Rightsizing Your Digital Health Technology’s Evidence Generation Strategy to Meet the Needs of Key US Stakeholders

Jul 29, 2025

Digital health technologies continue to proliferate in the US, but unique reimbursement and market access challenges remain. The traditional medical device buy-and-bill purchasing model buoyed by payer reimbursement via standardized codes, fee schedules, and claims submission processes is not designed to account for the unique aspects of many digital technologies. The US reimbursement system, including coding, coverage, and payment methodologies, has been slow to adapt to the emergence of digital health technologies, many of which enable expanded delivery of healthcare into new settings away from medical facilities. For example, devices used in the home such as walkers, orthotics, and CPAP machines have historically been reimbursed as durable medical equipment (DME). Many digital health technologies are also used in the home, but the U.S Centers for Medicare and Medicaid Services (CMS) has a strict definition of DME that many emerging digital technologies do not meet, leaving them without an available pathway to Medicare reimbursement.

Because these barriers exist, innovators have pivoted to other business models outside of the traditional reimbursement system while coding and payment systems continue to evolve to appropriately describe and value digital technologies. Direct-to-consumer, software-as-a-service, employer wellness programs, payer programs, and others have been pursued as alternative options with varying levels of success. Often companies deploy multiple models simultaneously or sequentially over time.

One premise of traditional medical device market access remains true for digital health technologies– evidence matters. However, evidence needs likely will differ depending on the business model. Published, peer-reviewed randomized controlled trials (RCTs) continue to be the gold standard for clinical evidence, but are not needed for all digital technologies or all stakeholders.

Alternative evidence development methods such as systematic literature reviews, prospective observational studies (e.g., registries), retrospective observational studies (e.g., chart review, claims analysis), workflow / time-and-motion analyses, and economic models can address the evidence needs of some stakeholders, and may not always require peer-reviewed publication to be considered.

Digital health technologies continue to proliferate in the US, but unique reimbursement and market access challenges remain. The traditional medical device buy-and-bill purchasing model buoyed by payer reimbursement via standardized codes, fee schedules, and claims submission processes is not designed to account for the unique aspects of many digital technologies. The US reimbursement system, including coding, coverage, and payment methodologies, has been slow to adapt to the emergence of digital health technologies, many of which enable expanded delivery of healthcare into new settings away from medical facilities. For example, devices used in the home such as walkers, orthotics, and CPAP machines have historically been reimbursed as durable medical equipment (DME). Many digital health technologies are also used in the home, but the U.S Centers for Medicare and Medicaid Services (CMS) has a strict definition of DME that many emerging digital technologies do not meet, leaving them without an available pathway to Medicare reimbursement. Because these barriers exist, innovators have pivoted to other business models outside of the traditional reimbursement system while coding and payment systems continue to evolve to appropriately describe and value digital technologies. Direct-to-consumer, software-as-a-service, employer wellness programs, payer programs, and others have been pursued as alternative options with varying levels of success. Often companies deploy multiple models simultaneously or sequentially over time. One premise of traditional medical device market access remains true for digital health technologies– evidence matters. However, evidence needs likely will differ depending on the business model. Published, peer-reviewed randomized controlled trials (RCTs) continue to be the gold standard for clinical evidence, but are not needed for all digital technologies or all stakeholders. Alternative evidence development methods such as systematic literature reviews, prospective observational studies (e.g., registries), retrospective observational studies (e.g., chart review, claims analysis), workflow / time-and-motion analyses, and economic models can address the evidence needs of some stakeholders, and may not always require peer-reviewed publication to be considered. INSERT IMAGE (MATT: I WILL HAVE THIS SHORTLY) BeaconOne supported a client developing an innovative digital health technology in women’s health that decided to pivot from a direct-to-consumer model to payer reimbursement. The client recognized the need to generate additional clinical and health economic evidence to encourage payer coverage. We supported the client in this transition by preparing an evidence development and payer engagement strategy grounded in primary research with BeaconOne’s panel of active payer decision makers. The client has initiated the recommended evidence development strategy and also adapted its payer engagement strategy. BeaconOne Healthcare Partners’ expertise sits at the intersection of evidence, reimbursement, and market access and can support innovators in identifying optimal alternative business models for their digital technology, understanding who the key stakeholders are for adoption, and what evidence they will require. Knowing this early in the product development process can help innovators realistically plan and budget for evidence generation activities and maximize efficiency of data collection, analysis, and dissemination

BeaconOne supported a client developing an innovative digital health technology in women’s health that decided to pivot from a direct-to-consumer model to payer reimbursement. The client recognized the need to generate additional clinical and health economic evidence to encourage payer coverage. We supported the client in this transition by preparing an evidence development and payer engagement strategy grounded in primary research with BeaconOne’s panel of active payer decision makers. The client has initiated the recommended evidence development strategy and also adapted its payer engagement strategy.

BeaconOne Healthcare Partners’ expertise sits at the intersection of evidence, reimbursement, and market access and can support innovators in identifying optimal alternative business models for their digital technology, understanding who the key stakeholders are for adoption, and what evidence they will require. Knowing this early in the product development process can help innovators realistically plan and budget for evidence generation activities and maximize efficiency of data collection, analysis, and dissemination