McDermott Will & Schulte, a global law firm

[McDermott Will & Schulte] shines particularly in the defense of antitrust claims in the healthcare and pharmaceuticals space.
– The Legal 500 US

Grounded in McDermott Will & Schulte’s approach of providing practical advice and tailored solutions, our health antitrust lawyers address the healthcare industry’s unique challenges with business-friendly strategies. Clients in this heavily regulated, rapidly evolving space turn to us for our creative defense of deals, government investigations and litigation.

We use pragmatic yet innovative tactics to respond to antitrust claims and risks. Our clients include:

• Pharmaceutical and medical device manufacturers
• Medical wholesaler distributors and group purchasing organizations (GPOs)
• Health InsurTech companies
• Hospitals and providers
• Payors
• Pharmacy benefit managers (PBMs)
• Health private equity firms

Deals

With the weight of our top-ranked healthcare law firm behind them, clients rely on and trust us to navigate highly complex antitrust issues. We guide them through the antitrust implications of mergers, acquisitions and joint ventures.

Thanks to our advocacy and other strategic actions, we have handled dozens of major US Federal Trade Commission (FTC) healthcare investigations that we guided through to close while avoiding any challenge. On the pulse of the FTC’s and US Department of Justice (DOJ)’s increasing focus on health antitrust issues, our team also advises on vertical and conglomerate mergers, serial acquisitions (e.g., rollups) and platform deals.

Government Investigations

Government agencies are ramping up their scrutiny of potential anti-competitive activity in the healthcare industry. Our health antitrust team stands prepared to represent clients through resulting investigations.

On behalf of our clients, we regularly handle investigations into allegations ranging from market allocation to criminal wage-fixing brought by the FTC, DOJ and state attorneys general – working swiftly and effectively to resolve inquiries.

Litigation

When we’re called upon to defend them, our clients know they are in the capable hands of first-chair litigators. Our team has decades of experience defending antitrust claims before courts around the United States.

Our track record includes successfully defending some of the largest health organizations against antitrust violations and class action litigation. However, we don’t just copy and paste the playbook from our past victories. We offer each client a tailored strategy supported by our extensive knowledge and unparalleled litigation skills to achieve the optimal result for their business.

Just one example of our industry-leading experience is McDermott Will & Schulte’s representation of a former senior executive at DaVita. In this first-ever criminal “no poach” market allocation case, we served as lead counsel from the outset of a DOJ investigation through the not-guilty jury verdict.

Healthcare and life sciences companies operate under the most difficult circumstances. They face pressure to drive innovation and growth while navigating intense government oversight and stakeholder scrutiny. Our lawyers guide you through critical business decisions, complex regulatory frameworks, and evolving market pressures – so you can lead transformation in a highly regulated environment.

Year after year, we are named “Healthcare Practice Group of the Year” by Law360 and ranked by PitchBook as the #1 law firm advising healthcare private equity investors. As one of the top healthcare law firms in the US, we represent every major stakeholder in the ecosystem – from healthcare providers and health systems to life sciences companies and investors.

Our global team delivers integrated legal counsel across regulatory, transactional, intellectual property, litigation, and other business-critical matters. Having served in leadership roles both in-house and within government, we provide the legal, commercial, and regulatory guidance you need across health and life sciences law to shape the future of the industry.

Our health and life sciences lawyers have held senior roles across key government agencies including the US Food and Drug Administration (FDA), Federal Trade Commission (FTC), Department of Health and Human Services (HHS), and Department of Justice (DOJ) – giving us unique insight into the enforcement challenges you face.

We don’t just understand how regulations are enforced – we know how healthcare policy is developed. Through McDermott+, our dedicated healthcare policy and strategic advisory arm, we help you navigate and shape the policy landscape that influences the industry. With a team that includes lawyers, physicians, policy professionals, data analysts, and veterans of Capitol Hill, we advocate for policies that support your healthcare mission.

Our lawyers also guide you across the life cycle of transformative deals, from formation and financing to commercialization, partnerships, and exit. We help you structure transactions that are aligned with market realities and designed to deliver long-term value.

