On December 28, 2024, a long-awaited Centers for Medicare & Medicaid Services (CMS) final rule became effective, significantly updating laboratory personnel requirements under Subpart M of the Clinical Laboratory Improvement...more
2/3/2025
/ Centers for Medicare & Medicaid Services (CMS) ,
CLIA ,
Clinical Laboratories ,
Compliance ,
Department of Health and Human Services (HHS) ,
Final Rules ,
Health Care Providers ,
New Regulations ,
Proposed Rules ,
Regulatory Requirements ,
Reporting Requirements
New regulations under the Clinical Laboratory Improvement Amendments (CLIA) introduced updated proficiency testing (PT) and PT referral rules that are now in effect. Although the regulations became effective on July 11, 2024,...more
1/6/2025
/ Centers for Medicare & Medicaid Services (CMS) ,
CLIA ,
Clinical Laboratories ,
Diagnostic Tests ,
Health Care Providers ,
Life Sciences ,
New Regulations ,
Regulatory Agenda ,
Regulatory Requirements ,
Technology Sector ,
Telehealth ,
Telemedicine
On March 5, 2024, the US Food and Drug Administration (FDA) granted clearance to market the first over-the-counter (OTC) continuous glucose monitor (CGM). Dexcom’s Stelo Glucose Biosensor System (Stelo) is an integrated CGM...more
Trending in Telehealth highlights state legislative and regulatory developments that impact the healthcare providers, telehealth and digital health companies, pharmacists and technology companies that deliver and facilitate...more
11/6/2023
/ Digital Health ,
Health Care Providers ,
Healthcare ,
Healthcare Reform ,
Legislative Agendas ,
Licensing Rules ,
Life Sciences ,
Medical Licensure Compact ,
Proposed Legislation ,
Regulatory Requirements ,
Rulemaking Process ,
State and Local Government ,
Telehealth ,
Telemedicine
Trending in Telehealth highlights state legislative and regulatory developments that impact the healthcare providers, telehealth and digital health companies, pharmacists and technology companies that deliver and facilitate...more
10/27/2023
/ Digital Health ,
Health Care Providers ,
Healthcare ,
Healthcare Reform ,
Legislative Agendas ,
Pharmaceutical Industry ,
Pharmacies ,
Regulatory Agenda ,
State and Local Government ,
Technology Sector ,
Telehealth ,
Telemedicine
Trending in Telehealth highlights state legislative and regulatory developments that impact the healthcare providers, telehealth and digital health companies, pharmacists and technology companies that deliver and facilitate...more
Trending in Telehealth highlights state legislative and regulatory developments that impact the healthcare providers, telehealth and digital health companies, pharmacists and technology companies that deliver and facilitate...more
This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity for July 2023. We discuss several criminal and civil enforcement actions that involve violations of the False Claims Act...more
9/1/2023
/ Advisory Opinions ,
Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Medicare ,
OIG ,
Over The Counter Drugs (OTC) ,
Pharmaceutical Industry ,
Physicians ,
Proposed Regulation ,
Regulatory Agenda ,
Reimbursements ,
Settlement
McDermott’s digital health team continually monitors legal developments affecting all aspects of the remote delivery of care. This inaugural issue of our Of Digital Interest Quarterly Roundup highlights key issues and trends...more
4/28/2023
/ Banking Sector ,
Controlled Substances ,
DEA ,
Digital Health ,
Financial Crisis ,
Health Care Providers ,
Pharmaceutical Industry ,
Prescription Drugs ,
Proposed Rules ,
Regulatory Agenda ,
Rulemaking Process ,
Silicon Valley ,
State and Local Government ,
Telehealth ,
Telemedicine
On December 23, 2022, US Congress approved a year-end omnibus legislative package, Consolidated Appropriations Act, 2023 (CAA 2023), which consists of all 12 fiscal year 2023 appropriations bills and numerous other...more