PROTECT 340B Act of 2021

Preserving Rules Ordered for The Entities Covered Through 340B Act of 2021 or the PROTECT 340B Act of 2021

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.

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.

Bill 117 HR 4390, also known as the PROTECT 340B Act of 2021, is a piece of legislation introduced in the US Congress. The bill aims to address issues related to the 340B Drug Pricing Program, which requires drug manufacturers to provide discounts on outpatient drugs to certain healthcare facilities that serve low-income and vulnerable populations.

The PROTECT 340B Act of 2021 seeks to increase transparency and accountability within the 340B program by requiring participating hospitals to report on how they are using the program's discounts. The bill also aims to prevent drug manufacturers from overcharging 340B covered entities for drugs by establishing a process for resolving disputes over drug pricing.

Additionally, the bill includes provisions to address concerns about the growth of contract pharmacies in the 340B program. It requires covered entities to report on their use of contract pharmacies and establishes penalties for non-compliance with program requirements. Overall, the PROTECT 340B Act of 2021 is intended to strengthen the 340B program and ensure that it continues to benefit the low-income and vulnerable populations it was designed to serve. The bill has garnered bipartisan support in Congress and is currently being considered by relevant committees for further review and potential passage.