From securing investment and commercializing innovation to scaling operations and protecting your market position, we support you at every stage of growth. Our team develops integrated legal strategies that help clear the path for your breakthrough technologies, next-generation therapeutics, AI-enabled healthcare solutions, and innovative care delivery models.

The McDermott Will & Schulte team has among the best attorneys I have ever worked with in terms of their ability to handle complex and sophisticated matters. It has a great mix of levels of seniority and areas of specialization.
– Chambers USA, Healthcare

The physician practice management (PPM) and ambulatory surgery center (ASC) industries have experienced explosive growth and unprecedented consolidation and capital investment within the past 10 years, yet continue to be highly fragmented and competitive. As physicians, management companies, private equity and other investors join forces to strengthen their positions in this dynamic environment, they face reimbursement, regulatory, compliance, billing and transactional implementation issues that can cause roadblocks to their success.

We’ll expand your field of vision so you can execute your objectives.

With unparalleled experience and industry knowledge, we’re uniquely equipped to help you identify and mitigate risk, uncover new opportunities and develop winning strategies that maximize long-term value.

Our dedicated, multidisciplinary team has helped shape the ASC and PPM industries over the past three decades and offers clients practical and operational approaches to addressing their unique legal, transactional and regulatory needs. We provide clients with innovative, business-oriented legal solutions tailored to their competitive and operational challenges, such as syndicating start-ups, transactions with management companies and health systems, and joint venture arrangements.

Transactions within the ASC/PPM sectors involve complex legal, regulatory and compliance issues and are closely watched by state regulators and payors to ensure that patient care remains guided by professional judgment, not profit motivations. Our cross-functional legal team has a deep understanding of local and regional issues and licensing requirements, strong relationships with regulatory authorities and extensive experience in all regulatory aspects of the PPM/ASC industries, from structuring transactions and antitrust enforcement, to reimbursement rules and managed care contracting. We even provide lobbying assistance to national and state-based associations dedicated to the PPM/ASC industries through our office in Washington, DC.

We also host an annual ASC/PPM Symposium, considered the premier national conference addressing the industry’s key business, transactional and regulatory issues, attended each year by hundreds of executives and decision makers from across the United States.

How can we help you transform healthcare?

Digital health legal solutions

Digital health solutions are fundamentally transforming the quality and delivery of healthcare. As the doctor-patient relationship evolves beyond the in-person encounter, digitized data and technology have converged with healthcare delivery and payment. Our digital health team works with clients to create solutions that improve access to medical services and engage patients in managing their healthcare, with an eye toward the complex and ever-evolving regulatory considerations affecting healthcare innovation.

We offer guidance on all aspects of digital health, including the formation, financing and governance of business entities, joint venture arrangements, and mergers and acquisitions. Drawing on our vast institutional knowledge and the creativity to drive forward-looking solutions, we counsel clients in a wide range of areas, including development, reseller marketing and distribution arrangements, intellectual property protection and licensing agreements, systems integration agreements, internet and new technology issues, product liability matters, and employment and noncompetition agreements, as well as related personnel issues.

Our team leads emerging and established organizations through the unique—and often unanticipated—transactional, regulatory and compliance challenges they face. Uniting our depth of experience and our ability to anticipate change, we help clients develop creative solutions to the obstacles that slow adoption and growth so they can keep moving forward in an ever-changing industry.

How can we help you transform healthcare?

Our areas of focus

• Health Information Technology
• Mobile Health
• Big Data and Data Strategies
• Data Privacy/Security HIPAA and State Laws
• Telehealth/Telemedicine

Health information technology

Complex legal and compliance issues surround the acquisition, implementation, use and management of health information technology (HIT). Our team offers advice on key matters in a quickly changing landscape, including patient consent issues involved with health information exchanges; electronic communication issues among and between providers, payers and patients; and matters involving electronic health records (EHRs), health information exchanges (HIEs), and the use and disclosure of protected health information (PHI). We also counsel our clients on compliance with the Health Insurance Portability and Accountability Act, state breach notification laws, Medicare and Medicaid EHR Incentive Program requirements, the False Claims Act, the Anti-Kickback Statute, and other federal and state healthcare regulatory laws.

