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Home Use of Oxygen to Treat Cluster Headache

CAG-00296R

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Dodick, MD, David	Title: President Organization: American Headache Society Date: 11/07/2010 Comment: November 7, 2010 Louis Jacques, MD Director, Coverage and Analysis Group Center for Medicare Management 7500 Security Boulevard Mail Stop S3-02-01 Baltimore, MD 21244 Re: Home Oxygen Therapy for Cluster Headache Comments on Proposed Decision Memo CAG-00296R The American Headache Society strongly opposesCMS’s proposed decision of October 8, 2010 whichwould limit Medicare coverage for home oxygen tocluster headache patients enrolled in futureclinical trials. We urge CMS to reconsider thisdecision, and we reassert our unequivocal positionthat oxygen therapy is both indicated andnecessary for many cluster headache sufferers.Indeed it is the only available therapyappropriate for most Medicare patients sufferingfrom this dreaded condition. The proposed decision turns the concept of“evidence-based medicine” on its head, producing aresult that denies relief to patients in the mostcompelling circumstances: It discounts the unequivocal findings of priorstudies on the grounds of methodologicalimperfections, making hopes for “better” evidencethe clear enemy of “good” and sufficient evidence. It discounts more than 40 years of successfuluse in clinical practice. To characterize thatexperience as merely “promising” totally ignoresthe enormous benefit this therapy has afforded toinnumerable patients. And it ignores the fact thatthe evidence supporting most other items andservices routinely covered by CMS is also based onsuccessful clinical practice, not randomized trials. It ignores the fact that oxygen is the standardof care for these patients and is taught as suchin every medical textbook and peer-reviewedpublication on the subject of cluster headachetreatment. For physicians to withhold thistherapy, absent contraindications in a particularpatient, would likely be construed by many asunethical, and perhaps by others as actionable. It introduces a classic “red herring” bysuggesting that there are safety issues withoxygen requiring further research in the elderlypopulation. Of course oxygen will becontra-indicated for some elderly patients. Thatgoes without saying and is equally true ofcountless pharmacological and other therapies forwhich Medicare provides undisputed nationalcoverage, while relying on the clinical judgmentof practitioners to withhold those services wherethey are medically contraindicated. Anappropriate penicillin antibiotic may not be givento a patient with a penicillin allergy, and betablockers are not appropriate for severelyhypotensive, bradycardic, or asthmatic patients. Similarly, oxygen therapy would not be appropriatefor a patient with severe obstructive pulmonarydisease or related pulmonary ailments but isnonetheless effective and necessary in the largergroup of elderly patients with cluster headache those without contraindication to oxygen. Theseclinical judgments are made by headachespecialists every day with respect to a wide rangeof therapies used in both elderly and non-elderlypopulations. Contrary to CMS’s assertion that it has used theearlier public comments to “inform” its decision,it appears that the Agency has totally ignoredthose comments which were uniformly supportive ofbroad coverage. Contrary to the assertion that CMS has notreceived any “expert opinions” (other than thepublic comments, which it has ignored), and withall due modesty, the American Headache Societyrepresents the established experts in this fieldof care. That expertise informed our initialrequest for a national coverage policy, and thatexpertise has been made readily available to theAgency. We urge CMS to reconsider its proposeddecision in light of what we believe is virtuallyunanimous expert opinion in favor of broad coverage. At least as troubling as the factors noted above,if not more so, is the fact that the path forwardsuggested in the proposed decision memo is averitable blind alley. CMS proposes furtherresearch comparing NBOT with a “clinicallyappropriate comparator.” Such research in theelderly population is unacceptable for bothpractical and ethical reasons. To perform a study with greater, or exclusive,involvement of the elderly population that uses anactive comparator against oxygen requires the useof a constricting drug, such as a triptan or anergot derivative, as the only possibly effectivecomparator. These drugs are generallycontraindicated in the elderly. Indeed, packageinserts on leading brands indicate that thesedrugs are not recommended for the elderly. See forexample this statement with respect to Imitrex byinjection, taken from the manufacturer’sPrescribing Information: “Geriatric Use: The use of sumatriptan in elderlypatients is not recommended because elderlypatients are more likely to have decreased