Home Use of Oxygen and Home Oxygen Use to Treat Cluster Headaches

August 1, 2021

Submitted electronically Submitted electronically to: SUBMIT A PUBLIC COMMENT FORM

Comments on CMS Proposed Decision Memo for Home Use of Oxygen and Home Use to Treat Cluster Headaches (CAG-00296R2) Posted July 2, 2021

Lincare is pleased to submit comments on the Centers for Medicare and Medicaid Services’ (“CMS”) above captioned Proposed Decision Memo. We appreciate you listening to our comments and look forward to working collaboratively with CMS on future DMEPOS policy revisions that will enable beneficiaries to receive medically necessary items and services in their homes. Care provided to beneficiaries in their homes is not just clinically efficacious and cost effective, but we know patients prefer to be in their homes and communities.Lincare is one of the nation’s largest providers of oxygen and other respiratory therapy services to patients in the home. We provide services and equipment, from over 800 operating locations in 48 U.S. states, and employ approximately 13,000 people. The vast majority of patients we serve are Medicare beneficiaries. Lincare is a member of the Council for Quality Respiratory Care (“CQRC”) and the American Association for Homecare (“AAH”) and supports the comments submitted by both industry associations.

Lincare supports expanding patient access to home oxygen but is concerned that the practical implications of the proposal to eliminate the Certificate of Medical Necessity (CMN) and subject all claims to medical record audit review could result in many patients – both chronic and acute – losing access to these therapies. To address this concern, we ask that the final coverage policy:

To protect patient access, it is imperative that medical necessity be based on objective documentation and not left to the discretion of contractors reviewing medical records.

Our primary concern regarding the draft National Coverage Decision is that it will ultimately lead to a return of the extraordinarily high volume of audits and appeals tied to provision of the home oxygen benefit we saw in the Medicare program over the past decade. While significant progress has been made in the last few years, the legacy of complicated audits which resulted in an unprecedented backlog of appeals that played out over years rather than months is not something to be repeated from the perspective of the system, the providers and suppliers, or the patients we all serve. We are concerned that the draft NCD will lead to significant increases in audit volume for two reasons:

1. The role of the Medicare Administrative Contractors (MACs). If CMS defers to the MACs to determine coverage, the decrease in consistency and clarity will lead to variations in practice patterns that will result in confusion and diminished adherence. Additionally, geographic variations will be challenging for Medicare beneficiaries who may spend parts of the year in different parts of the country. What is covered as a beneficiary spends the spring and summer in the Midwest may not be covered during winters spent in the South.
2. Elimination of pulse oximetry standards. Moving away from objective clinical readings as a coverage criterion in deference to more qualitive determinations by doctors will cause uncertainty. Additionally, it will create a significant administrative hurdle for durable medical equipment (DME) providers who will have to track down chart notes to extrapolate eligibility. This is counter to the many efforts CMS has made in recent years in reducing administrative burden for providers.

The combination of these factors will likely result in post-payment review challenges. Key to the success in reducing audit volume over the past few years has been clarity of expectations –and DME suppliers have worked hard to educate providers about how to comply to ensure access for their patients. If finalized this NCD would move away from that clarity and we would not be supportive of such a change.

Eliminating medical record review is consistent with the overall goal of making sure that the right patient gets the right equipment at the right time. It also supports the Administration’s health equity initiative. Our experience with the CERT Reports, shows that the medical record review does not identify patients who fail to meet the medical necessity requirements, but rather it focuses on “errors” that physicians make in their medical notes.

If CMS seeks additional documentation to support the prescription, we urge the adoption of the home oxygen templates, modified to meet the new requirements set forth in the Proposed Decision Memo. These documents to which the physician attests provide the information necessary to support a claim in a straight-forward and objective manner. By relying on the medical record instead, there is no guarantee the prescribing physician will hit the “magic words” a contractor seeks to approve the claim.

Lincare appreciates the opportunity to provide comments on the Proposed Decision Memo. Please contact me at jpederse@lincare.com with any questions or comments.

Sincerely,
Crispin Teufel
Chief Executive Officer

Jenna Pedersen
Chief Compliance Office

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Submitted electronically to: MCDFeedback@cms.hhs.gov

August 2, 2021

Subject: Comments on CMS Proposed Decision Memo for Home Use of Oxygen and Home Use to Treat Cluster Headaches (CAG-00296R2)

Apria Healthcare appreciates the opportunity to submit comments regarding the Centers for Medicare and Medicaid Services’ (CMS’) Proposed Decision Memo for Home Use of Oxygen and Home Use to Treat Cluster Headaches (CAG-00296R2). We are one of the nation’s leading providers of home respiratory services, including oxygen therapy, inhalation therapies, non-invasive ventilators, sleep apnea treatment, negative pressure wound therapy, and continuous glucose monitors. Apria Healthcare serves nearly 2 million patients through approximately 275 branches located throughout the United States.

Expansion of Patient Access to Home Oxygen Therapy
Apria Healthcare is pleased that CMS recognizes the critical importance of the use of home oxygen for the treatment of patients during the pandemic and supports CMS’ proposal to expand patient access to home oxygen therapy for patients with acute and chronic conditions. However, we are concerned with the proposals that move away from the use of objective coverage criteria and provide contractors more discretion to evaluate medical necessity.

Medical Documentation (Section B)
We strongly support CMS’s effort to reduce provider burden and remove the oxygen CMN requirement from the NCD and agree that these outdated forms are no longer necessary.

However, we have serious concerns about the potential for using subjective criteria, such as contractor decision, rather than objective criteria to determine medical need for home oxygen. We are concerned that if contractor audits rely upon subjective review of a patient’s medical record (which is controlled by the prescriber who has no financial incentive to complete according to Medicare’s detailed requirements for oxygen therapy), access to this life saving therapy would be limited. We therefore strongly recommend that the physician’s prescription (documented on a standard written order/SWO) be the only required documentation of medical need. If the treating physician orders the home oxygen, it should be assumed that it is reasonable and necessary for the patient, as is the assumption for other drugs covered by Medicare. For example, pharmacies filling prescriptions for patients with acute infections are not required to provide laboratory evidence of the infection in order to be reimbursed for a prescribed drug.

If CMS chooses to not rely solely on the physician’s prescription, we suggest that CMS mandate that hospitals and ordering physicians use the home oxygen Clinical Data Element (CDE) form (which would need to be updated to reflect the new NCD guidelines). If the CDE is not required, we then support the continued use of the CMN.

Laboratory Information (Section C)
We support the expanded coverage for patients with acute conditions and the associated removal of all references and instruction regarding a “chronic stable state.” However, we request further clarification of CMS’ reference to “time of need” in their proposal “that required qualifying blood gas studies be performed at the time of need.”

We urge CMS to eliminate testing altogether and rely solely on the physician’s prescription. This approach would simplify the qualification process and eliminate potential variability in test results due to external factors (e.g., skin pigmentation, altitude, etc.). It would also make it unnecessary to have non-clinical personnel (MACs) interpret clinical results and would eliminate the potential for a physician’s determination of medical need to be overridden by a non-clinical reviewer.

If testing remains a requirement, we strongly recommend simplifying the process by requiring a single qualifying test (PO2 at or below 55 mm Hg, or an arterial oxygen saturation at or below 88%), performed under the condition in which the patient demonstrates the need for home oxygen (e.g., during activity, at rest, etc.)

Health Conditions (Section D)
We are pleased to see that CMS recognizes that oxygen therapy in the home may be medically necessary to treat not just respiratory conditions, but also non-respiratory conditions for certain beneficiaries and is revising the language in this section to reinforce that patients suffering from any medical condition, be it of respiratory or non-respiratory origin, may receive home oxygen and oxygen equipment for the duration of illness, be it short or long term, if this service is otherwise reasonable and necessary.

However, we are concerned with CMS’ statement, “The MAC may determine the reasonable and necessary coverage of home oxygen and oxygen equipment for patients with conditions unrelated to hypoxemia.” Again, we strongly recommend that a physician’s prescription determine medical necessity rather than relying upon the MACs to determine coverage.

We support CMS’ proposal to remove the current requirement that other forms of treatment must have been tried but were not successful and agree that there are clinical circumstances for which this policy requirement is not relevant. We concur with CMS’ statement that “it is the responsibility of the treating practitioner to fully evaluate the patient who requires oxygen and provide other therapeutic interventions as necessary.” This statement supports our recommendation that the physician’s prescription be used to determine medical need.

We believe that CMS’ proposal to limit coverage to 90 days with potential renewal by the treating practitioner within 60-90 days for patients with acute conditions or those who are not hypoxemic is too restrictive and may not provide sufficient therapy for certain conditions. Coverage should continue until the treating physician discontinues the oxygen. However, if CMS does implement this limitation, we recommend that a new SWO be the only document required for continued medical necessity.

Thank you for your consideration of our comments and recommendations. Please feel free to contact me at Dan.Starck@apria.com if you have any questions.

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The Honorable Chiquita Brooks-LaSure
Administrator
U.S. Centers for Medicare & Medicaid Services
200 Independence Avenue, SW
Washington, DC 20201

Dear Administrator Brooks-LaSure,

On (1/11/19), the Alliance for Headache Disorders Advocacy (AHDA) submitted a formal request for reconsideration (the “appeal”) of the CMS Decision Memo for 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.

This letter is a response to the Proposed Decision Memo (PDM; CAG-00296R2) published on July 2, 2021 and is submitted during the defined period for public comments on reconsideration of the NCD.

On behalf of the fourteen member organizations of the AHDA, I want to thank you for the opportunity to provide comments on CAG-00296R2. We are grateful for your re-examination of the 1993 NCD 240.2 regarding home use oxygen therapy (HO2) and revising the consideration of home use of normobaric oxygen therapy for Cluster Headache (CH). Your proposed changes create an opportunity to provide essential treatment to a significantly underserved group of US citizens afflicted with CH. With the goal of maximizing equity and access to treatment for those affected, we request further clarification concerning how this treatment should be provided and to whom. Further, we highlight several places where your analysis of the evidence base for treatment of acute CH attacks is not consistent with current medical standards.

AHDA and our member organizations are concerned that the removal of NCD 204.2.2 and movement of the decision from CMS to the MACs to make coverage determinations regarding the use of home oxygen and oxygen equipment for CH, does not fully meet the needs of Medicare beneficiaries with CH.

Your analysis states, “Consequently, we believe that carefully chosen Medicare beneficiaries who suffer CH, will receive meaningful pain relief from oxygen therapy.” (p. 10 paragraph 4) and later “oxygen may be used as first line therapy for the treatment of CH.” (p.14 para 2). Further, you have highlighted several proposed steps to remove barriers to home use O2 prescription for CH patients. We fully agree with this analysis and this goal and we greatly appreciate the effort put forward in this revised policy to make home O2 therapy available to CH patients. However, we have concerns that the lack of full endorsement of home use O2 in this revised analysis as well as the lack of guidance on identifying appropriate patients or on the parameters of O2 treatment (the dose) will lead to confusion and inconsistency in the access of CH patients to this essential therapy.

We hereby request a statement by CMS to acknowledge that all standard medical textbooks and US medical specialty groups (American Headache Society, American Academy of Neurology, National Headache Foundation) as well as guidelines for CH therapy from US government agencies (National Institutes of Health¹, Agency for Healthcare Research Quality, Health Resources & Services Administration, and the Institute for Clinical Systems Improvement²) endorse HO2 as first-line therapy for CH. Further, there is no evidence to indicate that use of HO2 for CH poses any health risk when used as prescribed. In our previous letter of comment, we noted the results of the international Cluster Headache Questionnaire³ showing that the majority of respondents rated HO2 as equally effective to triptans but with less significant medical or emotional side effects. The same study found that 139 respondents age 65 or more rated HO2 no differently. Your analysis of this report suggests that the diagnosis of CH was not validated in this survey, however, a recent follow-up publication applied strict diagnostic criteria to a random sampling of 5% of the CHQ cohort found to be representative of the full cohort⁴. This confirmatory study found the diagnosis was confirmed in 97.5% (79/81 respondents; 73 ECH, 6 CCH, 2 probably not CH).

Similarly, in this PDM you state that there is no need for further clinical trials: “Therefore we propose to remove NCD 240.2.2, and allow the MACs to determine coverage for the use of home oxygen as a treatment option for CH, without the need for further clinical trials.” With this being the case, we state again for the record that it is clearly the position of all US medical associations and authorities on the treatment of Headache Medicine disorders that there is more than sufficient evidence for CMS to formally state support of coverage for home O2 for CH rather than move the decision-making process down to each of the 4 separate DME MAC jurisdictions and Medicare Advantage.

You are proposing to modify NCD 240.2, “in order to allow appropriate patient access to oxygen and oxygen equipment in the home when its use is reasonable and necessary to treat certain Medicare beneficiaries with CH.” We request clarification on what determines “reasonable and necessary” beyond a physician’s diagnosis of CH. As it stands, your proposed changes give MACs full discretion to authorize or deny claims for HO2 for CH patients with no guidance concerning how those decisions are made. The current PDM does not mandate creation of LCDs, which would at least provide some standard within a given MAC for making these determinations. In order to ensure that appropriate patients are selected, we recommend that you a) instruct MACs to use a clinician diagnosis (physician or allowable advanced practice provider) of episodic or chronic CH as the sole criterion for approval of home use oxygen and b) provide a template that summarizes the relevant patient data, diagnosis, and oxygen prescription and supplies for CH patients. It may be of value to include standard diagnostic criteria for CH in your revised policy 240.2 or to refer to the periodically revised headache disorders classification (see appendix below) that specifies those criteria. Clearly, home use O2 is not a first-line therapy for other primary headache disorders such as migraine. Careful selection of patients to ensure that they meet criteria for CH will direct this therapy towards those who stand to benefit most from it.

The PDM language suggested that this change would apply to “carefully chosen Medicare beneficiaries who suffer CH”. We request that the criteria for the “chosen” should be more clearly stated by the NCD; in our view, and in the view of every guideline published by US medical societies, this therapy is first-line treatment for acute attacks for every patient with a diagnosis of cluster headache. We strongly urge CMS not to create a situation in which federal contractors who have never examined the patient will routinely second-guess a treating clinician’s diagnosis or prescription.

