CMS: O2 Cluster Headache Treatment Not Covered
With the exception of clinical trials, home use of oxygen to treat cluster headaches remains a non-covered Medicare benefit. The Centers for Medicare & Medicaid Services (CMS) released a decision memorandum Jan. 4 stating that there remains insufficient evidence that in-home use of oxygen for the treatment of cluster headaches improves health outcomes.
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.
The final decision memo, which modifies the national coverage determination (NCD) for Home Use of Oxygen (240.2), echoes a proposed decision memorandum CMS released Oct. 8 regarding national coverage of oxygen to treat cluster headaches (CH) at home.
In both the proposed and final decision memos, CMS states that, although there is insufficient evidence that in-home use of oxygen to treat cluster headaches is reasonable and necessary, “… 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).”
CMS is allowing Medicare coverage for in-home oxygen treatments when furnished to Medicare beneficiaries diagnosed with CH (based on the diagnostic criteria used by the International Headache Society) who are participating in an approved clinical study comparing normobaric 100 percent oxygen (NBOT). For coverage, beneficiaries must have had at least five severe to very severe unilateral headache attacks lasting 15-180 minutes when untreated, and fulfill at least one clinically appropriate comparator for CH treatment.
Read the final decision memo to learn of the comparative questions and other conditions for coverage.