Articles and Blogs

On June 27, 2023, the Food and Drug Administration (“FDA”) issued its Final Guidance for the presentation of “Quantitative Efficacy and Risk Information” in Direct-to-Consumer (“DTC”) promotional labeling and advertisements for prescription drug and biological products, prescription animal drugs and DTC promotional labeling for over-the-counter animal drugs. The Final Guidance provides recommendations on how... READ MORE

After no enforcement actions for the first six months of 2023, enforcement from the Food and Drug Administration’s (“FDA”) Office of Prescription Drug Promotion (“OPDP”) is heating up with two new letters issued in the month of August. The first was a Warning Letter issued on August 4, 2023, to a pharmaceutical manufacturer for... READ MORE

On September 1, 2023, the Centers for Medicare & Medicaid Services (“CMS”) released a proposed rule (“Proposed Rule”) that calls for minimum staffing standards in long-term care facilities (“nursing homes”). If finalized, the changes in the Proposed Rule would be used to survey nursing homes for compliance and enforced as part of CMS’s existing survey,... READ MORE

NATIONAL AHA issues letter of support for ‘gold card’ legislation AHA presses CMS to do more on cost sharing, junk plans Amazon’s One Medical CEO to step down later this year Americans support Medicare drug price negotiations CMS threatens to cut hospices from Medicare if they can’t prove legitimacy Data breaches are down, but... READ MORE

In the past two years, many health systems have been selling their long-term care, home health, nursing home, hospice and lab businesses, largely due to rising costs and regulatory pressures. This trend reflects a shift from ownership to partnership models as hospital systems focus on cost reduction and operational simplicity. Despite some financial struggles... READ MORE

On August 16, 2023, a three-judge panel of the Fifth Circuit Court of Appeals issued an opinion in the ongoing litigation regarding the U.S. Food & Drug Administration (“FDA”) approval and regulation of mifepristone (brand name Mifeprex), a drug used in medically induced abortions. The panel vacated in part and affirmed in part a... READ MORE

In August 2023, the full Fifth Circuit joined the Sixth and D.C. Circuits in broadening the kinds of employment actions capable of supporting a Title VII claim. Traditionally in the Fifth Circuit as elsewhere, Title VII actions have been limited to “ultimate employment decisions”, typically involving hiring or firing. In Hamilton v. Dallas County,... READ MORE

On August 3, 2023, the U.S. District Court for the Eastern District of Texas (the “Court”) concluded that the Department of Health and Human Services, the Department of Labor and the Department of the Treasury (collectively “the Departments”) violated statutory rulemaking procedure and therefore vacated two aspects of the Departments’ guidance related to the... READ MORE

Health care experts questioned Kaiser’s strategy for its new health system, Risant Health. Kaiser’s strategy involves developing a nationwide health system aimed at large corporate customers that would compete with Amazon, Aetna CVS, Walmart Health and United Healthcare on cost. Critics note that Risant doesn’t have its own network of physicians (like Kaiser has... READ MORE

NATIONAL AHA shares proposals for drug shortage legislation with House committee America’s biggest hospital landlord sees deals souring Babylon Health files for bankruptcy Bankruptcies mounting in troubled nursing home industry Calls grow for national patient safety board: 3 leaders weigh in CMS details plan to allow Part D beneficiaries to pay in installments Healthcare... READ MORE