The recommendation for use of a template for home oxygen prescription for CH patients is based on both guidance from the GAO and CMS CERT data that indicate the vast majority of home O2 prescriptions have been made for appropriate patients using the existing template. In its 2019 report “CMS Should Assess Documentation Necessary to Identify Improper Payments” (GAO-19-277⁵), Recommendation 1 states “The Administrator of CMS should institute a process to routinely assess, and take steps to ensure, as appropriate, that Medicare and Medicaid documentation requirements are necessary and effective at demonstrating compliance with coverage policies while appropriately addressing program risks.” Using the existing home oxygen template⁶, we find there is already evidence that patients are being denied treatment even because contractors are claiming inadequate documentation. One estimate finds that 80% of claims were being denied, almost all of which were approved when presented to Administrative Law Judges (ALJs). At the same time, CMS CERT data show that over 97% of home O2 prescriptions were made for appropriate patients who meet criteria for oxygen therapy⁷. This discrepancy indicates that CMS must provide MACs with far greater guidance in using templates and approving claims, as the current status of these claims shows an unacceptably high rate of denials that prove unjustified. This also indicates that CMS has permitted contractors to waste significant time and program funds in unnecessary denials. If CMS fails to provide this guidance and instead gives greater leeway to MACs to deny claims without clear justification, the existing data indicate that many patients will be denied appropriate care and that program funds remain at risk for waste in unnecessary adjudication. Neither of these outcomes meets the goals of Recommendation 1 in the GAO-19-277, which HHS endorsed.

We are similarly concerned about prior statements from CMS or its representatives that patients with CH can “simply” present to an ED for high flow O2 therapy; one recent conversation conveyed a very clear formulation that CH patients could be “selected” for home use of HO2 on the basis of their response in that setting. Clearly, this is an untenable proposition that will pose a significant barrier to access to home HO2 for this group, which your PDM states is not your goal. Attacks of CH last for 15-90 minutes; this is consistently rated as the most painful condition experienced by humans, even when compared to other conditions known to be extremely painful (e.g. gunshot wounds, childbirth, kidney stones, pancreatitis) by people who have experienced both types of pain⁸. It is therefore completely inappropriate and an egregious disservice to CH patients to suggest they need to present to an emergency facility for oxygen therapy to “prove” they receive relief from this treatment. By the time a patient could present to such a facility, undergo triage, wait for evaluation and then begin treatment, the attack would have resolved. Certainly, no reasonable or compassionate person would suggest that a CH patient should wait in an emergency facility all day until an attack occurs just to establish there is a treatment response (nor would a busy ED service allow them to do so).

As previously noted, a significant benefit of reducing barriers to access to HO2 for this group will be to reduce the prescription and use of opioids for the treatment of acute CH attacks.

Regarding a modified home oxygen therapy template, we recommend the following: current practice standards, based on the evidence provided in a range of clinical trials, specify that HO2 should be prescribed using the following parameters^9,10,11:

• 100% O2 using a valve or flow regulator that provides 10-15 L/min for a minimum of 15 minutes
• non-rebreather full-face mask
• a collapsible reservoir

The existing evidence and the long clinical experience treating CH clearly show that following these parameters greatly increases the likelihood that home O2 therapy will provide relief from acute CH attacks.

In PDM Appendix C, Section D (the revised form of 240.2), you state “Oxygen coverage may be renewed if medically necessary when … the patient exhibits a continuing need for oxygen”. This suggests an assessment of treatment success, as any patient with a diagnosis of CH will have a “continuing need” for HO2 whenever CH attacks occur. While there are, by definition, periods of remission of attacks in those with episodic CH, non-authorization of continued HO2 prescription during those periods would create an undue burden on patients, as this creates a situation in which a patient could enter into a new CH period without an active HO2 prescription and would then need to a) contact their provider who would b) submit a new prescription which would then require c) re-authorization by the local MAC. The delay in authorization here could easily be weeks to months, leaving a patient without access to essential therapy. The only situation we can foresee in which HO2 would no longer be medically necessary is if the therapy is consistently ineffective.

At the same time, CMS needs to provide guidance to MACs regarding temporary return of home O2 equipment during periods of CH remission to reduce costs to the program. Current classification of CH recognizes two main forms: episodic (ECH) and chronic (CCH). In the case of ECH, cluster periods can last weeks to months at a time; between active bouts there can be periods of remission lasting months to years. This creates a situation in which MCR or MCD programs could be charged for rental of home O2 equipment during a prolonged period of dormancy of CH. We believe it is important for CMS to provide guidance to MACs and DME suppliers regarding optimal management of this situation, so as to meet the competing needs of patients requiring access to essential therapy and the obligation to minimize program costs. As noted above, it is not reasonable or practical to require a patient or their treating clinician to re-initiate authorization for this treatment at the start of every CH period. Rather, an authorization should be valid for a year, with the proviso that once a patient can contact their DME to arrange temporary return of equipment (and suspension of rental cost) when they enter a period of remission. This arrangement would necessarily permit re-delivery of home O2 equipment as soon as a patient is aware of the start of a new CH period, without requiring re-authorization (so long as the prescription is still active).

The evidence employed by CMS in their decision-making for their reconsideration of the NCD (CAG-00296R2) rests on an incomplete and highly selective review and interpretation of the published literature and available clinical practice guidelines (CPGs). Specifically, CMS states that they reviewed just one comparative trial, one systematic review and two guidelines. First of all, CMS failed to review and consider a relevant and supportive double-blind, randomized, crossover trial¹² that had been highlighted in the original Alliance for Headache Disorders Advocacy (AHDA) formal request for NCD reconsideration (January 11, 2019).

Regarding the prior CMS statement about existing clinical trials, we want to reiterate our dissenting opinion on your assessment of a prior RCT of HO2¹³. You have stated on record that “there was selection bias in this trial”. We have previously noted that the selection criteria used in this study were entirely clinically appropriate and served, in fact, to make a more conservative estimate of the benefit of HO2 in the acute treatment of CH attacks.

CAG-00296R2 also cites at length the importance of the recommendations of the VA/DoD CPG. It is therefore crucial to consider in depth the value and relevance of the VA/DoD CPG regarding use of oxygen for acute treatment of cluster headache.

The CAG-00296R2 states “As noted in the CPGs of the VA/DoD (2020), the use of inhaled oxygen may be first line therapy for CH in selected patients and if successful, is then in itself “optimum therapy.”” However, the VA/DoD CPG does not state that oxygen would be first line therapy for CH in selected patients. It states: “The first-line treatment of cluster headaches includes triptans and oxygen therapy.” There is no mention of any selection of patients who should be considered for oxygen treatment, and in particular, there is no recommendation that cluster headache patients should be selected for coverage of home oxygen therapy based on any obligatory prior trial (i.e. in an emergency department or doctor’s office setting).

The VA/DoD CPG goes on to state: “Although there is limited evidence for the use of NBOT in acute cluster headache, it is established as safe and often found to be effective in aborting cluster headaches in the clinical setting.” However, the VA/DoD CPG then appears to contradict itself by stating “The Work Group determined the benefits and harms were balanced given limited evidence proving either.” That is, if oxygen is established as safe, then what harms are being balanced against effectiveness?

Furthermore, the VA/DoD CPG states that with respect to their ratings for therapies “It is important to note that the GRADE terminology used to indicate the assessment … should not be confused with the recommendation’s clinical importance.” In other words, a therapy could be of high clinical importance but still receive a low GRADE score based on factors such as patient preference. In this vein, it is notable that the VA/DoD employed a single focus group including just 5 individuals within one city to draw conclusions about “the values and preferences of those most affected by the recommendations: patients and their caregivers”. Four to five focus groups are typically convened to adequately understand questions of interest and importance. Furthermore, this small focus group did not apparently include anyone with any personal experience with cluster headache. Consequently, evidence derived from this focus group lacks face validity. Nonetheless, the VA/DoD CPG appears to conclude from this focus group that: “Patient values and preferences were somewhat varied because some patients may not want to try this intervention. Also, supplemental oxygen is not always available in the clinical setting. Thus, the Work Group decided upon a “Neither for nor against” recommendation.” The preferences of a panel of 5 people, none of whom had experienced the excruciating pain of cluster headache, are neither relevant to (1) considering the willingness of patients with cluster headache to try this therapy or accept its inconvenience in the clinical setting (i.e. in the home in the case of Medicare beneficiaries), or (2) assessing the safety and efficacy of this therapy.

The recommendations presented in the VA/DoD CPG are also undermined by their incomplete review of the relevant medical literature. Specifically, they also did not consider the study of Dirkx, H.T., et al., (above), despite this article having had been published between the VA/DoD CPG specified date range of January 1, 2009 and March 6, 2019.

Importantly, the VA/DoD CPG recommendations regarding oxygen for cluster headache are in direct and anomalous contradiction to all other available authorities. The AHDA public comment letter (submitted September 11, 2020) referenced twenty other US and international authorities endorsing oxygen as first-line acute treatment of cluster headache attacks (i.e. American Academy of Neurology, American Headache Society, British Association for the Study of Headaches, Bulgarian Headache and Pain Society, Cochrane Database of Systematic Reviews, Czech Headache Society, European Federation of Neurological Societies, European Headache Federation, French Headache Society, German Migraine and Headache Society, German Society for Neurology, Hungarian Headache Society, Italian Society for the Study of Headaches, Netherlands Society of Neurology, Portuguese Neurological Society, Romanian Neurological Society, Spanish Headache Society, Swiss Headache Society, Taiwan Headache Society, United Kingdom, National Institute for Health and Care Excellence (NICE)). Notably, CAG-00296R2 also selectively avoids referencing or recognizing any of the judgements of the authorities cited above (apart from Robbins et al. Headache. 2016;56:1093-106 and Bennett et al. Cochrane Database Syst Rev. Dec 28 2015 (12):CD005219, see below).

Moreover, the VA/DoD CPG also directly contradicts the FDA’s determinations about the safety and efficacy of specific pharmaceuticals for primary headache disorders. The VA/DoD CPG states: “There is insufficient evidence to recommend for or against any particular medication for the acute treatment of cluster headache.” Whereas, the FDA approved for marketing sumatriptan 6mg subcutaneous for the acute treatment of cluster headache based on 2 randomized, double-blind, placebo-controlled, 2-period crossover trials¹⁴. Likewise, the VA/DoD CPG states: “There is insufficient evidence to recommend for or against valproate for the prevention of headache.” The FDA approved for marketing divalproex sodium for the prevention of migraine based on the results of 2 multicenter, randomized, double-blind, placebo-controlled clinical trials¹⁵.

In summary, the recommendations of the VA/DoD CPG should be discounted. The evidence and methodology of the VA/DoD CPG are utterly inadequate for evaluating the safety, efficacy, or appropriateness of oxygen for acute therapy of cluster headache for Medicare beneficiaries.

Finally, the CAG-00296R2 cites the systematic review of Bennett et al¹⁶ as supporting the absence of evidence for “home use of oxygen to treat CH improved health outcomes in Medicare beneficiaries”. However, no clinical studies are available at all that have evaluated the efficacy or safety of the home use of oxygen to treat CH specifically among Medicare beneficiaries. Nor is it at all feasible to perform a trial to try to do so. Nonetheless, Bennett et al did state that: “…we can have some confidence that… NBOT can terminate a cluster headache”, and that “It is generally accepted that about 70% of patients will receive significant relief”. Moreover with respect to safety, the Bennett study stated that the only reported adverse events from oxygen for cluster headache across the two trials they reviewed were 2 cases of claustrophobia from using the mask and 2 cases of running out of oxygen. In other words, no significant safety issues for oxygen for cluster headache were identified in these trials.

We do support your proposal to use this revision as an opportunity to open up access of oxygen and oxygen equipment to other beneficiaries besides those with CH. We also are supportive of your proposal to remove the need for documentation indicating other forms of treatment have been tried and failed before approval of oxygen.

In summary, in light of the fact that oxygen therapy is established, and accepted internationally, as safe and effective in the home setting for the treatment of Medicare beneficiaries with cluster headache, we respectfully request that CMS update the existing 204.2.2. NCD to reflect this as covered treatment. Short of that, we have provided evidence that clear guidance is needed for MACs to appropriately process claims for home oxygen therapy in the treatment of CH attacks.

Sincerely,

Chris Gottschalk, MD
President
Alliance for Headache Disorders Advocacy

APPENDIX:

The most recent edition of the International Classification of Headache Disorders, ICHD-3 (2018), specifies the following :

1. At least five attacks fulfilling criteria B-D
2. Severe or very severe unilateral orbital, supraorbital and/or temporal pain lasting 15-180 minutes (when untreated)¹
3. Either or both of the following:
   1. at least one of the following symptoms or signs, ipsilateral to the headache:
      • – conjunctival injection and/or lacrimation
      • – nasal congestion and/or rhinorrhea
      • – eyelid oedema
      • – forehead and facial sweating
      • – miosis and/or ptosis
   2. a sense of restlessness or agitation
4. Occurring with a frequency between one every other day and 8 per day²
5. Not better accounted for by another ICHD-3 diagnosis.
   1. During part, but less than half, of the active time-course of 3.1 Cluster headache, attacks may be less severe and/or of shorter or longer duration.
   2. During part, but less than half, of the active time-course of 3.1 Cluster headache, attacks may be less frequent.

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OPEN COMMENT PERIOD ON: Home Use of Oxygen and Home Oxygen Use to Treat Cluster Headaches (CAG-00296R2)

Submitted electronically to

July 30th, 2021

The Honorable Chiquita Brooks-LaSure
Administrator
U.S. Centers for Medicare & Medicaid Services
200 Independence Avenue, SW
Washington, DC 20201

Dear Administrator Brooks-LaSure,

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 proposed decision memo for home use of oxygen and home oxygen use to treat cluster headaches (CAG-00296R2) of July 2, 2021. This memo highlights significant progress for the coverage of home use oxygen for the acute treatment of cluster headache attacks for Medicare and Medicaid beneficiaries. We are supportive and appreciative that home use oxygen for the treatment of cluster headache attacks is now a coverable benefit. Thank you.

However, additional clarifications and changes are recommended before the policy is finalized.

