(Medicare National Coverage Determinations Manual)

Group II: Coverage is available for patients whose  arterial PO2 is 56 -59 mm Hg or whose arterial blood oxygen saturation is 89%, if there is:    Dependent edema suggesting congestive heart failure; or,   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 AVFL; or,   Erythrocythemia with a hematocrit greater than 56%.   In reviewing the arterial PO2 levels and the arterial oxygen saturation percentages specified above, the Medicare Administrative Contractors (MACs) must take into account variations in oxygen measurements that may result from such factors as the patient's age, the patients skin pigmentation, the altitude level, or the patient's decreased oxygen carrying capacity.  C. Nationally Non -Covered Indications   The Centers for Medicare & Medicaid Services will not cover oxygen therapy and oxygen equipment in the home in the following circumstances:    Angina pectoris in the absence of hypoxemia. This condition is generally not the result of a low oxygen level in the blood, and there are other preferred treatments; or,   Breathlessness without cor pulmonale or evidence of hypoxemia. Although intermittent oxygen use is sometimes prescribed to relieve this condition, it is potentially harmful and psychologically addicting; or,   Severe peripheral vascular disease resulting in clinically evident desaturation in one or more extremities. There is no evidence that increased PO2 improves the oxygenation of tissues with impaired circulation; or,   Terminal illnesses unless they affect the ability to breathe.   D. Other   The MAC may determine reasonable and necessary coverage of oxygen therapy and oxygen equipment in the home for patients who are not described in section B or precluded by section C of this NCD. Initial coverage for patients with other conditions may be lim ited to the shorter of 90 days or the number of days included in the practitioner prescription at MAC discretion. Oxygen coverage may be renewed if deemed medically necessary by the MAC.  MACs may also allow beneficiaries who are mobile in the home and would benefit from the use of a portable oxygen system in the home to qualify for coverage of a portable oxygen system either (1) by itself, or, (2) to use in addition to a stationary oxygen system.  (This NCD was last reviewed July 2022.)   (See 280.1 and the Medicare Benefit Policy Manual, Chapter 15, Covered Medical and Other Health Services, 110.)   240.2.1  Home Use of Oxygen in Approved Clinical Trials (Effective March 20, 2006)  (Rev. 57, Issued:  05- 26-06; Effective:  03 -20-06; Implementation:  10- 03-06)  A.  General   Oxygen is a colorless, odorless gas that comprises 21 percent of the atmospheric gases at sea level.  Historically, long term supplemental oxygen has been administered in higher than atmospheric concentrations to patients with chronic hypoxemia, generally resulting from cardiac and/or pulmonary disease.  The need for supplemental oxygen is assessed by direct or indirect measurement of the partial pressure of oxygen (conventionally expressed in millimeters of mercury, mmHg) and the oxygen saturation of hemoglobin in arterial blood (expressed as a percent).  Chronic oxygen therapy is generally administered via nasal cannulae, face mask, or tracheostomy, from a stationary or portable oxygen tank or an oxygen concentrator.   The medical literature documents health benefits as well as serious adverse events associated with supplemental oxygen use.  In this light, it is clear that the decision to initiate, continue, or discontinue the use of supplemental oxygen should be guided by high quality scientific evidence.   B.  Nationally Covered Indications   Effective for services performed on or after March 20, 2006 t he home use of oxygen is covered for those beneficiaries with arterial oxygen partial pressure measurements from 56 to 65 mmHg or oxygen saturation at or above 89% who are enrolled subjects in clinical trials approved by the Centers for Medicare & Medicaid S ervices and sponsored by the National Heart, Lung & Blood Institute (NHLBI).  C.  Nationally Non -Covered Indications   N/A  D.  Other   This policy does not alter Medicare coverage for items and service that may be covered or non -covered according to the existing national coverage determination for the home use of oxygen provided outside the context of approved clinical trials (National Coverage Determination Manual, section 240.2and 310.1).  (This NCD was last reviewed April 2006)   240.2.2-  Home Oxygen Use to Treat Cluster Headache (CH) (RETIRED)  (Rev. 11892; Issued: 03- 09-23; Effective: 04 -10-23; Implementation:04- 10-23)  Effective September 27, 2021, the Centers for Medicare & Medicaid Services removed the national coverage determination (NCD) for home oxygen use to treat cluster headaches. In the absence of an NCD, coverage determinations will be made by the Medicare Administrative Contractors under section 1862(a)(1)(A) of the Social Security Act, as allowed and described i n Chapter 1, Section 240.2 (Home Use of Oxygen), Subsection D, of Publication 100- 03 of the NCD Manual.   240.3 - Heat Treatment, Including the Use of Diathermy and Ultra-Sound for Pulmonary Conditions  (Rev. 1, 10- 03-03) CIM 35 -3  Not Covered   There is no physiological rationale or valid scientific documentation of effectiveness of diathermy or ultrasound heat treatments for asthma, bronchitis, or any other pulmonary condition and for such purpose this treatment cannot be considered reasonable a nd necessary within the meaning of 1862(a)(1)  of the Act.   Cross -reference:  150.5.   240.4 - Continuous Positive Airway Pressure (CPAP) Therapy For Obstructive Sleep Apnea (OSA) (Effective April 4, 2005) (Effective March 13, 2008)  (Rev. 96, Issued: 10- 15-08, Effective: 03 -13-08, Implementation: 08- 04-08)  A. General   Continuous Positive Airway Pressure (CPAP) is a non- invasive technique for providing single levels of air pressure from a flow generator, via a nose mask, through the nares. The purpose is to prevent the collapse of the oropharyngeal walls and the obstruction of airflow during sleep, which occurs in obstructive sleep apnea (OSA).   The apnea hypopnea index (AHI) is equal to the average number of episodes of apnea and hypopnea per hour.  The respiratory disturbance index (RDI) is equal to the average number of respiratory disturbances per hour.   