Disclosure of Drug Promotion Expenses: The Importance of Master Data Management and Considerations for Choosing a Reporting Solution

Transcription

1 Disclosure of Drug Promotion Expenses: The Importance of Master Data Management and Considerations for Choosing a Reporting Solution April 2010

2 This document contains information specific to Cegedim Dendrite and/or its parent company Cegedim SA. This document is protected by copyright laws and the information contained herein shall not be reproduced or distributed in whole or in part, under any circumstances without the prior written permission of Cegedim Dendrite and/or Cegedim SA. Names of Cegedim Dendrite solutions, products, and services are either trademarks or registered trademarks of Cegedim Dendrite. Original Publication Date: April 2010 Revised On: N/A

3 CONTENTS 1. INTRODUCTION MASTER DATA MANAGEMENT AND THE FORMAL FRAMEWORK Governance Stewardship Processes Technology IMPORTANT TRENDS IN MDM FOR COMPLIANCE REPORTING Transparency Covered Recipients Accuracy Flexibility BENEFITS OF MDM IN COMPLIANCE REPORTING CONSIDERATIONS FOR CHOOSING A REPORTING SOLUTION Spend Data Capture Spend Data Integration Manage Spend Data Report Creation and Submission FINAL THOUGHTS...11 April 2010 Confidential and Proprietary Information of Cegedim Dendrite. Not for Duplication Page 3 of 11

4 1. INTRODUCTION Aggregate Spend and Disclosure compliance is a significant focus in the Life Sciences industry. With many laws enacted, including the new federal law, and many more pending, the industry is faced with the daunting tasks of staying updated on both enacted and amended laws, gathering the necessary data for reporting, and submitting reports based on the varying requirements for each regulation. The increase in legislation on promotional spend disclosure underscores the need for a reliable single view of the customer across the enterprise. More than a business driver, Master Data Management (MDM) has also become the foundation for managing regulatory compliance. However, having clean, integrated, consistent data is often overlooked. In a recent survey of the industry, Cegedim Dendrite found that only 37 percent of respondents indicated that their company enforces corporate standards for Healthcare Practitioners (HCP) and spend data capture which applies to all suppliers and staff. This paper focuses on the importance of MDM, specifically as it pertains to aggregate spend and disclosure compliance. We highlight how to establish a formal framework for MDM, discuss trends in MDM for compliance reporting, and offer considerations for choosing an aggregate spend system. April 2010 Confidential and Proprietary Information of Cegedim Dendrite. Not for Duplication Page 4 of 11

5 2. MASTER DATA MANAGEMENT AND THE FORMAL FRAMEWORK Master Data Management is the management of common data attributes representing entities such as customers, products, etc. which are used across the business lines. These common (and similar) attributes are those which are used to define the entity in every system or source across the organization. The goal is to achieve consistency of definition and establish an authoritative version of the entities, thereby promoting efficiency within a database and across the organization. It is more than a technology solution. It is an enterprise-wide commitment to a process for managing how data is maintained, updated, integrated, and shared. And it is an essential practice to implement whenever business processes across the enterprise are reviewed with a common goal or whenever there is a need to consistently handle entities Aggregate Spend and Disclosure reporting is one such activity that warrants the implementation of MDM. For example, spend data is usually captured from several disparate sources across the enterprise such as HR, CRM, T&E, Meeting Management, Speaker Bureau, and Vendor systems, many of which do not communicate with one another and have independent customer lists. Using Master Data Management allows multiple data sources to come together and contribute to an enterprise-wide best version of a customer record. MDM can be used to standardize, cleanse, and harmonize spend data to achieve a single unique identifier for each HCP, or customer, as is required for reporting and compliance. The disclosure of drug promotion expenses also requires reporting aggregating spend across the enterprise with the ability to: Report on all types of HCPs Factor in affiliations (relationships) for roll-ups Report using standard State License Number (SLN) and specific Covered Recipient (CR) identifiers Trace the lineage and maintain history for any rectification React to changes in coverage and definitions of HCPs However, in order to achieve these results, a formal framework must be embraced. The solution is a combination of people (governance and stewardship), process, and technology. April 2010 Confidential and Proprietary Information of Cegedim Dendrite. Not for Duplication Page 5 of 11

