A California Superior Court recently approved the settlement of a hospital merger challenge brought by the California Attorney General’s Office against Cedars-Sinai Health System and Huntington Hospital. The action – and subsequent settlement – is noteworthy for at least two…
Continue Reading California Attorney General Settlement of Hospital Merger Challenge Potentially Raises the Stakes for Hospital Mergers Nationwide

In order to secure approval of a medical device, a sponsor must use one of several pathways prescribed by the FDA. The primary avenues are the 510(k) clearance, the Pre-Market Approval (PMA) and the de novo submission. This post will…
Continue Reading Winning with FDA: How to Manage a Successful 510(k) Device Submission

Claiming that “federal inaction” has caused a weakening of competition in many U.S. industries, on July 9 President Biden issued an Executive Order directing the Attorney General and the Chair of the Federal Trade Commission to “vigorously” enforce the antitrust…
Continue Reading Biden Executive Order Calls out the Healthcare Industry for More Vigorous Antitrust Scrutiny

While much of the antitrust world is focused on the actions brought by federal and state antitrust regulators against “big tech,” the Senate Judiciary Subcommittee on Competition Policy, Antitrust and Consumer Rights recently held a hearing to consider the impact …
Continue Reading Senate Antitrust Subcommittee Turns the Spotlight on Hospital Consolidation

On May 13, 2021, the Centers for Medicare and Medicaid Services (“CMS”) published an interim final rule with comment period addressing COVID vaccine education, administration, and reporting requirements for nursing homes. Designed to reduce the spread of COVID-19, the rule…
Continue Reading New COVID-19 Vaccine Requirements for Nursing Homes

Earlier this month, Peter Lucido, the Macomb County Prosecutor, who was also a former Republican State Senator and State Senate Majority Whip, announced a plan to investigate COVID-19 deaths in Macomb County nursing homes to determine whether Executive Order 2020-50,…
Continue Reading Long Term Care Facilities Should Prepare for County Investigations Into COVID Deaths

The COVID-19 pandemic has dramatically altered the way health care providers render services, including the proliferation of telehealth options available. Most have viewed telehealth expansion positively with its ability to increase access to services while reducing burdens for both patients…
Continue Reading OIG Puts Telehealth in its Crosshairs