Overview

Title

To amend title XVIII of the Social Security Act to provide a phase-in for plasma-derived products under the manufacturer discount program.

ELI5 AI

H. R. 1476 is about changing the rules so that people who make special medicines from plasma give smaller and smaller discounts on those medicines each year, starting from 2026. However, some medicines and companies aren't included in this change, which might make prices unfair between different groups.

Summary AI

H. R. 1476 proposes an amendment to title XVIII of the Social Security Act to implement a gradual phase-in for plasma-derived products under the manufacturer discount program. This legislation, known as the “PLASMA Act,” establishes specific percentage discounts on these products for applicable beneficiaries from 2026 to 2032, with the discounts reducing yearly percentages over time. The bill excludes certain groups of drugs and manufacturers from this phase-in, particularly those provided to low-income subsidy beneficiaries and small manufacturers.

Published

2025-02-21
Congress: 119
Session: 1
Chamber: HOUSE
Status: Introduced in House
Date: 2025-02-21
Package ID: BILLS-119hr1476ih

Keywords AI

social security act plasma-derived products manufacturer discount program plasma act drug pricing healthcare policy medicare pharmaceutical industry lis beneficiaries medical legislation

Sources

Bill Statistics

Size

Sections:
2
Words:
329
Pages:
5
Sentences:
7

Language

Nouns: 110
Verbs: 22
Adjectives: 3
Adverbs: 2
Numbers: 8
Entities: 25

Complexity

Average Token Length:
3.88
Average Sentence Length:
47.00
Token Entropy:
4.47
Readability (ARI):
23.34

AnalysisAI

General Summary of the Bill

H.R. 1476, introduced in the 119th Congress, seeks to amend the Social Security Act to integrate a phased approach to discount pricing for plasma-derived products under the manufacturer discount program. The bill, known as the “Preserving Life-saving Access to Specialty Medicines in America Act” or the “PLASMA Act,” is designed to accommodate certain plasma-derived products in Medicare Part D's pricing structure. This amendment outlines how discounts for these products should be calculated and gradually transitions over several years, starting in 2026.

Summary of Significant Issues

The bill presents several issues that warrant attention:

  1. Phased Discount Structure Favoritism: By creating a specific phased discount for plasma-derived products, the bill may end up favoring manufacturers of these products over those producing other pharmaceuticals. This could result in an unintended imbalance within the broader pharmaceutical market.

  2. Lack of Justification for Specific Percentages: The discount percentages and their gradual reduction are not explained, leading to potential questions about transparency in how these figures are determined.

  3. Disparities and Exclusions: Specific exclusions noted in the bill, particularly for drugs dispensed to Low-Income Subsidy (LIS) beneficiaries and products from small manufacturers, could result in uneven pricing dynamics. These exemptions might produce fairness concerns across different drug categories.

  4. Complexity and Understandability: The bill's references to existing sections of the Social Security Act and incorporation of legal terms may pose comprehension challenges for individuals who are not well-versed in legal or pharmaceutical jargon.

  5. Timeline Concerns: Since the bill sets forth changes that extend into the future, it may not fully consider potential shifts in the pharmaceutical market or technological advancements, which could impact the effective implementation of these policies.

Impact on the Public Broadly

For the general public, this bill could have significant implications, particularly for those who rely on plasma-derived products covered under Medicare Part D. The phased discount structure aims to make these products more affordable, potentially reducing out-of-pocket costs for beneficiaries and improving access to vital medications.

However, the bill’s focus on plasma-derived products means that other drug categories might not receive similar pricing benefits, potentially affecting broader drug affordability and access for individuals who rely on different types of medications.

Impact on Specific Stakeholders

Positive Impacts

  • Plasma Product Manufacturers: The bill favors manufacturers of plasma-derived products by affording them a gradual discounting structure, which could enhance their market position and financial viability.

  • Medicare Beneficiaries Using Plasma-derived Products: Individuals who rely on these medications might see a reduction in their treatment costs, improving both affordability and accessibility.

Negative Impacts

  • Manufacturers of Non-plasma Products: These manufacturers may not benefit from similar advantages and could find themselves at a competitive disadvantage due to the preferential treatment given to plasma-derived products.

  • Small Manufacturers and LIS Beneficiaries: The exclusions for certain drugs could create disparities and lead to less favorable pricing conditions for these stakeholders, potentially impacting their financial outcomes or access to necessary medications.

Overall, while the PLASMA Act aims to enhance the affordability of certain medications, careful consideration and potential adjustments are necessary to ensure fairness, transparency, and broader access across all medications.

Issues

  • The bill may favor manufacturers of plasma-derived products by allowing a phased-in discount structure, which could create an imbalance in the market for other types of pharmaceuticals. This potential favoritism is outlined in Section 2, where specific percentage discounts are designated for plasma-derived products.

  • The rationale behind the specific discount percentages and their gradual decrease over time is not provided, leading to potential concerns about transparency and fairness in how these figures were determined. This issue is highlighted in Section 2, particularly in the definitions of 'specified plasma-derived product percent'.

  • This amendment could lead to disparities in drug pricing, particularly between drugs that fall under the exclusions noted, like those dispensed to LIS beneficiaries or from specified small manufacturers, and those that do not. These exclusions may cause concerns over fairness across different drug categories and manufacturers. These issues are found in Section 2 under 'Limitations'.

  • The complexity of legal references and technical terms, such as those referencing sections of the Social Security Act, may pose challenges for laypeople to fully understand the bill's implications. This issue is present throughout Section 2.

  • The timeline for implementing these changes, starting from 2026 and beyond, might not adequately account for future changes in market dynamics or technological advancements, which could complicate policy execution and compliance. This concern is evident in Section 2, where the implementation timetable and percentages are specified.

Sections

Sections are presented as they are annotated in the original legislative text. Any missing headers, numbers, or non-consecutive order is due to the original text.

1. Short title Read Opens in new tab

Summary AI

The first section of the bill states the short title, which is the name by which the Act can be referred to or cited. This Act is called the "Preserving Life-saving Access to Specialty Medicines in America Act" or simply the "PLASMA Act".

2. Phase-in for plasma-derived products under manufacturer discount program Read Opens in new tab

Summary AI

This section of the Social Security Act introduces a phase-in period for the discounted pricing of plasma-derived products starting in 2026. It defines terms and percentages related to discounts, specifies which drugs and manufacturers fall under these new rules, and lists exceptions where this phase-in does not apply.