This page includes a summary of Verity responses to drug manufacturer communications to Covered Entities regarding contract pharmacy restrictions. It is updated as new information is received.

Manufacturers and their respective wholesalers have taken varied approaches to the restrictions they have imposed (e.g. removal of catalog items, non-340B prices in 340B catalogs, rejected manufacturer rebates), and these approaches are subject to change. We will communicate additional information and next steps to our Covered Entities as we learn more.

We are aware that 340B advocate groups, including 340B Health, continue to advocate for Covered Entities in relation to manufacturer activity, and we will continue to relay important information that we learn of as the situation develops. Please feel free to raise any questions to your account manager who will ensure the proper subject matter expert engages and responds to your query.

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February 28, 2022 – As previously communicated, AstraZeneca, Merck, Sanofi, Eli Lilly, Novartis, Novo Nordisk, Boehringer Ingelheim (BI), United Therapeutics (UT), UCB and Amgen have already taken action to limit 340B drug purchases under a variety of nuanced conditions, when  shipped to contract pharmacies. It is our current understanding that, with certain narrow exceptions, drugs from these manufacturers (and/or their wholesalers) will only be sold to designated or specified Covered Entities at 340B pricing when shipped directly to the Covered Entity or its child sites, inclusive of owned retail pharmacies.

Today’s update provides a copy of the Abbvie letter to Covered Entities, along with FAQs, and NDCs.  CLICK HERE for a copy of the Abbvie letter to Covered Entities, including the list of NDCs. For more information, refer to their website.

Abbvie NDCs will be blocked from system ordering in V340B for ALL ‘non-Federal Grantee Covered Entity designated’ contract pharmacy  relationships. All Federal Grantee CE types will continue to process orders, including Abbvie NDCs for their contract pharmacy relationships.

The V340B system will continue to accumulate blocked NDCs but will not order and replenish blocked NDCs systemically. All other unrestricted NDCs will continue to accumulate and replenish as part of your normal program settings. CLICK HERE for a comprehensive list of NDCs blocked from ordering in V340B, including those Abbvie NDCs that will be blocked as of February 1, 2022.

All manufacturers have communicated certain requirements and conditions to Covered Entities for continued extension of 340B pricing to certain contract pharmacies. Notably, Abbvie and four others have stated that Covered Entities that register with the 340B ESP  platform and upload 340B contract pharmacy claims data (“340B ESP Data”) in accordance with 340B ESP’s instructions will be allowed to have 340B pricing extended to their contract pharmacies as of today.

CLICK HERE for a summary of conditions set forth by five manufacturers working with 340B ESP to allow continued access to 340B pricing for certain contract pharmacies. This information also includes instructions on exporting claims data from V340B for Covered Entities that register on the 340B ESP website. We also recommend consulting the 340B ESP  website for the applicable terms and conditions as well as full registration instructions and data specifications.  Note that it is your responsibility, as the Covered Entity registering with 340B ESP, to ensure that you have any necessary consents from your contract pharmacy partners to upload the 340B ESP Data.

If you decide to register with 340B ESP or comply with other nuanced requirements from a given manufacturer, contact your Account Manager in writing with a request to remove that manufacturer’s’ drugs from the blocked list for your specified contract pharmacy affiliation(s) and we will gladly accommodate the request. CLICK HERE for a copy of the 340B Health analysis dated January 19, 2022 that details various exceptions to contract pharmacy restrictions.

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November 29, 2021 – As previously communicated, AstraZeneca, Sanofi, Eli Lilly, Novartis, Novo Nordisk, and Boehringer Ingelheim (BI) have already taken action to limit 340B drug purchases under a variety of nuanced conditions, when shipped to contract pharmacies. It is our current understanding that, with certain narrow exceptions, drugs from these manufacturers (and/or their wholesalers) will only be sold to Covered Entities at 340B pricing when shipped directly to the Covered Entity or its child sites, inclusive of owned retail pharmacies.

Earlier this month, Boehringer Ingelheim began to communicate its intentions directly to Covered Entities that, effective December 1, 2021, it will be limiting 340B drug purchases on additional NDCs when shipped to certain contract pharmacies. CLICK HERE for a copy of the Boehringer Ingelheim letter to Covered Entities. For more information, refer to their website. Additionally,

United Therapeutics communicated to Covered Entities, in July, similar intentions that would take effect December 1, 2021. CLICK HERE for a copy of the United Therapeutics letter to Covered Entities. For more information, refer to their website.

Finally, UCB began to communicate its intentions directly to Covered Entities that, effective December 13, 2021, it will be limiting 340B drug purchases when shipped to certain contract pharmacies. CLICK HERE for a copy of the UCB letter to Covered Entities. For more information, refer to their website.

