Page 47 - B Program News Today

Thursday, July 22, 2021 below are key updates affecting 340B Program covered entities and some initial recommended next steps as we continue to evaluate the proposal. Comments are due September 17, 2021. CMS confirmed it will continue its reimbursement cuts policy for certain 340B covered entities while it awaits a ruling from the Supreme Court in the ongoing litigation brought against HHS by the American Hospital Association (AHA). CMS also signaled that while certain 340B covered en...

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Thursday, July 8, 2021 On 2 July 2021, the Supreme Court announced that it has accepted the American Hospital Association’s (AHA) petition for certiorari in American Hospital Association v. Becerra. At issue is the Centers for Medicare and Medicaid Services’ (CMS) nearly 30 percent cut to payments for specified covered outpatient drugs (SCODs) under the Medicare Outpatient Prospective Payment System (OPPS) for certain hospitals participating in the 340B Drug Pricing Program (340B ...

Wednesday, July 7, 2021 Recent court decisions and the subsequent rescission of a key advisory opinion have left the status of contract pharmacy programs in continued flux. On 30 December 2020, the Department of Health and Human Services (HHS) released Advisory Opinion 20-06 (the Advisory Opinion) stating that drug manufacturers are required to deliver drugs to contract pharmacies and charge no more than the 340B ceiling price. On 16 June 2021, the U.S. District Court for the District...

Advertisement 340B Drug Pricing Discount Program Update: HRSA Now Demands That Drug Manufacturers Provide 340B Discounts To Contract Pharmacies Amid Ongoing Litigation Friday, July 2, 2021 Now approaching a year-long battle, drug manufacturers and 340B covered entities, which includes hospitals and community health centers, participating in the 340B Drug Pricing Discount Program (“340B Participants”) continue to dispute the issue of whether drug manufacturers are required to give ...

To embed, copy and paste the code into your website or blog: On 17 May 2021, the Acting Administrator of the Health Resources and Services Administration (HRSA), Diana Espinosa, sent letters to six pharmaceutical manufacturers stating that the manufacturers’ actions to limit access to 340B Program pricing for covered entities that dispense medications through contract pharmacies have resulted in overcharges and are in direct violation of the 340B statute. 1 The letters order the manufacturers...

Advertisement 340B Update: HRSA Issues Final Warning Letter to Pharmaceutical Manufacturers that Their Contract Pharmacy Actions Violate 340B Statute Wednesday, May 26, 2021 On 17 May 2021, the Acting Administrator of the Health Resources and Services Administration (HRSA), Diana Espinosa, sent letters to six pharmaceutical manufacturers stating that the manufacturers’ actions to limit access to 340B Program pricing for covered entities that dispense medications through contract pha...

Eli Lilly has fired back at the Department of Health and Human Services, saying the agency has capitulated to political pressure from Congress to "come down on drug manufacturers" that disagreed with the government's interpretation of the 340B law. Lilly has filed a motion for a preliminary injunction against a May 17 order from Health Resources and Service Administration

To embed, copy and paste the code into your website or blog: On May 17, 2021, the Biden Administration took its first major action impacting the 340B Drug Discount Program.  In a forceful statement, the Administration made plain its views on a major controversy that has pitted drug manufacturers against 340B covered entities for the past year - proclaiming that drug manufacturers are violating the 340B statute by restricting covered entity access to 340B discounts for drugs dispensed through 3...

Tuesday, May 18, 2021 On May 17, 2021, the Biden Administration took its first major action impacting the 340B Drug Discount Program.  In a forceful statement, the Administration made plain its views on a major controversy that has pitted drug manufacturers against 340B covered entities for the past year - proclaiming that drug manufacturers are violating the 340B statute by restricting covered entity access to 340B discounts for drugs dispensed through 340B contract pharmacies.  Ba...