McDermott Will & Schulte, a global law firm

Drawing on the combined resources, experience and record of our top-ranked health law and antitrust practices, McDermott Will & Schulte’s health antitrust lawyers provide clients with sophisticated, practical legal counsel where one of the most highly regulated, rapidly evolving industries meets one of the most complex area of law. We help hospitals, health systems and other providers identify antitrust risks and implement solutions that achieve business objectives and improve the delivery of services.

We regularly advise clients regarding the antitrust implications of provider mergers, acquisitions, joint ventures and joint operating agreements and defend those transactions before state and federal antitrust enforcement agencies. We assist clients in the development of clinical integration programs, accountable care organizations (ACOs) and other provider managed care contracting networks such as IPAs and PHOs, and the structuring of co-marketing arrangements, Medicaid collaboratives, trade associations and joint-purchasing arrangements.

We provide legal counsel on a broad range of day-to-day operations that may expose healthcare organizations to antitrust risks, including managed care contracts, economic credentialing, physician conflicts of interest, exclusive services agreements, purchase and use of discounted pharmaceuticals under the Non-Profit Institutions Act, integrated delivery systems, vertical integration and participation in information exchanges.

Our primary goal is to help clients avoid antitrust investigations and litigation. In so doing, we regularly develop and implement antitrust compliance plans, protocols, firewalls and training on appropriate policies and procedures. We also help clients identify and mount potential defenses and immunities, such as certificates of public advantage and joint actions to influence government policy (Noerr immunity). When investigations, civil litigation or class actions arise, our health antitrust litigators draw on their prior successes to mount a solid defense in court and before regulatory agencies.

Lo Studio è leader mondiale nell’assistenza legale in ambito sanitario e opera con un team di professionisti di altissimo livello dislocati negli Stati Uniti, in Europa e in Asia.

Lo Studio, attraverso il team di professionisti dedicati, vanta una vasta conoscenza delle tematiche legali legate al settore health and life sciences. Una profonda competenza del mercato e del business di riferimento consente allo Studio di affiancare con successo clienti che operano in tutti gli ambiti del settore sanitario.

McDermott Will & Schulte è riconosciuto dalle principali directories del mercato legale quale indiscusso leader mondiale dell’assistenza legale in ambito sanitario.

Nel 2015 le riviste The Legal 500 USA e Chambers USA – quest’ultima per il sesto anno consecutivo – hanno attributo a McDermott il ranking più alto nelle classifiche di settore. In Europa, il team tedesco di McDermott è stato riconosciuto tra i top performer del settore health and life sciences da Chambers Europe.

Lo Studio assiste in molteplici giurisdizioni (inclusa l’Italia) società leader nel settore farmaceutico, nella produzione e distribuzione di dispositivi medicali, ma anche investitori nel settore delle infrastrutture ospedaliere (banche, investitori istituzionali, fondi di private equity), società che si occupano dei servizi connessi alla gestione di ospedali, case di cura e infrastrutture sanitarie in genere.

Il team italiano è in grado di offrire ai propri clienti che operano nel settore health and life sciences una consulenza multidisciplinare annoverando avvocati di riconosciuta esperienza nell’ambito di operazioni corporate, nel banking and finance, nel diritto tributario, nella normativa antitrust e nella tutela della proprietà intellettuale e della privacy. L’interazione costante con i colleghi che operano in altre giurisdizioni consente di fornire risposte efficaci alle specifiche problematiche affrontate, anche in caso di arbitrati internazionali o di progetti che richiedono una consulenza cross-border.

How can we help you transform healthcare?

Healthcare delivery and reimbursement is shifting toward value-based care and vertical consolidation at a rapid pace, while the boom of health plan mega-mergers shows no signs of stopping. Those who want to grow and innovate within this disrupted healthcare environment face difficult regulatory and transactional legal obstacles. In order to thrive despite these challenges, you must be willing to take calculated business risks and adapt to a shifting landscape.

Creative legal solutions in the most complex markets

Our experienced team anticipates change and crafts creative, strategic solutions in even the most complex markets. Clients turn to us for our depth of knowledge on key issues and our unmatched skill in navigating the complicated industry issues they face, including numerous types of managed care arrangements and integrated delivery systems for health insurers, hospitals, academic medical centers, other institutional inpatient and outpatient facilities, medical groups and independent practice associations, physicians, medical discount programs and employers, as well as for investment bankers, venture capitalists and individual entrepreneurs. Our Firm also works closely with health insurers and their pharmacy benefit managers (PBMs) on prescription drug plans and pricing issues. Amidst uncertainty we offer a level-headed approach, fostering collaboration across industries and borders.