In response, effective December 1st, additional Boehringer Ingelheim NDCs will be blocked from system ordering in V340B for ALL ‘non-Federal Grantee Covered Entity designated’ Contract Pharmacy Relationships. All Federal Grantee CE types will continue to process orders, including Boehringer Ingelheim NDCs for their contract pharmacy relationships. United Therapeutics NDCs will be blocked from system ordering in V340B for ALL Contract Pharmacy Relationships. Contact your Verity Account Manager for a comprehensive list of NDCs blocked from ordering in V340B, including December 1st additions by Boehringer Ingelheim, and United Therapeutics.

Effective December 15th, UCB NDCs will be blocked from system ordering in V340B for ALL ‘non-Federal Grantee Covered Entity designated’ Contract Pharmacy Relationships. All Federal Grantee CE types will continue to process orders, including UCB NDCs for their contract pharmacy relationships. As the December 13 date gets closer, Verity will provide updated customer communications including the list of UCB blocked NDCs.

The V340B system will continue to accumulate blocked NDCs but will not order and replenish blocked NDCs systemically. All other unrestricted NDCs will continue to accumulate and replenish as part of your normal program settings.

All three manufacturers have communicated certain requirements and conditions to Covered Entities that can be met for continued extension of 340B pricing to certain contract pharmacies. Please refer to the respective letters and manufacturers’ websites for those specific conditions. If a Covered Entity decides to comply with the requirements put forth by any manufacturer, please contact your Account Manager in writing with a request to remove that manufacturer’s’ drugs from the blocked list for your specified contract pharmacy affiliation(s) and we will gladly accommodate the request.

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August 31, 2021 – Previously, , we communicated an extensive list of NDCs that Merck would begin restricting 340B pricing on certain contract pharmacy programs for certain Covered Entity types to be effective September 1. Merck has updated the list of NDCs, effectively shortening the list of drugs affected.

Please feel free to raise any questions to your account manager who will ensure the proper subject matter expert engages and responds to your query.

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August 29, 2021 – Earlier this month, Merck began to communicate its intentions directly to Covered Entities that, effective September 1, 2021, it will also be limiting 340B drug purchases when shipped to certain contract pharmacies.

Considering the foregoing, Verity Solutions is taking the actions to block all Merck NDCs from system ordering in V340B for ALL ‘non-Federal Grantee Covered Entity designated’ Contract Pharmacy Relationships, and All Federal Grantee CE types will continue to process orders, including Merck NDCs for their contract pharmacy relationships.

If a Covered Entity decides to comply with the requirements put forth by Merck, please contact your Account Manager in writing with a request to remove the Merck drugs from the blocked list for your specified contract pharmacy affiliation(s) and we will gladly accommodate the request.
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July 29, 2021 – In early July, Boehringer Ingelheim (BI) communicated its intentions directly to Covered Entities that, effective August 1, 2021, it will also be limiting 340B drug purchases when shipped to certain contract pharmacies.

Considering the foregoing, Verity Solutions is taking the actions to block all Boehringer Ingelheim (BI) NDCs defined in the list provided by BI from system ordering in V340B for ALL ‘non-Federal Grantee Covered Entity designated’ Contract Pharmacy Relationships, and All Federal Grantee CE types will continue to process orders, including Boehringer Ingelheim (BI) NDCs for their contract pharmacy relationships

If a Covered Entity decides to comply with the requirements put forth by Boehringer Ingelheim (BI), please contact your Account Manager in writing with a request to remove the Boehringer Ingelheim (BI) drugs from the blocked list for your specified contract pharmacy affiliation(s) and we will gladly accommodate the request.

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December 18, 2020 – On December 1, Novo Nordisk communicated its intentions that, effective January 1, 2021, it will also be limiting 340B drug purchases when shipped to certain contract pharmacies. Considering the foregoing, Verity Solutions has taken the action to block all Novo Nordish NDCs for system ordering in 340B for ALL Covered Entity Contract Pharmacy Relationships, EXCEPT ‘federal grantee and designee” Covered Entity types.

Effective January 1, 2021 Verity Solutions is expanding the deployment of comprehensive order blocking to now include Novo Nordisk drugs to all Covered Entity ‘nonfederal grantee/designee’ types with contract pharmacy relationships. For nonfederal grantee/designee Covered Entity types, the V340B system will continue to accumulate these blocked NDCs but will not order and replenish blocked NDCs systemically. All unrestricted NDCs will continue to accumulate and replenish as part of your normal program settings.

For any questions, please contact your account manager, who will ensure the proper subject matter expert engages and responds to your query.

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November 11, 2020 – In light of the foregoing, Verity Solutions has taken the following steps on behalf of our Covered Entity partners to allow orders to process on all Novartis drugs for all contract pharmacy relationships after November 16 unless the Covered Entity notifies Verity in writing that it wants to block these drugs from being ordered for its contract pharmacies.

