The Federal Anti-Kickback Statute and Safe Harbors Eric D. Fader, Geoffrey R. Kaiser, Christopher J. Kutner

The Anti-Kickback Statute (AKS) was first enacted through the Social Security Amendments of 1972 in order to combat fraud and abuse in the Medicare and Medicaid Programs. The purpose of the AKS is to remove the corrupting effects of kickbacks in health care by, among other things, outlawing behavior designed to game the system through the use of financial incentives intended to direct patient referrals to particular health care providers and away from other providers rendering the same type of care. But not every payment or practice offends the policies underlying the statute.
Beginning in 1991, the Office of Inspector General of the U.S. Department of Health and Human Services began promulgating regulatory safe harbors to supplement the statutory exceptions passed by Congress. Safe harbors are designed to protect certain common and salutary commercial arrangements the purpose of which is not to induce referrals in violation of the AKS. The safe harbors place these arrangements beyond the reach of AKS prosecution. This book covers all safe harbors currently in place, including investments, office and equipment leases, personal and management services, warranties, discounts and many others. The book also covers the interplay between the AKS and other laws, including the False Claims Act and Stark Law.

His clients include providers of intraoperative neurophysiologic monitoring (IONM) services, telehealth and telepharmacy companies, urgent care facilities, imaging centers, and private practices of all types. Eric has also represented insurers and third-party administrators, provider networks, medical device suppliers, equipment vendors, and providers of electronic medical records and other online health care services in contractual and regulatory matters. Eric advises on billing and reimbursement questions, federal and state anti-kickback and self-referral issues, HIPAA compliance (including privacy and data breaches), payor audits, hospital privilege and medical staff issues, and state licensure and certificate of need matters. His work also includes organizational matters, corporate governance and structuring/restructuring advice, operating agreements, shareholder and partnership agreements and disputes, labor and employment law issues, private securities offerings, joint ventures, mergers, and acquisitions.

A frequent writer and commentator on health care issues, Eric has written for and has been quoted in Bloomberg BNA, Law360 and Thomson Reuters Westlaw, among many others. Eric is the Editor of Rivkin Rounds, an electronic news bulletin for businesses, professionals, investors, and stakeholders in the health care industry.

Eric is a member of the American Society of Neurophysiological Monitoring (ASNM) and has been a webinar and symposium speaker for the ASNM. He served on the Board of Directors of Stayhealthy, Inc., a privately owned health solutions company committed to changing the way the world measures health and fitness.

Eric began his legal career as a securities lawyer and moonlighted for several years as a professional microcap stock trader. This activity afforded him unusual insights into the OTC markets which he has used in representing small public companies and those that invest in them.

Geoffrey (Jeff) R. Kaiser, who has extensive experience in enforcement matters affecting the health care industry, concentrates his legal practice on health care fraud and regulatory compliance issues, white collar criminal defense, False Claims Act litigation, integrity monitoring, and internal investigations. As head of the Compliance Investigations and White Collar Practice Group, and senior counsel in the Health Services Practice Group, Jeff is frequently called upon to handle matters implicating a range of healthcare fraud and abuse laws, including the False Claims Act and the Anti-Kickback Statute. The Health Services Practice Group at Rivkin Radler has been listed in the prestigious Legal 500. The practice is also recognized as notable by Chambers USA.

Before joining Rivkin Radler, Jeff served for nearly 10 years in the Criminal Divisions of the U.S. Attorney's Office for the Eastern District of New York and the U.S. Attorney's Office for the Southern District of New York. While at the Justice Department, he directed many white collar investigation and prosecutions, including with respect to health care fraud, securities fraud, mortgage fraud, mail and wire fraud, and bank fraud.

As Chief of Health Care Fraud Prosecutions and Deputy Chief of Public Integrity in the Eastern District U.S. Attorney's Office, Jeff directed investigations against individuals and corporations facing health care fraud allegations under a variety of criminal and civil statutes. In many instances, those investigations were rooted in allegations brought by whistleblowers under the False Claims Act. Jeff also exercised oversight responsibilities within the Public Integrity Section for all health care fraud cases within the Eastern District of New York. He received many recognitions and honors for his efforts as a federal prosecutor.

