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.

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5 Responses to “CMS: O2 Cluster Headache Treatment Not Covered”

  1. Kathy Batchler says:

    What is the cost of this therapy? I stopped my topamax use because of the expense and I do not have health coverage in the US.

  2. Dorothea Lashua says:

    Are you kidding me? Obviously these people have never suffered a CH – having the ability to treat yourself at home will be a cost savings to Medicare – other than the clinical trial the only other way for the sufferer to receive the O2 is to go to a hospital. Thank God I have insurance and have a very good neurologist.

  3. Kathleen Raby says:

    As a nurse and owner of a home medical equipment company, we have provided oxygen (by prescription) to many CH suffers. We see and hear of significant results with oxygen treatment for CH and at a cost that is significantly less than many of the questionable drugs these patients have taken. Fortunately for a few of our clients, private insurance has covered this therapy. For those who do not have coverage for O2 for CH we have tried to make the oxygen as affordable as possible because it works for so many. What a shame that CMS cannot see forest for the trees and keeps this simple and effective therapy from so many.

  4. Michael Everett says:

    Medicare alone in the world is the ONLY institution opposed to the use of oxygen for cluster headaches. Why is that? Medicare is a government entity, subject to pressures from Congress, which is corrupted by unlimited campaign contributions. Last year Glaxo which manufacture Imitrex AND the generic version which enables them to control the market and charge over $38 a unit. Last year Glaxo spent $1.7 billion lobbying Congress, much of it on Medicare bills. It’s a bad drug, slow-acting, sometimes doesn’t work at all, and causes rebound headaches. With 3 headaches a day, the cost is over $40,000 annually. Glaxo is not about to yield that market to an unpatented wonder drug like oxygen that costs $2-$3 to abort a cluster, and I’m convinced the fix is in to block our use of oxygen. If Medicare were really concerned that oxygen was a fatal substance, what about the tens of thousands of drug abusers who die annually from prescription medicine? With all their tests and memos, they are stringing us along while shilling for Glaxo. Now their their attacks on cluster patients have spread to private insurers, like my union retiree Plan, which has stopped reimbursing for oxygen. Am I angry? You bet I am. When I lay in bed writhing in pain 3-4 times a day I think of Medicare and the people who keep me in pain. These are suicide headaches, and there can be no question Medicare is killing some cluster patients with limited funds who give up and take suicide as the only sure cure for clusters. At age 73, I’ve been paying into Medicare since Day 1. What’s happened to America to foster such cruelty by throwing Seniors under the bus?

  5. o2 therapy says:

    o2 therapy is a treatment that provides you with extra oxygen, a gas that your body needs to work well. Normally, your lungs absorb o2 from the air. However, some diseases and conditions can prevent you from getting enough o2.

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