hepaticfunction, they are at higher risk for CAD, andblood pressure increases may be more pronounced inthe elderly (see WARNINGS: Risk of MyocardialIschemia and/or Infarction and Other AdverseCardiac Events).” http://us.gsk.com/products/assets/us_imitrex_injection.pdf (page 14). (Emphasis added) To design a new study around these drugs wouldthus impose an unethical, and thus unacceptable,cardiovascular and cerebrovascular risk onMedicare patients willing to participate in theresearch project. Indeed, with appropriatedisclosure of these risks, it seems unlikely thatpatients would be willing to participate. CMS’sdecision to cover oxygen therapy only for Medicarepatients enrolled in a clinical trial compoundsthe ethical problem, since those who might enrolldespite the risks of randomization might well bedoing so only in the desperate hope to gain accessto a treatment that CMS otherwise denies them.Alternatively, so many potential trialparticipants would need to be barred from thestudy that any study results would be applicableonly to a pre-selected group of low risk Medicarepatients, and by design, would not begeneralizable to the Medicare patient populationat large. To do a study with a greater enrollment of theelderly population using oxygen vs. a placebo isalso ethically unacceptable. Randomization toplacebo is generally considered ethical only incases where there is no known effective treatmentor standard of care. Otherwise, patients would bedenied treatment for a treatable condition, withthe attendant risks and suffering, for the sake ofresearch unlikely to meet the high burden of proofneeded to change practice. Since strong evidencealready exists to support the use of oxygentherapy, and randomization to placebo would leaveextremely painful attacks untreated, a researchtrial against placebo is unethical and unacceptable. Clinicians have few treatments to abort acluster headache in any population, and of the fewwe have, the only one that is largely safe andlargely effective in the elderly population isoxygen. To demand more and “better” studies inthese circumstances smacks of comparativeeffectiveness research at the expense of the mostvulnerable of patients. The most likely outcome ofsuch a course is that no study will be done, orwill be deferred for many years. Meanwhile, patients needlessly suffer despite theavailability of an eminently “reasonable” and forthese patients clearly “necessary” therapy. To summarize, and with all due respect to yourstaff, the proposed decision gives clinicians andresearchers no option that seems ethically soundor reasonably practical. There is strong evidenceto support the administration of oxygen to elderlypatients with cluster headache, and it representsthe only feasible treatment to relieve thisseverely painful condition for most Medicarepatients. It would be limited to use in patientswithout contraindication to oxygen, and it hasbeen the treatment of choice for over 40 years byexperts in this condition. We see no reasonablebasis for denying coverage. Respectfully submitted, David W. Dodick, MD President American Headache Society Less November 7, 2010 Louis Jacques, MD Director, Coverage and Analysis Group Center for Medicare Management 7500 Security Boulevard Mail Stop S3-02-01 Baltimore, MD 21244 Re: Home Oxygen Therapy for Cluster Headache Comments on Proposed Decision Memo CAG-00296R The American Headache Society strongly opposesCMS’s proposed decision of October 8, 2010 whichwould limit Medicare coverage for home oxygen tocluster headache patients enrolled in More
barnhart-hinkle, blair	Title: Director, Government Relations Organization: Cleveland Clinic Date: 11/04/2010 Comment: November 3, 2010 Coverage and Analysis Group Center for Medicare and Medicaid Services 200 Independence Avenue, SW Washington, DC 20201 Re: Proposed Decision Memo for Home Use of Oxygen to Treat Cluster Headache (CAG-00296R) Last month, Cleveland Clinic submitted a comment letter to CMS. After speaking with some of the CMS Agency staff and receiving clarification on the language included in the decision memo, we are submitting this comment letter and ask that it replace our prior comments. Cleveland Clinic (CC) is a not-for-profit, integrated healthcare system dedicated to patient care, teaching and research. Our health system is comprised of a main campus, ten community hospitals and 14 family health centers with over 2,100 salaried physicians and scientists. Last year, our system had more than four million patient visits and over 165,000 hospital admissions. We appreciate the dedication of the Agency staff on behalf of the Medicare Program and the work they devote to its administration. We believe it is important for hospitals to share information with CMS so the Agency staff has a better understanding of the challenges and practicalities faced by the hospitals regarding proposed changes which influence hospital activity. The following are the comments from Cleveland