On January 4, 2017, The Department of Health and Human Services published a new rule for the 340B drug discount program.  The new rule would protect Hospitals from Drug Manufacturers from overcharging and lay a clearer foundation for the calculation of the 340B price.  The provisions for the rule are:

• the requirement that a manufacturer calculate the 340B ceiling price on a quarterly basis;
• the requirement that a manufacturer charge $0.01 per unit of measure if the 340B ceiling price calculation results in a ceiling price that equals zero (penny pricing);
• the methodology manufacturers must use when estimating the ceiling price for a new covered outpatient drug;
• an explanation of how a civil monetary penalty (CMP) would be imposed on a manufacturer that knowingly and intentionally overcharges a covered entity; and
• an explanation of what would constitute an instance of overcharging to trigger a CMP