1. All Medicare patients with a cluster headache diagnosis should be eligible for insurance covered home use oxygen, not just “select” patients.
   • Home use oxygen for the acute treatment of cluster headache attacks is a first line therapy as recommended by evidence-based guidelines from both AHS and the American Academy of Neurology. There have been two Class I studies, Fogan et al. and Cohen et al., demonstrating that 100% high flow oxygen for up to 15 minutes during an attack is better than placebo. In both studies, oxygen was well tolerated with no serious adverse events. Guidelines have indicated that, based on available evidence, there is a Level A evidence for home use 100% high flow oxygen for the acute treatment of cluster headache attacks.
   • In addition, a large patient experience study with 2,193 subjects, 60% from the United States, demonstrating 77% of patients with cluster headache reported oxygen therapy to be effective, safe, and very well tolerated. In fact, 91% of patients with cluster headache reported that there we no adverse effects of oxygen therapy. This is strong evidence that oxygen therapy for cluster headache is safe. We would also like to highlight the impressively large sample size for this cluster headache study given that cluster headache is a rare disease with a lifetime prevalence of about one in 1000 people.
   • In all the above studies, there is no evidence or indication that home use oxygen is not safe for patients with a diagnosis of cluster headache.
   • The proposed decision memo expresses concern over study sample size and the mix of both international and national data. However, these well designed studies have appropriate sample sizes for a rare disease and inclusion of a wide breadth of patients (international and national) increases the generalizability of data thus increasing validitiy.
   • The above professional society guidelines and large patient experience study emphasizes the medical necessity that ALL Medicare patients with a cluster headache diagnosis be eligible for home use oxygen therapy.
2. The coverage determination should be made at the CMS/National level and not moved down to the individual Medicare Administrative Contractors (MAC).
   • MACs would establish their independent Local Coverage Determination (LCD) policies which may impact the consistency of coverage for patients with cluster headache which may expand healthcare disparities. Coverage determination, based on high levels of evidence for a first-line therapy that is safe and effective for a rare disease that is highly disabling, needs to be made at the CMS/National level to ensure equal ethical coverage for all Medicare and Medicaid beneficiaries.
3. For the acute treatment of cluster headache attacks with home-use oxygen, blood gas studies should not be required prior to approval for insurance coverage.

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. This recommendation is backed by high quality clinical trials and an increasing breadth of positive published patient experience.

From the patient perspective, having access to home oxygen therapy can be life changing, and for many it can be lifesaving. Cluster headaches are estimated to affect up to 1 million Americans, and despite the characteristic symptoms of the attacks and the incredibly high disability that they cause, it can take up to 7 years for a patient to be correctly diagnosed. And yet there is a simple, inexpensive, and highly effective, safe treatment available, but all too often, because of insurance coverage restrictions, this therapy has been unavailable. In a survey of patients living with cluster headache conducted by the American Migraine Foundation, it was 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. When you factor in the high suicidality rates of this disease (approximately 60% of sufferers contemplate taking their own lives), limiting access to treatment is inhumane and unethical. The AMF stands together with AHS in advocating for our patients so that they may receive, without restrictions, the treatment that they deserve.

For the reasons outlined above, the American Headache Society and the American Migraine Foundation respectfully requests that CMS provide the above recommended clarifications and revisions prior to finalization of the policy to all all Medicare and Medicaid beneficiaries with the diagnosis of cluster headache to have access to home-use oxygen.

On behalf of the American Headache Society and the American Migraine Foundation,

Peter Goadsby, MD, PhD, FAHS, AHS President

Lawrence Newman MD, FAHS, AMF Chair

Amaal Starling, MD, FAHS, AHS Advocacy Committee Chair

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Dear Administrator Brooks-LaSure,

Thank you for the opportunity to submit a public comment to advocate for coverage of home use oxygen therapy for the acute treatment of cluster headache attacks.

I am a board-certified neurologist and headache medicine specialist at Mayo Clinic in Scottsdale, Arizona. On a daily basis, I care for patients with headache disorders including cluster headache. I use evidence-based medicine to bring the safest, most effective, and most accessible care to my patients so that they can have the best health-related quality of life possible. For my patients with cluster headache, this includes the first-line therapy of high flow, home use oxygen for acute attacks. This is especially important for my patients with multiple attacks per day, vascular comorbidities, and contraindications to triptan medications - all clinical situations where sumatriptan cannot be used safely and effectively.

This letter is a response to the proposed decision memo for home use of oxygen and home oxygen use to treat cluster headaches (CAG-00296R2) of July 2, 2021. We are supportive and appreciative that home use oxygen for the treatment of cluster headache attacks is now a coverable benefit. Thank you.

However, additional clarifications and changes are recommended before the policy is finalized.

Standing in solidarity with my patients with cluster headache, I strongly support coverage of home use oxygen therapy for the acute treatment of cluster headache attacks by Medicare and Medicaid beneficiaries. I respectfully request that CMS provide the above recommended clarifications and revisions prior to finalization of the policy to all all Medicare and Medicaid beneficiaries with the diagnosis of cluster headache to have access to home-use oxygen.

- Amaal Starling, MD, FAHS, FAAN

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CMS Open Comment Period on Proposed Decision to Remove NCD for Home Oxygen Use to Treat Cluster Headache and Home Use of Oxygen (NCD 240.2.2, NCD 240.2)

July 28, 2021
The Honorable Chiquita Brooks-LaSure
Administrator
U.S. Centers for Medicare & Medicaid Services
200 Independence Avenue, SW
Washington, DC 20201

Dear Administrator Brooks-LaSure,

Our organizations and the patients we represent with Cluster Headache (CH) are encouraged by the Proposed Decision Memo to remove the National Coverage Determination (NCD) for home oxygen use to treat CH and home use of oxygen. This proposal is an excellent step toward improving patient access to high flow oxygen as the first-line treatment for the condition. While Clusterbusters and our partnering organizations are pleased with the suggested changes, we have reservations regarding some of the verbiage and provisions provided in the memo.

Remove “Selected Patients” and “Selected Individuals” from the Language
The Analysis portion of the Proposed Decision Memo discusses how “carefully selected individuals” with cluster headaches may benefit from the use of oxygen therapy. The document goes on to say, “inhaled oxygen may be first-line therapy for CH in selected patients.” Our organization and the neurologists and patients we work closely with are concerned those phrases will unnecessarily limit the ability of the prescribing doctor to make the best decision for their CH patient.

Oxygen is a safe treatment with “no or minimal physical and medical complications,” as demonstrated in Pearson et al. 2019, Headache 59(2):235-249. We feel the evidence shows that every CH patient should be offered home oxygen as a first line treatment the day they are diagnosed. Treating physicians should have the authority to determine the individuals who will benefit from home oxygen use to treat CH. People should not be forced to obtain their own oxygen to prove that it works.

The inclusion of the term “select” will cause hesitation for physicians who want to prescribe oxygen immediately. Modifying the language in the current document will ensure all Medicare patients with a CH diagnosis are eligible for insurance-covered home-use oxygen. No one with CH should be excluded from having access to this first-line treatment, and this change will prevent a cascade of coverage appeals when the Proposed Decision Memo goes into effect.

Make Home Oxygen Use to Treat Cluster Headaches a National Determination
Home oxygen use should be accessible to all CH patients prescribed high flow oxygen to treat their attacks regardless of their U.S. location. A national determination safeguards access for patients across the United States instead of relying on the decisions of Medicare Administrative Contractors (MACs) who may provide coverage for some while denying oxygen access to others in their Local Coverage Determination policies (LCDs).

Additionally, a visit to the Emergency Department (ED) or physician’s office to first demonstrate the effectiveness of high flow oxygen for CH is not feasible or practical when you consider the sudden and severe nature of acute cluster headaches. Requiring such appointments would be cost prohibitive and create an avoidable barrier to home oxygen use for CH.

Our organization has spent the better part of 20 years working toward the goal of oxygen coverage for Medicare patients, and we are grateful for the Proposed Decision Memo issued on July 2, 2021. Clusterbusters, Inc. and the undersigned are encouraged by the proposed changes and hope you will consider our suggested amendments for the final decision.

Sincerely,

Eileen Brewer
President, Clusterbusters
Phone: 443-538-8334
Email: Eileen@clusterbusters.org
On behalf of all Americans with Cluster Headache

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Thank you for finally making high flow oxygen a covered treatment for those suffering from cluster-headaches. This treatment literally saved the life of [PHI Redacted] several times over, as it has proven to be the single option to quickly abort the headaches without adverse reactions. In fact, of the numerous people I know who suffer from this ailment, ALL, not just a select few of them benefitted from this option.

I therefor have to ask for a few additional requirements for this proposal:

1. This treatment should be considered a generally available option for all patients diagnosed or are trying to determine their diagnosis. Coverage for 'a select few' of patients will not cover the vast majority of people that would benefit, if not save the lives of. Make the exceptions of the coverage be just that, exceptions, not the norm.
2. Testing of the treatment in an ER or doctors office is an immediately disqualifying requirement, as cluster headaches occur at random, often unpredictable times; they can't just trigger one on demand, which is what would be required to test the oxygen option. If there must be such a requirement, make it for a period of time after approving the treatment, maybe verify 30-90 days after the treatment is approved that it is indeed effective for that patient. At least then, the patient will have had the chance to try it before you decide to deny their coverage.
3. I don't understand the 4 district approvers clause. Why would there be regional differences in the coverage approval, which is what would happen when you have 4 different individuals making decisions for their own independent region? Just make the coverage requirements as tight as possible so that immediate coverage isn't dependent on differing opinions/judgements that may be approved by one but not the other.

Thank you again for getting this treatment covered. I beg of you to consider the items above to ensure the most amount of people that would benefit from this treatment will have access to it.

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[PHI Redacted]

The one treatment that works to abort nearly every attack (cluster headache), has been high flow medical oxygen. [PHI Redacted]

Statistics gathered from cluster headache sufferers put high flow oxygen therapy to abort a cluster headache at about 70% effective. I'd suggest that it would be even higher with proper technique.

As this therapy has virtually NO negative side effects when used correctly, coupled with low cost per use and high effectiveness in this population (with cluster headache), it should be a first line abortive therapy and should be used first with every patient suspected of having cluster headache.

LCD, Local Coverage Determination, is not appropriate as the efficacy of high flow oxygen therapy is not dependent upon locality, It is a universal therapy and this would lead to an unequal distribution and application of this amazing therapy.

There should NOT be a need to prove the efficacy of this therapy in a doctors office or in an emergency room before covering this therapy. Here is my reasoning:

In closing, I'm grateful that CMS is finally considering this therapy for coverage. It is Safe, Effective, and Inexpensive. It is a tried and true treatment for victims, and I am 100% behind it's use and will continue to do so. I urge those who shape this policy to make this therapy as available, with as few limitations as possible.

Respectfully,

Raymond J. Schwartz
Woodstock, Ohio

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I am a headache neurologist and health services researcher in Connecticut. I provide direct patient care to Veterans living with such headache diseases as cluster headache and conduct research intended to understand and improve headache healthcare quality and delivery for Veterans. I also served as a Champion on the VA/DoD Clinical Practice Guideline (CPG) for the Primary Care Management of Headache (Version 1.0, 2020).

As a clinician who has been caring for patients with cluster headache for nearly two decades, I have seen how the use of high-flow oxygen (especially when inhaled via non-rebreather mask) during a cluster headache attack is a safe and effective acute treatment for cluster headache when it is available to patients. I have also seen how those with limited or no readily available access to oxygen have suffered. Patients and providers caring for people living with cluster headache will share that the Emergency Room is a necessary evil. From a patient perspective, they would prefer to treat their cluster attacks in their homes rather than a chaotic Emergency Room. From a healthcare provider and health systems perspective, having cluster patients go to an Emergency Room to receive what can be an outpatient therapy is a poor use of healthcare resources.

Access to oxygen is something that factored into the GRADE of the VA/DoD CPG for Headache (Recommendation 37 - There is insufficient evidence to recommend for or against oxygen therapy for the acute treatment of primary headache). The workgroup for this key question, in following the GRADE framework (see Table B-4. Grade Evidence to Recommendation Framework; https://www.healthquality.va.gov/guidelines/pain/headache/VADoDHeadacheCPGFinal508.pdf) considered such things as “values and preferences” of patients and such “other implications” as “is this intervention generally available?”). The workgroup cited that oxygen is not always readily available, and discussed policy in effect as of July 2020 (when the VA/DoD CPG was made publicly available) outside of the VA/DoD. iT recognized that oxygen is oftentimes not readily available as an acute treatment for cluster headache. Other times it is not available at all. Having an effective treatment that is not readily accessible, or not accessible, at all influenced the GRADE of Recommendation 37.

Also impacting the GRADE of this recommendation was the exclusion of the article by Dirkx et al., The Journal of Headache and Pain, 2018 (doi: 10.1186/s10194-018-0917-4), where rates of patients treating their cluster headache attacks with two different flow rates were examined. No serious side effects were reported in either group. This article was published during the 10-year article examination period of the CPG but was not included in for consideration by the CPG reviewers.

In a future iteration of the VA/DoD CPG for Headache addressing the recommendation of oxygen as an acute therapy for cluster headache attacks, the Work Group would consider any updated data, revisit data that may have been missed (e.g., Dirkx et al.) and would factor policy changes impacting the availability of oxygen for the acute treatment of cluster headache.

These comments should be taken as my own and do no not necessarily reflect those of my employer.

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The U.S. Pain Foundation is pleased to provide comments on the CMS Proposed Decision Memo for Home Use of Oxygen and Home Oxygen Use to Treat Cluster Headaches (CAG-00296R2). The U.S. Pain Foundation is the largest 501(c)(3) organization for people who live with chronic pain from a myriad of diseases, conditions, and serious injuries. Our mission is to empower, educate, connect, and advocate for those living with chronic illness that causes pain, as well as their caregivers and health care providers.

Cluster headache is an extremely debilitating headache condition with pain so severe that it is often referred to as the “suicide headache.” These horrific, episodic attacks can last anywhere from 15 minutes to 3 hours and are characterized by excruciating, one-sided pain focused around the eye or temple. During an attack, one feels the urge to rock back and forth or pace. One of the first line treatments for Cluster headache that is also safe and has minimal side effects is oxygen. That is why we are pleased that the Proposed Decision Memo released on July 2, 2021, now lists home-use oxygen for Cluster headache as a “coverable treatment”. We are also pleased that CMS has removed the Fail-first requirements for this treatment as well as the “chronic stable state” language as this does not apply to the episodic nature of Cluster headache.

However, we are writing to also express concern about some other aspects of the Coverage Determination. First, all Medicare beneficiaries with a Cluster headache diagnosis should be eligible for home-use oxygen, not just “select patients.” We are concerned about CMS’s decision to move coverage determination down to the four Medicare Administrative Contractors (MACs) who would each create their own Local Coverage Determination policies. We believe this would add an unnecessary and potentially confusing and time-consuming administrative burden to patients already challenged to manage a debilitating and unpredictable condition.

We would also like more clarity about whether and when blood gas studies would be required prior to approval of home oxygen use for Cluster headache.

We again thank CMS for reconsidering the decision about coverage of home oxygen use for Cluster headache and hope you will take our views into consideration as you finalize the NCD. If you have questions about our comments, please feel free to contact me.

