This Week in 340B: May 9 - 15, 2023

In today’s complex and fast-changing healthcare regulatory environment, Emily Jane Cook helps healthcare organizations thrive. Innovative start-ups and established market leaders alike turn to Emily for broad-spectrum strategies to fuel new business initiatives and solve their most pressing compliance, transactional, reimbursement and litigation challenges. Emily is a practice area leader for the Healthcare Regulatory & Compliance practice. In addition to Emily’s role as a national authority on the 340B drug pricing program, Emily helps clients navigate the full suite of federal and state regulations that are essential to healthcare operations. She partners with a wide range of organizations, including non-traditional service providers and new market entrants to identify, protect and expand revenue opportunities, including via private-equity-backed ventures. Her comprehensive counsel encompasses evolving issues such as No Surprises Act (NSA) implementation, development of new provider types, Medicare provider-based and co-location rules, and trends in qui tam litigation and government investigations. She works closely with colleagues in McDermott’s transactional, litigation and private equity practices to deliver fully realized solutions for her clients. Emily’s deep insights into US healthcare regulation stem from her previous tenure at the US Department of Health and Human Services (HHS), Health Resources and Services Administration (HRSA). For more than five years, she worked with providers and across government agencies to address regulatory barriers to healthcare delivery. She advised senior HHS leadership on Medicare and Medicaid regulation and reimbursement issues affecting rural communities and providers, and served as senior policy advisor to the National Advisory Committee on Rural Health and Human Services. SHOW LESS RESULTS Obtained favorable outcomes for clients in whistleblower actions, government investigations, regulatory appeals and self-disclosures to federal and state regulatory agencies, preserving government program participation and reducing or eliminating government program refunds and administrative penalties. Counseled large national health systems and academic medical centers through the development and implementation of innovative care models, including collaborative care models across facilities and between different types of clinical professionals, intended to maximize care quality and efficiency while maintaining regulatory compliance. Successfully appealed adverse findings in government audits of 340B programs for multiple hospital clients and negotiated corrective action plans, enabling the hospitals to continue leveraging program participation to their patients and communities. Led successful advocacy efforts to obtain changes to established or proposed federal regulatory requirements, reducing regulatory burdens and enhancing reimbursement opportunities.

Minghao (Ming) Chuang advises on regulatory and transactional matters affecting a wide range of clients in the healthcare industry, such as health plans, hospitals, physician groups, ambulatory surgery centers, and digital health companies. Ming is experienced assisting clients navigating issues related to the California Knox-Keene Act, the Stark Law, the Anti-Kickback Statute, corporate practice of medicine and Medicare and Medi-Cal regulations.

Kelsey R. Reinhardt focuses her practice on regulatory and transactional matters affecting a wide range of clients across the healthcare industry. While in law school, Kelsey competed as a semi-finalist in the USC Gould School of Law Hale Moot Court Honors Program and served as events chair for the Women’s Law Association. CREDENTIALS Education University of Southern California, Gould School of Law, JD, 2021 University of Southern California, Davis School of Gerontology, BS, cum laude, 2016 Admissions California