Company: DRTSW
Filing Date: 2025-03-12
Form Type: 20-F
Source: 0001213900-25-023187
Chunk: 38

Company: Alpha Tau Medical Ltd.
Filing Date: 2025-03-12
Form: 20-F
Item: Item 3
Chunk 38
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 in obtaining coverage from Medicare or any other governmental or commercial
third-party payor. In addition, while we believe that we may be able to rely on certain existing procedure codes for certain elements
of the physician’s treatment efforts, we are not certain of this and as such may be required to seek new billing codes for our products,
and regulatory authorities may not approve the creation of separate codes. Additionally, even if we are successful, these billing codes
or the payment amounts associated with such codes may change in the future.

In addition to uncertainties
surrounding coverage policies, there are periodic changes to reimbursement levels. Third-party payors regularly update reimbursement amounts
and also from time to time revise the methodologies used to determine reimbursement amounts. This includes routine updates to payments
to physicians, hospitals and ambulatory surgery centers for procedures during which our products are used. These updates could directly
impact the demand for our products. By way of example, in the United States, payment rates under the Medicare Physician Fee Schedule are
regularly subject to updates to effectuate various policy goals. The Medicare Access and CHIP Reauthorization Act of 2015 repealed the
formula by which Medicare made annual payment adjustments to physicians and replaced the former formula with fixed annual updates and
a new system of incentive payments that began in 2019 that are based on various performance measures and physicians’ participation
in alternative payment models, such as accountable care organizations. The ongoing and future impact of these changes cannot be determined
at this time.

A primary trend in the United
States healthcare industry and elsewhere is cost containment. Government authorities and other third-party payors have attempted to control
costs by limiting coverage and the amount of reimbursement for particular products and services. Reimbursement may not be available, or
continue to be available, for the Alpha DaRT or the treatment services using the Alpha DaRT or any other products we may develop in the
future, or even if reimbursement is available, such reimbursement may not be adequate. We also will be subject to foreign reimbursement
policies in the international markets we expect to enter. Decisions by health insurers or other third-party payors in these markets not
to cover, or to discontinue reimbursing, our products could materially and adversely affect our business. If such decisions are made,
they could also have a negative impact on our ability to generate revenues.

On September 18, 2020, the
Centers for Medicare and Medicaid Services, or CMS, the federal agency responsible for administering the Medicare program