Category: Federal

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

In Federal, Judicial, Legislative, Pharma Industry, Regulatory, Research/ReportsJune 11, 2021166 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.

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 …

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

In Federal, RegulatoryJune 10, 2021437 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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Becerra’s Message to Pharma on 340B: “You Violate the Law, You Pay the Consequences”

In Federal, LegislativeJune 9, 20211631 Views

Tom Mirga

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 …

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

In Federal, Judicial, Legislative, Pharma Industry, Regulatory, Research/ReportsJune 9, 2021375 Views

Tom Mirga

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 …

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

In Federal, Judicial, Legislative, Pharma Industry, Regulatory, Research/ReportsJune 9, 2021497 Views

Tom Mirga

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 …

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

In Federal, Judicial, Legislative, Pharma Industry, Regulatory, Research/ReportsJune 9, 2021681 Views

Tom Mirga

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 …

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

In Federal, Judicial, Legislative, Pharma Industry, Regulatory, Research/ReportsJune 9, 2021958 Views

Tom Mirga

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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Novartis Says Its Reputation Has Been Injured By HRSA’s 340B Demand Letter

In Federal, JudicialJune 8, 2021650 Views

Tom Mirga

Novartis said HRSA's demand letter is hindering its “ability to recruit talent and build relationships with the stakeholders necessary to develop pharmaceuticals that patients need.” | Shutterstock

Drug manufacturer Novartis told a judge last week that the government’s May 17 public statement that the company’s actions have resulted in overcharges and are in direct violation of the 340B statute has injured Novartis’ reputation among its customers and …

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

In Federal, RegulatoryJune 8, 2021366 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 …

Lynn Barr, a Value-Based Payment and 340B Champion, is Appointed to MedPAC

In Federal, LegislativeJune 8, 2021485 Views

Tom Mirga

New MedPAC Commissioner Lynn Barr says. “I see first-hand how important the 340B program is to safety net patients and providers."

Lynn Barr, the founder and executive chair of a company that helps health systems implement value-based payment models and maximize 340B savings, has been appointed to the Medicaid Payment Advisory Commission (MedPAC).

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