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Month: May 2021

Breaking News

HHS Wants to Audit 340B Providers to See How They Use 340B Net Income

In Breaking, Federal, Regulatory2020 Views Tom Mirga
HRSA, headquartered in this suburban Washington office building, would be empowered to audit 340B covered entities to see how they use income from 340B drug purchases, under a Biden administration proposal issued today.

The Biden administration this afternoon proposed amending the 340B statute to let federal health officials audit 340B covered entities “to determine how net income from purchases under [340B] are used by the covered entity.”

The proposed legislation is

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Breaking News

Late Breaking Developments in Lilly and AstraZeneca’s 340B Contract Pharmacy Lawsuits

In Breaking, Federal, Judicial2380 Views Tom Mirga
A federal district judge in Indianapolis late this afternoon declined to temporarily restrain federal health officials from requiring drug maker Eli Lilly, based on a May 17 enforcement letter, to provide 340B discounts on drugs dispensed by contract pharmacies. | Shutterstock

A federal district judge in Indianapolis late this afternoon declined to temporarily restrain federal health officials from requiring drug maker Eli Lilly, based on a May 17 enforcement letter, to provide 340B discounts on drugs dispensed by contract

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As June 1 Deadline Looms, Drug Manufacturers and Feds Make Their Case in New Jersey Federal Court

In Federal, Judicial598 Views Tom Mirga
Drug makers Novo Nordisk and Sanofi and the federal government filed briefs Tuesday and Wednesday in federal district court in New Jersey in the two manufacturers’ separate challenges to the contract pharmacy requirements.

Drug makers Sanofi and Novo Nordisk and the federal government filed briefs Tuesday and Wednesday in federal district court in New Jersey in those two manufacturers’ separate challenges to the contract pharmacy requirements.

Sanofi and Novo Nordisk are

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Key Hearings Today in AstraZeneca and Lilly’s 340B Contract Pharmacy Lawsuits

In Federal, Judicial404 Views Tom Mirga
AstraZeneca and Eli Lilly will be before federal district judges today seeking to stop enforcement of 340B contract pharmacy requirements they oppose.

Federal judges in Delaware and Indiana will hear arguments today in drug manufacturers’ AstraZeneca and Eli Lilly’s separate lawsuits challenging the 340B contract pharmacy requirements.

A judge in Wilmington, Del., earlier this week denied AstraZeneca’s motion for an

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Vermont Places 340B-Related Strictures on PBMs and Adds Protections to Contract Pharmacies

In Legislative, State480 Views Tom Mirga
Vermont’s legislature has voted to bar pharmacy benefit managers (PBMs) from requiring claims modifiers on 340B-purchased drugs, except for claims paid directly or indirectly by Medicaid. | Tony Fischer https://www.flickr.com/photos/tonythemisfit/

Vermont’s legislature has voted to bar pharmacy benefit managers (PBMs) from requiring claims modifiers on 340B-purchased drugs, except for claims paid directly or indirectly by Medicaid.

PBMs also would be unable to restrict 340B contract pharmacies’ access to

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HHS Contract Pharmacy Advisory Opinion Author Returns to Private Sector

In Federal, Regulatory277 Views Tom Mirga
Former HHS General Counsel Robert Charrow, who wrote the Dec. 30 advisory opinion on 340B contract pharmacy, has rejoined his law firm.

Robert Charrow—the U.S. Health and Human Services (HHS) general counsel who memorably opined that drug companies must offer their products at or below the 340B ceiling price “be it the lunar surface, low-earth orbit, or a neighborhood pharmacy”—has

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Ex-HRSA Administrator Wakefield Back at HHS, Hospital Association Exec Joins Too

In Federal, Regulatory192 Views Tom Mirga
Former HRSA Administrator Mary Wakefield is back at HHS, serving as counselor to Secretary Xavier Becerra.

Mary Wakefield, who led the U.S. Health Resources and Services Administration (HRSA) from 2009 to 2015, is back at HHS.

HHS announced Tuesday that Wakefield accepted an appointment to serve as counselor to HHS Secretary Xavier Becerra.

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PhRMA Sues to Block Medicaid Best Price Change

In Federal, Judicial232 Views Tom Mirga
PhRMA is challenging a CMS Medicaid prescription drug best price rule that it says "will harm patients and manufacturers alike." | Shutterstock

Pharmaceutical Research and Manufacturers of America (PhRMA) has asked a federal judge to invalidate a federal regulation that would require drug makers, starting in January 2023, to include the full value of patient financial assistance in their Medicaid

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New Developments in 340B Contract Pharmacy Lawsuits

In Federal, Judicial1434 Views Tom Mirga
Federal judges yesterday issued orders in four lawsuits over 340B program contract pharmacy policy.

Federal courts in Delaware, Indiana, and New Jersey yesterday issued orders related to the federal government’s May 17 demand to six drug manufacturers to immediately resume unrestricted 340B pricing on drugs shipped to contract pharmacies.

The government

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Much Cheaper PrEP Drugs Could Mean Financial Upheaval for 340B Covered Entities

In Pharma Industry742 Views Ron Shinkman
Broad availability of low-cost generic pre-exposure prophylaxis drugs could significantly reduce 340B covered entities' revenues on billings for PrEP. | Shutterstock

Correction, Tuesday, May 25, 4:50 p.m. ET – Earlier today, we reported that the wholesale acquisition price for some of the generic PrEP products is now less than $30 per pill. The correct price is less than $30

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