HRSA Cites Almaject for 340B Price Data Lapse, No Sanctions Imposed 

Screenshot of HRSA manufacturer audit results page
New Jersey-based generic manufacturer Almaject was cited for an infraction by HRSA during a recent audit. However, the company will not be sanctioned.

The U.S. Health Resources and Services Administration (HRSA) has cited Almaject, a New Jersey-based maker of generic injectables, with failing to submit quarterly pricing data into the 340B Office of Pharmacy Affairs Information System, although the agency did not impose

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Breaking News

HRSA Refers Merck to HHS Inspector General Over its 340B Contract Pharmacy Policy

Merck flag with U.S. flag
Merck did not immediately comment on the governnment's referral yesterday to the HHS Inspector General for possible imposition of civil fines over the company's 340B contract pharmacy restrictions.

The U.S. Health Resources and Services Administration yesterday referred drug manufacturer Merck to the Department of Health and Human Services Office of Inspector General for possible imposition of civil fines over Merck’s 340B contract pharmacy restrictions.

Public Health Services Lt.

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Kalderos Announces New 340B Drug Claims Verification Tool

Kalderos Discount Hub logo
Kalderos has replaced its Review 340B claims verification tool with a new one named Discount Hub.

Pharmaceutical manufacturer contractor Kalderos has replaced Review, its 340B drug claims verification tool, with a new one named Discount Hub.

Chicago-based Kalderos announced the change in an Aug. 31 blog post and an Oct. 12 news release. It said Discount Hub

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HRSA Tells AbbVie and Amgen Their 340B Contract Pharmacy Restrictions Are Illegal

HHS HRSA building entrance and signage
HRSA sent AbbVie and Amgen letters yesterday telling the companies their restrictions on 340B pricing when providers use contract pharmacies are illegal and must stop or the companies could face stiff civil monetary penalties.

Federal health officials told drug manufacturers AbbVie and Amgen late yesterday their restrictions on 340B pricing when providers use contract pharmacies are illegal and must end or the companies could be fined.

The Health Resources and Services Administration’s last 340B

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Twice as Many Providers as in May Are Submitting 340B Drug Claims Data to 340B ESP, Pharma Contractor Says

340B ESP infographic
340B ESP says more that 1,000 covered entities—double the number in May—are submitting 340B drug claims data to it to be able to keep dispensing manufacturers’ drugs to patients at multiple contract pharmacies.

More than 1,000 covered entities—double the number in May—are submitting 340B drug claims data to Second Sight Solutions’ 340B ESP platform to be able to keep dispensing manufacturers’ drugs to patients at multiple contract pharmacies, a senior 340B ESP leader

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BIO CEO McMurry-Heath Steps Down Amid Reported Conflict with Board

Dr. Michelle McMurry-Heath headshot
BIO CEO Dr. Michelle McMurry-Heath has stepped down amid reports of ongoing dissension within the group over its direction.

Biotechnology Innovation Organization (BIO) on Monday announced the resignation of its CEO, molecular immunologist Dr. Michelle McMurry-Heath, after confirming over the weekend that she was on a leave of absence. BIO is the trade association and top lobbying group for

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PhRMA Makes its Case for Invalidating Arkansas’s First-of-its-Kind 340B Contract Pharmacy Law

PhRMA wordmark repeated on blue background
"There is no room for states, pharmacies, or other interests to step in and try to supplant” the federal government’s exclusive control over the 340B program, PhRMA told a federal district court in Arkansas late last week.

The 340B program “has always been uniquely federal in nature” and “there is no room for states, pharmacies, or other interests to step in and try to supplant” the federal government’s exclusive control over it, the brand drug industry said

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Amgen Announces Second Round of Refunds this Year for 340B Overcharges

Amgen wordmark on building facade
Drugmaker Amgen last week extended its existing 340B contract pharmacy restrictions to federal grantees.

Biotech company Amgen said last week it would pay refunds for 340B overcharges occurring in the third and fourth quarters of 2019.

The posting on the U.S. Health Resources and Services Administration website marks Amgen’s second 340B refund notice so far

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Genentech CEO Cites New York Times’ Front Page Story in Appeal for 340B Reforms

Alexander Hardy headshot
Genentech CEO Alexander Hardy cited a recent New York Times investigative article about 340B in an appeal to healthcare leaders to reform the 340B program together.

Genentech CEO Alexander Hardy on Tuesday urged healthcare leaders to reform the 340B program together in the wake of the recent New York Times exposé about a Virginia health system’s alleged misuse of the 340B program.

“As leaders in healthcare,

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Breaking News

Exclusive: HHS OIG Declines to Penalize Drug Manufacturers at This Time Over 340B Contract Pharmacy Restrictions

HHS signage and building
HRSA plans to host a webinar for federal grantees in the days leading up to the 2024 340B recertification period.

The U.S. Department of Health and Human Services Office of Inspector General (HHS OIG) has informed a bipartisan group of House lawmakers that the enforcement agency does not plan to impose civil monetary penalties against the drug makers that have

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