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On April 19, 2024—fourteen years after the Congressional deadline—the Health Resources and Services Administration published its final rule for the 340B Administrative Dispute Resolution process. Although HRSA restarted its stalled ADR rulemaking in 2020 after two 340B grantee organizations sued, HRSA “encountered policy and operational challenges with implementation” and started over in November 2022.
As HRSA stated, “the purpose of the 340B ADR process is to resolve (1) claims by covered entities that they have been overcharged for covered outpatient drugs by manufacturers and (2) claims by manufacturers, after a manufacturer has conducted an audit … that a covered entity has violated the prohibition on diversion or duplicate discounts.” In either case, the parties must engage in good faith efforts to resolve the dispute before filing.
The long-awaited final ADR rule represents a welcome development for 340B hospitals and grantees, but it is not without caveats. Here are three things
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As we welcome the fresh energy of spring, now is the perfect time for 340B covered entities to conduct a thorough review and update of their 340B program. Ensuring your program’s compliance and efficiency is akin to spring cleaning—tidying up, organizing, and preparing for the year ahead. Below, we outline essential steps and checks to maintain the excellence of your 340B program as we transition to this new season.
1. Review Your State’s Medicaid Website for New BIN/PCN/Group Updates
It’s essential to regularly check the Medicaid website for your carve-in states, looking for any updates related to Billing Identifier Number (BIN), Processor Control Number (PCN), and group numbers. These details are crucial for accurately processing pharmacy claims and securing appropriate 340B discounts. Often, at the beginning of the year, Medicaid agencies will update their websites with the latest BIN/PCN/Group numbers based on recent contracting information with Medicaid Managed Care organizations.
2. Fiscal Year-End Specific Checks
For
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