Jacqueline Green authored an article examining the drawbacks of the prior authorization process used by insurance companies.
Cozen O’Connor’s cross-disciplinary health care and life sciences team provides comprehensive services in one of the largest, most dynamic, and fastest-growing sectors of the U.S. economy. The health care and life sciences fields are heavily regulated, and all legal work in this area must be grounded in a specific and sophisticated understanding of applicable laws. We represent and advise companies of all stages that are bringing innovation to the market to achieve better efficiency, accuracy, and outcomes in all aspects of clinical health care. Many of our attorneys hold advanced scientific degrees and have worked at health care and life sciences companies, and we combine this deep industry knowledge with a demonstrated strength across the transactional, regulatory, and litigation areas of the law.
Investors focused on funding in the health care and life sciences industries, including private equity and venture capital firms.
Businesses in all phases of their company lifecycle, from rapidly growing start-ups to mature public companies.
Members of the health care sector, including pharmaceutical companies, hospitals and health systems, physician group practices and surgical specialties, long-term care facilities, behavioral health providers, accountable care organizations (ACOs), medical equipment manufacturers and suppliers, academic institutions, tissue banks, and insurers.
Members of the life sciences sector, including drug developers, biotechnology companies, medical device manufacturers, and health care entrepreneurs.
The expansive range of skills, knowledge, and experience within the team includes:
New technologies are transforming the practice of health care. 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 counsel clients on all aspects of digital health, from compliance with analogue-era regulatory requirements to health fraud and abuse laws.
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 advocates not only for individual digital health clients, but also for the industry as a whole. Through our Washington, D.C.-based Public Strategies firm and State Attorneys General Practice, we provide top-ranked government relations support, track relevant legislative activity, advocate before state and federal governments, and build effective trade associations and policy-based coalitions.
Health Care M&A
Modern health care institutions and non-institutional businesses require legal counsel who are well-versed in both corporate law and health law in order to complete major transactions. Cozen O’Connor brings sophisticated understanding of business, finance, health industry operations, and health regulations to every deal.
Cozen O’Connor serves as transaction 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. We can assist with all facets of a transaction, from initial acquisition structuring, due diligence, antitrust, fraud and abuse, reimbursement, quality of revenue, and tax matters, through document negotiation and implementation and closing. We have extensive experience negotiating joint ventures, alliances, and co-management arrangements, and arrange financing through public and private offerings, bonds, loans, and other investment vehicles. Our team can resolve compliance, antitrust, tax, and bankruptcy issues for health care and life science organizations.
Health Care Private Equity
Cozen O’Connor’s deep understanding of the unique legal, political, regulatory, macroeconomic, and business aspects of the health care industry benefits private equity firms and their portfolio companies when working to meet their strategic goals. Our clients rely on our comprehensive approach to due diligence of targets in the health care space and benefit from the guidance of our health care regulatory counsel. In this capacity, we are counsel to private equity sponsors and portfolio companies and advise in both buy-side and sell-side transactions. Our health care transactions team is current on market trends and market-based contract provisions. We routinely write, speak, and hold seminars on recent developments in the health care private equity space.
Emerging Business Venture Capital
Our team advises life science start-ups at all stages of a company’s lifecycle, from formation through financing and exit planning. Cozen O’Connor’s cross-disciplinary team is knowledgeable in all issues affecting emerging businesses, including employment, intellectual property, tax, real estate, and corporate governance. Our deep involvement in the field and breadth of experience allows the firm to function as a one-stop shop for life science start-ups seeking assistance in developing, protecting, and commercializing their developments and discoveries.
Life Sciences Transactions
Our life sciences transactions team handles all transactional needs in this fast-moving industry. We routinely serve as counsel to biotechnology companies at all stages of their life cycle, including early-stage therapeutics. In this capacity we handle MSAs, CRO agreements, development rights, licensing agreements, royalty contracts, university agreements, lab site development, and we resolve disputes with contract manufacturers. Our experience also includes the arrangement of mergers, acquisitions, consolidations, divestitures, workouts and restructurings; negotiation of joint ventures, alliances, and co-management arrangements; resolution of antitrust, tax, and bankruptcy issues; arrangement of financings through public offerings, bonds, loans, and other investment vehicles.
Fraud, Abuse, and Compliance
Clinical and non-clinical health care delivery is driven by compliance guidelines under federal and state law. We routinely advise our clients on federal and state fraud and abuse and related compliance matters, such as laws and regulations under the Federal Anti-Kickback Statute, the Federal Physician Self-Referral Prohibition (the Stark Law), the Federal Civil Monetary Prohibitions (CMPs), the Federal False Claims Act (FCA), and other issues arising from Medicare and Medicaid law. We also advise on guidance issued by the Center for Medicare and Medicaid Services (CMS) under the U.S. Department of Health and Human Services (HHS), Office of Inspector General (OIG), or U.S. Department of Justice (DOJ) initiatives, such as Civil Investigation Demands (CIDs) or DOJ referrals for litigation (i.e. criminal enforcement matters). Compliance and enforcement matters routinely arise in the course of health care operations and may be highlighted during transactional activity. Our team is sophisticated in this arena and has a granular understanding of these laws and their implications. Our team offers practical and efficient advice in all matters related to fraud and abuse and compliance.
