Month: February 2022

Breaking News

HRSA Picks Federal HIV/AIDS Policy Specialist Emeka Egwim To Be its Next 340B Program Director

In Breaking, Federal, RegulatoryFebruary 28, 20221599 Views

PHS Lt. Cmdr. Emeka Edwim is the new Director of HRSA's Office of Pharmacy Affairs, the HRSA unit that runs the 340B drug pricing program.

Emeka Egwim, a federal government HIV/AIDS policy specialist who also has served in the Medicaid Drug Rebate Program, is the new head of the federal 340B Drug Pricing Program.

In a letter this morning to its staff, the

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Despite Expected Jan. Publication Date, White House Review of New 340B ADR Proposed Rule Is Approaching 100-Day Mark

In RegulatoryFebruary 25, 2022499 Views

Tom Mirga

HRSA's proposed replacement for its year-old 340B administrative dispute resolution process has been under White House review for almost 100 days.

The U.S. Health Resources and Services Administration’s (HRSA) proposed replacement for its year-old 340B administrative dispute resolution (ADR) process has been under White House review for almost 100 days—nearly a month longer that the anticipated release date announced

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Hospitals Say the Three Confirmed to Have Left 340B Due to Fallout from COVID Are the Tip of the Iceberg

In Federal, RegulatoryFebruary 25, 2022596 Views

Tom Mirga

ProMedica Memorial Hospital in Ohio had to leave the 340B program last year when it lost eligibility due to fallout from COVID-19.

The U.S. Health Resources and Services Administration’s (HRSA) recent statement that only three hospitals so far have said on a federal form that they lost their 340B eligibility due to fallout from COVID-19 does not reflect the problem’s

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Rural Providers Ask Becerra for Action on 340B Contract Pharmacy and on Hospitals at Risk of Losing 340B Eligibility

In Federal, Regulatory, Trade AssociationFebruary 25, 2022236 Views

Tom Mirga

The NRHA wants HHS to act against drug companies that deny 340B pricing when covered entities use contract pharmacies and ensure that rural hospitals do not lose their 340B eligibility due to factors related to COVID-19.

The National Rural Health Association (NRHA) asked U.S. Health and Human Services (HHS) Secretary Xavier Becerra this week to act against drug manufacturers that deny 340B pricing when covered entities use contract pharmacies.

NRHA CEO Alan Morgan also

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New JAMA Study Casts Doubt on CMS Reason for Cutting Hospitals’ Medicare Part B Payments for 340B Drugs

In Research/ReportsFebruary 25, 2022333 Views

Tom Mirga

New research “raises doubt” about a major CMS reason for slashing hospitals’ Medicare Part B reimbursement for drugs purchased through the 340B program by almost one-third.

New research published in JAMA Network Open “raises doubt” about a major U.S. Centers for Medicare & Medicaid Services (CMS) justification for slashing hospitals’ Medicare Part B reimbursement for drugs purchased through the 340B program by almost one-third,

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Michigan Governor Signs Three Bills Addressing PBM and Insurer Discrimination Against 340B Entities and Contract Pharmacies

In Legislative, StateFebruary 23, 2022897 Views

Tom Mirga

Michigan Gov. Gretchen Whitmer (D) signed three bills today that prohibit PBMs and insurance carriers from discriminating against 340B covered entities and contract pharmacies.

Michigan Gov. Gretchen Whitmer (D) signed three bills today that prohibit pharmacy benefit managers (PBMs) and insurance carriers from discriminating against 340B covered entities and their contract pharmacies.

HB 4348 says PBMs and insurers shall not prohibit

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Federal Judge Denies Fla. Healthcare Providers’ Bid to Throw Out Gilead’s Suit Alleging 340B Fraud

In Federal, JudicialFebruary 23, 2022526 Views

Tom Mirga

A federal judge has denied a group of defendants’ motion to dismiss Gilead’s lawsuit against them alleging fraudulent 340B-related transactions of the company’s PrEP drugs.

A federal district judge in Florida has denied a group of defendants’ motion to dismiss Gilead’s lawsuit against them alleging fraudulent 340B-related transactions on the company’s HIV pre-exposure prophylaxis drugs Truvada and Descovy.

U.S. District Judge Aileen Cannon

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Pharma Consultant Sounds Alarm About Potential Sub-Zero 340B Prices on Some Brand Drugs Starting in 2024

In Federal, Legislative, Pharma IndustryFebruary 23, 2022806 Views

Tom Mirga

A graph from BioCentury's issue brief shows Humira's 340B ceiling price falling to a penny after 2016.

In less than two years, brand drug companies that now must sell their products to 340B covered entities for a penny due to a history of price increases above inflation may have to start paying entities for their

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340B INDUSTRY LEADER SPOTLIGHT

Mary Van Hoozer, Vice President of Sales & Account Management, SUNRx

In Industry Leader Spotlight, Sponsored ContentFebruary 23, 2022371 Views

Diane Slafsky

Q: Where did you grow up?

Arlington Heights, IL, which is a northwest suburb of Chicago (Go Cubs!)

Q: Where did you go to college/graduate school?

I received both

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AstraZeneca Court Ruling Means All Six of HRSA’s 340B Original Contract Pharmacy Violation Letters are Dead

In Federal, JudicialFebruary 17, 20221199 Views

Tom Mirga

After yesterday's court decision in AstraZeneca’s 340B contract pharmacy lawsuit, all six of HRSA's letters telling Astra, Lilly, Novartis, Novo Nordisk, Sanofi, and United Therapeutics that their actions are illegal are dead.

UPDATED Thursday, Feb. 17, 2022, 4:00 p.m. EDT—The U.S. Health Resources and Services Administration (HRSA) said this afternoon, “The 340B program is an essential component of the safety net system that helps make health care and prescription drugs

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