Our Joint Statement on Oxygen Therapy for Cluster Headache

We advocate for the Centers for Medicare & Medicaid Services to cover home use oxygen therapy for the acute treatment of cluster headache attacks

The American Headache Society (AHS) and the American Migraine Foundation (AMF) appreciate the opportunity to submit a public comment to advocate for coverage of home use oxygen therapy for the acute treatment of cluster headache attacks by Medicare and Medicaid beneficiaries.

For 60 plus years, AHS has been and continues to be the leading professional society of health care providers dedicated to the study and treatment of migraine, cluster and other headaches, as well as face pain. With over 1400 members and associates, the Society’s education, research, and advancement programs engage medical professionals throughout their careers, from the world’s most sought after thought leaders to those at the beginning of their professional work in headache medicine. Working alongside AHS, AMF advocates for, supports, educates, and engages over 40 million Americans who suffer the debilitating effects of headache diseases, including cluster headache. Founded by AHS in 2010, the AMF strives to mobilize a community for patient support and advocacy, as well as drive and support impactful research that translates into treatment advances.

This letter is a response to the opening of the analysis and request for public comments on the reconsideration of the National Coverage Determination (NCD) [CAG-00296R] of (1/4/11). This NCD denies coverage of home use of durable medical equipment for oxygen therapy for the acute treatment of cluster headache attacks for Medicare and Medicaid beneficiaries.

We strongly support coverage of home use oxygen therapy for the acute treatment of cluster headache attacks by Medicare and Medicaid beneficiaries. Cluster headache (known as ‘suicide headache’) is a severe pain disorder with devastating suffering along with employment, social and emotional consequences. Oxygen therapy has been demonstrated to be safe and effective.

The use of oxygen is a highly recommended first line therapy for cluster headache attacks by AHS guidelines. Oxygen therapy also features at the top of every professional society guideline internationally. This recommendation is backed by high quality clinical trials and an increasing breadth of positive published patient experience as outlined in detail in the Alliance for Headache Advocacy formal request submission.

Oxygen therapy and injectable sumatriptan are the main abortive options for an attack of cluster headache. No single therapy works or is medically appropriate for everyone, hence options are needed. There are two positive high quality randomized controlled trials with oxygen (compared with air) as an abortive for cluster headache attacks. Cluster headache attacks are unfortunately most often treated with opioids despite such patients having worse outcomes and being put at risk for opioid addiction, as well as the lack of opioid endorsement in professional society guidelines, and the availability of safe, effective, evidence based treatments such as oxygen (Choong et al reference below).

Recently a large patient experience study was published involving 2,193 subjects, 60% from the United States. Among the cluster headache subjects 65 years and older, 77% reported oxygen therapy to be effective (by comparison, 67% of subjects 65 years or older reported triptan therapy to be effective). Among respondents (irrespective of age) who had experienced trials each of oxygen, triptans, and opioids for acute treatment of cluster headache attacks, both oxygen and triptans were equally effective. Among cluster headache subjects 65 years and older, oxygen therapy was very well tolerated with minimal complications. Specifically, 91% of such respondents reported “no”, 6% reported “minimal”, and 3% reported “some” physical and medical complications. Among respondents (irrespective of age) who had experienced trials each of oxygen, triptans, and opioids for acute treatment of cluster headache attacks, opioids and triptans were more likely than oxygen to be associated with physical or medical complications, and opioids and triptans were more likely than oxygen to be associated with psychological or emotional complications. Studies like this attest to the continued effectiveness and tolerability of oxygen over years, something controlled clinical trials are not designed to do.

Oxygen therapy can prevent an expensive and unneeded Emergency Department visit. Oxygen treatment is particularly required when triptans are contraindicated (common in the older population), when there are multiple attacks a day, invaluable in pregnancy (often overlooked) and when preventative and other abortive therapies are not effective. Oxygen administered for about 20 minutes remains an extremely safe and effect abortive option for cluster headache attacks, devoid of medication interaction concerns.

In a recent survey of patients with cluster headache, AMF found that 74% of patients who had tried oxygen for the acute treatment of their attacks reported it to be effective/very effective, yet 41% of patients who were prescribed home oxygen were denied this treatment modality by their insurance company. Not surprisingly, patient comments reflected their disappointment with the inability to obtain this highly effective treatment. We have included some of the more poignant comments that show the lengths patients will go to in an attempt to find relief (welder’s oxygen), and the choices they are forced to make while in extremis (go to ED, pay out of pocket, use less effective therapies).

  • “Battled with insurance company until I could get approval. The painful nights, when I could not use an abortive treatment, caused mental anguish, financial hardship due to missed work and exhaustion from endless hours of missed sleep. Without oxygen to use as an abortive, I must rely on expensive drugs which have limitation on how often I can use them, so I’m left to suffer through many cluster attacks without any relief.”
  • “I had to go to the emergency room several days in a row since it was the only place to get oxygen. I could not get a prescription for oxygen at home. So I had to choose a medical bill or to suffer when I woke up at 3am with an attack.”
  • “I’ve had to use unorthodox methods (welding oxygen) to bypass outrageous costs of medical oxygen.”
  • “Extra stress, forces me to rely on more extreme meds when I could try less excessive abortives.”
  • “I was able to get access, but only if I paid out of pocket. Searching for a supplier that would accept private payment was a huge barrier though. It took me several weeks of daily phone calls and emails to find one that would work with me. I was told by several companies that if they accepted private pay customers, they could lose their Medicare provider status and that was their primary payer. So CMS isn’t just refusing to pay for home oxygen, they’re actively blocking patient access to treatments prescribed by their doctors by threatening to cut off payments to oxygen suppliers who fill our prescriptions.”
  • “The companies that supply it won’t sell it for a prescription that says it is for cluster headache, and insurance won’t cover it so I’m stuck with my preventative and a painkiller. Very frustrating.”

For the reasons outlined above, the American Headache Society and the American Migraine Foundation respectfully requests that CMS issue a revision to its National Coverage Determination (NCD) [CAG-00296R] to permit coverage of home use of oxygen for the treatment of cluster headache attacks by Medicare and Medicaid beneficiaries.

References:

  • Robbins, M.S., et al., Treatment of Cluster Headache: The American Headache Society Evidence-Based Guidelines. Headache 2016;56:1093-106
  • Fogan L. Treatment of cluster headache. A double-blind comparison of oxygen v air inhalation. Arch Neurol. 1985;42:362–363
  • Cohen, AS, Burns, B, Goadsby, PJ. High-flow oxygen for treatment of cluster headache: a randomized trial. JAMA. 2009;302(22):2451-2457
  • Pearson, S.M., et al. Effectiveness of Oxygen and Other Acute Treatments for Cluster Headache: Results from the Cluster Headache Questionnaire, an International Survey, Headache 2019;0:l-15
  • Choong, C. K. et al. Clinical Characteristics and Treatment Patterns Among Patients Diagnosed With Cluster Headache in U.S. Healthcare Claims Data. Headache 2017; 57(9), 1359–1374