxygen concentration can operate either on AC/DC power. The unit must also be capable of functioning as a stationary concentrator, operating 24 hours per day, 7 days per week

      Portable oxygen systems (i.e., tanks or concentrators) used with stationary oxygen systems are indicated when the above guidelines for home oxygen use and portability are met.
      [INFORMATIONAL NOTE: Special Circumstances: Airline Travel - members travelling should verify if their portable oxygen system is approved for use with their airline carrier.]


    Medicare Coverage:
    There are several National Coverage Determinations (NCDs) and Local Coverage Determination (LCDs) applicable to Home Oxygen Therapy. For additional information and eligibility, refer to the below NCDs and LCDs.

    National Coverage Determination (NCD) for Home Use of Oxygen (240.2).

    National Coverage Determination (NCD) for Home Oxygen Use to Treat Cluster Headache (CH) (240.2.2).

    National Coverage Determination (NCD) for Home Use of Oxygen in Approved Clinical Trials (240.2.1).

    NCDs available to be accessed at CMS National Coverage Determinations (NCDs) Alphabetical Index search page: https://www.cms.gov/medicare-coverage-database/indexes/ncd-alphabetical-index.aspx.

    Local Coverage Determination (LCD): Oxygen and Oxygen Equipment (L33797).

    Local Coverage Article: Oxygen and Oxygen Equipment - Policy Article (A52514)

    Local Coverage Determination (LCD): Positive Airway Pressure (PAP) Devices for the Treatment of Obstructive Sleep Apnea (L33718).

    Local Coverage Article: Positive Airway Pressure (PAP) Devices for the Treatment of Obstructive Sleep Apnea - Policy Article (A52467)

    LCDs Available to be accessed at Noridian Healthcare Services, LLC, (DME MAC), Local Coverage Determinations (LCDs) search page: https://www.cms.gov/medicare-coverage-database/indexes/lcd-list.aspx?Cntrctr=389&ContrVer=1&CntrctrSelected=389*1&s=38&DocType=All&bc=AggAAAAAAAAAAA%3d%3d&#ResultsAnchor.


    Medicaid Coverage:
    For members enrolled in Medicaid and NJ FamilyCare plans, Horizon BCBSNJ applies the above medical policy.

    FIDE-SNP:
    For members enrolled in a Fully Integrated Dual Eligible Special Needs Plan (FIDE-SNP): (1) to the extent the service is covered under the Medicare portion of the member’s benefit package, the above Medicare Coverage statement applies; and (2) to the extent the service is not covered under the Medicare portion of the member’s benefit package, the above Medicaid Coverage statement applies.

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    Horizon BCBSNJ Medical Policy Development Process:

    This Horizon BCBSNJ Medical Policy (the “Medical Policy”) has been developed by Horizon BCBSNJ’s Medical Policy Committee (the “Committee”) consistent with generally accepted standards of medical practice, and reflects Horizon BCBSNJ’s view of the subject health care services, supplies or procedures, and in what circumstances they are deemed to be medically necessary or experimental/ investigational in nature. This Medical Policy also considers whether and to what degree the subject health care services, supplies or procedures are clinically appropriate, in terms of type, frequency, extent, site and duration and if they are considered effective for the illnesses, injuries or diseases discussed. Where relevant, this Medical Policy considers whether the subject health care services, supplies or procedures are being requested primarily for the convenience of the covered person or the health care provider. It may also consider whether the services, supplies or procedures are more costly than an alternative service or sequence of services, supplies or procedures that are at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of the relevant illness, injury or disease. In reaching its conclusion regarding what it considers to be the generally accepted standards of medical practice, the Committee reviews and considers the following: all credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, physician and health care provider specialty society recommendations, the views of physicians and health care providers practicing in relevant clinical areas (including, but not limited to, the prevailing opinion within the appropriate specialty) and any other relevant factor as determined by applicable State and Federal laws and regulations.

