Special Pricing Situations

Drugs that are less than $0.01

HRSA issued a final rule titled “340B Drug Pricing Program ceiling price and Manufacturer Civil Monetary Penalties,” (82 FR 1210, January 5, 2017) that outlines the requirements for cases when the ceiling price calculation is less than $0.01. After a manufacturer uploads their data, if the ceiling price calculation is less than $0.01, the pricing component will publish the 340B ceiling price as $0.01. In these cases, the 340B ceiling price rounded to two decimal places will be multiplied by the package size and case pack size to equal the package adjusted price. Penny priced drugs will not show a raw ceiling price value. This is consistent with the Final Rule.

 

Package Adjusted Price = 0.01 × PS Defines the size of a single package for an NDC (i.e., if a case of a dozen bottles of 100 pills, PS = 100). × CSP Defines the size of the cases for an NDC (i.e., if a case of a dozen bottles of 100 pills, CSP = 12).

Example: (Package Size and Case Size)

AMP = 0.874526

URA The CMS Medicaid Drug Rebate (MDR) system performs the URA calculation using the drug manufacturer's pricing. The specific methodology used is determined by law and depends upon the drug's classification. Drug manufacturers remain responsible for correctly calculating the URA for their covered outpatient drugs. = 0.866926

URA is rounded to 4 digits after the decimal. AMP is rounded to 6 digits after the decimal

Raw ceiling price = 0.007600 340B ceiling price = 0.01

Package size is 100 mL (AMP is reported per mL) Case Package size is 6 vials per carton

Package adjusted price = 0.01 * 100 * 6 = $6.00