Company: DRTSW
Filing Date: 2025-03-12
Form Type: 20-F
Source: 0001213900-25-023187
Chunk: 40

Company: Alpha Tau Medical Ltd.
Filing Date: 2025-03-12
Form: 20-F
Item: Item 3
Chunk 40
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 sale of our product candidates, if approved or cleared.

By way of example, in the
United States, the Affordable Care Act, or ACA, made a number of substantial changes in the way healthcare is financed by both governmental
and private insurers. Among other ways in which it may affect our business, the ACA

  Established a new Patient-Centered Outcomes Research Institute to oversee and identify priorities in comparative clinical effectiveness research in an effort to coordinate and develop such rese...  

  Implemented payment system reforms including a national pilot program on payment bundling to encourage hospitals, physicians and other providers to improve the coordination, quality and efficie...  

  Expanded the eligibility criteria for Medicaid programs.  

Since its enactment, there
have been judicial, executive and Congressional 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. It is unclear how other
healthcare reform measures will impact our business. Any expansion in the government’s role in the U. S. healthcare industry may
result in decreased profits to us and/or lower reimbursement by payors for our product candidates, any of which may have a material adverse
effect on our business, financial condition or results of operations.

In addition, other legislative
changes have been proposed and adopted since the ACA was enacted. 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. The Medicare Access and CHIP Reauthorization Act of 2015, or MACRA, enacted on April 16, 2015, repealed the formula by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 are based on various performance measures and physicians’ participation in alternative payment models
such as accountable care organizations. It is unclear what effect new quality and payment programs, such