Shannon Wiley

Background

About Shannon Wiley

I enjoy an active healthcare regulatory and transactional practice with a heavy emphasis in the pharmaceutical and drug distribution chain space, with particular emphasis on specialty pharmacy, digital pharmacy, and infusion providers. I counsel pharmacies, infusion centers, manufacturers, GPOs, distributors, hubs, and data aggregators, among others, in contracting and business strategies and the related legal implications of state and federal laws including anti-kickback, civil monetary penalty law, false claims act, Drug Supply Chain Security Act, 340B, and HIPAA/HITECH. Arising from my focus on specialty pharmacy/pharma services operations, I have assisted with complex contracting strategies, the development of enhanced service programs, data arrangements, the construction of co-pay coupon programs, among other things. I assist infusion providers with federal and state specific laws related to starting and maintaining operations, such as the corporate practice of medicine and nurse practitioner independent practice. I also assist with day to day operations such as sales force interactions with referral sources, payor recoupment and termination, Medicare Part B and Part D billing issues, impermissible uses or disclosure of patient information, and licensure. I have been involved in multiple mergers and acquisitions within the space, including specialty pharmacies, infusion pharmacies and infusion suites, and GPOs, by providing comprehensive regulatory due diligence support, assisting with healthcare aspects of transaction documents, and assisting with post-close integration.