Company: AEMD
Filing Date: 2025-09-05
Form Type: 424B4
Source: 0001683168-25-006701
Chunk: 29

Company: AETHLON MEDICAL INC
Filing Date: 2025-09-05
Form: 424B4
Chunk 29
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 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.

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.

Coverage and Reimbursement

In both the U.S. and international
markets, the use of medical devices is dependent in part on the availability of reimbursement from third-party payors, such as government
and private insurance plans. Healthcare providers that use medical devices generally rely on third-party payors to pay for all or part
of the costs and fees associated with the medical procedures being performed or to compensate them for their patient care services. Should
our Hemopurifier or any other products under development be approved for commercialization by the FDA, any such products may not be considered
cost-effective, reimbursement may not be available in the United States or other countries, if approved, and reimbursement may not be
sufficient to allow sales of our future products on a profitable basis. The coverage decisions of third-party payors will be significantly
influenced by the assessment of our future products by health technology assessment bodies. If approved for use in the United States,
we expect that any products that we develop, including the Hemopurifier, will be purchased primarily by medical institutions, which will
in turn bill various third-party payors for the health care services provided to patients at their facility. Payors may include the Centers
for Medicare & Medicaid Services, or CMS, which administers the Medicare program and works in partnership with state governments
to administer Medicaid, other government programs and private insurance plans. The process involved in applying for coverage and reimbursement