Company: RGNT
Filing Date: 2025-02-12
Form Type: DRS/A
Source: 0001213900-25-012299
Chunk: 141

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-02-12
Form: DRS/A
Chunk 141
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 and conduct comparative clinical effectiveness
research, along with funding for such research.

Since its enactment, there
have been judicial and Congressional challenges to certain aspects of the ACA. By way of example, in 2017, the Tax Cuts and Jobs Act was
signed into law, which eliminated the tax-based shared responsibility payment imposed by the ACA on certain individuals who fail to maintain
qualifying health coverage for all or part of a year that is commonly referred to as the “individual mandate.” On December 14,
2018, a U.S. District Court Judge in the Northern District of Texas ruled that the individual mandate is a critical and inseverable feature
of the ACA, and therefore, because it was repealed as part of the Tax Cuts and Jobs Act, the remaining provisions of the ACA are invalid
as well. On December 18, 2019, the U.S. Court of Appeals for the Fifth Circuit ruled that the individual mandate was unconstitutional
and remanded the case back to the District Court to determine whether the remaining provisions of the ACA are invalid as well. The U.S.
Supreme Court is currently reviewing the case, although it is unclear how the Supreme Court will rule. Although the U.S. Supreme Court
has not yet ruled on the constitutionality of the ACA, on January 28, 2021, President Biden issued an executive order to initiate
a special enrollment period from February 15, 2021 through May 15, 2021 for purposes of obtaining health insurance coverage
through the ACA marketplace. The executive order also instructs certain governmental agencies to review and reconsider their existing
policies and rules that limit access to health care, including among others, reexamining Medicaid demonstration projects and waiver programs
that include work requirements, and policies that create unnecessary barriers to obtaining access to health insurance coverage through
Medicaid or the ACA. It is unclear how the U.S. Supreme Court ruling, other such litigation, and the health care reform measures of the
Biden administration will impact 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 by 2% per fiscal year, effective on April 1, 2013 and, due to subsequent legislative amendments to
the statute, will remain in effect through 2030, with the exception of a temporary suspension from May 1, 2020 through March