Company: BDRX
Filing Date: 2025-01-17
Form Type: F-1
Source: 0001214659-25-000922
Chunk: 211

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-17
Form: F-1
Chunk 211
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 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 from other healthcare reform measures, especially with regard to healthcare access, financing
or other legislation in individual states, could have a material adverse effect on the healthcare industry in the United States.

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In addition, there has been
heightened governmental scrutiny over the manner in which biopharmaceutical manufacturers set prices for their marketed products. Such
scrutiny has resulted in several recent U.S. Congressional inquiries and proposed and enacted federal and state legislation designed to,
among other things, bring more transparency to medicine pricing, review the relationship between pricing and manufacturer patient programs,
reduce the cost of medicines under Medicare, and reform government program reimbursement methodologies for pharmaceutical products. Notably,
on December 20, 2019, the Further Consolidated Appropriations Act for 2020 became law (P.L. 116-94) and included a piece of bipartisan
legislation called the Creating and Restoring Equal Access to