Company: CERO
Filing Date: 2025-04-15
Form Type: 10-K
Source: 0001213900-25-032134
Chunk: 151

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-04-15
Form: 10-K
Item: Item 1
Chunk 151
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 rebate liability under the Medicaid Drug Rebate Program by increasing the minimum
Medicaid rebate for both branded and generic drugs and biologics, expanded the 340B program, and revised the definition of average manufacturer
price (“AMP”), which could increase the amount of Medicaid drug rebates manufacturers are required to pay to states. 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.

34

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 remain in effect through 2031. The American Taxpayer Relief Act of 2012, 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