Healthcare

Overview

The healthcare industry is one of the largest and most critical sectors of the economy. Organizations operating in this industry face complex market, legal, regulatory, and risk-related issues. Having an integrated team of experienced advisors is a game-changer on the path to or in sustaining success.

Michael Best’s Healthcare group has a deep understanding of the industry’s market forces, technologies, trends, and regulatory environment. We partner with clients to help maximize opportunities, grow revenue, mitigate risk, connect with industry decision-makers, and efficiently achieve business goals.

Clients rely on our cross-practice Healthcare group for proactive, solution-oriented consulting and legal services. Our collective team of healthcare experts serve diverse clients throughout the health sector, including:
 

  • Integrated healthcare delivery systems, hospitals, clinics, and medical groups
  • Health data aggregators 
  • Insurers
  • Employer health coalitions
  • Start-ups with healthcare innovations
  • Trade associations
  • Vendors to healthcare providers and facilities such as electronic medical records or healthcare-related software
  • Senior housing and skilled nursing facilities 
  • Pharmaceutical and biotechnology companies
  • Universities and academic health centers 
  • Laboratories and diagnostic companies
  • Medical device manufacturers

Healthcare Service Areas

Operations

Michael Best serves as outside general counsel to many healthcare clients and advises on day-to-day operational matters such as:

  • Staff and physician employment and compensation
  • Negotiating vendor contracts, provider agreements, leases, and other contracts
  • Billing and payment issues
  • Medical staff and credentialing

Regulatory

Advising healthcare clients on regulatory compliance is always an element of our work in this heavily regulated sector. Our experience includes the False Claims Act, Anti-Kickback Statute, Physician Self-Referral Law (Stark Law), counseling regarding Medicare exclusion and Civil Monetary Penalty (CMP) actions, antitrust laws, tax exemption, HIPAA and privacy, and other regulations affecting healthcare clients.

We also represent clients in regulatory matters related to research, development, and marketing. Our Healthcare team has experience with the Food and Drug Administration (FDA), Federal Trade Commission (FTC), National Institutes of Health (NIH), The Joint Commission (TJC), and the Centers for Medicare & Medicaid Services’ Clinical Laboratory Improvement Amendments (CLIA) certification.

Innovation

Michael Best Strategies LLC (Strategies) is our dedicated business consulting, government relations, and public affairs affiliate. Strategies’ Healthcare Innovation Group includes former healthcare executives with decades of experience at an executive level within payor and provider organizations. 

The Healthcare Innovation Group works with leading innovators, payors, and health systems/providers who are solving real-world issues across the healthcare delivery spectrum. The group’s services are focused on validating innovative new therapeutics, medical devices, diagnostic tools, and other clinical solutions with a comprehensive assessment of the competitive landscape benchmarking solutions against one another on important metrics to payors and health systems/providers.

For innovators, the Healthcare Innovation Group’s work assists in securing early market share, leading to an accelerated revenue stream. For payors and health systems/providers, the group helps to drive the adoption of innovation through the development of a customized use case that is then taken all the way from the search process through market validation and a finalist presentation event, ultimately lowering acquisition costs and early-stage risk.

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Government Relations & Procurement

Michael Best Strategies, LLC (Strategies) is driven by a highly qualified team of professionals who work closely with businesses to achieve their strategic business objectives. Strategies works with clients to identify opportunities for engagement with government, industry partners, and communities to achieve each client’s objectives through strategic planning, pragmatic guidance on public policy development, and strategic governmental relations. For organizations that want to become government contractors, Strategies leverages deep government relationships and expertise to help clients identify the best opportunities to pursue.

Corporate & Transactional

We provide strategic legal counsel covering the entire business life cycle—from organization, financing, and operation through mergers, acquisitions, and divestitures. Our lawyers represent healthcare clients in contract negotiations, corporate formation and governance, deal structuring, financing, tax planning, dispute resolution, and more.