Provider Payment Disputes and Contracting
Given the current regulatory climate, the need for clear and enforceable payer contracts has never been greater. Cozen O’Connor counsels major health care clients in the areas of payer contracts, clinical integration, and value-based payment programs. Our attorneys are well-versed in the intricacies of payer contracts and their practical implications. We are also 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.
Our team offers start-to-finish contract counsel and is well-versed in all types of payer contract issues, including utilization management, “tiering and steering,” and the impact of corporate structure on government payment eligibility. We provide sophisticated front-end payer contract counsel, and we also defend and enforce payer contracts in high-stakes payment disputes, for which we are nationally known and respected. Cozen O’Connor is a recognized leader in value-based contracting and related risk-based payment programs. We also structure accountable care organizations and clinically integrated networks.
The firm represents health systems, hospitals, and drug and device companies in disputes against private insurers, including Medicare Advantage organizations, and federal and state government health care programs. The scope of our experience is vast and includes work on some of the most technically and legally complex disputes of the past decade. We advise on issues involving: Medicare certification, premium subsidies, disputes over Emergency Department (ED) reimbursement, 340B drug payment disputes, diagnosis-related groups (DRGs), enforcement of prompt pay penalties, 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 served as counsel in cases before the Provider Reimbursement Review Board (PRRB), the Departmental Appeals Board (DAB) of the Department of Health and Human Services, and state Medicaid Bureaus of Hearings and Appeals. We regularly appear in state and federal courts on behalf of our clients. In addition, we have achieved successful results for our clients in numerous confidential mediations and arbitrations.
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.
Hospitals and Health Systems
We represent non-profit and for-profit hospitals and health systems throughout the country on a daily basis in all aspects of their operations, including payor contracting and disputes, Medicare, Medicaid, HIPAA and data privacy and security, compliance, investigations, physician contracting, intellectual property protection and monetization, licensure, vendor contracting, medical staff issues, and governance matters. Several of our lawyers have spent a significant portion of their careers working as lawyers in hospital legal departments and the entire team is cognizant of the unique internal and external dynamics faced by hospital organizations and the executives that run them. We are also routinely involved in hospital mergers and acquisitions, bringing our deep knowledge of the hospital market and applicable laws and regulations as well as our transactional experience to bear to optimize transaction value, protect our client, and complete the transaction as quickly and efficiently as possible.
Physician Group Practices and Surgical Specialties
The dynamics of physician practice are evolving rapidly with the proliferation of digital health, the increased deployment of non-physician clinical professionals, the rise in asynchronous prescribing, and an increased investment in ancillary services, such as imaging and clinical laboratories. With this evolution, the legal complexity of physician practice has increased exponentially. Cozen O’Connor provides invaluable representation to primary care, surgical, and other specialty physician practices regarding both daily operations and fundamental transactions. We utilize our deep knowledge of, and experience with, issues affecting physician practices such as professional licensing, the use of management services organizations, and risk-based contracting throughout the country. We regularly represent parties on both sides of physician practice acquisitions involving private equity, hospitals and health systems, and other sources of capital.
Long-Term Care Facilities
Cozen O’Connor’s Health Care and Life Sciences team represents lifetime communities, skilled nursing facilities, and assisted living facilities in billing and tax-exemption compliance, licensure, and general operational and business matters. Our team also has a robust merger and acquisition practice involving lifetime communities and other long-term care facilities. Our breadth of experience with issues that are common to all health care providers, as well as the unique issues faced by long-term care providers who care for some of most vulnerable people in their communities for long periods of time, makes our team well-suited to assist in both day-to-day operations as well as fundamental purchase and sale transactions.
Government Enforcement and Litigation
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.
Our team has the ability to work in cooperation with Cozen O’Connor Public Strategies, the firm’s bipartisan Washington, D.C.-based government relations firm, which 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 firm’s State Attorneys General Practice, one of the largest in the country, 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.
Health Care Privacy & Security
Health data privacy and security is an important issue for all entities operating in the health care sector. Cozen O’Connor’s health care team helps clients meet the challenges of keeping health data secure and ensuring regulatory compliance. We closely track and advise clients on any changes or updates to relevant 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. We also advise clients handling health care data outside the HIPAA regulatory structure, such as wellness programs, wearable devices, and websites. We assist many new and start-up clients in emerging technology businesses as to any potential HIPAA or privacy obligations they may have.
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 covered entities, business associates, subcontractors, and institutional partners.
In response to an alleged privacy violation or data breach, our health care team can perform immediate forensic and recovery operations, satisfy notification obligations, liaise with government officials, and help craft 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 State AG Practice is well-positioned to assist with any inquiries at the state level. In addition, COSECURE, an ancillary business of the firm, works under privilege with our health care attorneys to perform HIPAA security risk analyses and forensic investigations upon discovery of security incidents or breaches.