OBJECTIVES:  Market access for innovative new technologies can be complex and time consuming. As cost-containment pressures intensify, evidentiary hurdles to justify new point-of-care (POC) tests continue to grow. Decentralized health care decision making also can be a significant hurdle. This study aimed to characterize the process and identify challenges for health technology assessment (HTA), pricing, reimbursement, and market access for a new POC test in the United States (US) and Canada. METHODS: We conducted desktop research of published literature, HTA reports, and third-party websites to identify the critical path and data most valuable to reimbursement decision making. We also conducted qualitative one-on-one interviews with payer decision makers in the US (15 payers) and Canada (1 payer advisor and 2 laboratory directors). RESULTS: Reimbursement is critical to rapid adoption of new technologies. There are multiple appropriate access pathways for various theatres of care (e.g., outpatient office/clinic, inpatient, emergency), all with varying requirements and value drivers. Payment for new diagnostic tests typically is handled regionally or locally; treating physicians and medical societies can influence these budget decisions. Test reimbursement processes may differ for inpatient versus outpatient use. Currently, the evidence hurdle for a POC test is not as high as for prescription medicines. CONCLUSIONS: Market access for a POC test is variable; adequate data to meet decision makers’ needs is not well understood. No roadmap exists for navigation of the critical path for POC tests, and evidence requirements in the US and Canada are not well established. Access for a POC test will be complex; regardless of pathway, decisions regarding reimbursement and adoption of new technology are diverse and dispersed across and within countries with varying levels of required evidence.