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340B

Manufacturer updates

340 b timeline 0323

June 27th, 2022

HRSA Update

On June 27th, 2022, HRSA has determined that UCB’s actions have resulted in overcharges and are in direct violation of the 340B statute. HRSA expects an update by July 11th and failure to restore 340B pricing may result in CMPs. 

May 6th, 2022

HRSA Update

On May 6th, 2022, HRSA has determined that Merck’s actions have resulted in overcharges and are in direct violation of the 340B statute. HRSA expects an update by May 20th and failure to restore 340B pricing may result in CMPs. 

October 4th, 2021

HRSA Update

On October 4th, HRSA notified Boehringer Ingelheim that they are violating federal law by refusing 340B pricing for drugs dispensed at Contract Pharmacies and may be subject to CMPs.

September 22nd, 2021

HRSA Update

On September 22nd, 2021, HRSA referred the cases of six pharmaceutical manufacturers to the OIG for their continued violations of 340B pricing restrictions at Contract Pharmacies.

May 17,th 2021

HRSA Update

On May 17th, 2021, HRSA sent six pharmaceutical manufacturers letters stating that their restriction of 340B pricing to Contract Pharmacies is in direct violation of 340B statute.

AbbVie

Effective February 1st, 2022, AbbVie will only provide 340B priced product to a single Contract Pharmacy if Covered Entity does not have an in-house pharmacy location. Grantees not subject to limitations.


*Imbruvica effective April 1st, 2022 

Contact: 

April 11th, 2023

Amgen

Effective April 11th, 2023, Amgen will only provide 340B priced product to a single Contract Pharmacy located within 40 miles of the parent site if the non-grantee doesn’t have an in-house pharmacy. Federal Grantees not subject to limitations.

January 3rd, 2022

Amgen

Effective January 3rd, 2022, Amgen will only provide 340B priced product to a single Contract Pharmacy if the Covered Entity does not have an in-house pharmacy location. Policy is limited to four drugs and doesn’t include Federal Grantees.

Contact: 

support@340Besp.com

January 1st, 2021

Amgen 

Effective January 1st, 2021, Amgen will no longer provide voluntary, “340B like” discounts, on orphan designated drugs to participating Covered Entities.

Contact:
340Brelations@amgen.com

June 1st, 2022

AstraZeneca

Effective June 1st, 2022, AstraZeneca will no longer provide voluntary, “340B like” discounts, on orphan designated drugs to participating Covered Entities.


*Calquence & Lynparza (October 1st, 2022) and Fasenra (January 1st, 2023) voluntary contracts restored.

October 1st, 2020

AstraZeneca

Effective October 1st, 2020, AstraZeneca will only provide 340B priced product to a single Contract Pharmacy.



Contact: membership@AstraZeneca.com 

Bausch Health

Effective August 1st, 2022, Bausch Health will only provide 340B priced product to a single Contract Pharmacy if Covered Entity doesn’t have an in-house pharmacy. Multiple contract pharmacy access is permissible through provision of claims data via 340B ESP. 

Contact:
support@340Besp.com


Bayer

Effective March 1, 2023, Bayer will only provide 340B priced product to a single Contract Pharmacy location if the hospital Covered Entity does not have an in-house pharmacy. Multiple contract pharmacy access is permissible through provision of claims data via 340B ESP. Grantees not subject to limitations.

Biogen

Effective February 1st, 2023, Biogen will only provide 340B priced product to a single Contract Pharmacy location if the Covered Entity does not have an in-house pharmacy. Policy is limited to two drugs and doesn’t include Federal Grantees.

September 1st, 2022

Boehringer Ingelheim

Boehringer Ingelheim announced effective September 1st, 2022, an expansion to their contract pharmacy policy to include grantees enrolled in the Consolidated Health Center Program (CH/CHC). All other Federal Grantees not subject to limitations.

Contact:
support@340besp.com

December 1st, 2021

Boehringer Ingelheim

Effective December 1st, 2021, BI will add its specialty product, OFEV, to the list of products subject to its 340B Contract Pharmacy policy. BI restrictions from August 1st, 2021, remain effective. Link to both notices below. 

Contact:
support@340Besp.com

Bristol Myers Squibb

Effective March 1st, 2022, BMS will recognize up to two designated 340B contract pharmacy
locations per 340B hospital that lacks an entity-owned pharmacy: one for IMiDs and a second for non-IMiDs. Federal Grantees not subject to limitations on non-IMiD products.


*Camzyos effective July 1st, 2022 

Contact:

Clovis

At this time, Clovis won’t be implementing its partnership with Kalderos to effectuate 340B drug discounted prices for 340B Contract Pharmacies. Clovis’ products remain available through all historically available channels.

Contact:
priceadmin@clovisoncology.com

December 10th, 2021

Eli Lilly

Lilly announced on December 10th, 2021, an expansion to their contract pharmacy policy allowing 340B priced product to a Contract Pharmacy if Covered Entity provides Claims Level Detail via 340B ESP platform for dispenses on or after October 29th, 2021.

