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Helio Health Group - The Future of Compliance Monitoring

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Traditional field-based monitoring activities are becoming increasingly outdated and producing less effective outcomes. What can pharmaceutical companies do to minimize risk with increased scrutiny from regulatory bodies? Helio Health Group's paper provides a glimpse into the future of Compliance Monitoring

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Helio Health Group - The Future of Compliance Monitoring

  1. 1. THE FUTURE OF COMPLIANCE MONITORING Helio Health Group
  2. 2. WHITE PAPER Publication Date 10.19.2017 Helio Health Group / THE FUTURE OF COMPLIANCE MONITORING 1 Can Pharma Keep Up? At the center of every functioning pharmaceutical manufacturing organization, there exists an effective compliance program monitoring the actions of its entities. Overseeing the day-to-day activities at these organizations can be a daunting task as they often consist of a complicated web of networks tied together to form a working body. Internally, manufacturers organize their structure to operate as efficiently and effectively as possible from Brand Management Strategy groups to Clinical Research and Development to Market Access and Product Pull through units; branches can also extend to external third parties to assist with execution and integration of systems and processes. With each touchpoint, strategies and decisions are being made at hyper-speed. Adding to that pressure is the increased scrutiny from regulatory bodies shaping internal corporate guidelines, it’s a challenge for manufacturers to maintain sales expectations while staying within the bounds of the law, oftentimes tip-toeing the line of compliance to maximize returns. Image 1. Pharma’s Largest Settlements Over the Past Five Years.1,2,3 Essentially, the role of a compliance program is to identify and mitigate touchpoints that are cause for risk – to sift out gray areas, process available information, determine if any of those interactions leave the company vulnerable to public scrutiny, litigations, fines, or punishment, eliminate the ongoing issues, and prevent the repeated action. The goal of an effective compliance program is to be the conscience of the working body. But how does a company monitor these touchpoints and measure potential risk with the subjectivity of each interaction and complexities of the industry? How does a company effectively monitor for regulatory risk without compromising sales and commercial objectives? 1 https://www.justice.gov/opa/press-release/file/918366/download 2 https://en.wikipedia.org/wiki/List_of_off-label_promotion_pharmaceutical_settlements 3 http://projects.propublica.org/graphics/bigpharma THE FUTURE OF COMPLIANCE MONITORING
  3. 3. WHITE PAPER Publication Date 10.19.2017 Helio Health Group / THE FUTURE OF COMPLIANCE MONITORING 2 Historically, compliance programs relied heavily on training initiatives to prevent risks from occurring. In an ideal world, a properly trained sales team, consisting of individuals with high integrity, would eliminate compliance risk. Ideal and reality, however, are very different and companies began implementing field-based monitoring activities which included ride-alongs with sales representatives, extensive review of travel expense reports, pre-activity approvals, and post-activity checklists. Even with these initiatives, pharmaceutical companies still found challenges in identifying risk areas that could have prevented huge fines or settlements (see Image 1.) The companies identified in this image represent only a few of many recent settlements where more effective compliance measures may have helped mitigate non-compliance behavior to prevent these outcomes. Traditional field-based monitoring activities are becoming increasingly outdated as they are producing less effective outcomes, are costly, and are not scalable based on resources. The federal government has continued to put pressure on the industry through investigations and lawsuits. Big Data, Alerts and Real-Time Functionality Pharmaceutical manufacturers will need to adapt to keep up with evolving trends. What might this entail? One approach would be to gather and assess as much information available, as quickly as possible. Big data, the industry's best un-kept secret, will be the key to unlocking insights from employee / customer behaviors, marketing channels, and even interactions relevant to compliance. Big data and Pharma have been tied together for quite some time and it's not a coincidence as the industry's flush with available datasets. Up until now, the majority of the focus has been centered on improving sales and commercial targets and the industry has only scratched the surface on effectively using data. Presently, manufacturers and consulting companies, such as Helio Health Group, are taking things one step further and are now developing tools that will aggregate available data sets, combine them with overlapping identifiers, and analyze the information with complex algorithms to digest and return findings for compliance related gains. In addition to utilizing datasets and algorithms, it will also be important for manufacturers to establish how insights are being delivered and what platforms are being used for delivery. Historically, traditional monitoring and auditing initiatives processed information retrospectively; as a result, any findings were identified much later than the actual occurrence. For Compliance related risks, there is a necessity to receive results in real-time to ensure detection of certain activities, such as kickbacks to customers and off- label promotion. Tools will need built-in alert functionality to detect and relay issues live along with the ability to summarize results in an organized fashion for key stakeholders to assess and understand. Big data, the industry's best un-kept secret, will be the key to unlocking insights from employee / customer behaviors, marketing channels, and even interactions relevant to compliance. Traditional field-based monitoring activities are becoming increasingly outdated as they are producing less effective outcomes, are costly, and are not scalable based on resources.
