Anne O'Brien

Collaborative and exacting health care regulatory and licensing counsel

Anne O'Brien helps health care providers and entities 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, pharmacists and other individual practitioners, Anne advises on:

• Regulatory compliance
• Licensure requirements
• 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 the Chicago office chair and national chair of the Licensing sub-group for the Health & Life Sciences Practice Group.

• Providing legal advice at the intersection of health care licensure and other regulatory requirements, including licensing and enrollment requirements for participating in Medicare, Medicaid, state health assistance and other programs.
• 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.
• 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 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 Illinois Healthcare and Family Services sought to bar pharmacists from participation in the Medicaid program.