On September 29, the Centers for Medicare & Medicaid Services (CMS) reported that the federal Departments of Health and Human Services, Labor, and the Treasury departments are seeking public input on the possibility of...more
Borne's long-awaited Report on regulation of healthcare products has fallen well short of pharmaceutical industry expectations. Indeed, it contains very few concrete proposals. ...more
This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity for July 2023. We discuss several criminal and civil enforcement actions that involve violations of the False Claims Act...more
In April 2022, CMS announced an initiative to pay for Medicare beneficiaries to receive free OTC COVID-19 test kits. Specifically, Medicare established a demonstration project to pay various eligible healthcare providers to...more
The expansion of over-the-counter (“OTC”) drug options has been a long time coming. Advocates in various fora, including within the U.S. Food and Drug Administration (“FDA” or the “Agency”), have focused on the potential for...more
Unintended downstream consequences are likely to abound in the wake of the June 24, 2022 Dobbs decision that overruled Roe v. Wade, as Mintz attorneys have addressed in other contexts here and here Those looking ahead have...more
I. Biden Administration Requirement for Insurance Companies to Cover Cost of At-Home COVID-19 Tests - On January 10, 2022, the U.S. Department of Health and Human Safety (HHS) announced that the Biden-Harris...more
The premier event for drug and medical device product liability lawyers to gain essential winning litigation strategies. ACI’s 26th Annual Flagship Conference on Drug and Medical Device Litigation is returning to New York...more
On December 15, 2020, the U.S. Food and Drug Administration (FDA) finally issued an emergency use authorization (EUA) for the first over-the-counter (OTC) fully at-home diagnostic test for COVID-19. The Ellume COVID-19 Home...more
Back in the early days of the COVID-19 pandemic, we published a post outlining the different kinds of diagnostic tests that were being marketed and the different roles of the two main federal regulators that oversee the...more
Health Canada has recognized for many years that the current regulatory regime on drug sampling, which significantly restricts the distribution of drug samples to both consumers and health care professionals, is outdated. For...more
While the United States now leads the world with the number of reported cases of COVID-19, the Coronavirus Aid, Relief, and Economic Security (CARES) Act (or “the Act”) takes major, though perhaps still incomplete, steps...more
• The U.S. Environmental Protection Agency (EPA) has published a new rule to address the handling, storage, transportation and disposal of hazardous waste pharmaceuticals by healthcare facilities and reverse distributors. •...more