  4. 4. WHITE PAPER Publication Date 10.19.2017 Helio Health Group / THE FUTURE OF COMPLIANCE MONITORING 3 Integrating with Current Compliance Monitoring Strategy As data analytics tools are developed and assessed for value-add by the industry, compliance groups should strongly consider incorporating these tools as part of their overall compliance strategy. Much like field- based monitoring, analytics tools can be the bridge to building strategic plans to effectively engage with sales and commercial operations to cultivate an environment that promotes ethical standards as a priority. Data analytics tools can work in conjunction with field-based monitoring initiatives to increase efficiency and effectiveness, and likely add barriers to prevent future risks. The key is to have buy-in from a corporate standpoint, and to effectively incorporate these tools to a compliance framework with data as the central element for analysis. Below are several examples of utilizing data analytics to enhance a company's Compliance Monitoring Strategy for identifying risks: ➢ Identifying Potential Off-Label Promotion Data Sets: Prescription Data; ICD 9 / ICD 10 Codes; Company Territory Alignment By coupling real-time prescription data with International Classification of Diseases codes (ICD 9 / ICD 10) and overlaying territory alignment data in a heat map, companies could identify areas where prescriptions are written in high volume or identify prescription rates for indications that are off-label. With this insight, Compliance can target specific sales representatives responsible for those territories and assign them for field-based monitoring to determine if off-label promotion is occurring. As prescription data is provided, tools can analyze before and after effects of field-based monitoring to determine its effectiveness. Image 2. Rate of Off-Label Scripts in Northern United States. ➢ Identifying Potential Kickbacks to HCPs Data Sets: Transparency Spend, Prescription Data, FMV Live transparency spend data can be analyzed and compared to established Fair Market Value (FMV) rates and can be overlaid with real-time prescription data to determine if healthcare professionals (HCPs) are receiving excessive, or frequent, payments for promotional discussions that could influence their prescribing behaviors. Compliance can apply field-based monitoring to determine whether consulting arrangements with highly utilized HCPs are valid and meet company requirements.
  5. 5. WHITE PAPER Publication Date 10.19.2017 Helio Health Group / THE FUTURE OF COMPLIANCE MONITORING 4 Image 3. Total payments to individual HCPs for a particular drug. ➢ E-Detailing Data Sets: Voice Recordings Voice analytics and call monitoring for e- detailing or virtual detailing can also be utilized as part of a robust compliance monitoring program. Companies can determine the potential for off-label promotion, false claims, and inconsistencies with adverse event reporting during interactions between patient services engagement team members, patients, and HCPs. Discussions can be recorded, transcribed and analyzed for key words or phrases and assigned a risk score. High risk conversations can then be analyzed and employees can be targeted for additional field- based monitoring or training initiatives. Image 4. Voice-to-Text Call Log with Potential Risks for Off-Label Promotion Identified. ➢ Social Media Monitoring Data Sets: Social Media Sites (Twitter, Facebook, Doximity) Performing analysis on key posts identified from scraping social media sites could uncover a variety of risks. Targeted monitoring of consumer posts related to pharmaceutical products may detect adverse effects that have not been reported to the Federal Drug Administration (FDA). Monitoring physician social media posts could potentially reveal whether HCPs are promoting drugs on a manufacturer’s behalf. A new study published by Reuters Health established that “Some cancer doctors use Twitter to promote drugs manufactured by companies that pay them, but they almost never disclose their conflicts of interest on the social media platform.”4 Tie this information with additional data sets, such as spend information or prescription data, and the outcomes could lead to key compliance insights. 4 https://www.reuters.com/article/us-health-twitter-medical-ethics/doctors-who-take-pharmaceutical-money-use-twitter-to-hype-drugs- idUSKCN1BM2EU Tie this information with additional data sets, such as spend information or prescription data, and the outcomes could lead to key compliance insights.
  6. 6. WHITE PAPER Publication Date 10.19.2017 Helio Health Group / THE FUTURE OF COMPLIANCE MONITORING 5 Challenges and Concerns Handling large amounts of data comes with its own set of challenges and risks. Data sources must be properly vetted, and reviewed for quality and accuracy, prior to consumption. Manufacturers will need to develop their own sets of policies and procedures for handling and sharing data across channels within the organization. Such initiatives may include developing training materials and guidelines for utilization of data, understanding Health Insurance Portability and Accountability Act (HIPAA) privacy laws, and creating focused groups within the organization responsible for the management of internal/external data. The industry will also require the proper technological resources to process the different data formats that are available. Certain data providers and sources will come equipped with a structure and organization which will make analysis easier. Other valuable datasets are often unstructured and noisy presenting significant challenges to users looking to process information. Manufacturers will need to invest in the appropriate technology and skillsets to deal with these hurdles. The Foreseeable Future Fusing resources together into a proactive monitoring process will not be an easy task but the potential is immense. Similar to the excitement garnered by the industry for potential sales and marketing gains, data analytics tools can have a huge impact from a compliance perspective in identifying trends, outliers, risky behaviors, and can ultimately be a driver for developing strategies for prevention and remediation. Informed manufacturers will eventually look to employ real-time analytics to capitalize on these benefits. As pharmaceutical manufacturers continue to receive scrutiny from the public and government entities, it will only be a matter a time before proactive monitoring becomes a necessity in day-to-day compliance operations. About Helio Health Group Helio Health Group specializes in providing life science companies with strategic and operational consulting in patient services, commercial and compliance operations utilizing advanced data science techniques. Our industry experts have extensive knowledge and experience in life sciences including CRM, operational excellence, medical, data strategy / governance and predictive modeling. For more information, go to www.heliohealthgroup.com. About the Authors Rich Huynh, Senior Manager | Rich is a senior manager at Helio Health Group and is based out of the Philadelphia office. Prior to Helio, Rich worked at Huron Consulting Group’s Life Sciences Practice. Rich received his BS in Chemical Engineering from Lehigh University. Rich has over 6 years of experience in assisting pharmaceutical and medical device companies with addressing regulatory compliance issues.

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