FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

HHS Imposes Fines for Drugmakers that Overcharge ‘Safety-Net’ Providers

Nov. 12, 2018

After facing years of delays, HHS has put its foot down on a final rule establishing fines for drugmakers that knowingly overcharge “safety-net” healthcare providers.

The rule, which implements civil monetary penalties for manufacturers that deliberately overcharge safety-net hospitals and clinics (medical centers that must legally provide care for patients regardless of their insurance status), was finalized in January 2017 but implementation was repeatedly delayed. The HHS has proposed moving forward and set the effective date as Jan. 1, 2019.

Drugmakers that knowingly and intentionally overcharge safety-net hospitals can be fined up to $5,000 per violation, the rule says.

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