Company: BDRX
Filing Date: 2025-01-28
Form Type: 424B3
Source: 0001214659-25-001409
Chunk: 209

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-28
Form: 424B3
Chunk 209
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 administers
the Medicare and Medicaid programs, also has authority to revise reimbursement rates and to implement coverage restrictions for most drugs
and biologics. Cost reduction initiatives and changes in coverage implemented through legislation or regulation could decrease utilization
of and reimbursement for any approved products we may market in the future. While Medicare regulations apply only to pharmaceutical benefits
for Medicare beneficiaries, private payors often follow Medicare coverage policy and payment limitations in setting their own reimbursement
rates. Therefore, any reduction in reimbursement that results from federal legislation or regulation may result in a similar reduction
in payments from private payors.

The ACA, as amended by the
Health Care and Education Affordability Reconciliation Act, was enacted in 2010 and substantially changed the way healthcare is financed
by both governmental and private insurers in the United States, and significantly impacted the pharmaceutical industry. The ACA was intended
to broaden access to health insurance, reduce or constrain the growth of healthcare spending, enhance remedies against healthcare fraud
and abuse, add new transparency requirements for healthcare and health insurance industries, impose new taxes and fees on pharmaceutical
manufacturers, and impose additional health policy reforms. With regard to biopharmaceutical products, the ACA, among other things, addressed
a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for therapeutics that are
inhaled, infused, instilled, implanted or injected, increased the minimum Medicaid rebates owed by manufacturers under the Medicaid Drug
Rebate Program and extended the rebate program to individuals enrolled in Medicaid managed care organizations, established annual fees
on manufacturers of certain branded prescription medicines, created a new Medicare Part D coverage gap discount program, and expanded
the 340B drug discount program. As another example, the 2021 Consolidated Appropriations Act signed into law on December 27, 2020 incorporated
extensive healthcare provisions and amendments to existing laws, including a requirement that all manufacturers of medicines and biological
products covered under Medicare Part B report the product’s average sales price, to the U.S. Department of Health and Human Services
beginning on January 1, 2022, subject to enforcement via civil money penalties.

Legislative and regulatory
changes under the ACA remain possible, but it is unknown what form any such changes or any law would take and how or whether it may affect
the biopharmaceutical industry as a whole or our business in the future. We expect that changes or additions to the ACA, the Medicare
and Medicaid programs and changes stemming