The Health Law Ticker

The California Department of Managed Health Care (DMHC) on March 4, 2022, assessed the largest penalty against a health plan in the Department’s history. DMHC and the California Department of Health Care Services (DHCS) jointly announced the results of enforcement actions against Local Initiative Health Authority for Los Angeles County, more commonly known as L.A. Care. The penalties assessed by DMHC and DHCS against L.A. Care include $55 million in fines, which consist of a $35 million fine from DMHC and a $20 million sanction from DHCS. The amount is by far the largest penalty ...

Congress and the Biden Administration are grappling with an economic stimulus bill that will touch many segments of American life, including health care, if it passes in the Senate. This has many clients wondering what impact the Biden Administration will have on the healthcare sector from a regulatory perspective. Early indications point to a focus on four issues that continue to resound: the Affordable Care Act (“ACA”), COVID-19-related regulatory relief, lowering prescription drug prices and restricting the occurrence of surprise billing … 

On October 24, 2018, Congress passed the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (the “SUPPORT Act”), two sections of which constitute the Eliminating Kickbacks in Recovery Act of 2018 (“EKRA”). EKRA was codified at 18 U.S.C. § 220.

Similar to the Anti-Kickback Statute, EKRA was enacted to address abusive payment arrangements but intended for the context of opioid epidemic treatment and recovery efforts. Specifically, EKRA prohibits the knowing and willful (1) solicitation or receipt of ...

On March 28, 2020, the Centers for Medicare & Medicaid Services (“CMS”) announced that the agency would provide relief to Medicare providers and suppliers by expanding the Accelerated and Advance Payment Program for the duration of the COVID-19 public health emergency.  According to CMS’ guidance, to qualify for accelerated or advance payments, the provider or supplier must:

• Have billed Medicare for claims within the prior 180 days
• Not be in bankruptcy
• Not be under active medical review or program integrity investigation
• Not have any outstanding delinquent Medicare ...

The start-up segment of our healthcare regulatory practice is focused on companies bringing digital health tools to market. As part of the efforts of the U.S. Food and Drug Administration (“FDA” or the “agency”) to clarify its regulatory stance on digital health tools, the agency released a revised guidance in 2019 entitled, Policy for Device Software Functions and Mobile Medical Applications - Guidance for Industry and Food and Drug Administration Staff (the “Guidance”) ...

The U.S. Supreme Court is now in its summer recess and we anecdotally have heard of Justice “sightings” in Europe and beyond.  This last session of the Court addressed many issues capturing both the political and popular imagination.  Less headline-grabbing and relatively modest in length (at only nine pages) was Justice Clarence Thomas’ opinion for a unanimous Court in Cochise Consultancy, Inc. et al. v. U.S. ex rel. Hunt.  (587 U.S. ____ (2019))  It directly impacts our healthcare compliance practice here at Nossaman by interpreting the statute of limitations for a False Claims Act (“FCA”) case so as to stretch it as long as possible.

Last Thursday, a jury in federal district court in St. Louis handed down a verdict in a False Claims Act (FCA) case that presents a laundry list of the challenges which can arise in a FCA case.  This one includes kickback allegations, Stark issues, both state and federal claims, individual liability, civil-criminal cooperation, a criminal indictment (later dropped), and even family law.  The defendants are neurologist, Dr. Sonjay Fonn, and his fiancee of nine years, Deborah Seeger, as well as their respective medical practice and medical device distributorship.

The verdict found ...