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Four States May Act on 340B Contract Pharmacy Access Bills this Week

Missouri is one of four states expected to act on a high-profile 340B contract pharmacy access bill or amendment this week.
This week will see major legislative action on up to four state 340B contract pharmacy access bills—including on two controversial [...]

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Draft Senate Bill Would Pay Hospitals to Stockpile Certain Generic Drugs if They Forgo 340B Discounts, Meet New Contracting Requirements

Sen. Mike Crapo (R-Idaho), ranking member of the Senate Finance Committee, said a bipartisan draft bill would "take meaningful strides toward mitigating and preventing prescription drug shortages."
A new Senate draft drug shortages bill would offer bonus payments to hospitals that stockpile certain generic drugs and agree [...]

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Three Things Hospitals and Grantees Need to Know About HRSA’s 340B Administrative Dispute Resolution Rule

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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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2024 Provider Audits Begin with No Adverse Findings

Federal regulators recently released the first 340B provider audits for fiscal year 2024 with no adverse findings.
The first fiscal year 2024 340B provider audit reports included no adverse findings for 19 organizations. The May 8 audit [...]

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Health System Appeal of False Claims Suit Against Drugmakers For Alleged 340B Overcharges Allowed to Move Forward

California-based health system Adventist Health System/West's lawsuit alleging drugmaker 340B overcharges was allowed to move forward in a federal appeals court.
A California health system’s lawsuit alleging “hundreds of millions” in overcharges by four drugmakers was recently released from required mediation [...]

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House Committee Clears Telehealth Medicare Extension Bill with PBM 340B Provision

Rep. David Schweikert (R-Ariz.) introduced legislation with certain Medicare telehealth extensions and a PBM 340B provision.
A key House of Representatives committee yesterday approved a bill to extend telehealth regulations that also would require pharmacy benefit [...]

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Missouri House Committees Advance 340B Contract Pharmacy Access Bill as Legislative Session Nears End

A Missouri House committee cleared a 340B contract pharmacy access bill in the final weeks of the state's legislative session.
With less than two weeks remaining in the Missouri legislative session, two key house committees approved a 340B contract pharmacy [...]

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Spring Cleaning of Your 340B Program

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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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IRA Draft Guidance Leaves 340B Details Unclear

The latest CMS guidance on implementing the Inflation Reduction Act's Medicare price caps left unresolved key 340B pricing details.
Recently released draft guidance for implementing Medicare price caps would allow voluntary provider use of 340B codes on claims, while [...]

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U.S. Drug Spending Increased 14 Percent in 2023; Clinic, Hospital Trends Diverge

Eric Tichy led research with seven of his colleagues that examined U.S. drug spending trends in 2023.
Drug spending increased by 13.6% in 2023 to $722.5 billion, according to recent research. It found divergent trends for clinic [...]

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