Company: RVRC
Filing Date: 2025-08-13
Form Type: S-1/A
Source: 0001213900-25-075747
Chunk: 147

Company: Revium Rx.
Filing Date: 2025-08-13
Form: S-1/A
Chunk 147
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 includes
a number of changes intended to address rising prescription drug prices in Medicare Parts B and D. These changes include caps on Medicare
Part D out-of-pocket costs, Medicare Part B and Part D drug price inflation rebates, a new Medicare Part D manufacturer
discount drug program (replacing the ACA Medicare Part D coverage gap discount program) and a drug price negotiation program for
certain high spend Medicare Part B and D drugs (with the first list of drugs announced in 2023). The IRA changes have varying implementation
dates that start in 2022. On August 29, 2023, HHS announced the list of the first ten drugs that will be subject to price negotiations.
The focus on healthcare reform, including reform of drug pricing and payment, has continued in the wake of the IRA. For example, in 2022,
subsequent to the enactment of the IRA, the Biden administration released an executive order directing the HHS to report on how the Center
for Medicare and Medicaid Innovation (“CMMI”) could be leveraged to test new models for lowering drug costs for Medicare
and Medicaid beneficiaries. The report was issued in 2023 and proposed various models that CMMI is currently developing which seek to
lower the cost of drugs, promote accessibility and improve quality of care. Further, in December 2023, the Biden administration
announced an initiative to control the price of prescription drugs through the use of march-in rights under the Bayh-Dole Act (which
allow the government, in specified circumstances, to grant or require a patent-holder of technology funded by the federal government
to grant a license to certain third parties). The announcement was followed by publication of Draft Interagency Guidance Framework for
Considering the Exercise of March-In Rights which for the first time includes the price of a product as one factor an agency can use
when deciding to exercise march-in rights. While march-in rights have not previously been exercised, given these actions, there can be
no certainty that such rights will not be exercised in the future.

Healthcare reform efforts have been and may
continue to be subject to scrutiny and legal challenge. For example, with respect to the ACA, tax reform legislation was enacted that
eliminated the tax penalty established for individuals who do not maintain mandated health insurance coverage beginning in 2019 and,
in 2021, the U.S. Supreme Court dismissed the latest judicial challenge to the ACA brought by several states without specifically ruling
on the constitutionality of the ACA. As another