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.
The COVID-19 pandemic launched the Occupational Safety and Health Administration (OSHA) into the national spotlight. The agency is using its platform to roll out increased enforcement. This article discusses proactive measures employers should take to avoid enforcement actions.
This guide provides a compilation of insights from legal practitioners around the world to assist in the identification and understanding of the laws and regulations that impact the drug and medical device industry.
This is a sample request for proposal for valuation services.
This is a sample business development agreement, for a non-exclusive cooperative marketing relationship to promote collection services (governed by Ohio law).
Foley & Lardner’s Top Trends for 2024 publication unpacks key developments in an uncertain regulatory landscape.
Since its inception in 1992, the 340B Drug Pricing Program (340B Program) has provided eligible health care providers (covered entities) access to significant discounts on the cost of outpatient pharmaceuticals from participating manufacturers.
Over the past 15 years, the 340B Program’s size and scope has expanded due to actions by Congress and the federal Health Resources and Services Administration (HRSA). This article provides an overview of the program's current state.
The provision of patient assistance, including transportation and other free or discounted items and services to patients by health care providers and suppliers implicate certain fraud and abuse laws.
These law include the prohibition on beneficiary inducements under the federal Civil Monetary Penalties (“CMP”) Law and the federal Anti-Kickback Statute (“AKS”).
This article provides a summary of the CMP Law and AKS and certain exceptions under those laws.
Pixels, cookies, and trackers continue to be front of mind for HIPAA regulated entities seeking clarity on their ability to advertise, market, and engage with existing and prospective patients. On March 18, 2024, the U.S. Department of Health and Human Services (HHS) issued updated guidance on the topic.