Company: CERO
Filing Date: 2025-04-15
Form Type: 10-K
Source: 0001213900-25-032134
Chunk: 153

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-04-15
Form: 10-K
Item: Item 1
Chunk 153
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 340B “ceiling price” for the manufacturer’s covered outpatient drugs. The
Affordable Care Act expanded the 340B program to include additional types of covered entities: certain freestanding cancer hospitals,
critical access hospitals, rural referral centers, and sole community hospitals, each as defined by the Affordable Care Act. Because the
340B ceiling price is determined based on AMP and Medicaid drug rebate data, revisions to the Medicaid rebate formula and AMP definition
could cause the required 340B discounts to increase.

35

The American Rescue Plan
Act of 2021 eliminated the statutory Medicaid drug rebate cap, previously set at 100% of a drug’s AMP, for single source and innovator
multiple source drugs, beginning January 1, 2024. Payment methodologies may be subject to changes in healthcare legislation and regulatory
initiatives as well. For example, CMS may develop new payment and delivery models, such as bundled payment models.

Recently, there has been
heightened governmental scrutiny over the manner in which manufacturers set prices for their marketed products. Such scrutiny has resulted
in several recent U.S. Congressional inquiries and proposed and enacted federal and state legislation designed to, among other things,
bring more transparency to drug pricing, review the relationship between pricing and manufacturer patient programs, reduce the cost of
drugs under Medicare, and reform government program reimbursement methodologies for pharmaceutical products.

At the state level, legislatures
have increasingly passed legislation and implemented regulations designed to control pharmaceutical product pricing, including price or
patient reimbursement constraints, discounts, restrictions on certain product access, and marketing cost disclosure and transparency measures,
and in some cases, designed to encourage importation from other countries and bulk purchasing.

We expect that additional
federal, state, and foreign healthcare reform measures will be adopted in the future, any of which could limit the amounts that federal
and state governments will pay for healthcare products and services, which could result in limited coverage and reimbursement and reduced
demand for our products, once approved, or additional pricing pressures.

Employees and Human Capital Resources 

As of April 8, 2025, we had
eight full-time employees, including two executive officers and six employees conducting Research and Development. Our employees are not
represented by labor unions or covered by collective bargaining agreements and we consider our relationship with our employees to be good.

Compensation and Benefits

Our employee-related objectives
include, as applicable, identifying, recruiting, retaining, and incentivizing our management team and our clinical, scientific and other
employees and consultants