This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for May 2024. We discuss several notable cases and enforcement resolutions, including the US Court of Appeals for the District of Columbia Circuit’s (DC Circuit) favorable decision for drug manufacturers in the ongoing Section 340B dispute and the resolution of several enforcement actions, including some that alleged violations under the False Claims Act (FCA) and federal Anti-Kickback Statute (AKS). We also review several US Department of Health and Human Services (HHS) agency actions, such as a final rule that provides robust civil rights protections for individuals with disabilities, and a new process for submitting independent dispute resolution (IDR) requests under the No Surprises Act that are improperly batched or bundled. We also preview the telehealth extension and remote monitoring legislation that is currently working its way through the House of Representatives. Additionally, we discuss a recently issued Office of Inspector General (OIG) report pertaining to continued fraud and abuse risks with off-the-shelf orthotic braces.

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for April 2024. We discuss several US Department of Health and Human Services (HHS) agency actions, including the Calendar Year (CY) 2025 Medicare Advantage (MA) Capitation Rates and Part C and Part D Payment Policies released by the Centers for Medicare and Medicaid Services (CMS), new final rules related to nursing home staffing, access to Medicaid and the Children’s Health Insurance Program (CHIP), and the Food and Drug Administration’s (FDA) new final rule on laboratory-developed tests (LDTs). We also review the Federal Trade Commission (FTC) ruling to potentially ban the majority of noncompete agreements. Additionally, we discuss one favorable Office of Inspector General (OIG) advisory opinion and several criminal and civil enforcement actions pertaining to healthcare fraud, including alleged violations under the False Claims Act (FCA), federal Anti-Kickback Statute (AKS) and Physician Self-Referral Law (Stark Law).

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for March 2024. We summarize a US Court of Appeals for the Second Circuit decision interpreting the intent standard under the federal Anti-Kickback Statute (AKS). We also discuss several criminal and civil enforcement actions pertaining to healthcare fraud, including alleged violations under the False Claims Act (FCA), AKS and Physician Self-Referral Law (Stark Law). We then review several US Department of Health and Human Services (HHS) agency actions, including several HHS Office of Inspector General (OIG) audits regarding Provider Relief Fund spending and diabetes drug and opioid prescriptions, as well as an upcoming OIG study of vertical integration of prescription drug pharmacy benefits managers. We also cover other government activities, including a multi-agency request for information about the involvement of private equity in the healthcare system and a proposed rule concerning compounding drugs.

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for February 2024. We discuss various regulatory developments, including guidance on the use of AI in coverage decisions and texting patient information in hospitals, as well as new regulations on the confidentiality of substance abuse patient records and telehealth prescription of opioids. We also discuss several criminal and civil enforcement resolutions and activities that involve alleged violations of the False Claims Act (FCA), Anti-Kickback Statue (AKS), HIPAA and other claims.This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for February 2024. We discuss various regulatory developments, including guidance on the use of AI in coverage decisions and texting patient information in hospitals, as well as new regulations on the confidentiality of substance abuse patient records and telehealth prescription of opioids. We also discuss several criminal and civil enforcement resolutions and activities that involve alleged violations of the False Claims Act (FCA), Anti-Kickback Statue (AKS), HIPAA and other claims.

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for January 2024. We discuss several US Department of Health and Human Services (HHS) agency actions, including the new Innovation in Behavioral Health Model (IBH) released by the Centers for Medicare & Medicaid Services (CMS), amendments to New York’s Section 1115 Medicaid waiver, new final rules related to prior authorization and conscience rights, and the Food & Drug Administration’s (FDA) approval of Florida’s drug importation program. We also discuss four favorable Office of Inspector General (OIG) Advisory Opinions and several criminal and civil enforcement actions pertaining to healthcare fraud, including alleged violations under the False Claims Act (FCA), federal Anti-Kickback Statute (AKS) and Physician Self-Referral Law (Stark Law).