Scott Landau is a business-oriented lawyer known for his creative, results-driven approach to legal problems. He counsels hospitals, healthcare providers, and startups on regulatory compliance, data privacy and security, strategic transactions and arragements, and care delivery reform, and represents clients across multiple industries in civil litigation and government enforcement matters.
An experienced healthcare regulatory advisor, Scott regularly counsels providers, wellness companies, startups and tech companies on how to structure and operate their businesses in compliance with federal and state laws and regulations governing the healthcare sector, including: the “Stark” law; the Anti-kickback Statute; Medicare rules and conditions of participation; Telehealth/Telemedicine rules and regulations; HIPAA; the FDCA, DSHEA, and other FDA regulatory regimes; state corporate practice of medicine restrictions; and state public health and licensure laws. Scott also works with providers, healthcare ventures, and technology providers to structure legally compliant arrangements with hospitals, providers, independent practice associations (IPAs), management services organizations (MSOs), data analytics consultants, and drug and device manufacturers.
Scott is a trusted advisor to organizations with data and privacy concerns, and helps HIPAA covered entities and “business associates” ensure that protected health information (PHI) is managed and disseminated in compliance with federal and state confidentiality laws. Scott also advises healthcare concerns on delivery and payment reform issues. He develops and structures innovative payment and service delivery models; negotiates and drafts value and savings-based payment arrangements; and advises on participation in government sponsored alternative and bundled payment testing models.
Scott is an experienced and versatile litigator, having spent nearly two decades in both the private and public sectors representing clients in hundreds of civil matters in federal and state courts and in ADR proceedings. As lead counsel, Scott has obtained dozens of pre-trial dismissals “on the papers,” and has successfully tried multiple cases to verdict. Scott also has an active appellate practice and has handled complicated appeals before the U.S. Court of Appeals for the Second Circuit and the Appellate Divisions of the New York State Supreme Court. Scott also counsels clients on complicated eDiscovery issues and legal hold and ESI preservation policies and protocols.
Scott regularly defends clients in federal and state government investigations, audits, and reviews, as well as in qui tam actions. In multiple enforcement matters, Scott has successfully convinced the government not to proceed, and in litigated matters he has obtained dismissals and favorable settlements. He has also conducted dozens of internal investigations for providers related to alleged healthcare fraud and billing improprieties, and has prepared voluntary self-disclosures to both federal and state regulators across a wide-range of regulatory frameworks.
Prior to co-founding AEL, Scott was Associate General Counsel for the Mount Sinai Health System (Mount Sinai), one of the most prestigious not-for-profit academic health care and hospital systems in the country. In that capacity, Scott handled a full-spectrum of litigation, regulatory, and transactional matters, and counseled Mount Sinai’s clinically integrated network, IPA, and ACOs on transitioning to “population health” based models of accountable and integrated healthcare delivery and value- based payment.
From 2008-2014, Scott served as an Assistant U.S. Attorney for the Eastern District of New York (EDNY), where he handled affirmative civil health care fraud matters, FCA cases, and defensive programmatic, regulatory, and employment disputes.
From 2002-2008, Scott was a litigation associate at Proskauer Rose LLP, where he represented commercial clients in health care, sports, securities, land use, and life sciences related disputes.
Scott serves on the Board of Directors of the Mount Sinai Medical Legal Partnership (www.msmlp.org), a not-for-profit organization that coordinates pro bono legal representation for our community’s most vulnerable patients, so that they can address and resolve their legal issues and reduce dependence on/utilization of expensive health care services.
Litigation and Appellate
- Obtaining dismissal of putative class action alleging that “flu shot” reminder text message sent by physician’s practice violated the Telephone Consumer Protection Act (TCPA); dismissal affirmed on appeal by Second Circuit Court of Appeals in noteworthy decision regarding TCPA’s “health care exception” and scope of “prior express consent” (Latner v. Mount Sinai Health System, Inc., 2016 WL 10571897 (SDNY Dec. 14, 2016), aff’d 879 F.3d 52 (2d Cir. 2018));
- Obtaining dismissal of FCA qui tam action alleging that medical school misappropriated federal grant funds by treating allegedly “ineligible” patients in connection with 9/11 first responder treatment program (US ex rel. Ramos v. Icahn School of Medicine at Mount Sinai, 2015 WL 5472933 (SDNY Sept. 16, 2015));
- Representing and successfully resolving FCA qui tam action alleging that hospital and medical school overcharged federal Medicare program and New York State Medicaid program for outpatient radiology services;
- Convincing plaintiffs to voluntarily withdraw lawsuits in New York State court against healthcare provider alleging breach of contract and deceptive trade practices following submission of motions to dismiss demonstrating that plaintiff’s claims were legally and factually deficient;
- Successfully representing and settling lawsuit on behalf of medical school against former services vendor for breach of contract, conversion, and unjust enrichment stemming from failure to remit fees vendor collected by vendor on school’s behalf;
- Litigating and negotiating innovative “structured settlement” agreement in putative class action lawsuit against hospital system alleging that physical access barriers and practices failed to accommodate individuals with disabilities and thus violated Title II of the Americans With Disabilities Act (ADA);
- On behalf of United States, obtaining reversal by Second Circuit of district court award of damages in Federal Tort Claims Act (FTCA) action (tried to verdict) in which plaintiff claimed injuries based on allegedly tortious acts, for failure to meet FTCA’s “private analogue” requirement;
- Representing academic medical center in federal government investigation regarding part-time employment and office space rental arrangements with cardiology practice;
- Representing hospitals in responses to federal and state government subpoenas for documents and testimony in investigations regarding alleged arrangements with community physicians;
- Representing institutional owner of captive insurance company and its third-party administrator in New York State Department of Financial Services (DFS) investigation into complicated reinsurance transactions;
- Conducting internal investigations into alleged billing improprieties and regulatory compliance violations perpetrated by physicians and administrators;
- As Assistant U.S. Attorney, investigating civil claims against wholesale drug company regarding repackaging and redistributing pre-filled supportive drugs for chemotherapy patients;
- As Assistant U.S. Attorney, prosecuting and settling civil fraud claims against commercial laboratory for making payments to induce physicians to utilize testing services.
