Kaytie Ravega

Practical health care innovation counsel

Kaytie Ravega helps businesses large and small refine their novel health care ideas in compliant ways, prepare the agreements necessary for implementation, assess the compliance of existing practices and navigate the complex web of regulatory requirements governing pharmacies of all kinds, businesses throughout the pharmaceutical manufacturing and supply chain, labs and telehealth providers.

Her skillset stems from her experience as an in-house attorney and chief compliance officer for a health care app and national pharmacy company, in addition to more than 15 years of health law practice. With a deep understanding of the interrelationships among the different, sometimes conflicting, regulatory structures affecting these health care businesses, Kaytie:

• Formulates and implements strategies to navigate innovation forward.
• Drafts and negotiates the contracts that serve as the foundation of the business partnerships.
• Looks ahead to trends and risks that may affect client goals.
• Assesses current business models and builds consensus to address compliance gaps.

• Advises clients on automation and technology implementation. Clients turn to Kaytie for advice involving remote dispensing and telepharmacy, regulating use of robots, multidose dispensing and compliance packaging.
• Counsels app developers, drug manufacturers, pharmacies, distributors, PBMs, DMPOs and others about health care regulatory requirements, partnership development, and data privacy and security, including anti-kickback laws, HIPAA and other laws regulating their data.
• Advises clients around credentialing and licensure requirements, including when entering into telehealth arrangements and transactions involving pharmacies, PBMs, DMPOs, drug manufacturers or drug distributors.
• Drafts and negotiates a variety of agreements related to health care business arrangements and transactions. Kaytie has experience drafting and negotiating agreements related to pharmacy operations and vendors, PBM networks, GPOs, DMPOs, drug and device distribution, telehealth provider arrangements and partnerships, as well as the purchase and sale of health care entities or lines of business.
• Helps physicians across the country navigate their telehealth licensure requirements, including addressing exceptions to licensure requirements where they exist, handling telehealth-specific registrations and understanding state-specific practice requirements in the telehealth context. 

• Supported the development and launch of a national organization focused on eliminating race-based disparities in health care while improving health equity and health care access.
• Guided national pharmacy chains through development, launch and implementation of Covid-19 vaccination programs.
• Counseled drug manufacturer on design and implementation of distribution system and contracts for newly approved FDA prescription product, as well as virtual manufacturer licensure, sampling program, compliance program development, sales rep training, fraud, waste, abuse prevention, promotional review and other matters related to product launch throughout the U.S.
• Advised telehealth provider in design of corporate structure, contract negotiations and compliance matters for partnership formations for physicians, pharmacies, marketers and related service providers.