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The Honorable Chiquita Brooks-LaSure
Administrator
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

Dear Administrator Brooks-LaSure

I applaud the progress from the Centers for Medicare and Medicaid Services (CMS) in reviewing the CMS Decision Memo for Nationai Coverage Determination (NCD) [CAG-00296R] that currently does not allow coverage of home use oxygen therapy for beneficiaries with cluster headache (CH) disease. While I appreciate your attention to this issue, I strongly urge to you to clarify that all beneficiaries with a diagnosis of cluster headache should be eligible for coverage with this revision.

Cluster headache is widely recognized as one of the most severely painful disorders known. Approximately 500,000 people in the US may experience cluster headache, where pain occurs in abrupt and agonizing attacks, in cyclical patterns that can last for weeks to months. Fifteen percent of people with cluster headache experience attacks of excruciating pain eve1y day.

High flow rate 100% oxygen therapy provides critical relief from the acute pain of cluster headache so that patients can regain quality of life. Oxygen therapy for the treatment of cluster headache is effective within minutes. This is a crucial therapeutic benefit for a condition where recurrent individual attacks often reach extreme pain levels within seconds. It is the only reliable, safe, and effective acute therapy available for individuals living with cluster headache.

I have both personal and professional familiarity with this specific medical issue. [PHI Redacted] and I can attest to the extraordinary effectiveness, rapidity, and reliability of oxygen therapy for their relief. Moreover, as a practicing anesthesiologist, and past Chief of Obstetric Anesthesiology at the Johns Hopkins Hospital, I am highly familiar with the detailed benefits and risks of medical gas therapies, including those for oxygen. I am confident that high flow 100% oxygen therapy is safe for use at home by Medicare beneficiaries for the acute treatment of cluster headache attacks.

Oxygen therapy has been an undisputed first line agent for acute treatment for cluster headache attacks, since it was first reported in 1952. This medical consensus is supported by broad clinical experience and by controlled clinical trial research data that suppoti its efficacy and safety, including enrolled subjects up to 70 years of age (Cohen et al. JAMA 2009; 302:2451-2457 .). There are no published clinical trial reports or case reports, whatsoever, of any serious adverse event or serious side effects of use oxygen therapy for cluster headache in patients of any age group. As a consequence, oxygen therapy is cited as the standard of care in the practice guidelines and texts for cluster headache therapy of the National Institutes of Health, Agency for Healthcare Research Quality, American Headache Society, American Academy of Neurology, Health Resources & Services Administration, European Federation of Neurological Societies, National Headache Foundation, and the Institute for Clinical Systems improvement. The Veterans Administration covers home oxygen therapy for its beneficiaries with cluster headache.

There is no safe and effective alternative to oxygen therapy for many Medicare eligible cluster headache patients. Available altemative acute therapies carry clear and serious risks. While 6mg subcutaneous sumatriptan is an FDA approved treatment for this cluster headache indication, it is not proven safe for use more than twice per day, or daily for weeks on end. Cluster headache attacks may occur up to eight times per day. CMS also limits availability of sumatriptan, often to no more than 10 treatments per month. Sumatriptan is contraindicated in the setting of cardiovascular ischemic risks or stroke which are prevalent among Medicare eligible patients.

As a result of the current NCD, Medicare and Medicaid covered cluster headache patients often receive unnecessaiy, costly, and typically ineffective, emergency department services and hospital admissions. The duration of cluster headache attacks (mean approximately one hour, maximum three hours) makes this treatment impractical in emergency departments; attacks often end before patients can reach hospital-based treatment. Furthe1more, the common nocturnal timing of attacks, and their frequency (i.e. often multiple times per day, eve1y day, for weeks) makes emergency department treatment infeasible.

Lack of availability of home oxygen therapy has led to prescription of opioids for cluster headache patients resulting in adverse outcomes. Opioid medications are typically ineffective for this disorder, but carry established risks of dependency, abuse, and addiction. The lack of availability of home oxygen for relief from excruciating cluster headache attacks may also lead to patient self-harm; cluster headache is associated with a 20-fold increased risk of suicide. Finally, further financial hardship may fall to low-income Medicare or Medicaid beneficiaries if they have been prescribed home oxygen for cluster headache but must pay for this out of pocket due to the current NCD.

It is the unifonn consensus medical opinion that home use of oxygen for cluster headache is ve1y safe and highly effective. This is beyond dispute. The value of this therapy is not in clinical equipoise. It is therefore unethical for CMS to withhold coverage of this treatment from Medicare and Medicaid patients.

According to the Proposed Decision Memo, some "carefully chosen" beneficiaries may be eligible for insurance covered home use oxygen. The updated NCD should provide more clarity as to who qualifies as a "chosen" patient. Based on available information, including any patient diagnosed with CH would be appropriate. Requiring patients to have received a trial of oxygen in an emergency depmiment or provider office is not only unrealistic given the nature of these attacks, but also expensive and medically inappropriate. If a patient holds the diagnosis, requiring them to visit a health care facility during an attack before providing access to the appropriate treatment is unnecessaiy and almost cruelly burdensome. Additionally, since the proposal is to move the claims approval process to the Medicare Administrative Contractors (MACs), it is crucial that CMS provide them with the guidance they need when referencing this revised policy. The CMS should immediately clarify that any beneficiary with a cluster headache diagnosis is eligible for coverage.

I appreciate you reconsidering Medicare coverage of home oxygen for treating CH, and I look forward to further clarity in the final decision.

Sincerely,

Andy Harris, M.D.
Member of Congress

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At VieMed, we would like to submit the following comments regarding the CMS Proposed Decision Memo for the current national coverage determination(NCD) for Home Use of Oxygen:

• VieMed supports the CMS proposal that would remove the certificate of medical necessity. We believe this is redundant paperwork that is used as a billing tool and not utilized as a true proof of medical necessity. We recommend that the language of the NCD will be strengthened so the physician’s notes along with the standard written order/prescription will provide enough documentation to clarify medical necessity. We recommend that the NCD not include vague language that leaves interpretation open to the MACs.
• VieMed supports the proposal for expanding coverage for both acute and chronic conditions. We would like to see the language to outline how to differentiate and what will be required for both types of conditions. For both acute and chronic conditions, we recommend no additional testing and allow the physician’s re-evaluation to determine the continued need of the patient.
• VieMed requests that the 36-month capped rental not include short term coverage of acute conditions when determining the capped period. Multiple rounds of short-term coverage can lead to a potential access issue if the patient develops a chronic need for oxygen.
• VieMed supports expanding coverage for cluster headaches. We also support the recommendation that home oxygen therapy may be medically necessary to treat not just respiratory conditions, but also non-respiratory conditions. We feel this is reinforced by CMS recognizing in the memo that respiratory function can be impaired from conditions other than lung disease.
• VieMed supports the proposal to remove the mention of “chronic stable state” from the NCD.
• VieMed supports the proposal to remove the requirement of tried and failed alternate therapies.

VieMed feels that these changes will further the CMS goal of putting patients over paperwork and allow for physicians to appropriately treat their patients utilizing home oxygen therapy while providing proper coverage for the patient.

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I. Introduction

The American Association for Homecare (AAHomecare) is pleased to submit comments on the Centers for Medicare and Medicaid Services’ (CMS’) Proposed Decision Memo for Home Use of Oxygen and Home Use to Treat Cluster Headaches (CAG-00296R2). We would like to submit these updated comments. Please disregard AAHomecare's previous comments submission.

AAHomecare is the national association representing DMEPOS suppliers, manufacturers, and other stakeholders in the homecare community. Our members are proud to be part of the continuum of care that assures Medicare beneficiaries receive cost-effective, safe and reliable home care products and services, including home oxygen equipment and related services. Our members serve approximately 80 percent of all Medicare home oxygen patients across the country. In light of this, we are uniquely qualified to comment on CMS’ proposed decision memo.

II. CMS Proposed Decision Memo

In its proposed Decision Memo, CMS proposes to remove the current national coverage determination (NCD) at section 240.2.2 of the Medicare NCD Manual (CMS Pub. 100-03). CMS also proposes to modify its NCD for Home Use of Oxygen at section 240.2 of the Medicare NCD Manual to expand patient access to oxygen and oxygen equipment in the home, and to permit the DME MACs to cover the use of home oxygen and oxygen equipment to treat cluster headaches and to treat other acute conditions.

III. Summary of Comments

AAHomecare appreciates CMS’ recognition that, since the onset of the COVID-19 public health emergency (PHE), “the ability to provide home oxygen has been crucial to treatment of patients during the pandemic,” and that “the ability to provide home oxygen was crucial for many patients.” (CMS Proposed Decision Memo, Sections II and VI). As a result of our members’ experience with patients both before the pandemic as well as patients with COVID-19 who have needed supplemental oxygen therapy, we fully support CMS’ proposal to expand coverage for oxygen and oxygen equipment in the home for short- and long-term use, and for patients with both acute and chronic conditions. We also support CMS’ proposal to remove the requirement for a beneficiary to have tried and failed alternative therapies. We support, with caveats explained in the following paragraph, CMS’ proposal that could improve the documentation requirements by eliminating the use of the oxygen certificate of medical necessity (CMN).

While we appreciate CMS’ proposal to expand coverage to include acute and chronic patients and remove the CMN requirement, we have serious concerns about the apparent lack of objective data that would be used to support a patient’s medical need. Without clear and objective criteria, medical review audits will continue to be based upon a subjective review of the medical record, which is wholly within the control of the prescriber, and for which the prescriber has no financial or other incentive to document consistent with Medicare’s traditional detailed requirements. We therefore strongly recommend that the prescription, or the standard written order (SWO) be the sole required documentation of medical need. If CMS chooses to require additional documentation, we strongly recommend that CMS make mandatory for hospital systems and physicians a revised version of the clinical data element template (CDE) for home oxygen. The home oxygen CDE, modified to be consistent with the revised oxygen NCD, would incorporate all required elements of the SWO. If CMS chooses to not make the home oxygen CDE mandatory, then we support the continued use of the CMN, as long as CMS allows the medical need details (such as test results) on the CMN to substantiate a beneficiary’s medical need for home oxygen. To protect patient access, it is imperative that medical necessity be based on objective documentation and not left to the discretion of contractors reviewing medical records.

A. Comments.

1. Support Expanded Coverage for Patients with Acute Conditions

AAHomecare fully supports CMS’ proposal to expand coverage of home oxygen therapy to beneficiaries with acute and chronic conditions, for short- and long-term therapy. We concur with CMS’ statement that “this expansion is appropriate as it will remove the limitation on reasonable and necessary treatments with home oxygen and oxygen equipment for beneficiaries.” As became evident during the COVID-19 PHE, this will also give physicians more options to provide the best course of treatments. We also support CMS’ proposed expansion of coverage for cluster headaches.

2. Medical Need Documentation Must be Clear and Objective (Section B)

AAHomecare supports CMS’ proposal to eliminate the CMN as it is currently only utilized as a billing tool and is not used to demonstrate medical need. The CMN is a burdensome requirement for both oxygen suppliers and prescribers who must complete this document. Oxygen suppliers often have difficulty meeting the CMN requirement because many of the forms are returned incomplete from prescribers and then require multiple communications between the prescriber and supplier to have it completed accurately.

While we agree that the NCD is not the appropriate venue to detail documentation requirements, we recommend that CMS/DME MACs implement clear and objective documentation requirements consistent with the final oxygen NCD. Like prescription drugs that are dispensed based on a valid physician prescription, the medical need for oxygen should be determined by the physician and a valid SWO should be sufficient to document medical need for acute or chronic patients. AAHomecare also recommends that CMS require a new SWO to document a beneficiary’s medical need beyond 90 days for patients with acute conditions.

AAHomecare has serious concerns about a potential shift from using objective criteria to subjective criteria to determine medical need for home oxygen. The proposed Decision Memo alludes to potential contractor discretion, but if contractor discretion becomes the standard without being replaced by the SWO and/or the objective CDE template, the uncertainty of whether medical record documentation meets subjective criteria may produce unintended consequences on the back end with potential unfounded negative outcomes in audit findings. We therefore strongly urge CMS and the DME MACs to rely upon objective criteria to determine medical need.

The current Medicare oxygen NCD states the “initial claims for oxygen therapy for hypoxemic patients must be based on the results of a clinical test that has been ordered and evaluated by the treating practitioner.” (p. 19 of NCD 240.2). We support defining the test to be used as an arterial blood gas (ABG) or pulse oximetry. CMS appears to have concerns in the proposed Decision Memo that pulse oximetry tests may under-report low oxygen saturation levels. We therefore recommend that CMS and/or the DME MACs clarify the oximetry test results ranges that would qualify a beneficiary with acute or chronic health conditions requiring supplemental oxygen therapy.

If Medicare insists on requiring medical need documentation beyond the SWO, AAHomecare supports the use of a single, simplified, modified version of the CMS CDE template for home oxygen therapy. The CDE includes all required elements of the SWO. The CDE elements assist suppliers and providers with meeting all the documentation requirements for home oxygen. CMS would need, however, to require hospital systems and prescribers to implement the CDE templates within their respective electronic health record (EHR) systems to meet all the documentation requirements. If such a CDE requirement cannot be implemented on a timely basis, we recommend that the SWO along with any required documentation of testing be sufficient to meet the billing and qualification requirements to document medical need. Of course, the current draft CDE for home oxygen would need to be revised based upon the final revised oxygen NCD.

DME MACs’ LCD, as well as their LCA, “Standard Documentation Requirements for All Claims Submitted to DME MACs” (A55426) must be revised to be consistent with this NCD. The current version of A55426 contains multiple references to the CMN and other documentation that would need to be updated if the proposed NCD is finalized.

3. Laboratory Evidence (Section C)

Chronic Stable State: AAHomecare fully supports CMS’ proposal to remove all references and instructions in the NCD regarding the clinical criterion “chronic stable state,” to enable patients with certain diseases to better recover from an acute illness. This term is no longer relevant as CMS proposes to expand coverage for patients with acute conditions.

“Time of Need”: AAHomecare requests that CMS clarify the term “time of need.” In its proposed Decision Memo, CMS states,

The “time of need” means during the patient’s illness when the presumption is that the provision of oxygen will improve the patient’s condition in the home setting, whether that condition represents a long-term chronic illness or an expected short-term recovery from an acute disorder. For an inpatient hospital patient this would ordinarily be (as stated in the 1993 NCD) within 2 days of discharge. For those patients whose initial oxygen prescription does not originate during an inpatient hospital stay (such as individuals with CH), the time of need would logically be during period when the treating practitioner notes signs and symptoms of illness that may be relieved by oxygen in the patient who is to be treated at home.

AAHomecare recommends that CMS clarify “time of need” as the date the therapy is ordered to initiate oxygen therapy.

