Monica Chmielewski

Practice Areas

Monica R. Chmielewski is a member of the Health & Life Sciences Group and has more than 25 years of experience in life sciences, food and drug law, healthcare, pharmacy, and supply chain matters. She advises pharmaceuticals, biotech and medical device companies, health systems, academic medical centers, hospitals, physician groups, manufacturers and distributors, and pharmacies on regulatory compliance; transactional matters; clinical research; grants, grant administration, and compliance; product development and commercialization; and sourcing, manufacturing, and distribution issues. Her practice encompasses the full spectrum of life sciences and healthcare law, including clinical trial compliance, conduct and regulation, the structure and conduct of decentralized clinical trials, US Food and Drug Administration submissions and approvals, pharmaceutical and medical device manufacturing, licensing and commercialization, virtual care compliance, and corporate integrity matters.

Experience

Regulatory Compliance, Clinical Research, and Supply Chain

Monica provides daily counsel to numerous health systems, hospitals, academic medical centers, pharmacies and biotech, pharmaceutical and medical device companies. As such, she regularly assists clients with the following issues:

Regulatory compliance governing all aspects of clinical research

Investigations of research misconduct

Institutional Review Board (IRB) issues

The conduct of U.S. and international clinical trials

Research grants and funding

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

Supply chain matters (including formation of and contracting with group purchasing organizations)

Corporate practice of medicine and dentistry prohibitions

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

Supply chain and procurement issues

She also has participated as transactional counsel in numerous health care, life science, and corporate transactions, including the merger, purchase and sale, or transfer of sponsorship of hospitals, pharmacies, contract research organizations (CROs), physician-owned surgery centers, health systems, home health agencies, hospices and physician practices; and the formation of ancillary services joint ventures; and counsels investors (venture capital and private equity) in investments, acquisitions, and sales.

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 daily counsel on supply chain and materials management issues, and counsels on group purchasing organization (GPO) negotiations and formation. She also counsels 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.

Compliance

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.

Telemedicine

“Foley is the premier firm for telehealth counsel.”

“A market leader in telemedicine issues.” “This is the Dream Team.”

– Chambers USA: America’s Leading Business Lawyers (2020, 2021)

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.

Education