Christopher J. Kutner represents managed care organizations, physician groups, hospitals, and ancillary service providers, including laboratories, health care benefit administrators, and suppliers of medical equipment.

As partner in the Health Services Practice Group, Chris represents national and regional health plans in the acquisition of similar plans. He recently coordinated the acquisition and integration of a Connecticut managed care plan by a

larger, New York City-based health maintenance organization (HMO). He is representing a multi-facility alcohol and substance abuse service provider in a stock sale transaction. He also represented a regional, boutique laboratory in an asset sale. Moreover, a regional laboratory management company hired Chris to advise on acquisitions, state and federal regulatory compliance, and managed care contracting. He advises health care providers with managed care contracting and dispute resolution and with respect to compliant practice structures and permissible arrangements concerning, among other issues, referrals.

He has represented a national managed care company in connection with its acquisition of managed long term care plans (MLTCPs) and a county government in the sale of its Medicaid managed care plan including eight outpatient treatment facilities. His managed care experience makes him well-suited for advising health care consumers with benefit and medical necessity opinions as well as assisting with external appeals with state regulators.

A partner in Rivkin Radler's Compliance, Investigations White Collar Practice Group, Chris represents health care providers who are being audited or investigated by, among others, the New York State Department of Health, Office of Professional Medical Conduct (OPMC), the New York State Medicaid Inspector General (OMIG), the U.S. Department of Health and Human Services; Office of Inspector General (OIG), the New York Attorney General, and the U.S. Attorney& Offices for all districts in New York and New Jersey.

Ada Kozicz concentrates her practice on regulatory and transactional matters within the health care industry.

An associate in Rivkin Radler's Health Services Practice Group, Ada represents health care providers, medical groups, hospitals, outpatient facilities, and other business entities that serve the health care industry. She advises clients on a wide variety of legal matters, including formation of business entities, joint ventures, employment negotiations, and compliance programs involving Medicaid and Medicare, Stark and Anti-Kickback Law, and the False Claims Act.

Ada also practices in Rivkin Radler's Privacy, Data & Cyber Law Practice Group, where she advises clients both in and outside of the health care industry on complying with HIPAA and the HITECH Act, and responding to any threats or breaches to an organization’s privacy and cybersecurity. She was honored by the Long Island Business News as a 2018 "30 Under 30" award recipient, and by the Huntington Township Chamber of Commerce as one of 30 "Celebrate Long Island" Young Professionals honorees in 2017.

Ada is a frequent contributor to the firm's electronic health law news bulletin, Rivkin Rounds, available at https://www.rivkinradler.com/rivkin-rounds/.

Benjamin P. Malerba is a partner in the Health Services and Privacy, Data and Cyber Law Practice Groups. Ben counsels a cross-section of health care providers and facilities, including IPAs, ACOs, provider networks, ambulatory surgery centers, diagnostic and treatment centers, dialysis facilities, and hospitals and federally qualified health centers, on general healthcare business transactions, state licensing issues, corporate practice of medicine and fee-splitting prohibitions, regulatory compliance, disputes with managed care companies, federal and state anti-kickback statutes, self referral statutes, and federal and state privacy laws. His practice also covers data breach and response, cybersecurity and data security, with a particular focus on security breaches related to the Health Insurance Portability and Accountability Act of 1996 (HIPAA).

Ben has particular experience representing ambulatory surgery centers (ASCs) and ambulatory surgery management companies, counseling them on a wide variety of corporate and commercial transactions, including mergers and acquisitions of existing ASCs, the establishment of de novo centers, and syndications. He regularly represents ASCs and other facilities before the New York State Department of Health and the New York State Public Health and Health Planning Council. He also has represented clients before federal and state government agencies, including the Department of Health and Human Services; Office for Civil Rights in its investigations into HIPAA-related security breaches. Ben also counsels clients on the development and implementation of compliance programs for health care providers and business associates under HIPAA and on preparing for and responding to HIPAA breaches and investigations.