Overview

The federal Anti-Kickback Statute (AKS) is one of the best-known federal fraud and abuse statutes, due largely to its wide-ranging effects on business relationships in the health care, pharmaceutical, and medical device sectors. The newly-updated second edition of this primer explains how AKS is a criminal statute that prohibits transactions intended to induce or reward referrals for items or services reimbursed by the federal health care programs. It further details the anti-corruption statute and how it is designed to protect federal health care program beneficiaries from the influence of money on referral decisions and thus is intended to guard against overutilization, increased costs, and poor quality services.

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9781639051670

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Karen is the Practice Leader of the firm’s Health Law Practice. She counsels health care clients on regulatory, transactional, and operational issues, including Medicare coverage and reimbursement, the development and implementation of health care compliance programs, and licensure and certification matters. In addition, Karen advises clients on the legal, practical, and fraud and abuse implications of business arrangements and sales and marketing practices. Her experience includes matters related to the anti-kickback statute, the Stark law, state statutes prohibiting kickbacks and self-referrals, and the federal Physician Payments Sunshine Act. Karen applies her compliance and regulatory experience in transactional as well as litigation contexts. In addition to counseling health care entities on regulatory matters arising in connection with mergers and acquisitions, she has successfully defended clients subject to state and federal surveys, Medicare and Medicaid overpayment and reimbursement appeals, and state licensure proceedings. Karen also represents clients subject to state and federal investigations alleging violation of the anti-kickback statute, the federal False Claims Act, and other state and federal laws. Karen also specializes in the representation of laboratories and diagnostics companies. She regularly counsels on compliance with CLIA and state laboratory licensure laws, federal and state limitations on billing for diagnostic services, and legal restrictions on sales and marketing activities. Karen has served as regulatory counsel in a number of mergers and acquisitions involving laboratories and diagnostics companies and has represented numerous laboratories and diagnostics companies in state and federal government investigations. Karen has written and lectured on a variety of issues confronting laboratories and others in the health care industry. She is the co-author of What Is…the Anti-Kickback Statute?, a book recently published by the American Bar Association.  Rachel Yount is an associate at Mintz, based in the Washington, D.C., office. She is well versed in the federal anti-kickback statute, the Stark Law, state fraud and abuse laws, beneficiary inducement prohibitions, provider-based rules, Medicare and Medicaid program requirements, and the federal Physician Payments Sunshine Act. She routinely advises clients on the legal, practical, and fraud and abuse implications of business arrangements and sales and marketing practices. Rachel regularly assists with implementing effective health care compliance programs for clients in various health care sectors, including managed care organizations, health systems, and pharmaceutical manufacturers, to name a few. She has assisted both with developing brand new compliance programs for health care companies just starting out and maturing existing compliance programs to support health care companies’ efforts to expand. Samantha Kingsbury is Of Counsel in Mintz’s Health Law Practice, based in the Boston office. Samantha’s practice focuses on health care enforcement defense matters, which often involve criminal, civil, and/or administrative actions brought against health care providers and companies by state and federal governmental and regulatory agencies, including the U.S. Department of Justice and the offices of its U.S. attorneys. She advises clients on issues related to the Anti-Kickback Statute, the Stark Law, the False Claims Act, and the Eliminating Kickbacks in Recovery Act, as well as state statutes prohibiting kickbacks, self-referrals, and the submission of false claims. Samantha also assists clients with conducting internal investigations, preparing self-disclosures to relevant agencies and/or payors, and developing internal compliance programs.

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