ANDREW P. RUSCZEK is a Member of the Firm in the Health Care and Life Science practice, in the Boston office of Epstein Becker Green. He provides regulatory and compliance advice to a broad range of clients in the health care and life sciences industries, including hospitals, academic medical centers, and related providers as well as pharmaceutical, medical device, and biotechnology companies.
Mr. Rusczek’s practice encompasses many legal areas within the health care and life sciences space. He has particular experience with respect to the following types of matters:
- Hospital and payor affiliations, including negotiations of affiliation agreements, revisions to governance documents, regulatory approvals, and diligence matters
- Regulatory and compliance issues for pharmaceutical and device companies
- Formation and operation of accountable care organizations, physician-hospital organizations, independent practice associations, and related multi-provider networks
- Compliance with the federal Anti-Kickback Statute, the Stark Law, and other fraud and abuse laws, such as in the context of product discount arrangements, relationships with physicians, and health care transactions
- Development of comprehensive privacy and security policies and related guidance documents in accordance with the European Union General Data Protection Regulation (GDPR) and HIPAA, HITECH, and state privacy laws
- Human subjects research conduct and related issues, both domestically and internationally
Mr. Rusczek has gained a strong understanding of the operational aspects and business of pharmaceutical and device companies through prior on-site placements at three different companies. In these positions, he advised clients on various legal issues, including fraud and abuse laws, clinical trials and related issues (such as privacy, subject recruitment, site contracting, informed consent forms, and FDA requirements for INDs), market research, promotional review activities, patient assistance programs, group purchasing organization and customer contracts, discount and pricing arrangements, sales representative contracts, and state manufacturer conduct and disclosure laws as well as FDA regulations and other requirements related to manufacturing.
Before joining Epstein Becker Green, Mr. Rusczek was a partner at a New England regional law firm and served as chair of its Health Care & Life Sciences Group. He also served as a community member of the Brigham and Women’s Hospital Institutional Review Board (2010-2015).
Mr. Rusczek has been listed in Chambers USA: America's Leading Lawyers for Business in the Massachusetts – Healthcare category (2019-2020). He has also been selected by his peers for inclusion in The Best Lawyers in America© in the field of Health Care Law (2017-2021), and included on the New England Rising Stars list in the area of Health Care (2013-2019).
While attending the University of Pennsylvania (UPenn) Law School, Mr. Rusczek earned a Master of Bioethics from UPenn School of Medicine to better assist future clients with ethical issues involved with human subjects research.
- University of Pennsylvania Law School (J.D., cum laude, 2008)
- University of Pennsylvania School of Medicine (M.BE., 2008)
- Bowdoin College (A.B., magna cum laude, 2002)
- Phi Beta Kappa
- American Health Lawyers Association
- Boston Bar Association