Cardinal Health Expert Shares How Hospitals Can Prepare For 340B Drug Pricing Program Changes

For hospitals considering enrollment in the Federal 340B Drug Pricing Program, the Health Resources and Services Administration's recent Omnibus Guidance could have significant impact on plans and operations.




Feb. 4, 2016

/PRNewswire/ -- For hospitals considering enrollment in the Federal 340B Drug Pricing Program, or those already participating in the program, the Health Resources and Services Administration's (HRSA) recent Omnibus Guidance, often referred to as the 'Mega-Guidance,' could have significant impact on plans and operations, once the final guidance is published in

September 2016


In a new blog post on the Cardinal Health thought leadership site, Essential Insights, Daniel Neal, director of 340B Product and Service Marketing, summarizes the Mega-Guidance's key proposed changes, including a new requirement that has patients meet six conditions — an increase from the current three – for eligibility to receive medication purchased at 340B prices, as well as a revised criteria for qualifying sites of care.

As a result of the Mega-Guidance, Neal discusses four ways hospitals can prepare for the potential impact of the proposed ruling, including:

  • Assess the potential impact of the proposed program changes. For example, if you already have a strong network of contract pharmacies, or if you are considering creating one, carefully review the current projected prescription volume that would flow through those channels. If prescriptions filled at those sites could no longer qualify for 340B pricing, what would be the financial impact?
  • Develop contingency plans for each risk area. For example, if your facility would be significantly impacted by the rule's proposed changes to 'managed Medicaid' prescriptions, determine what kind of agreements would need to be developed for those prescriptions to continue to qualify for 340B pricing. Consider meeting with your state Medicaid office to get insight on how best to develop your related contingency plan.
  • Conduct an audit of your 340B program — not just measuring against current standards, but also by the proposed Mega-Guidance. Now more than ever, 340B covered entities recognize the significance of maintaining a compliant program. Regardless of which facets of the proposed rule get implemented, the ability to navigate complex and evolving guidelines is key to protecting critically important program savings.
  • Make your voice heard. HRSA's official comment period for this proposed Mega-Guidance is over, but it's important for all stakeholders to share their perspectives on these proposed changes. Sharing your perspective with your congressional representatives, other elected officials and advocacy groups is critical to ensuring HRSA fully understands the potential impact the proposed changes may have on the way covered entities provide patient care.

"As with any worthwhile initiative — especially in today's evolving healthcare landscape – creating a strong 340B program for your hospital is best viewed not as a destination, but as a journey," says Neal. "When managed correctly, including appropriate oversight, planning and preparation, this program can continue to be a cornerstone of an eligible hospital's ability to improve access to care and sustain their community mission."

To learn more about the Mega-Guidance changes and Neal's insight, read his full blog post on Cardinal Health's Essential Insights.

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