Pulse Oximetry Tests: We are concerned about CMS’ apparent questioning of the utility of pulse oximetry tests, given that this test provides clear objective data to determine a beneficiary’s medical need. CMS must establish clear and objective clinical criteria to establish medical necessity, as explained above. AAHomecare therefore requests that CMS clarify the oximetry test results range that would qualify a beneficiary with acute issues and the range of oximetry test results that would qualify a beneficiary with chronic health issues.

We strongly suggest limiting oxygen testing requirements to either (1) SpO2 or PaO2 at rest or during activity (without the need for a formal exercise study), or (2) SpO2 overnight. Additionally, for oxygen prescribed for hospital discharge, if more than one arterial blood gas or pulse oximetry test is performed during a beneficiary’s hospital stay, the test result obtained closest to the hospital discharge date should be evidence of the need for home oxygen therapy.

4. Health Conditions (Section D)

AAHomecare agrees with CMS’ recognition that oxygen therapy in the home may be medically necessary to treat not just respiratory conditions, but also non-respiratory conditions for certain beneficiaries. We appreciate CMS’ statement in the proposed Decision Memo that respiratory function can be impaired from various causes, not just lung disease.

AAHomecare fully supports CMS’ statement in the proposed Decision Memo that “the NCD should allow for maximum flexibility to clinically appropriately provide coverage of home oxygen and oxygen equipment, regardless of duration of need.” We also support CMS’ proposed elimination of examples of medical conditions that may require the use of home oxygen, because they inappropriately limit coverage. While CMS states that it wishes to provide “maximum flexibility to clinically appropriately provide coverage of home oxygen and oxygen equipment,” CMS also appears to provide the MACs with discretion to limit that flexibility. We are concerned with CMS’ statement that “[t]he MAC may determine the reasonable and necessary coverage of home oxygen and oxygen equipment for patients with conditions unrelated to hypoxemia,” given the proposed NCD’s clear direction that it is the prescriber who determines medical need for oxygen. Any MAC interpretation, for example in an LCD, to limit the NCD language, would be inappropriate and inconsistent with the clear direction in the proposed NCD to rely upon the prescriber to determine medical need.

AAHomecare further agrees with CMS’ proposal to remove the current requirement that the beneficiary must have unsuccessfully tried alternative therapies prior to the use of oxygen in the home, and CMS’ statement that it is the responsibility of the treating practitioners to fully evaluate the patient and what they require. This underscores our recommendation that the SWO be used as the determinant of medical need.

For patients with acute conditions, CMS proposes that the coverage may be renewed when a treating practitioner determines within 60-90 days of initiating treatment that the patient exhibits a continuing need for oxygen. We recommend that CMS change the timeframe to ‘within 120 days’ and clarify in the final NCD that this renewal of medical need can be documented by the prescriber in a new SWO. We believe the proposed 60–90-day timeframe is too restrictive and may not provide enough time for patients to be seen by their provider.

5. Portable Oxygen

The current home oxygen NCD 240.2, Section E, contains verbiage related to portable oxygen systems. We recommend that CMS eliminate all references to portable oxygen in the NCD because the NCD is about the national coverage criteria for home oxygen therapy, of which portable oxygen is a subset. There is simply no need to separately specify portable oxygen in the NCD.

B. Conclusion

Thank you for the opportunity to comment. Please contact me at kimb@aahomecare.org if you have any questions.

Sincerely,

Kimberley S. Brummett
VP, Regulatory Affairs

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Comment:
[PHI Redacted] has suffered from cluster headache attacks since 2004. For almost 17 years, this neurological disorder has severely impacted our quality of life. When a cluster headache attack occurs, he experiences severe pain on the left side of his head, especially around the eye socket, his eyes and nose water, he has nasal congestion and the effected eye lid swells. He has acute attacks that come in cycles that may occur two or three times per year. Seasonal and barometric changes can trigger a new cycle to begin. He is is now having three or four attacks per day and our first line of defense is high flow home oxygen therapy which helps to abort the attack within 15 minutes from onset avoiding 45 minutes to an hour or more of pain followed by exhaustion. Home oxygen therapy is a safe an effective treatment for cluster headaches because you need to use it at the onset of an attack. You just can’t wait to receive oxygen therapy at an Emergency Room or health care provider’s office. It is difficult to function and by the time you get there the attack may have passed. After years of searching, we have a neurologist, who prescribed home oxygen therapy for [PHI Redacted] . Having access to home oxygen therapy for cluster attacks has reduced the duration of attacks, improved his ability to function and improved our quality of life.

We are asking for CMS to honor our pain and finalize the Proposed Decision Memo, with revisions, to allow All Medicare patients with a diagnosis of cluster headache to have access and coverage for home-use oxygen.

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We appreciate that CMS has made changes in this national coverage article (NCA) to replace the language “treating physician” with “treating practitioner.” This will ensure that the clinically appropriate use of home oxygen therapy is available to all Medicare patients. Medicare covers services provided by nurse practitioners (NPs) as long as they are covered Medicare services and the NP is legally authorized to perform the service in the State in which they are performed. Under Medicare regulations, treating practitioners (including nurse practitioners) are authorized to complete the written order and prescription for DMEPOS, including oxygen equipment, and when required perform the face-to-face encounter. This language is also consistent with Local Coverage Article A55426: Standard Documentation Requirements for All Claims Submitted to DME MACs, which uses the term “treating practitioner.”

However, in this NCA we did note that in subsection “D.” there is an instance where the term “physician” is used instead of “practitioner.” We respectfully request that the term “physician” be replaced with “practitioner” in the sentence that reads: “Initial coverage for patients with conditions unrelated to hypoxemia is limited to the shorter of 90 days or physician prescription.” This will maintain consistency with the rest of the NCA and ensure that patients are not incorrectly denied access to reasonable and necessary treatment.

We appreciate your consideration of these comments and again thank CMS for updating language throughout this NCA, and other Medicare Coverage Determinations, to ensure that patients who choose nurse practitioners and other Medicare qualified clinicians as their providers of choice are able to maintain access to medically necessary treatments.

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On behalf of the members of the Council for Quality Respiratory Care (CQRC), I want to thank you for the opportunity to provide comments on the Proposed Decision Memo for Home Use of Oxygen and Home Oxygen Use to Treat Cluster Headaches (CAG-00296R2) (Proposed Decision Memo). We are emailing our full comment letter as well. In brief, the CQRC supports expanding patient access to oxygen used outside of institutional settings (home oxygen), but is concerned that the practical implications of the proposal to eliminate the Certificate of Medical Necessity (CMN) and subject all claims to only medical record audit review could result in the vast majority of patients – both chronic and acute – losing access to these therapies. To address this concern, we ask that the final coverage policy:

Eliminating medical record review is consistent with the overall goal of making sure that the right patient gets the right equipment at the right time. It also supports the Administration’s health equity initiative. During the pandemic, it became clear that individuals in communities of color are being under-prescribed medically necessary home respiratory therapy. Our members’ experience, which CMS contractors verify annually through the CERT reports, shows that the medical record review does not identify patients who fail to meet the medical necessity requirements, but rather it focuses on “errors” that physicians make in their medical notes. Because physician reimbursement is not affected by these reviews, there is no incentive for them to modify their practices. Thus, it is unclear what benefit there is to the Medicare program for this process to continue.

If CMS seeks additional documentation to support the prescription, we urge the adoption of the home oxygen templates, modified to meet the new requirements set forth in the Proposed Decision Memo. (See Appendix) These documents to which the physician attests provide the information necessary to support a claim in a straight-forward and objective manner. They may be especially helpful to protect access for Black patients whose physicians prescribe oxygen, but whose pulse oximetry test exceeds the levels listed in the Proposed Decision Memo. Relying on the medical record instead would be like playing Russian Roulette with these patients because there is no guarantee the prescribing physician will hit the “magic words” a contractor seeks to approve the claim.

If CMS were not to adopt the use of these documents and not eliminate medical record review, we ask that CMS maintain and reinstate the Certificate of Medical Necessity (CMN) as the document used to establish medical necessity. It is the only objective document that suppliers are able to rely upon during the audit and appeals process that will support a patient’s access to the therapy that his/her physician has prescribed. Without some level of objective support outside of the medical record, the denial rate will result in suppliers leaving the Medicare program. Simply put, suppliers cannot operate a business with nearly 80 percent of their claims locked in the audit and appeals process because of flaws in a document they do not create and over which they have no influence.

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The HOMES Association is grateful for the opportunity to provide comment on the proposed decision to remove the National Coverage Determination (NCD) for Home Oxygen Use to Treat Cluster Headache (240.2.2) and to modify the NCD for Home Use of Oxygen (240.2). We are supportive of CMS efforts to updates the NCD’s and increase beneficiary access to medically appropriate home oxygen therapy.

• Expanding coverage to include Acute and Chronic medical conditions. The HOMES Association fully supports the decision to expand coverage to include acute conditions. There is a demonstrated clinical need for oxygen therapy for many patients suffering from acute conditions. The Association however would like to point out that from a practical standpoint the provision of short-term oxygen therapy by DME providers poses a unique set of challenges that the current oxygen reimbursement model fails to address. As such we recommend CMS consider adopting the following policies for the provision of acute care oxygen therapy.
  • Rental claims for oxygen equipment should be excluded from the current capped rental methodology. The current 36 month capped rental methodology for oxygen equipment poses many challenges for patients and providers. With the expansion of coverage to include acute conditions there is a far greater potential for oxygen patients to have short term treatment periods which will count towards the 36 months of allowed payment. For patients who receive multiple periods of treatment there is a strong potential for access issues as providers may be hesitant to accept new patients with only limited number of months available on the capped rental period.
  • Consider increased payment rate for acute care oxygen therapy. The current reimbursement rates for home oxygen therapy are derived predominantly from the competitive bidding program. At the time of bidding providers were not able to provide acute care (short term) oxygen therapy and as such the current rates are dependent on the model in which the majority of oxygen patients were on service for an extended period of time. The financial constraints associated with providing oxygen on a short term basis are far different that the constraints of providing oxygen to a chronic (extended use) patient.

  In addition, we have concerns with the following provision.

• Proposed re-evaluation period for acute care patients. The proposal suggests patients be requalified “within 60-90 days after the DME has been initially placed”. We believe that this 30 day time period is too restrictive and may be difficult for patients to be seen by their treating physicians in this narrow window. Especially considering the post pandemic wait times many patients have experienced when trying to schedule appointments with MD’s and specialists (pulmonologists) in particular. We recommend CMS consider expanding this window for re-evaluation to between the 31st and 122nd day of oxygen therapy.

Thank you for the opportunity to submit comments on this important issue. The HOMES Association is committed to assisting CMS affect positive change for the DMEPOS industry and we welcome any opportunity to discuss strategies for improvement.

Sincerely,

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The undersigned organizations appreciate the opportunity to offer comments in response to the Centers for Medicare & Medicaid Services (CMS) Proposed Decision Memo on Home Use of Oxygen and Oxygen Use to Treat Cluster Headaches (CH) (CG-00296R2).

CMS proposes to remove NCD 240.2.2 and allow the Medicare Administrative Contractors to determine the appropriate use of oxygen and oxygen equipment for cluster headaches while concurrently revising NCD 240.2 to expand coverage for home use of oxygen. CMS is also seeking comment on the specific language to be included in the National Coverage Determinations Manual based on the revisions in the proposed decision memo.

COMMENTS:

We would like to express our support and appreciation for the inclusion of the following modifications:

1. We applaud CMS for its decision to expand coverage to include short and long-term use of supplemental oxygen for acute and chronic respiratory conditions and to provide coverage for conditions unrelated to hypoxemia, especially recognizing the increased need for oxygen for many acute conditions, including those individuals who require oxygen upon discharge from the hospital due to COVID.
2. Allowing maximum flexibility of the treating practitioner to determine clinically appropriate oxygen use based on medical need without the patient having to first try and fail other therapeutic alternatives is an important change and one that can help improve overall patient care. Requiring that a patient try and fail alternative treatments prior to the provision of supplemental oxygen puts the patient at unnecessary risk and we support the recommendation that this language be removed.
3. We are supportive of CMS’ proposed recertification changes for those individuals who are not hypoxemic or who demonstrate continued improvement from an acute disease. We agree with CMS’ assessment that many patients recovering from an acute illness may not need long-term supplemental oxygen use. Limiting initial coverage to the shorter of 90 days or physician prescription, while at the same time allowing the treating practitioner to continue supplemental oxygen use if it is determined within 60 – 90 days after the equipment is placed in the “home” that renewal is medically necessary, can result in improved utilization and cost savings.
4. We concur with the proposal to eliminate references to “chronic stable state” and to replace it with “time of need.” This gives the treating practitioner the ability to determine when the need for oxygen outside the hospital setting will improve the patient’s condition, which has been limited due to the current restrictions. The language to be included in the manual states: “For those patients whose initial oxygen prescription does not originate during an inpatient hospital stay, the time of need would be during the period when the treating practitioner notes signs and symptoms of illness that can be relieved by oxygen (emphasis added) in the patient who is to be treated at home.” We caution how this may be interpreted by the MAC’s. Our reading of the language implies that “notes signs and symptoms” is the initial assessment of the patient’s need for supplemental oxygen by the treating practitioner. We ask CMS to clarify this understanding in the final decision memo.
5. In our comments submitted in September 2020, we supported the removal of the Certificate of Medical Necessity (CMN) and recommended that the Clinical Data Element Order Template currently on the CMS website be used in its place. Although we agree with CMS’ rationale to eliminate the CMN documentation as burdensome, we believe the electronic template is an important tool in validating the medical record for audit purposes and encourage CMS to require its use in lieu of the CMN. We are concerned that without this failsafe, patient access could be an issue if left to the discretion of the DME MACs.
6. We applaud CMS’ proposal to remove the specific list of examples included in the section related to Conditions of which Oxygen May be Covered in NCD 240.1. Although the list was never intended to be inclusive as CMS suggests, it has caused confusion in the past, and we support removal of the examples thereby allowing patients suffering from any medical condition to receive supplemental oxygen if it is determined to be medically necessary.

RECOMMENDATIONS:

We support the major changes outlined in CMS’ proposed decision memo and we believe consideration should be given to further revisions in the final decision memo. Our recommendations and rationale for additional changes are listed below:

1. Eliminate “home” from the NCD and retitle it to read “Outpatient Use of Supplemental Oxygen.”
   Rationale: As indicated in previous comments, the term “home use of oxygen” implies that it can only be used within the “four walls of a home.” This can be confusing and does not reflect today’s standards for supplemental oxygen use outside the inpatient hospital setting. Oxygen is frequently utilized away from the home while performing the usual activities of daily living that require exertion and may increase the need for supplemental oxygen. We feel it is important to provide clinically appropriate supplemental oxygen support for any patient who has a disease characterized by both acute and chronic hypoxemia regardless of location of need.