If a Covered Entity notifies Verity in writing that it wants to block any Novartis NDCs, as described above, the V340B system will continue to accumulate Novartis NDCs but will not order and replenish blocked NDCs systemically. All changes to a Covered Entity’s written instructions must also be communicated in writing.

For any questions, please contact your account manager, who will ensure the proper subject matter expert engages and responds to your query.

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October 1, 2020 – Verity Solutions sent an update to all Covered Entity partners regarding recent activity by certain pharmaceutical manufacturers and our latest actions on behalf of our Covered Entities.

In summary, Verity Solutions has expanded the deployment of comprehensive order blocking for Eli Lilly, AstraZeneca, and Sanofi drugs to all Covered Entity contract pharmacy relationships only. The V340B system will continue to accumulate these blocked NDCs but will not order and replenish blocked NDCs systemically. At this time, no blocking actions are being taken for Novartis and Merck drugs as the information available regarding these manufacturer intentions is inconclusive at best.

For any questions, please contact your account manager, who will ensure the proper subject matter expert engages and responds to your query.

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September 4, 2020 – Various stakeholders, primarily drug manufacturers, have issued communications over the past few weeks that either request or attempt to compel covered entities to provide varying levels of claims data as a condition of continued access to 340B drug pricing in the context of traditional contract pharmacy relationships, while others have indicated an intention to limit the use of contract pharmacies by Covered Entities altogether. The following is a summary of those communications to date along with Verity Solutions’ interpretation. We will update this space as new information becomes available.

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Merck, Sanofi and Novartis – Each has issued communications to 340B Covered Entities requesting submission all of contract pharmacy claims data related to the dispense of their respective products on a bi-weekly basis to the 340B ESP website powered by Second Sight Solutions and owned by the Berkeley Research Group.

– Merck communicated a registration deadline of August 14th.
– Sanofi and Novartis communicated a registration deadline of October 1st.
– Claims to be reviewed for duplicate discounts for Medicaid (FFS and MCO), Medicare Part D and Commercial Claims.
– Merck has asserted that if Covered Entities do not provide a “significant response” to this request, they may take further action to address 340B program integrity through “less collaborative and substantially more burdensome” actions. At this juncture, we have not seen any additional detail published.
– Sanofi and Novartis have asserted that if Covered Entities do not opt-in, they will “no longer be eligible to place Bill To/Ship To replenishment orders” for their products dispensed through a contract pharmacy. At this juncture, we have not seen any additional detail published.
– After the August 14th deadline passed, 340B ESP sent out an invitation on August 17th for a training session the next day, August 18th. During this session, it was revealed that 340B ESP is requesting that ALL of a Covered Entity’s contract pharmacy claims be uploaded and 340B ESP would pull out only those for the participating manufacturers. Verity Solutions believes there is more explanation and justification warranted on this topic. We remain waiting for additional details to become available.

Lilly and AstraZeneca – Both manufacturers have asserted that they are implementing limited distribution of their 340B priced drugs to Covered Entities’ contract pharmacies.

– Lilly limited distribution of Cialis effective July 1, 2020 and will no longer sell this drug at 340B prices for shipment to contract pharmacies.
– On September 1, 2020, Lilly communicated its intent to expand this limited distribution policy, effective immediately, to include all of their drugs with labeler codes 00002, 00077 and 66713 with an exception for their Insulins in specific circumstances.
– AstraZeneca, starting October 1st, has indicated it will only ship to a Covered Entity’s owned Outpatient Pharmacy. If a Covered Entity does not have one, then Astra Zeneca has indicated it will ship to only one contract pharmacy location per Covered Entity. To date, Astra Zeneca has not offered further clarification as to whether it intends to limit a Covered Entity’s use of a single contract pharmacy to a single contract pharmacy licensed location or to all HRSA registered licensed locations of the contract pharmacy.
– With respect to AstraZeneca, Verity Solutions believes additional clarification is in order concerning questions such as:
– If the Covered Entity owns multiple outpatient pharmacies, can they all be included?
– Does the letter’s stipulation of “only 1 Contract Pharmacy” mean only one pharmacy, or only one pharmacy chain?

Kalderos Pay – Technology company Kalderos has announced it will launch a new product module as of September 8 that Kalderos asserts has the ability to replace Covered Entity purchases at statutorily mandated discount prices with “rebates” to Covered Entities after purchase. To date, we are not aware of any decisions by a manufacturer or manufacturers to implement the Kalderos product.

Read the full letter to Verity Solutions’ customers: Customer Comm Mftr Actions FINAL_9-4-2020

Limited Distribution Plan Notice for Eli Lilly and Company Products: 200901_Eli_Lilly_and_Company_Limited_Distribution_Plan_Public_Notice_4_ (1)