Advocacy is one of ABC’s central priorities – we know that it is one of the most highly valued services of ABC’s activities. We have excellent but limited resources, so we must be focused. At ABC’s board retreat this week, we determined four priorities to address this year, chosen based on the SEQuaLS member satisfaction survey results and the likelihood of success.
1. Increasing plasma flexibility. We seek regulations to more easily use apheresis plasma collected concurrently with another product as needed, be it for patient transfusion, or for further manufacturing into another pharmaceutical product. This item is on the Food and Drug Administration’s regulatory agenda for 2016.
2. Reducing platelet quality control (QC) burden. Current apheresis technology has a high degree of consistency in producing acceptable products. However, FDA requires complex stratification by collection location, instrumentation and personnel,and virtually 100 percent of products must be tested. This unnecessary work and expense produces a cost to blood centers for minimal or no safety gain. We are engaging the FDA on this issue.
3. Source plasma freezing time. Current FDA regulations require freezing source plasma within two hours of collection. As such, centers must install expensive, low-temperature freezers at all source plasma collection locations. This requirement is to ensure that various coagulation factors in plasma are preserved. However, source plasma is no longer primarily used for producing coagulation components. The plasma fractionators themselves and EU regulations do not have this requirement. Appropriate products are made in other countries with less restrictive and burdensome freezing requirements. We are just beginning to engage the FDA on this issue.
4. Improving reimbursement for blood products and services. This is a very large issue, and must be attacked on many fronts. We succeeded when we acted quickly on the outpatient prospective payment system (OPPS) issue with the Centers for Medicare & Medicaid Services last year. ABC has worked for several years to investigate the overall reimbursement structure for blood, seeking a mechanism that will ensure the stability of the blood supply, while recognizing the “insurance” value of available blood for disaster and medical procedures. These efforts resulted in the Department of Health and Human Services funding a study by the RAND Corp. We will continue to facilitate the work on this study. When it is completed, we must make further advocacy efforts to make sure the report findings are considered and acted on appropriately. You can learn more from the RAND Corp. at the Annual Meeting in Jacksonville, Fla. in March.
So it will be a busy year in advocacy, and other issues will undoubtedly arise. We welcome your suggestions and need your input and support. Join ABC’s Advocacy Listserv to get involved.
Susan Rossmann, MD, PhD; Board President; email@example.com