For clients ranging from physicians, hospitals and health systems to practice management companies, HIT vendors and medical billing companies, we offer skillful support with software and hardware procurement, implementation, service level agreements and warranties, and associated contract and regulatory compliance aspects.

mHealth

Mobile healthcare devices, including wearables and medical apps, empower patients to better understand their health. These devices capture consumer-generated health data, analyze it and provide mobile feedback to consumers. These mHealth applications may also deliver healthcare information to providers and researchers in order to facilitate efficient coordination of care. Our team assists clients with the transactional and regulatory issues that arise when businesses engage with patients, consumers, providers or researchers about their health needs, whether through mobile devices or other connected devices outside of traditional healthcare provider settings. We also offer counsel on issues arising from emerging digital health tools, such as mobile medical apps, that the US Food and Drug Administration (FDA) may consider regulated devices.

Big data and data strategies

We assist clients with the design and deployment of big data strategies. Supported by a flexible, yet sustainable, privacy and security protection infrastructure, big data strategies can capture, aggregate, transform and analyze key data. Businesses use these sophisticated analytics to effectively implement improvements in healthcare quality, coordination, accessibility and affordability for the benefit of payers, employers and healthcare consumers. Our team helps identify, manage and resolve legal issues associated with high-volume analytics and data mapping, privacy and security protections, data licensing and clinical research activities, including federal and privately sourced data. We also assist in forging collaborations between industry stakeholders to leverage strengths and accelerate initiatives.

Data privacy/security HIPAA and state laws

The Health Insurance Portability and Accountability Act (HIPAA) governs the use and disclosure of identifiable health information. Using our industry-leading best practices, we counsel a diverse range of clients in navigating these complex rules. We conduct audits, develop customized plans, policies and procedures for privacy and security compliance, and even facilitate HIPAA-related training sessions.

If a crisis does arise, we also advise clients regarding security breaches, risk assessment, mitigation and remediation, and negotiate settlements and resolution agreements with the US Department of Health and Human Services Office for Civil Rights. Together with lawyers in our privacy and data protection practice, our digital health team has guided companies through the successful resolution of many privacy and security incidents, including hundreds of incident responses and breach remediation efforts involving PHI. From cyber attacks and malicious insiders, to lost laptops, unsecured data and mailing mishaps, we have handled the full spectrum of information incidents.

We draw on this experience to bring calm to the storm and provide guidance from beginning to end, including developing and implementing effective audits, protection and loss-prevention programs, and simplifying the notification process across jurisdictions.

Telehealth/telemedicine

Bringing the doctor-patient relationship out of the confines of an in-person encounter, telehealth integrates information technology with traditional healthcare and wellness practices. Remote healthcare, also called telemedicine, is changing the way medical services are delivered. Thanks to advances in technology and information systems, these new diagnostic tools and methodologies can improve access to and consistency of medical services—an important benefit to consumers and providers alike. Our clients turn to us for guidance regarding licensure, patient consent and recordkeeping, data privacy, risk mitigation, and navigating the varied state-based regulations and regulatory definitions associated with telehealth. We help assess business strategies and advise on government and commercial reimbursement standards so clients can succeed in this rapidly changing, highly regulated industry.

Standout team of renowned practitioners assisting clients across an array of healthcare organizations, including major for-profit and nonprofit providers, medical device manufacturers, academic medical centers and pharmaceutical companies.
– Chambers USA

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, children's hospitals, 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.

The [Health & Life Sciences] team at [the firm] is top-notch. Their attorneys are practical, concise, and take the time to understand business strategy and imperatives as they deliver their advice.
– The Legal 500 US, Healthcare: Health Insurers

Healthcare innovation and new payment and reimbursement models are top priorities in managed care law, with partnerships and consolidation taking center stage to provide – and get paid for – better health outcomes. Those who want to grow and innovate within this evolving healthcare environment face complex regulatory requirements and significant scrutiny around transactions. To thrive despite these challenges, you must be willing to take calculated business risks and adapt to a shifting landscape.

