Mary L. Hendrickson
Advogado
Mary Hendrickson recorre aos seus anos de experiência interna para ajudar os clientes a navegar pelas leis regulatórias e programas de conformidade, bem como em questões transacionais. Ela sabe como equilibrar as exigências dos negócios e da lei para reduzir riscos e desenvolver soluções criativas para questões complexas. Além de ser advogada, Mary é doutora em Farmácia e já atuou em diversos ambientes de prática farmacêutica.
Mary has extensive experience advising pharmacies and health care entities, including health care systems and providers, wholesale distributors, reverse pharmaceutical distributors, pharmaceutical manufacturers, and pharmacy benefits managers (PBMs) on regulatory, transactional, and compliance program matters. She advises companies on regulatory compliance matters involving state pharmacy boards, the U.S. Food and Drug Administration (FDA), the U.S. Environmental Protection Agency (EPA), the U.S. Drug Enforcement Administration (DEA), Medicare Part D, and 340B programs, as well as related health care regulations. She has in-depth experience evaluating, restructuring, and advancing compliance programs of all sizes and advising executive management and board members on compliance matters, including the audit committee’s responsibility associated with compliance program oversight and enterprise risk management (ERM) programs. Mary is adept at guiding companies through these many risks and challenges to achieve a positive outcome.
In addition, Mary has extensive experience working in the health care and pharmaceutical supply chain, including with wholesale distributors, third-party logistics (3PLs), and reverse pharmaceutical distributors. Her experience includes advising all types of entities that intersect with EPA, FDA, DEA, and other health care regulators to minimize risk in managing not only the forward movement of product in the supply chain, but also the return of product or disposition of hazardous, pharmaceutical, infectious, medical, and controlled substance waste.
Before joining Foley, Mary served on the leadership teams at companies of various sizes, including Fortune 10 companies. In these roles she distilled complex regulatory and compliance concepts to inform and lead business solutions, reduce risk, and increase operational efficiency. Throughout her career, she has been a trusted advisor to executive teams, board members, management, and staff in both private and publicly held companies.
Filiações
- Member, Wall Street Journal Chief Compliance Officer Council
- Membro da Ordem dos Advogados do Estado do Illinois
Apresentações e publicações
- Speaker, “Simplifying Inflation Rebate Penalties under Medicare B and D,” American Conference Institute (ACI)’s Rx Drug Pricing Boot Camp (March 20, 2024)
- Speaker, “Medicare Part B Drug Pricing” at the American Conference Institute (ACI)’s Rx Drug Pricing Boot Camp (November, 2023)
- Co-author, “HHS OIG: New “General Compliance Program Guidance” Provides Voluntary Steps Towards Increased Effectiveness,” Healthcare Law Today (November 7, 2023)
Plano de pagamento de receitas médicas do Medicare da Lei de Redução da Inflação: novas orientações da CMS