Milken Institute Flags Reimbursement Gaps As A Core Constraint On Women’s Health Startups

A new Milken Institute report is putting coverage and reimbursement alongside funding gaps and research shortfalls as a central obstacle for women’s health startups. Based on a February workshop convened by the Women’s Health Network, the report argues that innovators often make an avoidable mistake: building a product first and figuring out how it will be paid for later.

That sequencing matters because moving between payment pathways can be difficult once development is underway. According to Jenica Patterson, senior director of the Women’s Health Network, companies can lose a revenue-generating opportunity if they are not thinking about coverage and reimbursement earlier on. For women’s health in particular, the challenge is compounded by weaker evidence bases in many areas of care, which can leave payers unconvinced even when the clinical need is clear.

The reimbursement problem starts before launch

The report lays out four issues that companies should address before product development is far along: commercialization, clinician engagement, payer engagement and coding. The throughline is that reimbursement is not something to solve at launch; it shapes trial design, product positioning and the practical route to market.

On commercialization, the report says innovators need to decide upfront whether they are pursuing a self-pay model, commercial insurance coverage or public-program coverage. Switching later can be difficult, especially from self-pay to payer coverage, because it may require substantial product modifications to align with payer expectations and standards.

The trade-off is straightforward but consequential. Self-pay can offer faster market entry, pricing flexibility and direct consumer engagement, but it can also limit access because patients must pay out of pocket and it may be harder to scale broadly. Payer coverage can support broader access and scalability, but companies face pricing pressure and a longer route to market.

Patterson said self-pay can generate revenue quickly and lets companies control pricing, but it can exclude populations such as Medicaid beneficiaries. She also said that if a company later wants insurance coverage, it may discover that its earlier clinical work did not collect the evidence needed for reimbursement, forcing it to run another clinical trial or gather more data.

Why women’s health faces a steeper burden

The report ties the sector’s reimbursement difficulties to longstanding research gaps. Patterson noted that women were not required by federal law to be included in NIH-supported clinical research until 1993. In her view, that history still affects payer confidence because the underlying data are often insufficient.

That creates a strategic burden for women’s health companies: they may need to think two or three steps ahead about what evidence future payers will want, not just what is necessary to support an initial product concept. The signal for founders and investors is that a weak reimbursement strategy in this category is often also an evidence strategy problem.

The report also says clinician engagement should begin early so that products fit into clinical workflows and practices. Because clinicians already face heavy administrative burdens, solutions that disrupt workflow are less likely to gain traction. It recommends engaging a range of providers, including primary care clinicians, OB/GYNs, midwives and behavioral health specialists.

Payer engagement belongs in that early planning too. The report says innovators should speak with medical directors and payer innovation teams during development, not wait until launch, to understand expected clinical endpoints, study design, economic evidence and coverage criteria. It also stresses that payer evidence requirements differ from FDA requirements and should ideally be built into clinical trials from the start.

Coding and positioning can determine access

The fourth area is coding. The report says companies need an early coding strategy because coding can directly affect reimbursement, coverage and time to market. Innovators may use an existing code or pursue a new one, but either path has consequences for commercialization.

Language matters as well. The report says neither commercial nor public payers will cover products marketed as wellness or lifestyle enhancements. Instead, innovators should emphasize treatment of disease if they want reimbursement and want to avoid unnecessary obstacles.

One company cited as having navigated a difficult transition is Maven Clinic. According to the report, Maven began in the direct-to-consumer market and used that position to build evidence that later helped convince employers and payers to cover its services.

The broader industry takeaway is that women’s health companies are not only contending with capital scarcity or historical underinvestment. They are also operating in a reimbursement environment where product-market fit depends on evidence, coding and clinical workflow decisions made far earlier than many startups assume.