Company: CERO
Filing Date: 2025-02-07
Form Type: 424B3
Source: 0001213900-25-011071
Chunk: 206

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-02-07
Form: 424B3
Chunk 206
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 The legislation also extended Medicaid drug rebates, previously due only on fee-for-service Medicaid utilization, to include
the utilization of Medicaid managed care organizations as well and created an alternative rebate formula for certain new formulations
of certain existing products that is intended to increase the amount of rebates due on those drugs.

Other legislative changes
have been proposed and adopted since passage of the Affordable Care Act. The Budget Control Act of 2011, among other things,
included automatic reductions to several government programs, including aggregate reductions to Medicare payments to healthcare providers
of up to 2.0% per fiscal year, which went into effect in April 2013 and will remain in effect through 2031. The American Taxpayer
Relief Act was signed into law, which, among other things, reduced Medicare payments to several types of providers, including hospitals,
imaging centers and cancer treatment centers, and increased the statute of limitations period for the government to recover overpayments
to providers from three to five years.

There have been executive,
judicial and congressional challenges to the Affordable Care Act. We cannot predict what additional challenges to the Affordable Care
Act may arise in the future, the outcome thereof, or the impact any such actions may have on our business. Additionally, the Biden administration
has introduced various measures in recent years, focusing on healthcare and medical-product pricing, in particular. It remains to
be seen how these measures will affect our business and there is uncertainty as to what other healthcare programs and regulations may
be implemented or changed at the federal and/or state level in the U.S., but it is possible that such initiatives could have an adverse
effect on our ability to obtain FDA approval or clearance and/or successfully commercialize products in the U.S. in the future.
For example, any changes that reduce, or impede the ability of healthcare providers to obtain reimbursement for medical procedures in
which the products we currently, or intend to, commercialize are used, or that reduce medical procedure volumes, could adversely affect
our operations and/or future business plans. The financial impact of U.S. healthcare reform legislation over the next few years
will depend on a number of factors, including the policies reflected in implementing regulations and guidance and changes in sales volumes
for medical devices affected by the legislation. From time to time, legislation is drafted, introduced, and passed that could significantly
change the statutory provisions governing coverage, reimbursement, pricing, and marketing of medical device products. In addition, third-party
payor coverage and reimbursement policies are often revised