AABB is a leading voice in advocating government and public health policies to support the highest possible quality of care for blood and stem cell donors and patients requiring transfusions or cellular therapies. In 2016, AABB’s advocacy efforts will focus on the following issues. Working in collaboration with other interested organizations, the association will advance these positions before policymakers in federal agencies and Congress, as well as influential healthcare organizations, hospitals and the public.
Ensuring Blood Safety and Availability
The U.S. blood supply is very safe. However, as biologics, blood products involve inherent risks – both infectious and non-infectious – that require ongoing vigilance and attention. As the healthcare sector consolidates and faces ever-tightening budgets, future progress in blood safety is threatened. Lacking financial incentives to invest in blood safety, innovation is at risk. Faced with limited reimbursement for blood products and services, blood centers and hospitals cannot afford to invest in new safety measures and companies will not invest in new technologies -- such as screening tests for emerging diseases -- when there is substantial uncertainty whether their products will be widely adopted by cost-restrained blood centers. In addition, certain unnecessarily cumbersome, costly and outdated regulations make it especially difficult for blood centers, hospitals and companies to invest in promising new blood safety advances.
As the U.S. blood market contracts, careful attention also must be paid to the impact on blood availability. Faced with extreme budgetary constraints, blood centers increasingly operate with just-in-time inventories. If blood demands increase unexpectedly, as in the case of a sustained disaster, or blood donations drop, which frequently happens during extreme weather or holiday seasons, limited supplies of blood "on the shelf" may not be adequate to meet patient needs.
Globally, blood safety and availability should be a public health priority. There is a need for enhanced blood safety and transfusion practices in various regions across the globe. In addition, it is essential to encourage the training of transfusion medicine workforces, particularly in developing countries.
Promoting a Sustainable U.S. Blood Supply: AABB will educate policy-makers, hospitals and other key constituents about the fragility of the U.S. blood system and the value of blood to the public health. We will advocate policies to sustain a safe and available blood supply, particularly in the event of a disaster.
Supporting Rational Regulation and Implementation of Blood Safety Technologies: AABB will continue to support revised Food and Drug Administration (FDA) regulations and policies aimed at protecting patients from bacterial contamination and exposure to infectious diseases via blood transfusions without overly burdening hospitals and blood providers. The association will strive to reach consensus positions regarding pathogen reduction regulation and implementation issues (e.g., rescinding requirements for redundant blood screening measures). AABB will urge FDA to update, and when appropriate rescind, outdated and/or overly burdensome regulations. For example, the association will continue to advocate changes in FDA policies relating to plasma products. In addition, AABB will promote the use of risk-based decision making in FDA regulations and policies.
Promoting Improved Medicare Reimbursement for Blood and Transfusion Services: AABB will continue to advocate for improved inpatient and outpatient reimbursement for blood and related therapies at the Centers for Medicare and Medicaid Services (CMS). In addition, since future Medicare payments are based on the charge data hospitals provide today, AABB will continue to educate hospitals about the need to bill accurately for transfusion related services.
Fostering Enhanced Donor Care: AABB will support policies to enhance blood donor care and safety. For example, the association will promote policies to address iron deficiencies in blood donors. We will also support research and policy decisions aimed at protecting donors, including young individuals, and continue to promote the value of donor hemovigilance.
Supporting NIH-sponsored Transfusion Medicine Research: AABB will continue to support enhanced National Institutes of Health (NIH) research funding in transfusion medicine. AABB will actively promote research initiatives designed to improve blood safety, identify and encourage appropriate use of blood transfusions, and enhance care for pediatric and adult patients.
Championing Global Blood Safety Policies: As a global leader in transfusion medicine, AABB will support policies to improve blood safety and transfusion practices throughout the world. For example, AABB will work with the Asia Pacific Economic Cooperation’s blood supply chain partnership training network to improve blood safety, prevent the spread of communicable diseases through transfusion and provide access to quality management systems in APEC countries.
Promoting Appropriate Patient Blood Management
Wide variability in the use of transfusions in the U.S. indicates that there is both excessive and inappropriate use of blood. Patient blood management (PBM) is an evidence-based, multidisciplinary approach to optimizing the care of patients who might need a transfusion. PBM encompasses all aspects of patient evaluation and clinical management surrounding the transfusion decision-making process, including the application of appropriate indications, minimizing blood loss and optimizing patient red cell mass, as well as capturing patient outcomes and adverse events associated with transfusion decisions. PBM can significantly reduce the number of unneeded blood transfusions, while ensuring that blood components are available for the patients who need them. Some hospitals in the U.S. have implemented PBM programs resulting in substantial reductions in blood use and associated costs. However, more hospitals need to be encouraged to deploy similar strategies to benefit patients and preserve limited healthcare resources across the country.
