Signaling a possible future approach to regulating Schedule II-V prescribing via telemedicine in lieu of in-person examinations, on January 17 the DEA issued a notice of proposed rulemaking regarding its next iteration of...more
This report compiles several important developments that shaped the healthcare and life sciences industries in 2024 and spotlights key areas to watch in 2025. Each section addresses either an industry sector within healthcare...more
US Congress on December 20, 2024 passed a last-minute temporary government funding bill that keeps the government open for three months. As part of this package, a number of existing telehealth flexibilities were also...more
The Biden administration announced on January 30, 2023 that the COVID-19 Public Health Emergency (PHE) would officially end on May 11, 2023. The PHE declaration, which first was issued by the Secretary of the US Department of...more
Companies marketing products or services for coronavirus (COVID-19) should be aware of key areas of healthcare law and regulation, including Food and Drug Administration regulation, clinical laboratory testing oversight,...more
7/9/2020
/ Centers for Medicare & Medicaid Services (CMS) ,
Clinical Laboratory Testing ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Food and Drug Administration (FDA) ,
Immunity ,
Product Defects ,
Public Readiness and Emergency Preparedness Act (PREP Act) ,
Risk Mitigation ,
Suppliers ,
Supply Chain ,
Telehealth
CMS posted an expanded set, dated April 29, of Medicare regulatory flexibility measures for hospice organizations related to the coronavirus (COVID-19) pandemic, supplementing the previous COVID hospice flexibilities guidance...more