Speaker Programs February 8, 2017 Shauna C. Liu Richard F. Eschle, Pharm.D., J.D.

Transcription

1 Speaker Programs 2017 February 8, 2017 Shauna C. Liu Richard F. Eschle, Pharm.D., J.D. 1

2 Disclaimer The opinions expressed in this presentation are mine and do not necessarily reflect of those of my employer. 2

3 Today s Discussion Speaker Programs as a business tactic and the regulatory environment What the company can do to position for effective and compliant programs Recording and Reporting Value Transfers The Role of Monitoring 3

4 Fact or Fiction At the start of a presentation, a speaker played a Harry Potter animation that depicted him in the animation as a character from the movie. The Speaker told the audience a magic group needs a magic wizard. Immediately upon completing a program presentation the speaker left the meeting room without informing the host or attendees and never returned. It was later discovered that he went to the bar, ordered another meal and drinks because he wanted some alone time. An invited male physician was escorted to an event by a very attractive, much younger female. When the company personnel asked her background they were told that she was his office manager (no one had ever seen her in the office before). 4

5 About Speaker Programs Speaker programs are an effective way to educate and inform HCPs about a company s products, and can benefit patient care When executed properly, speaker programs are a legitimate Sales/Marketing technique If not executed properly, speaker programs may risk accusations of off-label promotion, false claims, antikickback statue violations and PhRMA code implications Scrutiny is high, compliance is critical! 5

6 Profits before Patients - Companies under Scrutiny Several former Insys employees arrested and charged with violating anti-kickback statute. Payments to HCPs for sham educational programs in order to induce HCPs to prescribe their product. HCP signatures were forged 4 plead guilty, including one speaker. Paid to settle complaint that speaker programs were used to provide kickbacks to HCPs Programs were conducted at high-end venues, where little or no time was spent on product information. Attendees were repeatedly invited to programs, with members of the same practice or who knew each other, with presentations on the same topic. 6

7 Recommended Practices Ensure policies and supporting business rules are established for effective planning and execution Have a well defined business plan that addresses need, number and type of speaker programs Provide necessary training, and educate both speakers and sales representatives about the potential risks Establish a working group to share learnings and drive consistency and alignment across the organization 7

8 The Speaker Selection should be based on defined criteria and the speaker s willingness to abide by company policy The company is fully responsible for the speaker s statements/actions The rules of promotion apply Should understand how to appropriately share clinical experience and answer questions 8

9 The Sales Representative Controls all aspects of program planning and execution Must own his/her role as program monitor Should feel empowered to intervene when needed Needs to understand how to make real time decisions to address unexpected issues 9

10 The Speaker Bureau Vendor Must understand and execute to your business rules Should accurately communicate on your behalf and know when to seek guidance Needs to receive feedback, because at the end of the day the company is responsible for the vendor s actions Picking the right partner is critical! 10

11 Tracking Speaker Program Data Speaker honoraria, travel/lodging, meals, etc. are value transfers that must be monitored and reported To meet reporting requirements companies need to have a way to record and calculate value transfers Establish a high standard for data integrity, and hold all parties accountable 11

12 Why Monitor Speaker Programs Speaker programs involve payments and other value transfers to HCPs. Monitoring will help assess compliance and identify potential risk. Action taken to address observations will help ensure speaker programs are meeting intended objectives. Good practices are identified and can be reinforced 12

13 Data Monitoring Routinely reviewing speaker program data, is a useful way to help ensure compliance to business rules Some points to consider: Contracts established Payments in accordance with FMV Venues and meals in accordance with company requirements Approved materials used Attendance requirements met 13

14 Event Monitoring Allows the company to assess overall program compliance in areas that can t be measured by data Provides an account of oral comments made and how questions are handled Offers an opportunity for real time feedback 14

15 Questions? 15

16 Thank you for your participation! 16