The Biden administration last Friday, as widely expected, proposed withdrawing or repealing a Trump administration final rule that will automatically extinguish all U.S. Health and Human Services (HHS) regulations if HHS does not renew each regulation within a certain timeframe.
…Category: Regulatory
2021 is on track to rival peak year 2018 in lobbying intensity on the 340B drug pricing program.
Attention on health care lobbying in Washington today focuses on the huge sums the drug industry is spending fighting Democratic drug price
…The U.S. Health Resources Services Administration (HRSA) has ordered two drug manufacturers that it audited—Akorn Inc. and BioComp Pharma—to repay 340B covered entities for overcharges.
HRSA updated its fiscal year 2021 audit results on its website last week. …
The federal government and the two groups that sued it separately to force it to issue long delayed 340B administrative dispute resolution (ADR) regulations agreed last night to keep stays in place in both lawsuits until Jan. 3, 2022. Meanwhile,
…UPDATE Tuesday, Oct. 26, 2021, 5:00 p.m. EDT—We have updated this article to reflect new information from the California Department of Health Care Services (DHCS) about the timeframe for the U.S. Centers for Medicare & Medicaid Services (CMS) to complete
…The Biden administration yesterday formally announced that it wants to repeal a regulation issued during ex-President Trump’s last days in office that has helped to cast doubt on the authority of federal health care guidance, including for the 340B program.
…Bristol Myers Squibb’s Celgene subsidiary has removed purchasing limits due to demand-related supply constraints on its injectable acute myeloid leukemia (AML) drug Vidaza that have been in place since May 2020.
BMS announced the switch back to normal sales in
…The U.S. Health and Human Services Department (HHS) is poised to rescind Trump administration regulations that have added to doubt about the authority of HHS guidance documents, including those for the 340B program.
During the Trump administration, the U.S Health
…Hundreds of family planning clinics that lost their Title X federal grants and 340B eligibility because they opposed a Trump-era rule barring them from providing abortion referrals might return to Title X and 340B soon.
The U.S. Department of Health
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