On November 6, 2023, U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued a General Compliance Program Guidance (GCPG) as part of its plan to renovate its library of compliance program...more
For the first time in almost 10 years, the U.S. Food and Drug Administration (FDA) released a draft guidance related to certain communications by firms to healthcare providers (HCPs) of scientific information on unapproved...more
On September 12, 2023, the U.S. Food and Drug Administration (FDA) issued warning letters to eight companies, including two major drugstore retail chains, for their involvement in the production or promotion of unapproved...more
In November 2021, the Centers for Medicare & Medicaid Services (CMS) rescinded a short-lived program to expedite national Medicare coverage for innovative devices amid safety concerns for Medicare patients.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 explosive growth in telehealth over the past five years has resulted from, among other things, the Centers for Medicare & Medicaid Services’ (CMS) extension of Medicare reimbursement to remote monitoring of patients by...more
The U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) is continuing its long-laid plans to update its existing compliance program guidance documents (CPGs). On April 24, 2023, OIG...more