The US Centers for Medicare & Medicaid Services

Belluscura PLC

("Belluscura" or the "Company" or "Group")

The US Centers for Medicare & Medicaid Services

Proposed Broadening of Home Use of Oxygen to Treat Cluster Headaches

The US Centers for Medicare & Medicaid Services (CMS) is proposing changes to two separate, but medically related, National Coverage Determinations (NCDs) relating to home oxygen therapy.

First, CMS proposes to remove its NCD at section 240.2.2 of the Medicare NCD Manual, ending coverage with evidence development, and allow the Medicare Administrative Contractors (MACs) to make coverage determinations regarding the use of home oxygen and oxygen equipment for Cluster Headaches (CH).

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 contractors to cover the use of home oxygen and oxygen equipment in order to treat CH and other acute conditions.

Currently Section 240.2, effective since October 27, 1993 provides for home oxygen therapy only if the patient is in the chronic stable state.  CMS has noted, "We note that since the inception of the Public Health Emergency (PHE) due to the COVID 19 pandemic, CMS has begun to permit health care services to increase the capacity of the American health care system outside the setting of the traditional inpatient hospital, including the treatment of acute illnesses."

CMS is seeking comments on its proposed decisions consistent with the public process established by §1862(l) of the Social Security Act. 

Robert Rauker, Belluscura CEO commented: "If approved, this gives another substantial opportunity for Belluscura, in particular with the launch of its X-PLO₂R DX Model in the first half of 2022. Shareholders will be kept fully updated on developments from the CMS."

For further information please contact:

About Belluscura plc (www.belluscura.com)

Belluscura is a UK medical device company focused on developing oxygen enrichment technology spanning broad industries and therapies. Our innovative oxygen technologies are designed with a global purpose: to create improved health and economic outcomes for the patients, healthcare providers and insurance organisations.

About RNS Reach announcements

RNS Reach is an investor communication service aimed at assisting listed and unlisted (including AIM quoted) companies to distribute media only / non-regulatory news releases such as marketing messages, corporate and product information into the public domain. An RNS Regulatory announcement is required to be notified under the AIM Rules for Companies.