Overview


This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant activity between June 21 and July 20, 2022. During this period, the Supreme Court of the United States overturned Roe v. Wade, which historically recognized the constitutional right to abortion, in Dobbs v. Jackson Women’s Health Organization. This decision has legal implications for virtually all healthcare organizations. The Supreme Court also upheld the US Department of Health & Human Services (HHS) regulations regarding the disproportionate share hospital (DSH) payment formula, finding that individuals “entitled to Medicare Part A benefits” are all individuals qualifying for the program and not just those whose hospital bills were actually paid by Medicare. This issue also reviews several criminal and civil enforcement actions related to Anti-Kickback Statute (AKS) and beneficiary inducement issues, as well as false claims allegations.

In addition to examining recent Office of Inspector General (OIG) advisory opinions, we offer an update on the OIG’s Special Fraud Alert providing guidance on telemedicine arrangements and OIG’s Annual Health Care Fraud and Abuse Control Program Report. We also examine recently published Centers for Medicare & Medicaid Services (CMS) rules and guidance regarding innovation models, the Clinical Laboratory Improvement Amendments of 1998 (CLIA) regulations, and long-term care facilities requirements.