Compliance isn't a one-time solution.
A compliant operation goes beyond establishing good policies and procedures. It is a constant analysis of statutory and regulatory activities, both proposed and enacted, at the Federal and State levels, coupled with your contracting strategies. That's why we preach the need for in-house, knowledgeable resources that own compliance, whether your systems and processes are insourced or outsourced. We can help you get there through our decades of experience, deep understanding of the programs at all levels, and knowledge of how to establish a highly effective and functional organization.
Interpretations of statutes and regulations for Government Pricing calculations are a must. Our policy templates provide a proven baseline that adapt to your specific situation, with every policy position cited back to the relevant statutory and regulatory language, accelerating development so you can focus on your operation.
State Transparency Services: Monitoring, Price Impact Modeling, Reporting
The patchwork of State price transparency regulations is constantly changing. Our team is plugged into these changes and can monitor them for your organization. When new requirements emerge or you are ready for a pricing action, we will identify the States and programs that require reporting. And if needed, our team will submit the information on your behalf.
Government Pricing Methodology Assessment
Every product and contracting strategy has unique characteristics. Our team has seen them all. Whether you have branded oral solids, specialty drugs, generics, or radiopharmaceuticals; off-invoice discounts, back-end rebates, price protection, service fees, bundles, or value-based arrangements; our team will help you assess your methodology for statutory and regulatory compliance.
Pricing & Compliance Assessments & Restatements
Assessing compliance requires a thorough and detailed approach. Our team has helped numerous manufacturers review their calculations at the transaction level to identify issues. And when restatements are necessary, we help you gather the materials and submit the information to the relevant agencies.
Regulatory Research & Impact Analysis
Considering a new contracting strategy? Acquiring a new product? Our team has the knowledge and knows where to look to identify the statutory and regulatory requirements for your new approach. And with our unparalleled operational experience, we will identify the impacts to your organization and assist you on the changes necessary to move forward.
Calculation Management & Execution Services
If executing and submitting calculations do not align with your operational strategy, let our team work behind the scenes on your behalf as your operation. We will gather and reconcile your data, perform the necessary calculations, work with you to address anomalies and exceptions, and prepare the materials for submission.
Regulatory Process Development & Change Management
For emerging pharma, standing up a regulatory pricing operation and enrolling in the various programs can be daunting. Lean on our experience and know how. We can guide you through the process, or execute it on your behalf, and prepare your organization to be successful at launch and beyond.