Policy & Medicine – Legal, Regulatory, and Compliance Issues
Legal, Regulatory, and Compliance Issues. Mary Riordan, Senior Counsel at the US Health and Human Services Office of Inspector General (HHS-OIG) provided significant updates on current HHS-OIG initiatives, enforcement actions, and upcoming compliance guidelines during her presentation at the 25th Annual Pharmaceutical and Medical Device Ethics …
Home Main – Policy & Medicine
The United States Department of Justice (DOJ) recently announced that Teva Pharmaceuticals USA Inc. and Teva Neuroscience Inc. will pay $450 million to resolve allegations of violating the Anti-Kickback Statute (AKS) and the False Claims Act (FCA). The settlement represents a significant enforcement action under these statutes and may have ...
Reevaluating the RUC Committee: Addressing ... - Policy & Medicine
1 day ago · The shortage of primary care providers across the United States leaves patients struggling to access preventive and primary care services. As highlighted in a recent article by Shawn Martin, one solution to addressing this shortage is to ensure primary care services receive reasonable valuation within Medicare’s reimbursement structure.
About Us – Policy & Medicine
About Policy & Medicine. Policy & Medicine offers a daily look at legal, regulatory, and compliance issues affecting the pharmaceutical and device industry. Since its inception in 2008, Policy & Medicine has become one of the most widely followed websites in its field. Policy & Medicine provides detailed analysis of many important compliance ...
Global – Policy & Medicine
Oct 8, 2024 · CMS 508. Congress 437. State Policy 343. Medical Legal 323. Pharmaceutical and Device 279. DOJ 266. Open Payments 261. Physician Payment Sunshine Act 257. Drug Prices 207.
International – Policy & Medicine
Thomas Sullivan May 12, 2023 0. Recently, the Department of Justice (DOJ) reached a $765,000 settlement with Danco Laboratories, LLC, to resolve allegations that…. COVID-19.
Medical Legal – Policy & Medicine
Eighth Circuit Deals Blow to Pharmaceutical Industry in 340B Decision. Thomas Sullivan May 29, 2024 0. The Eighth Circuit Court of Appeals recently ruled that the State of Arkansas is able to block manufacturers from limiting the…. Medical Legal.
What a Trump Presidency Could Mean for the Life Sciences Industry
6 days ago · With Donald Trump now confirmed as the President-elect, the life sciences industry is bracing for significant policy shifts that could impact everything from drug pricing to regulatory practices. Trump’s previous term may offer clues about his likely approach to healthcare, Food and Drug Administration (FDA) regulations, and trade policies ...
FDA – Policy & Medicine
FDA Issues Final Rule, Confirming IVDs are Devices Under the FD&C Act. Thomas Sullivan May 10, 2024 0. The United States Food and Drug Administration (FDA) recently published a final rule, making it explicit that in vitro diagnostic…. FDA.
2021 – Policy & Medicine
False Claims Amendments Act of 2021 Continues to Wind Through Congress. Thomas Sullivan Dec 23, 2021 0. Earlier this year, Senator Chuck Grassley and a bipartisan group of senators introduced the False Claims Amendment Act of 2021,…. FDA.