Blog Posts

340B Lobbying Continues Rapid Pace Including by Big Name Firms

There was a flurry of 340B lobbying activity at the start of 2024, including spending by the joint drugmaker-provider lobbying group, 340B Working Table.
The 340B drug discount program—and congressional activity associated with it—remained a hot topic for lobbyists in the first three months [...]

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340B Webinar – It’s a Risky Business: Risk Mitigation and 340B Program Compliance

SPONSORED CONTENT

Attention 340B Covered Entities:  For most covered entities, the 340B program is essential to their organization’s bottom line – so protecting it becomes necessary. 340B program risks are numerous and often not fully recognized. Duplicate discounts, diversion, and poor documentation are common findings from a HRSA audit. People and processes are often insufficient to fully recognize and address compliance risks. At the same time, lawmakers at the federal and state levels are increasing attention on ensuring that providers are good program stewards.

340B program managers should employ multiple strategies to ensure effective risk management programs are in place. Automation and technology tools can enable a comprehensive approach to managing compliance risk. Processes can fail, and people can miss critical compliance elements, but technology mitigates the gaps in risk management.

This webinar will emphasize how non-compliance is not an option, examine the benefit of a proactive compliance approach vs. a reactive one, and

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Attorneys Expect Many Filings under Newly Reconstituted 340B Dispute Resolution Process

Kyle Vasquez, an attorney for Polsinelli, said he expects a "wave of filings" under HRSA's latest ADR rule because it is more flexible than the prior process.
Attorneys for both covered entities and drug manufacturers say they expect a significant number of filings to the newly re-established [...]

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Drug Industry Vendor, Free-Market Legal Non-Profit Echo PhRMA’s Call for Appeals Court to Rehear Arkansas 340B Contract Pharmacy Case

Two groups filed amicus briefs asking for a full appeals court panel to rehear a case on Arkansas' 340B contract pharmacy access law.
A drug industry vendor and a conservative non-profit each urged a full federal appeals court to rehear a case on [...]

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Maine Issues Draft Rule for 340B Hospital Reporting Requirements with New Data, Enforcement Provisions

After Maine passed one of the nation's first 340B provider reporting laws last year, a state health agency has proposed a rule for implementation.
The state agency tasked with implementing Maine’s state 340B hospital reporting requirement has proposed a rule with additional data and [...]

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Novartis to Refund Covered Entities After Adjusting 340B Ceiling Prices for 100-Plus Products

Drugmaker Novartis has announced it will refund 340B providers for more than 100 products after adjusting their 340B ceiling prices.
Thousands of covered entities that purchased more than one hundred Novartis products between late 2019 and early 2023 will be [...]

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COLUMN: Despite 340B Opponents’ Unprecedented Tactics, Many States Progress on Contract Pharmacy Protection Legislation

Ted Slafsky, publisher and CEO of 340B Report, writes about the surge in state 340B legislation in his latest column.
After over 30 years of working in Washington, D.C., I have become accustomed to the expression “politics ain’t beanbag.” The [...]

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News Alert

Providers Generally Supportive, PhRMA Pans Final 340B Dispute Resolution Rule

After HHS released the long-awaited final rule for resolving 340B administrative disputes, provider groups generally supported and PhRMA denounced the updated process.
Provider advocates celebrated—with some reservations—the recently issued final rule reshaping the Administrative Dispute Resolution (ADR) process for 340B stakeholders. On [...]

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Key Senator Says 340B Overhaul May Clear Congress in End-of-Year Package

Sen. John Thune (R-S.D.) told hospital executives that 340B legislation could clear Congress as part of a broader healthcare package late this session.
Sen. John Thune (R-S.D.), who is spearheading a major bipartisan 340B reform package, told hospital executives Tuesday that 340B legislation [...]

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