As a non-lawyer veteran in the device industry, Machelle Shields currently focuses her practice on compliance and regulatory services for life science companies, including device/technology reimbursement strategy (coding coverage and payment), the infrastructure needs of start-up device companies and all aspects of compliance program design, operation, and implementation across the healthcare spectrum – physicians, hospitals, Medicare Advantage, device, pharmaceutical companies and other healthcare providers.
Machelle served as Vice President and Compliance Officer for Medtronic’s Spinal and Biologic Division for four years. During this time she executed and implemented Kyphon’s Corporate Integrity Agreement (reimbursement focused) and laid the foundation for a second Corporate Integrity Agreement. Machelle has also worked as a Federal Monitor team lead for a device company’s deferred prosecution agreement.
Machelle is a TN Supreme Court Rule 31 Listed General Civil Mediator and is certified by the HCCA in Compliance, Privacy and Research Compliance, a MGMA Certified Medical Practice Executive and holds three coding certifications from the AAPC and AHIMA. Machelle speaks regularly at industry meetings and is frequently a guest speaker at the University of Memphis School of Law regarding ethics and compliance.