Page 51 - B Program News Today

In Featured, News by Ged Kenslea December 21, 2020 Amgen joined eight other rogue drug companies by declaring last week that it will refuse to sell ‘orphan drugs’ (expensive drugs for rare diseases) at the legally required ‘340B price’ as required by section 340B of the U.S. Public Health Services Act Refusals are tone-deaf moves by obscenely wealthy drug companies during height of coronavirus pandemic WASHINGTON (December 21, 2020) AIDS Healthcare Foundation (AHF) will host a social...

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and analyses; and other health policy news. Week in Review Highlight of the Week: On Wednesday, HHS finalized its review of Phase 3 Provider Relief Fund applications and began distribution of the funds. Read more about this action and other news below. I. Regulations, Noti...

To embed, copy and paste the code into your website or blog: On December 14, 2020, the U.S. Health Resources and Services Administration (HRSA) published a final rule (Final Rule) in the Federal Register defining an administrative dispute resolution (ADR) process for the 340B Drug Pricing Program (340B Program). The Final Rule takes effect 30 days after that date of publication, on January 13, 2021. The Final Rule establishes an ADR process for two types of disputes: “Claims by covered entiti...

To embed, copy and paste the code into your website or blog: On December 10, 2020, the Health Resources and Services Administration (HRSA) released a Final Rule to establish an administrative dispute resolution (ADR) process and ADR panels to resolve certain 340B Program disputes between drug manufacturers and 340B covered entities. The establishment of a 340B ADR process was mandated by the Affordable Care Act (ACA) more than 10 years ago. Nevertheless, the timing of the release has raised con...

To embed, copy and paste the code into your website or blog: On December 14, 2020, HRSA established a long overdue Administrative Dispute Resolution (ADR) process that allows covered entities and drug manufacturers to bring claims against each other related to the 340B Drug Pricing Program (340B Program). The ADR process will allow covered entities and drug manufacturers to formally request agency review of alleged 340B violations. The ADR process will begin amid contentious disputes about the ...

1. 340B ADR Process Established At long last, more than ten years after Congress directed it to do so, HHS has finalized an alternative dispute resolution (“ADR”) process for both providers and pharmaceutical manufacturers participating in the 340B Program. 85 Federal Register 80632 (Dec. 14, 2020), available athttps://www.govinfo.gov/content/pkg/FR-2020-12-14/pdf/2020-27440.pdf (“ADR Rule”). This Rule will allow aggrieved providers to bring pharmaceutical manufacturers to a final and ...

Reply Dec. 16, 2020 Attorney General William Tong today led a bipartisan coalition of attorneys general urging the U.S. Department of Health and Human Services (HHS) to hold accountable drug manufacturers that are unlawfully imperiling access to affordable prescriptions for low-income patients. Subscribe "Drug manufacturers are unlawfully attempting to disrupt arrangements that have long made it easier for low-income Americans to access prescription drugs. HHS must immediately step in to protec...

Tuesday, December 15, 2020 On December 10, 2020, the Health Resources and Services Administration (HRSA) released a Final Rule to establish an administrative dispute resolution (ADR) process and ADR panels to resolve certain 340B Program disputes between drug manufacturers and 340B covered entities. The establishment of a 340B ADR process was mandated by the Affordable Care Act (ACA) more than 10 years ago. Nevertheless, the timing of the release has raised concerns regarding the effe...

New HHS Board Will Hear 340B Drug Pricing Disputes Tuesday, December 15, 2020 On December 14, 2020, HRSA established a long overdue Administrative Dispute Resolution (ADR) process that allows covered entities and drug manufacturers to bring claims against each other related to the 340B Drug Pricing Program (340B Program). The ADR process will allow covered entities and drug manufacturers to formally request agency review of alleged 340B violations. The ADR process will begin amid co...

Tuesday, December 15, 2020 The U.S. Health Resources and Services Administration (HRSA) recently released a draft final rule (Final Rule) that establishes a binding administrative dispute resolution (ADR) process concerning drug costs under the Federal 340B Drug Discount Program (340B Program). As per its terms, the Final Rule will be formally published on Dec. 13, 2020 and will take effect on Jan. 13, 2021. The Final Rule comes after a nearly 10-year wait for HRSA to establish an ADR...