Contact:
340B@lilly.com

September 1st, 2020

Eli Lilly

Effective September 1st, 2020, Lilly restricted access for 340B priced product to Contract Pharmacies, except insulin.


Contact:
340B@lilly.com

EMD Serono

Effective March 1, 2023, EMD Serono (EMDS) will only provide 340B pricing for REBIF and GONAL-F to a single Contract Pharmacy if a hospital Covered Entity does not have an in-house pharmacy location. Grantees not subject to limitations.

Exelixis

Effective July 6th, 2022, Exelixis will only provide 340B pricing on COMETRIQ and CABOMETYX to a single Contract Pharmacy within the specialty pharmacy network if the Covered Entity does not have an in-house pharmacy location. Federal Grantees not subject to limitations. 

Contact:
340B@exelixis.com

Gilead

Effective May 2nd, 2022, Gilead will only provide a 340B price on branded hepatitis C products to a single Contract Pharmacy if the Covered Entity does not have an in-house pharmacy location. 

 

Contact: 

July 1st, 2022

GlaxoSmith Kline

Effective July 1st, 2022, GSK will no longer offer voluntary 340B pricing on two orphan drugs (NUCALA and ZEJULA) to Covered Entities subject to the 340B orphan drug exclusion. This change will not impact Covered Entities not subject to the orphan drug exclusion.

Contact:
US.340B@gsk.com 

April 1st, 2022

GlaxoSmith Kline

Effective April 1st, 2022, GSK will only provide 340B priced product to a single Contract Pharmacy if the Covered Entity does not have an in-house pharmacy location. Federal Grantees not subject to limitations.

Contact

 

March 7th,  2023

Janssen

Effective March 7th, 2023, Janssen will only provide 340B priced product to a single Contract Pharmacy located within 40 miles of the parent site if the non-grantee doesn’t have an in-house pharmacy. An additional specialty pharmacy part of limited distribution system may be designated. Federal Grantees not subject to limitations.

Contact: 

January 1st, 2022

Janssen

Effective January 1st, 2022, Janssen will no longer offer voluntary 340B pricing on orphan drugs to Covered Entities subject to the 340B orphan drug exclusion. This change will not impact separate agreements with impacted Covered Entities.

May 31st, 2022

Merck

Merck announced on April 28th, 2022, an expansion to their 340B Program integrity initiative to include Consolidated Health Centers. All previous requirements remain effective.

Contact:

September 1st, 2021

Merck

Effective September 1st, 2021, Merck will only provide 340B priced product to a single Contract Pharmacy if the Covered Entity does not have an in-house pharmacy location. Grantees not subject to limitations. 

Contact:
340Bdata@merck.com

Novartis

Effective November 16th, 2020, Novartis will restrict 340B priced product to Contract Pharmacies based on a 40 mile radius for hospital Covered Entities. Federal Grantees not subject to limitations.

Contact: Novartis.340B@novartis.com

December 2nd, 2022

Novo Nordisk

Novo Nordisk announced on December 2nd, 2022, an expansion to their contract pharmacy policy allowing 340B priced product to a Contract Pharmacy if Covered Entity provides Claims Level Detail via 340B ESP platform for dispenses on or after January 1st, 2023.

Contact:

340BInfo@novonordisk.com

January 24th, 2022

Novo Nordisk

Novo Nordisk announced effective February 1st, 2022, an expansion to their hospital contract pharmacy policy. 340B hospitals that lack a wholly owned pharmacy can designate two contract pharmacy locations: one retail and one specialty.


Contact:
 

January, 1st 2021

Novo Nordisk

Effective January 1st, 2021, Novo Nordisk will restrict 340B priced product to Contract Pharmacies for hospital Covered Entities. Federal Grantees not subject to limitations.


Contact: 340BInfo@novonordisk.com 

Pfizer

Effective March 1st, 2022, Pfizer will recognize up to two designated contract pharmacy locations per 340B hospital that lacks a wholly owned: one for Xeljanz and a second for oral oncology products. Multiple contract pharmacy access is permissible through provision of claims data via 340B ESP.  
 
Contact:

Sanofi

Effective March 1st, 2021, Sanofi will only provide 340B priced product to a Contract Pharmacy if Covered Entity provides Claims Level Detail via 340B ESP platform. 


Contact: Sanofi340Boperations@sanofi.com
 

UCB

Effective December 13th, 2021, UCB will only provide 340B priced product to a single Contract Pharmacy if the Covered Entity does not have an in-house pharmacy location. Federal Grantees not subject to limitations.

Contact:
support@340Besp.com

United Therapeutics

Effective December 1st, 2021, United Therapeutics will only provide 340B priced product to a Contract Pharmacy if Covered Entity provides Claims Level Detail via 340B ESP platform. 

Contact:
340B@unither.com

Woodward

Effective April 1, 2023, select Woodward Pharma products will only be available at a 340B ceiling price through direct distribution via DCS and no longer available via full line distributor 340B accounts.

*12 additional NDCs effective March 15th, 2023

Contact: 
340b-clientsservices@
directcustomersolutions.com