We work tirelessly to facilitate connections through mergers, acquisitions, affiliations and joint ventures, conducting full due diligence while identifying and negotiating arrangements built with regulatory and technological assessments and solutions in mind.

Our team provides guidance to Accountable Care Organizations (ACOs) on the Medicare Shared Savings Program requirements for their organizational and contractual arrangements. We also advise trade associations on communications to their membership regarding legal developments, draft comments on proposed regulations and subregulatory guidance, and offer strategic counseling in dealing with state and federal agencies.

With an impressive depth of national and international regulatory knowledge, we’re at the forefront of health industry innovation. And as the United States’ top-ranked healthcare law firm, we offer unmatched experience addressing the legal obstacles facing health plans, managed care arrangements and ACOs, including providing counsel on:

• Administrative services only arrangements
• Requirements under the Affordable Care Act, such as tax issues and risk management
• Antitrust and trade regulation
• Bankruptcy and workout plans
• Consumer-directed health plans
• Prescription drug pricing
• Conversions and tax-exempt issues
• Corporate integrity agreements and compliance programs
• ERISA
• The Federal Employees Health Benefits Program
• HIPAA privacy and security
• Tiered-benefit arrangements and disease management programs
• Medical discount programs
• The Medicare Advantage Program and Medicare Part D
• Federal and state licensure of plans and insurers

Drawing on our robust, cross-functional, cross-border team, we provide cutting-edge solutions and creative counsel to our health plan clients to navigate the changing healthcare landscape.

Spurred by the shift to value-based care, the healthcare market is transforming at a rapid pace as systems join forces to tackle some of the industry’s biggest challenges. We counsel provider organizations across the United States and around the world on all aspects of healthcare investments, operations and regulatory matters. The results are operational efficiencies and reduced costs, optimized investments in technology and innovation, and improved patient care and safety.

Moving swiftly to capitalize on opportunities

Clients—including nonprofit, for-profit, faith-based and governmental hospitals; healthcare systems; and physician groups of all sizes—frequently turn to us to serve as outside general counsel. We work to seamlessly supplement in-house general counsel by providing responsive, accurate and forward-thinking legal advice on a variety of issues:

• Corporate governance
• Labor and employment needs for medical staff
• Employee benefits
• Professional services
• Provider and physician satisfaction
• Compliance with Medicare reimbursement regulations, fraud and abuse laws, Stark Law, HIPAA and data privacy laws
• Licensing and accreditation for the institution and its professionals
• Tax-exemption matters

As the top-ranked healthcare law firm, we advise clients on all elements of the health industry, whether by offering counsel through detailed and efficient due diligence; evaluating sophisticated and nuanced tax benefits, antitrust and health regulatory issues; or negotiating strong, practical transaction documents. Applying our wealth of experience and understanding of the rapidly changing business, legal and regulatory terrain, we help clients develop winning strategies and seize opportunities.

We create connection through mergers, acquisitions, affiliations and joint ventures, all while identifying solutions that minimize risk and maximize success for patients, providers and investors. Our extensive experience and practical approach to facilitating collaboration across industries and borders gives us unique insight into the relationship-building nuances that help healthcare leaders make these vital alliances a reality.

And with highly experienced lawyers throughout the Firm, we provide clients coordinated, cross-functional, cross-border counsel in key areas beyond healthcare as well, including tax, labor, employment and employee benefits, litigation and intellectual property.

Today’s health market has entered a new age of collaboration, innovation and disruption.  With the shift to value-based care turning the healthcare industry on its head, forward thinking leaders are looking toward innovative alliances through mergers and acquisitions to improve quality of care and delivery, financial outcomes, and operational efficiencies.

Making these innovative and transformative business ventures a reality comes with significant regulatory and transactional challenges, and there are many opportunities for a deal to go off course.

That’s why you need the full weight of the industry’s leading healthcare law firm behind you.

As the industry’s top-ranked law firm for health and life sciences ventures, we’re passionate about our role in shaping the alliances that will lead to superior healthcare delivery. With more than 400 major hospital and health system transactions under our belts in the past five years, we are deeply experienced with helping clients find creative and unexpected solutions in the most complex healthcare and life sciences markets.
Whether they’re forming partnerships across industries or across the world, our unparalleled experience enables us to champion our clients’ visions. Our team’s cross-functional, cross-border capabilities, practical and operational approach, and extensive experience fostering game-changing collaborations give us unique insight into the relationship-building nuances that help healthcare leaders make these vital alliances a reality. Our transaction leaders bring highly focused skills and broad industry experience to bear on all elements of a transaction, earned from decades of fostering game-changing alliances in the healthcare space through merger and acquisitions, private equity and venture capital investment, joint ventures, and strategic investments and alliances.

