Health Regulatory & Compliance

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?

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

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 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.

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.
– 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 has exceptional depth across healthcare. The team provides the highest quality advice, and they deliver every time.
– Legal 500 US, Healthcare: Service Providers

As innovative treatments proliferate and cost-effectiveness becomes paramount, healthcare is increasingly being delivered in the sub-acute space. Interest in specialty pharmacy, home health, hospice, therapy, behavioral health, residential care, day care and long-term care is at an all-time high, creating tremendous potential. At the forefront of this market expansion, we offer strategic, creative advice to help forward-thinking leaders capitalize on burgeoning opportunities.

We’ll help you overcome challenges and seize opportunity.

Possibility abounds for strategic clients who seek to expand on their existing lines of service, as well as for financial clients who see the growing value of sub-acute providers. At the same time, investors, owners and operators of public and private, for-profit and nonprofit service providers face a host of challenges, including evolving consumer demands, increased regulatory involvement, shifting reimbursement models, new delivery systems and technologies, and related business and legal hurdles.

We provide practical, multidisciplinary counsel on the myriad legal, regulatory, reimbursement and policy issues associated with the management and operation of sub-acute providers, payors and their business partners, as well as investors, real estate investment trusts (REITs) and lenders.

As the Office of the Inspector General increases its involvement in this growing sector, our compliance audits and training programs are specifically designed to provide clients with the tools required to meet the challenge of planned and unplanned governmental scrutiny. Our cross-functional team includes experienced medical, coding and valuation professionals, and we advise clients on a broad range of issues:

• Mergers, acquisitions, joint ventures and the development of new business lines
• Debt and equity financing
• Formation of provider networks
• Payor negotiations
• Medicare and Medicaid reimbursement matters
• State, Certificate of Need (CON) and licensure issues
• Contracts with third-party providers and employees
• Federal and state tax planning
• Antitrust and environmental compliance
• Government relations and legislative initiatives