In November 2021, the Centers for Medicare & Medicaid Services (CMS) rescinded a short-lived program to expedite national Medicare coverage for innovative devices amid safety concerns for Medicare patients. CMS has strived...more
The U.S. Food and Drug Administration (FDA) is continuing its effort to provide industries with updated guidance for digital health technologies. On April 3, 2023, the FDA released draft guidance titled “Marketing Submission...more
The medical product and healthcare service industry is one of the most closely regulated sectors in the U.S. Several agencies actively exercise authority with constantly changing legislation and policies to keep pace with...more
2/13/2023
/ False Claims Act (FCA) ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Healthcare ,
Life Sciences ,
Manufacturers ,
Medical Devices ,
Medicare ,
Pharmaceutical Industry ,
Private Equity ,
Telemedicine
Host Mary O'Brien interviews Wilson Sonsini partner Paul Gadiock exploring the convergence of the gaming and healthcare industries....more
On November 1, 2022, the Centers for Medicare & Medicaid Services (CMS) issued the 2023 Physician Fee Schedule (PFS) Final Rule. CMS publishes a PFS annually so as to make changes in federal healthcare reimbursement and...more
President Joe Biden was sworn into office on January 20, 2021. As with any incoming administration, new policies will be pursued while those of the previous administration are furthered, abandoned, or undone. The federal...more
3/1/2021
/ Biden Administration ,
Cannabis Products ,
Cannabis-Related Businesses (CRBs) ,
Centers for Medicare & Medicaid Services (CMS) ,
Cybersecurity ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
Health Insurance ,
Healthcare ,
Healthcare Costs ,
Hospitals ,
Physicians ,
Popular
On November 20, 2020, the Department of Health and Human Services (HHS) announced it was terminating the U.S. Food and Drug Administration's (FDA) Unapproved Drugs Initiative (UDI), which is further described in...more
On November 16, 2020, the Office of Inspector General (OIG) issued a Special Fraud Alert (the Alert) regarding speaker programs hosted by pharmaceutical and medical device companies. Speaker programs are company-sponsored...more
During this unprecedented time, digital health is disrupting our healthcare delivery system for the better. Digital health companies are working hard to provide innovative telehealth, digital screening, and testing services....more