On July 11, 2025, the U.S. Department of Health and Human Services (“HHS”), Office of Inspector General (“OIG”) posted a report that announced the findings of a cybersecurity audit it conducted of a large Northeastern...more
The Centers for Medicare & Medicaid Services (“CMS”) has extended the window for skilled nursing facilities (“SNFs”) to file off-cycle Medicare revalidation documents until January 1, 2026. This marks CMS’ third deadline...more
The Centers for Medicare & Medicaid Services (“CMS”), Center for Clinical Standards and Quality recently announced upcoming changes to skilled nursing facility (“SNF”) profiles on the Medicare Care Compare website. Care...more
In their song, “Surprise, Surprise,” the Rolling Stones lamented about being caught off guard by a disappointing relationship. Sixty years later, foreign manufacturers may face the surprise of an unannounced inspection by the...more
5/23/2025
/ Compliance ,
Enforcement Actions ,
Food and Drug Administration (FDA) ,
Government Agencies ,
Imports ,
Inspection Rights ,
International Trade ,
Life Sciences ,
Manufacturers ,
New Regulations ,
Regulatory Requirements
The Georgia Department of Community Health (“DCH”) board recently authorized the final adoption of new staffing rules for personal care homes and assisted living communities. These rules are designed to implement a July 1,...more
5/23/2025
/ Assisted Living Facilities (ALFs) ,
Change of Ownership ,
Compliance Dates ,
Final Rules ,
Georgia ,
Healthcare Facilities ,
Healthcare Workers ,
New Regulations ,
Nursing Homes ,
Regulatory Requirements ,
State and Local Government
On January 23, 2025, the U.S. Court of Appeals for the Fourth Circuit affirmed a federal district court’s ruling against the Pharmaceutical Coalition for Patient Access (“Coalition”), rejecting its challenge to an unfavorable...more