Company: AEMD
Filing Date: 2025-06-26
Form Type: 10-K
Source: 0001683168-25-004780
Chunk: 57

Company: AETHLON MEDICAL INC
Filing Date: 2025-06-26
Form: 10-K
Item: Item 1
Chunk 57
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, as amended
by subsequent legislation, further reduces Medicare’s payments to providers by two percent through fiscal year 2032These reductions
may reduce providers’ revenues or profits, which could affect their ability to purchase new technologies. Furthermore, the healthcare
industry in the United States has experienced a trend toward cost containment as government and private insurers seek to control healthcare
costs by imposing lower payment rates and negotiating reduced contract rates with service providers. In July 2021, the Biden Administration
released an executive order, “Promoting Competition in the American Economy,” which contained provisions relating to prescription
drugs. On September 9, 2021, in response to this executive order, the U.S. Department of Health and Human Services, or HHS, released a
Comprehensive Plan for Addressing High Drug Prices that outlines principles for drug pricing reform and sets out a variety of potential
legislative policies that Congress could pursue as well as potential administrative actions HHS can take to advance these principles.
Further, the IRA, among other things (i) directs HHS to negotiate the price of certain high-expenditure, single-source drugs and biologics
covered under Medicare and (ii) imposes rebates under Medicare Part B and Medicare Part D to penalize price increases that outpace inflation.
These provisions will take effect progressively starting in fiscal year 2023, although they may be subject to legal challenges. HHS has
and will continue to issue and update guidance as these programs are implemented. It is currently unclear how the IRA will be implemented
but is likely to have a significant impact on the pharmaceutical industry. In addition, in response to the Biden administration’s
October 2022 executive order, on February 14, 2023, HHS released a report outlining three new models for testing by the Center for Medicare
and Medicaid Innovation which will be evaluated on their ability to lower the cost of drugs, promote accessibility, and improve quality
of care. It is unclear whether the models will be utilized in any health reform measures in the future.

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Legislation could be adopted
in the future that limits payments for our products from governmental payors. In addition, commercial payors such as insurance companies,
could adopt similar policies that limit reimbursement for medical device manufacturers’ products. Therefore, it is possible that
our product or the procedures or patient care performed using our product will not be reimbursed at a cost-effective level. We face similar
risks relating to adverse changes in reimbursement procedures and policies