Understanding the 340B Legislation: A Comparative Analysis of the ACCESS and SUSTAIN Acts

In recent developments surrounding the 340B Drug Pricing Program, two significant legislative proposals have emerged: the ACCESS Act and the SUSTAIN Act. These bills aim to address challenges within the program while offering distinct approaches to achieve their objectives.

Common Goals and Measures

Both the ACCESS Act and the SUSTAIN Act seek to enhance the integrity and effectiveness of the 340B program through several key measures. They emphasize improved reporting and transparency, including annual data submissions, public disclosure of compliance information, and enhanced reporting requirements. Additionally, both propose the establishment of a clearinghouse. The ACCESS Act focuses on a claims data clearinghouse to prevent duplicate discounts, while the SUSTAIN Act emphasizes accurate accounting for 340B drugs and includes mechanisms for verifying discounts.

Key Differences

Despite their common goals, there are notable differences between the two bills. For instance, the ACCESS Act restricts the number of contract pharmacies and allows mail-order pharmacies under specific conditions, whereas the SUSTAIN Act mandates detailed address information in agreements and periodic audits without specific limits on contract pharmacies. Eligibility criteria for 340B patients also differ: the ACCESS Act ties eligibility to receiving healthcare services within federal grant scope, while the SUSTAIN Act expands eligibility to include child sites.

Penalties and Sanctions

In terms of penalties, the ACCESS Act outlines civil monetary penalties and potential program removal for violations, while the SUSTAIN Act includes monetary penalties and requires corrective action plans for non-compliance.

Specialty and Mail-Order Pharmacies

The ACCESS Act explicitly addresses requirements for specialty and mail-order pharmacies, whereas the SUSTAIN Act focuses broadly on program integrity without specific mentions of these entities.

Focus on Clearinghouse Functions

Both acts propose establishing clearinghouses within the 340B Drug Pricing Program, albeit with differing operational approaches:

• ACCESS Act (Section 16): Focuses on a claims data clearinghouse to prevent duplication, mandating compliance with non-duplication requirements and data provision to manufacturers within one year.
• SUSTAIN Act (Section 8): Establishes a clearinghouse to prevent duplicate discounts and ensure accurate drug accounting, with responsibilities including data transmission, privacy/security, accurate data submissions, and managing repayment processes.

Conclusion

The ACCESS and SUSTAIN Acts share the goal of enhancing program integrity in the 340B Drug Pricing Program but differ in their approaches to addressing key issues such as contract pharmacy limits, patient eligibility, penalties, and the specifics of clearinghouse operations. These legislative proposals reflect ongoing efforts to optimize the program’s functionality while ensuring transparency and compliance.

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This comparative analysis provides insights into the evolving landscape of the 340B Drug Pricing Program, highlighting legislative efforts aimed at reform and improvement.