Ilenna J. Stein is an attorney in Holland & Knight's Boston office, and she is a member of the firm's Healthcare & Life Sciences Team. Ms. Stein advises clients in various sectors of the healthcare industry on healthcare regulatory matters, fraud, abuse and compliance matters, and corporate transactional matters.
In particular, she counsels pharmaceutical manufacturers, medical and dental device manufacturers, pharmacies (retail, specialty, long-term care, mail order and compounding), pharmacy benefits managers, dialysis companies, physician groups, home health agencies, private duty companies, healthcare technology companies, insurers and wholesale drug distributors. Specifically, Ms. Stein provides regulatory guidance and advice on matters concerning compliance with the federal Anti-Kickback Statute (AKS), Medicare, Medicaid, Health Insurance Portability and Accountability Act (HIPAA), Physician Payments Sunshine Act (Sunshine Act), Corporate Practice of Medicine (CPOM), and other federal and state healthcare laws. Ms. Stein also has experience assisting clients in drafting policies and procedures as well as in implementing compliance programs.
Ms. Stein advises clients in a variety of corporate and contractual transactions, including mergers and acquisitions, licensing matters and structuring transactions. Ms. Stein directly represents buyers and sellers in corporate transactions and advises private equity firms investing in the healthcare space. In addition, she counsels insurers and lenders underwriting representation and warranty (R&W) insurance or loaning funds, respectively, in connection with healthcare transactions. She also has experience handling, responding to, and successfully appealing Medicare and state Medicaid payment audits, as well as HIPAA investigations by the Office for Civil Rights (OCR). In addition, Ms. Stein provides healthcare regulatory advice to educational clients, such as colleges and independent schools, on matters concerning healthcare.
Ms. Stein is the co-chair of the Diversity Committee at Holland & Knight's Boston office.
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