The United States Needs A Better Testing Playbook For Future Public Health Emergencies.

The absence of a comprehensive national playbook for developing and deploying testing has hindered the United States' ability to rapidly suppress recent biological emergencies (for example, the COVID-19 pandemic and outbreaks of mpox). We describe here the Testing Playbook for Biological Emergencies, a national testing playbook we developed. It includes a set of decisions and actions for US officials to take at specific times during infectious disease emergencies to implement testing rapidly and to ensure that available testing meets clinical and public health needs. Although the United States had multiple plans at the federal level for responding to pandemic threats, US leaders were unable to quickly and efficiently operationalize those plans to deploy different types of tests during the COVID-19 pandemic in 2020-21, and again during the US mpox outbreak in 2022. The playbook fills a critical gap by providing the necessary specific and adaptable guidance for decision makers to meet this need.

Structuring the patient-physician encounter: Joint creation of an actionable roadmap to health.

The patient׳s experiences and costs related to their care are largely dictated by each patient-physician interaction along the continuum of care. However, the amount of time that a physician spends with a patient creating a medical action plan is highly variable and often not related to the severity or complexity of the patient׳s condition. Adding a structured process to guide and inform patient-physician encounters, including outlining expectations and follow-up by both sides is needed. Addressing these barriers to the physician-patient relationship would reduce variation in care, minimize unnecessary trial and error tactics and instead focus on predicted cost effective actions.

The business value and cost-effectiveness of genomic medicine.

Genomic medicine offers the promise of more effective diagnosis and treatment of human diseases. Genome sequencing early in the course of disease may enable more timely and informed intervention, with reduced healthcare costs and improved long-term outcomes. However, genomic medicine strains current models for demonstrating value, challenging efforts to achieve fair payment for services delivered, both for laboratory diagnostics and for use of molecular information in clinical management. Current models of healthcare reform stipulate that care must be delivered at equal or lower cost, with better patient and population outcomes. To achieve demonstrated value, genomic medicine must overcome many uncertainties: the clinical relevance of genomic variation; potential variation in technical performance and/or computational analysis; management of massive information sets; and must have available clinical interventions that can be informed by genomic analysis, so as to attain more favorable cost management of healthcare delivery and demonstrate improvements in cost-effectiveness.

Realizing the promise of personalized medicine.

Scientific advances have begun to give doctors the power to customize therapy for individuals. However, adoption of this approach has progressed slowly and unevenly because the trial-and-error treatment model still governs how the health care system develops, regulates, pays for, and delivers therapies. Aspinall, the president of Genzyme Genetics, and Hamermesh, chair of a Harvard Business School initiative to improve leadership in health care organizations, discuss the barriers to personalized medicine and suggest ways to overcome them. The blockbuster model for developing drugs, the authors point out, is still what most major pharmaceutical companies follow, even though its days are numbered. What the industry must embrace in its place is a business model based on a larger portfolio of targeted--and therefore more effective and profitable--treatments, not a limited palette of one-size-fits-all drugs. The current regulatory environment overemphasizes large-scale clinical trials of broad-based therapies. Instead, the focus should be on enrolling subpopulations, based on diagnostic testing, in trials of targeted drug treatments and on monitoring and assessing effectiveness after drugs are approved. A dysfunctional payment system complicates matters by rewarding providers for performance of procedures rather than for accurate diagnosis and effective prevention. Aspinall and Hamermesh call for coordinating regulation and reimbursement so that incentives are provided for the right outcomes. Finally, the authors urge changing physicians' habits through education about genomics, diagnostic testing, and targeted therapies. They say that medical schools and physician organizations must become committed advocates of personalized medicine so that patients and the medical industry can get all the benefits it offers.