Mark helps providers of patient care and entities that conduct biomedical research understand, anticipate, and resolve regulatory compliance issues.
In the research arena, Mark provides counsel to universities, academic medical centers, biotech companies, and other research entities regarding compliance with laws and regulations governing diverse aspects of pre-clinical and clinical research, including, for example, grants administration, conflicts of interest and transparency considerations, human subjects protection, research integrity, and FDA restrictions on drug promotion. He assists hospitals and educational institutions with internal investigations into research misconduct allegations and also advises in connection with the development and implementation of organizational policies on individual and institutional conflicts of interest, compliance reporting systems, industry relations, and translational research collaborations.
In the realm of patient care, Mark has for many years counseled hospitals, health systems, and other health care providers concerning reimbursement and compliance issues. He is a former partner in the Health Care Practice Group of Choate, Hall & Stewart in Boston, where he represented major medical centers, community hospitals, specialty hospitals, physicians, long-term care providers, laboratories, dialysis companies, and other health care entities regarding diverse aspects of Medicare and Medicaid billing and reimbursement, Public Health Service grants reimbursement, state and private insurer payment systems, and fraud and abuse laws. He litigated payment appeals at the Provider Reimbursement Review Board, HHS Departmental Appeals Board, and other public agencies, as well as in state and federal trial and appellate courts. He has also defended routine and special audits by Medicare Administrative Contractors and investigations by the HHS Office of the Inspector General and the Department of Justice.
Immediately prior to joining Verrill Dana, Mark was a special consultant to Harvard University, where he worked with the Office of the President and Provost to draft a University-wide policy on faculty conflicts of interest. He also consulted to Harvard Medical School, where he assisted the Office of Academic and Research Integrity and the University’s Office of General Counsel in investigations of alleged research misconduct and conflicts of interest.
Mark lives with his wife Ellen, an educator at the Concord Museum and the Boston Museum of Science, and with a shifting bestiary of pets. He devotes time to advocacy organizations for individuals with bleeding disorders and serves as the Secretary of the National Hemophilia Foundation. In his spare time, he loses himself in painting, at which he occasionally surprises. As a general matter, he can be guilted into almost any social cause, client need, or personal favor.