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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As Interest in Legislation Grows, Congressional Research Service Issues Back-to-Back Reports on 340B Program

Congressional Research Service wordmark and logo
The Congressional Research Service issued a summary of the range of policy actions affecting 340B contract pharmacy use in recent years

Congress’ nonpartisan research office has issued a four-page backgrounder on litigation over the 340B contract pharmacy program and a two-pager on the entire drug discount program. They could be a sign that 340B hearings and/or bills are coming.

The Congressional

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New York State Stands by its 340B-Related Antitrust Claims Against CVS

CVS retail building
New York State last week reasserted claims that CVS Health illegally forces 340B providers to use its 340B TPA Wellpartner.

The New York State attorney general last week reasserted that CVS Health abused its market power by forcing 340B covered entities who use CVS to dispense 340B-priced drugs to use the retail chain’s third-party administrator Wellpartner to process their 340B

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340B COVID-19 Flexibilities Will Continue Through Mid-January

Screenshot of HRSA COVID-19, 340B program resources page
HHS extended the COVID-19 public health emergency (PHE) to mid-January, which keeps in place 340B program flexibilities that started in March 2020.

The U.S. Department of Health and Human Services (HHS) late last week extended the COVID-19 public health emergency (PHE) to mid-January, giving some 340B-eligible entities more time for immediate enrollment in the program without having to wait for the next

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Hospital Group Urges MedPAC to Drop Part B Pay-Cut Proposal, Cites 340B Impact

MedPAC chart of drugs add-on amounts
The AHA wants MedPAC to drop a Medicare Part B drug reimbursement policy option it is considering making to Congress on the grounds that it will hurt 340B hospitals.

The American Hospital Association is urging the Medicare Payment Advisory Commission to abandon a Medicare Part B drug reimbursement policy option it is considering making to Congress, arguing that the proposed change would hurt 340B hospitals’ ability to provide care

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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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Federal Court Clears Way for Medicare to Boost 340B Hospitals’ Part B Drug Payments

U.S. District Court Washington D.C. building
A federal district court in Washington, D.C., cleared the way for CMS to resume paying hospitals at ASP +6% for 340B drugs in as quickly as two weeks.

A federal district judge on Monday cleared the way for the Centers for Medicare and Medicaid Services (CMS) in as quickly as two weeks to resume paying hospitals at the rate of average sales price (ASP) plus 6% for their

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HRSA Allows Immediate 340B Enrollment in Florida, South Carolina Due to Hurricane

Satellite image Hurricane Ian
A satellite image of Hurricane Ian on Sept. 28 on its approach to Florida as a Category 4 storm.

The U.S. Health Resources and Services Administration (HRSA) has granted Florida and South Carolina 340B program enrollment flexibility, as public health emergencies (PHEs) were declared in both states in the aftermath of Hurricane Ian, which left widespread destruction, flooding, and

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Groups Representing 340B Hospitals Praise Federal Court Decision Halting Deep Medicare Part B Cuts

U.S. District Court for the District of Columbia building
The federal district court in Washington, D.C. has ordered the government to immediately begin to pay 340B hospitals at full rates for Medicare Part B covered drugs.

In a big victory for 340B hospitals, a federal judge in Washington, D.C. ruled yesterday that the government must immediately begin to pay 340B hospitals the full Medicare Part B drug payment rate for the remainder of calendar year (CY)

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Manchin and Braun Call on HHS To Take Immediate Action Against Drug Manufacturers in Contract Pharmacy Battle

Sen. Joseph Manchin (D-WV) and Sen. Michael Braun (R-IN) headshots
Senators Manchin (D-WV) and Braun (R-Ind.) are urging HHS to take action against drug manufacturers who have placed restrictions in the contract pharmacy setting.

Government health officials need to take immediate action to fully enforce the law against drug makers who are denying 340B drug discounts to providers who use contract pharmacies to dispense 340B-priced drugs, U.S. Senator Joe Manchin (D-W.VA.) and U.S. Senator

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