Note: The following was submitted to the CMS on July 30, 2021.

The U.S. Pain Foundation is pleased to provide comments on the Centers for Medicare & Medicaid Services’ (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 using the information listed below.

Sincerely,

Cindy Steinberg
Director of Policy & Advocacy
U.S. Pain Foundation
781-652-0146
cindy@uspainfoundation.org