Safe harbors (and other strategies) for life sciences and healthcare ...
5 pages - 683.5 KB
Pressly permissible under the local law of the host country ... safe harbor, life sciences, and healthcare companies routinely.
Document in text mode:
1As published by the American Bar Association in the December 2021 issue of The Health LawyerINTRODUCTIONFor life sciences and healthcare companies ac-customed to operating within the bounds of U.S. fraud and abuse laws, certain gaps be-tween domestic and international anti-cor-ruption laws can cause compliance challenges is article focuses on two such gaps.First, unlike the Anti-Kickback Statute (AKS), the Foreign Corrupt Practices Act (FCPA) lacks safe harbors that expressly permit a range of routine interactions between pharmaceuti-cal, medical device, and healthcare companies, on the one hand, and individual healthcare professionals (HCPs) and institutions, on the other Attorneys from the FCPA Units of the U.S Department of Justice (DOJ) and U.S Securities and Exchange Commission (SEC) generally do not approach these issues from a U.S healthcare compliance perspective; they are often skeptical of certain arrangements with HCPs that are common in the United States and can be struc...
Relevant files:
Health care sharing ministries: what are the risks to consumers and ...
Pdf Available5 pages - 425.0 KB
By ja volk · 2018 · cited by 1 — the federal individual mandate, but the law does not ... under the safe harbor, as long as an hcsm meets the ... state law explicitly exempts health.
5895Understanding the final rules to revise the anti-kickback statute ...
Pdf Available5 pages - 989.5 KB
The law also prohibits paying remuneration intended to induce or ... based statute, an arrangement that falls outside of a safe harbor is ...
7073Promoting medical products globally - baker mckenzie
Pdf Available5 pages - 2.2 MB
The supervision of a healthcare practitioner licensed by law to direct their use. ... unsolicited requests draft guidance appears to create a safe harbor.
7172Marketing healthcare services-traps for the ...
Pdf Available1 page - 156.1 KB
Applicable to the marketing of healthcare services. while ... and a safe harbor for certain types of discounts and ... violate any state or federal law.
7694Expanded availability of anti-kickback statute safe harbors
Pdf Available5 pages - 298.3 KB
Personal services and management contracts safe harbor (“personal services safe ... law and the safe harbor to the anti-kickback statute.”).
6262Discounts as kickbacks for medical equipment
Pdf Available2 pages - 151.7 KB
Whether to federal healthcare program beneficiaries (i.e., patients), ... medicare or medicaid, unless the safe harbor applies.
9420