Collaborative and exacting health care regulatory and licensing counsel
Anne O'Brien helps health care entities and providers navigate the web of regulations governing their current operations and new business initiatives. With clients including pharmacies, wholesale distributors, manufacturers, 3PLs, 503B outsourcing facilities, DMEPOS suppliers, hospitals, clinics, long-term care facilities, behavioral health providers, and pharmacists and other individual practitioners, Anne advises on:
- Regulatory compliance
- New business models and related initiatives
Having cultivated healthy working relationships with regulators throughout the country and bringing a meticulous approach to managing the myriad regulatory obligations facing her clients, Anne delivers compliance strategies that are practical and effective. Clients appreciate Anne's collaborative style, in which she develops a deep familiarity with their business needs to inform the legal counsel she provides.
Anne is national chair of the Licensing sub-group of the firm’s Health & Life Sciences Practice Group.
Experience in Action
- Providing legal advice at the intersection of health care licensing and other regulatory requirements, including licensing and enrollment requirements for participating in Medicare, Medicaid, state health assistance and other programs.
- Providing advice, counsel and representation to pharmacies, pharmacists, wholesale distributors, manufacturers and behavioral health providers in disciplinary and regulatory matters pending before boards of pharmacy, the U.S. Drug Enforcement Administration (DEA) and other governmental agencies across the country.
- Representing pharmacies, wholesale distributors, DME suppliers and manufacturers in drafting and submission of required notices and applications to boards of pharmacy, DEA and other governmental regulators due to change of ownership (CHOW), restructuring, change of location or change of name.
- Representing health care professionals and entities in regulatory actions brought by Medicare to terminate provider status and petitioning for reinstatement of eligibility to participate in Medicare.
- Representing health care entities in audits by public and private payors.
- Defending medical negligence claims for health care professionals and organizations.
- Advising pharmacies, wholesale distributors and health care technology companies on regulatory compliance issues related to new business models and new markets.
- Defending pharmacies in Medicaid recoupment actions in which the Illinois Department of Healthcare and Family Services (HFS) seeks to recover payments to providers based on extrapolation audits.
- Counseling health care clients on fraud, waste and abuse, including the False Claims Act, Anti-Kickback Statute and Stark Law.
- Obtained dismissal of Medicaid recoupment action in which HFS sought to bar pharmacists from participation in the Medicaid program.
Professional & Civic Activities
- American Society for Pharmacy Law (Past President, 2020-2021; President, 2019-2020; President-Elect, 2018-2019; Treasurer, 2016-2018; Member of Finance and Audit Committee, 2016-2018; Program and Education Committee - Education Subcommittee, chair, 2022-present, member, 2010-2018)
- American Health Law Association (Member)
- Chicago Bar Association (Member)
- Illinois Bar Association (Member)
News & Insights
- Presentation"Trends in State Licensing and Medicare & Medicaid Enrollment"Quarles & Brady's Pharmacy Law Symposium
- Presentation"Texas Abortion Bills S.B. 4 and S.B. 8"National Association of Chain Drug Stores Pharmacy Compliance Roundtable (Webinar)
- News Release
- Presentation"New Technology"Quarles & Brady Pharmacy Law Symposium
- Presentation"Hot Topics in Pharmacy Law"Quarles & Brady Pharmacy Law Symposium
- News Release
- News Release
- Presentation"Industry/Business of Pharmacy"Quarles & Brady Pharmacy Law Symposium
- Article“The Compliance and Innovation Balancing Act in Pharma and Biotech”Pharmaceutical Compliance Monitor
- News Release
- Presentation“Pharmacy Promotional Activities, Their Impact and Their Future: Coupons, Gift Cards, Reward Programs and Inducements"American Pharmacists Association, Orlando, Florida
- Presentation"Physician Extender Collaboration & Supervision"Fourth Annual Prescription Drug Abuse Symposium, Indianapolis, Indiana
- Presentation"DEA Compliance in a New Era"Indiana Society for Healthcare Risk Management, Carmel, Indiana
- PresentationIllinois Pharmacy Law UpdateUniversity of Illinois College of Pharmacy CE Program, Chicago, Illinois
- Presentation"Trends in the Regulation of Automation"American Society for Pharmacy Law Seminar XXIII
- 6.5.2010Presentation"Illinois Pharmacy Law Update"University of Illinois College of Pharmacy and College of Medicine CE/CME Program
- University of New Hampshire School of Law (J.D., 1991)
- University of Illinois Urbana-Champaign (B.A., 1988)
- Major: Microbiology
- Northwestern University, Kellogg School of Management, Certificate, Quarles & Brady Leadership Program (2018)
- U.S. District Court, Central District of Illinois, 1997
- U.S. District Court, Northern District of Illinois, 1991