6 2.1 Governance In order to be successful, it is necessary to have executive sponsorship of MDM as an enterprise wide initiative. All departments must be willing to put forth the effort to adhere to standards for disclosure policies; and governance allows you to enforce the master data policy internally and to your vendors. 2.2 Stewardship Stewardship gives you control over who contributes the necessary information. For accurate and comprehensive data integration and management, you must identify who collects and verifies the data, what the minimum fields to be captured are for a Customer/Account, and the correct reporting identifier according to state and federal requirements. 2.3 Processes Automated and manual processes in the data lifecycle allow you to have one consistent view of your customers. This includes defining how exceptions are managed when Spend Customer records need manual review and scrubbing. 2.4 Technology Embrace technology as part of the MDM framework to ensure data integration, data quality, match/merge, single view, and proper unique identifier. Set process flow for how to manage affiliations or handle systems that lack the required minimum data fields. Third-party solutions can provide pre-built interfaces for jump starting the initiative. April 2010 Confidential and Proprietary Information of Cegedim Dendrite. Not for Duplication Page 6 of 11

7 3. IMPORTANT TRENDS IN MDM FOR COMPLIANCE REPORTING An initial meeting about MDM will probably uncover many questions: What are our data sources and how are we getting the information? Who are we paying and what do we need to report on? What are our needs for data preparation? How do we address change management? How do we integrate updates? Once the landscape is set, however, there are some other issues that need to be considered according to the trends in current and future gift laws. 3.1 Transparency It is essential that you are able to track proper payment history and verify that your data is accurate and complete. Some aggregate spend and disclosure reports are now posted online for the public to view. This access makes it easy to challenge data, and you need to be prepared to make all your information available for public scrutiny. 3.2 Covered Recipients With the expanding definition of a customer, the complexity of affiliations between Healthcare Professionals (HCPs), non-healthcare Professionals and Organizations, and a proliferation of merger and acquisition activities, an extra layer of data management is required. You need to be sure to track and maintain information on relationships and affiliations, and make sure that all recipients are in the Customer Master, whether they are reportable/non-reportable/hcp/non-hcps, so that you are ready to adapt to changing definitions in legislation. If you establish a rich definition of the Customer upfront, it will be easier to change relationships downstream. 3.3 Accuracy All reports have different requirements, and some regulations require you to use a particular customer identifier such as Massachusetts covered recipient ID or NPIs. In order to do this you must maintain a unique internal recipient identification that you can match to reference an industry standard. 3.4 Flexibility It is important to support multiple views of your data so you can manage and report in any situation that may arise within your company (co-promotion) or according to a new law that may be enacted. April 2010 Confidential and Proprietary Information of Cegedim Dendrite. Not for Duplication Page 7 of 11

8 4. BENEFITS OF MDM IN COMPLIANCE REPORTING The goal of Aggregate Spend is to have the ability to define a Recipient, integrate, track changes, resolve and update information, maintain affiliations with entities, and associate multiple industry identifiers and addresses across the lifetime of a record with a consistent process. A customer master data management solution ensures that a unique recipient identification process is in place through the integration and resolution of multiple versions of the recipient across the organization. Implementing an MDM for aggregate spend reporting will allow you to: Improve the completeness and accuracy of reporting Improve compliance and enhance understanding of your overall spend Improve reaction time to changing needs or updated legislation Leverage the investment in Data Governance across the organization Improve relationships with Recipients The foundation of MDM also allows you to minimize costs through a centrally managed repository of customer data, which in turn ensures that data procurement is streamlined. So the next time you want to integrate new sources of data, you can do it via the repository rather then establishing another silo. You eliminate redundant costs of scrubbing siloed data as opposed to a single unique best-of-breed record. April 2010 Confidential and Proprietary Information of Cegedim Dendrite. Not for Duplication Page 8 of 11

