Distance Learning

Specialty Pharmacy: A Primer on Regulatory and Compliance Concerns (Intermediate) - On Demand Recording

Recorded On: 01/18/2018

Time: 90 minutes
Session Format: On Demand Recording

Specialty pharmacy is expected to be a $235 billion industry sector in 2018, up from $92 billion in 2012, and by 2020 will represent 44% of pharmacy revenues.  Specialty pharmacies often deliver high cost medications, with individualized care plans, and typically provide increased coordination of care amongst the provider, pharmacy, nursing care, the payer and the patient.  Their business models, operations and risks are distinctly different from those of traditional “brick and mortar” pharmacies.   

This overview session will address the role and state of the industry sector, basic regulatory concerns with specialty pharmacy business models and operations, and identify some key compliance risks.  Our presenters include a former member of  a state pharmacy board who now operates a specialty pharmacy, an attorney whose practice revolves around counseling specialty pharmacies in issues ranging from set-up and ongoing operations to investigation responses, and a representative from the HHS Office of Inspector General, Office of Investigations, who will speak about the OIG’s areas of interest with respect to specialty pharmacies.  

  • AHLA Member: $145
  • Non-AHLA Member: $275

Sponsoring AHLA Group:

  • Regulation, Accreditation, and Payment 

Michael Cohen, DHSc, JD, PA-C

Operations Officer, Investigations Unit

U.S. Department of Health & Human Services
Office of Inspector General
Miami Lakes, FL

Michael R. Hess


Bass, Berry & Sims PLC
Memphis, TN

Dr. Sajal Roy, PharmD

Chief Executive Officer

Factor One Source/FAST Pharmacy
Cumberland, MD

Judith A. Waltz

Partner and Business Lawyer

Foley & Lardner LLP
San Francisco, CA

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