Mallinckrodt Is the Third Drug Company This Month to Announce Refunds for 340B Overcharges

Mallinckrodt wordmark building-mounted sign
Mallinckrodt's SpecGx subsidiary is providing refunds for 340B overcharges on 22 NDCs for purchases from Q3 2019 through Q2 2020.

Drug manufacturer Mallinckrodt’s SpecGx generic pharmaceutical subsidiary is providing refunds for 340B overcharges on 22 NDCs for purchases from Q3 2019 through Q2 2020.

This is the third time this month that a drug manufacturer has announced 340B refunds for

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Drug Makers Ask Michigan Lawmakers to Erase Section from New 340B State Law

Copy of State of Michigan bill no. 4351
Michigan 340B hospitals say drug manufacturers are lobbying state lawmakers to erase language from a new state law that the hospitals say stops the drug makers from imposing claims submission requirements as a condition for 340B pricing.

Drug manufacturers are asking Michigan state legislators to erase language in a new state law that Michigan hospitals say bars the companies from withholding 340B pricing if a covered entity refuses to hand over its contract pharmacy claims data, 340B

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Amgen and GSK Announce Refunds for 340B Overcharges – May 22

Enbrel autoinjector product tubes
Amgen is providing refunds for 340B overcharges for four NDCs of its top-selling drug Enbrel during 2016 and 2017.

Drug manufacturer Amgen is providing refunds for overcharges during varying periods over three years on some of its top selling drugs including Enbrel ($4.8 billion in U.S. sales in 2020), Neulasta ($2 billion), Kyprolis ($710 million), Aranesp ($629 million), Epogen

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Drug Industry-Funded Consumer Group Slams 340B on Conservative News Site

Screenshot of RealClear Health 340B Program story, "340B Program Isn't Working for Patients"
Industry-supported consumer protection group National Consumers League sharply criticized 340B hospitals and contract pharmacies in a recent opinion article for a conservative-leaning news site.

America’s oldest consumer protection group, shunned by some former allies in the labor movement for alleged favoritism toward its corporate donor Amazon, has slammed the 340B program in a commentary for the conservative-leaning news and opinion website RealClearHealth.

“Sadly, as

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AstraZeneca Stops Voluntary 340B Pricing on Orphan Drugs to Rural and Cancer Hospitals

AstraZeneca wordmark building-mounted sign
Effective June 1, AstraZeneca will stop offering voluntary 340B pricing on orphan drugs to critical access hospitals, sole community hospitals, rural referral centers, and free-standing cancer hospitals.

Drug manufacturer AstraZeneca effective June 1 will stop offering voluntary 340B pricing on its orphan drugs to critical access hospitals, sole community hospitals, rural referral centers, and free-standing cancer hospitals, the company said yesterday.

“AstraZeneca is making this change to

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Merck Adds 45-Day Time Limit on Replenishment Orders to its 340B Contract Pharmacy Policy

Merck and U.S. flags
Merck has imposed 45-day time limit on replenishment orders under its restrictions on 340B pricing when covered entities use contract pharmacies.

Merck is the latest drug company among the 16 that restrict 340B pricing when covered entities use contract pharmacies to impose a 45-day time limit on replenishment orders under its policy.

Merck disclosed the change last week in the same letter

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News Alert

Merck Extends its Conditions on 340B Pricing Involving Contract Pharmacies to Health Centers

Merck exterior building sign
Merck extended its restrictions on 340B pricing involving contract pharmacies to community health centers.

Drug manufacturer Merck today extended its restrictions on 340B pricing involving contract pharmacies to community health centers. The restrictions have applied only to hospital covered entities until now.

Other grantee covered entities remain exempt “at this time,” Merck said, adding

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340B Report Holding May 18 Webinar on Implementing Drug Makers’ New 340B Contract Pharmacy Rules

customers in line at a pharmacy
Multiple 340B covered entities and consultants say they have hit roadblocks trying to navigate drug manufacturers restrictions on 340B pricing when entities contract with outside pharmacies to dispense 340B drugs.

340B Report, an independent news organization covering the 340B drug pricing program, is holding its first event—a May 18 webinar about implementing drug manufacturers’ controversial new rules on 340B contract pharmacies. It is an exclusive and free

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Providers Alarmed About 45-Day Lookback Clauses in Drug Makers’ 340B Contract Pharmacy Policies

closeup of sand in an hourglass
Covered entities are concerned about 45-day time limits for claims submissions and replenishment orders in drug manufacturers' 340B contract pharmacy policies.

Drug manufacturer Sanofi drew attention this month when it added 45-day time limits for replenishment orders and claims submissions to its conditions on 340B pricing when covered entities use contract pharmacies.

Pfizer and Amgen also recently added similar 45-day lookback requirements

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Influential HIV/AIDS Group Asks Gilead to Exempt Ryan White Clinics from Company’s 340B Contract Pharmacy Restrictions

Gilead exterior office sign
Gilead Sciences will expand its data reporting requirements for 340B pricing on branded hepatitis C products to contract pharmacies wholly owned by covered entities.

Ryan White Clinics for 340B Access (RWC-340B) has asked drug manufacturer Gilead to exempt all Ryan White clinics from the company’s conditions on 340B pricing on its branded hepatitis C treatments when covered entities use contract pharmacies.

RWC-340B made the

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