Global Pharma Company: Streamlining the Sunshine Act Reporting Process

Background

A small but growing global pharmaceutical company faced challenges with its Sunshine Act compliance, primarily due to its reliance on manual processes. These manual methods resulted in reporting delays and increased compliance risks. Additionally, the company used multiple disconnected systems to track healthcare professional (HCP) spend and engagement management, leading to inefficiencies.

Challenge

The primary challenge was to streamline the Sunshine Act reporting process to minimize delays and reduce compliance risks. The existing system’s fragmentation necessitated a solution that could integrate various data sources and automate processes to ensure accurate and timely reports.

Solutions

The company adopted PwC’s Interactions Hub (iHub) and Transparency Spend Transparency Hub (tHub) integrated SaaS solutions. The implementation involved:

• Engagement Manager Integration: Centralization of Healthcare Provider/Organization HCP/O interaction approval and tracking, including automated Fair Market Value (FMV) calculations, real-time contract approval, and integration with Oracle ERP. The system also automated duplicate payment detection and real-time threshold monitoring for various spending limits.
• Data Transformation and Validation: Automation of data standardization, mapping, and validation processes to enhance compliance and reduce manual data entry.
• Transparency Spend Platform: PwC provided automated data aggregation, spend classification, configurable reporting, and audit trail functionality as the Managed Service Provider.
• Stakeholder Engagement: Bi-weekly workshops and regular updates with stakeholders ensured thorough needs assessment and risk evaluation.

Anticipated Results

The transformation is expected to lead to substantial improvements:

• Operational Efficiency: Expected to achieve a 60% reduction in manual data entry and an 85% decrease in data reconciliation efforts.
• Compliance Improvements: Error rate decrease from 12% to less than 1%, with a 100% on-time submission rate and clean external audits for two consecutive years.
• Return on Investment (ROI): The company eliminated penalties for late/incorrect reporting and ensured regulatory compliance, leading to substantial cost savings. Additionally, the solution provided automatic updates for new regulatory requirements.