0
PROTECT 340B Act of 2023
12/21/2024, 9:05 AM
Summary of Bill HR 2534
The bill includes several key provisions, including increased transparency and accountability measures for drug manufacturers participating in the program. It also seeks to address concerns about the rising costs of prescription drugs by requiring manufacturers to provide discounts on drugs covered by Medicare Part B.
Additionally, the PROTECT 340B Act of 2023 includes provisions to improve oversight of the program and ensure that participating hospitals and clinics are using the discounts to benefit low-income patients. The bill also aims to address concerns about the potential for abuse and misuse of the program by implementing stricter reporting requirements and penalties for non-compliance. Overall, the PROTECT 340B Act of 2023 is designed to strengthen and protect the 340B Drug Pricing Program, ensuring that it continues to provide vital support to safety-net hospitals and clinics serving low-income patients.
Congressional Summary of HR 2534
Preserving Rules Ordered for The Entities Covered Through 340B Act of 2023 or the PROTECT 340B Act of 2023
This bill prohibits pharmacy benefit managers (PBMs) and health insurance plans from discriminating against health providers participating in the 340B drug pricing program, including pharmacies contracted with such providers to dispense 340B drugs. The 340B program allows certain providers to receive covered outpatient drugs at reduced prices from manufacturers.
Specifically, PBMs and insurance plans may not
- reimburse 340B participants at a lower rate than other entities not participating in the program;
- impose differing terms (such as fees, charge-backs, or audits) on 340B participants;
- interfere with an individual's choice to receive drugs from a 340B participant;
- require 340B participants to identify which drugs fall within the program; or
- refuse to contract with a 340B participant on the basis that they utilize the program.
Further, insurance plans may not deny coverage of drug because it is a 340B drug.
Violations of this bill are subject to a civil penalty of not more than $5,000 per violation per day.
These prohibitions also apply to prescription drug (Part D) sponsors under Medicare.
The bill also provides for a process to prevent duplicate 340B drug discounts to states under Medicaid.
