In AstraZeneca’s 340B Lawsuit, Focus Shifts to HRSA’s May 17 Violation Letter

AstraZeneca and the federal government have filed a new round of briefs in the drug manufacturer’s 340B contract pharmacy lawsuit.

AstraZeneca and the federal government have filed a new round of briefs in the drug manufacturer’s 340B contract pharmacy lawsuit, this round focused on the government’s May 17 letter telling the company its contract pharmacy actions are illegal.

In a

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340B Won’t be Overlooked if There’s a Grand Bargain on Drug Pricing, Analyst Predicts

340B “will not be overlooked” if the drug industry strikes a grand bargain with Congress and the Biden administration on lowering drug prices, biopharma policy analyst Michael McCaughan predicts.

The 340B program “will not be overlooked” if the drug industry strikes a grand bargain with Congress and the Biden administration on lowering drug prices, biopharma policy analyst Michael McCaughan predicted this week during a talk on drug pricing reform

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Kalderos Urges Feds to Protect Hospitals from Losing 340B Eligibility During Pandemic

Drug industry vendor Kalderos is urging leaders in Washington to temporarily shield hospitals from losing their 340B eligibility during the COVID-19 pandemic.

Drug industry vendor Kalderos is urging leaders in Washington to temporarily shield hospitals from losing their 340B eligibility during the COVID-19 pandemic.

“Kalderos is urging a rapid federal response to protect these hospitals,” the company said in a July 23

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Retired Senator Enzi, Who Backed 340B Inquiries, Dies Following Accident

Retired U.S. Sen. Mike Enzi (R-Wy.), who co-led inquiries into stewardship of the 340B program while in Congress, has died at age 77.

Retired U.S. Sen. Mike Enzi (R-Wy.), who co-led inquiries into stewardship of the 340B program while in Congress, died on Monday after being injured in a bicycle accident in his hometown of Gillette, Wyo. He was 77.

Enzi was a

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News Alert: U.S. House Votes to Highlight Need to Halt Pharma’s “Unlawful” 340B Actions

U.S. Rep. Abigail Spanberger (D-Va.) said her successful amendment today to a spending bill sends big pharma the message "Stop hiking drug prices on consumers and discriminating against our 340B providers and pharmacies."

The U.S. House voted this evening “to highlight the need to protect the integrity of the 340B program by halting pharmaceutical manufacturers’ unlawful actions that have resulted in overcharges to 340B covered entities.”

Reps. Abigail Spanberger (D-Va.) and David McKinley

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HRSA Posts Novartis Notice About 340B Refunds on a Top-Selling Drug—With Contract Pharmacy Strings Attached (Updated)

Novartis exempted Mississippi 340B providers from its contract pharmacy restrictions following a new state law.

UPDATE Tuesday, July 27, 2021, 1:45 p.m. Eastern—Drug manufacturer Novartis provided the following statement:

“Novartis recently notified the Health Resources and Services Administration (HRSA) that we inadvertently neglected to offer the 340B ceiling price to covered entity types added by

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For 340B Hospitals, Some Consolation in Otherwise Disappointing CMS Drug Reimbursement Rule

CMS proposes extending "pass-through" status for 24 drugs and three biosimilars in 2022—a move that would temporarily shield the medicines from the deep payment cut for 340B hospitals.

Hospitals groups were deeply disappointed last week with the U.S. Centers for Medicare & Medicaid Services’ (CMS) proposal to continue a nearly 30% cut in Medicare Part B reimbursement for hospitals’ 340B purchased drugs in place since 2018.

Another provision

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Pedley Provides 340B Update but Avoids Contract Pharmacy Controversy

Due to litigation, 340B program director Rear Adm. Krista Pedley could say little about the drug discount program during yesterday’s 340B Coalition virtual summer conference.

Rear Adm. Krista Pedley, Director of the U.S. Health Resources and Services Administration’s (HRSA) Office of Pharmacy Affairs (OPA), gave a brief update on the 340B program during yesterday’s 340B Coalition virtual summer conference. She explained that “due to current

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House GOP Starts Crafting Health Care Bills in Anticipation of Retaking Majority

Rep. Brett Guthrie (R-Ky.) will run to chair the House E&C Committee next session--and is considered by some lobbyists as the favorite to win--if Republicans maintain control of the House.

The top Republicans on two U.S. House health subcommittees are leading a party effort to “craft legislative proposals that Republicans can advance after retaking the majority” in the November 2022 midterm elections. It is not known whether the group will

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340B Program Flexibilities to Continue As COVID-19 Emergency Extended

HHS Secretary Xavier Becerra this week extended the COVID-19 public health emergency until mid-October.

U.S. Health and Human Services (HHS) Secretary Xavier Becerra on Monday extended the COVID-19 national public health emergency (PHE) for another 90 days, to Oct. 17. The move extends 340B program flexibilities implemented during the pandemic’s early days.

In

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