Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 108

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1
Chunk 108
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 is cost containment. We expect that there will continue to be a number of federal and state proposals to implement governmental
pricing controls and limit the growth of healthcare costs, including the cost of prescription drugs. For example, in March 2010, the Patient
Protection and Affordable Care Act (“ACA”), which, among other things, increased the minimum Medicaid rebates owed by most
manufacturers under the Medicaid Drug Rebate Program; introduced a new methodology by which rebates owed by manufacturers under the Medicaid
Drug Rebate Program are calculated for drugs that are inhaled, infused, instilled, implanted or injected; extended the Medicaid Drug Rebate
Program to utilization of prescriptions of individuals enrolled in Medicaid managed care plans; imposed mandatory discounts for certain
Medicare Part D beneficiaries as a condition for manufacturers’ outpatient drugs coverage under Medicare Part D; and established
a Center for Medicare Innovation at CMS, to test innovative payment and service delivery models to lower Medicare and Medicaid spending.

Legislative and regulatory changes under the ACA
are possible, but it is unknown what form any such changes or any law would take and how or whether it may affect the pharmaceutical industry
as a whole or our business in the future. We expect that changes or additions to the ACA, the Medicare and Medicaid programs, and changes
stemming from other healthcare reform measures, especially with regard to healthcare access, financing or other legislation in individual
states, could have a material adverse effect on the healthcare industry in the United States.

Moreover, there has been heightened governmental
scrutiny over the manner in which manufacturers set prices for their marketed products, which has resulted in several Congressional inquiries
and proposed and enacted federal and state legislation designed to, among other things, bring more transparency to product pricing, review
the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for drug
products. Notably, the Further Consolidated Appropriations Act for 2020 into law (P.L. 116-94), which became law on December 20, 2019,
includes a piece of bipartisan legislation called the Creating and Restoring Equal Access to Equivalent Samples Act of 2019 (the “CREATES
Act”). The CREATES Act aims to address the concern articulated by both the FDA and others in the industry that some brand manufacturers
have improperly restricted the distribution of their products, including by invoking the existence of a REMS for certain products, to
deny generic and biosimilar product developers access to samples of brand products. Because generic and biosimilar product