Today, U.S. Representatives Lloyd Doggett (TX-35), Rosa DeLauro (CT-03), and Patrick E. Murphy (FL-18) led a bipartisan group of lawmakers in calling on the FDA to expand Zika testing for blood donations collected in high-risk areas in an effort to prevent possible contaminations and blood shortages. Current testing costs run from $7 to $10 per unit with a limited number of facilities able to conduct Zika screening. To fulfill the obligation of enacting Zika blood testing to protect public health, the members of Congress are also calling on CMS to provide reimbursements for blood collection facilities administering these tests. Additional signers of these letters are U.S. Reps. Ted Deutch (FL-21), Eddie Bernice Johnson (TX-30), David Jolly (FL-13), Ileana Ros-Lehtinen (FL-27), and Frederica S. Wilson (FL-24).
"As you are aware, many blood donors would have no way of knowing they carried the Zika virus, since eighty percent of those infected are asymptomatic, and many others have only mild symptoms," the lawmakers wrote to the FDA. "We must implement widespread universal screening now to prevent any further contamination of the blood supply before it occurs and to preempt a widespread shortfall in the blood supply."
"Blood centers that are voluntarily testing donations for the Zika virus are currently at an additional competitive disadvantage, as are hospitals that are purchasing tested blood to keep their patients safe," they added in a letter to CMS. "CMS needs to address this by allowing hospitals to be properly reimbursed for blood that has been tested for Zika, so that blood centers can be paid in full for the costs of administering these tests."
Please find the full text of both letters below:
The Honorable Dr. Robert M. Califf, MD
Commissioner, Food and Drug Administration
10903 New Hampshire Ave
Silver Spring, MD 20993
Dear Commissioner Califf,
We write to express our continuing concern for the safety of our national blood supply with the Zika virus present in domestic mosquitoes. While we appreciate the Food and Drug Administration’s quick response to the emergence of locally transmitted cases in Miami and the recommended cessation of blood donations in Miami-Dade and Broward Counties, we believe it is more critical than ever that the Food and Drug Administration (FDA) recommends a policy of universal testing of blood donations in high-risk areas.
A testing requirement could be introduced on a prioritized basis, beginning with states adjacent to Florida and along the Gulf of Mexico, which are at the highest risk of active transmission. Following this, the FDA should determine which inland areas are the highest priority and phase in blood testing for these locations. The FDA should also phase in testing for domestic destinations that receive large numbers of international travelers from where Zika is endemic. This testing requirement should be implemented in a way that avoids overwhelming the capacity of current testing facilities, with more areas included as testing ability increases. As you are aware, many blood donors would have no way of knowing they carried the Zika virus, since eighty percent of those infected are asymptomatic, and many others have only mild symptoms.
Two tests have been approved under the FDA’s Investigational New Drug Application (IND) protocol: cobas, by Roche Diagnostics; and Procleix, by Grifols and Hologic, Inc. There are four testing sites currently using the technology: Qualtex in Atlanta; Gulf Coast Regional Blood Center in Houston; and the American Red Cross and Creative Testing in Tampa. Blood centers have used testing under IND successfully in the past, most recently in testing for West Nile Virus.
In addition to the blood centers in Miami-Dade and Broward Counties, more blood and tissue donation centers have begun to voluntarily use these IND tests, but those that fail to test their donations are leaving the safety of our national blood supply at risk. Donations had to be temporarily halted in those two counties, with recently collected blood quarantined until it can be tested. Additionally, blood centers that had received units of blood from that area have to quarantine those units until further guidance is issued. This is putting a strain on the blood supply, and could have been largely avoided if blood was already being tested in Miami-Dade and Broward Counties.
At a time when the Zika virus was only actively transmitted in a single ZIP code, the FDA recommended that blood donations be blocked for almost 4.5 million people. Many other blood centers around the country are issuing donation bans for anyone who has recently traveled to Miami-Dade or Broward County. While the FDA is assessing blood recommendations on a case-by-case basis, it is our fear that if locally transmitted Zika is found in a larger area, blood donation bans could expand to the state or along the Gulf Coast. We must implement widespread universal screening now to prevent any further contamination of the blood supply before it occurs and to preempt a widespread shortfall in the blood supply.
The cost of testing is less than $10 per blood donor—a small amount, when compared to the millions of dollars required for the lifetime care of a single infant born with microcephaly or the effects of a nationwide blood shortage.
Thank you for your timely response.
For a signed copy of this letter to the FDA, click here.
The Honorable Andrew Slavitt
Acting Administrator
Centers of Medicare and Medicaid Services
U.S. Department of Health and Human Services
Hubert H. Humphry Building
Washington, D.C. 20201
Dear Acting Administrator Slavitt,
As you know, following the active transmission of the Zika virus in Miami, Florida, the Food and Drug Administration recommended testing blood donations for the Zika virus in both Miami-Dade County and Broward County.
Two tests have been approved under the FDA’s Investigational New Drug Application (IND) protocol: cobas, by Roche Diagnostics; and Procleix, by Grifols and Hologic, Inc. Both of the available tests are individual nucleic acid tests (NATs), and cannot be used to test a multi-donor pools, raising the costs per donor. The current cost of testing blood donations for Zika is estimated at $7 to $10 per donor; a cost incurred by blood centers and then passed along to hospitals. We urge the Centers for Medicare and Medicaid Services (CMS) to create a code for hospitals to use to get reimbursed for the additional cost of blood that has been tested for the Zika virus, in order to protect our blood supply and protect the financial security of our hospitals and blood donation centers.
In addition to the blood centers in Miami-Dade and Broward Counties, more blood and tissue donation centers have begun to voluntarily use these IND tests to secure their blood supply against the Zika virus, and to protect their supply from being contaminated, quarantined, or destroyed in the event of active Zika transmission in their region. In the past three to five years, many blood centers have been struggling financially, and many operate on margins of less than two to three percent.
Blood centers that are voluntarily testing donations for the Zika virus are currently at an additional competitive disadvantage, as are hospitals that are purchasing tested blood to keep their patients safe. CMS needs to address this by allowing hospitals to be properly reimbursed for blood that has been tested for Zika, so that blood centers can be paid in full for the costs of administering these tests.
Many blood donors would have no way of knowing they carried the Zika virus, since eighty percent of those infected are asymptomatic, and many others have only mild symptoms. The Zika virus has only been actively transmitted in a single ZIP code, but the FDA recommended that blood donations be tested in a region that encompasses almost 4.5 million people. We request that CMS work to allow blood centers to fulfill their obligation to the FDA and to the American public, and that a new reimbursement code for tested blood is implemented.
We look forward to hearing your reply.
For a signed copy of this letter to CMS, click here.
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