H.R. 4299: Protecting Patient Access to Cancer and Complex Therapies Act
This bill, known as the Protecting Patient Access to Cancer and Complex Therapies Act, seeks to amend the Social Security Act to introduce a rebate system for certain drugs and biological products that are subject to maximum fair price negotiations. Here’s a breakdown of the main components of the bill:
Key Provisions
- Rebate System: Manufacturers of selected drugs must provide a rebate based on specific calculations regarding the total number of units sold and the payment amounts associated with those units. This rebate is in addition to any existing rebate requirements under other laws.
- Maximum Fair Price (MFP) Negotiations: The bill establishes that selected drugs will have payments calculated based on a fair price, known as the MFP, plus a defined percentage to determine beneficiary coinsurance amounts.
- Reporting Requirements: The Secretary of Health and Human Services will be responsible for providing manufacturers with quarterly reports on drug utilization and payment amounts, which manufacturers must respond to with the corresponding rebate amounts within a set timeframe.
- Federal Trust Fund: Rebate amounts collected from manufacturers will be deposited into the Federal Supplementary Medical Insurance Trust Fund, helping fund Medicare services.
- Civil Penalties: The bill establishes civil penalties for manufacturers that fail to comply with rebate requirements, ensuring adherence to the new system.
- Implementation Timeline: The bill lays out timelines for the implementation of the rebate system, including a provision for the Secretary to define an initial price applicability period.
- Definitions and Calculations: The bill provides definitions for terms related to the rebates, including how coin amounts are calculated and the specific percentages that will be applied for both the Average Sales Price (ASP) and the Maximum Fair Price (MFP).
- Provisions for Existing Drugs: The bill does clarify that the rebate mechanism can coexist with existing programs and requirements without necessitating changes in pricing structures for drugs that are already marketed.
- Coordination with Medicaid: Rebate requirements under this bill will also coordinate with existing Medicaid programs to streamline compliance and oversight.
Impact on Drug Pricing
The net effect of this bill is designed to lower costs for patients by enforcing price rebates on drugs that are deemed overpriced under national pricing standards. The changes would impact how manufacturers set prices for selected drugs since they would need to consider the additional rebate obligations.
Civil Monetary Penalties
Failure to comply with the provisions set out in this bill could result in civil monetary penalties for manufacturers, creating an incentive for adherence to the new requirements.
Conforming Amendments
The bill will also make necessary conforming amendments to other sections of the Social Security Act to ensure consistency in how rebates and payments are handled across various programs.
Relevant Companies
- PFE - Pfizer Inc. may be affected due to its portfolio of oncology drugs that could fall under the rebate requirements.
- NVS - Novartis AG, known for its cancer therapies, would also need to comply with the rebate structure for its selected drugs.
- AMGN - Amgen Inc. might see changes in product pricing strategies as a result of this legislation.
This is an AI-generated summary of the bill text. There may be mistakes.
Sponsors
4 bill sponsors
Actions
2 actions
| Date | Action |
|---|---|
| Jul. 07, 2025 | Introduced in House |
| Jul. 07, 2025 | Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned. |
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