On Monday, September 14, 2015, HRSA posted a manufacturer refund notice on its website regarding Heritage Pharmaceuticals Inc. (Heritage) and 340B pricing for products using NDC labeler code 23155. According to the notice, Heritage did not extend 340B pricing to covered entities on drug purchases made between April 18, 2008 and December 31, 2014. As a result, a 340B covered entity may have purchased identified Heritage products above the 340B ceiling price.
Currently under the 340B statute, manufacturers that participate in Medicaid must enter into a Pharmaceutical Pricing Agreement (PPA) affirming they will not charge above the 340B ceiling price when selling covered outpatient drugs to 340B covered entities.
Please note that the proposed rule for 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation was published in the Federal Register in June of 2015. This proposed rule will require drug manufacturers to calculate 340B ceiling prices for each covered outpatient drug by National Drug Code (NDC) on a quarterly basis. In addition, it also applies a system of civil monetary penalties for drug manufacturers with a PPA that knowingly and intentionally charge a covered entity more than the ceiling price for a covered outpatient drug. A drug manufacturer may be fined up to $5,000 for each instance of overcharging the covered entity. The fine will be in addition to repayment for an instance of overcharging.
Covered entities who purchased drugs from Heritage between the stated timeframe may be eligible for a refund for products using NDC labeler code 23155. Covered entities will need to provide documentation of purchases and covered entity eligibility status in order to claim a refund. Requests for refunds must be made by August 1, 2016 by contacting Mr. Damian Finio at 340B@heritagepharma.com.
The notice can be viewed in its entirety at: http://www.hrsa.gov/opa/programrequirements/manufacturerletters/2015/heritageletter.pdf.
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