Company: CERO
Filing Date: 2025-02-07
Form Type: 424B3
Source: 0001213900-25-011071
Chunk: 205

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-02-07
Form: 424B3
Chunk 205
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 marketability of any
product candidates for which we receive regulatory approval for commercial sale may suffer if the government and third-party payors fail
to provide adequate coverage and reimbursement. In addition, emphasis on managed care in the United States has increased and could
increase the pressure on pharmaceutical pricing. Coverage policies and third-party reimbursement rates may change at any time. Even if
favorable coverage and reimbursement status is attained for one or more products for which we receive regulatory approval, less favorable
coverage policies and reimbursement rates may be implemented in the future.

Healthcare Reform

The United States and
many foreign jurisdictions have enacted or proposed legislative and regulatory changes affecting the healthcare system. The United States
government, state legislatures and foreign governments also have shown significant interest in implementing cost-containment programs
to limit the growth of government-paid healthcare costs, including price controls, restrictions on reimbursement, and requirements for
substitution of generic products for branded prescription drugs and biologics. In recent years, Congress has considered reductions
in Medicare reimbursement levels for drugs and biologics administered by physicians. CMS, the agency that administers the Medicare and
Medicaid programs, also has authority to revise reimbursement rates and to implement coverage restrictions for some drugs and biologics.
Cost reduction initiatives and changes in coverage implemented through legislation or regulation could decrease utilization of and reimbursement
for any approved products. While Medicare regulations apply only to drug benefits for Medicare beneficiaries, private payors often follow
Medicare coverage policy and payment limitations in setting their own reimbursement rates. Therefore, any reduction in reimbursement
that results from federal legislation or regulation may result in a similar reduction in payments from private payors.

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The Affordable Care Act
substantially changed the way healthcare is financed by both governmental and private insurers, and significantly impacts the pharmaceutical
industry. The Affordable Care Act is intended to broaden access to health insurance, reduce or constrain the growth of healthcare spending,
enhance remedies against healthcare fraud and abuse, add new transparency requirements for healthcare and health insurance industries,
impose new taxes and fees on pharmaceutical and medical device manufacturers, and impose additional health policy reforms. Among other
things, the Affordable Care Act expanded manufacturers’ 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.