   The description of “home” in the current NCD language can be a barrier to full understanding of the need for portable oxygen. There is a clearly defined, relatively small number of patients with certain very severe diseases (e.g., interstitial lung disease, pulmonary hypertension, post COVID pulmonary disease, bullous emphysema, etc.) that cause profound hypoxemia that is refractory to correction on an outpatient basis with the commonly supplied oxygen systems. Portable oxygen units that provide a reasonably long duration of high oxygen concentrations are needed on an outpatient basis to supply essential needs and for the usual activities of daily living.

2. Revise coverage and payment criteria by establishing a classification system based on clinical needs.
   

   Rationale: By removing the CMN, CMS has the opportunity to revise oxygen coverage and payment decisions based on the standard of care and not solely based on the criteria of “continuous flow/liters per minute.” Setting forth categories that accurately reflect the patient’s need for supplemental oxygen, based on the physician assessment, is needed to bring policies up to date along with the other changes CMS is proposing. The following is an example of a physician ordered equipment classification that could meet this need:

   Category 1 (Stationary System Only) Use of oxygen limited to sleep only, clinically moribund, bed bound, or activities limited to less than a 50-foot radius. Example: Stationary concentrator with a 50 foot oxygen hose and a compressed gas cylinder for emergency backup for power outage or stationary device failure.

   Category 2 (Transportable System) Limited/occasional mobility outside of a 50-foot radius (e.g., medical appointment, religious services, family visits). Example: Stationary concentrator with a 50-foot hose, plus as needed supply of compressed gas cylinders (e.g., E cylinder on a wheeled cart).

   Category 3 (Ambulatory System) Support for exercise/exertion or for continuous use also including need for frequent ambulation. Example: An “ambulatory delivery system” is defined as a small device that is “portable” allowing the beneficiary to move about freely while carrying or rolling a lightweight unit without assistance and with enough ease to perform medically required exercise/exertion or their usual activities of daily living for the required duration. An example would be a portable oxygen concentrator (POC) or lightweight containers filled from a transfilling concentrator.

   Category 4 (Refractory hypoxemia) This is the group referenced previously with profound hypoxemia refractory to commonly used oxygen systems described in the previous categories requiring higher flow rates, high concentration supplemental oxygen, and portability.

3. Utilize oximetry to determine the appropriate device setting(s) that should be ordered to provide adequate oxygen saturations at rest and during usual activities of daily living: “Titrate to Saturate”.

   Rationale: Once the appropriate clinical category and optimal delivery device and accessories have been determined, every patient should be titrated to an adequate oxygen saturation on the device(s) they will be using while at rest and during the activities they will perform daily. For example, a setting of 2 liters per minute on one device may not provide the same oxygen delivery to the patient as a different type of device on a similar setting. The delivery may also be different if the device is set to intermittent flow versus continuous flow. Upon initiation of supplemental oxygen therapy, and periodically thereafter, the setting(s) on every oxygen delivery system prescribed should be adjusted to provide adequate oxygen saturation for the patient at rest and during their usual activities of daily living. This may require different setting on their stationary system and portable systems.

4. The NCD for oxygen is based on data derived from studies of adults and we suggest that the NCD not be used to establish standards of care for children.
5. The use of oxygen during sleep should be assessed while using positive airway pressure (PAP) devices for those with sleep disordered breathing, and as per the rest of the document, supplemental oxygen approval does not require a total time of desaturation.
6. We would like to again point out, that while “service” is not part of the NCD process that we recognize and support that the services of a respiratory therapist are part of the standard of care in the clinical assessment, education, treatment, and care of individuals who require supplemental oxygen.

We appreciate the opportunity to comment on the proposal and your consideration of inclusion of our recommendations. We would also look forward to the opportunity to have further meetings with CMS to discuss how these issues could be addressed.

• American Association for Respiratory Care
• American College of Chest Physicians
• American Lung Association
• American Thoracic Society
• Asthma and Allergy Network
• COPD Foundation
• Dorney Koppel Foundation
• Pulmonary Fibrosis Foundation
• Respiratory Health Association
• US COPD Coalition

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[PHI Redacted]

At home oxygen use is critical for seniors, especially since the alternative abortives AND preventives pose significant negative cardiac issues. Expecting any benefit from ER experience with this condition is pointless. Knowledge of cluster headeache is minimal with many physicians, and not any less so in the typical ER. Countless cluster patients can attest to fruitless visits and agonizing pain with an enormous bill at the end…to no avail.

[PHI Redacted]

Please adopt an ongoing approval of oxygen therapy for seniors with cluster headache….their suffering is immense, frequent, life altering, and totally unnecessary. Requiring constant reevaluation and approval for continued use is needlessly cruel and expensive.

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The American Association for Respiratory is among a group of pulmonary and patient advocate organizations that have submitted joint comments in response to CMS’ subject proposed decision memo.

In addition to those comments, the AARC would like to offer separately one additional recommendation that is of particular concern to our members. It involves paragraph 240.2.F. in the National Coverage Determination (NCD) concerning respiratory therapists. CMS proposes to remove this section from the NCD since the DME benefit does not include clinical services.

Recommendation: CMS should retain the paragraph about noncoverage of the professional services of a respiratory therapist.

Although CMS acknowledges clinical services are not part of the DME benefit, we call your attention to the section on Respiratory Equipment, Supplies and Services as part of the DME Quality Standards. Suppliers are required to offer respiratory services 24 hours a day, 7 days a week as needed by the patient and caregivers. As part of the delivery and set-up requirements, suppliers must also comply with the current versions of the AARC’s Respiratory Care Clinical Practice Guidelines which include “Oxygen Therapy in the Home or Alternative Site Health Care Facility.” Further, several states mandate that direct patient care during the setup must be provided by a respiratory therapist and cannot be provided by non-licensed personnel.

The services of a respiratory therapist are the standard of care when it comes to clinical assessment, education, treatment, and care of individuals who require supplemental oxygen and who need other respiratory equipment and services. While we recognize that CMS has always maintained coverage of durable medical equipment is only about payment for the equipment itself, it is difficult to ignore the fact that respiratory therapists are an essential part of the services that go hand and hand in providing the equipment. For these reasons we believe it is important to keep the reference as a way of recognizing their role while at the same time acknowledging their services are not part of the DME benefit.

Thank you for considering this request.

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MAMES COMMENTS

PROPOSED DECISION MEMO FOR HOME USE OF OXYGEN AND HOME OXYGEN USE TO TREAT CLUSTER HEADACHES (CAG-00296R2)

Submitted electronically July 28, 2021 via CMS website

The following comments on the Proposed Decision Memo for Home Use of Oxygen and Home Oxygen Use to Treat Cluster Headaches (CAG-00296R2) are submitted by the Midwest Association for Medical Equipment Services (MAMES), an eight state regional association representing Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) suppliers in Iowa, Kansas, Minnesota, Missouri, Nebraska, North Dakota, South Dakota and Wisconsin. MAMES represents close to 300 members that includes DMEPOS suppliers, manufacturers, distributors, consultants and other service providers.

In its proposed Decision Memo, CMS proposes to remove the current national coverage determination (NCD) at section 240.2.2 of the Medicare NCD Manual (CMS Pub. 100-03). CMS also proposes to modify its NCD for Home Use of Oxygen at section 240.2 of the Medicare NCD Manual to expand patient access to oxygen and oxygen equipment in the home, and to permit the DME MACs to cover the use of home oxygen and oxygen equipment to treat cluster headaches and to treat other acute conditions.

Comments

MAMES fully support the following:

• Support CMS proposal that would place patient over paperwork by elimination of the use of the oxygen certificate of medical necessity (CMN). There are concerns that the proposed NCD does not clearly clarify, which leaves open to the DME MAC interpretation, the medical necessity requirements for oxygen. MAMES recommend that the physician evaluation and prescription or standard written order (SWO), be clearly defined as meeting medical necessity requirements, similar to prescription drugs. MAMES recommend clear language that eliminates varying interpretations of the language.
• Support CMS proposal to remove the requirement for a beneficiary to have tried and failed alternative therapies. It should be the responsibility of the treating practitioner to fully evaluate the patient and determine the needs of the patient. MAMES agree it is clinically inappropriate to withhold oxygen for hypoxemic patients while awaiting the results of other therapeutic measures to take effect.
• Support coverage for Cluster Headaches.
• Support CMS proposal to expand coverage for oxygen and oxygen equipment in the home for short- and long-term use, for patients with acute and chronic conditions. MAMES would like CMS to consider clear language outlining the requirements for acute and chronic conditions.
• Support expanded coverage for patients with acute conditions. MAMES has concerns that a 60-90 re-evaluation may be difficult to meet and would recommend expanding this to 31-120 days for re-evaluation. COVID-19 has some physician scheduling four months in advance.
• For short term coverage of acute conditions, MAMES requests consideration the 36 month capped rental not include short term coverage when determining the capped period.
• For acute conditions, MAMES recommends no additional testing requirements at reevaluation, but allow the physician reevaluation or prescription/standard written order (SWO) meet the continued medical need to extend coverage beyond 90 days, when necessary.
• Support CMS proposal to remove all references and instructions regarding the clinical criterion “chronic stable state,” to enable patients with previously non-covered diseases to recover from an acute illness.
• Support CMS recognition that oxygen therapy in the home may be medically necessary to treat not just respiratory conditions, but also non-respiratory conditions for certain beneficiaries.
• Support CMS’ statement that respiratory function can be impaired from various causes, not just lung disease.
• Support the NCD should allow for maximum flexibility to clinically appropriately provide coverage of home oxygen and oxygen equipment, regardless of duration of need, and elimination of examples of medical conditions that may require the use of home oxygen.

MAMES appreciates the opportunity to provide comments.

Respectfully,

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The Jurisdiction A Council, Region B Council, Jurisdiction C Council and Region D Advisory Committee, were formed to provide state/regional associations, national associations and other members of the Councils an opportunity to liaison directly with the DME MAC staff. By representing each state and various associations, the Councils address key issues from throughout the jurisdictions and consolidate these into a format that allows for communication of and discussion of processes and systems. The Council goals are to proactively work on efforts to solve mutually identified areas of concern.

The Medicare Councils convened to review the CMS Proposed Decision memo for Home Use of Oxygen and Home Use to Treat Cluster Headaches (CAG-00296R2) Posted July 2, 2021. Below are the Councils comments on CMS Proposed Decision Memo.

CMS Proposed Decision Memo

In its proposed Decision Memo, CMS proposes to remove the current national coverage determination (NCD) at section 240.2.2 of the Medicare NCD Manual (CMS Pub. 100-03). CMS also proposes to modify its NCD for Home Use of Oxygen at section 240.2 of the Medicare NCD Manual to expand patient access to oxygen and oxygen equipment in the home, and to permit the DME MACs to cover the use of home oxygen and oxygen equipment to treat cluster headaches and to treat other acute conditions.

Comments

The Medicare Councils fully support the following:

• Support CMS proposal that would place patient over paperwork by elimination of the use of the oxygen certificate of medical necessity (CMN). We have concerns that the proposed NCD does not clearly clarify, which leaves open to the MAC interpretation, the medical necessity requirements. We recommend that the physician evaluation and prescription or standard written order (SWO), be clearly defined as meeting medical necessity requirements, similar to prescription drugs. We recommend clear language that eliminates varying interpretations of the language.
• Support CMS proposal to remove the requirement for a beneficiary to have tried and failed alternative therapies. It should be the responsibility of the treating practitioner to fully evaluate the patient and determine the needs of the patient. We agree it is clinically inappropriate to withhold oxygen for hypoxemic patients while awaiting the results of other therapeutic measures to take effect.
• Support coverage for Cluster Headaches.
• Support CMS proposal to expand coverage for oxygen and oxygen equipment in the home for short- and long-term use, for patients with acute and chronic conditions. We would like CMS to consider clear language outlining the requirements for acute and chronic conditions.
• Support expanded coverage for patients with acute conditions. We have concerns that a 60-90 re-evaluation may be difficult to meet and would recommend expanding this to 31-120 days for re-evaluation. COVID-19 has some physician scheduling four months in advance.
• For short term coverage of acute conditions, we request consideration the 36 month capped rental not include short term coverage when determining the capped period.
• For acute conditions, we recommend no additional testing requirements at reevaluation, but allow the physician reevaluation or prescription (SWO) meet the continued medical need to extend coverage beyond 90 days, when necessary.
• Support CMS proposal to remove all references and instructions regarding the clinical criterion “chronic stable state,” to enable patients with previously non-covered diseases to recover from an acute illness.
• Support CMS recognition that oxygen therapy in the home may be medically necessary to treat not just respiratory conditions, but also non-respiratory conditions for certain beneficiaries.
• Support CMS’ statement that respiratory function can be impaired from various causes, not just lung disease.
• Support the NCD should allow for maximum flexibility to clinically appropriately provide coverage of home oxygen and oxygen equipment, regardless of duration of need,” and elimination of examples of medical conditions that may require the use of home oxygen.

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I work in the cluster (and migraine) community and have witnessed way too much suffering and neglect from policy makers regarding treatment for cluster. Cluster is an underdiagnosed and misdiagnosed disease. I have witnessed people having cluster attacks and I cannot even watch this because it's so disturbing. Please cover oxygen for people with cluster!

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The pain of a cluster headache is definitively unbearable. The longer one waits to abort a cluster headache, the harder it is to stop. Not being able to abort it fast can be fatal as self-medication, blood pressure and despair rise. [PHI Redacted]

[PHI Redacted] As the pain of a cluster headache builds, it takes your breath, vision, sanity, stomach contents, orientation, even your will to live away. It’s debilitating, oppressive, sharp, jolting, pressurized, thick and more violent with each passing minute. Unchecked, it comes in increasingly intense, unpredictable and unrelenting surges up and around the twitching, tearing eye. It’s unfathomable. It can even jolt you awake from sleep.

There is no drug safe enough and reliable enough to take as often as cluster headaches come that can stop them like oxygen can. In-home oxygen is not only effective and less toxic, it’s cheaper for everyone. [PHI Redacted] For public health and safety, please finalize the Proposed Decision Memo with revisions to allow ALL Medicare patients with a diagnosis of cluster headache to access home-use oxygen. The coverage determination should be made at the CMS / National level and not moved down to the individual Medicare Administrative Contractors (MAC).

