Understanding U.S. Market Access: A Foundation for Patient-Centric Success 

U.S. Market Access is the pathway by which innovative healthcare solutions reach patients, ensuring they receive and benefit from these interventions while navigating health insurance (payer) systems, regulatory requirements, and economic considerations. Market access involves a comprehensive approach to address reimbursement, evidence generation, stakeholder engagement, and payer strategies, all aimed at delivering equitable and affordable access to medical innovations. 

Breaking Down U.S. Market Access 

For those new to the concept, U.S. market access can be understood through four key components: 

1. Reimbursement – Reimbursement covers payer medical policy coverage decisions, appropriate coding, and ensuring fair payment rates. It also encompasses billing processes and programs that support patient access to care. 

2. Clinical/Health Economics/Patient & Provider Impact – Demonstrating the value of a medical innovation requires robust data, including clinical effectiveness, cost-efficiency, and its potential impact on patient and provider experience. 

3. Stakeholder-Specific Value – Different stakeholders, including payers, providers, patients, and policymakers have unique priorities. A successful strategy addresses these specific needs to support adoption and use. 

4. Managed Care Payer Strategies – Medicare, Medicaid, Commercial Insurance, companies as well as self-insured employers and health systems play a central role in patient access. Establishing a cohesive payer access plan is critical to success.  

Together, these components emphasize the need for a coordinated and evidence-based approach to navigate complex healthcare payers like Medicare, Medicaid, and private insurance. 

An Example of Market Access in Action: Prostate Cancer Diagnostic Test 

A recent example of effective market access involved a prostate cancer AI molecular diagnostic test facing challenges with proposed Medicare reimbursement. The Centers for Medicare & Medicaid Services (CMS) initially proposed a reimbursement rate of $760 per test, which did not align with the test’s complexity, resource utilization and costs. 

Dream Big Health market access consulting played a key role in supporting the test’s pricing strategy. Despite an initial rejection of our crosswalk pricing recommendation, we worked closely with the client to develop a structured approach to rebut Medicare’s proposed pricing.  

• Drafting and submitting a letter to CMS detailing critical technological, process and resource requirement differences versus our recommendation and that of CMS.  

• Engaging directly with CMS through formal review and public comment reconsideration processes. 

As a result, CMS reversed its decision, approving a reimbursement rate of $3,800 per test—a fivefold increase. This case study illustrates the need for proactive planning and specialized market access expertise.