Company: AEMD
Filing Date: 2025-07-25
Form Type: DRS
Source: 0001683168-25-005397
Chunk: 32

Company: AETHLON MEDICAL INC
Filing Date: 2025-07-25
Form: DRS
Chunk 32
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 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.

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