Company: AEMD
Filing Date: 2025-06-26
Form Type: 10-K
Source: 0001683168-25-004780
Chunk: 212

Company: AETHLON MEDICAL INC
Filing Date: 2025-06-26
Form: 10-K
Item: Item 1A
Chunk 212
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 by CMS as guidelines in setting their coverage and reimbursement
policies and amounts. However, no uniform policy requirement for coverage and reimbursement for medical devices exists among third-party
payors in the United States. Therefore, coverage and reimbursement can differ significantly from payor to payor. If CMS or other agencies
limit coverage or decrease or limit reimbursement payments for doctors and hospitals, this may affect coverage and reimbursement determinations
by many private payors for any products that we develop.

Should our Hemopurifier or any future products,
be approved for commercialization, certain health reform measures and adverse changes in reimbursement policies and procedures may impact
our ability to market and sell our products.

Healthcare costs have risen
significantly over the past decade, and there have been and continue to be proposals by legislators, regulators and third-party payors
to decrease costs. Third-party payors are increasingly challenging the prices charged for medical products and services and instituting
cost containment measures to control or significantly influence the purchase of medical products and services.

For example, in the United
States, the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010, or collectively,
ACA, among other things, reduced and/or limited Medicare reimbursement to certain providers. On June 17, 2021, the U.S. Supreme Court
dismissed a challenge on procedural grounds that argued the ACA is unconstitutional in its entirety because the “individual mandate”
was repealed by Congress. Further, on August 16, 2022, President Biden signed the Inflation Reduction Act of 2022, or IRA, into law, which
among other things, extends enhanced subsidies for individuals purchasing health insurance coverage in ACA marketplaces through plan year
2025. The IRA also eliminates the "donut hole" under the Medicare Part D program beginning in 2025 by significantly lowering
the beneficiary maximum out-of-pocket cost and creating a new manufacturer discount program. It is unclear how any such challenges, and
the healthcare reform measures of the Biden administration will impact the ACA and our business. The Budget Control Act of 2011, 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