Healthcare & FDA Law Blog

When it comes to healthcare law, few regulations are as critical and as complex as the Anti-Kickback Statute (AKS). This federal law prohibits the exchange of anything of value to induce or reward referrals of business to federal healthcare programs. In other words, if a healthcare provider offers or accepts any kind of kickback for […]

Kickbacks are improper payments or compensation made in exchange for preferential treatment, services, or referrals. They are illegal in many industries, especially in regulated sectors like healthcare, government contracting, real estate, and corporate procurement. These arrangements are often disguised as consulting fees, referral bonuses, or profit-sharing. In the U.S., laws such as the federal Anti-Kickback [...]

The Stark Law, also known as the Physician Self-Referral Law, is a federal statute that prohibits physicians from referring patients for certain designated health services (DHS) payable by Medicare to an entity with which the physician or an immediate family member has a financial relationship, unless an exception applies. The law is designed to prevent […]

A doctor not paying rent for a surgery space, equipment, or medical suite leads to consequences that extend beyond a typical lease default. In addition to potential eviction or legal action, the situation can raise serious regulatory and compliance risks. This happens if the lease wasn’t properly structured under laws like the Anti-Kickback Statute (AKS), […]

Pharmacies should consult with experienced healthcare lawyers to understand what conduct may qualify as a HIPAA violation, the penalties for violations, and to get answers to HIPAA compliance questions.

Physicians and medical practices who merge their practices, sell, or acquire a medical practice need to notify their clients about the transaction so they can make informed decisions about their doctors and their medical records.

A MSO helps separate the medical side of a med spa from the business side of the med spa. A properly drafted MSA helps clarify the roles of the MSO and federal and state compliance issues.

Chiropractors marketing stem cell therapies face FDA and FTC enforcement risks due to unapproved treatments and misleading advertising claims. Learn how to avoid regulatory penalties, structure legal partnerships, and ensure compliance with state and federal laws.

Clinical trial companies must comply with FDA regulations, informed consent laws, and IRB requirements to ensure ethical and legal compliance. Learn how to navigate 21 CFR Part 50 & 56, manage patient safety protocols, and avoid regulatory penalties when conducting research.