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The 340B Showdown: HRSA Proceeds Towards Enforcement Despite Litigation

FDA Law

Department of Health and Human Services (“HHS”), which reported that discounted purchases totaled $38 billion in 2020, a 27% increase compared to 2019. Manufacturers may choose not to participate in this program, but the federal government will not reimburse for their outpatient drugs under Medicaid or Medicare Part B if they do not.

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District Court Interprets EKRA

FDA Law

In general, EKRA prohibits, knowingly and willfully, soliciting, receiving, paying or offering kickbacks in exchange for referring to, inducing a referral to, or using the services of a recovery home, clinical treatment facility, or laboratory. The Eliminating Kickbacks in Recovery Act (“EKRA”). 18 U.S.C. § 18 U.S.C. § 18 U.S.C. § EKRA Issue.

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District Court Interprets EKRA

FDA Law

In general, EKRA prohibits, knowingly and willfully, soliciting, receiving, paying or offering kickbacks in exchange for referring to, inducing a referral to, or using the services of a recovery home, clinical treatment facility, or laboratory. The Eliminating Kickbacks in Recovery Act (“EKRA”). 18 U.S.C. § 18 U.S.C. § 18 U.S.C. § EKRA Issue.