Creative solutions for complex ACO, health plan, and managed care legal matters

Our experienced Accountable Care Organization (ACO) law 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, new reimbursement and care delivery models, 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 pharmacy benefit managers (PBMs) on prescription drug plans and pricing issues.

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

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

As the United States’ top-ranked health & life sciences law firm, we offer unmatched experience addressing the legal obstacles facing health plans, managed care organizations, 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 deeply experienced team of healthcare lawyers, we provide cutting-edge solutions and creative counsel to our health plan and ACO clients to help them achieve their business goals.

McDermott Will & Schulte offers exceptional knowledge and advice in healthcare transaction and regulatory matters.
– Chambers USA

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.

McDermott Will & Schulte has a very deep healthcare regulatory bench. They are subject matter experts.
– Chambers USA

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.

McDermott Will & Schulte is the only firm we would call when working on a private equity transaction, especially within the healthcare space... they continually bring that diverse deal experience to every new engagement.
– Legal 500 US

Among the most active markets in private equity, the healthcare industry provides ripe investment opportunities for funds that can navigate the complex regulatory landscape. As the industry’s top-ranked law firm for health and life sciences ventures, we understand key regulatory issues, communicate clearly with regulators and counsel on the other side of the table, and close deals in a cost-effective, timely manner to maximize value.

Partnering with you to create the future of the industry

We collaborate with those at the forefront of health industry innovation to foster the unique partnerships and business ventures that are transforming healthcare. Our cross-functional legal counsel removes the false barriers that often arise between transactional and regulatory issues. Thus, we’re able to minimize due diligence redundancies, assist financing sources so that legal questions are handled appropriately, and move deals swiftly from negotiation to implementation. Whether you’re working on a deal in the US or a cross-border transaction, with more than 150 lawyers across 20 global offices, we have the experience and capabilities you need to accomplish your objectives.

Our experienced private equity team has advised on hundreds of healthcare deals covering the gamut of clinics, hospitals, inpatient/outpatient services, practice management, laboratory services, information technology, managed care, devices and supplies, business processing outsourcing, revenue cycle management and more.

We are the only firm ranked in the top tier by all of the major rankings and directories, including Chambers USA, which has named us “Health Law Firm of the Year” three times. We work hand-in-hand with our top-ranked private equity practice, which means private equity funds can rely on us as a comprehensive legal solution.

Our clients have the confidence to execute because they know they have the full weight of the leading health
care law firm behind them. We offer counsel on the full range of investment and financing activities, including growth investments and buy-and-build strategies; control, non-control and minority investments; buyouts and recapitalizations; auction processes; strategic dispositions and exit strategies; and bankruptcy, out-of-court restructurings and workouts.

Skilled at helping private equity firms and their portfolio companies acquire distressed assets, our global restructuring and insolvency team offers strategic advice on navigating the peculiarities associated with asset sales in Chapter 11 and 7 bankruptcy cases, UCC Article 9 foreclosures and out-of-court restructurings. Our clients rely on our experience when acquiring assets through a debtor’s plan of reorganization in Chapter 11 bankruptcy cases because of our skilled handling of the various associated legal complications. We’re also successful with section 363 bankruptcy sales and pursuing “stalking horse” status for our clients.

Our finance team provides critical legal services during healthcare buyout transactions. Our solid relationships with numerous lenders active in the private equity marketplace allow us to think creatively in evaluating financing approaches. We are particularly skilled at tailoring multilayered financing packages to meet the unique characteristics of each deal, thanks to our vast experience with structuring acquisitions, recapitalization, refinancing and disposition of portfolio companies, as well as transactions for add-ons and restructurings.

We also serve as general counsel for portfolio companies, advising on major transactions and day-to-day legal matters, as well as providing efficiency and continuity for platform acquisitions, bolt-on transactions, operational and compliance issues, and sales.