Company: INDP
Filing Date: 2025-03-13
Form Type: 10-K
Source: 0001493152-25-010136
Chunk: 28

Company: Indaptus Therapeutics, Inc.
Filing Date: 2025-03-13
Form: 10-K
Item: Item 1
Chunk 28
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 third-party reimbursement for any product or a decision by a third-party payor not to
cover a product could reduce physician usage and patient demand for the product and also have a material adverse effect on sales.

Healthcare
Reform

In
March 2010, the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act, each as amended,
collectively known as the ACA, was enacted, which substantially changed the way healthcare is financed by both governmental and private
insurers, and significantly affected the pharmaceutical industry. The ACA contains a number of provisions, including those governing
enrollment in federal healthcare programs, reimbursement adjustments and changes to fraud and abuse laws. By way of example, the ACA:

    ●
    increased the minimum level
    of Medicaid rebates payable by manufacturers of brand name drugs from 15.1% to 23.1% of the average manufacturer price;

    ●
    required collection of
    rebates for drugs paid by Medicaid managed care organizations;

    ●
    required manufacturers
    to participate in a coverage gap discount program, under which they must agree to offer 70 percent point-of-sale discounts off negotiated
    prices of applicable brand drugs to eligible beneficiaries during their coverage gap period, as a condition for the manufacturers’
    outpatient drugs to be covered under Medicare Part D; and

22

    ●
    imposed a non-deductible
    annual fee on pharmaceutical manufacturers or importers who sell “branded prescription drugs” to specified federal government
    programs.

Other
legislative changes have been proposed and adopted in the United States since the ACA was enacted. On March 11, 2021, the American Rescue
Plan Act of 2021 was signed into law, which eliminated the statutory Medicaid drug rebate cap, beginning January 1, 2024. The rebate
was previously capped at 100% of a drug’s average manufacturer price, or AMP. Most recently, on August 16, 2022, the Inflation
Reduction Act of 2022, or IRA, was signed into law. Among other things, the IRA requires manufacturers of certain drugs to engage in
price negotiations with Medicare (beginning in 2026), with prices that can be negotiated subject to a cap; imposes rebates under Medicare
Part B and Medicare Part D to penalize price increases that outpace inflation (first due in 2023); and replaces the Part D coverage gap
discount program with a new