September 10, 2015

August 17 – 19, 2015 brought approximately 350 industry colleagues to Washington, DC where, Center for Business Intelligence (CBI) hosted the 9th Annual Transparency and Aggregate Spend Conference. My inaugural view into this conference was over five years ago, as a sole proprietor who had just hung her compliance consulting shingle out for the first time. Back then, there were a lot of the big guys in attendance: Cegedim, Deloitte, Huron, Porzio and ironically even AHM. With my knees wobbling together as a first time, independent attendee, I timidly made my way into the exhibit hall after picking up my name badge. Why was I hesitating? What was my dread? I had been working within the pharma industry focused on HCP Interactions for over a decade and had certainly heard of the then looming Sunshine Act before! What was I afraid of?
During that conference, I recall a small number of solution providers being in attendance, each proclaiming THE answer on what it was and how to prepare for Sunshine, (now the Open Payments Program). Attendees enjoyed and were inspired by the systems, screenshots, potential process flows and purchasing incentives for manufacturers. We were all wide-eyed! For me, I wondered how I was going to decipher this if there is no clear definition of requirements. Where was the line in the sand; the proverbial stake in the ground outlining what to do? Then it occurred to me – this is what I was afraid of! Fear of the unknown! And ya know what? I was not alone. Joining me in my apprehension were giant companies and experienced consultants. They, too, were trying to understand exactly where CMS was going to end up regarding their data points and collection requirements.
It was quite a different experience at this conference in 2015! As we know, CMS defined requirements in 2012 and data collection began August 2013. The life sciences industry has supplied over 2.6 million lines of identifiable general payments and CBI delivered a valuable and educational conference for the ninth year in a row! Topics of discussion during the preliminary workshop included Standardizing Processes for Validating and Verifying Data as well as one of our own, when our Global Director for Solutions Management collaborated with the panel on Leveraging the Customer Master. With over 70 attendees in this pre-conference workshop, organizations of all sizes and complexities fired off questions and collectively problem-solved using specific examples such as collecting data outside of spend sources, technology available to capture TOVs (transfer of values) across the pipeline, attesting data and scenarios of dispute resolution.
Data attestation and best practices to reduce compliance risk was another hot topic, suggesting a tiered approach involving a CMS Attester, Business Owner, Certification of Data Source and a Periodic/Ongoing Review. This best practice results in a definition of ownership, provides organizational accountability and identifies potential issues quicker and at a more granular level, allowing for improved accuracy and completeness.
A strong theme throughout the conference was globalization — and the challenges with unique country and HCP identifiers. Each country having their own rules around the identifier to capture is causing angst, inefficiencies and redundancies. A standard, best practice approach is certainly needed — but when and how are the questions that need to be answered. An additional trouble spot under the global umbrella was consent management for doctors in Europe. The speakers were suggesting that not only is soliciting consent from HCPs challenging but keeping the consent is not easy. HCPs can revoke their consent to share data whenever they want to, so companies need to consider an annual consent management strategy. There was a suggestion that if sales reps asked for the consent to share their data they would most likely receive it as compared to other people in the organization who many not interact with the rep as much. Additional coverage on CBI 9th Annual Transparency and Aggregate Spend can be found here:
Experiencing the development and path of Open Payments to date and looking to the horizon of global transparency, I can’t help but think of five years ago and appreciate the true pioneers and leaders from all stakeholder categories: life sciences manufacturers, HCOs, HCPs, industry associations and of course, solution providers who collectively thought out of the box, managed the unknown and put that stake in the ground leading us now towards a best practice for transparency.
At CBI and other conferences I’ve seen a strong desire among attendees to simply be “in the know” regarding practices among peer organizations. This is particularly evident when comparing audience engagement. The sessions presented by pharma company employees almost always generate the greatest level of interaction. Sometimes these folks know each other, sometimes they don’t, but regardless they are simply curious about other company’s experiences and how their “colleagues” are reacting to and addressing common industry problems. We have a lot of work to do still in perfecting in regards to financial transparency but collaborations and knowledge sharing which occur at these conferences are certainly paving the way!
Stepping back, I am taken by how all of this has evolved based on mutual concern and perhaps some enlightened self-interest. Subject matter experts built and then refined processes and technology, even when it was difficult to discern how best to proceed. Rather than being stymied by the fear of the unknown, we worked together, shared ideas, and built solutions together. In the words of Babe Ruth, “The way a team plays as a whole determines its success. You may have the greatest bunch of individual stars in the world, but if they don’t play together, the club won’t be worth a dime.” That sounds like the lesson we have all learned.

Contributed by:

Lisa Keilty, Global VP of Compliance and Strategic Solutions, AHM

Lisa joined AHM after serving as founder of the Compliance Consulting firm PMC2 and spending over 26 years in the life sciences and meeting management industry. Leading such organizations as Pfizer, Bristol Myers Squibb and Biogen Idec through numerous international projects, financial transparency and reporting requirements, Lisa’s industry expertise has saved Life Sciences and Meeting Management organizations over 30 million dollars. As a member of the Business Development team, Lisa’s primary focus will be Thought Leadership, Demand Generation and Solution Design.