Health & Life Sciences
Health and life sciences counsel with a national reputation for excellence
Capabilities at a glance
- A diverse team of attorneys offering comprehensive legal support for the issues facing health care clients — from regulatory counseling, board representation and litigation to mergers and acquisitions (M&A) and beyond.
- Focused on providing business-savvy, pragmatic health care advice tailored to each client’s risk tolerance.
- Attorneys with true insider perspectives into the health care industry, including current and former pharmacists, nurses, physical therapists, EMTs, regulatory board members and more.
- A highly responsive, nimble team that can respond quickly to assist clients with time-sensitive matters.
A sensible, relationship-focused approach to health law
Our client-centric focus, relationships with regulators and practical approach to advising clients contributes to our national reputation as one of the strongest legal teams serving the health care industry. Because we maintain long-term relationships with our clients, we really get to know you, your business and your risk tolerance. Our attorneys use this understanding to provide clear guidance on exactly how regulation will impact your operations and make recommendations based on our deep knowledge of the enforcement landscape in a given jurisdiction.
We maintain meaningful working relationships with heath care regulators — many built over decades. We know which regulators are enforcing which laws in which states, and we frequently exercise our ability to influence potential legislation that would adversely impact our clients. Regulators often describe our attorneys as fair, reasonable and respectful; these are qualities our team intentionally personifies, as our experience has proven that extensive knowledge combined with integrity is the most effective way to advocate for our clients’ interests.
Advising health care businesses of all kinds on everyday challenges
We counsel clients from every corner of the health care industry regarding the unique regulatory, ethical and competitive issues they confront on a daily basis. Our health law attorneys have represented clients in all 50 states involving state regulatory boards. Our diverse client base includes:
- Pharmaceutical, medical technology and device manufacturers and distributors
- Retail and wholesale pharmacies
- Pharmacy compounders
- Urban and rural hospitals and health systems
- Rural health clinics and federally qualified health centers
- Health care payers, insurers and lenders
- Academic medical centers
- Research institutions
- Ambulatory surgery centers
- Laboratories
- Diagnostic facilities
- Biotechnology companies
- Durable medical equipment suppliers
- Physician clinics
- Long-term care facilities
- Home health agencies
- Health care consultants
- Electronic medical records vendors
- Data security specialists
News & Insights
Health & Life Sciences Focus Areas
340B Program
As one of the premier pharmacy law groups in the country, Quarles maintains a thriving nationwide practice that guides clients through the complex world of the 340B drug pricing program. Our 340B team has represented nearly every type of stakeholder involved in the 340B pharmaceutical care delivery system, and we naturally leverage our larger pharmaceutical experience to ensure that any proposed actions or procedural changes are considered with the entire picture in mind.
Behavioral Health
We advise and represent providers, integrated behavioral health clinics, substance abuse clinics, outpatient and residential treatment centers, and health plans to navigate this ever-changing space. We understand the care and commitment needed by our clients to provide behavioral health services, and we help them manage risk while reaching their business goals.
We have vast experience in the behavioral health profession, including representing providers practicing in the mental illness, substance abuse and developmental disability industries. These growing and constantly evolving industries present a complex regulatory environment for businesses operating in this space. We provide a broad and full range of behavioral health legal services, including regulatory and compliance advice, licensing, reimbursement and enrollment issues, policy and procedure evaluation and creation, corporate compliance, privacy and security, internal and federal investigations, mergers and acquisitions, telehealth, pharmacy, civil litigation and more.
Please contact Nick Meza or Jaya White for more information.
Clinical Laboratories
Our attorneys advise clinical laboratories and related stakeholders on complex and evolving regulatory issues, including licensing and compliance with state and federal requirements such as the Clinical Laboratory Improvement Amendments (CLIA). We advise on the False Claims Act (FCA), the Anti-Kickback Statute, the Eliminating Kickbacks in Recovery Act (EKRA) and the Stark law — and how each may affect the unique role clinical labs play in the health care realm.
Our attorneys work closely with clients on day-to-day operational issues that arise, including employment law, contractual matters, intellectual property (IP) protection and litigation and enforcement risk management. We assist in negotiating and drafting key contracts such as provider and service agreements. Our team closely advised our clinical laboratory clients during the COVID-19 pandemic, assisting with structuring lab relationships with testing vendors and navigating myriad unique issues arising from those arrangements.
Please contact Mark Bina or Jaya White for more information.
Government and Internal Investigations, Litigation, and Fraud, Waste and Abuse Compliance
At Quarles, we understand the health care industry is steeped in regulations that often create obstacles for even the most well-intentioned organizations and individuals. As the regulatory landscape changes, we help you stay proactive and prepared so you are ready to comply with new mandates and avoid regulatory missteps. We also analyze the risks and benefits to voluntarily disclosing any potentially false claims made to the government.
Health Care Transactions
Our Health Care Transactions team always approaches transactions holistically. We are a group comprising a mix of highly skilled business law attorneys with particular experience in health care transactions and knowledgeable health care lawyers who specifically focus on health care transactions. As an integrated team, we bring a well-rounded approach to deals to ensure all bases are covered.
Health Information Technology, Privacy and Security
As the laws and standards governing information privacy continue to evolve and the regulatory and business pressures on the health and life sciences industry mount, our Health Information Technology, Privacy and Security team remains at the cutting edge. We use our vantage point at the forefront of change to help clients better position themselves to meet their goals and stay abreast of trends. We routinely advise clients on the full gamut of information technology, privacy and security laws, best practices and evolving trends affecting the health care industry.
