Office of Pharmacy Affairs Information System (OPAIS) Pricing Component Update

Office of Pharmacy Affairs Update

340B Ceiling Price and Package Adjusted Price

Consistent 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 raw ceiling price (average manufacturer price (AMP) minus the unit rebate amount (URA), before it is rounded to two decimals);
  • the package size;
  • the case pack size; and
  • the package adjusted price. 

Manufacturers will also be able to view the AMP and URA that were used to calculate the published 340B ceiling price for their labeler code.

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 $0.01

AMP = 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 $0.01

AMP = 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 Information

Please visit HRSA OPA’s 340B OPAIS Educational Resource page and the 340B Prime Vendor website HRSA Exit Disclaimer to view newly published FAQs and published tutorials. For technical assistance, or if you need further information, the 340B Prime Vendor Program is available at ApexusAnswers@340bpvp.com or by phone at 888-340-2787.

 

Date Last Reviewed:  April 2019