Monica R. Chmielewski

Partner

Overview

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.

Health Care and Life Sciences Operations and Compliance

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.

Fraud and Abuse, FCA and Health Care Fraud Investigations

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.

Regulatory Compliance

Ms. Chmielewski assists in providing daily counsel to numerous hospitals, academic medical centers, biotech and pharmaceutical and medical device companies regarding compliance with regulations governing all aspects of clinical research, IRB issues, the conduct of international clinical trials, government investigations and audits, pharmaceutical product promotion, CME, preparation of research contracts, grant administration, 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, ACO formation and operation, HIPAA, physician recruitment, corporate compliance issues, medical staff and peer review, accreditation matters, and Medicare reimbursement 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, physician-owned surgery centers, health systems, home health agencies, hospices and physician practices; and the formation of ancillary services joint ventures.

Telemedicine

Ms. Chmielewski 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.

Prior to her law firm practice, Ms. Chmielewski served as in-house counsel for Takeda Pharmaceuticals North America Inc. in Illinois, and as in-house counsel for Ascension Health in Missouri.

Recognition

In 2014, The Legal 500 recognized Ms. Chmielewski for her work in the area of life sciences.

Education

Ms. Chmielewski 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.

Admissions

Ms. Chmielewski is admitted to practice in Illinois and Michigan.

Representative Matters

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Foley represented Indiana University Health in the sale of a majority interest in La Porte Health System, La Porte, Indiana, to Community Health Systems. IU Health retained a minority interest in the venture. Community Health Systems, through an affiliate, will manage the business and operations of La Porte Health System.
BidMed is a newly formed company that acquires used medical equipment from hospitals and sells same, as a reseller, on behalf of the hospitals. We provided this client with counsel on its business operations, the various state and federal laws and regulations that it is required to comply with (inclusive of FDA registration implications) and assisted it with composition of its standard business terms and conditions and template contracts.
This matter involved the sale and acquisition of 51% of the rights and interest in Arkansas Surgical Hospital. As legal counsel for the Hospital, Foley provided daily counsel on compliance with the federal fraud and abuse laws (as they related to hospital operations, physician arrangements and contractual arrangements), composed necessary transaction documents and assisted with negotiation of same.

Capabilities

Insights