Benzinga | Jan 31, 2022 07:35AM EST

BrainsWay Announces Final Local Coverage Determination Issued By Regional Medicare Administrative Contractor Palmetto GBA Providing Coverage Of Deep TMS For The Treatment Of OCD

BrainsWay Ltd. (NASDAQ & TASE: BWAY) ("BrainsWay" or the "Company"), a global leader in advanced noninvasive neurostimulation treatments for mental health disorders, today announced that a final Local Coverage Determination (LCD) has been published providing coverage applicable to the BrainsWay Deep TMS(tm) system for the treatment of obsessive-compulsive disorder (OCD).

The final LCD was issued by the Medicare Administrative Contractor (MAC) Palmetto GBA, which covers Medicare patients in Alabama, Georgia, North Carolina, South Carolina, Tennessee, Virginia, and West Virginia, representing over 9 million covered lives. The final LCD was published following a formal meeting hosted by Palmetto last year and a subsequent review period. The formal LCD will be effective on March 13, 2022.

"This formal policy issued by Palmetto, one of seven MACs in the U.S., brings the total number of covered lives eligible for Deep TMS OCD coverage to approximately 60 million, an important reimbursement achievement for our company," said Christopher von Jako, Ph.D., President and Chief Executive Officer of BrainsWay. "This final LCD is supported by the large body of compelling clinical evidence demonstrating the meaningful benefits derived by OCD patients from treatment with our innovative Deep TMS technology. We continue to work diligently to secure further coverage policy decisions from additional payors, and believe that, over time, other MACs will issue draft policies for Deep TMS coverage of OCD."

The patient selection criteria included in Palmetto's final LCD is closely aligned with the Clinical TMS Society's recommended OCD coverage policy. The U.S. Food and Drug Administration (FDA) granted BrainsWay De Novo clearance in August 2018 for Deep TMS as an adjunct form of therapy for patients suffering from OCD.

About Obsessive-Compulsive Disorder

Obsessive-compulsive disorder (OCD) is a chronic and debilitating condition with a lifetime prevalence in the United States of 2.3%. Characterized by uncontrollable, reoccurring thoughts (obsessions) and behaviors (compulsions) that the sufferer feels compelled to repeat over and over, OCD is considered by the World Health Organization (WHO) to be one of the top 10 debilitating medical conditions associated with a decreased quality of life and loss of income. Due to the complexity and heterogeneity of the condition, coupled with the high percentage of patients that are drug-resistant, many patients suffering from OCD do not respond well to first line treatment options. The economic burden on the U.S. healthcare system for OCD treatments is estimated to be over $7 billion per year.