Nicole Martin discusses OIG's proposed rule that would amend the Anti-Kickback Statute safe harbors, as well as regulatory requirements under the Civil Monetary Penalty Law regarding beneficiary inducements.
Cozen O’Connor provides practical and cost-effective legal counsel to health care industry clients. We help them manage risk and seize opportunities in this era of regulatory uncertainty, government scrutiny, innovation, challenging economics, and shifting demographics.
The firm serves health systems, hospitals, physician groups, long-term care and nursing home providers, life sciences and health technology companies, private equity and venture capital investors, suppliers, drug and device companies, and health care entrepreneurs.
Our multi-disciplinary health care team is led by the former deputy general counsel to one of the region’s largest health systems, and includes attorneys with decades of relevant healthcare regulatory, litigation, and transactional experience.
Cozen O’Connor stands out from other large law firms for being able to provide comprehensive health law services nationwide, while maintaining an entrepreneurial business model that can scale offerings and rates to fit the specific needs of each client.
Our Health Law Group represents clients in the areas of:
Cozen O’Connor is nationally known as a “go-to firm” for reimbursement disputes. Clients draw on our deep knowledge of laws governing the Medicare and Medicaid programs, as well as the financial and operational considerations specific to public and private-payor disputes.
The reimbursement dispute practice is led by Mark Gallant, a Band 1 Chambers-recognized attorney who served as deputy chief counsel to the Centers for Medicare & Medicaid Services (CMS), managing all litigation for the federal government under the Medicare and Medicaid programs. He heads a team with specific experience in reimbursement litigation.
The firm represents health systems, hospitals, and drug and device companies in litigation against private insurers, the federal government and state programs. The scope of our experience is vast and includes work on some of the most technically and legally complex disputes of the last decade.
We advise on issues involving: Medicare certification, premium subsidies, diagnosis-related groups (DRGs), site-of-service, out-of-network reimbursement, network termination, suspension of payments, continuity-of-care, recoupments, coding downgrades, coverage, ERISA, sequestration and intergovernmental transfers. We have had cases before the Provider Reimbursement Review Board (PRRB) and the Departmental Appeals Board (DAB) of the Department of Health and Human Services and regularly appear in state and federal courts on behalf of our clients.
Cozen O’Connor’s practice is unusual in that we are capable of managing large multi-state or multi-plaintiff reimbursement litigation, but are also flexible enough to adjust our service model to meet specific client needs, including through use of alternative or contingency fee agreements.
Payer Contracts & Value-Based Programs
Given the current regulatory climate, the need for clear and enforceable payer contracts has never been greater. The Health Law Group at Cozen O’Connor counsels major health care clients in the areas of payer contracts, clinical integration and value-based payment programs.
Cozen O’Connor represents health systems, hospitals, and large physician groups. Led by Christopher Raphaely, the former deputy general counsel to Jefferson Health System and general counsel to the system’s accountable care organization and captive professional liability insurance companies, our group is well versed in the intricacies of payer contracts and their practical implications.
Our Health Law Group offers start-to-finish contract counsel. We negotiate payer contracts of all types and provide advice on cutting-edge contracting issues, such as utilization management, “tiering and steering,” and the impact of corporate structure on government payment eligibility. We provide sophisticated front-end payer contract counsel, and defend and enforce payer contracts in high-stakes payment disputes.
Cozen O’Connor is also a recognized leader in value-based contracting and related risk-based payment programs. We structure accountable care organizations (ACOs) and clinically integrated networks.
HIPAA & Health Data
No entity can operate in the health care field without paying constant and careful attention to health data privacy and security. Cozen O’Connor’s Health Law Group helps major corporate clients meet the challenges of achieving regulatory compliance and keeping health data secure.
Led by Gregory Fliszar, Cozen O’Connor represents HIPAA-defined “covered entities” (health systems, hospitals, physician groups, and other providers) and “business associates.” Cozen O’Connor also advises clients handling health care data outside the HIPAA regulatory structure, such as wellness programs, wearable devices, and websites. Our attorneys closely track health privacy and security laws, including HIPAA and HITECH, FTC, FDA, Gramm-Leach-Bliley, the GDPR, U.S. Privacy Shield, alcohol and drug abuse records, federal communications and trade statutes, and myriad state-based privacy and data breach laws.
Among the most important services Cozen O’Connor provides is comprehensive loss prevention. Our attorneys conduct deep-dive audits under the umbrella of attorney-client privilege; develop policies and procedures that integrate sophisticated physical, technical and administrative safeguards; conduct client training on data privacy and security compliance; and draft and review contracts with business associates, subcontractors and institutional partners.
