For Life Sciences companies, compliance with both the U.S. and global transparency requirements is a complex and ever-changing task. Multiple layers of legislation – from state and federal to international – have been enacted to create transparency in the interactions between pharma and medical device companies and healthcare providers that make up their massive customer base. These requirements include the Sunshine Act, various U.S. state laws and European laws and directives specifying how transfers of value (TOV) from pharma companies to physicians must be tracked and reported. For example, the European Federation of Pharmaceutical Industries and Associations (EFPIA) directive covers 33 countries in Europe. In addition, local European laws exist and vary, such as in France, Portugal and the Netherlands. Other countries like Japan and Australia and emerging markets like Columbia and Turkey have also enacted local or regional laws or directives governing TOV transparency and reporting.
Taking up the challenge
While the laws provide the benefit of increased transparency, their complexity and swiftness of implementation left many companies unprepared to meet them efficiently or effectively. The reasons are many, including:
- Infrastructure – Many affected companies simply did not have the means and processes in place to properly capture, gather, manage and report the data needed to adhere to the compliance mandates.
- Point-of-transaction technology – There were no efficient or automated ways to capture the TOV data at the point of a transaction. Often used manual reporting tends to be fraught with human error and misreporting.
- Data management – The sheer volume of internal and external data to keep track of make it difficult for Life Sciences companies to manage it reliably.
- Multiple, disparate sources systems – Numerous systems and data sources across various geographies add to the complexity of global compliance.
- Currency conversion – Transactions may be captured in one currency but must be reported in another currency.
- Managing cross-border interaction – Without a comprehensive or single system for tracing TOV data, Life Sciences companies lack visibility to accurate, complete data.
- Data privacy – In the EU, Hospital Casemix Protocol (HCP) data is mandated for privacy laws.
- Consent Management – Related to EFPIA, HCPs must consent to be reported individually; otherwise, they appear in aggregate. Compliance management systems should be able to capture and manage this requirement.
Getting accurate data is key
The most important element is and has always been accurate data management before it even comes to reporting. There are inherent challenges in submitting, collecting, reconciling, organizing and reporting TOV data across all internal and external systems to create a proverbial Golden Record – the authoritative master record for a specific individual or organization that includes all of the consolidated data points from multiple sources.
The data from various system sources must be analyzed, authenticated, de-duplicated and updated to ensure that each record is accurate and complete. Today, technologies are available that can easily track and organize records from source system A, to system B, to system C, linking and integrating disparate pieces of data automatically with the appropriate Golden Record. Some can even augment incomplete data sets. In other words, companies can have all their records merged into a single, current, accurate and complete master record, which is then stored in the central database, instead of housing multiple, inconsistent records related to a single individual or organization in multiple disparate databases.
Top three best and leading practices for global data management
When working with clients who have global presence, LexisNexis experts find that getting alignment across the organization is paramount to success. In terms of data management, there are certain best and leading practices that companies are advised to follow for optimal results. Best practices are commercial or professional procedures that are accepted or prescribed as being correct or most effective, while leading practices are emerging best practices that gain acceptance from proven methods in a commercial or professional setting. Application of best and leading practices is based on circumstances and strategic objectives and should be looked at on a situational basis. The following are top three best and leading practices for global data management.
1) Transactional standardization, remediation and validation
Companies should remediate TOVs before submission to enterprise transparency reporting system. The leading practice is to remediate and validate TOVs before submission to enterprise transparency reporting system; it is also recommended to categorize TOVs by each remediation issue (1:m). In addition, this best practice involves standardizing and remediating “as you go,” and the leading practice employs standardization engine and taking advantage of the economies of scale.
2) Recipient validation
Covered recipients must be matched to an authoritative source. The leading practice recommends using “search-to-create” capabilities in source systems and linking profiles in the reporting system.
3) Regionally aware
This best practice centers around a transparency reporting system having proper flexibility to provide user access, visibility and accountability based on a variety of parameters unique to each Life Science company and across its various geographies.
Wrapping it up
While the U.S. and international transparency requirements of reporting TOV data make sense, meeting the requirements in an efficient and effective way involves multiple steps and processes, including transaction submissions, record creation, data tracking, validation, standardization, categorization, editing and remediation. Following best and leading practices and leveraging the latest TOV expense management and compliance solutions out there is essential for organizations to achieve simplicity and reliability in their operations.
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