Delivering Compliance in the Cloud TM

Transcription

1 Delivering Compliance in the Cloud TM Manage HCP Related Travel and Entertainment s Ensure Regulatory Compliance Manage HCP Relationships

2 BACKGROUND Legislators in both Europe and the US have been very active over the last few years formalizing both the nature of the business relationship between Life Sciences companies and Health Care Providers (HCPs) and the role that government plays in managing those relationships. A movement is underway in both the US and Europe towards greater regulation of Life Science company business practices. In the US, the Patient Protection and Affordable Care Act of 2010, specifically disclosure provisions of the Physician Payment Sunshine Act, have imposed on Life Sciences companies significant and complex tracking and reporting requirements for all HCP related payments and benefits in kind. This legislation, affecting all Life Sciences companies doing business in the US, requires these companies to report, by March , details of their financial relationships with HCPs. These reports will be made public in September In France, the so-called French Sunshine Act, Loi Bertrand, due to take effect in 2013, goes even further in its reporting requirements for Health Product Companies. The act requires publication, on company websites, of all agreements with individual HCPs, together with details of payments or transfers of value. Discussions have started in other parts of Europe, influenced in part by the European Federation of Pharmaceutical Industries and Associations code of practice on HCP payments that is due to come into effect in These discussions combine representatives of the Life Sciences Industry, HCP professional bodies and government, focusing on the need for setting stricter controls over the relationships between Life Sciences companies and HCPs, and how to better track and report on Life Science company interactions with HCOs and HCPs. A good example of these initiatives is the UK Ethical Standards in Health and Life Sciences Group (ESHLSG), which is due to publish its recommendations at the end of Approaches to regulation (whether though legislation or industry codes of conduct) and the details of their practical implementation may vary, but it is clear that a movement is underway in both the US and Europe towards greater regulation of Life Science company business practices. Whether the protection of patient interests or the management of government-funded healthcare is perceived as the main driver for these initiatives, the result is the same: there will be stricter controls of business practices and more stringent tracking and reporting obligations. DELIVERING COMPLIANCE IN THE CLOUD 01

3 BUSINESS CHALLENGE The Sunshine Act and similar regulatory developments outside the US have significantly increased the complexity and administrative burden of compliance for Life Sciences companies. For those companies operating in an international marketplace, ensuring compliance has never been more difficult or expensive. Ensuring compliance has never been more difficult or expensive, particularly for those companies operating in an international marketplace. A 2013 survey* of legal, compliance and finance executives in a wide range of Life Sciences companies The The MediSpend and MobileXpense suite is a scalable, cloud-based, on-demand solution. There is no need to purchase and maintain expensive infrastructure and software. MEETING THE CHALLENGE In this new regulatory environment, Life Science compliance and finance professionals are faced with the following operational challenges: 1. Understanding and keeping up to date with compliance requirements across all of their operating countries 2. Ensuring business and compliance processes and systems are robust enough to meet upcoming/future regulations 3. Reducing the increasing cost of compliance found that more than 85% of Life Sciences executives expect the regulatory burden on their companies to increase significantly during the next few years, and over 70% expected a significant increase in the cost of remaining compliant. Over 90% of survey respondents found it challenging to keep up-to-date with changes in compliance regulations across multiple jurisdictions. In addition, less than 55% were confident in the ability of their current processes and systems to monitor HCP interactions, and the necessary accuracy, completeness and timeliness of regulatory reporting. * Life Sciences survey commissioned by MobileXpense covering both US and European Pharmaceutical and Medical Device companies. To address these challenges, processes and systems need to be in place to accurately and easily: CAPTURE all HCP related spend CONTROL accuracy of HCP spend records and ensure that spend falls within the limits set for the appropriate jurisdiction CONSOLIDATE payables records to ensure both compliance with aggregate spend limits and accurate regulatory reporting REPORT HCP spend to the appropriate regulatory authorities in the required format, while working with HCPs to resolve disputes over their individual aggregate spend records To meet this challenge, MobileXpense together with Medispend have developed the first end-to-end compliance solution. This SaaS cloud solution seamlessly integrates the best-in-class MobileXpense expense reporting system with the industry-leading Medispend aggregate spend reporting family of products. The result is a Life Sciences Spend Compliance Solution that is fully compliant with US state and federal laws as well as all current European legislation and industry codes of conduct. The solution has been designed to quickly and seamlessly migrate your processes and data from existing systems. 02 DELIVERING COMPLIANCE IN THE CLOUD DELIVERING COMPLIANCE IN THE CLOUD 03

