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Advertising and Promotion Regulatory Affairs Conference

This event is now offered in a new entirely virtual format.


Session 8: Communications and Pricing Disclosures: From State/Federal Transparency Requirements to Formulary Placement and Value-Based Contracting Communications

Session Chair(s)

Kevin M Madagan, JD

Kevin M Madagan, JD

  • Partner
  • Reed Smith, LLP, United States
Advertising and promotional regulatory affairs professionals are increasingly confronted with promotional communication issues involving cost and pricing data. These communications can be voluntary company initiatives or triggered by government-mandated transparency laws. Although many professionals historically relied on their legal and compliance colleagues to oversee these communications, regulatory affairs professionals are increasingly being asked to play a role in ensuring the accuracy of the data and underlying message in these communications. Importantly, these professionals must also account for new state laws, which are now being enacted around the country in different forms, that demand certain price disclosures when engaging in certain types of promotional activity. Consequently, to operate effectively in 2020, advertising and promotional regulatory affairs professionals must remain well-informed of current industry standards and state/federal requirements governing cost and price disclosures in promotional communications.
Learning Objective : At the conclusion of this session, participants should be able to:
  • Discuss Trump Administration efforts to increase transparency in health care costs
  • Identify current state and federal price transparency standards
  • Understand FDA and industry positions about price disclosures, including industry standards from AdvaMed and PhRMA
  • Understand the key aspects of disclosing pricing programs in a promotional setting

Speaker(s)

Kevin M Madagan, JD

Speaker

Kevin M Madagan, JD

  • Partner
  • Reed Smith, LLP, United States
Darshan  Kulkarni, JD, PharmD, MS

Speaker

Darshan Kulkarni, JD, PharmD, MS

  • Principal Attorney
  • The Kulkarni Law Firm, United States
Jonathan  Bigelow

Communications and Pricing Landscape: Federal Developments

Jonathan Bigelow

  • Executive Director
  • Coalition For Healthcare Communication, United States
Don  May, MPA

Speaker

Don May, MPA

  • Executive Vice President, Payment and Health Care Delivery
  • AdvaMed, United States

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