The U.S. Health Resources and Services Administration (HRSA) told drug manufacturer Celgene nearly five years ago the company “must ensure” that covered entities could buy its cancer drugs Revlimid, Pomalyst, and Thalomid at the 340B ceiling price through Celgene’s limited
Read More »Category: Regulatory
A Vermont community health center that co-initiated 340B administrative dispute resolution (ADR) proceedings against AstraZeneca over its conditions on 340B contract pharmacy yesterday asked the panel hearing its claim to deny the drug company’s motion to stay the proceedings.
Little
Read More »Three drug manufacturers—including two that have imposed conditions on 340B contract pharmacy—posted public notices this week to 340B covered entities about refunds for charges above 340B ceiling prices.
Bristol Myers Squibb (BMS) and Novo Nordisk’s notices came to light yesterday
Read More »340B program flexibilities will continue under the eighth 90-day extension of the COVID-19 national public health emergency (PHE) late last week.
U.S. Health and Human Services (HHS) Secretary Xavier Becerra renewed the PHE on Friday, Jan. 14.
Read More »The Centers for Medicare & Medicaid Services (CMS) yesterday proposed changing Medicare Part D rules to curb plan sponsors and pharmacy benefit managers’ skyrocketing use of direct and indirect renumeration fees (DIR)—PBMs’ controversial practice of clawing back drug payments to
Read More »A federal judge in Sacramento, Calif., late yesterday declined to stop California Medicaid’s transfer of managed care drug coverage to Medicaid fee for service that took effect on Jan. 1. Health centers enrolled in the 340B drug pricing program pledged
Read More »The U.S. Health Resources and Services Administration (HRSA), the agency that runs the 340B drug pricing program, has a permanent leader again for the first time in almost a year.
Carole Johnson started in her position as HRSA administrator on
Read More »The Biden administration is rescinding an unimplemented Trump-era regulation that would have pegged Medicare Part B drug reimbursement for 50 expensive, physician-administered drugs on the lowest price that drug manufacturers provide in similar countries.
The U.S. Centers for Medicare &
Read More »The first 340B covered entity registration period of the year will be Jan. 1-18, 2022, for an effective start date of April 1, 2022.
Eligible hospitals, health centers, clinics, and their child sites and contract pharmacies registered during the period
Read More »Just over 850 hospitals in the 340B program asked the federal government yesterday to appeal a judge’s Nov. 5 ruling that halted enforcement actions against two drug companies that deny 340B pricing when hospitals and others use contract pharmacies. They
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