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SUSTAIN 340B -The Imperative for a Clearinghouse to Strengthen the 340B Program

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The 340B program remains essential in ensuring equitable access to crucial medications for vulnerable, underserved populations. The program provides safety net providers with critical resources necessary to expand health related services to low-income and uninsured individuals. Over the past decade, controversy, criticism, and disagreement between manufacturers and program participants, along with regulatory agency indecision, has put the 340B program’s longevity and efficacy into question. To secure its sustainability, all 340B stakeholders must embrace a paradigm shift. Outmoded practices of mistrust and secrecy among stakeholders serve as obstacles to progress and must give way to transparency and collaboration.

Challenges to Sustainability

The sustainability of the 340B program, which is primarily funded through significant discounts from pharmaceutical manufacturers, faces major hurdles if the program continues to be perceived by manufacturers as expanding well beyond the program’s original scope and intent.  The program’s expansion, driven by the Affordable Care Act (ACA), has significantly

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Instead of Dismissing Medicare Advantage 340B Case, Judge Allows Hospitals to Amend

Humana's request to dismiss an Alabama health system's Medicare Advantage lawsuit was denied by a federal judge.
A federal judge denied health insurer Humana’s request to dismiss an Alabama health system’s suit against its Medicare Advantage plans [...]

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Twenty-One Percent of 340B Hospitals Will Not Receive Lump Sum Payments: Research

A JAMA research letter found that one-fifth of 340B hospitals will not receive repayment from Medicare for previous underpayments.
One-fifth of 340B hospitals will garner no repayment from Medicare for past underpayments, according to a recent analysis by a [...]

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Cosette Pharmaceuticals Offers 340B Provider Refunds on 38 Drugs

North Carolina-based drug manufacturer Cosette will refund 340B providers for 38 medications.
Cosette Pharmaceuticals recently announced refunds to 340B covered entities for 38 medications sold over a year and half. The refunds [...]

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Kansas is Fifth State to Enact 340B Contract Pharmacy Access Law

Kansas Gov. Laura Kelly speaks at a rally.
Kansas Gov. Laura Kelly (D) signed a sweeping state budget bill on April 24 that contains a provision to prohibit drugmaker 340B contract pharmacy restrictions in the state.
Kansas Gov. Laura Kelly (D) signed a sweeping state budget bill late Wednesday that contains a provision to prohibit drugmaker [...]

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Key Senator Says 340B Overhaul Bill Could Be Introduced Next Month, But Some are Skeptical of Short Turnaround

Sen. John Thune (R-S.D.) said a bipartisan Senate bill to overhaul the 340B program could be formally introduced as soon as May.
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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Navigating HRSA 340B Program Audits

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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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Bausch Health Becomes 22nd Drugmaker to End or Loosen 340B Contract Pharmacy Restrictions in Arkansas

Drugmaker Bausch Health has exempted all Arkansas covered entities from its 340B contract pharmacy restrictions in response to a state law recently upheld by a federal appeals court.
Drug manufacturer Bausch Health announced it will exempt all Arkansas providers and pharmacies from its 340B contract pharmacy policy, including [...]

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CBO Recommendation: Restrict 340B Access to Get Hospitals to Join ACOs

The Congressional Budget Office report recommended restricting 340B access to incentivize hospitals to join accountable care organizations.
As part of a report on incentivizing use of accountable care organizations (ACOs), Congress’ primary research arm recently recommended excluding [...]

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Small Business Group Whose Messaging Mirrors Drug Industry Takes Aim at 340B in New Video, Social Media Posts

A small business lobbying organization launched an online campaign critical of the 340B drug discount program.
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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