Home Use of Oxygen to Treat Cluster Headache

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.

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