Local Coverage Determination (LCD): Oxygen and Oxygen Equipment (L33797) Links in PDF documents are not guaranteed to work. To follow a web link, please use the MCD Website. Contractor Information CONTRACTOR NAME CONTRACT TYPE CONTRACT JURISDICTION STATE(S) NUMBER CGS Administrators, LLC DME MAC 17013 - DME MAC J-B Illinois Indiana Kentucky Michigan Minnesota Ohio Wisconsin CGS Administrators, LLC DME MAC 18003 - DME MAC J-C Alabama Arkansas Colorado Florida Georgia Louisiana Mississippi New Mexico North Carolina Oklahoma Puerto Rico South Carolina Tennessee Texas Virgin Islands Virginia West Virginia Noridian Healthcare Solutions, DME MAC 16013 - DME MAC J-A Connecticut LLC Delaware District of Columbia Maine Maryland Massachusetts New Hampshire New Jersey New York - Entire State Pennsylvania Rhode Island Vermont CONTRACTOR NAME CONTRACT TYPE CONTRACT JURISDICTION STATE(S) NUMBER Noridian Healthcare Solutions, DME MAC 19003 - DME MAC J-D Alaska LLC American Samoa Arizona California - Entire State Guam Hawaii Idaho Iowa Kansas Missouri - Entire State Montana Nebraska Nevada North Dakota Northern Mariana Islands Oregon South Dakota Utah Washington Wyoming LCD Information Document Information LCD ID Original Effective Date L33797 For services performed on or after 10/01/2015 LCD Title Revision Effective Date Oxygen and Oxygen Equipment For services performed on or after 08/02/2020 Proposed LCD in Comment Period Revision Ending Date N/A N/A Source Proposed LCD Retirement Date DL33797 N/A AMA CPT / ADA CDT / AHA NUBC Copyright Notice Period Start Date Statement 06/18/2020 CPT codes, descriptions and other data only are copyright 2019 American Medical Association. 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CMS National Coverage Policy CMS Pub. 100-03, Medicare National Coverage Determinations Manual, Chapter 1, Section 240.2, 240.2.1,240.2.2, 270.4 Coverage Guidance Coverage Indications, Limitations, and/or Medical Necessity For any item to be covered by Medicare, it must 1) be eligible for a defined Medicare benefit category, 2) be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, and 3) meet all other applicable Medicare statutory and regulatory requirements. The purpose of a Local Coverage Determination (LCD) is to provide information regarding “reasonable and necessary” criteria based on Social Security Act § 1862(a)(1)(A) provisions. In addition to the “reasonable and necessary” criteria contained in this LCD there are other payment rules, which are discussed in the following documents, that must also be met prior to Medicare reimbursement: • The LCD-related Standard Documentation Requirements Article, located at the bottom of this policy under the Related Local Coverage Documents section. • The LCD-related Policy Article, located at the bottom of this policy under the Related Local Coverage Documents section. • Refer to the Supplier Manual for additional information on documentation requirements. • Refer to the DME MAC web sites for additional bulletin articles and other publications related to this LCD. For the items addressed in this LCD, the “reasonable and necessary” criteria, based on Social Security Act § 1862(a)(1)(A) provisions, are defined by the following coverage indications, limitations and/or medical necessity. Home oxygen is covered only when both the reasonable and necessary criteria discussed below and the statutory criteria discussed in the Policy Article are met. Refer to the Policy Article for additional information on statutory payment policy requirements. Home oxygen therapy is reasonable and necessary only if all of the following conditions are met: 1. The treating practitioner has determined that the beneficiary has a severe lung disease or hypoxia-related symptoms that might be expected to improve with oxygen therapy, and 2. The beneficiary's blood gas study meets the criteria stated below, and 3. The qualifying blood gas study was performed by a treating practitioner or by a qualified provider or supplier of laboratory services, and 4. The qualifying blood gas study was obtained under the following conditions: • If the qualifying blood gas study 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 • If the qualifying blood gas study is not performed during an inpatient hospital stay, the reported test must be performed while the beneficiary is in a chronic stable state – i.e., not during a period of acute illness or an exacerbation of their underlying disease, and 5. Alternative treatment measures have been tried or considered and deemed clinically ineffective. In this policy, the term blood gas study refers to either an oximetry test or an arterial blood gas test. Group I criteria include any of the following: 1. An arterial PO2 at or below 55 mm Hg or an arterial oxygen saturation at or below 88 percent taken at rest (awake), or 2. An arterial PO2 at or below 55 mm Hg, or an arterial oxygen saturation at or below 88 percent, for at least 5 minutes taken during sleep for a beneficiary who demonstrates an arterial PO2 at or above 56 mm Hg or an arterial oxygen saturation at or above 89 percent while awake, or 3. A decrease in arterial PO2 more than 10 mm Hg, or a decrease in arterial oxygen saturation more than 5 percent from baseline saturation, for at least 5 minutes taken during sleep 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, or 4. An arterial PO2 at or below 55 mm Hg or an arterial oxygen saturation 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 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. Initial coverage for beneficiaries meeting Group I criteria is limited to 12 months or the treating practitioner-specified length of need, whichever is shorter. (Refer to the Certification section for information on recertification.) Group II criteria include the presence of: A. An arterial PO2 of 56-59 mm Hg or an arterial blood oxygen saturation of 89 percent at rest (awake), during sleep for at least 5 minutes, or during exercise (as described under Group I criteria), and B. Any of the following: 1. Dependent edema suggesting congestive heart failure, or 2. 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 3. Erythrocythemia with a hematocrit greater than 56 percent. Initial coverage for beneficiaries meeting Group II criteria is limited to 3 months or the treating practitioner specified length of need, whichever is shorter. (Refer to the Certification section for information on recertification.) Group III includes beneficiaries with arterial PO2 levels at or above 60 mm Hg or arterial blood oxygen saturations at or above 90 percent. For these beneficiaries there is a rebuttable presumption of non-coverage. If all of the coverage conditions specified above are not met, the oxygen therapy will be denied as not reasonable and necessary. Oxygen therapy will also be denied as not reasonable and necessary if any of the following conditions are present: 1. 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. 2. Dyspnea without cor pulmonale or evidence of hypoxemia 3. 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. 4. Terminal illnesses that do not affect the respiratory system LONG TERM OXYGEN THERAPY CLINICAL (LTOT) TRIALS Oxygen and oxygen equipment is covered for beneficiaries who are enrolled subjects in clinical trials approved by CMS and sponsored by the National Heart, Lung, and Blood Institute (NHLBI) and who have an arterial PO2 from 56 to 65 mm Hg or an oxygen saturation at or above 89 percent.