Company: CMND
Filing Date: 2025-01-22
Form Type: 20-F
Source: 0001213900-25-005490
Chunk: 162

Company: Clearmind Medicine Inc.
Filing Date: 2025-01-22
Form: 20-F
Item: Item 4
Chunk 162
---
ors are increasingly
reducing reimbursements for medical products, drugs and services. For products administered under the supervision of a physician, obtaining
coverage and adequate reimbursement may be particularly difficult because of the higher prices often associated with such drugs.

In addition, the U. S. government, state legislatures
and foreign governments have continued implementing cost-containment programs, including price controls, restrictions on coverage and
reimbursement and requirements for substitution of generic products. Adoption of price controls and cost-containment measures, and adoption
of more restrictive policies in jurisdictions with existing controls and measures, could further limit sales of any product. Decreases
in 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, Congress enacted 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,
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 fraud and abuse changes. Additionally, the ACA increased the minimum level of Medicaid rebates payable by manufacturers
of brand name drugs from 15.1% to 23.1%; 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 manufacturer’s
outpatient drugs to be covered under Medicare Part D; and imposed a non-deductible annual fee on pharmaceutical manufacturers or importers
who sell “branded prescription drugs” to specified federal government programs.

Since its enactment, there have been judicial and
Congressional challenges to certain aspects of the ACA, and we expect there will be additional challenges and amendments to the ACA in
the future. Other legislative changes have been proposed and adopted since the ACA was enacted, including aggregate reductions of Medicare
payments to providers of 2% per fiscal year, which was temporarily suspended from May 1, 2020 through March 31, 2021, and reduced payments
to several types of Medicare providers. Moreover, there has recently been heightened governmental