Apnea is defined as a cessation of airflow for at least 10 seconds.  Hypopnea is defined as an abnormal respiratory event lasting at least 10 seconds with at least a 30% reduction in thoracoabdominal movement or airflow as compared to baseline, and with at  least a 4% oxygen desaturation.   The AHI and/or RDI may be measured by polysomnography (PSG) in a facility- based sleep study laboratory, or by a Type II home sleep test (HST) monitor, a Type III HST monitor, or a Type IV HST monitor measuring at least 3 channels.  B. Nationally Covered Indications   Effective for claims with dates of service on and after March 13, 2008, the Centers for Medicare & Medicaid Services (CMS) determines that CPAP therapy when used in adult patients with OSA is considered reasonable and necessary under the following situations:   1. The use of CPAP is covered under Medicare when used in adult patients with OSA. Coverage of CPAP is initially limited to a 12 -week period to identify beneficiaries diagnosed with OSA as subsequently described who benefit from CPAP.  CPAP is subsequently covered only for those beneficiaries diagnosed with OSA who benefit from CPAP during this 12- week period.  2. The provider of CPAP must conduct education of the beneficiary prior to the use of the CPAP device to ensure that the beneficiary has been educated in the proper use of the device.  A caregiver, for example a family member, may be compensatory, if consiste ntly available in the beneficiary's home and willing and able to safely operate the CPAP device.   3. A positive diagnosis of OSA for the coverage of CPAP must include a clinical evaluation and a positive:   a. attended PSG performed in a sleep laboratory; or   b. unattended HST with a Type II home sleep monitoring device; or   c. unattended HST with a Type III home sleep monitoring device; or   d. unattended HST with a Type IV home sleep monitoring device that  measures at least 3 channels.   4. The sleep test must have been previously ordered by the beneficiarys treating physician and furnished under appropriate physician supervision.  5. An initial 12 -week period of CPAP is covered in adult patients with OSA if either of the following criterion using the AHI or RDI are met:   a. AHI or RDI greater than or equal to 15 events per hour, or   b. AHI or RDI greater than or equal to 5 events and less than or equal to 14 events per hour with documented symptoms of excessive daytime sleepiness, impaired cognition, mood disorders or insomnia, or documented hypertension, ischemic heart disease, or history of stroke.   6. The AHI or RDI is calculated on the average number of events of per hour.  If the AHI or RDI is calculated based on less than 2 hours of continuous recorded sleep, the total number of recorded events to calculate the AHI or RDI during sleep testing must be at a minimum the number of events that would have been required in a 2- hour period.   7. Apnea is defined as a cessation of airflow for at least 10 seconds.  Hypopnea is defined as an abnormal respiratory event lasting at least 10 seconds with at least a 30% reduction in thoracoabdominal movement or airflow as compared to baseline, and with at  least a 4% oxygen desaturation.   8. Coverage with Evidence Development (CED): Medicare provides the following limited coverage for CPAP in adult beneficiaries who do not qualify for CPAP coverage based on criteria 1 -7 above.  A clinical study seeking Medicare payment for CPAP provided to a beneficiary who is an enrolled subject in that study must address one or more of the following questions:   a. In Medicare- aged subjects with clinically identified risk factors for OSA, how does the diagnostic accuracy of a clinical trial of CPAP compare with PSG and Type II, III & IV HST in identifying subjects with OSA who will respond to CPAP?   b. In Medicare- aged subjects with clinically identified risk factors for OSA who have not undergone confirmatory testing with PSG or Type II, III & IV HST, does CPAP cause clinically meaningful harm?   c. The study must meet the following additional standards:   d. The principal purpose of the research study is to test whether a particular intervention potentially improves the participants health outcomes.  e. The research study is well -supported by available scientific and medical information or it is intended to clarify or establish the health outcomes of interventions already in common clinical use.   f. The research study does not unjustifiably duplicate existing studies.  g. The research study design is appropriate to answer the research question being asked in the study.  h. The research study is sponsored by an organization or individual capable of executing the proposed study successfully.  i. The research study is in compliance with all applicable Federal regulations concerning the protection of human subjects found at 45 CFR Part 46.  If a study is Food and Drug Administration -regulated, it also must be in compliance with 21 CFR Parts 50 and 56.  j. All aspects of the research study are conducted according to the appropriate standards of scientific integrity.   k. The research study has a written protocol that clearly addresses, or incorporates by reference, the Medicare standards.   l. The clinical research study is not designed to exclusively test toxicity or disease pathophysiology in healthy individuals.  Trials of all medical technologies measuring therapeutic outcomes as one of the objectives meet this standard only if the disease or condition being studied is life -threatening as defined in 21 CFR 312.81(a) and the patient has no other viable treatment options.   m. The clinical research study is registered on the ClinicalTrials.gov Web site by the principal sponsor/investigator prior to the enrollment of the first study subject.   n. The research study protocol specifies the method and timing of public release of all pre -specified outcomes to be measured, including release of outcomes if outcomes are negative or study is terminated early.  The results must be made public within 24 mont hs of the end of data collection.  If a report is planned for publication in a peer -reviewed journal, then that initial release may be an abstract that meets the requirements of the International Committee of Medical Journal Editors.  However, a full repor t of the outcomes must be made public no later than 3 years after the end of data collection.