FDA FDA Issues First Untitled Letter of 2024 Thomas Sullivan Feb 27, 2024 0 The United States Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) recently issued the first…
FDA FDA Releases Finalized Guidance on Use of Real-World Data in New Drug and… Thomas Sullivan Feb 26, 2024 0 Recently, the United States Food and Drug Administration (FDA) finalized two guidance documents that outline how sponsors can use…
DOJ DOJ Declines Prosecution of HealthSun After Company Uses Voluntary… Thomas Sullivan Feb 23, 2024 0 Recently, the United States Department of Justice sent a letter regarding their decision to decline prosecution of HealthSun…
Guidelines Pharmaceutical Industry Pushes Back on Draft Guidance Issued by FDA Over… Thomas Sullivan Feb 22, 2024 0 Towards the end of last year, the United States Food and Drug Administration (FDA) issued a draft guidance that revisited its…
Medicare ACOs Do Not Positively Influence Chronic Mental Health Treatment for… Thomas Sullivan Feb 21, 2024 0 A recent study found that accountable care organizations do not have a positive influence on treatment and outcomes for chronic…
Affordable Care Act Risk Adjustment Payment Program in the ACA Seems to Be Working Thomas Sullivan Feb 20, 2024 0 A recent analysis conducted by Oliver Wyman Actuarial and backed by the Blue Cross Blue Shield Association, found that overall,…
Anti Kickback DOJ Reaches $45 Million Settlement with Skilled Nursing Facilities Over… Thomas Sullivan Feb 19, 2024 0 The United States Department of Justice (DOJ) recently reached a $45.6 million settlement with six skilled nursing facilities…
Opioids North Carolina Reaches $1.45 Million Settlement with South Carolina Medical… Thomas Sullivan Feb 16, 2024 0 North Carolina Attorney General Josh Stein recently announced a $1.45 million settlement with South Carolina clinic Med First…
CMS AMGA Opposes Disincentives for Health Care Providers that Commit… Thomas Sullivan Feb 15, 2024 0 AMGA recently sent a letter to the United States Centers for Medicare and Medicaid Services (CMS) Administrator Chiquita…
False Claims Act California Company Reaches $6 Million False Claims Settlement with DOJ Thomas Sullivan Feb 14, 2024 0 Ultragenyx Pharmaceutical, a company based in California, recently agreed to pay $6 million to settle allegations that it caused…