Healthcare Regulatory and Compliance
- Furnishing regulatory advice to hospitals and physician practices regarding both routine and non-routine compliance, billing, and reimbursement issues;
- Advising healthcare technology startup on how to structure business operations as well as arrangements with healthcare providers to comply with the federal Antikickback statute, HIPAA, and New York and New Jersey state-based healthcare regulations and requirements.
- Advising hospitals and providers on how to structure arrangements with referring physicians, including professional service agreements (PSAs), license and service agreements (LSAs), and employment arrangements, to comply with the Stark law, the Anti-kickback law, and other applicable regulatory requirements;
- Counseling noted health and wellness company on compliance with FDA rules and requirements regarding branding, marketing, and advertising of cosmetic products.
- Conducting reviews and risk assessments for academic medical centers, hospitals, and physician practices to remediate compliance program gaps and enhance effectiveness of program activities to meet obligations under applicable laws, CAPs and CIAs, and industry best practices.
- Advising physician practices and “captive” PCs on compliance with state corporate practice of medicine restrictions and other state-based licensure requirements;
- Counseling hospitals and physicians on compliance with New York State “Surprise Medical Bills and Emergency Services” law and rules;
- Advising hospitals on compliance with Medicare Conditions of Participation and provider-based billing rules;
- Counseling on and preparing voluntary disclosures for hospitals regarding Medicare billing irregularities pursuant to HHS OIG Provider Self-Disclosure Protocol (SDP).
Transactions and Arrangements
- Negotiating and drafting partnership agreements between health system and nationally recognized private equity backed primary care provider for provision of concierge medical services in New York metropolitan market;
- Restructuring and redesigning community hospital’s “captive” PC-based ambulatory practice network and associated arrangements to improve patient care, ensure regulatory compliance, and increase operational and financial efficiencies.
- Negotiating deal terms and drafting agreements associated with physician practice acquisitions by health care systems and hospitals;
- Negotiating employment agreements, PSAs, and LSAs between physicians, physician practices, hospitals, faculty practices, and other healthcare providers;
- Representing community hospital in connection with minority-interest investment in orthopedic ambulatory surgery center;
- Negotiating commercial and IT agreements with vendors, drug and device manufacturers, and biomedical service and supply vendors.
- Designing, structuring, and drafting participation agreements and program handbooks and policies for rehabilitation provider network and post-acute care provider network.
Healthcare Delivery and Payment Reform
- Counseling clinically integrated network (CIN) on fraud and abuse, HIPAA, antitrust, and other regulatory issues associated with clinical operations, value and shared-savings based incentive arrangements, and data sharing;
- Advising healthcare providers on best practices and risk mitigation associated with Medicare Advantage risk adjustment coding activities;
- Structuring legally compliant value and shared-savings based incentive programs and participation agreements for IPA, CIN, and Medicare Shared Savings Program (MSSP) ACOs;
- Counseling MSSP ACO participants on compliance with MSSP regulations regarding contents of participation agreements, provider incentive payments, beneficiary incentives, data sharing, and waivers of application of fraud and abuse laws;
- Advised healthcare providers on rules and requirements for participation in government sponsored alternative payment models, including the MSSP, Bundled Payments for Care Improvement (BPCI), the Comprehensive Care for Joint Replacement Model (CJR), and the Oncology Care Model (OCM);
Data Privacy and Security
- Representing hospital in U.S. Department of Health and Human Services (HHS) Office of Civil Rights (OCR) investigation and settlement of alleged HIPAA violations and with implementation of corrective action plan (CAP);
- Counseling CIN and ACO entities on PHI management and data sharing issues associated with new and innovative care management models;
- Advising health care system on IT and cyber-security policies, protections, risk mitigation, and cyber-incident and breach responses.
- Designed and drafted standard terms and conditions (T&Cs) for purchase and lease agreements regarding biomedical device cybersecurity and safety.