Medicare Advantage is the dominant Medicare delivery system, now covering 54% of all Medicare enrollees. With the increase in enrollment and federal spending, however, has come increased scrutiny from enforcement and...more
The US Food and Drug Administration (FDA) is confronted with significant challenges in its inspection processes due to recent layoffs. Among other effects, the latest reduction in force of full-time FDA employees is raising...more
Patient assistance programs (PAPs) emerged to help patients who lack health insurance or prescription drug coverage obtain critical, and often, life-saving medications. This is especially true for rare disease patients, whose...more
In honor of Rare Disease Day on February 28, 2025, we will publish a series of posts throughout the month on As Prescribed and Health Law Scan, focusing on issues impacting the rare disease community....more
The Boston Bar Association hosted its fifth annual White Collar Crime Conference on May 2, 2024, featuring prosecutors from the US Attorney’s Office for the District of Massachusetts (the Office) and the Office of the...more
The US Department of Justice (DOJ) Civil Division released its annual fraud statistics on February 22, highlighted by False Claims Act (FCA) settlements and judgments exceeding $2.68 billion in fiscal year 2023. DOJ released...more
As we at Morgan Lewis pride ourselves on excellent client service, we feel it is our duty to provide critical dispatches from the romantic world of healthcare fraud. Specifically, we want to highlight developments in the...more
The US Department of Justice (DOJ) announced on June 8, 2023 that Steven King, a compliance executive of pharmacy holding company A1C Holdings LLC, was convicted of defrauding Medicare out of more than $50 million in a scheme...more
The US Supreme Court’s decision in United States ex rel. Polansky v. Executive Health Resources confirms the relative ease by which the US government can exercise its dismissal authority under False Claims Act (FCA) Section...more
The US Department of Justice’s (DOJ’s) Civil Division released its annual fraud statistics on February 7, covering fiscal year 2022. Settlements and judgments under the False Claims Act (FCA) exceeded $2.2 billion in the...more
Last month, we had an engaging Fast Break session covering compliance topics regarding healthcare professionals’ relationships with pharmaceutical and medical device manufacturers. We were joined by Terrence Burek, senior...more