In 2008, AABB will focus on the following public policy and regulatory priority issues affecting transfusion medicine and cellular therapies.

Public Policy Issues

Biovigilance:  AABB will support the establishment of a national biovigilance program to capture and analyze data regarding non-infectious risks associated with receiving a blood transfusion or a tissue transplant.  Such a program must be a sustainable public/private initiative and seek to coordinate and integrate existing efforts in order to reduce duplication.  AABB will explore funding possibilities and also continue to explore the possibility of serving as a federally-designated patient safety organization. 

Medicare Reimbursement: AABB will continue to advocate for improved inpatient and outpatient reimbursement for blood and related therapies at CMS and, if not successful, will take the message directly to Congress.  In particular, AABB will analyze cost data included in the Bureau of Labor Statistics’ (BLS) producer price index (PPI) for blood. Staff will develop and advance positions regarding the appropriate use of the PPI in adjusting Medicare inpatient DRG payments.  Activities will continue to be coordinated with other organizations with interests in blood-related reimbursement policies.  AABB will also take a leading role in collaborating with other interested parties on efforts aimed at improving Medicare reimbursement for cellular therapies.  In addition, AABB will continue its broad efforts to educate hospitals about appropriate billing and reimbursement for blood and transfusion therapies as well as cellular therapies. 

International Blood Safety: AABB will advocate ongoing, and if appropriate, increased federal support for blood safety initiatives under the President’s Emergency Plan for AIDS Relief (PEPFAR). 

Cord Blood and Other Cellular Therapies:  AABB will continue to promote AABB’s standards and accreditation programs in the national cord blood program being established by the Health Research and Services Administration (HRSA).  In addition, AABB, in collaboration with other interested organizations, will support regulatory and legislative measures to advance cellular therapies.

NIH Support for Transfusion and Cellular Therapy Research: AABB will advocate greater federal support for research in transfusion medicine and cellular therapies. 

Disaster Preparedness: AABB plays a key role in ensuring the blood supply is sufficient to prepare for and respond to emergencies, primarily through coordination of the AABB Interorganizational Task Force on Domestic Disasters and Acts of Terrorism.  AABB will continue to educate agency and Congressional policymakers about the need to prioritize blood needs, especially at the local level, during disasters and the important role the Task Force plays in preparing for and responding to disasters.  AABB will continue to represent the Task Force on the Healthcare Sector Coordinating Council, a broad coalition of private sector healthcare entities charged with working with the Department of Health and Human Services (HHS) and the Department of Homeland Security (DHS) on disaster preparedness.  In addition, as a related matter, AABB will continue to lead efforts to ensure a safe and adequate blood supply in the event of a flu pandemic through its Interorganizational Task Force on Influenza Pandemics and the Blood Supply and will advocate the blood community’s positions to federal agencies, and Congress, if needed.

Regulatory/FDA Issues

AABB will continue to interact with the Food and Drug Administration (FDA) on all issues related to donor and patient safety and to address the FDA priorities of greatest concern to AABB members.  AABB will address all significant blood and cellular therapy related proposed rulemakings, guidances or other FDA policies as presented at advisory committee meetings, FDA Liaison meetings, or public forums, or released through the Federal Register. The regulatory agenda remains flexible to accommodate the need to respond to new FDA regulations, technological advances and emerging threats.  However, AABB considers the following issues among the top priorities for 2008.

Regulations Affecting Donor Eligibility and Donation Suitability: AABB will work with committee and task force members to address the many issues and data requests included in the recent comprehensive proposed rule on donor eligibility and donation suitability.

Donor History Questionnaire:  AABB will work with the Donor History Task Force to develop an acceptable post implementation study for the abbreviated Donor History Questionnaire (aDHQ) that FDA can issue to industry in a guidance document concurrently with their recognition of the aDHQ. FDA has indicated that collection of post implementation data for the aDHQ will be necessary and that FDA does not have an appropriate mechanism for collection and analysis of such data. 

Plasma Regulations:  AABB will continue to advocate for change in FDA regulations pertaining to plasma as members seek to maximize the use of life-saving blood donations for transfusions and for further manufacture while mitigating incidence of TRALI in recipients. AABB will work with an interorganizational task force and FDA to address these plasma issues. 

Cellular Therapies:  AABB will comment on all proposed regulations, guidance or related FDA activities addressing human cells, tissues and cellular and tissue related products (HCT/Ps) and will seek comment from affected industry on the logistics and practicalities that will be impacted.

Disaster Preparedness:  In conjunction with the interorganizational task forces on disasters and pandemic influenza, AABB will continue efforts to work with FDA on developing scenarios in which certain regulatory criteria could be temporarily modified in order to provide for a safe and adequate blood supply in emergency circumstances. 

Tissue:  AABB will advocate to FDA the position(s) of the Tissue Committee concerning tissue safety and respond to relevant, related proposed regulations or guidance. 

Circular of Information for Blood:  AABB will interact with FDA during agency review of proposed changes to the Circular of Information by the Circular of Information Task Force.  The task force has proposed changes to the Circular, especially the plasma section in an effort to reflect current clinical use of the products.

Donor Reentry:  AABB will continue to work with FDA and the appropriate AABB task force to resolve issues related to reentry of donors deferred due to reactive screening test results without confirmatory test results.