Clinic. We believe that CMS should provide complete coverage for oxygen for patients struggling with Cluster Headaches. Oxygen is a proven treatment for cluster headache, supported by the highest level of clinical evidence and congruent with compassionate and ethical standards. It has been the standard of care for Cluster Headache patients for over a decade. Dr. David Dodick, current President of the American Headache Society and Professor of Neurology at the Mayo Clinic has written “Cluster headaches, the pain of cluster headache is often described… as boring, tearing, or burning and with such descriptive analogies as a hot poker in the eye or as if the eye is being pushed out… and has been nicknamed the suicide headache.” (Dodick et al, 2000). Suicide can occur in this patient population as they try to escape the excruciating pain. During their attacks, patients pace, cry, and yell, unable to sit or lie down. They become utterly disabled each episode, unable to function normally, let alone work while in this state without access to rapid, aggressive acute treatment. Cluster headaches reach maximum intensity rapidly, within five to fifteen minutes, too fast for an oral medication to take effect. Injections of FDA- approved vasoconstrictive agents are the only pharmaceutical option, and these are both expensive and dangerous in this high risk Cluster headache patient population with high prevalence of vascular disease. Furthermore, since these headaches recur up to 8 times per day, treatment with vasoconstrictive agents would result not only in dangerous risk of heart attack and stroke, but the cost of such treatment is very expensive. Treatment with generic FDA-approved sumatriptan injection for only 2 attacks per day would be $160, and for FDA-approved dihydroergotamine injections (DHE) would be $70 per day. That daily cost would only cover 2 attacks per day. The need to provide acute and prompt treatment for these patients has been described by one of us (SJT) in an article on the ethics of placebo-controlled studies for Cluster Headache. “Thus, the savage severity of the attacks, the merciless repetition, the rapidity of onset and quality of the pain, and the incapacitating associated features make untreated cluster headache a potential emergency.” Most Neurologists oppose placebo-controlled trials in Cluster Headache for these reasons, preferring active double dummy trials given the severity of the attacks (Tepper et al, 2002). Problems with acute treatment: vascular contraindications and ageThe only FDA approved medications for acute treatment of Cluster Headache are sumatriptan injections and DHE injections. Both medications narrow coronary and cerebral arteries, posing potentially life-threatening adverse events in patients with known vascular disease. They are contra-indicated in patients with known or suspected vascular disease. The FDA-approved prescribing information suggests careful workup even for those with risk factors for vascular disease prior to administration of these medications. A large epidemiologic study by Schurks et al, (2006) notes: “The most consistent lifestyle feature associated with Cluster Headache is current smoking.” This fact is confirmed in multiple epidemiologic studies of Cluster Headache (Manzoni et al, 1983; Levi et al, 1992; Manzoni, 1998; Bahra, 2002). The male predominance of the disorder, combined with a history of habitual smoking, puts these patients at risk for premature vascular disease and its consequences (Ekbom, 1970) and therefore most often, the serotonin agonists, sumatriptan and dihydroergotamine, are contraindicated for treatment of severe, disabling Cluster Headache attacks. In addition, regardless of smoking status, vascular disease becomes common in an aging population. Until or unless the individual patient can be medically cleared to receive the serotonin agonists, the only effective medication available for rapidly terminating a cluster headache is 100% oxygen. Oxygen The Evidence for Efficacy According to the American Headache Society and International Headache Society, inhaled 100% oxygen is the standard of care for cluster headache relief. If delivered at the onset of an attack at a rate of 7-10 liters/min for 15 minutes by a non-rebreathing (high flow) mask, the rate of headache relief is approximately 70% at 15 minutes (Cohen et al, 2000; Horton, 1956; Kudrow, 1981; Fogan, 1985; Disabato et al, 1993). In their review, Dodick and colleagues (2000) state: “Oxygen inhalation has been the standard of care for the symptomatic relief of cluster since it was introduced as an effective therapy by Horton” at the Mayo Clinic (1956). The American Academy of Neurology (AAN) published the official guidelines for treatment of Cluster Headache in August of 2010 (Francis et al, 2010). They state:“Two Class I crossover studies have investigated 100% oxygen vs placebo for the acute treatment of CH. Fogan’s study evaluated 100% oxygen