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Category: Regulatory

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

In Federal, Judicial, Legislative, Pharma Industry, Regulatory, Research/Reports335 Views Tom Mirga
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.
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 dozen price increases on Revlimid from 2005, when Celgene bought the drug, through 2019. It was …
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CMS Seeks Medicare DSH Calculation Change That Could Disqualify Some Hospitals From 340B

In Federal, Regulatory501 Views Ron Shinkman
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.

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

In Federal, Judicial, Legislative, Pharma Industry, Regulatory, Research/Reports463 Views Tom Mirga
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.
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 to numerous health system representatives that 340B Report interviewed. (All current and former health …
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Bristol Myers Squibb/Celgene Myeloma Drugs: Patient-Safety or Profit Motive? Part 3

In Federal, Judicial, Legislative, Pharma Industry, Regulatory, Research/Reports603 Views Tom Mirga
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.
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 mainly in Europe as an over the counter sedative and morning sickness medicine for …
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Bristol Myers Squibb/Celgene Myeloma Drugs: Patient-Safety or Profit Motive? Part 2

In Federal, Judicial, Legislative, Pharma Industry, Regulatory, Research/Reports796 Views Tom Mirga
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.
Editor’s note: We invited Bristol Myers Squibb (BMS), which bought Celgene in November 2019, to respond to allegations of illegal or questionable conduct by Celgene with respect to its myeloma drugs and the 340B program. BMS said: “Bristol Myers Squibb …
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Bristol Myers Squibb/Celgene Myeloma Drugs: Patient-Safety or Profit Motive? Part 1

In Federal, Judicial, Legislative, Pharma Industry, Regulatory, Research/Reports1176 Views Tom Mirga
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 to

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White House Clears Path for HRSA to Rescind Trump’s Health Center 340B Insulin Rule

In Federal, Regulatory487 Views Tom Mirga
The Biden administration moved a step closer yesterday to rescinding a Trump administration rule governing what 340B health centers can charge patients for insulin and epinephrine auto-injectors. | Shutterstock
The White House Office of Management and Budget (OMB) has completed its review of a key regulatory step toward rescinding the Trump administration’s final rule to require health centers to provide insulin and injectable epinephrine to low-income patients at the …
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CMS Moves to Delay Multiple-Best-Price Rule For Value-Based Drug Purchases

In Federal, Regulatory217 Views Ron Shinkman
CMS has proposed delaying the effective date of a rule that would allow multiple best prices in value-based drug purchasing arrangements. | Shutterstock
The U.S. Centers for Medicare & Medicaid Services (CMS) has proposed to delay implementing a portion of a regulation encouraging value-based purchasing for drugs in the Medicaid program that may lead to drugs having multiple best prices.
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Sanofi and Novartis Fight HRSA’s 340B Contract Pharmacy Demand Letters

In Federal, Regulatory664 Views Tom Mirga
Sanofi yesterday sent HRSA a long letter defending its limits on 340B contract pharmacy. | Shutterstock
Drug manufacturer Sanofi yesterday sent the U.S. Health Resources and Services Administration (HRSA) a 30-page defense of its requirement that 340B covered entities must submit their contract pharmacy claims data to a vendor to continue to be able to access …
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