Company: RGNT
Filing Date: 2025-01-27
Form Type: DRS/A
Source: 0001213900-25-006676
Chunk: 141

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-01-27
Form: DRS/A
Chunk 141
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 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 31,
2021, unless additional Congressional action is taken. Additionally, the American Taxpayer Relief Act of 2012, among other things, 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 The Medicare Access and CHIP Reauthorization Act of 2015, or CHIP, repealed the formula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.

We expect additional state
and federal health care reform measures to be adopted in the future, particularly in light of the new presidential administration, some
of which could limit the amounts that federal