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Home Use of Oxygen and Home Oxygen Use to Treat Cluster Headaches (CAG-00296R2)

Introduction

VGM Group, Inc. ("VGM") is pleased to submit comments on the Proposed Decision Memo for Home Use of Oxygen and Home Oxygen Use to Treat Cluster Headaches (CAG-02696R2).

VGM was founded in 1986 and is now the nation's largest and most comprehensive Member Service Organization (MSO) for post-acute healthcare suppliers. VGM's array of services include DME/HME, Respiratory, Sleep, Wound Care, Complex Rehab, Women's Health, Home Modifications, and Orthotic and Prosthetics suppliers. Over 2,500 suppliers with nearly 7,000 NPI locations rely on VGM to connect them to a valuable array of resources every single day. The HME industry plays an integral role in the lives of millions of Americans. We are commenting on behalf of our thousands of home medical equipment suppliers that continue to serve the sick and injured high risk population within their homes.

In the proposed decision memo, CMS propose to remove the current national coverage determination (NCD) at section 240.2.2 of the Medicare NCD Manual (CMS Pub 100-03). CMS also proposes to modify the NCD for Home Use of Oxygen at section 240.2 of the Medicare NCD Manual to expand beneficiary access to oxygen and oxygen equipment in the home, and to permit coverage for the use of home oxygen and oxygen equipment to treat cluster headaches in addition to treat other acute and chronic illnesses. VGM agrees with many of the proposed modifications within the NCD for home oxygen and oxygen equipment with certain considerations that are listed below.

1. VGM supports expanding patient access to oxygen and oxygen equipment used in and outside of the home through the coverage of home oxygen therapy for individuals with acute conditions for short term use.
   CMS has identified that the DMEPOS suppliers have played a vital role during the COVID-19 pandemic to assist with treating beneficiaries at home. This has allowed the beneficiaries to have access to medically necessary equipment such as home oxygen that is ordered by their treating practitioner as part of the treatment plan to treat their medical condition. The access to treatment at home, provided by DMEPOS suppliers, also allowed hospitals to have space for those with more severe needs, illnesses, and traumatic conditions.
   

   The following are considerations for acute illnesses which have been identified as those beneficiaries needing home oxygen for short term use at 90 days.

   • An acute illness requiring home oxygen for short term use should be separated from the chronic conditions that require home oxygen for long term use in the sense that initial blood gas studies should not be required for the acute conditions. Short term use of home oxygen should be based on the prescription written by the treating practitioner in addition to their evaluation.
   • Blood gas studies should not be required if the treating practitioner has identified the medical need beyond 90 days of initial use for those beneficiaries that start out as an acute condition. A re-evaluation by the treating practitioner should suffice as justification for the medical need if oxygen is required beyond 90 days. However, the re-evaluation should be allowed to occur within 30-120 days from the initial date of therapy instead of 60-90 days as proposed. This wider range will allow more time for the treating practitioner to determine appropriate forms of therapy in addition to allowing appropriate time for the beneficiary to been seen and evaluated as the practitioners scheduling becomes challenging.
   • Home oxygen equipment has its own payment category titled oxygen and oxygen equipment that only allows payment on a monthly rental basis for 36 months. Then the following 24 months do not allow for monthly rental reimbursement even though the DME supplier is still responsible for the equipment. For those beneficiaries meeting the acute illness requirements for short term use, the monthly rental payment should not count against the 36 monthly cap payment. There needs to be consideration for those situations that a beneficiary may need home oxygen equipment more than one time for an acute illness for short term use and should not count against the 36-monthly rental. In the current environment of the 36-month rental cap, this could become a claims processing challenge to keep track of the rental months for both the DME MAC, the DME supplier, and the treating practitioner. In addition, this will cause access issues for home oxygen for the beneficiaries because of the financial impact to DME suppliers. Another factor to consider for those cases where a beneficiary may experience multiple acute illnesses, there could be multiple suppliers involved for each occurrence.
   • With the preliminary order or any order not considered as part of the medical record, within the acute illness category for short term use, CMS needs to provide clear direction to the DME MACs, the DME suppliers, and the treating practitioners with objective information that would be considered for coverage of an acute illness requiring short term oxygen use. Both the NCD and the LCD cannot be gray in interpretation as this will cause access issues for beneficiaries requiring home oxygen.

2. VGM supports removing "chronic stable state" language for those beneficiaries that are not inpatient at a hospital where testing is within 48 hours of discharge. VGM supports changing the language to "time of need" however, there needs to be clarification on the definition of "time of need".
   VGM agrees with CMS in that by removing the clinical criterion of "chronic stable state" will expand the availability of home use of oxygen to beneficiaries with medical conditions that warrant the need as ordered by the treating practitioner. Clarity does need to be proved by defining "time of need".
3. VGM supports removing the language for unsuccessfully tried alternative therapies prior to the use of oxygen in the home. There are medical conditions that require home oxygen to be the first line of therapy. CMS has identified there is not a substitution for the use of oxygen in the home. The conclusion for the medical need of home oxygen use is evaluated and determined by the treating practitioner.
4. VGM supports the clarification on exercise testing by broadening the language to functional performance of the patient or formal exercise testing.
5. VGM supports CMS' recognition that oxygen therapy in the home may be medical necessary to treat not just respiratory conditions, but also non-respiratory conditions for certain beneficiaries. We support CMS' statement that respiratory function can be impaired from various causes, not just lung conditions, that affect the ability to breathe.
6. VGM supports the removal of the CMS Certificate of Medical Necessity (CMN) known as the CMS-484 form.
   The CMN has caused unnecessary burden within the healthcare community. The initial purpose of the CMN, which was validating a certificate of medical need, has changed since the initial NCD was implemented in 1993. It's been proven that that the CMN has been a tool for claims processing because the medical necessity must be supported within the medical record. In addition, it's been proven during the public health emergency the CMN form is not necessary for claims processing. Removing the CMN requirement for initial claims, recertifications, and any revisions will reduce the burden within the healthcare community including the treating practitioners and DME suppliers.
7. VGM requests clarification for the subjective and objective information needed for coverage and documented within the medical record.
   The treating practitioners and DME suppliers need clarification on medical necessity requirements for any beneficiary needing to use home oxygen to treat a medical condition identified by the treating practitioner. Leaving policies open to discretion and open to interpretation will create/cause access issues for beneficiaries.
8. VGM requests clarification regarding the pulse oximetry language outlined in the proposed decision memo.
   It's understood that FDA approved pulse oximeters provide a variation among beneficiaries being tested based on certain conditions such as ethnicity or any type of factors causing inaccuracy leading to limited access to treat a medical condition benefiting from the use of home oxygen.
   The proposed language recommends leaving the discretion to the DME MACs for those individuals needing oxygen for use within the home. There needs to be clear direction as to the expectations for pulse oximetry requirements for the healthcare community. The direction cannot be vague information as this will delay access for beneficiaries, and even hinder accessing home oxygen.
9. VGM Supports the coverage for cluster headaches.

Conclusion

VGM and its membership of thousands of home medical equipment suppliers and the millions of beneficiaries they serve greatly appreciate concern and efforts being made toward improving the NCD for home use of oxygen to meet the current environment and advances in technology.

While modifications are being considered and reviewed, the key mission needs to revolve around continuing to enhance accessibility for the beneficiaries and not to create additional roadblocks. Please contact us with any questions. We welcome continued discussions.

Sincerely,

Ronda Buhrmester, CRT
Senior Director of Payer Relations & Reimbursement
VGM Group, Inc, Waterloo, Iowa
www.vgm.com
ronda.buhrmester@vgm.com
888-665-6518

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Home oxygen is the standard of care for the treatment of cluster headache. Cluster headache is one of the most painful diseases in existence, which is why it is unfortunately referred to as "suicide headache", as the pain has driven people to commit suicide. In addition to improving quality of life, coverage of oxygen can reduce health care costs as it can reduce urgent care/emergency department utilization.

Mathew PG, Garza I. Headache. Semin Neurol. 2011 Feb;31(1):5-17. doi: 10.1055/s-0031-1271313. Epub 2011 Feb 14. PMID: 21321829.

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I treat patients with cluster migraine. The fastest, most effective, and most COST effective treatment is home oxygen.

Oxygen use saves untold misery, reduces visits to ER's and reduces medication burden. It is HIGHLY effective with NO side effects.

• All Medicare patients with a cluster headache diagnosis should be eligible for insurance covered home-use oxygen, not just “select” patients.
• The coverage determination should be made at the CMS/National level and not moved down to the individual Medicare Administrative Contractors (MAC).
• For the acute treatment of cluster headache attacks with home-use oxygen, blood gas studies should not be required prior to approval for insurance coverage

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Thank you for the opportunity to provide comments on the proposed decision memo regarding Medicare coverage of home oxygen use. The American Academy of Family Physicians (AAFP), representing more than 133,500 family physicians and medical students, supports the proposal from the Centers for Medicare and Medicaid Services (CMS) to:

I am an academic headache doctor who has been treating cluster headache for the last 30 years. I must express how disturbing it has been that many of my patients have not had oxygen available to them because of CMS policy. Cluster headache attacks are the most painful attacks that exist, according to multiple surveys. Uncontrolled cluster is a soul-destroying disease.

Overall the evidence that supports oxygen for cluster is good, and at least as good as many other generic headache medications, which do not get funding for Phase 3 level research into off-label uses. The evidence is about as strong for oxygen for cluster as amitriptyline for migraine. Other off-label generics are commonly used for cluster which are much more dangerous than oxygen – for example high dose verapamil and lithium. Yet my patients have not been able to access oxygen, except those who in desperation use industrial oxygen jury-rigged for home use. Every textbook of headache medicine for the last 30 years has recommended oxygen. The alternative FDA approved cluster abortive, injectable sumatriptan, is problematic because it’s safety for use every day is uncertain, yet the incredible pain of many times per day cluster attacks makes it unethical to not try to get adequate doses to patients, which may help avoid suicide (yes, cluster headache is the suicide headache.) So I have been prescribing two injections daily which is 60 per day (migraine patients can treat 2 migraine attacks per week to avoid medication overuse which probably does not occur in cluster.) Because they did not have the oxygen option, I have had to loosen my safety restrictions in cluster patients who those who have cardiac risk factors.
Also, oxygen is the economical treatment for cluster, being many times cheaper than the alternative sumatriptan injection.
So thank you, truly, for loosening the cruel restrictions on the use of oxygen for cluster headache attacks.

My concern is that the CMS language is not blanket clearance. It fails to state that oxygen is among the most evidence-based treatments for cluster headache, and certainly safer than any pill or injectable alternative.

The proposed CMS rule pushes the decision off to other administrative authorities who will each decide for their region. Incredibly it took the advocacy community more than a decade of work to get CMS to come this far. There is, with the proposed language, an opportunity for each CMS authority to continue to harm cluster patients.
So please, simply approve high-flow oxygen for home use in the management of cluster headache attacks. This will benefit my patients enormously, prevent suicide, improve pain control without opioids, and avoid the complications of desperate analgesic use, and reduce the economic cost of treating cluster headache

Sincerely,
William B. Young, MD
Professor of Neurology, Thomas Jefferson University

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Oxygen is safe, effective, and a first line treatment for cluster headache. My colleagues and I previously wrote an editorial that oxygen is the optimal "as needed" medication for cluster headache (Burish et al. 2020, Headache 60(10):2592-2593). This editorial was based on our previous study which showed that patients over 65 found oxygen to be one of the most effective treatments for cluster headache (Pearson et al. 2019, Headache 59(2):235-249).

Going to a physician's office, urgent care, or emergency room for oxygen is not a good strategy for attacks that occur up to 8 times a day, every day, and are most common at 2 AM. Therefore home oxygen is necessary.

I think that a diagnosis of cluster headache should be all that is necessary for all CMS patients to be covered for home oxygen.

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[PHI Redacted] Home use oxygen removes the difficulty of having to go to the emergency room while suffering the headache to get oxygen treatment.

It allows immediate access to oxygen treatment for CH sufferer and sooner relief from these debilitating headaches.

While CH is chronic, CH happens sporadically and can be frequent. With removal of the CMN, the doctor only needs to access and prescribe one time instead of for each visit to the emergency room – bringing an outcome that removes the cost of emergency room and other medical attention to $00 and healthcare to immediate instead of after hours of suffering.

I applaud the opportunity to modernize CH care and the possibility of helping many sufferers access healthcare conveniently instead of after an agonizing time traveling and waiting to get care.

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CMS proposed removal of 240.2.2 will help mitigate the concerns of the 1 in 1000 suffering from Cluster Headache (CH), a severe, lifelong neurological condition aka suicide headache, insured by Medicare/Medicaid. Because home oxygen and injectable triptans are the only two Level A abortive medications for CH and because many CH patients cannot tolerate the triptans, the only remaining, FDA approved acute treatment option left is home oxygen. So thank you CMS for your considerable decision. The revisions to NCD 240.2 are also welcome; please consider how Cluster Headache (CH) are a neurological disease, not a respiratory disease. Therefore, the coverage decision needs to remain at the national level vs delegating the decisions on a case by case basis for coverage down to regional, CMS approved, Medical Administrative Contractors (MCA).

Again, CH is a neurological disease, not a respiratory disease.

“Oxygen inhibits neuronal activation in the trigeminocervical complex after stimulation of trigeminal autonomic reflex, but not during direct dural activation of trigeminal afferents” -PubMed 2009 Sep;49(8):1131-43.doi: 10.1111/j.1526-4610.2009.01501.x.
“Oxygen causes a marked decrease in cerebral blood flow that is coincident with the reduced degree of pain in cluster headache.” 2021 National Headache Foundation.
Patients endure multiple, spontaneous, debilitating painful attacks per day, for months or even years at a time. For the 1 in 1000 patients, insured by Medicare, access to medical grade oxygen mitigates some of the fears of aging with CH.

Finally, CMS published a statement in the ‘National Coverage Analysis Tracking Sheet…’ stating; “CMS received a formal request for a national coverage determination to reconsider coverage of the home use of oxygen for cluster headache. In addition to the formal request specific to the home use of oxygen for cluster headache, lessons learned from the COVID public health emergency have compelled us to review NCD 240.2 to ensure patient access to oxygen as needed both in the current environment and if necessary, in the future.”

Thank you for acknowledging how the thousands of Covid 19 patients experiencing respiratory difficulties contributed to the reconsideration process. The CMS statement acknowledges it’s insured, with many different diagnoses depend on home oxygen coverage.

