CMS May Cover O2 Tx for Cluster Headaches

The Centers for Medicare & Medicaid Services (CMS) issued a proposed decision memorandum Oct. 8 regarding national coverage for the home use of oxygen to treat cluster headaches. “The evidence does not demonstrate that the home use of oxygen to treat cluster headache improves health outcomes in Medicare beneficiaries with cluster headache (CH),” CMS states in the proposed decision memo. “However,” CMS continues, “we believe the available evidence suggests that the home use of oxygen to treat CH is promising and supports further research … through the Coverage with Study Participation (CSP) form of Coverage with Evidence Development (CED).”

Cluster headaches, as described in Harrison’s Principles of Internal Medicine, 16th edition, are episodic (339.01 Episodic cluster headache) or chronic (339.02 Chronic cluster headache) unilateral headaches that begin with one to three short-lived headaches per day over many weeks followed by a period of remission. Cluster headaches are characterized by severe stabbing pain in the head, usually behind one or both eyes, often accompanied by redness and tearing of one or both eyes, and nasal congestion.

Medicare currently has a national coverage determination (NCD) for Home Use of Oxygen (240.2) that provides for coverage of home oxygen under specific conditions when the patient has significant chronic stable hypoxemia. The NCD does not, however, address the home use of oxygen for the treatment of cluster headaches.

CMS is proposing Medicare coverage for home oxygen use to treat CH when furnished to Medicare beneficiaries with CH:

  • Who have had at least five severe to very severe unilateral headache attacks lasting 15-180 minutes when untreated. The headaches must be accompanied by at least one of the following findings: 
  1. ipsilateral conjunctival injection and/or lacrimation; or
  2. ipsilateral nasal congestion and/or rhinorrhea; or
  3. ipsilateral eyelid edema; or
  4. ipsilateral forehead and facial sweating; or
  5. ipsilateral miosis and/or ptosis; or
  6. a sense of restlessness or agitation.
  • Who are participating in an approved prospective clinical study comparing normobaric 100 percent oxygen (NBOT) with at least one clinically appropriate comparator for the treatment of CH (see the proposed decision memo for study requirements).

Aside from the use of home oxygen to treat CH, this proposed decision does not modify the existing requirements for coverage of oxygen currently identified in sections 240.2 and 240.2.1 of the NCD; nor does this proposed decision include any consideration of hyperbaric oxygen (HBO) for any indication.

CMS is accepting public comment on this proposed determination and expects to complete its national coverage analysis (NCA) by Jan. 6, 2011.


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