The United States blood system is at a significant crossroads. We believe that policy makers and key stakeholders must be engaged to ensure a modern-day system with reliable access to safe blood products that meet clinical and public health emergency needs for all. In recent years, organizations central to collecting and preparing blood products have been sounding an alarm over the future stability of the US blood system. Their concerns reflect a system that has been subject to a set of changing external forces including: clinical practice guidelines promoting judicious use of blood products, health care payment reform promoting cost-effectiveness and efficiency, and additional expectations for screening and safety. Despite these profound shifts, our system for collecting, paying, and promoting innovation for safe blood products has remained largely unchanged. In the near term, policy makers must determine whether they will intervene to support the blood system in this dynamic environment or let the market forces prevail. The choices they make will affect countless Americans.
A Complex System
The most recent data on blood collection and use reflect ongoing clinical and market changes, notably steadily declining collection and use since 2008. The National Blood Collection and Utilization Survey (NBCUS) shows a decrease of nearly 14 percent in the number of red blood cell units transfused between 2013 and 2015. This decline is mirrored by a decrease in collections of nearly 12 percent during that same period. The change in clinical demand for blood products reflects positive advances in care, grounded in research over the past decade, demonstrating that better clinical outcomes can be achieved with less blood product for many groups of patients. The incorporation of the evidence for more restrictive transfusion practices into clinical guidelines has led to widespread adoption.
As hospitals search for cost savings in response to health care payment reform, they have become powerful negotiators as purchasers of blood products. The 2015 NBCUS collected price per unit paid by hospitals and found that for all types of blood products, the median price actually declined from 2013 to 2015. Blood centers operate under competitive contracts established with inpatient hospitals and outpatient transfusion facilities, with the price of each blood component dependent on numerous factors including the blood product, type, special testing required, and the rarity of the product. In response to the decline in demand and flat-to-declining compensation from the health care system, the blood collection industry reports declining infrastructure, including the loss of research and development capacity and limited ability to incorporate new technology to improve blood safety.
The blood system’s underlying fragility and the cloudy policy landscape that surrounds it became evident last year as public health officials worked aggressively to manage the emerging risk from Zika virus (ZIKV). As part of a host of public health actions, the federal government worked to mitigate the risk of blood-borne transmission and safely manage the nation’s blood system. In a period of uncertainty around the extent of risk through transmission and the potential, however remote, of a transfusion leading to significant health consequences, including Guillain-Barré syndrome and neurologic damage in newborns, the Food and Drug Administration (FDA) issued guidance for blood to be screened for ZIKV. This new expectation that blood organizations would add ZIKV screening for all blood products placed significant pressure on them and highlighted the underlying financial strain they continue to face. ZIKV screening implementation costs have been estimated to be more than $100 million annually. The ability to adopt significant advances in safety will falter if left to the blood organizations already under financial pressure.
The stability, safety, and availability of the US blood supply and underlying blood infrastructure is the result of a complex blood system composed of both the public and private sectors. On the private side, blood is collected largely from unpaid, altruistic donors then processed into component products, screened for safety, and sold to health care institutions for use. This process is generally performed by nonprofit blood centers, which currently screen for nine pathogens—including HIV, hepatitis B and C, and ZIKV. Hospitals and transfusion centers negotiate prices with the blood collection centers and are reimbursed for these costs as part of the overall payment they receive from patients or their insurers for an inpatient stay or as a separate service if blood is used during an outpatient procedure. Because of tight expiration time frames and the need to meet unanticipated demands—such as in a mass casualty event—more blood is collected than is needed, and product is routinely discarded.
On the public side, oversight of the system is shared across different—although coordinating—agencies under the Department of Health and Human Services (HHS). The assistant secretary for health is the designated federal blood safety officer and holds responsibility for advising the HHS secretary on policy related to blood safety and availability, including convening public meetings of the federal Advisory Committee on Blood and Tissue Safety and Availability. Separate from the assistant secretary for health, the FDA is responsible for assuring the safety of the blood products through its regulatory role, including determining the testing of products for safety and investigating any adverse events. Another entity, the Office of the Assistant Secretary for Preparedness and Response, through its Biomedical Advanced Research and Development Authority, supports technology innovations in the blood system. The National Institutes of Health provides the scientific foundation for policy making and improvements in blood safety. And finally, the Centers for Disease Control and Prevention, in collaboration with the assistant secretary for health, conducts regular surveys of blood collection and use.
Recently, policy makers across these agencies have drawn attention to the challenges in the blood system. Recognizing the potential fragility of the blood system, HHS in 2016 commissioned work to understand the current state, external pressures, and potential solutions for stabilizing the blood system. The effort included input from experts in the public and private sectors and culminated in a report released in November 2016. The overall finding was that although the blood market may work to control costs, it will not necessarily allow for the investment required to advance research and development nor does it account for the costs of new public health measures, such as testing for emerging diseases or the implementation of promising safety innovations—such as pathogen reduction, or inactivation, which has the potential to inactivate a broad spectrum of infectious organisms, eliminating the need for individual tests for each one. The 2016 report lists a series of recommendations aimed at addressing this imbalance including a need to strengthen the data collection for better system evaluation, support and facilitate technology adoption of benefit to the public, and subsidize the ability of blood centers to maintain surge capacity.
More broadly, these challenges and the report’s recommendations raise some fundamental questions: Is blood a public good? And, if so, what role should the federal government play in supporting the blood system as it responds to dynamic changes in supply and demand? We believe that the answers to these questions are central to the work of policy makers as they determine the appropriateness of providing supplemental funding to the blood system in the short run, and perhaps long run. The public and private sectors must engage and act on these key policy decisions to ensure that all Americans have equitable, safe access to the blood products that are so important to their health and well-being.