Polsinelli Podcasts - Confusion to Clarity on the Future of the 340B Program
On September 23, 2023, one year ago, President Biden signed the Securing the U.S. Organ Procurement and Transplantation Network Act into law, which allowed competitive bidding for various federal contracts under the Organ...more
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,...more
The Organ Procurement and Transplantation Network (OPTN) is a public-private partnership that manages the US organ donation and transplantation system. Today, more than 100,000 people are on the organ transplant waiting list,...more
White House Expected to Sign Law Opening Competitive Bidding for Organ Procurement and Transplantation Network Activities On July 27, 2023, the U.S. Senate passed H.R. 2544 - Securing the U.S. Organ Procurement and...more
This new legislation supports the Health Resources and Services Administration ("HRSA") modernization initiative announced in March, including several actions to strengthen accountability and transparency in the Organ...more
Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector. ...more
On March 22, 2023, the Health Resources and Services Administration (HRSA), an HHS subagency, announced major reforms for the nation’s organ transplant system. Chief among the reforms is to increase competition and...more
On March 22, 2023, the Health Resources and Services Administration (HRSA), an agency of the U.S. Department of Health and Human Services, launched the Organ Procurement and Transplantation Network Modernization Initiative...more
After some implementation delays, the final rule updating Organ Procurement Organization (OPO) performance measures took effect April 1, 2021. The final rule, titled, “Medicare and Medicaid Programs: Organ Procurement...more
On December 17, 2019, the Centers for Medicare & Medicaid Services (“CMS”) issued a proposed rule to revise the Conditions for Coverage that Organ Procurement Organizations (“OPOs”) must satisfy in order for organ procurement...more
Compliance Today (February 2020) - On December 17, the U.S. Department of Health and Human Services (HHS) announced in a press release, “As directed by President Trump in his July 10 Executive Order on Advancing American...more
On December 17, 2019, CMS and HRSA announced two proposed rules intended to: (1) enforce accountability from Organ Procurement Organizations (OPO) for their performance; and (2) promote more organ donations from living...more