9 5. CONSIDERATIONS FOR CHOOSING A REPORTING SOLUTION Data integration is the first step in the aggregate spend reporting process. A customer master data management component creates a unique customer record from disparate data sources to facilitate identification and consistency. Once a centralized master data hub has been established, this data can be leveraged by an aggregate spend solution to create state and federal reports and ensure compliance. The main functions you need in a solution are the ability to capture data, integrate the data, manage the data, and report on the data per the various regulations. 5.1 Spend Data Capture Your solution should capture, cleanse, and augment spend data collected from all data sources such as CRM/SFA, ERP, T&E, Third Party, and Grants systems. The system, including vendors, should strive to use the Customer Master Reference Data for consistency and accuracy of data across the organization. To avoid issues in the future, identify and engage all spend sources early in the process. This helps define the data needs of all the groups involved and better prepares them for any changes that may arise in the future. And internal education on the entire process of data capture, integration, and reporting helps people realize that data standards are critical to maintain compliance. Since all vendors use different technology, the solution needs to provide flexibility to vendors to load data via system interfaces, Microsoft Excel file uploads, or data entry screens. Keep in mind, however, that if the vendor has direct access to an application, you need to manage vendor access to the system in a secure segregated manner. 5.2 Spend Data Integration When integrating spend data, it is essential to establish a unique identity for the HCPs or other customers across systems. This unique identifier provides validity to your data, and allows you to better maintain relationships and affiliations, as well as manage and resolve exceptions by matching against the customer master. Also make sure you have processes in place to monitor vendor spend data feeds to ensure that no information is lost. 5.3 Manage Spend Data Efficient spend management should not only allow you to view, edit, and monitor spend data, but also alert you to threshold violations that you can configure and manage as defined by the latest regulations or company specific rules. You need a solution with flexibility to handle state report format changes as well as data mapping and aggregation based on your company s business and legal interpretation of regulations. And a system with an audit trail will allow you to track data or rule changes by users so there is accountability to actions. 5.4 Report Creation and Submission The ultimate goal of an aggregate spend and disclosure solution is to be able to accurately and efficiently report your spend data per the mandated report formats. A spend reporting system should allow you to easily generate state reports, be prepared for federal reporting, and generate ad-hoc reports and analysis as desired. The system needs to be ready to adapt to the trend toward reporting against company policies, not just state and federal compliance, and configure spend types using your terminology. It is also important to maintain an archive of submitted reports and templates so that you have a history of your data. April 2010 Confidential and Proprietary Information of Cegedim Dendrite. Not for Duplication Page 9 of 11

10 Some additional considerations for choosing a solution for your aggregate spend and disclosure reporting: Look for the ability to manage all your spend data in a single system so you can analyze data in multiple views. Insist on ease of integration with your customer master, which will drive the validity of your reports. Implement the management of templates for state reports including interpretations for enacted legislation. Make sure the solution has the desired flexibility you need across each step, from capturing spend to reporting. This may include the ability to add expense vendors, add report templates, support compliance configurations within systems, create reports in the future, and perform ad-hoc analysis. Remember the system not only has to support your reporting needs now; it has to adapt to updates to legislation or changing corporate policies in the future. April 2010 Confidential and Proprietary Information of Cegedim Dendrite. Not for Duplication Page 10 of 11

11 6. FINAL THOUGHTS Aggregate Spend and state reporting is an increasingly complex issue for Life Science companies. As companies continue to struggle with identification of data sources, consistent standards for data sources, single and unique views of customers across data sources, and various other data anomalies as part of this process, it becomes increasingly important to have a more holistic and consistent approach to aggregate spend and state reporting. Customer Master Data Management is a vital, and often overlooked, aspect of the aggregate spend reporting process. However, effective cmdm will not only lead to better relationships with your customers, it will also improve your company s compliance and reaction time to new legislation in today s rapidly changing environment. Please contact Cegedim Dendrite today for more information: Cegedim Dendrite Americas Corporate Headquarters 1425 U.S. Highway 206 Bedminster, NJ USA Tel.: or April 2010 Confidential and Proprietary Information of Cegedim Dendrite. Not for Duplication Page 11 of 11