340B Dispute Resolution Process On Ice As Feuds Between Pharma, Providers, HHS Heat Up
Biden Administration’s regulatory freeze suspends HHS action to appoint an administrative dispute resolution board for the 340B program. Good news for manufacturers?
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As stakeholders begin to mull the impact of the Arthrex opinion, HHS withdraws its advisory opinion concluding manufacturers are legally bound to provide 340B discounts to contract pharmacies, and Lilly takes aim at 340b contract pharmacy ‘replenishment’ model.
HIV community is pushing back against the change, arguing that revenue lost from reduced reimbursement will cripple providers, which use the extra funds for wrap-around patient support and services.
Ruling halts the 340B rule, and may have relevance in a suit brought by PBMs challenging the ‘rebate rule,’ which was issued in final form after HHS had suspended action on the reg.