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