Company: DRTSW
Filing Date: 2025-03-12
Form Type: 20-F
Source: 0001213900-25-023187
Chunk: 180

Company: Alpha Tau Medical Ltd.
Filing Date: 2025-03-12
Form: 20-F
Item: Item 4
Chunk 180
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 and elsewhere, there is significant interest in promoting
changes in healthcare systems with the stated goals of containing healthcare costs, improving quality or expanding access. Current and
future legislative proposals to further reform healthcare or reduce healthcare costs may limit coverage of or lower reimbursement for
our product candidates, if cleared or approved, and the procedures associated with the use of such products. The cost containment measures
that payors and providers are instituting and the effect of any healthcare reform initiative implemented in the future could impact our
revenue from the sale of our products.

The implementation of the
Affordable Care Act, or ACA, in the United States, for example, has changed healthcare financing and delivery by both governmental and
private insurers substantially, and affected medical device manufacturers significantly. The ACA, among other things, provided incentives
to programs that increase the federal government’s comparative effectiveness research and implemented payment system reforms including
national pilot program on payment bundling to encourage hospitals, physicians and other providers to improve the coordination, quality
and efficiency of certain healthcare services through bundled payment models. Additionally, the ACA expanded eligibility criteria for
Medicaid programs and created a new Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative
clinical effectiveness research, along with funding for such research.

Since its enactment, there
have been judicial, executive and political challenges to certain aspects of the ACA. On June 17, 2021, the U. S. Supreme Court dismissed
the most recent judicial challenge to the ACA without specifically ruling on the constitutionality of the ACA.

In addition, other legislative
changes have been proposed and adopted since the ACA was enacted. For example, the Budget Control Act of 2011, among other things, reduced
Medicare payments to providers, effective on April 1, 2013 and, due to subsequent legislative amendments to the statute, will remain in
effect through 2032, with the exception of a temporary suspension from May 1, 2020 through March 31, 2022, unless additional Congressional
action is taken. Additionally, the American Taxpayer Relief Act of 2012, among other things, further reduced Medicare payments to several
providers, including hospitals, and increased the statute of limitations period for the government to recover overpayments to providers
from three to five years.

We expect additional state,
federal and foreign healthcare reform measures to be adopted in the future, any of which could limit the amounts that federal and state
governments will pay for healthcare products