Company: CERO
Filing Date: 2025-04-15
Form Type: 10-K
Source: 0001213900-25-032134
Chunk: 150

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-04-15
Form: 10-K
Item: Item 1
Chunk 150
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 for a drug product does not imply that an adequate reimbursement rate will be approved. Further,
one payor’s determination to provide coverage for a drug product does not assure that other payors will also provide coverage for
the drug product. Adequate third-party reimbursement may not be available to enable us to maintain price levels sufficient to realize
an appropriate return on our investment in product development.

The 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.

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’