Shamika Mazyck

Responsive, thorough and innovative health care regulatory counsel

Shamika Mazyck advises pharmacies, wholesale drug distributors, drug manufacturers, practitioner groups, home infusion providers and a variety of health care-related entities. She comprehensively understands home health, Nurse Compact, pharmacy and practitioner scope of practice laws. Shamika has had conversations with regulators throughout the country about licensure requirements for entities that provide limited in-home services (e.g., clinical trial monitoring or vaccine administration). Her unique insight allows her to identify licensure barriers and assist with resolving and defending compliance concerns.

With a background in environmental consulting and occupational health and safety management in acute care facilities before launching her legal career, Shamika focuses on:

• Health care regulatory analysis and compliance
• Health care regulatory due diligence assessments for private equity firms
• Health care licensing analysis
• Health care contracts

Clients appreciate the extensive knowledge of the operational realities of health care providers that Shamika brings to her legal counsel. Adept at building relationships and leading multidisciplinary groups of people, she develops comprehensive regulatory compliance programs and procedures built on collaborative decision making and innovative solutions.

• Advising on a variety of regulatory compliance matters, including federal and state regulations governing privacy, licensure, controlled substance delivery, provider self-referral, decentralized clinical trials, practitioner scope questions in telehealth, vaccine scope of practice and delivery models, credentialing and licensure requirements for telemedicine, obtaining regulatory approval for novel methods of operation and service delivery, and other issues.
• Advocating for health care business proposals before state regulatory bodies.
• Advising on analysis and drafting of provider contracts, including wholesale drug distribution, supply chain, specialty pharmacy, scope of practice and health equity agreements, as well as agreements relating to telehealth provider arrangements.
• Assisting private equity firms with assessing the compliance of existing practices and identifying risk prior to acquisition.
• Guides clients on operationalizing home infusion models by analyzing licensure requirements, conducting licensure gap analyses and seeking waivers of applicable regulations.
• Advises on a variety of nursing issues, including the Nurse Licensure Compact, telenursing, use of nurses in call centers and nursing agency licensure.

• Assisted in national health equity organization development and launch.
• Guided national pharmaceutical chain through development, staffing, compliance, billing and operational issues to quickly acquire and administer COVID-19 vaccinations.
• Provided key regulatory and contracting support for drug manufacturer in setting up licensure, promotional materials, and distribution plan and contracts for newly approved drug.
• Helped client navigate through regulatory barrier for administering drug trials in the home.