Whereas the Committee finds that:
- Maintaining an adequate supply of safe blood for transfusion is integral to public health and a national priority.
- Ten percent of hospital based procedures require the use of blood.
- Within the Medicare population 16.7% of inpatient claims included blood use
- Blood utilization data understate the need to have reserve “blood on the shelf” prior to commencing many medical and surgical procedures
- When considering the potential need, the data indicate 20% of hospital procedures require or could require the use of blood
- Dramatic reductions in blood use (~25% currently, with projections of up to 40% by 2020) ongoing since 2008 have created a current crisis of economic instability in blood banking, which has worsened since the committee examined this issue in 2013
- Instability in the blood centers threatens to exacerbate existing spot blood shortages, reduce resilience in the face of public health emergencies through elimination of surge capacity, and reduce ability to provide the most appropriate routine and specialty products and services
- The following manifestations of a blood crisis have already been observed:
- Reduction in resources for implementation of available new safety measures (e.g. pathogen reduction technologies, bacterial testing of platelets, tests for emerging infectious diseases such as babesiosis, dengue and Chikungunya, etc.)
- Increased unit cost of blood due to ~25% reduction in revenues (ca $1.3B) with inability to implement corresponding reductions in fixed costs related to infrastructures necessitated by regulatory and safety requirements
- Reduced viability of blood collection centers with many operating in deficit
- Mergers and closures in the face of competition among blood providers
- Reduced resources for product safety related research and development, including epidemiologic surveillance and blood safety technologies (e.g. , donor screening tests)
- Difficulty in providing products to meet specialized patient needs (e.g., antigen matched units for transfusion in patients with sickle cell disease)
- Disproportionate burden for vulnerable patient populations and/or those with rare diseases
- The large gap in inpatient hospital reimbursement (accounting for 80% of blood utilization) relative to the production costs of blood components contributes significantly to the economic stress experienced by blood centers
- Anti-trust laws constrain the ability of the blood centers to engage in collective discussions of system-wide cost and supply management
- A study contracted with the RAND Corporation to investigate causes of instability and recommend remedies for stabilization of the US blood system will take 12 to 18 months
- These findings indicate a clear and present need to address the immediate crisis and to manage a longer term paradigm shift to stabilize blood centers in the U.S. and ensure it continues to meet public health needs
Therefore, the Committee recommends that the Secretary:
- Request an interim report from the RAND Corporation at the next meeting of the ACBTSA
- Facilitate a process for blood centers to collaborate and dialogue on innovative strategies to address their new economic realities (e.g., an anti-trust safe harbor)
- Provide advocacy to CMS and Congress on measures that could be taken to address the gap in reimbursement of blood components as a special need in the public health system potentially including:
- a “carve-out” enabling direct “pass-through” CMS reimbursement of blood centers for the actual cost of the blood components including implementation of newer safety innovations based on the special role of transfusion as a public good in supporting modern health care
- immediate line item additive congressional funding for hospital purchase of blood components
- Assure that studies of the crisis in the blood system address the following issues:
- Whether open competition among blood centers is the optimal model for the U.S. blood supply in the present environment
- Adverse effects of an unconstrained competitive environment in blood collection with avoidance of potentially adverse outcomes for public health (e.g. monopoly or oligopoly behaviors in the absence of suitable controls)
- Need for preservation of surge capacity to address public health emergencies
- Need to maintain resources for research, product innovation and implementation of newer measures to assure and advance blood safety, efficacy and availability
- Structural causes of the gaps and misalignments between costs of blood production [including the cost of maintaining a reserve inventory in excess of predicted need (i.e., the “insurance value of blood”)] and charges to hospitals