Today is President Biden’s 155th day in office, and he has yet to pick someone to run the U.S. Health Resources and Services Administration (HRSA), the federal agency responsible for the 340B drug pricing program.
This normally might be a
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Category: Regulatory
U.S. Health and Human Services (HHS) Secretary Xavier Becerra this morning announced his six appointees to the long-awaited 340B administrative dispute resolution (ADR) board.
The move will be welcomed by the 340B provider community, which has pushed for the creation
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President Biden last Friday nominated career civil servant Christi Grimm to serve as Inspector General of the U.S. Health and Human Services Department (HHS).
The HHS Office of Inspector General (OIG) has issued numerous reports on the 340B program on
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HHS Withdraws 340B Contract Pharmacy Advisory Opinion, Says May 17 Demand Letters Are Unaffected
The U.S. Health and Human Services Department (HHS) yesterday withdrew its December 2020 legal advisory opinion (AO) that the 340B statute unambiguously requires drug manufacturers to
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The Biden administration this morning formally announced plans to rescind the controversial Trump administration final rule requiring community health centers to pass along all 340B drug discount savings on insulin and injectable epinephrine to low-income patients, as a condition for
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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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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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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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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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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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