CBI held the 10th Annual Forum on Transparency and Aggregate Spend at the Ritz-Carlton in Washington, D.C. from 15th – 17th August, 2016. The forum provided an excellent opportunity for pharmaceutical, biotech, and medical device executives to connect and share information about best practices pertaining to Federal, State, and worldwide HCP reporting.
The conference delivered a sea of knowledge with regard to open payments, the EFPIA disclosure code, and compliance initiatives and risks. Transparency, in general, was the word of the day(s). The different subject matters that were covered in the conference included:
– Investigator payments and their fair market value
– Impact of EFPIA Disclosure Code and Open Payments reporting on U.S. & European meetings
– Clinical research and the transparency issues involved
– CMS update on Open Payments reporting
– The ways in which transparency programs can assist in mitigating compliance risks
– Legal and regulatory issues related to the utilization of transparency data
– Data analytics surrounding activities of key opinion leaders
– Recent enforcement initiatives and proposed changed in regulations
Day One – August 15th, 2016
Day one was a pre-conference day in which attendees were offered two pre-conference workshops. The first workshop was led by Nancy Lanis from Henry Schein, Inc., Michael Hunn from Draeger Medical Systems, Inc., and Gina Nese from MicroVention, Inc. and covered topics related to transparency reporting for loaner medical devices, supplies, dental manufacturers, and distributors.
The second workshop was led by Marlize Eckert from GCO (Global Conference Organisers) B.V., Deborah Munzer and Johan Holm from AstraZeneca, and Andrew Powrie-Smith from the European Federation of Pharmaceutical Industries and Associations (EFPIA) and covered the impact of the EFPIA disclosure code and Open Payments on the United States and European meetings and event management. Also covered in the workshop was a breakdown of physician consent by HCP across the EU.
Day Two – August 16th, 2016
Day two opened with welcome and opening remarks from Richard Eschle, Pharm D., JD, Executive Director of Corporate Compliance and Ethics at Eisai, Inc. Following opening remarks, the keynote address was delivered by two distinguished members of the CMS Division of Data and Informatics (DDI), including their director, Robin Usi.
Their key message was that CMS is balancing the process of meeting complex federal healthcare transparency regulations and simplifying the data collection process for manufacturers and that CMS and other federal regulators are regularly “mining the open payments data”. They continued to share 2015 data highlights too.
Next, two panelists from the US Department of Justice and one panelist from the Massachusetts office of the Attorney General helped attendees understand the trends in recent enforcement targets by their offices.
The takeaways from the three panelists were: Ms. Laura M. Kidd Cordova – there is an increased use of data assets by their department, and there is an inclination to pursue criminal and not just civil litigation, Mr. David M. Scheffler – the department is actively using data analytics as a tool and for every dollar ($1) the DOJ spends in investigating violations, they recover $6, and Mr. R. David Walk, Jr. – his department is actively swapping in data analytics resources for feet on the beet, and he noticed that 2015 open payments data is reflecting a sharp decrease in honoraria and a sharp increase in charity, and commented that such data results are often further explored.
Moving on, the President and CEO of MMIS, Michaeline Daboul presented case studies on how the publically available open payments data and analytics are currently being used by industry regulators and manufacturers.
She further shared that qordata, Medispend, and a few others are offering ready capabilities to help manufacturers mine the open payments data. The final morning session included distinguished industry compliance and transparency reporting directors from Ariad, Daiichi Sankyo, Sunovion, and Shionogi Pharmaceuticals, and they discussed data usage.
The highlight of this panel discussion was their response to the question as to what keeps them up at night. Their summary responses were: not knowing what is in their data, concern about outliers in their data, concern about any data missing from their report, and concern about lack of readiness to answer the question, “You had the data, why you did not know what is in it?”
Regina Alvarado and Jamie M. Mastroianni from Deloitte & Touche LLP also presided over an interesting session that was titled, ‘Comprehend the Status of the Pending Nurse Practitioner Bill and Implementation Challenges’.
As the title implies, the session covered the current status of the bill and the challenges associated with its implementation. Seth H. Lundy and Brian Bohnenkamp from King & Spalding LLP also led a panel titled ‘Will Federal and State Enforcers Work Together to Target Open Payments Data? An Update on Transparency Reporting at the State Level’.
The afternoon then featured a panel on ‘Traversing Sunshine Reporting for Clinical Research and Ways to Improve It’ that was moderated by Seth Whitelaw, editor of Life Science Compliance Update, and with panelists from the AMA, AstraZeneca, Johnson & Johnson, and HCA.
Rounding out the afternoon was a panel on how to structure and initiate a global transparency compliance program. The panel was moderated by John Patrick Oroho from Porzio Life Sciences, LLC, and featured panelists from Bristol-Myers Squibb, AstraZeneca, and Porzio Life Sciences, LLC.
Day Three – August 17th, 2016
Day three allowed attendees to decide how they wanted to spend their morning and what areas they wish to acquire more information about. There were ten concurrent sessions from which attendees could choose five to attend.
The topics covered included how to improve systems for data remediation and validation, what an Open Payments audit would look like, how to manage differences between EFPIA and U.S. transparency regulations, and transparency disclosure guidelines around the world.
Let’s not forget, qordata’s Practice Leader and Associate Partner, Ned Mumtaz, also led a workshop titled, ‘Rounding Out the Transparency Team – Adding Data Analytics’. In the workshop, he covered many different topics, including:
– Adding analytics function to transparency reporting compliance team
– Enabling your compliance team to contribute more to building compliance and strategy
– Elevating the integration of IT, analytics, and systems intelligence in the transparency reporting compliance program
The day ended with a presentation by Thomas Sullivan, an overview of the two full years of Open Payments data, media coverage of the data, and what that means for the future.
All in all, the conference was a huge success, and qordata is glad to have been a part of it. Let’s not forget our booth was one of the busiest, and our team outdid itself in responding to queries about how our Open Payments Analytics can help pharma companies manage the risk of open payments and report accurate data to CMS!
