Top 5 Transparency Reporting Recommendations for the Newly Commercializing Life Sciences Company
Over the last 14+ years, Alanda Software has worked with countless Life Sciences Companies who, at the start of the relationship, were just entering the world of Transparency Reporting. Working with clients who have recently commercialized tends to be very different to those who have been under Transparency obligations for a long period and are transitioning from rigid or unduly expensive platforms or have outgrown a more manual approach. These new companies do not have the breadth of knowledge and experience that comes from years of Transparency data collection and cleansing as well as report preparation and submission. It comes down to the well-known phrase “you don’t know what you don’t know”.
What we have found helpful during the implementation phase is providing our clients with a high-level list of transparency-related recommendations which will benefit them later down the line for reporting. Centered around best practices within the industry, we have compiled a list of 5 reporting recommendations for newly commercializing Life Sciences manufacturing companies.
Ascertaining Your Jurisdictions
Ascertaining your jurisdictions directly relates to the many transparency reporting regions and their requirements. Where a Life Sciences manufacturing company does business determines what report(s) they will need to prepare and submit. Pharmaceutical Sales rep territories may consist of multiple states and countries where transparency reporting is required. The who and the where are very important to identify early on to ensure the required data points are collected. For example, the state of Oregon requires Sales Rep interactions with HCPs to be reported, which includes the type and length of the interaction. Knowing this information is needed ahead of time is beneficial to the Sales Rep who could document it at the time of interaction instead of trying to recall many months later when the data is to be reported.
The same can be said with regard to many other Transparency Disclosure reports, each unique in their own way with different information requirements. Many companies use internal/external systems to manage Sales Rep interactions with HCPs and HCOs. These systems will also need to be configured/designed to collect the required data points. It would be advantageous to implement this during initial training instead of later down the line, which could lead to missing information within the data.
Data Source Discovery
Life Sciences manufacturing companies are obligated to report multiple data types for transparency. It is common for different data types to come from different sources. These can consist of Internal Financial and Expense Systems, Third Party Vendors, and more. Some examples of common spend types are Consulting, Grants, Speaker Programs, Educational Items, Research studies, Sponsorships, etc. It is important to identify what kind of HCP and HCO interactions are taking place within those categories and where the transfers of value are being recorded. This process usually involves multiple areas of the business to help identify the respective business owners, vendors, systems, etc. Performing this data discovery as early as possible will streamline the collection process for transparency reporting. This process is unfortunately not a one-time ordeal. It will continue as the business grows with more products and outreach resulting in more interactions. A company may not be participating in any grants or sponsorships in the beginning, but that may change, and it is essential to identify when that happens to ensure the data collection is completed.
Decision Maker Identification
Throughout the reporting process there are many decisions to be made. From the collection of data all the way to the submission of the Transparency report itself there are many questions to answer:
How do we want to collect the data? What format and cadence? What standard procedures should we have in place for our Sales Representatives in capturing information? How do we want to handle incomplete information? Who is responsible for interpreting what is in scope for each report? What is our definition of HCP? What do we want our baseline Spend Type list to be? Who is going to attest to the data?
Having a plan for who will be answering the simple as well as the hard-hitting questions will help streamline the process immensely. We have seen time and time again a project gets delayed due to the absence of a decision maker. It may amount to more than one person depending on the topic but knowing who to go to with each question and choice provides everyone involved with confidence.
Regularly Required Data Points
Even though there are many different data points that are collected across the Federal, State and International Transparency reports, there are a set of standard pieces of information that one would want to ensure are collected from all spend sources. There are high-level expense elements as well as detail-level recipient information that will be essential for transparency disclosures. This information is typically known by the parties involved but may not always get recorded. Recipient information can be difficult to gather at a later date once the interaction, event, etc. is over. Knowing and collecting these data points will ensure reports are set up for success. Take the easy path towards data completeness.
Expense-Related Data Points:
- Transfer of Value Date
- Amount of Transfer of Value
- Related Product (Drug, Device, etc.)
- Type of Spend (Grant, Consulting, etc.)
- Expense Location
Recipient-Related Data Points:
- HCP or HCO Name
- HCP Specialties and Credentials
- HCP or HCO Address/Contact Info
- HCP or HCO Regional/Global Identifiers (TIN, NPI, etc.)
HCP/HCO Master Data Source
A master data source for HCPs and HCOs is a centralized repository that houses information about these respective entities. Its purpose is to ensure that accurate and consistent profiles for HCPs and HCOs are available and accessible across various business systems. When spend data is captured by these systems as well as other data sources, it is important that the correct HCO or HCP involved is identified. When this data is reported for transparency purposes, that Doctor, Nurse, Hospital, is now tied to that published information. Life Sciences manufacturing companies are held to a high standard of reporting accurate data. To ensure that the correct person or organization is reported, having a trusted Master Data source to supply these profiles is highly beneficial.
A self-managed set of profiles comes with a few obvious flaws; manual error, possible duplicates, and missing information. A Master Data Source takes on the important task of gathering, maintaining, and providing accurate profiles to give Life Sciences manufacturing companies the confidence they need when reporting. A great example is with US state reporting – an HCP may have provided consulting services in New York where they practice yet their profile shows they also have a medical license in Massachusetts and Connecticut. Without that full profile, the company interacting with the HCP may not realize the reporting obligations they have in those two states and only review the NY transparency requirements.