What to know about Operating Clinical Laboratories – Nuts and Bolts

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What to know about Operating Clinical Laboratories – Nuts and Bolts

Elizabeth Sullivan and Emily Johnson are both Members of McDonald Hopkins, a business law and advocacy law firm, and will lead the presentation What to Know About Operating Clinical Laboratories – Nuts and Bolts at the Healthcare Compliance Symposium 2022 on April 28, 2022.

Elizabeth SullivanLiz, based in the Cleveland office, is Chair of McDonald Hopkins’ national Healthcare Practice Group and a member of the firm’s Board of Directors. She began her legal career in the Healthcare Practice group at McDonald Hopkins and later served as an attorney in the legal department at The Cleveland Clinic Foundation before returning to McDonald Hopkins as a member.

While at the Cleveland Clinic, Liz provided regulatory advice and transactional guidance to various service lines, including the clinical laboratory, professional pathology, imaging, transplant, and remote and distance health teams.  Over the course of her career, Liz has assisted various types of healthcare providers, including clinical laboratories, hospitals, physician specialty groups, telehealth providers, transplant centers, and surgery centers.

Liz has experience providing regulatory, licensing, compliance, reimbursement, contractual, and corporate guidance to clients. She has advised clients on state professional licensure laws, CLIA standards, state laboratory laws, government and private payor reimbursement policies and billing rules, federal and state fraud and abuse rules and regulations, state telehealth laws, and HIPAA rules and regulations. She has provided assistance to entities during licensure and accreditation surveys, government investigations, and through payor audits and disputes.   

In addition to providing regulatory guidance to clients, Liz is also knowledgeable in evaluating how a business opportunity or arrangement implicates a provider’s unique regulatory framework.  Liz has counseled clients not only on the regulatory aspects of an arrangement as described above, but she is also experienced in reviewing and negotiating relevant contractual and legal documentation in connection with contemplated business arrangements.

Liz earned a J.D. and Certificate of Advanced Studies in Health Law from the University of Pittsburgh School of Law, an M.A. in Bioethics and a B.A., cum laude, in Political Science from Case Western Reserve University.

Emily Johnson Healthcare ComplianceEmily Johnson, based in the Chicago office, focuses her practice on matters primarily for clients in the healthcare industry. She provides regulatory and compliance assistance on both a federal and state level. She has assisted clinical laboratories, hospitals, long-term acute care hospitals, community hospitals, physician specialty groups, telehealth providers, surgery centers, healthcare associations, pharmacies, and other healthcare providers on regulatory, licensing, compliance, reimbursement, contractual, and corporate matters. She has provided support to entities during licensure and accreditation surveys and assisted in navigating state professional licensure laws, CLIA standards and state and federal laboratory laws and regulations, government and private payor reimbursement, state and federal fraud and abuse rules, state telehealth laws, and state and federal pharmacy regulation. She also has advised clients on direct to consumer testing issues and applicable state requirements.

She also has experience with provider-based compliance issues and the 340B Federal Drug Pricing Program, including implementation, program compliance, audit preparation, and preparing for audits conducted by the Office of Pharmacy Affairs.

In addition, she has significant experience with HIPAA compliance, including drafting HIPAA policies and procedures, breach response and notification, drafting responses to investigations conducted by the Office for Civil Rights, and advising clients on proactive HIPAA compliance and breach prevention.

Prior to joining McDonald Hopkins, Emily served as healthcare attorney/senior consultant at a national legal-based healthcare management consulting firm and outside counsel to the National Association of Boards of Pharmacy.

Emily earned a J.D. from The John Marshall Law School in 2010. She received a B.A., Dean’s List, from Illinois Wesleyan University in 2005.

Click here for more information or to register for the Symposium!

 

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