Hospitals Reevaluating CCP Usage Following Changes to Emergency Use Authorization

February 26, 2021

The Food and Drug Administration recently revised its recommendations for the Emergency Use Authorization for COVID-19 convalescent plasma (CCP). The revised EUA provides for enforcement discretion until May 31; after that date, only high-titer CCP will be approved for transfusion under the EUA. Additionally, BARDA’s contracts with America’s Blood Centers and the American Red Cross are likely ending in March.

As a result, hospitals will need to work directly with blood suppliers to purchase CCP. The bundled payment that hospitals receive from Medicare for inpatient services will encompass the cost of CCP, although in some cases, hospitals may qualify for a New COVID-19 Treatments Add-on Payment (NCTAP) if their costs exceed the amount of the bundled payment received for a patient. 

AABB conducted a survey to assess how FDA’s recent revisions to the EUA, as well as hospitals having to purchase CCP, might impact the usage and demand for CCP among hospital transfusion services. Staff from 224 hospitals responded to the survey, which was conducted Feb. 22-24, 2021.

More than 38% of hospitals plan to continue to use high-titer COVID-19 convalescent plasma (CCP) as a treatment option for patients with COVID-19 through May 31 and beyond, according to data from AABB’s recent survey of member hospital transfusion services. 

While almost two-fifths of hospitals plan to continue the use of CCP, the study results also indicated that a similar percentage (37.1%) are not yet clear on whether the upcoming changes will impact CCP usage. The majority of hospitals indicated that the availability of high-titer CCP units would be the most significant factor in determining CCP use in the future.

Only 5.8% of the responding hospitals plan to discontinue CCP as a treatment option (or have already done so). Staff at these hospitals cited a lack of stronger efficacy data, as well as a shift toward other treatment options, as common factors impacting the decision to discontinue or reduce CCP use.

The majority of hospitals did not indicate that the anticipated cost of purchasing CCP from blood suppliers would impact CCP utilization at their hospitals. More than half of the responding hospitals reported that CCP changes to the reimbursement structure would not impact the use of CCP as a treatment option for COVID-19. 
 
AABB released a graphic summary of the findings of the findings from this survey. Results of previous hospital surveys are available on the AABB Survey and Reports web page