Company: CERO
Filing Date: 2025-11-19
Form Type: 10-Q
Source: 0001213900-25-112619
Chunk: 111

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-11-19
Form: 10-Q
Item: Item 1
Chunk 111
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 as a public
company, future government shutdowns or substantial leadership, personnel, and policy changes could impact our ability to access the
public markets and obtain necessary capital in order to properly capitalize and continue our operations.

47

The impact of recent healthcare reform
legislation and other changes in the healthcare industry and in healthcare spending on us is currently unknown, and may adversely affect
our business model.

Our revenue prospects could
be affected by changes in healthcare spending and policy in the United States and abroad. We operate in a highly regulated industry and
new laws, regulations or judicial decisions, or new interpretations of existing laws, regulations or decisions, related to healthcare
availability, the method of delivery or payment for healthcare products and services could negatively impact our business, operations
and financial condition.

There have been, and likely
will continue to be, legislative and regulatory proposals at the foreign, federal and state levels directed at broadening the availability
of healthcare and containing or lowering the cost of healthcare. For more information, see the section of titled “Business –
Healthcare Laws and Regulations – Healthcare Reform” in the Annual Report on Form 10-K for the year ended December 31,
2024.

For example, the Medicare
Drug Price Negotiation Program, administered by CMS as part of the Inflation Reduction Act of 2022, commonly referred to as the IRA,
may apply to our products if they are selected for negotiation, which could materially reduce the amount of revenue we can generate from
our products if they are approved. Prior to the enactment of the One Big Beautiful Bill Act of 2025 (“OBBBA”), orphan drugs
were exempt from Medicare price negotiation under the IRA only if they had received a single orphan designation and were approved solely
for the corresponding rare disease or condition. The OBBBA amended this exemption to apply more broadly: now, any orphan-designated drug
is exempt from price negotiation, regardless of the number of orphan designations it has received, provided the drug’s approved
indications are exclusively for those rare diseases. The OBBBA also included significant reforms to Medicaid, including an estimated
$1 trillion in reduced federal Medicaid spending from 2025 through 2034, the imposition of work requirements for certain adult enrollees,
more frequent eligibility redeterminations, and increased cost-sharing for beneficiaries. These changes are expected to reduce overall
Medicaid enrollment and access to care. Although the effect on our future product candidates or business is unknown, any decrease in
the number of insured patients