The Federal Anti-Kickback Statute and Safe Harbors

(Paperback)

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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.

Author Bio

Eric Fader has represented health care providers andother corporate clients in connection with business planningand contractual issues, transactional matters, and federaland state regulatory compliance for more than 30 years. His clients include providers of intraoperative neurophysiologicmonitoring (IONM) services, telehealth and telepharmacycompanies, urgent care facilities, imaging centers,and private practices of all types. Eric has also representedinsurers and third-party administrators, provider networks, medical devicesuppliers, equipment vendors, and providers of electronic medical records andother online health care services in contractual and regulatory matters.Eric advises on billing and reimbursement questions, federal and stateanti-kickback and self-referral issues, HIPAA compliance (including privacyand data breaches), payor audits, hospital privilege and medical staff issues,and state licensure and certificate of need matters. His work also includesorganizational matters, corporate governance and structuring/restructuringadvice, operating agreements, shareholder and partnership agreements anddisputes, labor and employment law issues, private securities offerings, jointventures, mergers, and acquisitions. A frequent writer and commentator on health care issues, Eric has writtenfor and has been quoted in Bloomberg BNA, Law360 and ThomsonReuters Westlaw, among many others. Eric is the Editor of Rivkin Rounds,an electronic news bulletin for businesses, professionals, investors, andstakeholders 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 privatelyowned health solutions company committed to changing the way the worldmeasures health and fitness. Eric began his legal career as a securities lawyer and moonlighted forseveral years as a professional microcap stock trader. This activity affordedhim unusual insights into the OTC markets which he has used in representingsmall public companies and those that invest in them. Geoffrey (Jeff) R. Kaiser, who has extensive experiencein enforcement matters affecting the health care industry,concentrates his legal practice on health care fraudand regulatory compliance issues, white collar criminaldefense, False Claims Act litigation, integrity monitoring,and internal investigations. As head of the Compliance,Investigations and White Collar Practice Group, andsenior 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 hasbeen listed in the prestigious Legal 500. The practice is also recognized asnotable by Chambers USA. Before joining Rivkin Radler, Jeff served for nearly 10 years in the CriminalDivisions of the U.S. Attorneys Office for the Eastern District of NewYork and the U.S. Attorneys Office for the Southern District of New York.While at the Justice Department, he directed many white collar investigationsand prosecutions, including with respect to health care fraud, securitiesfraud, mortgage fraud, mail and wire fraud, and bank fraud. As Chief of Health Care Fraud Prosecutions and Deputy Chief of PublicIntegrity in the Eastern District U.S. Attorneys Office, Jeff directed investigationsagainst individuals and corporations facing health care fraud allegationsunder a variety of criminal and civil statutes. In many instances, thoseinvestigations were rooted in allegations brought by whistleblowers underthe False Claims Act. Jeff also exercised oversight responsibilities within thePublic Integrity Section for all health care fraud cases within the EasternDistrict of New York. He received many recognitions and honors for hisefforts as a federal prosecutor. Christopher J. Kutner represents managed care organizations,physician groups, hospitals, and ancillary serviceproviders, including laboratories, health care benefitadministrators, and suppliers of medical equipment. As partner in the Health Services Practice Group,Chris represents national and regional health plans inthe acquisition of similar plans. He recentlycoordinated theacquisition 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 serviceprovider in a stock sale transaction. He also represented a regional,boutique laboratory in an asset sale. Moreover, a regional laboratory managementcompany hired Chris to advise on acquisitions, state andfederal regulatory compliance, and managed care contracting. He adviseshealth care providers with managed care contracting and dispute resolutionand with respect to compliant practice structures and permissible arrangementsconcerning, among other issues, referrals. He has represented a national managed care company in connection withits acquisition of managed long term care plans (MLTCPs) and a countygovernment in the sale of its Medicaid managed care plan including eightoutpatient treatment facilities. His managed care experience makes himwell-suitedfor advising health care consumers with benefit and medical necessityopinions as well as assisting with external appeals with state regulators. A partner in Rivkin Radlers Compliance, Investigations & White CollarPractice Group, Chris represents health care providers who are beingaudited or investigated by, among others, the New York State Departmentof Healths Office of Professional Medical Conduct (OPMC), the New YorkState Medicaid Inspector General (OMIG), the U.S. Department of Healthand Human Services Office of Inspector General (OIG), the New YorkAttorney General, and the U.S. Attorneys Offices for all districts in NewYork and New Jersey. Ada Kozicz concentrates her practice on regulatoryand transactional matters within the health care industry. An associate in Rivkin Radlers Health Services PracticeGroup, Ada represents health care providers, medicalgroups, hospitals, outpatient facilities, and other businessentities that serve the health care industry. She advisesclients on a wide variety of legal matters, including formationof business entities, joint ventures, employmentnegotiations, and compliance programs involving Medicaid and Medicare,Stark and Anti-Kickback Law, and the False Claims Act. Ada also practices in Rivkin Radlers Privacy, Data & Cyber Law PracticeGroup, where she advises clients both in and outside of the health careindustry on complying with HIPAA and the HITECH Act, and respondingto any threats or breaches to an organizations privacy and cybersecurity.She was honored by the Long Island Business News as a 2018 30 Under30 award recipient, and by the Huntington Township Chamber of Commerceas one of 30 Celebrate Long Islands Young Professionals honoreesin 2017. Ada is a frequent contributor to the firms electronic health law news bulletin,Rivkin Rounds, available at https://www.rivkinradler.com/rivkin-rounds/. Benjamin P. Malerba is a partner in the Health Servicesand Privacy, Data & Cyber Law Practice Groups. Bencounsels a cross-section of health care providers andfacilities, including IPAs, ACOs, provider networks,ambulatory surgery centers, diagnostic and treatmentcenters, dialysis facilities, and hospitals and federallyqualified health centers, on general healthcare businesstransactions, state licensing issues, corporate practice ofmedicine and fee-splitting prohibitions, regulatory compliance, disputeswith managed care companies, federal and state anti-kickback statutes, selfreferralstatutes, and federal and state privacy laws. His practice also coversdata breach and response, cybersecurity and data security, with a particularfocus on security breaches related to the Health Insurance Portability andAccountability Act of 1996 (HIPAA). Ben has particular experience representing ambulatory surgery centers(ASCs) and ambulatory surgery management companies, counseling themon a wide variety of corporate and commercial transactions, includingmergers and acquisitions of existing ASCs, the establishment of de novocenters, and syndications. He regularly represents ASCs and other facilitiesbefore the New York State Department of Health and the New York StatePublic Health and Health Planning Council. He also has represented clientsbefore federal and state government agencies, including the Department ofHealth and Human Services Office for Civil Rights in its investigations intoHIPAA-related security breaches. Ben also counsels clients on the developmentand implementation of compliance programs for health care providersand business associates under HIPAA and on preparing for and respondingto HIPAA breaches and investigations.