Home Use of Oxygen

CMS NCA document | source_status=Closed | review_type=3rd Recon | public_comment_open=False | document_id=CAG-00296R3

On September 27, 2021, we issued a national coverage determination (NCD) for Home Use of Oxygen (NCD 240.2). We are amending the NCD in order to conform section D with the specific time period specified in §1834(a)(5)(E) of the Social Security Act (the Act). [1] Section D pertains to the Medicare Administrative Contractor (MAC) authority to determine reasonable and necessary coverage for patients who are not described in section B or excluded in section C. Specifically, we amended the period of initial coverage for these patients from 120 days to 90 days, in order to align with the 90-day statutory time period. The first paragraph of section D will state: Effective July 8, 2022, 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 limited 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. See Appendix A for expected NCD Manual language for section D. The scope of this decision is limited and we did not reconsider other sections of NCD 240.2. Further, it does not include consideration of either NCD 240.2.1, Home Use of Oxygen in Approved Clinical Trials, or NCD 20.29, Hyperbaric Oxygen Therapy.

Decision Memo: TO: Administrative File: CAG-00296R3 FROM: Coverage and Analysis Group SUBJECT: Decision to Amend National Coverage Determination for Home Use of Oxygen (NCD 240.2) to Conform to §1834(a)(5)(E) of the Social Security Act DATE: July 8, 2022 I. Decision On September 27, 2021, we issued a national coverage determination (NCD) for Home Use of Oxygen (NCD 240.2). We are amending the NCD in order to conform section D with the specific time period specified in §1834(a)(5)(E) of the Social Security Act (the Act). [1] Section D pertains to the Medicare Administrative Contractor (MAC) authority to determine reasonable and necessary coverage for patients who are not described in section B or excluded in section C. Specifically, we amended the period of initial coverage for these patients from 120 days to 90 days, in order to align with the 90-day statutory time period. The first paragraph of section D will state: Effective July 8, 2022, 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 limited 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. See Appendix A for expected NCD Manual language for section D. The scope of this decision is limited and we did not reconsider other sections of NCD 240.2. Further, it does not include consideration of either NCD 240.2.1, Home Use of Oxygen in Approved Clinical Trials, or NCD 20.29, Hyperbaric Oxygen Therapy. II. Background Throughout this document we use acronyms. Please find below a list of these acronyms and corresponding full terminology: CMS - Centers for Medicare & Medicaid Services MAC – Medicare Administrative Contractor NCA - National Coverage Analysis NCD - National Coverage Determination US - United States III. Timeline of Recent Activities May 12, 2022 CMS initiates this national coverage analysis and posts the proposed decision memorandum. The 30-day public comment period begins. June 10, 2022 30-day comment period closes. CMS receives no public comments. IV. Public Comment CMS responds in detail to the public comments on a proposed decision when issuing the final decision memorandum. Public comments sometimes cite the published clinical evidence and give CMS useful information. Public comments that give information on unpublished evidence such as the results of individual practitioners or patients are less rigorous and therefore less useful for making a coverage determination. CMS received no public comments on the proposed decision by June 10, 2022. We, therefore, are adopting our proposed change in this final decision. V. CMS Analysis Introduction NCDs are determinations by the Secretary with respect to whether or not a particular item or service is covered nationally by Medicare (§1869(f)(1)(B) of the Act). In order to be covered by Medicare, an item or service must fall within one or more benefit categories contained within Part A or Part B, and must not be otherwise excluded from coverage. Moreover, with limited exceptions, the expenses incurred for items or services must be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member (§1862(a)(1)(A) of the Act). Home Use of Oxygen (NCD 240.2) On September 27, 2021, CMS updated NCD 240.2, Home Use of Oxygen. Specifically, section D of NCD 240.2 was updated to allow MACs to 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 that coverage determination. Further, section D specifies that the initial coverage period for patients with these conditions may be limited to the shorter of 120 days or the number of days included in the practitioner prescription, at MAC discretion. When finalizing the language in NCD 240.2 section D in response to public comments, we allowed for an initial coverage period of oxygen therapy and oxygen equipment in the home for up to 120 days for the beneficiaries who are not described in section B or precluded by section C of that coverage determination. However, at that time, we inadvertently neglected the 90-day time limit in §1834(a)(5)(E) of the Act. The other sections of the NCD do not contain language related to the initial coverage period. CMS is required to follow the limitations contained in the Act. Therefore, we have revised section D to conform with the 90-day period required by §1834(a)(5)(E), and changed the first paragraph of section D of NCD 240.2 to read: Effective July 8, 2022, 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 limited to the shorter of 90 days or physician prescription at the discretion of the MAC. Oxygen coverage may be renewed if deemed medically necessary by the MAC. [Emphasis added]. VI. Conclusion CMS is amending NCD 240.2, section D, to conform to the 90-day time period specified in §1834(a)(5)(E) of the Act. See Appendix A for the proposed NCD Manual language for section D. APPENDIX A Medicare National Coverage Determinations Manual Draft This NCD is subject to formal revisions and formatting changes prior to the release of the final NCD contractor instructions and publication in the Medicare National Coverage Determinations Manual. Table of Contents (Rev.) 240.2 Home Use of Oxygen (Rev.) * * * * * D. Other Effective July 8, 2022 , 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 limited 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 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 last reviewed July 2022 .) (See §280.1 and the Medicare Benefit Policy Manual, Chapter 15, “Covered Medical and Other Health Services,” §110.) [1] Section 1834(a)(5)(E) of the Act provides: (E) RECERTIFICATION FOR PATIENTS RECEIVING HOME OXYGEN THERAPY.—In the case of a patient receiving home oxygen therapy services who, at the time such services are initiated, has an initial arterial blood gas value at or above a partial pressure of 56 or an arterial oxygen saturation at or above 89 percent (or such other values, pressures, or criteria as the Secretary may specify) no payment may be made under this part for such services after the expiration of the 90-day period that begins on the date the patient first receives such services unless the patient’s attending physician certifies that, on the basis of a follow-up test of the patient’s arterial blood gas value or arterial oxygen saturation conducted during the final 30 days of such 90- day period, there is a medical need for the patient to continue to receive such services. Decision Summary: On September 27, 2021, we issued a national coverage determination (NCD) for Home Use of Oxygen (NCD 240.2). We are amending the NCD in order to conform section D with the specific time period specified in §1834(a)(5)(E) of the Social Security Act (the Act). [1] Section D pertains to the Medicare Administrative Contractor (MAC) authority to determine reasonable and necessary coverage for patients who are not described in section B or excluded in section C. Specifically, we amended the period of initial coverage for these patients from 120 days to 90 days, in order to align with the 90-day statutory time period. The first paragraph of section D will state: Effective July 8, 2022, 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 limited 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. See Appendix A for expected NCD Manual language for section D. The scope of this decision is limited and we did not reconsider other sections of NCD 240.2. Further, it does not include consideration of either NCD 240.2.1, Home Use of Oxygen in Approved Clinical Trials, or NCD 20.29, Hyperbaric Oxygen Therapy. Related Material: Literature Review FDA Material Other Material 1 Federal Coverage Denial Notice