340B Affording Care for Communities and Ensuring a Strong Safety-net Act; 340B ACCESS Act
Summary
H.R. 5256, the "340B Affording Care for Communities and Ensuring a Strong Safety-net Act" or "340B ACCESS Act," aims to reform the 340B drug pricing program. The bill introduces changes to patient definitions, duplicate discount prevention, hospital child site requirements, and contract pharmacy regulations. It also focuses on ensuring patient affordability, enhancing covered entity transparency, and establishing a claims data clearinghouse.
Expected Effects
The bill will likely lead to increased oversight and regulation of the 340B program. This could result in some covered entities facing stricter eligibility requirements and reporting obligations. The establishment of a claims data clearinghouse and enhanced transparency measures may improve program integrity and reduce instances of duplicate discounts and non-compliance.
Potential Benefits
- Increased patient affordability through sliding fee scales and reduced out-of-pocket obligations.
- Enhanced program integrity by preventing duplicate discounts and ensuring compliance with regulations.
- Improved transparency through data submission and reporting requirements for covered entities.
- Clearer definitions of patient eligibility and covered entity responsibilities.
- Better oversight of contract pharmacies and hospital child sites.
Potential Disadvantages
- Increased administrative burden for covered entities due to additional reporting and compliance requirements.
- Potential limitations on the use of contract pharmacies for certain hospital covered entities.
- Possible financial strain on covered entities required to provide discounts to eligible patients.
- Risk of civil monetary penalties for non-compliance with new regulations.
- Potential for reduced access to 340B drugs if covered entities are unable to meet stricter eligibility criteria.
Constitutional Alignment
The bill's alignment with the Constitution is primarily based on Congress's power to regulate interstate commerce (Article I, Section 8, Clause 3) and to provide for the general welfare (Article I, Section 8, Clause 1). The regulations imposed on healthcare providers and drug manufacturers fall under the commerce clause, as they directly affect the distribution and pricing of pharmaceuticals across state lines. The provisions aimed at increasing access to affordable drugs can be seen as promoting the general welfare by improving public health.
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).