H.R.1476 - Preserving Life-saving Access to Specialty Medicines in America Act; PLASMA Act (119th Congress)
Summary
H.R.1476, also known as the PLASMA Act, aims to amend Title XVIII of the Social Security Act to implement a phase-in for plasma-derived products under the manufacturer discount program. This bill focuses on modifying the discount program for these specialized medicines, particularly concerning how the discounted price is calculated for applicable beneficiaries. The goal is to ensure continued access to these life-saving specialty medicines.
Expected Effects
The bill will likely result in a phased implementation of manufacturer discounts for plasma-derived products under Medicare Part D. This phase-in approach will affect the negotiated prices beneficiaries pay, particularly those who have not yet met their annual out-of-pocket threshold. The changes are scheduled to begin in 2026 and extend through 2032, with varying discount percentages depending on the year and whether the beneficiary has met their out-of-pocket threshold.
Potential Benefits
- Ensures continued access to life-saving plasma-derived products for Medicare beneficiaries.
- Provides a gradual phase-in of manufacturer discounts, potentially mitigating abrupt financial impacts on manufacturers.
- Offers predictable discount rates for plasma-derived products, allowing for better financial planning for both beneficiaries and manufacturers.
- May encourage manufacturers to continue producing these essential medicines by phasing in the discounts.
- Could lead to more affordable specialty medicines for beneficiaries, especially those with high medical costs.
Most Benefited Areas:
Potential Disadvantages
- The phase-in approach may delay the full benefit of discounts for beneficiaries, particularly in the initial years (2026-2029).
- The complexity of the discount calculations (varying by year and out-of-pocket threshold) could create confusion for beneficiaries and administrators.
- Manufacturers may still face financial pressures despite the phase-in, potentially impacting the supply or innovation of plasma-derived products.
- The bill's limitations for certain drugs dispensed to LIS beneficiaries and specified small manufacturers could create disparities in access.
- The long-term impact on the overall cost of Medicare Part D and the sustainability of the program is uncertain.
Constitutional Alignment
The bill appears to align with the Constitution's general welfare clause, as it aims to improve healthcare access for seniors, a vulnerable population. Specifically, the preamble of the Constitution mentions the goal to "promote the general Welfare". Article I, Section 8 grants Congress the power to lay and collect taxes, duties, imposts and excises, to pay the debts and provide for the common defense and general welfare of the United States.
Impact Assessment: Things You Care About ⓘ
This action has been evaluated across 19 key areas that matter to you. Scores range from 1 (highly disadvantageous) to 5 (highly beneficial).