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AABB 2019 Advocacy Agenda

AABB advances policies that promote adequate, appropriate access to safe, clinically effective transfusion medicine and cellular therapies by supporting the following priorities:

A Sustainable Blood System
Access to Cellular Therapies
Coverage and Reimbursement for Blood, Blood Products, Transfusion Medicine and Cellular Therapies
Patient and Donor Care and Safety in Transfusion Medicine and Cellular Therapies
Research to Support Access to Safe, Clinically Effective Transfusion Medicine and Cellular Therapies

A Sustainable Blood System
  • Promote blood transfusions as essential, life-saving treatments. Blood transfusions are medically necessary, routine treatments for patients with chronic health conditions, such as anemia, hematological disorders and cancer as well as for patients who experience blood loss due to trauma or surgical procedure. In addition, blood components must be immediately available in emergencies for resuscitation, traumas, massive hemorrhage protocols and other critical treatments, such as for burn victims. Depending on the reason that a patient needs a blood transfusion, the individual may receive a specific blood component, including red blood cells, platelets, plasma and/or cryoprecipitate. In the absence of a blood transfusion, patients may experience damage to body organs, injury, permanent handicap or death. AABB is committed to advancing policies that promote patients’ access to these vital therapies.

  • Support a sustainable blood system as a critical component of the healthcare system. Blood is an irreplaceable, essential public health resource. However, several existing trends and challenges threaten to disrupt the current U.S. blood system as it exists today, including: (1) reduced blood utilization due to changing medical practices, such as the implementation of patient blood management and the availability of new drugs and medical technologies; (2) an aging donor pool and changes in donor eligibility, which have resulted in the need to recruit different donors; and (3) consolidation throughout the health care system. Additionally, the blood sector faces mounting economic pressures from existing and emerging voluntary and mandatory safety measures, which though intended to protect the health of patients and donors are costly to implement. For example, an emerging infectious disease may require the immediate development and implementation of a new screening test or the implementation of pathogen reduction, but payment policies may not be aligned with the new requirements. These existing trends and challenges limit the ability of the blood system to invest in research and development and adopt innovative technologies. AABB supports policies intended to strengthen the blood system and recognize it as an integral part of the healthcare system. 

  • Encourage regular blood donation as needed to maintain a stable supply of safe blood with sufficient capacity to respond to emerging infectious diseases, disasters and emergencies. The nation’s blood supply is maintained by a steady stream of altruistic blood donors. Blood must be collected, tested and processed before it is ready to be transfused. Therefore, heightened blood demands resulting from a disaster or emergency are met by blood that was collected and processed in advance of the event. In addition, emerging infectious diseases are likely to reduce the pool of individuals eligible to donate blood. Thus, AABB supports policies that foster a stable blood supply by encouraging regular blood donation.

  • Support patients’ access to matched, specific blood types as well as universal blood components. Blood transfusions are personalized medicine, and patients must have access to the most appropriate treatment options.  For instance, chronically transfused patients, such as those with sickle cell disease, may require multiple transfusions of red blood cells. To prevent alloimmunization, patients must have access to and receive antigen-matched blood. If a patient becomes alloimmunized against blood group antigens, the patient will require and must have access to antigen-negative blood. On the other hand, O-negative red blood cells are universal and can be transfused to nearly all patients. However, O-negative blood units are rare (~6% of the population) and make up a small portion of the U.S. blood supply. These units must be available for trauma patients and premature infants, when time may not allow for a patient’s blood to be tested prior to receiving a transfusion. AABB promotes policies that encourage the appropriate utilization of blood, so the right blood is available for the right patient at the right time. 
Access to Cellular Therapies
  • Support patients’ access to safe, medically appropriate cellular therapies. Cellular therapies are constantly evolving, innovative therapies that originate as human cells and are transplanted or infused to replace or repair damaged tissue or cells. They include both standard of care treatments, such as hematopoietic stem cell transplant for hematologic malignancies, as well as novel treatments for a wide variety of diseases or conditions. The 21st Century Cures Act, signed into law in December 2016, is intended to accelerate the development of medical products, and established a new expedited review process for regenerative medicine therapies. In addition, the Food and Drug Administration (FDA) recently approved innovative cellular therapy products. AABB is committed to advancing public policies that promote the safety and availability of cellular therapies.

  • Encourage research related to cellular therapies. Many cellular therapy products are in the development pipeline and have the potential to provide patients with new treatment options. As researchers and companies discover, develop and scale up the production of innovative cellular therapies, they need to ensure the safety of the products. AABB supports research aimed at developing new cellular therapies and ensuring that cellular therapies are safe and effective. 