Our transaction leaders bring highly focused skills and broad industry experience to bear on all elements of a transaction. We seamlessly integrate technical specialties with transactional, regulatory and controversy-contextual knowledge (e.g., Medicare reimbursement, the Stark Law) and have significant daily experience advising on these matters at operational and strategic levels. This cross-functional approach enables our team to anticipate change and craft creative solutions that avoid redundancy and delay, so that transactions are executed in a timely, cost-effective manner. Our deep regulatory bench and broad transactional backgrounds give us insight into the regulatory, reimbursement and operational issues that, in less experienced hands, can derail transactions and destroy value.

Because we have counseled hospitals and health systems across the United States and around the globe, our dedicated healthcare M&A teams have a complete understanding of the federal and state regulatory landscape and can quickly identify the local regulatory matters that, in conjunction with federal laws and regulations, will influence the outcome of a transaction.

Together, we’re pushing boundaries and knocking down barriers to usher in a new age of healthcare collaboration.

Regulation in the healthcare industry is pervasive and extraordinarily complex. To stay ahead of emerging regulations and minimize the risks associated with non-compliance, health industry leaders need experienced legal counsel who are well-versed in existing laws and have a finger on the pulse of new legal and regulatory developments.

We’ll be your guide on the road to innovation.

Almost every aspect of healthcare is overseen at the federal, state or local levels, and often by a range of private organizations as well, creating a regulatory maze of transactional structuring and due diligence, operations, compliance plan implementation, self-disclosure and defense. With centuries of combined experience providing counsel to some of the world’s most important healthcare organizations, we have the diverse and expansive capabilities necessary to clear your path to success.

With our team of former prosecutors and Office of Inspector General officials, Health and Human Services and US Food and Drug Administration (FDA) regulators, and compliance leaders, we are able to provide clients with real-world, practical approaches to managing the most complex regulatory challenges. As a result, our client base extends across all facets of the healthcare industry.

Our healthcare regulatory lawyers have unrivaled experience in all key areas of healthcare, including anti-kickback and self-referral laws, False Claims Act defense, reimbursement counseling, patient data privacy under HIPAA and the HITECH Act, health reform initiatives and tax issues, especially in these key areas:

• Affordable Care Act
  The Patient Protection and Affordable Care Act and the Health Care and Education Reconciliation Act of 2010 (collectively, the Affordable Care Act) has expanded access to health insurance for tens of millions of US citizens and generated a complete overhaul of the nation’s health system. We help clients understand and navigate these changes, advising on industry best practices and the development of educational programs. Drawing on the knowledge and resources of lawyers in our highly regarded health, employee benefits, life sciences, executive compensation, government strategies and tax groups, we offer comprehensive service to help clients meet the challenges of the new healthcare landscape.
• Clinical and Database Research
  Adherence to good clinical practices is fundamental to research. We represent academic medical centers, pharmaceutical companies and research institutions on all aspects of FDA, National Institutes of Health, National Cancer Institute, and Animal and Plant Health Inspection Service regulatory matters. Our experience includes advising on procedures and other compliance matters, preparation for and representation during inspections and audits of device and drug trials, representation in enforcement actions, and advising on establishing organizations to conduct clinical research.
• Fraud and Abuse/Stark Law
  Healthcare fraud and abuse costs the industry billions. Without adequate processes in place to prevent fraudulent activities, providers may be subject to costly investigations. We advise clients in all areas of Medicare and Medicaid fraud and abuse statutes, the Stark Law, and other federal and state self-referral prohibitions, and provide guidance regarding safe harbor regulations. Our fraud and abuse consultation includes planning and structuring transactions to minimize fraud and abuse implications, and providing advisory opinions on potential concerns. We conduct audits and represent clients targeted in inspector general and grand jury investigations, often working with our white-collar defense team to provide effective, multifaceted representation.
• FDA/Product Regulation
  Members of our FDA and health industry advisory practices are nationally recognized by U.S. News – Best Lawyers and LMG Life Sciences. We provide comprehensive advice on all aspects of the development, clinical research, product application and review, manufacture, distribution, marketing and reimbursement of drug, biologic, device and other products regulated by the FDA.
• Tax-Exempt Organizations
  Tax-exempt healthcare organizations are subject to intense regulatory scrutiny by Congress, the Internal Revenue Service and state attorneys general. As the industry’s top-ranked healthcare law firm, and one of the largest and most-respected tax practices, we provide comprehensive tax planning, compliance and advocacy services to nonprofit hospitals and other tax-exempt healthcare organizations. We regularly advise healthcare clients on the special tax issues that arise in the context of joint operating arrangements, horizontal integrations, conversions and sales of assets and the resulting foundations, joint ventures, physician practice acquisitions, academic medical center relationships with physicians, and captive insurance and other risk-management arrangements.