Sponsors (4)
The bill phases in discounted prices for covered plasma-derived biologics that should reduce out-of-pocket costs and create more predictable pricing, but savings arrive gradually and unevenly, while manufacturers and program administrators face revenue and implementation burdens.
Medicare Part D beneficiaries who use covered plasma-derived biologics will face lower out-of-pocket costs over time due to a phased discounted price beginning in 2026.
Manufacturers of plasma-derived products and Part D sponsors gain clearer, predictable rules for calculating discounted prices each year, improving pricing transparency and planning.
Low-income subsidy (LIS) beneficiaries are protected from the phase-in rule for certain dispensed drugs, shielding vulnerable patients from potential changes in cost-sharing timing.
Many Medicare Part D beneficiaries may not see immediate price reductions in 2026 because the discounted price is phased in over multiple years and varies by out-of-pocket status.
Manufacturers of plasma-derived products will face altered revenue timing and potentially lower negotiated prices, which could influence supply, investment, or pricing strategies.
Exempting certain small manufacturers and LIS-dispensed drugs creates uneven impacts across beneficiaries and products, leaving some patients with higher costs than others.
Based on analysis of 2 sections of legislative text.
Establishes a multi‑year phase‑in for the Part D "discounted price" calculation for certain plasma‑derived biologic products, effective for dispensings beginning in 2026, with exemptions for low‑income subsidy drugs and specified small manufacturers.
Changes how Medicare Part D counts a manufacturer “discounted price” for plasma‑derived biological products first marketed on or before August 16, 2022 by creating a multi‑year phase‑in rule that applies when those products are dispensed to Part D enrollees beginning in 2026. The phase‑in sets a specified percent (which varies by beneficiary out‑of‑pocket status) to determine the discounted price calculation, while excluding certain low‑income subsidy drugs and some small manufacturers from the new rule. The amendment mainly alters an accounting/price‑sharing mechanism in the Social Security Act that affects Part D cost flows for plasma‑derived products, updates internal cross‑references, and renumbers existing subparagraphs for consistency.
Official title: Amend title XVIII of the Social Security Act to provide a phase-in for plasma-derived products under the manufacturer discount program.
Introduced February 24, 2025 by Thomas Roland Tillis · Last progress February 24, 2025