Policy & Medicine

Eli Lilly Found Liable for Defrauding the Medicaid Program

Thomas Sullivan Aug 9, 2022 0

On August 3, 2022, a jury found Eli Lilly liable for underpaying rebates under the Medicaid Drug Rebate Program and ordered the company to pay more than $61 million in damages. The lawsuit was initially brought by a former executive of a network of regional drug wholesalers under the False Claims Act, so the company is liable for treble damages,…

Policy and Medicine Compliance Update July 2022 Issue:…

Thomas Sullivan Jul 22, 2022 0

Policy and Medicine Compliance Update – June 2022 Issue:…

Thomas Sullivan Jun 24, 2022 0

Eli Lilly Found Liable for Defrauding the Medicaid Program

On August 3, 2022, a jury found Eli Lilly liable for underpaying rebates under the Medicaid Drug Rebate Program and ordered the company to pay more than $61 million in damages. The lawsuit was…

Improving Seniors’ Timely Access to Care Act of 2022 Entering…

In late July 2022, the United States House of Representatives Ways and Means Committee marked up H.R. 8487, the Improving Seniors’ Timely Access to Care Act of 2022, unanimously voting to advance the…

Biotronik Reaches Nearly $13 Million Settlement with DOJ Over…

On July 22, 2022, the United States Department of Justice (DOJ) announced a $12.95 million settlement with Biotronik Inc., a medical device manufacturer, to resolve allegations that the company…

CMS Announces Enhancing Oncology Model Successor to Oncology…

In June, the Centers for Medicare & Medicaid Services (CMS) announced the Enhancing Oncology Model, a successor to the Oncology Care Model. The new voluntary model will start in July 2023 and run…

CMS and FDA Show United Front on Aduhelm Approval and Coverage

Earlier this year, Centers for Medicare and Medicaid Services (CMS) Administrator Chiquita Brooks-LaSure and Food and Drug Administration (FDA) Commissioner Robert M. Califf, MD, released a joint…

Report Finds that Branded Drug Prices Increased an Average of 5%…

Earlier this year, Iqvia released a report, The Use of Medicines in the U.S. 2022, which outlined some of the usage and spending trends with an outlook to 2026. The report notes that while patient…

Court Rules in Favor of Three Major Opioid Distributors in West…

On Monday, July 4, 2022, United States District Court Judge David Faber ruled in favor of three opioid distributors – Amerisource Bergen Drug Co., Cardinal Health Inc., and McKesson Corp. – finding…

Analysis of Drug Formulary Exclusions from the Patient’s…

Earlier this year, Robert Popovian, Pharm.D.; Anne M. Sydor, Ph.D.; and Peter Pitts conducted an analysis of drug formulary exclusions from the patient’s perspective. The authors noted that pharmacy…

CMS Issues First Fines to Non-Compliant Hospitals Under Price…

On June 7, 2022, the Centers for Medicare and Medicaid Services (CMS) issued the first fines with respect to the transparency rules that took effect in January 2021. Under the transparency rules,…

HHS OIG Issues Advisory Opinion on Continuing Medical Education,…

In June 2022, the United States Department of Health and Human Services Office of Inspector General (HHS OIG) released OIG Advisory Opinion No. 22-14. HHS OIG was responding to a written request for…

FDA Releases Draft Guidance on Benefit-Risk Principles

On May 10, 2022, FDA published draft guidance entitled, “Benefit-Risk Considerations for Product Quality Assessments”, which describes the benefit-risk principles applied by FDA when conducting…

Clinical Education Alliance Accelerates Primary Care Education…

Clinical Education Alliance (CEA) Holdings today announced the acquisition of Rockpointe Corporation, a premier healthcare education company and provider of accredited continuing medical education…