(Corrects paragraph 8 to clarify the potential impact of AbbVie’s lawsuit.)
April 8 (Reuters) – AbbVie has filed a lawsuit against the U.S. government, seeking clearer guidance on patients eligible for a drug discount program.
Under the 340B program, drugmakers are required to supply medicines at significantly reduced prices to eligible health care providers serving low-income populations.
However, AbbVie wants an updated eligibility definition from the government, saying existing guidance has created loopholes that allow hospitals and clinics to claim drug discounts for patients with minimal or unrelated contact, or even to seek multiple discounts for the same prescription.
The drugmaker claimed that these loopholes have transformed a program intended for the “safety-net” into a discretionary revenue stream for hospitals.
The company seeks to implement a statute under which a 340B discount would only apply if the provider is directly managing the patient’s specific condition and has seen the patient for a thorough medical visit within the previous 12 months.
The move marks the latest escalation in a long-standing battle between drugmakers and healthcare providers over the multi-billion dollar 340B program.
The lawsuits, which have had mixed success, have argued that the state laws conflict with the federal law governing 340B. Drugmakers have argued for years that the widespread use of contract pharmacies in the 340B program leads to a lack of transparency and makes it more likely that some drugs are discounted when they should not be.
AbbVie’s case, filed in the U.S. District Court for the District of Columbia, targets federal regulators’ interpretation of who qualifies as a “patient,” a definition that could narrow which prescriptions are eligible for discounted pricing under the program.
(Reporting by Christy Santhosh in Bengaluru, Diana Jones in Chicago; Editing by Anil D’Silva)
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