4 REPORT CAPTURE CAPTURE CONSOLIDATE CONTROL Capture all HCP related expenses in the fullfeature MobileXpense expense management system. This system supports: Dynamic data entry workflow linked to expense category, which removes unnecessary data entry fields, while ensuring that all mandatory fields are properly completed. Comprehensive database of validated HCP data, such as physician number, available through search and select functions within the expense entry fields. Extensive data entry automation, including auto-complete suggestions based on previous user entries. input feeds from all major credit card providers. Tax compliant templates for over 50 countries. Both MobileXpense and MediSpend benefit from straight-forward ERP connectivity that allows all HCP data to be captured and processed without the need for major IT projects. Compliance with US and European Life Sciences spend regulations is built into the service. CONTROL The MobileXpense system has several control layers to support and automate the compliant processing of HCP expenses. Real-Time warnings if the HCP information entered does not match with data contained in the validated MediSpend database or other HCP databases (this feature also allows you to auto-build your own CRM database for HCPs). Real-time exceptions warnings for expenses that appear not to meet regulatory standards (both missing mandatory information and amount thresholds). Automated compliance approval workflow, based on exception warning flags. CONSOLIDATE In addition to capturing all HCP related expense data, the MediSpend Spend Tracking system captures all HCP spend records, such as invoices, generated outside of MobileXpense. This SaaS system delivers: Easy data interfacing and real-time data integration. Real-time warnings when aggregate spend for an individual HCP exceeds regulatory limits. A Resolution Center dashboard to manage and resolve non-compliant aggregate expenses. REPORT MediSpend s One-Click reporting tools fully automate the production and validation of regulatory reports. MediSpend Notification Center, which allows you to liaise with HCPs to verify the accuracy of their aggregate spend record. validation based on rules-based engine, which automatically flags items that require attention before report submission. Accurate jurisdiction based reports. On-demand custom reports, to support business analysis. MobileXpense SaaS Customer Systems MediSpend SaaS IN SUMMARY Understanding and keeping current with compliance requirements across all operating countries: Compliance with US and European Life Sciences spend regulations is built into the service. As a customer, you will be notified in writing of all upcoming regulatory changes and informed about how we plan to address those changes with modifications or enhancements to our systems. Ensuring business and compliance processes and systems are robust enough to meet upcoming/future regulation: With the service, compliance is built into our solution with business rule driven exceptions flags and SOLUTION ARCHITECTURE Complete Validate & Flag Exceptions Review/Correct Settle s End API Feed of HCP s Spend approval workflows. Our system configuration is continually updated and enhanced based on industry feedback and legal counsel provided by the Regulatory Law Group, PLLC. Reducing the increasing cost of compliance: The MediSpend and MobileXpense suite is a cloud-based, on-demand solution. There is no need to purchase and maintain expensive infrastructure and software. The solution s high level of data-entry automation, as well as the automation of compliance checks, approval workflows and regulatory report generation avoids costly re-work and significantly reduces the costs associated with processing and reporting on HCP related spend. Employee s Compliance Mgmt. HCP Pre-approved Upload Receipts Archive Receipts Submit No pre-approval Check Non-Compliant HCP Related Consolidate HCP Correct/Enhance HCP Spend Store Speed HCP Related Generate Regulatory ing Prepare/Review HCP Resolution Center MediSpend Notification Center End Consolidate HCP Physicians Professional Network Review/Correct 04 DELIVERING COMPLIANCE IN THE CLOUD DELIVERING COMPLIANCE IN THE CLOUD 05

5 SOLUTION OVERVIEW Dynamic data entry workflow linked to expense category Extensive data entry automation Link validated HCP data to expenses Easy Entry Spend Tracking HCP & HCO Validation Enterprise System Integration Easy user workflows Notification & dispute resolution center One-Click ing Jurisdiction-based reporting One-click report validation On-demand custom reports HCP & HCO validation Reference database includes 5 million US HCPs Auto build customer master Fully compliant with US Sunshine Act and European Regulations Fully tax compliant Automated rule-based approval workflow Straight-forward ERP connectivity easily exportable to external databases Fully integrated with MediSpend solutions Real-Time Exception Warnings Seamless Integration Manage Physician Relationships Proactive HCP notification Track physician inquiries HCP verified data CONTACT US AND ASIA PACIFIC Call: + 1 (888) Ext.8200 Visit: info@medispend.com Follow: twitter.com/medispend EUROPE, MIDDLE EAST AND AFRICA Call: + 32 (0) Visit: info@mobilexpense.com Delivering Compliance in the Cloud TM MediSpend is a comprehensive cloudbased aggregate spend tracking and reporting compliance solution designed specifically for Life Science companies and pre-configured to fit your specific needs. Seamless System Integration HCP & HCO Validation One-Click ing MobileXpense is a recognized global leader in Travel and Management solutions, supporting customers in over 60 countries and 20 languages worldwide. Seamless Integration with MediSpend Easy Entry and HCP Selection Real Time Exception Warnings