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New HRSA Rule Implements 340B Civil Monetary Penalties on Drug Manufacturers for Overcharges to Hospital Organizations

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New HRSA Rule Implements 340B Civil Monetary Penalties on Drug Manufacturers for Overcharges to Hospital Organizations

Yesterday, the Health Resources and Services Administration (“HRSA”) published a Final Rule which formally establishes civil monetary penalties against drug manufacturers that “knowingly and intentionally” overcharge hospitals and other providers for 340B drugs, with enforcement responsibilities being overseen by the Health and Human Resources Office of Inspector General.

The Final Rule also regulates the methodology manufacturers use to calculate ceiling prices for every outpatient drug covered under the 340B program, with new requirements to update these price files by National Drug Code (“NDC”) on a quarterly basis. As part of these new requirements, HRSA reaffirmed its long-standing policy on “penny pricing,” which requires manufacturers to a sell drug at a penny if it raises the drug’s price to a level which triggers an inflationary penalty and results in a 340B ceiling price calculation of zero.

Furthermore, whereas 340B providers were previously required to request refunds directly from a manufacturer that miscalculated a drug pricing estimate, HRSA will now require manufacturers to proactively offer refunds or credits on their own for the difference between estimated and actual prices.

The new regulatory provisions go into effect starting April 1, 2017. Murer anticipates these new requirements will result in much more transparent pricing throughout the 340B program, and will help avoid instances where drugs are provided to hospitals and other providers at inflated and arbitrary prices.

Please let us know if you have any questions regarding the new civil monetary penalty and how it may affect the 340B program going forward. Murer is available to discuss the rule in more detail or explain its potential impact to providers in the future. We will continue to monitor the agency’s policies, and all the latest updates can be found at www.murer.com. Please contact our office for more information at (708) 478-7030.

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