Technology is turning the 21st century into the century of personalization. Whereas a department store once showcased its wares in its windows hoping to entice the masses, stores of all sizes now send specific ads based on your preferences directly to your smart phone. Start-ups have made it possible to order eyeglasses made to fit from the comfort of your home or clothes tailored to your specifications.
While adding to convenience, the power of this rapid personalization is that it is poised to transform health care as well. Imagine a world where treatments are based on your exact genetic make-up or that of the cancer or bacteria afflicted you—or picture a time in which your entire health history helps to craft clinical outcome goals. This is not science fiction. This is the promise of “precision health” in which we are able to use huge new sets of data and computing power to help patients and their clinicians’ figure which diseases and symptoms matter, reduce side effects, increase the likelihood that treatments will work, and eliminate wasteful spending along the way. Unfortunately, policy is not keeping pace with science. The rate at which we are converting our investments in research into useful medical treatments is stifled by a mix of misaligned incentives, underinvestment in the last mile of translational research, and outdated approaches to reimbursement and regulation.
Shifting Resources
We draw these conclusions after being in roles in which we helped to craft health policy; thus, we have a keen appreciation of how hard it can be to move the regulatory state and the legislative process in order keep pace with innovation. Yet, there is more that can be done now—by government, academia and the private sector—to make precision health a reality, improve health outcomes, reduce unnecessary health care costs, and cement U.S. global leadership in this new field. First, while we recognize that the National Institutes of Health (NIH), the world’s leader in biomedical research is underfunded, it should not shortchange precision health. It is a travesty that the current NIH budget has about 25 percent less purchasing power than its budget of 10 years ago. As a result, the NIH has diverted resources from translational precision health research at a point in time when early stage life sciences venture capital life science funding is also decreasing. This means promising projects are dying on the vine. Instead of cutting investment, the NIH should shift more resources to precision health. Moreover, to increase the odds of ongoing private sector investment in this field, the NIH also should co-invest in projects that are viewed by both the public and private sector as encouraging.
Early Market Access
Second, the FDA has to open the doors to early market access to promising treatments. Specifically, the FDA should offer "conditional approval,” based on smaller pivotal trials, for precision health diagnostics and therapeutics that in preliminary Phase 2 trials appear to have substantial cost savings (greater than 10 percent reductions in total cost of care) and large quality improvements. Early market access reduces cost to bring these products to market and will stimulate R&D for innovations with these characteristics. We understand the risks in this approach, and that’s why early market access must be limited to precision health uses, and all patients must be registered so that outcomes and costs can be independently assessed. Products that do not deliver cost and quality benefits should either be removed from the market if unsafe and the remaining period of market exclusivity should be adjusted.
Clarity Over Cost-Coverage
Third, the Centers for Medicare and Medicaid Services (CMS) has sent unclear signals to the market concerning development, coverage and payment for precision health. The goal for CMS should be clarity that it will cover precision health products that lower costs and improve outcomes. CMS could advance the adoption of precision health tools by offering either reimbursement carrots or sticks for providers. For example, CMS could encourage the use of precision health tools by building it into quality measure reporting for Accountable Care Organizations. A concerted effort to liberate privacy-protected patient data on precision health cost and outcomes from Medicare, Federal Employees, Military Health and Veteran Administration would massively help the private sector adopt precision health approaches that work. Finally, the federal government is a enormous purchaser of health care for federal workers, and could drive market adoption by requiring its health plans to cover precision health approaches that are approved by the FDA and covered by Medicare at low cost to patients.
Implementation and Adoption
Lastly, to complete the last mile of implementation of precision health we will need doctors, hospitals and other providers to learn to use these tools and treatment in their practices. Since the adoption of evidence-based approaches can be notoriously slow, one catalytic step would be a program modeled on the Department of Education's "Race to the Top" that offers financial rewards to successful early adopters of precision health programs that reduce costs and improve outcomes.
These policy changes are as simple as the field of precision health is complex. But this is the role government can, and should, play: investing in promising technologies, removing unnecessary barriers to growth, and doing what it can to stimulate a new market. If America does that, then our country can lead the world in precision health, creating jobs and saving lives for decades to come.
