Beginning July 1, 2024, Novo Nordisk Inc. (labeler codes 00169 and 71090), and Novo Nordisk Pharma Inc. (labeler code 73070)1, herein referred to as Novo Nordisk, will revise its policy regarding bill to/ship to distribution of 340B product under a contract pharmacy (CP) arrangement for all Covered Entity (CE) types as described below.  This policy supersedes previous Novo Nordisk policies.2

Novo Nordisk’s policy does not deny access to 340B-priced covered outpatient drugs to any CE.  Novo Nordisk will continue to offer 340B prices to all 340B CEs, and each may purchase as much Novo Nordisk product at the 340B price that it wishes.  The changes announced in this notice solely impact Novo Nordisk-facilitated shipment of its products to CPs (which are not themselves CEs and have no statutory right to receive the products).  Novo Nordisk’s policy limits when it will accept requests to provide services that go beyond the federal statutory requirements and facilitate CE requests that drugs be transferred to third party locations.  Nothing in this policy precludes Novo Nordisk from making further changes to its 340B policy and/or asserting any rights it may have.

As of July 1, 2024, Novo Nordisk’s criteria for CP bill to/ship to arrangements will be as follows:

  • Hospital CEs and Grantee CEs: Novo Nordisk will allow a maximum of two CP designations for hospital and grantee CEs.
  • Hospital CEs: Novo Nordisk will continue to facilitate bill to/ship to orders to an unlimited number of CPs that are wholly owned and operated by a hospital CE where the hospital CE provides claims level data associated with 340B dispenses made by those wholly owned CPs.
  • Grantee CEs: Novo Nordisk will facilitate bill to/ship to orders to an unlimited number of CPs where the grantee CE provides claims level data associated with 340B dispenses made by those CPs.

These conditions will apply whether a hospital or grantee CE has an in-house pharmacy or does not.

Novo Nordisk will continue to utilize the 340B ESP™ Second Sight Solutions platform (ESP™ platform) to collect CP designation applications and de-identified claims data sufficient to allow Novo Nordisk to identify potential ineligible discounts, thereby enhancing program integrity.

All CEs may designate any two CPs consistent with Novo Nordisk’s policy on the ESP™ platform.  All applications will be reviewed by Novo Nordisk prior to approval.  Contract pharmacy designations shall apply to the CE parent and all related child sites of the CE. 

Novo Nordisk will allow hospital CEs to make changes to CP designations based on this policy change, and designate any two CPs (whether retail or specialty) on a one-time basis. Any change requests must be submitted by June 1, 2024. No action is required for hospital CEs that have already registered up to two CPs, and that do not wish to make changes to their CP designations.

For a grantee CP designation to be effective on July 1, 2024, a grantee CE designation must be submitted to the ESP™ platform by June 23, 2024.

Below is additional information on the process for designating any two CPs consistent with Novo Nordisk’s policy:

  • CP designations may be changed once every twelve (12) months from the date the designation was approved by Novo Nordisk.  Novo Nordisk will permit changes to CP designations within the twelve-month period if a CE/CP relationship is terminated.
  • CEs that have registered an account on the ESP platform may designate two CPs by navigating to the Entity Profile tab.
  • CEs that wish to register a new account on the ESP platform can create a new account at https://www.340besp.com/ and may designate two CPs by navigating to the Entity Profile tab.
  • CEs that elect not to register an account on the ESP platform can make their two CP designations by visiting https://www.340besp.com/designations.

Novo Nordisk’s policy for CP bill to/ship to arrangements for hospital CEs designating wholly owned CPs beyond the two permitted CP designations remains unchanged.  Novo Nordisk will allow bill to/ship to orders to an unlimited number of CPs that are wholly owned and operated by a hospital CE where the hospital CE provides claims level data associated with 340B dispenses made by those wholly owned CPs.

Consistent with Novo Nordisk’s previous policy, additional hospital wholly owned CP designations approved beyond the permitted two CP designations must register at https://www.340besp.com and provide 340B claims level data for those wholly owned CP designations within 30 days from the date of the initial 340B purchase on or after July 1, 2024, and within 45 days of the date of dispense for a CP to remain eligible to receive shipments of 340B-priced covered outpatient drugs. Refer to Submitting CP Claims Level Data for additional information on claim level data submission requirements. 

Novo Nordisk will also facilitate bill to/ship to orders to an unlimited number of CPs (both wholly owned, and non-wholly owned) beyond the two permitted CP designations for grantee CEs where the grantee CE provides claims level data associated with 340B dispenses made by those CPs.  Grantee CEs seeking additional CP designations beyond the permitted two CP designations must provide timely CP claims level data for additional CP designations via the ESP platform.

Additional CP designations for grantee CEs beyond the permitted two CP designations must register at https://www.340besp.com and provide 340B claims level data within 30 days of the initial purchase on or after July 1, 2024, and within 45 days of the date of dispense for a CP to remain eligible to receive shipments of 340B-priced covered outpatient drugs. Dispenses occurring more than 45 days prior to July 1, 2024, will not be considered for any CE/CP arrangement.  Refer to Submitting CP Claims Level Data for additional information on claim level data submission requirements.

Novo Nordisk will monitor the timing and completeness of the claims data submitted via the ESP platform.  If it is determined that claims data is not being timely submitted for any CP relationship, Novo Nordisk may terminate the bill to/ship to relationship for that CP.  CEs may contact Second Sight Solutions at support@340BESP.com with any questions on how to utilize the ESP platform for CP designations and/or claims level data submissions.

Please direct any questions about this revised policy to 340BInfo@novonordisk.com.

 

1 Novo Nordisk’s policy also applies to the following NDCs:  80644-0012-01 (inner NDC 80644-0012-02) and 80644-0013-01 (inner NDC 80644-0013-02).

2 Novo Nordisk’s previous policies were communicated on December 1, 2020, February 1, 2022, December 2, 2022, and June 1, 2023.