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Category: Federal

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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Rep. Porter Files Bill to Require Medicare Part B inflation-Based Rebates

Tom Mirga, Editor at Large Views
U.S. Rep. Katie Porter's (D-Calif.) Freedom from Price Gouging Act would require drug manufacturers to pay a Medicare Part B rebate for certain drugs if the price of such drugs increases faster than inflation.

U.S. Rep. Katie Porter (D-Calif.), a California Democrat with a significant national profile, yesterday introduced legislation to require drug manufacturers to pay a Medicare Part B rebate for certain drugs if the price of such drugs increases faster than inflation.

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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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CMS Seeks Medicare DSH Calculation Change That Could Disqualify Some Hospitals From 340B

Ron Shinkman Views
CMS's proposed change to the Inpatient Prospective Payment Systems could cause some hospitals to be disqualified from the 340B program.

The U.S. Centers for Medicare & Medicaid Services is proposing a change to the Medicare disproportionate share hospital (DSH) payment methodology that could cause some hospitals in seven states to be disqualified from the 340B program.

Tucked into the more

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Becerra’s Message to Pharma on 340B: “You Violate the Law, You Pay the Consequences”

Tom Mirga, Editor at Large Views
HHS Secretary Xavier Becerra told a Senate committee this morning his department has sent drug companies "a clear message" that if they violate the 340B statute, they will "pay the consequences."

U.S. Health and Human Services (HHS) Secretary Xavier Becerra told a U.S. Senate Appropriations subcommittee this morning that his department has sent “a clear message” to six drug manufacturers denying 340B discounts on drugs shipped to contract pharmacies “that we

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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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