Jamie Darch (Liebert) joined Ropes & Gray in 2014 and is a partner in the health care group. Jamie provides transactional, regulatory, and compliance advice to a range of health care clients, including pharmaceutical and medical device manufacturers, wholesalers, distributors, pharmacies, hub vendors, hospitals, provider groups, home health and home care providers, and health care-focused private equity funds.
Jamie has worked on an array of private equity transactions in the health care space, as well as strategic transactions by pharmaceutical manufacturers. Jamie advises clients on compliance with health care regulatory laws, including the Anti-Kickback Statute, the False Claims Act, state laws governing licensure and changes of ownership complications, telehealth requirements, HIPAA and state data privacy laws, and 340B, as well as benchmarking against industry best practices.
Jamie also provides regulatory advice regarding data sharing and data use agreements, including in the research context, data de-identification and aggregation arrangements, clinical trial agreements, and arrangements with contract research organizations.
Experience
- Counsels hospitals, medical device manufacturers, and other HIPAA covered entities navigating HIPAA compliance, including recent OCR guidance on use of tracking technologies, through proactive internal assessments and breach response investigations.
- Assists pharmaceutical manufacturers and device companies with in-depth reviews for high risk topics or areas of concerns, focusing heavily on the provision of patient and provider support (e.g., copay assistance, donations to copay foundations, manufacturer patient assistance programs, nurse education, hub/reimbursement support, provider training, genetic testing) and associated fraud and abuse, promotional, and privacy considerations.
- Advises multiple clients navigating complex licensure change of ownership and certificate of need requirements for pharmaceutical and medical device manufacturers, wholesalers, distributors, pharmacies, home health agencies, and home care providers (including New York Licensed Home Care Services Agencies).
- Assists the compliance function of a leading pharmaceutical manufacturer in performing deal diligence and post-acquisition compliance integration reviews.
- Provides advice with respect to multiple clients, including a national pharmacy, a global pharmaceutical manufacturer, and a large urban hospital system, regarding adherence to Corporate Integrity Agreements, including compliance and quality program requirements, board oversight, and reporting obligations.
- Advises covered entities, contract pharmacies, and manufacturers on compliance with the 340B Drug Discount Program.
- Assisted a medical device company with the implementation of a compliance program and provided ongoing compliance advice regarding discounts, evaluation products, and innovative sales models.