Resource Library

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.

This article discusses the Center for Medicare & Medicaid Services (CMS) final regulation interpreting the 60-day Refund Rule for Medicare Parts A/B (Traditional Medicare) and C/D (Medicare Advantage (MA) and the Prescription Drug Plans).

Navigating the complexities of a product recall can be challenging, but having a well-structured plan in place minimizes risks and ensures compliance.

In this checklist, we outline the six key steps every company should follow when faced with a potential recall—ranging from the initial determination of whether a recall is necessary to conducting a thorough after-action review. This guide can serve as a resource for any business looking to protect consumers and its brand during a recall event.

This article provides recommendations on how to minimize regulatory risks associated with patient assistance programs in the United States.

This sample policy covers medical providers giving financial assistance to eligible patients for costs not covered by insurance.

This article discuses the Federal Trade Commission (FTC) finalized amendments to the Negative Option Rule, now retitled the “Rule Concerning Recurring Subscriptions and Other Negative Option Program.“

The rule represents a significant overhaul of the regulatory framework governing how companies handle subscription services and automatic renewals.

This multi-jurisdictional guide covers common issues in pharmaceutical advertising laws and regulations.

Topics covered include advertisements to healthcare professionals, gifts and financial incentives, hospitality and related payments, and transparency and disclosure.