Company: DRTSW
Filing Date: 2025-03-12
Form Type: 20-F
Source: 0001213900-25-023187
Chunk: 39

Company: Alpha Tau Medical Ltd.
Filing Date: 2025-03-12
Form: 20-F
Item: Item 3
Chunk 39
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, issued a final
rule implementing a new mandatory payment model for radiation oncology services: the Radiation Oncology Alternative Payment Model, or
the RO Model. Although the RO Model was originally intended to begin on January 1, 2022, subsequent legislation delayed its implementation
until a date to be determined through future rulemaking. The RO Model, as currently structured, would significantly alter CMS’ payment
methodology from a fee for service, or FFS, paradigm to a prospective payment for all radiotherapy services furnished during a 90-day
episode of care for fifteen (15) different cancer types, regardless of the modality used or site of service. Under the RO Model, all providers
of radiotherapy services, including physician group practices, hospital outpatient departments and free-standing radiation therapy centers
located within a randomly selected Core Based Statistical Area, or CBSA, would be required to participate. The CBSAs selected for the
RO Model would contain approximately 30% of all eligible Medicare FFS radiotherapy episodes in the U. S. Any provider outside of the CBSAs
would continue to receive Medicare reimbursement based on an FFS methodology. It is uncertain the impact, if any, of the RO Model, if
implemented, on the Medicare reimbursement to our customers when using our Alpha DaRT technology, if authorized for marketing, or our
business, financial condition, or results of operations.

Outside of the United States,
reimbursement levels vary significantly by country. For example, in the EU, member states impose controls on whether products are reimbursable
by national or regional health service providers and on the prices at which medical devices are reimbursed under state-run healthcare
schemes.

Healthcare policy changes, including recently
enacted legislation reforming the U. S. healthcare system, could harm our business, financial condition and results of operations.

In the United States, there
have been and continue to be a number of legislative initiatives to contain healthcare costs. Federal and state lawmakers regularly propose
and, at times, enact legislation that would result in significant changes to the healthcare system, some of which are intended to contain
or reduce the costs of medical products and services. Current and future legislative proposals to further reform healthcare or reduce
healthcare costs may limit coverage of or lower reimbursement for our product candidates and the treatment associated with the use of
our 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