Improving Seniors’ Timely Access to Care Act of 2022 Entering Markup Phase
In late July 2022, the United States House of Representatives Ways and Means Committee marked up H.R. 8487, the Improving Seniors’…
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Biotronik Reaches Nearly $13 Million Settlement with DOJ Over Alleged False…
On July 22, 2022, the United States Department of Justice (DOJ) announced a $12.95 million settlement with Biotronik Inc., a…
CMS Announces Enhancing Oncology Model Successor to Oncology Care Model
In June, the Centers for Medicare & Medicaid Services (CMS) announced the Enhancing Oncology Model, a successor to the…
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…
Report Finds that Branded Drug Prices Increased an Average of 5% Last Year
Earlier this year, Iqvia released a report, The Use of Medicines in the U.S. 2022, which outlined some of the usage and spending…
Court Rules in Favor of Three Major Opioid Distributors in West Virginia…
On Monday, July 4, 2022, United States District Court Judge David Faber ruled in favor of three opioid distributors – Amerisource…
Analysis of Drug Formulary Exclusions from the Patient’s Perspective
Earlier this year, Robert Popovian, Pharm.D.; Anne M. Sydor, Ph.D.; and Peter Pitts conducted an analysis of drug formulary…
CMS Issues First Fines to Non-Compliant Hospitals Under Price Transparency…
On June 7, 2022, the Centers for Medicare and Medicaid Services (CMS) issued the first fines with respect to the transparency…
HHS OIG Issues Advisory Opinion on Continuing Medical Education, Stark Law…
In June 2022, the United States Department of Health and Human Services Office of Inspector General (HHS OIG) released OIG…
FDA Releases Draft Guidance on Benefit-Risk Principles
On May 10, 2022, FDA published draft guidance entitled, “Benefit-Risk Considerations for Product Quality Assessments”, which…