The U.S. Food and Drug Administration (FDA) issued a final rule on Jan. 31, 2024, to amend the medical device current good manufacturing practice requirements of the quality system regulation under 21 CFR 820....more
On Jan. 12, 2024, the U.S. Department of Health and Human Services (HHS) officially released unredacted documents detailing the U.S. Food and Drug Administration’s (FDA) reasons for recommending that the Drug Enforcement...more
On Nov. 6, 2023, the U.S. Department of Health and Human Services Office of Inspector General (OIG) issued the General Compliance Program Guidance (GCPG) for healthcare providers and other industry stakeholders. The GCPG...more
Recently, two ophthalmology practice groups — Kleiman Evangelista Eye Centers of Texas (KEEC) and SouthEast Eye Specialists, PLLC (SEES) — reached large settlements with the U.S. government over allegations that the groups’...more
Over the past few years, the conversation surrounding recreational and medical use of psilocybin has shifted due to growing evidence of its significant mental health benefits. This newfound social acceptance of psilocybin has...more
On April 17, 2023, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) issued a notice of proposed rulemaking (NPRM) that would modify the Standards for Privacy of Individually Identifiable...more
On May 2, 2023, the U.S. Department of Justice (DOJ) announced the indictment of two New York state pharmacy owners, Taesung Kim and Dacheng Lu, for their participation in an alleged $29 million healthcare fraud scheme. Kim...more
Most healthcare providers received Provider Relief Fund (PRF) payments (as described in greater detail in a previous McGuireWoods client alert) from the Health Resources and Services Administration (HRSA) earlier in the...more
On Jan. 30, 2023, President Joe Biden announced that the COVID-19 public health emergency (PHE) will end May 11, 2023. Under the PHE, the federal government implemented a range of modifications and waivers impacting Medicare,...more
5/2/2023
/ CARES Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
Health Insurance ,
Infectious Diseases ,
Medicaid ,
Medicare ,
Public Health Emergency ,
Telehealth ,
Telemedicine
Two Weeks Left: Approaching Deadline to Report Period 4 Provider Relief Fund Payments -
Most healthcare providers received Provider Relief Fund (PRF) funding (as described in greater detail in a previous McGuireWoods...more