  • Advance a sustainable supply of high-quality cord blood products. Cord blood is a valuable source of stem cells and other immune privileged cells, which are used to treat blood cancers, such as leukemia and lymphoma, as well as other diseases. AABB supports policies that promote the availability of high-quality cord blood products for current and future medical indications, including the reauthorization of the Stem Cell Therapeutic and Research Act, which authorizes the C.W. Bill Young Cell Transplantation Program and the National Cord Blood Inventory. 

Coverage and Reimbursement for Blood, Blood Products, Transfusion Medicine and Cellular Therapies
  • Protect and improve coverage and reimbursement policies related to blood, blood products, transfusion medicine and cellular therapies. Unfortunately, flawed coverage and reimbursement policies can limit patients’ access to products and services, stifle research and development, and impede the adoption of new technologies. For instance, Medicare payment policy does not immediately capture costs associated with new technologies, and it takes years for payment rates to reflect increased costs to providers that result from new regulatory requirements. AABB promotes coverage and payment policies that support patients’ access to blood, blood products, transfusion medicine and cellular therapies.

  • Advance coverage and payment policies that support patients’ access to medically necessary transfusion medicine and cellular therapies throughout the continuum of care. Together with patients and their families, healthcare providers should determine what setting of care meets the needs of an individual patient. Many patients requiring blood transfusions or cellular therapies will need to be treated in the hospital. However, patients may require blood transfusions or cellular therapies while receiving services in a variety of settings, such as hospitals, skilled nursing facilities, hospice and home care. AABB believes that payers’ coverage and payment policies should be flexible and support patients’ access to blood transfusions and cellular therapies in safe, appropriate settings of care.
Patient and Donor Care and Safety in Transfusion Medicine and Cellular Therapies
  • Promote enhanced patient and donor care and safety by supporting innovation and the appropriate regulation and timely introduction of new products and safety technologies for transfusion medicine and cellular therapies. As biologics, blood, blood components and cellular therapies involve inherent risks – both infectious and non-infectious – that require ongoing vigilance and attention. New products and technologies, such as screening tests for infectious diseases and pathogen reduction technology are intended to protect the blood supply from infectious diseases, including bacteria and emerging infectious agents. Similarly, as patients are offered a wide array of new cellular therapy treatments in various clinical settings, it is important to ensure that they are receiving high-quality, safe care. AABB supports appropriate regulation that helps protect patient and donor care and safety without stifling innovation or unnecessarily hindering patient access to quality care.

  • Encourage the revision of regulations and guidances that: (1) are duplicative, outdated, unnecessary or overly burdensome; (2) unnecessarily restrict access to products and technologies; and (3) stifle innovation. Science, technology and medicine are constantly evolving, which may result in existing regulations or guidances becoming unnecessary or obsolete. AABB believes that the public and private sectors should continue to work together to ensure that the regulatory paradigm is aligned with current knowledge, and that it adapts to new technologies and innovation.

  • Support the use of evidence-based policymaking, which includes but is not limited to risk assessment. Risk-based models enable decisionmakers to evaluate blood safety in the context of a range of emerging risks and other societal priorities that must compete for limited resources. They also balance demands for safe blood with the need to ensure that blood is available for patients. AABB supports the use of validated risk-based models to inform policymaking and support decisions related to blood safety interventions and new technologies. 

  • Support patient blood management as an evidence-based, multidisciplinary approach to improving patient outcomes, potentially reducing health care costs and safeguarding the nation’s blood supply. Under patient blood management programs, teams of providers consider a variety of aspects of patient evaluation to ensure that transfusions are given when appropriate and indicated. In addition to emphasizing the body of evidence in support of patient blood management, AABB supports a patient-centric approach to transfusion that recognizes the multi-factorial nature of decision-making surrounding transfusion.
Research to Support Access to Safe, Clinically Effective Transfusion Medicine and Cellular Therapies
  • Support biovigilance as well as research related to patient and donor care and safety. Biovigilance is the detection, gathering and analysis of information regarding the untoward and unexpected events associated with blood collection and transfusion and the transplantation of cells, tissues and organs.  Hemovigilance falls under biovigilance, and involves tracking adverse events associated with blood collection and transfusion. AABB supports biovigilance and other research, which produces data that can enable more thorough risk assessments and inform policies intended to protect patient and donor care and safety while not adversely impacting the availability of the nation’s blood supply.

  • Encourage research related to blood availability and the collection, analysis and public reporting of data related to the blood system. Data related to the blood system - such as data on blood supply availability, operations and utilization – are essential for identifying trends and ensuring that the blood supply is without shortages and capable of responding to emerging infectious diseases, disasters and emergencies. Research and development may result in the availability of novel technologies and products that change trends related to blood supply availability, operations and utilization. AABB supports research as well as the collection and analysis of timely, relevant data since this information is essential to developing policies related to the sustainability of the blood supply and blood system.

February 2019