Kansas Gov. Laura Kelly (D) signed a sweeping state budget bill late Wednesday that contains a provision to prohibit drugmaker [...] …
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Senate Minority Whip John Thune (R-S.D.) said bipartisan legislation to overhaul the 340B program could be introduced as soon as [...] …
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In the complex landscape of healthcare, compliance with the Health Resources and Services Administration’s (HRSA) 340B program is paramount for covered entities. As organizations strive to optimize their participation in the program, one critical aspect is preparing for HRSA audits. To shed light on this crucial process, we turn to Kristin Andolfo, a seasoned expert in navigating HRSA audits. Kristin is a 340B ACE Senior Consulting Advisor at The Craneware Group.
With over 300 HRSA audits under its belt, along with extensive experience in handling manufacturer, state, and external audits, The Craneware Group is uniquely positioned to offer valuable insights on how covered entities can effectively prepare for HRSA audits. See our step by step below guide below:
1. Alert and Gather All Key Players
The first step in preparing for a HRSA audit is to ensure that all relevant stakeholders within the organization are informed and engaged. This includes representatives from pharmacy, finance, compliance, and any
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Drug manufacturer Bausch Health announced it will exempt all Arkansas providers and pharmacies from its 340B contract pharmacy policy, including [...] …
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As part of a report on incentivizing use of accountable care organizations (ACOs), Congress’ primary research arm recently recommended excluding [...] …
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A small business lobbying organization, created as a more conservative alternative to the U.S. Chamber of Commerce, this week launched [...] …
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Japanese drugmaker Takeda recently announced refunds to 340B covered entities for 28 drugs, including one of its top-selling attention-deficit medications. [...] …
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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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Following the recent death of former Arkansas governor and U.S. Sen. David Pryor, he is being remembered for his important [...] …
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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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