Company: AEMD
Filing Date: 2025-09-05
Form Type: 424B4
Source: 0001683168-25-006701
Chunk: 28

Company: AETHLON MEDICAL INC
Filing Date: 2025-09-05
Form: 424B4
Chunk 28
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 an annual excise tax of 2.3% on any entity that manufactures or imports
medical devices offered for sale in the United States, with limited exceptions. However, the 2020 federal spending package permanently
eliminated, effective January 1, 2020, this ACA-mandated medical device tax. 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on procedural grounds that argued the ACA is unconstitutional in its entirety because the “individual mandate” was repealed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 possible that the ACA will be subject to judicial or congressional
challenges in the future. It is unclear how such challenges and any additional healthcare reform measures will impact the ACA.

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Other legislative changes have
been proposed and adopted since the ACA was enacted. The Budget Control Act of 2011, as amended by subsequent legislation, further reduces
Medicare’s payments to providers by two percent through fiscal year 2032. These 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