On Oct. 20, 2023, the U.S. Department of Health and Human Services Office of Inspector General (OIG) issued unfavorable Advisory Opinion 23-08 (AO 23-08), continuing its long-held position that the provision of value-added...more
On Nov. 30, 2023, the Illinois Supreme Court, in Mosby v. The Ingalls Memorial Hospital et al., held that certain healthcare providers’ biometric data, used for healthcare operational purposes under the Health Insurance...more
On Nov. 1, 2023, the Department of Health and Human Services (HHS), the Centers for Medicare & Medicaid Services (CMS) and the Office of the National Coordinator (ONC) issued a proposed rule, the “21st Century Cures Act:...more
In late August 2023, the Department of Health and Human Services (HHS) recommended rescheduling marijuana from a Schedule I substance to a Schedule III substance under the Controlled Substances Act (CSA), signaling the...more
On Aug. 7, 2023, the U.S. Food and Drug Administration (FDA) released draft guidance, “Registration and Listing of Cosmetic Product Facilities and Products: Guidance for Industry,” which would require facilities that...more
In an effort to formalize its Sept. 15, 2021, Statement of the Commission on Breaches by Health Apps and Other Connected Devices, as previously discussed in a McGuireWoods Oct. 5, 2021, alert, the Federal Trade Commission...more
In recent years, various federal agencies, including the Department of Health and Human Services Office of the Inspector General and the U.S. Food and Drug Administration (FDA), have increasingly scrutinized compounded...more
On May 24, 2023, the U.S. Department of Health and Human Services (HHS) released its first Language Access Annual Progress Report (the Report) reflecting on its advancements since the 2022 HHS Equity Action Plan (Equity Plan)...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 June 5, 2023, the Centers for Medicare & Medicaid Services (CMS) published a final rule in the Federal Register that withdraws COVID-19 vaccination mandates for certain providers’ staff members and withdraws long-term care...more
The U.S. government entered into two recent settlements with healthcare providers who allegedly denied deaf and hearing-impaired patients or their caregivers auxiliary aids for effective communication. These settlements...more
On May 1, 2023, the White House announced it would end the COVID-19 vaccine requirements for federal employees, federal contractors and international air travelers effective May 11, the same day the federally declared...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
With increased demand for cosmetic procedures and wellness treatments among both the older and younger generations, the med spa industry is booming. The global med spa market is expected to grow from $14.4 billion in 2022 to...more
A Texas federal court recently denied a pharmaceutical supplier’s motion to dismiss claims brought by a whistleblower under the federal False Claims Act (FCA) alleging violations of the Anti-Kickback Statute (AKS) and...more