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AABB 2017 Advocacy Agenda

AABB’s advocacy agenda is a working document.  We update it annually as well as when new issues arise.

AABB is committed to advocating for policies that support two broad objectives: (1) ensuring that patients and healthcare providers have adequate, appropriate access to safe transfusion medicine and cellular therapies; and (2) promoting patient and donor care and safety in transfusion medicine and cellular therapies. The association advances these goals by focusing on the following priorities:

Promoting a sustainable U.S. blood system with sufficient surge capacity as a critical component of the healthcare system and emergency preparedness.

The current U.S. blood system is fragile and there are several widely recognized threats to the sustainability of a safe, accessible blood supply. Examples of urgent challenges currently facing the U.S. blood system include vulnerabilities to emerging threats and public health emergencies, barriers to innovation and the adoption of new technologies, changes in clinical practice, a shrinking donor pool, flawed payment policies, workforce shortages and lack of integrated health information technology. These exigencies are especially problematic since blood and blood components are routine, medically necessary treatments for patients with chronic health conditions as well as life-saving therapies for patients who have experienced traumas, mass casualty events and other unforeseeable circumstances.

AABB will advocate for policies that address immediate threats to the sustainability of the blood system and recognize the importance of surge capacity and the availability of blood in disasters and emergencies. We will advocate for policies that promote the collection, analysis and public reporting of data on blood utilization, which is essential to understanding and planning for blood shortages and disasters. In addition, AABB will continue educating policymakers and other stakeholders about the significant challenges facing the blood system, which jeopardize the nation’s emergency preparedness capabilities as well as the public’s health.

Promoting access to safe cellular therapies.

Cellular therapies include both standard of care treatments, such as hematopoietic stem cell transplant for hematologic malignancies, as well as more innovative treatments for a wide variety of diseases or conditions. These constantly evolving, innovative therapies originate as human cells and are transplanted or infused to replace or repair damaged tissue or cells. Examples of these cells include hematopoietic stem cells, skeletal muscle stem cells, mesenchymal stem cells, lymphocytes, dendritic cells and pancreatic islet cells.

AABB supports policies that promote a sustainable U.S. supply of high quality cord blood products for unrelated allogeneic use in hematopoietic stem cell transplantation. In addition, AABB advocates for the appropriate regulation of cellular therapies, and supports clinical trials involving cellular therapies.

Promoting adequate coverage and payment policies for transfusion medicine and cellular therapies.

Blood banks and providers of transfusion medicine and cellular therapies are facing significant financial challenges, which may be exacerbated by policy changes that increase the number of uninsured individuals, reduce meaningful, affordable coverage of transfusion medicine and cellular therapy products and services or decrease payments to providers. In addition, Medicare payment policy is not able to 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.  Unfortunately, flawed coverage and reimbursement policy can stifle the development and implementation of new technologies. For instance, 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 when there is substantial uncertainty whether their products will be widely adopted by cost-restrained blood centers.

AABB will advocate for coverage and payment policies that ensure that patients continue to have access to safe, available blood, blood components, transfusion medicine services and cellular therapies. AABB will defend against policies that increase the number of uninsured individuals, reduce coverage of transfusion medicine and cellular therapy products and services or decrease payments to providers. Additionally, AABB is committed to protecting and improving Medicare coverage and reimbursement policies applicable to transfusion medicine and cellular therapies.

Promoting policies that support the appropriate regulation and implementation of products and technologies for transfusion medicine and cellular therapies. 

The U.S. blood supply is safe. However, as biologics, blood and blood components involve inherent risks – both infectious and non-infectious – that require ongoing vigilance and attention. New products and technologies, such as screening tests for emerging infectious diseases, pathogen reduction technology and rapid bacterial tests, are intended to protect the blood supply from infectious diseases and bacterial contamination. AABB works to promote access to safe, effective products and technologies related to transfusion medicine and cellular therapies.

AABB supports policies aimed at protecting patients from bacterial contamination and exposure to infectious diseases via blood transfusions without overly burdening hospitals and blood providers. AABB promotes the use of a risk-based decision making approach in FDA regulations and policies.

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. AABB will urge FDA to update, and when appropriate revise or rescind regulations and guidances that: (1) do not result in increased safety; (2) are duplicative, outdated, unnecessary or overly burdensome; (3) unnecessarily restrict access to products and technologies, and (4) stifle innovation.

Cellular therapies are rapidly evolving. As patients are offered a wide array of new treatments in various clinical settings both within the United States and abroad, it is important to ensure that they are receiving high-quality, safe care. While regulation of cellular therapy 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. AABB advocates 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.  In addition, AABB promotes the harmonization of standards for emerging cellular therapies.

Promoting policies that support patient and donor care and safety in transfusion medicine and cellular therapies.

AABB’s steadfast commitment to improving patient and donor care and safety in transfusion medicine and cellular therapies is exemplified by our role as a global leader in standards setting, accreditation, implementation of quality systems and education.  AABB develops standards for blood banks and transfusion services, cellular therapies, perioperative services, relationship testing, immunohematology reference laboratories, molecular testing and patient blood management. AABB’s accreditation programs are aimed at improving the quality and safety of the activities covered by the standards. Additionally, AABB educates the transfusion medicine and cellular therapies community on current science and best practices that support patient and donor care and safety.

AABB recognizes the importance of obtaining additional clinical evidence to better understand when the transfusion of certain blood components is most beneficial.  AABB also supports the need for enhanced data regarding transfusion-associated adverse events and incidents. In addition, AABB promotes patient blood management (PBM), an evidence-based, multidisciplinary approach to optimizing the care of patients who might need a transfusion. PBM can significantly reduce the number of unneeded blood transfusions, while ensuring that blood components are available for patients who require these limited, essential medicines. Thus, AABB supports policies that encourage the use of PBM as a means of improving the quality of patient care and potentially reducing healthcare costs.

AABB will continue to advocate for policies that support patient and donor hemovigilance programs.  Similarly, AABB will promote research and policies that foster enhanced donor and patient care.  In addition, AABB will support policies that ensure that patients and donors are adequately informed about the benefits and risks associated with the donation and transplantation of cellular products.

February 2017