2024 Advocacy Agenda
Promoting the value of blood to patients, communities, and the healthcare system.
About this agenda
America’s Blood Centers (ABC) urges the Administration, Congress, and industry stakeholders to promote the value of blood to patients, communities, and the healthcare system through the following actions:
To meet evolving trends in where and when individuals prefer to donate blood, blood centers are now opening new locations that provide convenient opportunities to donate.
However, blood centers may face over a year’s delay before they can open these locations due to regulatory wait times. Until the new facility receives final FDA approval, blood products manufactured (utilizing the same procedures already approved at other facilities operated by the same blood center) cannot be shipped across state lines, even though all products are already acceptable for distribution in the state of manufacture. These delays threaten patient access to life-saving blood for both routine and emergency care.
To ensure a safe and available blood supply, FDA product licensure should be streamlined to ensure blood centers are quickly able to fully utilize these new locations.
Only 3% of Americans donate blood each year. Recent FDA changes in donor deferral criteria have expanded the pool of eligible individuals, but funding is needed to ensure awareness of these changes.
Recent changes include an end to the indefinite deferral for geographic exposure to bovine spongiform encephalopathy and a move to a universal individual behavior assessment for all donors. These changes will allow more gay and bisexual men to donate blood as well as many current and former members of the military and their families.
Congress should support local blood center efforts to recruit potential donors, including those that have previously been ineligible to donate due to these government policies, to ensure a robust blood supply.
Blood centers throughout the U.S. work to ensure that blood is available to patients when they need it most.
Unfortunately, due to some payment policies, blood transfusions are not equally available to all patients, including those in the Medicare Hospice program, those receiving treatment in an outpatient clinic, or those suffering from trauma and receiving blood through emergency management services.
Studies show extensive benefits to patients and the healthcare system they rely on when they have access to blood transfusions and are assured care when and where it’s needed.
Congress should ensure Medicare payment policies allow patient access to blood transfusions when and where the patients needs.
In addition to the above priorities, ABC supports the following policy priorities:
- Establish targeted federal initiatives to support increased diversity in the donor base, such as funding for increased molecular red blood cell typing for frequently transfused patients including those with Sickle Cell Disease or Thalassemia.
- Establish funding for research on the predictive social and psychological factors in blood donor motivation to attract and retain donors and ensure long-term stability of the nation’s blood supply.
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- Explore federal funding mechanisms to facilitate implementation of safety and technology measures when mandated by FDA or when market incentives otherwise do not exist.
- Increase federal resources for data gathering on the collection and utilization of blood components as needed to support evidence-based decision making in federal regulatory policy.
- Advocate for funding and programs that increase the surge capacity of the nation’s blood supply.
- Apply evidence-based decision making to FDA testing requirements to ensure testing burdens are justified by commensurate increases in safety, eliminating current FDA testing requirements without appropriate safety justifications (e.g. HBsAg).
- Revisit FDA policy on the acceptance of international data for use in the approval of new products or technologies, and different policies and procedures.
- Lower the U.S. Platelet Content Requirement (PCR), the minimum number of platelets per unit, to expand platelet supply availability and align with international standards.
- Implement a rational, flexible approach to the regulation of plasma products, advocating FDA licensure of recovered plasma to give blood centers the ability to convert plasma from transfusable to further manufacture without requiring expiration for more effective blood inventory management.
America's Blood Centers provides representation and advocacy on behalf of our member blood centers, ensuring their voices are heard in the development of national health policy and before decisionmakers in federal agencies and the U.S. Congress.Â
How it was developed: our value framework
Our Advocacy Agenda was built through our Value Framework, which consists of five core pillars that emphasize the contribution ABC member blood centers bring to their local communities and the nation’s healthcare system.
ABC member blood centers ensure a safe and adequate blood supply, saving and improving the lives of millions of Americans each year
ABC members promote the altruistic gift of blood from millions of individuals nationwide, maintaining a critical donor base and educating current and future generations on the need for blood
ABC members re-invest in the health of their local communities through such things as cellular therapy services, transfusion medicine expertise, disease management programs, and research
ABC members partner with federal, state, and local agencies to confront public health threats and promote medical and scientific innovation
ABC members provide competition in the market, ensuring value while controlling overall healthcare market expenditures for blood components
To maximize the value of community blood centers, ABC supports policies that:
Recognize the value of blood components to the overall healthcare system through fair and adequate reimbursement
Promote safety through strong evidence and risk-based decision-making
Foster education initiatives related to the need for appropriate use of blood
Reduce regulation that otherwise fails to promote reasonable safety, value add, or innovation
Safeguard the viability of community blood centers through fair competition within the healthcare market, ensuring continued patient access to safe and appropriate blood components.