vs placebo (regular air), at a rate of 6 L/min for up to 15 minutes during an acute attack. Nineteen patients treated up to 6 attacks. The primary endpoint was headache relief following treatment. A total of 56% of patients breathing oxygen perceived substantial headache relief, compared with 7% of those treated with placebo (p < 0.01). Adverse events were not reported. A more recent study by Cohen et al. assessed 100% oxygen at 12 L/min for 15 minutes vs regular air for the acute treatment of CH. Patients treated 4 attacks, 2 with each treatment, in a crossover fashion. The primary endpoint was pain-free response at 15 minutes. Patients were pain-free at 15 minutes in 78% of attacks treated with oxygen, compared to 20% of attacks treated with air (p < 0.001). No serious adverse events occurred. [Conclusion]: One hundred percent oxygen should be offered for acute treatment of CH (Level A evidence).” Oxygen was assessed as AAN Class 1. As noted, in 2009, two seminal studies were published establishing proof of oxygen’s profound efficacy in the treatment of acute cluster headaches. The first study was the Class 1 randomized control clinical study by Cohen and colleagues that established again the efficacy of O2 in acute treatment of cluster headaches. It was felt important enough to be published in JAMA in 2009 (Cohen et al, 2009). The second study, which won the Wolff award for the most outstanding research published in the field of Headache for 2009, demonstrated that the effect of O2 in terminating Cluster Headache attacks occurs centrally in the brainstem at the level of the efferent parasympathetic outflow from the Superior Salivatory Nucleus to the Sphenopalatine Ganglion and out. Oxygen specifically inhibits this known outflow in Cluster Headache (Akerman et al, 2009). The need for oxygen in cluster patientsThe clinical issue is that cluster headache patients combine the problem of rapid escalation of excruciating headache pain, and the potential contraindication of the FDA-approved vasoactive medications to terminate the attacks (sumatriptan, DHE) in patients with vascular disease, which is more prevalent in the elderly Since Cluster Headache is epidemiologically correlated with smoking and with aging, vast numbers of patients are precluded from any other acute treatment, except oxygen. Oxygen becomes the only proven acute treatment available to terminate the attacks for vast numbers of Cluster patients. Its availability is critical and denying coverage is ethically comparable to denying pain medication to cancer pain patients. The denial of these medications is medically and ethically unsupportable. In addition to the proven efficacy and the need, oxygen is actually less expensive than parenteral sumatriptan and DHE. Thus, even an economic justification for denial is unfounded. Complete coverage for oxygen for Cluster Headache patients is critical. We urge CMS to approve coverage of home oxygen therapy for cluster patients. For further input, we suggest CMS consult with the governing boards of both the American Headache Society and the International Headache Society, where we believe there is uniform opposition to the proposal to limit coverage for oxygen therapy. The American Academy of Neurology Practice Guidelines, published in August of 2010, state that oxygen is AAN Class 1, and that “One hundred percent oxygen should be offered for acute treatment of Cluster Headache (Level A evidence)”. The issue of whether further active-control comparison studies are needed has been raised. The problems with further studies are several: 1. In the population of need, there is no comparable medication with which to compare oxygen, because of the likely contraindication of the FDA-approved vasoconstrictive agents. Thus, there is no way to do comparison studies in the older Cluster Headache population using active controls. 2. As noted above, there is consensus that placebo-controlled trials for non-regulatory reasons in Cluster Headache patients are unethical. 3. There is no need in any case for further placebo-controlled studies of oxygen given the level of evidence currently available, which is at the highest level. 4. Any further studies only delay availability of the standard of care of Cluster Headache acute treatment. We would welcome the opportunity to provide any additional information that you might find helpful. Thank you for conducting a thoughtful process that allows us to provide input on such important issues, and for your consideration of this information. Please do not hesitate to contact us if you need additional information. Sincerely, Stewart J. Tepper, MD Professor of Medicine (Neurology) Cleveland Clinic Lerner College of MedicineDirector of Research Neurological Center for Headache and Pain Cleveland Clinic Mark J. Stillman, MD Director Neurological Center for Headache Cleveland Clinic Deborah E. Tepper, MD Neurological Center for Headache Cleveland Clinic References Akerman S, Holland PR, Lasalandra MP, Goadsby PJ. Oxygen inhibits neuronalactivation in the trigeminocervical complex after stimulation of trigeminalautonomic reflex, but not during direct dural activation of trigeminal afferents.Headache. 