In response to an alleged privacy violation or data breach, the Health Law team can perform immediate forensic and recovery operations, satisfy notification obligations, liaison with government officials and design public messages to protect clients from liability. We lead complex internal investigations for high-profile health clients and represent them in federal and state government regulatory investigations, enforcement actions, state attorneys general litigation, class actions and individual plaintiff lawsuits.
The firm’s work in health data privacy and security is significantly bolstered by our strong Washington D.C.-based government affairs and state attorneys general groups. Cozen O’Connor Public Strategies is at the forefront of tracking legislative developments on health data, and the firm’s 50-state AGs practice is well positioned to assist as regulatory responsibility devolves to the state level.
New technologies are transforming health care in America. From the growth in telehealth and telemedicine to the revolution in electronic data collection and analysis, digital health is affecting nearly every aspect of health care delivery.
Cozen O’Connor is a leader in digital health law. We represent innovative telehealth and telemedicine companies, technology companies, health care analytics firms, provider groups, and medical device manufacturers. Our attorneys bring decades of diverse experience in health care, technology, and emerging business development, and provide comprehensive regulatory and corporate counsel.
We advise innovative digital health clients on compliance with analogue-era regulatory requirements, including all state and federal privacy and security rules; health fraud and abuse laws; and FCC, FDA, FTC and state consumer protection requirements.
Our attorneys also provide integrated corporate counsel, assisting technology firms and health care companies on corporate structure, private equity, IP, commercialization, licensing, marketing and contracts. We partner with emerging companies through every stage of their business life cycle. Our attorneys advise digital and tech-focused companies on medical liability risk management and coverage and reimbursement strategies with both government and private payors.
Cozen O’Connor not only advocates for individual clients, but also for the digital health industry. Through our Washington D.C.-based Public Strategies firm and State Attorneys General practice, we provide top-ranked government relations support. We track relevant legislative activity; advocate before state and federal governments; and build effective trade associations and policy-based coalitions.
Health Care Government Investigations
Cozen O’Connor defends health care clients in high-stakes federal and state agency investigations and litigation, including actions involving False Claims Act, qui tam, Anti-Kickback, Stark Law, and Sunshine Act claims. We are known for our ability to achieve early and decisive resolutions.
Health Care Transactions
Modern health care institutions require legal counsel who are well-versed in both corporate law and health law in order to complete major transactions. Whether arranging venture capital funding for a health technology start-up or executing a hospital merger, Cozen O’Connor brings sophisticated understanding of business, finance, health industry operations, and health regulations to every deal.
We serve as transactional counsel for hospitals, health systems, physician groups, ACOs, clinically integrated networks, medical device manufacturers, private equity sponsors and portfolio companies, academic medical centers and research organizations.
Cozen O’Connor’s full-service corporate practice handles complex business transactions for health clients, including mergers and acquisitions, divestitures, joint ventures and co-management agreements, venture capital and private equity investments, public offerings and recapitalizations. We also assist with antitrust due diligence and reporting, as well as tax analysis and structuring.
Our health care team provides counsel on transactions unique to the health care industry. We form ACOs, clinically integrated networks and physician practice groups, and negotiate contracts between providers and a multitude of different vendors. Cozen O’Connor represents management service organizations (MSOs), contract research organizations (CROs), tissue banks and other nonprofit data centers. Clients rely on Cozen O’Connor’s detailed understanding of the health care business, health IP, payor policies and federal research guidelines.
Health Care IP
We represent generic pharmaceutical companies in litigation under the Hatch-Waxman Amendments to the Food, Drug & Cosmetics Act and the Biologics Price Competition and Innovation Act (BPCIA). Our team advises clients on FDA citizen petitions, regulation of drug registration, labelling, and marketing.
Cozen O’Connor Public Strategies, the firm’s bipartisan Washington D.C.-based government relations firm, provides outreach to public officials on matters of health law and policy. We advocate for clients before the Centers for Medicaid & Medicare Services, Department of Justice, Food & Drug Administration, state departments of health & welfare, and state and federal legislatures.
The increased use of cannabis for medical purposes presents health care institutions, providers, and suppliers with a complex set of legal considerations. Cozen O’Connor has an interdisciplinary team of attorneys ready to advise on all applicable state and federal laws.
State Attorneys General
With one of the largest state attorneys general practices in the country, Cozen O’Connor represents clients in state AG investigations and litigation (including multi-state and federal co-enforcement actions). The state AG team has experience counselling health care clients faced with state-based consumer protection, antitrust, false claims, drug pricing, and data privacy claims.