Company: BWAY
Filing Date: 2025-04-22
Form Type: 20-F
Source: 0001171843-25-002347
Chunk: 140

Company: Brainsway Ltd.
Filing Date: 2025-04-22
Form: 20-F
Item: Item 5
Chunk 140
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 governmental.
In addition, there is currently an out-of-pocket market for our Deep TMS systems for OCD. Deep TMS for smoking addiction is not currently
eligible for reimbursement. We plan to seek to obtain coverage as we progress in our commercialization for this indication. In October
2023 the Clinical TMS Society, an influential peer group, published the first coverage recommendations for smoking addiction, which we
have highlighted as part of our efforts to educate payors.

The sale or lease of a medical device utilized for
in-office medical treatments depend, in part, on the extent to which such treatments using that device will be covered by third-party
payors, such as government healthcare programs (e. g., Medicare), private insurance, and managed healthcare organizations. Even if a third-party
payor covers a particular treatment, the resulting reimbursement payment rates may not be adequate to cover a provider’s cost to
purchase such medical device or ensure that purchase or lease will be profitable for the provider. Additionally, patients who are treated
in-office for a medical condition generally rely on third-party payors to reimburse all or part of the costs associated with the treatment
and may be unwilling to undergo such treatment in the absence of coverage and adequate reimbursement.

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;
safe, effective, and medically necessary; appropriate for the specific patient; cost-effective; supported by high quality evidence published
in peer reviewed medical journals; included in clinical practice guidelines; and supported by medical community acceptance and demand.

Physician reimbursement under Medicare generally
is based on a defined fee schedule, or the Physician Fee Schedule, through which payment amounts are determined by the relative values
of the service rendered in a physician office setting or by a physician in a facility setting. Medicare coverage for TMS also has specific
patient history requirements. Medicare coverage for Deep TMS generally requires one to four failed (inadequate response or intolerable)
trials of psychopharmacologic agents (such as antidepressant medications).

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In the United States, there is no uniform policy
of coverage and reimbursement among private third-party payors. Reimbursement rates from private payors vary depending on the procedure
performed, the commercial payor, contract terms, and other factors. Private third-party payors often rely upon Medicare coverage policy
and payment limitations in setting their own reimbursement policies, but also have