2009 Sep;49(8):1131-43. Bahra A, May A, Goadsby PJ. Cluster headache: A prospective clinical study with diagnostic implications. Neurology. 2002;58:354-361.Cohen AS, Burns B, Goadsby PJ. High-flow oxygen for treatment of cluster headache: a randomized trial. JAMA. 2009 Dec 9;302(22):2451-7.Disabato F, Fusco BM, Pelaia P, Giacovazzo M. Hyperbaric oxygen therapy in cluster headache. Pain 1993; 52:245.Dodick DW, Rozen TD, Goadsby PJ, Silberstein SD. Cluster headache. Cephalalgia. 2000 Nov;20(9):787-803.Ekbom K. Patterns of cluster headache with a note on the relations to angina pectoris and peptide ulcer. Acta NeurolScand 1970; 46:225-37. Fogan L. Treatment of cluster headache. A double-blind comparison of oxygen air inhalation. Arch Neurol 1985; 42:362-3. Francis GJ, Becker WJ, Pringsheim TM. Acute and Preventive Pharmacologic Treatment of Cluster Headache. Practice Guidelines of the American Academy of Neurology, Neurology 2010;75;463-473; DOI: 10.1212/WNL.0b013e3181eb58c8; accessed at http://www.neurology.org/cgi/reprint/75/5/463. Horton BT. Histaminic cephalalgia: differential diagnosis and treatment. Mayo Clin Proc 1956; 31:325±33. Kudrow L. Response of cluster headache attacks to oxygen inhalation. Headache 1981; 21:1-4. Levi R, Edman GV, Ekbom K, Waldenlind E. Episodic cluster headache. II: High tobacco and alcohol consumption in males. Headache. 1992;32:184- 187. Manzoni GC, Terzano MG, Bono G, Micieli G, Martucci N, Nappi G. Cluster headache—Clinical findings in 180 patients. Cephalalgia. 1983;3:21-30. Manzoni GC. Gender ratio of cluster headache over the years: A possible role of changes in lifestyle. Cephalalgia. 1998;18:138-142. Mathew NT: Cluster headache: clinical features and pathophysiology. Semin Headache Manage 1996, 1:1–4. Schürks M, Kurth T, de Jesus J, Jonjic M, Rosskopf D, Diener HC. Clusterheadache: clinical presentation, lifestyle features, and medical treatment. Headache. 2006 Sep;46(8):1246-54. Tepper SJ. Rapoport AM, Sheftell FD. Ethical Considerations in Cluster Headache Research. Current Pain and Headache Reports 2002; 6:47-51. Less November 3, 2010 Coverage and Analysis Group Center for Medicare and Medicaid Services 200 Independence Avenue, SW Washington, DC 20201 Re: Proposed Decision Memo for Home Use of Oxygen to Treat Cluster Headache (CAG-00296R) Last month, Cleveland Clinic submitted a comment letter to CMS. After speaking with some of the CMS Agency staff and receiving clarification on the language included in the decision memo, we are submitting this comment letter and ask that it More
Coles, Barry	Date: 11/01/2010 Comment: [PHI Redacted] It amazes me that statements like that in the "Proposed Decision Memo for Home Use of Oxygen to Treat Cluster Headache (CAG-00296R) would come from a country that leads the world in other aspects. Here in Australia high flow oxygen is recommended by Neurologists for CH as the least offensive abortive treatment. It also amazes me that a colony like Australia would be so far ahead of more influential countries in effective treatments like high flow oxygen. I would suggest you talk with the sufferers who do know rather than Doctors who only work on assumption not from experience. Below is a link to the US based CH web site, have a browse through there and read the results that people have from using high flow oxygen, you may be enlightened. Regards Barry Coles Australia http://www.clusterheadaches.com Less [PHI Redacted] It amazes me that statements like that in the "Proposed Decision Memo for Home Use of Oxygen to Treat Cluster Headache (CAG-00296R) would come from a country that leads the world in other aspects. Here in Australia high flow oxygen is recommended by Neurologists for CH as the least offensive abortive treatment. It also amazes me that a colony like Australia would be so far ahead of more influential countries in effective treatments like high flow More
Wold, Robert	Title: President Organization: Clusterbusters, inc Date: 10/31/2010 Comment: Oxygen is the most effective and most important abortive treatment available for cluster sufferers. There are no more studies needed to prove this wasting time and removing its coverage will only cost more suffering and more lives. Spend the money for another useless study on educating the doctors that treat people with cluster headache that high flow oxygen should be the first prescrition they write. That alone will stop many people from committing suicide.
Robinson, Jaynetha	Date: 10/30/2010 Comment: Oxygen works. [PHI Redacted]it is unfathomable that you would consider making it harder for patients to get the safest and cheapest medicine available. Shame on you.

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