Pedley’s Promotion May Presage Hiring of a New 340B Program Director

Rear Adm. Krista Pedley’s promotion, and OPA’s new place within the HRSA administrator’s office, are symbolic of the 340B program’s growing importance in prescription drug pricing policy, and reflects how highly regarded Pedley is in HRSA and HHS.

U.S. Public Health Service (PHS) Rear Adm. Krista Pedley, who has led the federal 340B drug pricing program for more than a decade, has been promoted within the U.S. Health Resources and Services Administration (HRSA) in conjunction with a major

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Biden Appoints Acting Leaders at HRSA, CMS, and HHS

President Biden named HHS career civil servant Norris Cochran to be the acting head of HHS pending a Senate vote on Xavier Becerra's nomination for the post. | Source: C-SPAN

President Biden has accepted the resignation of U.S. Health Resources and Services Administration (HRSA) Administrator Tom Engels, whom former President Trump appointed to the post in November 2019. Diana Espinosa, a career civil servant who has served as HRSA’s deputy

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Health Centers Scramble to Secure a Freeze on 340B Insulin Rule

The Biden administration caught health center leaders off guard by not explicitly instructing HHS's new leadership to put a Trump administration 340B-related rule on ice. | Source: Shutterstock

Community health center leaders are concerned that the Biden administration yesterday asked, but did not order, the U.S. Health and Human Services Department (HHS) to postpone tomorrow’s scheduled implementation of a controversial Trump administration final rule that will require health

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Azar and Verma Touch on 340B in Valedictory Remarks

Outgoing HHS Secretary Alex Azar (left) and CMS Administrator Seema Verma touched on 340B in farewell remarks.| Source: C-SPAN

Outgoing U.S. Health and Human Services (HHS) Secretary Alex Azar and Centers for Medicare & Medicaid Services (CMS) Administrator Seema Verma both referred to 340B—obliquely in Azar’s case, directly in Verma’s—in recent farewell remarks.

In an interview with Modern Healthcare

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Health Centers File 340B Dispute Resolution Petitions Against Drug Manufacturers

The National Association of Community Health Centers (NACHC) last night on its members’ behalf asked a new federal 340B program administrative dispute resolution (ADR) panel to order drug manufacturers Eli Lilly and Co., Sanofi, and AstraZeneca to lift all “qualifications,

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Nevada ADAP Postpones Controversial 340B Policy Change

Nevada’s AIDS Drug Assistance Program (ADAP) on Tuesday postponed “through April 1, 2021, if not longer,” a 340B program policy change strongly opposed by the state’s Ryan White CARES Act grantees.

The state health department’s Division of Public and

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AstraZeneca, Lilly, and Sanofi Sue HHS to Block Requirement To Give 340B Discounts To Contract Pharmacies

AstraZeneca, Eli Lilly and Co., and Sanofi sued HHS in defense of their 340B contract actions just hours before covered entities could begin challenging those actions in a new 340B administrative dispute resolution process. | Source: Shutterstock

In a major escalation of the fight over 340B contract pharmacy, drug manufacturer AstraZeneca late yesterday asked a federal court to declare that it “is not required to offer 340B discounts to contract pharmacies.”

As we went to press, we

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HRSA Releases Details and FAQs About New 340B Dispute Resolution System

The U.S. Health Resources and Services Administration (HRSA) headquarters building in Rockville, Md.

The U.S. Health Resources and Services Administration (HRSA) Tuesday afternoon posted a new webpage describing the steps health care providers and drug manufacturers must follow to invoke the 340B program’s new administrative dispute resolution (ADR) process. It simultaneously posted 11

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340B Providers Blindsided by Bausch Health’s Decision to Drop AmerisourceBergen as Distributor

340B covered entities are scrambling to respond to the fallout from Bausch Health's surprise announcement that it ended its relationship with AmerisourceBergen to distribute its 340B-priced branded products. | Source: Shutterstock

Drug manufacturer Bausch Health blindsided 340B covered entities on New Year’s Eve, announcing that starting the very next day, Jan. 1, more than 200 of its branded products and future branded products would no longer be available through distributor AmerisourceBergen

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Senate Democratic Chairs-in-Waiting Waste No Time Going to Bat for 340B Providers

The incoming Democratic chairs of two key U.S. Senate committees want the federal agency in charge of the 340B program “to take immediate action to clarify that implementation of a rebate model by [drug] manufacturers would violate a material condition

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