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    Index:
    Home Oxygen Therapy
    Oxygen Therapy at Home
    Oxygen Concentrators
    Concentrators, Oxygen
    Portable Oxygen Systems

    References:
    1. American Lung Association, Supplemental Oxygen. Accessed 2/20/2015 at URL address: http://www.lung.org/lung-disease/copd/living-with-copd/supplemental-oxygen.html

    2. National Heart, Lung and Blood Institute. How Does Oxygen Therapy Work? Accessed 2/20/2015 at URL address: http://www.nhlbi.nih.gov/health/health-topics/topics/oxt/howdoes

    3. Agency for Healthcare Research and Quality. National Guideline Clearinghouse. Cluster headache and other trigemino-autonomic cephalgias. National Institute for Health and Clinical Excellence (NICE)’s guideline on “Diagnosis and management of headaches in young people and adults” (2012). Accessed 2/20/2015 at URL address: http://www.guideline.gov/content.aspx?id=34898

    4. Pierson, D.J. National Institutes of Health. Pulse oximetry versus arterial blood gas specimens in long-term oxygen therapy. Lung. 1990;168 Suppl:782-8. Accessed 2/20/20115 at URL address: http://www.ncbi.nlm.nih.gov/pubmed/2117192

    5. National Lung Health Education Program. Home Oxygen Options. Accessed 2/20/2015 at URL address: http://www.nlhep.org/Style%20Library/PageSets/PageSet-Guide_to_Prescribing/home-oxygen-options-4.htm

    6. Beck, Ellen, MD, William J. Sieber, PhD, and Raul Trejo, MD, University of California, San Diego, La Jolla, California. Am Fam Physician. 2005 Feb 15;71(4):717-724. American Academy of Family Physicians. Management of Cluster Headache. Accessed 2/20/2015 at URL address: http://www.aafp.org/afp/2005/0215/p717.html
    7. National Institute for Health and Clinical Excellence (NICE)’s guideline on “Diagnosis and management of headaches in young people and adults” (2012) Accessed 2/20/2015 at URL address: http://www.guideline.gov/content.aspx?id=34898

    8. Tanneberger, S. , I. Malavasi, P. Mariano, F. Pannuti and E. Strocchi. Planning palliative or terminal care: the dilemma of doctors’ prognoses in terminally ill cancer patients Annals of Oncology, (2002) 13 (8): 1320-1322. Oxford Journals. Accessed on 2/20/2015 at URL address: http://annonc.oxfordjournals.org/content/13/8/1320.1.long

    9. Centers for Medicare and Medicaid Services (CMS) National Coverage Determination (NCD) for Home Use of Oxygen (240.2) 10/27/1993. Accessed 2/20/2015.

    10. Centers for Medicare and Medicaid Services (CMS) Local Coverage Determination for Oxygen and Oxygen Equipment LCD 11446. 1/1/2014. Accessed 2/20/2014.

    11. Centers for Medicare and Medicaid Services (CMS) Local Coverage Determination for Oxygen and Oxygen Equipment LCD 11468. 1/1/2014 Accessed 2/20/2014.

    12. 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. J Clin Sleep Med 2009;5(3):263-276. Available at: http://jcsm.aasm.org/viewabstract.aspx?pid=27497

    Codes:
    (The list of codes is not intended to be all-inclusive and is included below for informational purposes only. Inclusion or exclusion of a procedure, diagnosis, drug or device code(s) does not constitute or imply authorization, certification, approval, offer of coverage or guarantee of payment.)

    CPT*

      HCPCS
        A4575
        A4606
        A4608
        A4615
        A4616
        A4617
        A4619
        A4620
        A9900
        E0424
        E0425
        E0430
        E0433
        E0434
        E0435
        E0439
        E0440
        E0441
        E0442
        E0443
        E0444
        E0445
        E0446
        E0455
        E0555
        E0580
        E1352
        E1353
        E1354
        E1355
        E1356
        E1357
        E1358
        E1390
        E1391
        E1392
        E1405
        E1406
        K0738

      * CPT only copyright 2020 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.

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      Medical policies can be highly technical and are designed for use by the Horizon BCBSNJ professional staff in making coverage determinations. Members referring to this policy should discuss it with their treating physician, and should refer to their specific benefit plan for the terms, conditions, limitations and exclusions of their coverage.

      The Horizon BCBSNJ Medical Policy Manual is proprietary. It is to be used only as authorized by Horizon BCBSNJ and its affiliates. The contents of this Medical Policy are not to be copied, reproduced or circulated to other parties without the express written consent of Horizon BCBSNJ. The contents of this Medical Policy may be updated or changed without notice, unless otherwise required by law and/or regulation. However, benefit determinations are made in the context of medical policies existing at the time of the decision and are not subject to later revision as the result of a change in medical policy

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