Additional clinical evidence is needed to better understand exactly when transfusion of certain blood components is most beneficial. There is also a clear need for enhanced, national data regarding transfusion-associated adverse events and incidents. Having a national outcomes and research database is critical for participation in global harmonization and research activities. Globally, expanded PBM efforts are needed to minimize clinical variation and ensure availability of scarce blood products for patients in need.
Promoting PBM Best Practices: AABB will educate policy makers regarding the importance of PBM as a means of improving the quality of patient care and potentially reducing healthcare costs. AABB will explore opportunities to promote improved reimbursement for PBM-related products and services.
Improving Patient Safety in Transfusion Medicine: AABB will continue to advocate support for a national hemovigilance system to collect and analyze data related to the adverse events and incidents associated with blood transfusion. AABB will urge blood establishment computer software (BECS) and electronic health record (EHR) companies to adopt standardized hemovigilance adverse event definitions. In addition, the association will ask individual states and the federal government to support hemovigilance efforts and encourage hospitals and hospital systems to participate in the association's patient safety organization as a means of improving both facility-based and national transfusion-related patient care.
Supporting Quality Cellular Therapies
Cellular therapy (CT) is the transplantation of human cells to replace or repair damaged tissue and/or cells. With new technologies and innovative products and practices, many different types of cells may be used as part of a therapy or treatment for a variety of diseases and conditions. Some of the cells that may be used include hematopoietic (blood-forming) stem cells (HSC), skeletal muscle stem cells, mesenchymal stromal cells, lymphocytes, dendritic cells, and pancreatic islet cells. With ongoing research, various cell types will be developed into promising novel cell therapy treatments for a variety of life-threatening conditions, including cancers, autoimmune and infectious diseases, spinal cord injuries, and neurological disorders. While regulation of CT products is needed to ensure the safety and efficacy of stem cell based products, it is vital that the regulatory system help protect patient and donor health without stifling innovation or unnecessarily hindering patient access to quality care.
The field of cellular therapy is rapidly evolving as scientific and clinical advances are made involving novel therapies using a variety of stem cell based products. As patients are offered a wide array of new treatments in various clinical settings both within the United States and abroad, it is important that steps be taken to ensure that they are receiving high-quality, safe care. Consumers need information regarding the effectiveness of particular treatments, as well as any potential risks and benefits associated with the therapy.
In addition to government regulations – such as those implemented by the FDA – voluntary standard and accreditation programs play an important role in promoting quality care. Standards and accreditation programs, such as AABB’s cellular therapy standards, establish a uniform level of practice dedicated to supporting donor and patient safety and care.
Advocating Appropriate Cellular Therapy Regulation: AABB will advocate for clear regulatory pathways that promote rapid translation of research findings in the novel cellular therapy and regenerative medicine arenas to therapies that provide life-saving cures for chronic and terminal diseases in an ethical manner without stifling innovation. The association will actively engage with FDA and other interested organizations in promoting policies that fosters rapid progress in the novel therapies field and avoids overly burdensome regulation of existing cellular products. In addition, AABB will support the harmonization of international regulatory requirements by working with regulatory and professional organizations across the globe.
Promoting Donor and Patient Care and Safety: AABB will support policies to advance cellular therapy donor and patient care and safety. For example, the association will promote efforts to ensure both patients and donors and patients are adequately informed about the benefits and risks associated with donation and transplant of cellular products.
Supporting Medicare Reimbursement for Cellular Therapies: AABB will continue to support enhanced Medicare coverage and payment policies for cellular therapies. For example, the association will work with other professional and patient organizations to promote coverage for HSC transplants for patients with sickle cell disease and other life-threatening conditions and enhanced payments for stem cell collection, processing and transplantation.
Promoting Standards for Emerging Cellular Therapies: AABB will advocate for domestic and international adoption of novel cellular therapy standards as a means of protecting patient health and ensuring optimal outcomes. Standards should address all aspects of product collection, processing, storage and administration, including patient care and clinical outcomes. The association will work with other professional societies, healthcare quality organizations, government agencies and other stakeholder organizations to gain support for quality standards and accreditation programs in novel cellular therapies and regenerative medicine and promote harmonization of standards whenever possible.
Advancing Cellular Therapy Worldwide: On the international front, AABB will support the adoption of national quality management systems approaches in individual countries as a means of improving patient care. The association also will pursue avenues to improve workforce readiness in the global cellular therapy arena.
Promoting a Sustainable Cord Blood Supply: Recognizing the value of both public and private cord blood banks, AABB will advocate policies to support a sustainable supply of high quality cord blood products.