Medicare telehealth post-Public Health Emergency (PHE): With the COVID-19 PHE concluding on May 11, 2023, many of the telehealth flexibilities the Centers for Medicare & Medicaid Services (CMS) implemented during the PHE will sunset at varying times.
Between now and 2030, the biopharma sector is expected to be rocked by a number of high-profile patent cliffs that are likely to reshape the market in potentially unpredictable ways. A “patent cliff” refers to the end of IP protection for a drug that has enjoyed market exclusivity since its launch.
This article highlights key considerations for hospitals in evaluating, developing, and implementing an ASC transaction, with a focus on fraud and abuse considerations related to investing alongside physicians. It also highlights the type of regulatory analysis that providers and others contemplating transactions involving health care entities must consider and address.
This article discusses the ruling by a California Court of Appeal that ultimately determined a hospital's decision to terminate an employee for failing to comply with its flu vaccine mandate did not violate California's Fair Employment and Housing Act (FEHA).
This article discusses the US Drug Enforcement Agency's (DEA) new regulation temporarily extending the “full set” of COVID-19 waivers for prescribing controlled substances via telemedicine.
Originally published by Foley & Lardner LLP on May 11, 2023.
This article discusses the friendly-PC model, which is a common structure designed to comply with state corporate practice of medicine doctrines. The friendly-PC model involves a professional service corporation (PSC) conducting a medical practice in affiliation with a management services organization (MSO).
Although the friendly-PC model may be a solution to the corporate practice of medicine doctrine, it can create unintended consequences for employee benefit plans sponsored by the PSC and MSO.
This article discusses the U.S. Food and Drug Administration's draft guidance regarding the implementation of Decentralized Clinical Trials (DCTs) for drugs, biological products, and devices.
This article discusses the U.S. Food and Drug Administration's draft guidance on artificial intelligence/machine learning (AI/ML)-enabled devices.
The draft guidance — "Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions" — was issued on April 3, 2023.
This article covers a newly passed Florida law that requires health care providers and digital health technology platforms using certified electronic health record technology (CEHRT) to ensure that all patient information is physically maintained within the United States or Canada.
This article provides an overview of current trends in using AI systems to meet the challenge of extracting clinically useful information from highly complex genomic data.