On June 18, 2025, the U.S. Supreme Court delivered a major decision in United States v. Skrmetti, allowing Tennessee’s ban on gender-affirming care for minors to take effect. The ruling reflects a substantial realignment in...more
7/2/2025
/ Affordable Care Act ,
Constitutional Challenges ,
Department of Health and Human Services (HHS) ,
Enforcement Actions ,
Gender Identity ,
Health Care Providers ,
New Legislation ,
SCOTUS ,
Section 1557 ,
State Bans ,
Transgender ,
United States v Skrmetti
The U.S. Food and Drug Administration (FDA), and the Office of Human Research protections (OHRP) released draft guidance titled, “Considerations for Including Tissue Biopsies in Clinical Trials.” Although non-binding, the...more
The Drug Enforcement Administration (DEA) and the U.S. Department of Health & Human Services (HHS) just finalized their March 2023 proposed rule regarding telemedicine prescribing of buprenorphine. The final rule, effective...more
1/17/2025
/ Compliance ,
Controlled Substances ,
Controlled Substances Act ,
DEA ,
Department of Health and Human Services (HHS) ,
Final Rules ,
Prescription Drugs ,
Public Health ,
Public Health Emergency ,
Regulatory Requirements ,
Ryan Haight Act ,
Substance Abuse ,
Telemedicine
On June 26, 2024, the U.S. Food and Drug Administration (FDA) released draft guidance addressing use of diversity action plans (Plans) in the conduct of clinical research entitled “Diversity Action Plans to Improve Enrollment...more
On February 1, 2024, the Substance Abuse and Mental Health Services Administration (SAMHSA), U.S. Department of Health and Human Services, announced a final rule updating the regulations regarding Opioid Treatment Programs...more
2/12/2024
/ Certifications ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Final Rules ,
Licensing Rules ,
Medical Evaluation Reports ,
Opioid ,
Public Health Emergency ,
SAMHSA ,
Substance Abuse ,
Telemedicine
On November 2, 2023, the Centers for Medicare and Medicaid Services (CMS) issued its 2024 Physician Fee Schedule final rule (Final Rule) for calendar year 2024 that will, in part, implement some of the most important changes...more
The U.S. Food & Drug Administration (FDA) issued final guidance (Final Guidance) regarding informed consent titled “Informed Consent: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors” on August...more
The Office of Inspector General of the U.S. Department of the Health and Human Services (OIG) recently changed the language describing a compliance officer’s role in relation to other responsibilities he or she may have...more