Strong clinical, coding, and reimbursement strategies are the backbone of a competitive market access plan, and alignment across these domains is essential to commercial success. This integrated approach is not just theoretical, it plays out in practical, real-world engagements that shape how products are positioned, paid for, and adopted in clinical practice. In this Insight, we discuss how Avalere Health’s Clinical, Coding, and Reimbursement team provides manufacturers with comprehensive support, using a real-world example to demonstrate how early, coordinated strategy can transform market access risk into a clear pathway to appropriate coverage, accurate tracking, and adequate reimbursement at launch. 

How Our Team Works Together: A Real-World Example 

A manufacturer preparing to launch an innovative diagnostic for early cancer detection approached Avalere Health 18 months before the anticipated FDA approval, recognizing that the market access strategy needed to begin well before launch. 

Our clinical team immediately assessed the evidence landscape, identifying gaps in the clinical data that payers would likely require for coverage decisions. The team recommended additional real-world evidence studies to demonstrate clinical utility and cost-effectiveness, and assisted the client in designing these studies with payer evidence requirements in mind.  

Simultaneously, our coding and reimbursement (C&R) specialists evaluated existing Current Procedural Terminology (CPT) codes and determined that while the test could technically be billed under an existing unlisted code, pursuing a Category I CPT code would strengthen the commercial viability and market access success: A CPT code specific to the service boosts provider confidence in appropriate and timely reimbursement, thus improving its utilization and patient access. The C&R team developed a comprehensive CPT application strategy, including clinical vignettes, engagement strategies with key opinion leaders and advocacy in the space, and worked in partnership with the clinical team to identify applicable peer-reviewed literature. The client was guided through the CPT code application process, including development of necessary collateral and preparation for the CPT Editorial Panel Meeting. A well-thought-out plan of action resulted in securing a unique Category I code that clearly defined the service and its value. The team then worked to understand how this new code would be valued under the Medicare Physician Fee Schedule, modeling various payment scenarios, analyzing gap-fill methodologies, and developing strategies for engaging with CMS during the pricing process.  

At the completion of the project, the client had:  

• A unique CPT code approved and published 

• A strong clinical evidence package aligned with payer expectations 

• Favorable Medicare payment rates  

• Coverage policies from several major payers already in development  

• Provider billing guidance and training materials ready for launch 

By integrating clinical, coding, and reimbursement strategic planning, we transformed what could have been years of post-launch market access challenges into a successful commercial launch with clear pathways to payment from day one. 

Our Team of Experts are Ready to Help You 

Our multidisciplinary team, comprising pharmacists, nurses, physicians, and certified medical coders—brings decades of combined experience. This breadth of perspective reflects firsthand experience working within the healthcare system and enables a comprehensive understanding of how clinical, coding, and reimbursement decisions are made in practice. Whether supporting an emerging company preparing for its first product launch or an established manufacturer advancing a next-generation innovation, the team offers the expertise needed to navigate the complexities of market access. 

Questions Life Sciences and Device Companies Should Ask During Launch Planning 

As manufacturers prepare to launch new products, they should be asking themselves several questions, the answers to which will shape XYZ. Avalere Health works with market access teams to investigate and answer the following: 

• What clinical evidence dowe need to support payer coverage decisions? 
• How is our product classified in primary clinical and pricing compendia? What are the implications of the current classificationon coverage? 
• Should we pursue a new CPT code or use existing codes?
• Does an ICD-10-CM code exist that accurately describesour indication? 
• How will Medicare pay for our product under different care settings?
• What is the timeline for securing coverage from major payers?
• How do we develop provider billing guidance and prevent coding errors?
• What is our strategy if CMS proposes unfavorable payment rates?
• How do we position our product against competitive alternatives in the coding and payment landscape?

Insights from Our Experts 

“Dedicated codes mean earlier diagnosis, better access to treatments, and stronger data-driven support that aligns with the goals of all healthcare stakeholders in raising awareness, tracking health outcomes, ensuring access to appropriate care, and monitoring the overall state of public health. Appropriate codes ensure that every patient’s voice is accounted for and every patient receives the most appropriate care they need.” 

— Mariia Salova, MD, MS 

“A solid coding and reimbursement strategy is not enough anymore to be successful in the market. A truly successful launch starts with understanding how customers use the code set and designing a strategy that makes using a new product seamless. Avalere has optimized dozens of coding strategies to make them more dynamic and find an edge in the market that our clients did not even know was there.” 

— Becky Davidson, MBA 

“The most successful market access strategies start early, ideally in the development phase. By understanding payer requirements before your clinical trials are finalized, you can design evidence generation strategies that directly support coverage decisions. This proactive approach can save years of post-launch market access challenges.” 

— Casey Hopkins, PharmD, CPB 

“Medical coding is not just about billing, it is about how your product is defined in the healthcare system. The right coding strategy can differentiate your product, clarify its value proposition, and open doors to appropriate reimbursement. We have seen products succeed or struggle based entirely on their coding approach.” 

— Tiana Easterling, CPC 

“Understanding how payment rates are established and adjusted over time is crucial for long-term commercial success. Whether you are navigating Medicare’s complex payment methodologies or engaging with commercial payers, having experts who understand the technical details and policy nuances makes all the difference.” 

— Pamela Gortman, CCS, CPC, CDEO, CPMA, CRC, CVBA 

“Understanding the clinical course of disease, how care is delivered and managed in practice is essential to developing effective strategies for clients. This understanding underpins clinical analysis needed to support protocol development, qualitative research, health care transactions, and advocacy work, ensuring strategies are grounded in real-world clinical decision making.” 

— Emily Young, RN, MPH 

Let’s Connect 

To read more about what topics are on the minds of our subject matter experts in Advisory, please browse our Insights. 

To learn more about our team, please check out our bios here. 

Whether you are preparing for a product launch, navigating post-market access challenges, or planning your long-term reimbursement strategy, our Clinical, Coding, and Reimbursement team is ready to help you succeed. Contact us today to discuss how we can support your market access goals.