340B Ceiling Price and Package Adjusted PriceConsistent with the 340B Ceiling Price and Manufacturer Civil Monetary Penalties Final Rule (Final Rule) (82 FR 1210, January 1, 2017), which became effective January 1, 2019, the pricing component of the 340B OPAIS began publishing a ceiling price rounded to two decimal places on April 1, 2019. Beginning July 1, 2019, HRSA will publish additional data in order to provide a more meaningful price in the marketplace and to provide increased transparency of the factors involved in the 340B ceiling price calculation. These additional data elements will not affect the manufacturer instrument file or instrument file upload process, and will not affect the 340B ceiling price. In addition to the 340B ceiling price rounded to two decimal places, the new data displayed to covered entities and manufacturers will include:
The 340B ceiling price that published on April 1, 2019 provided a price at the unit level. In order for covered entities to understand the price that is paid in the market, HRSA will also publish the package adjusted price in the 340B OPAIS. The package adjusted price is equal to the raw ceiling price (prior to rounding to two decimal places) times the package size and case package size. The exception to this rounding convention occurs when the 340B ceiling price is less than $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. This is consistent with the Final Rule. Example 1: Calculation when the 340B Ceiling Price is More than $0.01AMP = 14.546842 URA = 3.345800 Package size is 100 mLs (AMP is reported per mL) Case Package size is 6 vials per carton Raw ceiling price equals (14.546842 - 3.345800) or 11.201042 Package adjusted price equals (14.546842 - 3.345800)*100*6 or 6720.625200 Displayed package adjusted price will be $6720.63 Displayed ceiling price will be $11.20 Example 2: Exception When the 340B Ceiling Price is Less than $0.01AMP = 0.874526 URA = 0.866926 Package size is 100 mLs (AMP is reported per mL) Case package size is 6 vials per carton Raw ceiling price = (0.874526 - 0.866926) or 0.007600 Since this value is less than $0.01 it will round up to 0.01 per unit. $0.01 will display as the ceiling price and will be used in the package adjusted price calculation. Package adjusted price = 0.01*100*6 or $6.00 More InformationPlease visit HRSA OPA’s 340B OPAIS Educational Resource page and the 340B Prime Vendor website |
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