On May 24, 2024, the Massachusetts Division of Insurance (the “Division”) issued Insurance Bulletin 2024-06, “inducements, rebates and affiliated entities” (the “Bulletin”). The Bulletin is addressed to “all licensed...more
Although often well-intentioned, offering free or discounted items or services to patients (e.g., gifts, rewards, writing off copays, free screening exams, free supplies, etc.) may violate federal and state laws governing...more
On Tuesday, February 27, the next installment of Rivkin Radler’s Healthcare Compliance Lunch & Learn series, will be presented by Rivkin Radler Partners, Geoffrey Kaiser and Benjamin Malerba. The program, “Prohibitions on...more
As we continue to assess the ripple effects from the Supreme Court's denial of certiorari in GlaxoSmithKline v Teva Pharms USA (GSK v Teva), a recent decision by Judge Andrews in the U.S. District Court for the District of...more
While direct patent infringement is a strict liability offense, liability for inducing another’s infringement requires an element of intent. Specifically, the party accused of inducement must have known of the patent and...more
The Department of Health and Human Services’ Office of Inspector General (“OIG”) has offered an opinion on providing a gift card to certain Medicare Advantage plan enrollees who complete specific steps in an online patient...more
The US Court of Appeals for the Federal Circuit overturned a district court determination that the claim terms “resilient” and “pliable” were indefinite. The Federal Circuit found that the claims, while broad, were...more
On January 4, 2022, the District Court for the District of Delaware granted Hikma Pharmaceuticals USA Inc.’s (“Hikma”) motion to dismiss Amarin Pharma Inc.’s (“Amarin”) infringement claims, finding that Hikma’s “skinny label”...more
The UK Supreme Court found in Kostal UK Ltd v Dunkley that it was an unlawful inducement for an employer to offer a pay deal to employees “over the head” of its recognised trade union. However, the position would have been...more
Amateur Athletes Protection and Compensation Act. The Amateur Athletes Protection and Compensation Act of 2021 (Protection Act), the sixth federal proposal governing student-athlete name, image, and likeness (NIL)...more
There has been a longstanding and regrettable practice in the healthcare industry of pharmaceutical and medical device companies giving physicians gifts as illegal inducements. Concerned about this continued trend, the U.S....more
PublicCEO Article Examines California Precedent-Setting Bias Tainting Decision - City councilmembers are policymakers. They are the voice of their constituents. Occasionally, this role shifts to mirror that of a judge...more
This LawFlash discusses awarding equity grants to newly hired employees as “inducement grants” outside the shareholder approved plan and the pros and cons of making inducement grants....more
Health care fraud continues to be a top enforcement priority for U.S. prosecutors, and nowhere is this more true than for the medical technology sector. From 2014-2019, the U.S. Department of Justice (DOJ) brought enforcement...more
The U.K. Financial Conduct Authority has welcomed the U.S. Securities and Exchange Commission’s extension of no-action relief addressing a potential conflict between U.S. regulation and the inducements and research provisions...more
The U.K. Financial Conduct Authority has published the outcome of its review of the research unbundling reforms implemented in the EU by the revised Markets in Financial Instruments Directive. MiFID II has applied across the...more
The European Securities and Markets Authority has launched a call for evidence on the impact of the inducements and costs and charges disclosure requirements under the revised Markets in Financial Instruments Directive. MiFID...more
Welcome back to your weekly dose of InsurTech insight. Hopefully in time you’ll come to think of us as a kind of General Assembly for InsurTechs, but instead of learning technological skills, you’ll learn practical...more
Consumers in West Virginia have found a new subject on which to file lawsuits. Within the past couple of years, litigation over reverse mortgages has become a bigger part of consumer lending litigation in West Virginia....more
With Advisory Opinion 18-09, the OIG continued its trend of approving arrangements between Medicare Supplemental Health Insurance (Medigap) insurers and preferred hospital network organizations (PHOs). As in prior advisory...more
A recent Office of Inspector General (OIG) advisory opinion approved a proposal under which a hospital has established a caregiver center that provides or arranges for free or reduced-cost support services to caregivers in...more
In what is becoming a steady trend, the Office of Inspector General (OIG) published another favorable opinion for an arrangement seeking to implement programs that support and engage family members who are increasingly...more
MiFID II contains a number of inducements requirements, including rules relating to conflicts of interest, research, hospitality, corporate access, and payment for order flow. This Client Alert outlines these requirements and...more
Last week, the U.S. Attorney’s Office for the District of Massachusetts announced that it had entered into an agreement with a Massachusetts-based medical device manufacturer to settle allegations that the Company had...more
In clinical research, compensating research subjects as an incentive for their participation is a common practice. However, paying research subjects can also pose ethical issues and create the potential for abuse such as...more