Skip to main content
U.S. flag

An official website of the United States government

Return to Search

Home Oxygen for Cluster Headache

Guidance for the NCD for the Home Use of Oxygen to Treat Cluster Headache (CH) that concludes that the currently available evidence does not demonstrate that the home use of oxygen to treat CH improves health outcomes among Medicare beneficiaries.

Issued by: Centers for Medicare & Medicaid Services (CMS)

Issue Date: January 30, 2020

The NCD for the Home Use of Oxygen to Treat Cluster Headache (CH), released by CMS in January 2011, concludes that the currently available evidence does not demonstrate that the home use of oxygen to treat CH improves health outcomes among Medicare beneficiaries.  Absent such evidence, CMS has concluded that additional clinical research is appropriate under Coverage with Evidence Development (CED).  The NCD specifies that home use of oxygen to treat CH is covered for beneficiaries with CH participating in an approved prospective clinical study comparing normobaric 100% oxygen (NBOT) with at least one clinically appropriate comparator for the treatment of CH. 

The clinical study must address one or more aspect of the following questions

  1. Prospectively, compared to individuals with cluster headache who do not receive NBOT, do Medicare beneficiaries with CH who receive NBOT have improved outcomes as indicated by:
    1. Pain relief
    2. Time to pain relief
    3. Durability of pain relief
  2. Prospectively, among Medicare beneficiaries with cluster headache, which method of oxygen delivery provides the most benefit as indicated by:
    1. Pain relief
    2. Time to pain relief
    3. Durability of pain relief
  3. Prospectively, among Medicare beneficiaries with cluster headache, what other factors, if any, predict patient’s response to 100% oxygen therapy as indicated by:
    1. Pain relief
    2. Time to pain relief
    3. Durability of pain relief

The results of additional clinical research may potentially provide sufficient evidence to inform future NCDs on the topic.  CMS will maintain a list of all approved studies and post that list on this website.

Decision Memo

 

Currently, no clinical trials involving the home use of oxygen to treat cluster headache have been approved by CMS for Coverage with Evidence Development.

HHS is committed to making its websites and documents accessible to the widest possible audience, including individuals with disabilities. We are in the process of retroactively making some documents accessible. If you need assistance accessing an accessible version of this document, please reach out to the guidance@hhs.gov.

DISCLAIMER: The contents of this database lack the force and effect of law, except as authorized by law (including Medicare Advantage Rate Announcements and Advance Notices) or as specifically incorporated into a contract. The Department may not cite, use, or rely on any guidance that is not posted on the guidance repository, except to establish historical facts.