On March 9th, the U.S. Department of Health and Human Services (HHS) finalized two rules that are designed to give patients access to their health data and to increase interoperability among health care providers and payers using health information technology.  The two rules, issued by the HHS Office of the National Coordinator for Health Information Technology (ONC) and Centers for Medicare & Medicaid Services (CMS), implement interoperability and patient access provisions of the 21st Century …

On Monday, March, 30, 2020, CMS released a blanket waiver (the “Waiver”) of the physician self-referral law under section 1135 of the Social Security Act to enable health care provider responses to the COVID-19 outbreak.  Effective retroactively to March 1, 2020, the Waiver broadly eliminates certain key Stark Law requirements for direct financial relationships between entities that provided designated health services (“DHS”) and physicians and physician organizations (or immediate family members of physicians).  The Waiver…

The Wall Street Journal’s Health Forum convened—virtually—on March 24th during an extraordinary period in global health: the novel coronavirus is threatening populations, overwhelming provider systems, and sending economies into uncharted territory. The interactive event assembled executives, investors, health professionals, industry experts, and leaders in health policy to provide insight into managing the crisis. Sheppard Mullin attended the Forum and has summarized below some of the outstanding content covered throughout the day.…

As the COVID-19 pandemic continues and our health system is pushed to and beyond capacity, lawmakers and stakeholders are assessing different ways to handle the incredible volume of patients suddenly needing care. One approach being examined, largely at the state level although supported at the federal level, is expanding the scope of practice for different types of individual health care providers.…

In light of the widely reported shortage of personal protective equipment (PPE), ventilators, and other medical devices, the U.S. Food and Drug Administration (FDA) is working around the clock to authorize medical supplies for the US healthcare system, including relaxing its rules for importing and distributing PPE and ventilators and their accessories (e.g., vent splitters for multiple patient ventilation).  FDA’s policies on permitting uncleared medical devices shift daily toward greater relaxation of regulatory hurdles for…

Hospice providers within regions administered by NGS are reporting that NGS is presently finalizing and serving out final 2019 hospice cap repayment demands.  This action, which tacks on sequestration (funds never received) to revenue, is entirely inappropriate and must be rescinded.…

Make no mistake, the antitrust laws remain in full effect.  The leadership of the Antitrust Division of the Department of Justice (“DOJ”) and the Federal Trade Commission (“FTC”) have made clear that these enforcers “stand ready to pursue civil violations of the antitrust laws, which include agreements between individuals and business to restrain competition through increased prices, lower wages, decreased output, or reduced quality as well as efforts by monopolists to use their market power…