Health Insurance Industry Partners (PBMs, TPAs, DMPOs and URAs)
What sets our Health Insurance Industry Partners team apart is our knowledge of the entirety of the legal landscape affecting PBMs, TPAs, URAs and DMPOs. This area is rapidly evolving, and our team engages in ongoing analysis and evaluation of state and federal laws affecting these entities. We have the depth and breadth of industry knowledge along with years of experience resolving the day-to-day legal and strategic business issues confronting our clients.
Health Litigation
Our Health Care Litigation team has the extensive experience and legal skills to protect your interests in any eventuality. Our health care litigators have a first-hand understanding of the health care industry. We regularly litigate high-exposure cases, both in trial and appellate court and in administrative proceedings. We always take a calm, considered approach to potential litigation and during emergency or crisis situations, we move quickly to help shape your response.
Hospitals and Health Systems
Over decades, our Hospitals and Health Systems team has been assisting clients with all the issues associated with running hospitals and other health care institutions, from the routine to the complex. Few of our peers of any size match our varied experience and resources.
Infusion, Home Health and Non-Physician Provider Services
Our attorneys have extensive experience representing clinics, in-home health care providers, infusion providers, and hospice and therapeutic service providers. Due to our relationships with licensing and certification agencies as well as practitioner boards, we are familiar with the legal and regulatory compliance landscape and regularly assist clients in analyzing and navigating difficult business considerations in the provision of their health care services.
Licensing
Over decades, Quarles has grown its licensing practice to provide a full suite of services. Our licensing team understands the extensive and unique reporting requirements applicable to health care entities of all types, including pharmacies, wholesalers, 3PLs, repackagers, 503B outsourcing facilities, PBMs, DMEPOS suppliers, hospitals, clinics, home health agencies, hospice, long-term care, behavioral health and many more. We assist these clients with areas such as changes of ownership (CHOW), relocations, reorganizations, expansions/de novos and rebranding. Our experience with the various regulatory agencies that govern your business and our relationships with the licensing boards, DEA, state Medicaid Programs, Centers for Medicare and Medicaid Services (CMS), regional offices (RO) and Medicare Administrative Contractors (MAC) offer a comprehensive and integrated approach to accomplish your business goals. We work with both independents and pharmacy networks comprised of hundreds of locations.
For more information, please contact Anne O'Brien.
Long-Term Care and Senior Housing
Our attorneys help providers navigate regulatory issues such as state licensure and federal certification actions. We work with our clients to ensure fraud and abuse compliance, which often involves responding to audits, subpoenas and search warrants as well as providing necessary self-disclosures to the government. We regularly analyze business models to ensure compliance with the Stark Law, Anti-Kickback Statute, the False Claims Act and related regulatory compliance laws.
Managed Care and Clinically Integrated Networks
Our Managed Care and Clinically Integrated Networks team provides legal and strategic guidance related to managed care transactions and the creation, development and administration of clinically integrated networks. We have helped clients create and operate successful clinically integrated networks with as few as 100 clinicians and one of the nation’s largest, with 53 hospitals and 8,400 clinicians. Our attorneys work with groups in three broad areas: health care providers, health care payers and other health care entities and related companies. We focus on finding practical solutions for our clients, while at the same time mitigating risk and achieving legal compliance in constantly evolving legal and business environments. Our experience includes clinical integration program design, managed care contract negotiations, corporate governance and administration, antitrust and insurance law compliance, data sharing, aggregation and analytics compliance, and regulatory compliance, including advising clients regarding fraud and abuse issues such as the Stark Law, Anti-Kickback Statute and False Claims Act.
Please contact John Hintz for more information.
Pharmaceutical Manufacturers
Our attorneys represent human and veterinary pharmaceutical manufacturers in all areas of Food and Drug Administration (FDA) regulation, including both pre- and post-approval matters. On the pre-approval side, our team has experience in the investigational new drug (IND) applications process, new drug applications (NDA) and clinical studies compliance investigations. Post-approval experience includes advertising and promotion review, drug product life-cycle extension advice, drug import and export, supply chain and DSCSA, quality agreements, FDA inspections, and warning letter and 483 responses. We also have extensive experience in FDA regulation of pharmacy compounding for both human and animal drugs.
Please contact Ted Sullivan for more information.
Pharmacy, Drug and Device
Our Pharmacy Law team represents pharmacies of all kinds, discount medical plan organizations (DMPO), third-party administrators (TPA), drug and device manufacturers and other pharmaceutical companies. In addition to representing clients before all 50 state boards of pharmacy, we help our pharmacy clients in a wide variety of areas such as 340B, DEA compliance, specialty pharmacy, drug and device distribution, licensing, veterinary pharmacy, FDA regulatory matters, pharmaceutical manufacturing, HIPAA and privacy, and mergers and acquisitions.
Provider and Physician Groups
While we have a significant practice representing hospitals and health care systems, we also have significant experience representing individual providers and group practices. We understand the full gamut of laws that confront medical practitioners, and we are familiar with the legal landscape as well as the business side of things.
Telehealth
Quarles’ Telehealth team includes attorneys who are licensed health care providers, those who have owned their own health care businesses and an attorney with significant in-house counsel experience at a health care technology startup, app and pharmacy. Our on-the-ground experience helps us understand your business and perspective.