Our Transactions team has extensive experience with significant transactions, covering every angle from corporate governance and taxation to employee benefit plans and environmental due diligence. We’ve assisted many healthcare clients with major projects such as corporate restructurings, mergers, acquisitions, and joint ventures; developing new service offerings or partnerships (e.g., laboratories, ambulatory surgery centers, specialty clinics); and constructing new or replacement facilities.

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Privacy & Cybersecurity 

Our Privacy & Cybersecurity team serves as counsel to many clients in the healthcare, life sciences, and healthtech industries. We advise them on matters such as regulatory compliance; product design; health data commercialization; technology transactions; clinical trials; consumer communications; investigations and enforcement; and data breach incident preparation and response.

We have experience with the full spectrum of privacy and data security regulations around the world, including those applying specifically to health data: HIPAA Privacy Rule and Security Rule, HITECH Act, GINA, ACA, FTC Health Breach Notification Rule, employment-related privacy regulations, online and telephone marketing regulations, and state laws on privacy and data protection.

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Dispute Resolution

When necessary, we represent healthcare clients in litigation, internal investigations, government enforcement actions, and crisis management. Michael Best’s Healthcare group has experience defending individual healthcare providers including the Centers for Medicare & Medicaid Services (CMS), insurers, and institutions in medical malpractice litigation, including jury and bench trials; administrative proceedings such as licensing board actions; investigations related to alleged fraudulent billing, and Medicaid audit and recoupment actions.

Our seasoned litigation team includes more than 50 lawyers and other professionals. Michael Best’s first-chair litigators have significant jury and court trial experience and when necessary, they take cases to trial and win. Our team also serves clients outside the courtroom, achieving successful results through arbitrations, mediations, and all forms of alternative dispute resolution.

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Intellectual Property

Michael Best’s IP attorneys and technical professionals help clients develop, manage, protect, and enforce their brands and technologies worldwide. Our IP group provides a full range of legal services related to patent, trademark, trade secret, copyright, advertising and promotions, and internet law. We also advise on technology licensing, contracts, and terms and conditions. We work with many clients in fields such as life sciences, biotech, pharmaceuticals, medical devices, diagnostics, and computer sciences.

Our IP group has more than 150 lawyers and IP professionals, including more than 25 patent engineers, scientists, and registered agents. Many have advanced technical degrees and business experience in areas like biotechnology, chemistry, computer science, engineering, and physics. Others have served as examiners in the U.S. Patent and Trademark Office. Our legal, technical, and industry experience put us in a unique position to help clients commercialize and protect their inventions.

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Drug Policy & Prevention

Michael Best Advisors offers government affairs, regulatory advice, marketing strategy, and public relations services focusing on healthcare, pharmaceuticals, drug policy, prevention of illicit drug use, law enforcement, homeland security, and healthy communities.

Our team members have held leadership positions in the U.S. Department of Justice, U.S. Attorney’s Office, Department of Homeland Security, Drug Enforcement Administration, Department of the Treasury, White House, House of Representatives, and INTERPOL. Clients get the benefit of our inside experience, high-level insight, and powerful network that spans the public and private sectors.

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Mission-Driven Organizations

Michael Best helps mission-driven enterprises—both nonprofit and for-profit—design and implement market-based strategies to achieve maximum impact at the intersection of business and social good. We have significant experience with the special legal needs of tax-exempt nonprofits, for-profit social enterprises, and hybrid joint ventures. We also have deep experience and connections with stakeholders such as foundations, service provider nonprofits, impact investors, entrepreneurs, and government thought leaders.

Our clients include healthcare, educational, scientific, human services, charitable, religious, and cultural institutions; trade and professional organizations; and family foundations. In addition to advising these organizations on corporate governance and a variety of day-to-day matters, we have experience in conversion from tax-exempt to taxable status (and vice versa), including within regulated industries; and in mergers and acquisitions involving tax-exempt organizations.

Other Services

As a full-service law firm, Michael Best also provides counsel in labor and employment, benefits, and immigration; real estate and construction; and other areas relevant to healthcare clients.

Primary Contacts

Primary Contacts

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