Your organization’s success relies on understanding evolving market dynamics and navigating a complex statutory and regulatory environment. Drug, device, and diagnostic firms, from established to start-up, come to Á¿×Ó×ÊÔ´Íø when they want experienced partners who can help with regulatory strategy, coding, coverage, and payment solutions, investment strategy, navigating the complexities of federal and state law, or even creating new policy. Á¿×Ó×ÊÔ´Íø, working with our partner companies, provides consulting with depth and breadth throughout the life sciences sector and the broader healthcare industry.
We work with drug, device, and diagnostic companies and their trade associations, pharmacies, physician specialty societies, hospitals, health systems, and community health centers, as well as investment firms and their portfolio companies.
Before joining Á¿×Ó×ÊÔ´Íø, our team spent years as senior officials in Medicare and Medicaid; cabinet-level health secretaries; and policy advisors to governors and other elected officials. They also served as directors of large nonprofit and social services organizations, top-level advisors, and C-level executives. Our team is expert in federal and state policy, reimbursement, actuarial consulting, medical coding support, public affairs, and corporate development.
Our Life Sciences team, comprised of experts across our firm, can help with:
We help you navigate the complexities of FDA regulation to help with product development and marketing authorization strategies and regulation throughout the product lifecycle.
Regulatory policy counseling
Product development and target product profile
FDA authorization strategy
Post-approval compliance
Contact our FDA Experts:
We help your organization understand the commercial market for life sciences products and develop strategies to support patient access, product launches and growth, and value.
Market intelligence, including market, customer, and stakeholder analysis
Strategic planning, considering risk-based contracting, value-based care, and population health
Business development and strategy
Formulary and market access insights
Go-to-market and launch strategies
Contact our Commercial Experts:
David Kulick, Managing Director, Á¿×Ó×ÊÔ´Íø
Alex Rich, Managing Director, Á¿×Ó×ÊÔ´Íø
Experts in Medicare, Medicaid, and the commercial market, we help you understand and navigate the complexities of coding, coverage, and payment for approved products and develop and execute strategies to support product access and value.
Code assessment and recommendation
Coverage mapping and guidance
Payment strategy across settings
CMS engagement
Emerging technology strategies
Alternative payment model (APM) development
Payment change impact modeling
Contact our Reimbursement Experts:
Amy Bassano, Managing Director, Medicare, Á¿×Ó×ÊÔ´Íø
Zach Gaumer, Principal, Á¿×Ó×ÊÔ´Íø
Clare Mamerow, Principal, Á¿×Ó×ÊÔ´Íø
We help you understand how evolving Federal policy impacts your business and develop strategies for creating and advancing Federal policy that advances value and your business.
Congressional and Administration intelligence and strategy
Policy development and strategy
Multi-sector alliances to create and advance new policy
Policy modeling and CBO scoring projections
Contact our Federal Experts:
Amy Bassano, Managing Director, Medicare, Á¿×Ó×ÊÔ´Íø
Zach Gaumer, Principal, Á¿×Ó×ÊÔ´Íø
Clare Mamerow, Principal, Á¿×Ó×ÊÔ´Íø
We help you understand how evolving State policy impacts your business and develop strategies to support product access and value in Medicaid programs.
State-related access issues
State policy impact modeling
State research support
Contact our State Experts:
Stephen Palmer, Managing Principal, Á¿×Ó×ÊÔ´Íø
Matt Powers, Managing Director, Á¿×Ó×ÊÔ´Íø
We work with investment firms and their portfolio companies to provide insight that helps you invest wisely in the rapidly evolving healthcare marketplace.
Comprehensive due diligence studies
In-depth research projects
Billing and compliance reviews
Identification, analysis, and outlook on federal, state, and local reimbursement/regulatory issues
Contact our Investment Strategy Experts:
David Kulick, Managing Director, Á¿×Ó×ÊÔ´Íø
Alex Rich, Managing Director, Á¿×Ó×ÊÔ´Íø
Project Spotlight
Pipeline research and policy recommendations to address new innovative therapies
A large national pharmaceutical manufacturer hired Á¿×Ó×ÊÔ´Íø, The Moran Company, and Leavitt Partners, both Á¿×Ó×ÊÔ´Íø subsidiaries, to assess the current pipeline of innovative therapies, examine current reimbursement policies to assess long-term compatibility with the adoption of innovative therapies and novel delivery mechanisms, and make policy recommendations to address any challenges identified through the process.