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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340B Publisher & CEO: 340B Ceiling Price Website Is Welcome Step but Needs Improvement

screenshot of HRSA website ceiling price lookup instructions
340B Report Publisher and CEO Ted Slafsky commends HRSA for its ceiling price website but encourages improvements to the site.

After a nine-year delay, federal officials in April 2019 did as Congress ordered and began posting 340B ceiling prices on a secure website. For the first time, providers enrolled in the 340B program had a tool to help them make

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Breaking News

HRSA Sends Merck 340B Contract Pharmacy Cease and Desist Letter, Agency’s First in Seven Months

Merck wordmark on building-mounted sign
HRSA told Merck today the company's conditions on 340B pricing when hospitals and health centers use contract pharmacies are illegal and must stop or Merck could face civil monetary penalties.

The federal government told drug manufacturer Merck today its conditions on 340B pricing when hospitals and health centers use contract pharmacies are illegal and must stop, or the company could face penalties of up to $6,323 per each instance of

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HIV/AIDS Clinics Tell FTC that PBMs Usurp 340B Discounts for Themselves

sculpture of a man and horse outside a federal building
The "Man Controlling Trade" statute outside the FTC's Washington, D.C., headquarters. HIV/AIDS clinics recently submitted comments to the commission about PBMs' business practices.

Pharmacy benefit managers (PBMs) should be stopped from usurping 340B drug discounts from HIV/AIDS clinics and other safety-net providers, Ryan White Clinics for 340B Access (RWC-340B) told the U.S. Federal Trade Commission (FTC) last week.

RWC-340B asked the commission for

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48 Hospitals Seek Readmission to 340B After Losing Eligibility Due to COVID-19 Pandemic

health care workers in hazmat suits with COVID-19 patient
Forty eight hospitals that lost their eligibility for 340B drug discounts for reasons related to the COVID-19 pandemic are seeking reinstatement to the 340B program.

At least 48 hospitals lost their eligibility for 340B drug discounts for reasons related to the COVID-19 pandemic and are seeking reinstatement to the 340B program, the U.S. Health Resources and Services Administration (HRSA) said this week.

April 14

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Today Is Last Day for Some Hospitals to File Paperwork for 340B Reinstatement

screenshot of HRSA 340B drug pricing program
Today is the last day for hospitals that have lost their 340B eligibility during the COVID-19 pandemic to file paperwork to be reinstated to the drug discount program.

Today is the last day for hospitals that have lost their 340B eligibility due to the COVID-19 public health emergency to file paperwork to be reinstated to the drug discount program.

A federal spending bill signed on March 15 included 

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COVID-19 Public Health Emergency Extended Through July 15

COVID-19 public health emergency sign

U.S. Health and Human Services Secretary Xavier Becerra has extended the COVID-19 public health emergency for another 90 days, through July 15. It was due to end on Saturday, April 16.

Major hospital groups and group purchasing organizations asked Becerra

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Astellas Providing Refunds for 340B Overcharges from Q3 2020 Through Q2 2021

Astellas building mounted sign
Astellas Pharma announced the suspension of its contract pharmacy policy in Maryland and Mississippi.

Astellas Pharma is issuing 340B covered entities refunds for overcharges on three NDCs for its prostate cancer treatment Xtandi and on four NDCs for its overactive bladder medication Myrbetriq for the period from Q3 2020 through Q2 2021.

Astellas posted 

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Lilly Providing Refunds for 340B Overcharges During Q3 2019

Lilly outdoor sign
Drug company Lilly is providing refunds for 340B overcharges on 14 NDCs during 3Q 2019.

Drug manufacturer Lilly is giving 340B covered entities refunds for overcharges on 14 NDCs during Q3 2019 after restating Medicaid average manufacturer prices and best prices “to account for lagged transactional data,” the company says on a notice on the

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Next Month’s 340B Registration Period Overlaps with Deadline for Hospitals Seeking Reinstatement

arrows pointing to Registration
The Q2 2022 registration period for 340B overlaps with the April 14 deadline for hospitals that lost their 340B eligibility due to the COVID-19 public health emergency to file paperwork for reinstatement.

The next period for 340B registration of new covered entities, outpatient facilities, and contract pharmacies will begin tomorrow, April 1, and end on Friday, April 15.

Eligible hospitals, health centers, clinics, and their child sites and contract pharmacies registered during

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