Instructor Biography

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Monica R. Chmielewski

Foley & Lardner LLP

Monica R. Chmielewski is a partner and health care lawyer with Foley & Lardner LLP. She focuses her practice solely in representing health care providers and pharmaceutical and medical device companies in the area of health care, health care transactional work, clinical research and food and drug law. Ms. Chmielewski is co-chair of the firm’s Life Sciences Industry Team. She is also vice chair of the firm's Health Care Industry Team.

Ms. Chmielewski counsels healthcare entities and pharmaceutical companies regarding the operation and functions of their corporate compliance and integrity programs, including assisting with the composition and development of programs; reviewing and assessing existing program effectiveness; providing compliance education and training of personnel, executive management and board members; coordinating internal investigations of compliance related concerns; and recommending any needed corrective action. She has counseled, in both in-house and outside counsel roles, individual hospitals, health systems, hospices, skilled nursing facilities and pharmaceutical companies on matters of corporate compliance.

Ms. Chmielewski’s experience includes particular compliance issues arising under the False Claims Act, Stark Law, Anti-Kickback Statute, EMTALA, Civil Monetary Penalties Law, licensure/certification, and HIPAA; working with providers on properly responding to governmental and accreditation audits and more formal investigations; and working directly with provider compliance officers and general counsel to advise them on the latest legal and Office of Inspector General requirements and standards.