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[PHI Redacted] has used oxygen therapy for the treatment of cluster headaches for over 30 years. It has been an absolute life saver. In the past we have paid out of pocket - and the amount of relief that it provides to him can't be measured in dollars. Right now he is in a cycle, and when he feels a headache come on, he will use the oxygen for about 10 minutes at high levels (12-15). The use of oxygen enables him to lead a somewhat normal life during his cluster cycle. He brings his canister to work, and I have even been able to order oxygen internationally while abroad, so he is not afraid to travel. Oxygen therapy coupled with the use of Verapamil has enabled him to live a productive life.

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[PHI Redacted]

Oxygen therapy is proven safe, low-cost, and has very few side effects or risks. Long term use of oxygen is not only optimal in relieving the agony of having a cluster-headache, but safe, and inexpensive. Many of the drugs and devices used to treat it cost $1000s of dollars each! Most of those expensive treatment options don’t work nearly so well as does oxygen.

Please extend coverage to home use oxygen therapy for cluster-headaches!

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[PHI Redacted]
Oxygen therapy is truly a Godsend in patients with CH. Not only is it fast and effective but there are no side effects. [PHI Redacted]
I firmly believe that ALL CH patients should be eligible to receive home oxygen therapy and the determination should be at the CMS/National level. There is absolutely no need to obtain arterial blood gases prior to approval unless there is a history of chronic lung disease.
The approval for home oxygen therapy for CH patients should have been made many years ago particularly considering the robust support in peer reviewed literature. Why should such patients be denied this effective therapy which is risk free. [PHI Redacted] The insurer turned down any applicant who used oxygen and there were no exceptions.
Isn’t it time to accept the well studied role of oxygen to abort CH and cover patients who will surely benefit from it.

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I'm writing to request that the Proposed Decision Memo for home use Oxygen therapy be approved with modifications. Oxygen therapy is a recognized abortive treatment for Cluster Headaches and one that has to be readily available at a moments notice when a headache attack begins. Thus the need for home use is imperative (not at a Dr's Office or ER). [PHI Redacted] Coverage should be made for all Cluster Headache sufferers without limitation. There should not be any other considerations to determine coverage, other than a prescription from a doctor that recognizes the importance and significance that Oxygen can have to a CH sufferer. Please make High Flow Home Use Oxygen treatment a covered item for all Cluster Headache patients.

Regards,
Aaron Spahn

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[PHI Redacted]
In fact, all Medicare patients with a CH diagnosis should be eligible for insurance covered home-use oxygen, not just "select" patients.
The coverage determination should be made at the CMS/National level and not moved down to the 4 individual DME Medicare Administrative Contractors (MAC) who would establish their own Local Coverage Determination (LCD) policies.
Clarification is needed as to whether blood gas studies would be required prior to approval of home use oxygen for CH. I do not think this should be necessary. Thanks, again.

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[PHI Redacted] I fully support the inclusion of home oxygen care by CMS as a treatment for cluster headache. Home oxygen is without question the most effective abortive treatment for a CH attack. CH attacks are brutal and come on quickly. Going to a hospital during an attack is not an option for the vast majority of sufferers. Going ANYWHERE while suffering an attack is difficult. Home oxygen, I should note, is also comparatively cheap when compared to pharmaceutical-based abortive treatments.

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My name is Dr. Olivia Begasse de Dhaem. I am a board-certified neurologist and headache specialist. I treat patients with cluster headache.

As a headache doctor, I received a call on a Saturday night from a patient's wife because her husband wanted to die of suicide to stop his active cluster attack. He had lost access to home oxygen. He ran out of triptans. He did not want to take the opioids prescribed by his Primary Care Provider because he knew they would not help for cluster attacks. He learned that from other patients with cluster attacks via the clusterbusters group. He felt out of options. Cluster attacks are the worst pain attacks of humankind. People with cluster attacks are among the most resilient and strongest people I ever met. And yet, suicide sometimes feel like an option because the pain is excruciating. The wife was asking if there would be anyway home oxygen could get covered as soon as possible. Oxygen does work and can work within minutes. It is safe. It is recommended as the standard of care first-line therapy for cluster attacks based on guidelines from the American Headache Society (Robbins, M.S., et al., Headache 2016;56:1093-106). Oxygen works better than opioids for cluster attacks. If CMS covers home-use oxygen, less people will be subjected to opioids which have many devastating side effects. Cluster attacks are the worst pain known to humans and are accompanied by symptoms such as tearing and change in the side of the pupils, droopy eyelids. It is unsafe to ask patients to drive by themselves to the emergency room to get high flow oxygen. The periods of attacks are also way too long for a visit to the emergency department and also for an hospital admission.

I am relieved that CMS is considering coverage of home-use oxygen for patients with cluster attacks.

Home oxygen is the evidence-based standard of care, first line treatment, and the safest option for cluster attacks. There is absolutely no medical reasons to exclude any patients from home oxygen coverage for cluster attacks. It should be covered and available for everyone with cluster attacks.

I have to write it twice for emphasis because I cannot highlight this enough: Home oxygen is the evidence-based standard of care, first line treatment, and the safest option for cluster attacks. Hence, the fail first requirement has to be removed.

Please contact me directly with any questions. I am happy to serve as a resource. I thank you in advance for making the necessary changes of access to everyone and prior requirements before approving this very important bill that will help save lives.

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Home use of oxygen therapy should be a covered treatment for all patients with a diagnosis of Cluster Headache. Over the last 14 years I have observed the beneficial and side effects of more than 15 different pharmaceuticals for [PHI Redacted] Cluster Headache. None have been tolerable either because they were not sufficiently effective in reducing the pain or they cause unacceptable side effects or drug interactions. Home oxygen therapy has been the only successful therapy that reduces the severity and duration of pain and allows him to participate in his work and family life as much as possible around the Cluster Headache. This condition is so life-impacting that having access to such a straightforward treatment that can help is almost miraculous. Please make that miracle available for everyone who needs it.

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[PHI Redacted]

In the late 90's, I found out about the use of high-flow Oxygen (15-25 lpm) to abort attacks through the budding internet [PHI Redacted] It brings tears to my eyes to think of anyone needlessly suffering while this proven oxygen treatment is available to them.

Please help in making it as easy as possible for cluster patients to have access to as much oxygen as they need. [PHI Redacted] And anything short of 15 lpm is simplly not going to work, so a proper regulator would be another necessity.

Please, I'm begging you. The pain is out of this world and oxygen is safe, available and very effective.
Thank you for hearing me out.
Ofer

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[PHI Redacted] I like your proposed changes, but I do have some concerns.

This phrase in your memo “we believe that carefully chosen Medicare beneficiaries who suffer CH, will receive meaningful pain relief from oxygen therapy“ alarms me. Carefully chosen how? Knowing what we know about medical bias, especially as it relates to women and people of color being under or misdiagnosed, in what way can you defend “carefully choosing” Medicare beneficiaries? Why not open the therapy up to all cluster headache patents? Oxygen is not habit forming, and is not nearly as expensive as the triptan based medications: why throttle this access even further? If, as further down in your memo, you say that Oxygen can be used as a first line therapy for the treatment of CHs. Why not first line treatment for all diagnosed patients?

Additionally, pushing the coverage determination down to the 4 regional MACs introduces regional variations on coverage decisions that can introduce additional bias against people of color. The determination for coverage should be made at the national level, so that people moving regions can get the same coverage wherever they are in the country.

I welcome coverage of Home Oxygen for Medicare CH patients. [PHI Redacted]

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I just heard about the oxygen policy update for cluster headache (CH) suffers. Thank you for your decision that home-use oxygen for (CH) is finally a “Coverable treatment”. While this is great news, a few areas of concern many (CH) suffers have are:

All Medicare patients with a (CH) diagnosis should be eligible for insurance covered home-use oxygen, not just “select” patients. The coverage determination should be made at the CMS/National level and not moved down to the 4 individual DME Medicare Administrative Contractors who would establish their own Local Coverage Determination policies. Also, please clarify whether blood gas studies would be required prior to approval of home use oxygen for CH.

I’m thrilled that home-use oxygen for (CH) is finally a “Coverable treatment”.

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Thank you for making Oxygen, this very necessary treatment available to more of those who need it. Although I believe it should be available to all those with Cluster Headache not just a "select few". [PHI Redacted] This precious pain free time for people who are suffering is from a treatment which is simple and inexpensive as compared to expensive pharmaceuticals. Please make this life altering and sometimes life saving treatment available to all people suffering from this horrible condition.

Thank you

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Thank you for the direction of Home-use oxygen for cluster headache. I would like to go over what I am happy and excited for as well as what I hope you will consider.

1. Home-use oxygen for CH now being listed a "coverable treatment". - This is necessary so that a person who experiences cluster attacks can treat immediately and end an attack in 5-10 minutes instead of 2-3 hours. This is the safest, and least amount of side effects for the patient.
2. Removal of the Certificate of Medical Necessity (CMN) requirement
3. Removal of a fail first requirement (e.g. recognition that oxygen itself may be “optimum therapy”) A person who experiences cluster headache attacks should not have to try and fail other medications in order to access oxygen. Triptans can be contraindcated for some but can create more attacks since a person experiencing cluster attacks often gets 1-8+ attacks per day. Triptans have limits per day, oxygen does not. Things I would like you to consider in your final language:
1..Removal of “chronic stable state” language as this does not apply to CH which occurs in bouts of relatively short duration. Identified key areas of concern that we want to address, in order of importance:
2. ALL Medicare patients with a CH diagnosis should be eligible for insurance covered home-use oxygen, not just "select" patients. I would be concerned that only select patients can get to oxygen. This needs to be as easy as possible for doctors and patients. In the best interest of patients, this language needs to be clear that patients having the diagnosis of cluster headache entails they should have access to oxygen when a doctor prescribes.
3. The coverage determination should be made at the CMS / National level and not moved down to the 4 individual DME Medicare Administrative Contractors (MAC) who would establish their own Local Coverage Determination (LCD) policies. [PHI Redacted]. Patients need access and the companies need to fill the prescription as prescribed by a doctor. Patients need protection from a DME company trying to force the patient into services they do not need (for instance trying to force them to rent a concentrator in order to get service).
4. Clarification is needed as to whether blood gas studies would be required prior to approval of home use oxygen for CH. [PHI Redacted], oxygen is vital. Triptans have caused adverse side effects and it cannot be utilized any further. [PHI Redacted]. I hope you will do what is best for cluster headache disease patients and allow them access to oxygen high flow protocol so they can get back to living more quickly. [PHI Redacted]. This is a huge difference when dealing with the most painful condition known to man. [PHI Redacted].

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As a rural Home Oxygen provider, I am in agreement with the proposed changes to Oxygen.
We have struggled on several occasions to get the documentation just right to be able to bill insurance. All while a patient is struggling to breath and needs oxygen necessary for continued survival. Within 5 minutes of oxygen deprivation, the brain can become permanently damaged and possibly lead to death. Although, this would be in an extreme case, continued lowering of SATS can effect other organs of the body leading to long term complications. Some patients need oxygen therapy for only acute symptoms until the underlying issue is resolved. With COVID-19, more issues related to hypoxia are continuing to arise. Some are acute and some are chronic.

We have only provided oxygen for cluster headaches to a few patients with commercial insurance in the past. In those incidences, the oxygen therapy helped relieve the extreme pain from migraines.
Thank you for allowing providers time to comment on the proposed rule.

I am hopeful that some, if not all the proposed changes will be approved.

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This is good policy to see from CMS as a respiratory therapist and business owner. The oxygen policy and use of oxygen has been restrictive for decades.

OSA needs to be addressed here as well as the concurrent use policy. Oxygen should also be an option for non compliant OSA treatment. Increasing oxygen levels is the next best solution for OSA after PAP therapy and surgery is ruled out.

We experience the frustration from physicians when LCD coverage isn't met but clinically and objectively the treatment would be O2 without severe lung disease.

Hope this a sign of things to come.

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I am very confused about your requirements for arterial blood gases. "we also propose that required qualifying blood gas studies be performed at the time of need."

The use of "required" suggests that pulse oximetry cannot be substituted for an arterial blood gas. A blood gas is a very painful procedure with significant risks.This decision memo would be greatly enhanced by specifying that "blood gas should be performed only if medically indicated or if pulse oximetry is inadequate to measure degree of hypoxemia and need for oxygen therapy."

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As a home oxygen equipment provider, it is my responsibility to apply the NCD, LCD, and Policy Article coverage criteria to medical records provided by physicians and other prescribers when they order home oxygen equipment for patients with hypoxemia to determine if Medicare will cover the charges. It has also been my responsibility to educate local prescribers on Medicare requirements, because no mechanism appears to exist whereby Medicare educates them on these requirements. Educating prescribers on the chronic condition requirement, the chronic stable state testing requirement, and the proper completion of the CMN have consistently been among my more difficult responsibilities because prescribers understand oxygen to be a first-line treatment for hypoxemia and can't understand why Medicare would not cover it when they prescribe it.

Over the last 7 years in this position, I have seen countless patients who were prescribed home oxygen, but Medicare would not cover it because their condition was acute instead of chronic, or they were treated/evaluated in the Emergency Room instead of being admitted to the Hospital, or they were tested for hypoxemia without documentation that they were in a "chronic stable state" (whatever that means, as different auditors interpret it differently). Each of these patients were prescribed home oxygen so that they could treat their symptoms appropriately at home (at the cost of ~$120 per month to the Medicare program), without being admitted to a hospital at the cost of hundreds of dollars per day to the Medicare program. In nearly every situation, upon learning that Medicare would not cover their home oxygen equipment, these patients would choose to forgo this treatment that their doctor had prescribed and instead simply hope that they did not suffer undue complications or side effects resulting from their untreated hypoxemia.

This wasn't always the case. Before the expansion of Competitive Bidding pricing into rural areas, our policy was to deliver the oxygen first, based solely on the doctor's order, then chase the medical records to determine if we would either bill Medicare for the service or simply write it off. In those days, home oxygen equipment was reimbursed at nearly $200 per month, meaning we could afford to have a few write off patients on the books. Now, with oxygen reimbursement approaching half that level and 40% of suppliers gone from the marketplace, we simply can't afford to provide services unless someone is paying for them. I am encouraged that Medicare plans to begin supporting these needy patients who have been left without treatment against medical advice.

The elimination of the CMN requirement is also welcome. Since I entered the industry, the CMN has been used by Medicare auditors solely as an excuse to deny coverage based on clerical errors. Its original purpose was for the prescriber to certify the medical need, but now only the medical record itself is proof of coverage criteria—leaving the CMN without purpose or function. Its elimination is long overdue.

In short, I welcome the changes CMS proposes to the NCD and look forward to swift implementation.

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