Off-label, Anti-Kickback, and Other Risks within Speaker Program Compliance

Transcription

1 Off-label, Anti-Kickback, and Other Risks within Speaker Program Compliance Neal J. Rafferty US Compliance Officer Merz North America The content & statements in this presentation are solely my own and in no way reflect the views and opinions of Merz North America.

2 Speaker Program Risk & Investigation of Non-Compliance Where is the Risk? Speaker(s) Content Program Venue HCP Audience Unapproved Attendees Field Employees Marketing Company Leadership

3 Purpose & Scope of Speaker Programs Rx manufactures have a responsibility to provide Healthcare Professionals (HCPs) with education and training on the safe and effective On-Label use of Rx products. One way that a manufacturer provides educational and training opportunities to HCPs is through company-sponsored Speaker Programs. In a company-sponsored Speaker Program, one HCP educates other HCPs about an Rx product or related healthcare topic.

4 Promotional Speaker Program Risk Areas Speaker payments (per program and aggregate) Speaker utilization Audience attendance Training & certifying speakers Narrowing the scope on communication by the HCP - Ensuring speakers use only approved materials Responding to off-label questions Speaker/attendee specialty

5 Speaker Program Compliance Policy Questions Annual training for HCP speakers? Who facilitates the training? Webinar training vs. live meeting? Speaker certifications to prevent off-label discussions? Do you allow HCP speakers to answer unsolicited off-label questions? If so, what is your guidance? Do you have a compliance checklist completed for each program? Who is responsible to completing? Are HCP speakers allowed to add/omit content to speaker decks? How often are you checking-in with marketing to review speaker utilization and other metrics?

6 Use OIG 7 Elements to Mitigate Speaker Program Risks SP Written Policy Have a Compliance Lead Field & Speaker Training Lines of Communication Risk-Based Review Monitor Programs Respond Promptly Enforce Standards Reassess Often

7 Annual Assessment & Concept Review Risk assessment metrics for Compliance to consider: Where to allocate the department s limited recourses? By Brand, Business Unit, Geography What did the data tell you from the preceding year? Number of programs & attendees, management reporting, investigations, attendee survey data Speaker Selection Criteria Medical expertise & Reputation in the medical community Knowledge products and therapeutic areas treated by products Communication & Platform skills Geographic location and influence mapping Past Policy Adherence

8 Speaker Training: Setting the tone for a compliant bureau What does the training look like Content Payment & Venue Frequency Compliance Payment Speaker Utilization and setting expectations Internal & External Allows organizations to self-police to correct problems Ongoing evaluation process critical to program success

9 Monitoring Strategies for Speaker Programs Off-label promotion is a significant risk To Prevent, Detect, and Deter improper communication Assists the organization in identifying & acting on real or potential compliance issues before they become bigger problems Strategies Announced or Unannounced Monitoring What role do other company employees play in monitoring Are there expectations placed on the 3 rd party program facilitator Allows organizations to self-police to correct problems Ongoing evaluation process critical to program success

10 Investigations into non-compliance Magnitude of the Problem Insolated incident or systemic problem Policy gap or ineffective training Company response & remediation Documentation Process Active vs. Passive (commission or omission) Discipline, retraining, enhanced monitoring? Implications on current or future programming

11 Lessons from the Novartis Allegations In March 2016, DOJ expanded the investigation into past Novartis speaking events, demanding additional documents on 80,000 speaker programs The government allegations focus on 10 years of programs between January 2002 and November 2011, Novartis allegedly violated the FCA by paying kickbacks to physicians under the guise of speaker programs to induce them to write prescriptions for Novartis drugs in violation of the AKS Specific Violations include: Repeat programs with the same speakers, topic, and attendees Clusters of doctors who would present the same topic to each other, taking turns in the roles of speakers and attendees Speaker programs were merely social events and held in inappropriate venues Novartis paid doctors for speaker programs that did not occur or were not attended by the doctors Novartis claimed were present Novartis allegedly knew that its speaker programs could violate the AKS based on its internal policies and its monitoring program findings but did not implement sufficient safeguards or remediate violations

12 DOJ s focus on Monitoring in Novartis March 9, 2011, report from the Ethics & Compliance department to Novartis s Board of Directors: Of 22 monitored speaker programs in Q4 2010: 8 programs (36%) violated modest meal policy 3 programs (13%) speaker did not present slides 107 programs monitored in programs (41%) violated modest meal policy 8 programs (7%) the speaker did not present slides in entirety 35 programs (33%) had inconsistencies with supporting documentation, the most common being the names and number of attendees on the sign in sheet not matching the names and number of attendees recorded in the [database] system Reps always received advanced notice of compliance monitoring

13 Handling the Unexpected Difficult Situations Speaker fails to show AV fails to work Is there a back-up plan? HCP Attendee arrives unannounced and uninvited Is there a process for vetting? Turning away an inappropriate attendee Precise language regarding what to say? Correcting an errant speaker Making corrective statements to the audience Cancelling a program at the last minute Contract & compliance implications

14 Summary An effective monitoring approach provides a method to assist in identifying off-label promotional risk to the business that may have been otherwise undetected internally Risk assessment processes and monitoring plans should vary based on organizational need and no one size fits all Assists in identifying if the controls and policies developed to remediate risk are working Compliance Department input throughout the process from concept approval through sun-setting of speaker bureau provides a good faith effort by the organization to adhere to government expectation & policy

15 Questions???