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.
Learn how US health care regulation and policy may change in the wake of the US Supreme Court's 2024 decision overturning the Chevron doctrine, as well as takeaways for your organization.
This article discusses the US Department of Health and Human Services (HHS) final rule amending Health Insurance Portability and Accountability Act (HIPAA) privacy regulations to provide significant additional protections for protected health information relating to reproductive health care.
On April 23, 2024, the U.S. Federal Trade Commission finalized a rule, by a vote of 3-2, abolishing the vast majority of employee covenants not to compete across the United States.
While certain health care providers will be exempted from the rule, many will not. As such, and if the rule survives legal challenge, health care industry participants should carefully consider how the rule will impact their recruitment and retention strategies going forward.
This resource covers how to create and enforce effective document retention policies, especially for organizations in the health-care industry.