Company: BWAY
Filing Date: 2025-04-22
Form Type: 20-F
Source: 0001171843-25-002347
Chunk: 18

Company: Brainsway Ltd.
Filing Date: 2025-04-22
Form: 20-F
Item: Item 5
Chunk 18
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 is profitable for the provider. Reimbursement by a third-party payor may depend upon a number of
factors, including the third-party payor’s determination that a treatment is neither experimental nor investigational, and is safe,
effective, and medically necessary, appropriate for the specific patient, cost-effective, supported by peer-reviewed medical journals
and included in clinical practice guidelines.

In the United States, there is no uniform policy
of coverage and reimbursement among third-party payors, including private insurers. Therefore, coverage and reimbursement for treatments
can differ significantly from payor to payor. However, many third-party payors often rely upon Medicare coverage policies and payment
limitations in setting their own coverage and reimbursement policies and methodologies. Private insurance coverage for Deep TMS as a treatment
for MDD generally requires 1 to 4 prior failures of anti-depressant medications.

Medicare coverage for Deep TMS as a treatment for MDD generally requires that certain specified clinical
criteria relating to medical necessity are met and documented. In particular, subject to variations by payor and locale, under applicable
payor policies, Deep TMS may be covered for MDD if: (i) prescribed by a licensed physician, knowledgeable in the use of TMS (ii) as a
treatment for an adult with a confirmed diagnosis of MDD and no contraindications, (iii) where there is sufficient documentation of failure
of between 1 and 2 previous medication trials (depending on the relevant Medicare Administrative Contractor policy). Other relevant coverage
factors considered under these policies include resistance to treatment with psychopharmacologic agents for depression, history of response
to repetitive TMS, and whether the individual is a candidate for electroconvulsive therapy (ECT) and TMS is less burdensome to the patient.
Reimbursement for Deep TMS as an MDD treatment is also generally limited to 36 treatment sessions.

Since 2021, there has been emerging reimbursement
coverage for Deep TMS for the treatment of OCD. While the criteria for this emerging Deep TMS for OCD coverage varies with each payor,
generally coverage requires the failure of a combination of between two and four medication trials of two different classes (with most
requiring two failed trials), for specified periods, and may also require a trial of psychotherapy, before qualifying for reimbursement.
Maintaining the reimbursement coverage obtained since 2021 and obtaining coverage from additional payors may be difficult, and payors
may condition coverage on the satisfaction of varied criteria