Policy & Medicine

COVID Didn’t Seem to Slow Down FDA Drug Approvals

Thomas Sullivan May 18, 2022 0

While COVID-19 has impacted almost every facet of our lives over the last few years, one area that it didn’t seem to have a huge impact on is drug approvals by the United States Food and Drug Administration (FDA). Average review time in the United States did not decrease either during the pandemic nor in the early months following the re-opening of…

Policy and Medicine Compliance Update April 2022 Issue…

Thomas Sullivan Apr 23, 2022 0

Policy and Medicine Compliance Update March 2022 Issue…

Thomas Sullivan Mar 12, 2022 0

COVID Didn’t Seem to Slow Down FDA Drug Approvals

While COVID-19 has impacted almost every facet of our lives over the last few years, one area that it didn’t seem to have a huge impact on is drug approvals by the United States Food and Drug…

CMS and HHS Release Notice of Benefit and Payment Parameters…

On April 28, 2022, the United States Centers for Medicare and Medicaid Services (CMS) and Department of Health and Human Services (HHS) released the 2023 Notice of Benefit and Payment Parameters Final…

Marketers Sentenced for Role in Health Care Kickback Scheme

In mid-April 2022, two marketers were sentenced in federal court to twelve months of probation and hundreds of thousands of dollars in restitution for their role in a kickback scheme. According to…

Amazon Subsidiary Reaches $5.79 Million Settlement Over Insulin…

Recently, the Department of Justice (DOJ) announced a $5.79 million settlement with PillPack, an Amazon subsidiary, in a fraud lawsuit for over-dispensing insulin. The settlement covers allegations…

California Looking to Add Gender-Affirming CME to Required CME…

The California Senate Health Committee recently passed a bill through Committee to improve access to gender affirming care. Under the legislation, staff and contracted providers of a Medi-Cal managed…

Otis Brawley on the National Cancer Act and Its Impact on Health…

During the American Academy of Dermatology Annual Meeting in March 2022, Otis W. Brawley, MD, MACP, FRCP(L), Bloomberg Distinguished Professor of Oncology and Epidemiology at Johns Hopkins, spoke…

CVS Reaches $484 Million Opioid Settlement with Florida

At the end of March 2022, CVS Health announced a $484 million settlement with the State of Florida to resolve long-standing claims related to prescriptions for opioid medications that were filled at…

DOJ Joins Whistleblower Suit Against EHR Company for Alleged…

Earlier this year, the United States Department of Justice filed a notice of partial intervention into a whistleblower suit against Modernizing Medicine (ModMed), an electronic health records (EHR)…

DOJ Files Suit Against Methodist Hospitals Over Alleged False…

On April 11, 2022, the United States filed a complaint-in-intervention, alleging that Methodist Le Bonheur Healthcare (MLH) and Methodist Healthcare Memphis Hospitals (collectively, Methodist), paid…

HHS OCR Announces Four Enforcement Actions for HIPAA Violations

On March 28, 2022, the United States Department of Health and Human Services Office of Civil Rights (HHS OCR) announced four new enforcement actions against healthcare providers for violations of the…

Budget Increase for the FDA in 2023?

In March 2022, United States President Joe Biden released his budget request for Fiscal Year 2023, which included a significant boost for the United States Food and Drug Administration (FDA) – an…

Sun Pharma Reaches $485 Million Settlement Over Alleged…

On March 23, 2022, Sun Pharmaceutical Industries Ltd. reached a $485 million settlement to resolve class action lawsuits that alleged its subsidiary, Ranbaxy, Inc., engaged in an anticompetitive…