Company: RVRC
Filing Date: 2025-12-12
Form Type: S-1/A
Source: 0001213900-25-121070
Chunk: 153

Company: Revium Rx.
Filing Date: 2025-12-12
Form: S-1/A
Chunk 153
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 Rebate Program are calculated for drugs that are inhaled, infused, instilled, implanted or injected; increased
the minimum Medicaid rebates owed by most manufacturers under the Medicaid Drug Rebate Program; extended the Medicaid Drug Rebate program
to utilization of prescriptions of individuals enrolled in Medicaid managed care organizations; subjected manufacturers to new annual
fees and taxes for certain branded prescription drugs; created a new Medicare Part D coverage gap discount program, in which manufacturers
must agree to offer point-of-sale discounts off negotiated prices of applicable brand drugs to eligible beneficiaries during their coverage
gap period, as a condition for the manufacturer’s outpatient drugs to be covered under Medicare Part D. More generally, the
ACA expanded healthcare coverage through Medicaid expansion and the implementation of the “individual mandate” for health
insurance coverage.

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Beyond the ACA, there have been ongoing healthcare
reform efforts. Drug pricing and payment reform was a focus of the Trump administration and has been a focus of the Biden administration.
For example, federal legislation enacted in 2021 eliminates the statutory cap on Medicaid drug rebate program rebates (currently set
at 100% of a drug’s “average manufacturer price”), effective January 1, 2024. As another example, the IRA, 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