Monica R. Chmielewski is a partner and health care and life sciences lawyer with Foley & Lardner LLP. She focuses her practice solely in representing health care providers, pharmaceutical and medical device companies, and pharmacies in the area of health care, health care transactions, clinical research, supply chain, and food and drug law. Monica is co-chair of the firm’s Life Sciences Industry Team. She is also vice chair of the firm's Health Care Industry Team.
Regulatory Compliance, Clinical Research, and Supply Chain
Monica assists in providing daily counsel to numerous hospitals, pharmacies, academic medical centers, and biotech, pharmaceutical and medical device companies. Her work regarding compliance with regulations governing all aspects of clinical research, investigations of research misconduct, Institutional Review Board (IRB) issues, the conduct of U.S. and international clinical trials, government investigations and audits, pharmaceutical product promotion (including counsel on off-label promotion), 510K applications, the regulation of software as a medical device, mobile medical applications, Continuing Medical Education (CME), preparation of research contracts, grant contracts and administration, Pharmacy Benefit Managers (PBM) matters, good clinical practice (GCP) issues, customs import and export issues, hospital and physician issues, joint venture and other collaborative efforts, preparation and review of hospital, physician and other provider contracts, accountable care organization (ACO) formation and operation, HIPAA, physician recruitment, corporate compliance issues, medical staff and peer review, accreditation matters, and supply chain and procurement issues. She also has participated as transactional counsel in numerous health care and corporate transactions, including the merger, purchase and sale, or transfer of sponsorship of hospitals, pharmacies, physician-owned surgery centers, health systems, home health agencies, hospices and physician practices; and the formation of ancillary services joint ventures.
Monica has in-depth knowledge of federal and state regulation of the drug and device supply chain, pharmacies, and laboratories. She advises entities (industry), health care providers, investors, and lenders on transactional matters and regulatory compliance, including mergers and acquisitions, recapitalizations, buyouts, restructurings, joint ventures, and broad range of commercial transactions. Monica provides counsel to health plans in their procurement of and contracting with PBMs for mail, retail, and specialty drug services in connection with commercial and government health care programs. In addition, she provides counsel regarding PBM audits, as well as on regulatory issues for various retail and specialty pharmacies, including state Boards of Pharmacy inspection and adverse findings, compounding pharmacy matters, and licensure among others; provides daily supply chain counsel, and counsels on group purchasing organization (GPO) negotiations and formation; and counsels investors (venture capital and private equity) in pharmacy investments, acquisitions, and sales.
Monica counsels health care entities, pharmaceutical and medical device companies, pharmacies and laboratories 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.
Monica advises a number of clients, including hospitals, health systems and physician groups on regulatory and compliance issues presented by telemedicine and telehealth. Her counsel includes, but is not limited to, structuring and negotiating professional services agreements for telemedicine services and composing telemedicine policies and procures.
Fraud and Abuse, False Claim Act, and Health Care Fraud Investigations
Monica’s experience includes particular compliance issues arising under the False Claims Act (FCA), Stark Law, Anti-Kickback Statute, EMTALA, Civil Monetary Penalties Law, licensure/certification, and HIPAA. Monica works with providers on properly responding to governmental and accreditation audits and more formal investigations as well as directly with provider compliance officers and general counsel to advise them on the latest legal and Office of Inspector General requirements and standards.
Monica was listed in the 2020 edition of Chambers USA: America's Leading Business Lawyers in the practice area of Healthcare: Pharmaceutical/Medical Products Regulatory. In 2014, The Legal 500 recognized Monica for her work in the area of life sciences.
Monica earned her law degree, cum laude, from Wayne State University and is a member of the Order of the Coif. She received an undergraduate degree in government and ancient history and archeology from Franklin and Marshall College in Pennsylvania.
Monica is admitted to practice in Illinois and Michigan.