Coverage & Integration

Project conducted by: Randy

Client: A leading US clinical laboratory 

Objective: Provide a clinical laboratory/test developer evidence to support both reimbursement and broad primary care integration for a drug-drug interaction (adverse drug event) test. 

Randy led a 500+ physician market research study, a decentralized clinical trial, and a pilot study (with one of the largest US primary care systems) to produce physician decision-making and real-world outcomes data.

Other Deliverables:

• Evidence generation planning - AV (analytical validity), CV (clinical validity), and CU (clinical utility)

• Multiple high-impact publications 

Outcome: Client expanded their commercial and CMS coverage for the product, the primary care system adopted the test at all nationwide facilities, and client is in development of a next-generation product.