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Category: Judicial

340B Entity Groups Accentuate Positives in 340B Contract Pharmacy Court Opinion

Tom Mirga, Editor at Large Views
The 340B statute “is silent as to the role that contract pharmacies may play in connection with covered entities’ purchases of 340B drugs," a judge ruled Wednesday in a suit filed by AstraZeneca.

Groups representing 340B covered entities are emphasizing the positives in what they say was a federal judge’s otherwise disappointing opinion Wednesday on whether drug makers must offer 340B ceiling prices when covered entities use contract pharmacies.

The groups’ message is,

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Supreme Court Preserves ACA and, with it, the Health Care Reform Law’s 340B Provisions

Tom Mirga, Editor at Large Views
340B hospital challenge to Medicare Part B reimbursement could reverse long-standing legal doctrine.

The U.S. Supreme Court ruled 7-2 this morning that Texas and a dozen other Republican-led states lacked standing to challenge the constitutionality of the Affordable Care Act.

In addition to expanding health insurance to 21 million Americans, the ACA included

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BREAKING: Judge Hands HHS Major Setback in AstraZeneca’s 340B Contract Pharmacy Lawsuit

Tom Mirga, Editor at Large Views
U.S. District Judge Leonard Stark today rejected HHS's conclusion that the 340B statute requires drug makers to offer 340B pricing when covered entities use contract pharmacies.

A federal district judge ruled today that the U.S. Health and Human Services Department’s (HHS) position that the 340B statute requires drug manufacturers that participate in the 340B program to offer discounts on drugs dispensed by contract pharmacies “is not

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Two Closely Watched 340B Lawsuits Will Soon Get a New Judge

Tom Mirga, Editor at Large Views
U.S. District Judge Ketanji Brown Jackson, the judge assigned to two closely watched 340B-related lawsuits, has been elevated to the U.S. Court of Appeals for the District of Columbia Circuit.

In a 53-44 vote, the U.S. Senate yesterday confirmed President Biden’s nomination of Ketanji Brown Jackson, the federal district judge who has been assigned to two closely watched 340B-related lawsuits, for a seat on the U.S. Court of Appeals for

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Bristol Myers Squibb/Celgene Myeloma Drugs: Patient-Safety or Profit Motive? Part 6

Tom Mirga, Editor at Large Views
Our six-part investigative series takes an in-depth look into a question often asked by 340B providers: Why can’t they access 340B pricing on one of Bristol Myers Squibb/Celgene’s most profitable drug products? We also delve into serious fraud allegations, Congressional oversight, and the possibility of a renewed focus on this contentious area under new leadership at the U.S. Health and Human Services Department. Throughout the series, we also provide BMS/Celgene's viewpoint, their justification for their drug pricing practices, limited distribution policies and why they believe they are following the law.

Part 6 of 6—What Happens Next For Revlimid, Pomalyst, Thalomid, and 340B?

As we described in Parts 2 and 3 of this series, in 2018, an ex-Celgene vice president responsible for the company’s 340B program compliance alleged in a whistleblower

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Bristol Myers Squibb/Celgene Myeloma Drugs: Patient-Safety or Profit Motive? Part 5

Tom Mirga, Editor at Large Views
Our six-part investigative series takes an in-depth look into a question often asked by 340B providers: Why can’t they access 340B pricing on one of Bristol Myers Squibb/Celgene’s most profitable drug products? We also delve into serious fraud allegations, Congressional oversight, and the possibility of a renewed focus on this contentious area under new leadership at the U.S. Health and Human Services Department. Throughout the series, we also provide BMS/Celgene's viewpoint, their justification for their drug pricing practices, limited distribution policies and why they believe they are following the law.

Part 5 of 6—Revlimid “didn’t get any better…. You just got better at making money”

Last September, the Democratic-controlled U.S. House Oversight and Reform Committee released a 45-page report focused on Celgene and Bristol Myers Squibb’s (BMS’s) nearly two

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Bristol Myers Squibb/Celgene Myeloma Drugs: Patient-Safety or Profit Motive? Part 4

Tom Mirga, Editor at Large Views
Our six-part investigative series takes an in-depth look into a question often asked by 340B providers: Why can’t they access 340B pricing on one of Bristol Myers Squibb/Celgene’s most profitable drug products? We also delve into serious fraud allegations, Congressional oversight, and the possibility of a renewed focus on this contentious area under new leadership at the U.S. Health and Human Services Department. Throughout the series, we also provide BMS/Celgene's viewpoint, their justification for their drug pricing practices, limited distribution policies and why they believe they are following the law.

Part 4 of 6—How Do Celgene’s Revlimid Policies Affect 340B Hospitals and Patient Care?

The impact on health care providers of being unable to access Revlimid at the 340B price is significant, financially and in terms of patient care, according

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Bristol Myers Squibb/Celgene Myeloma Drugs: Patient-Safety or Profit Motive? Part 3

Tom Mirga, Editor at Large Views
Our six-part investigative series takes an in-depth look into a question often asked by 340B providers: Why can’t they access 340B pricing on one of Bristol Myers Squibb/Celgene’s most profitable drug products? We also delve into serious fraud allegations, Congressional oversight, and the possibility of a renewed focus on this contentious area under new leadership at the U.S. Health and Human Services Department. Throughout the series, we also provide BMS/Celgene's viewpoint, their justification for their drug pricing practices, limited distribution policies and why they believe they are following the law.

Part 3 of 6—The Path From Thalidomide, to Revlimid, to a 340B Whistleblower Lawsuit

The myeloma drugs Revlimid and Pomalyst are analogues of Thalomid, aka thalidomide—a drug that still haunts those who remember the late 1950s and early 1960s. Marketed

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Bristol Myers Squibb/Celgene Myeloma Drugs: Patient-Safety or Profit Motive? Part 2

Tom Mirga, Editor at Large Views
Our six-part investigative series takes an in-depth look into a question often asked by 340B providers: Why can’t they access 340B pricing on one of Bristol Myers Squibb/Celgene’s most profitable drug products? We also delve into serious fraud allegations, Congressional oversight, and the possibility of a renewed focus on this contentious area under new leadership at the U.S. Health and Human Services Department. Throughout the series, we also provide BMS/Celgene's viewpoint, their justification for their drug pricing practices, limited distribution policies and why they believe they are following the law.

Part 2 of 6—A Pharmaceutical Industry Insider’s Claims of Massive Fraud Against 340B Providers

Editor’s note: We invited Bristol Myers Squibb (BMS), which bought Celgene in November 2019, to respond to allegations of illegal or

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Bristol Myers Squibb/Celgene Myeloma Drugs: Patient-Safety or Profit Motive? Part 1

Tom Mirga, Editor at Large Views
Our six-part investigative series takes an in-depth look into a question often asked by 340B providers: Why can’t they access 340B pricing on one of Bristol Myers Squibb/Celgene’s most profitable drug products? We also delve into serious fraud allegations, Congressional oversight, and the possibility of a renewed focus on this contentious area under new leadership at the U.S. Health and Human Services Department. Throughout the series, we also provide BMS/Celgene's viewpoint, their justification for their drug pricing practices, limited distribution policies and why they believe they are following the law.

Part 1 of 6—Why Can So Few 340B Hospitals Buy and Dispense the Highly Profitable Cancer Drug Revlimid?

Possibly more than a thousand hospitals in the 340B drug discount program can’t buy or dispense Revlimid, a widely-used oral drug

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