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340B “Mega Reg” Discussed at Recent NACHC Policy & Issues Forum

At last month’s NACHC Policy & Issues 340B Pharmacy session in Washington, D.C., the focus was primarily on  audit preparedness and speculation on what the “Mega Reg” may include.  Most of us in the 340B community believe that more clarity on Patient Definition is needed and will be included.   Hudson Headwaters is optimistic that the Mega Reg will address gray areas in the current definition and protect the program from being stretched in ways that create problems down the road.

We hope, too, that the new regulations will more clearly define the mission of the 340B program.  Organizations like the Alliance for Integrity and Reform (AI Rx 340B)  recently reported that one of the most troubling issues with the 340B program is that 340B hospitals don’t provide enough charity care.  I wonder at such allegations given that the current 340B program guidance does not require covered entities to provide discounts on medications to its needy patients.  Indeed, entities have been told for years that the program is intended to allow members of the Safety Net to purchase drugs at the discounted 340B price so that the benefit of that purchasing power could be used to support and expand needed services for the vulnerable populations they serve.  Clearly, the charity care that Safety Net providers deliver extends far beyond affordable medications.  Federally Qualified Health Centers (FQHCs), for example, are required to have an income-based, sliding-fee program available for services provided within the scope of grant funding.   Pharmacy is usually included in such programs.

The 340B program has been tremendously successful in supporting the stability and growth of a broad range of services for those who might otherwise go without, or who would have to travel great distances to find services.  Stakeholders associated with the success of the 340B program should be proud of what has been accomplished.  Those truly focused on the goal of sound and robust health care, available for everyone, should support the current program and not seek to limit it to being simply an indigent drug program.  Let’s hope for clarity in the “Mega Reg” that will strengthen and preserve the 340B program and help unify all of the parties involved.


Jim Donnelly

Vice President of Pharmacy Services

Hudson Headwaters Health Network