Members of Congress Urge CMS to Take Action to Reduce Preventable False-Positive Diagnostic Test Results for Sepsis

Bipartisan letter sent to U.S. Department of Health and Human Services encourages the establishment of a new, national standard of care for sepsis testing accuracy to prevent patient harm, reduce healthcare costs, and combat antibiotic resistance

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Magnolia Medical Technologies

Dec 07, 2021, 13:15 ET

SEATTLE, Dec. 7, 2021 /PRNewswire/ -- Magnolia Medical Technologies, Inc., inventors of Steripath®, the only FDA 510(k)-cleared device platform indicated to reduce blood culture contamination for sepsis testing¹, commended U.S. Representatives Mike Levin (D-CA), Gus Bilirakis (R-FL), and eight of their colleagues for sending a joint, bipartisan letter urging the Centers for Medicare and Medicaid Services (CMS), an agency within the U.S. Department of Health and Human Services (HHS), to prioritize a quality measure for hospitals and healthcare systems to achieve a blood culture contamination of one percent or less. The letter encouraged the development and implementation of clinical practices and technologies that are proven to reduce contamination that can lead to the false-positive diagnosis of sepsis, and also outlined appropriate incentives for their adoption.

Each year, more than 1.4 million patients with false-positive blood culture results are put at risk for sepsis misdiagnosis which can have serious impacts, including unnecessary and prolonged antibiotic therapy, extended hospital stays, increased risk of hospital-acquired infections, and increased morbidity and mortality. The problem of sepsis misdiagnosis costs the U.S. healthcare system an estimated $6 billion² every year.

"By embracing an innovative approach to blood culture processing, CMS can advance the accuracy of the diagnosis of blood stream infections, including sepsis, to improve patient outcomes and avoid costly complications from misdiagnosis," said Representative Gus Bilirakis. "This common-sense step is a win-win for patients and the healthcare system as a whole, which is why my bipartisan colleagues and I are enthusiastically encouraging CMS to take this important step."

"We urge CMS to take meaningful action to reduce the preventable error of blood culture contamination which represents an immense and avoidable economic and public health burden," Representatives Levin and Bilirakis wrote in the letter. "By prioritizing the development and implementation of a specific quality measure for blood culture contamination and appropriately incentivizing the use of clinical practices and technologies that are proven to reduce (and nearly eliminate) contamination, CMS can directly and dramatically reduce the number of false-positive blood tests for sepsis, one of the deadliest infections Americans confront."

"We applaud the efforts of Representatives Levin, Bilirakis, and the rest of their colleagues from Congress who joined them in sending this important bipartisan letter," said Greg Bullington, CEO and co-founder of Magnolia Medical Technologies. "Magnolia is committed to diagnostic accuracy and the prevention of patient harm. We have worked tirelessly to create an extensive scientific and clinical evidence base proving that we can significantly improve the accuracy of sepsis testing. We look forward to CMS making this proposed national quality measure a reality."

Earlier this year, the U.S. House of Representatives passed H.R. 4355, the Military Construction, Veterans Affairs, and Related Agencies Appropriations Act, 2022 (MILCON-VA Act). The legislation's committee report directs the Department of Veterans Affairs (VA) to prioritize the development of a quality measure to achieve a blood culture contamination rate of one percent or less, preventing unnecessary, avoidable health risks and harm to veterans due to a misdiagnosis of sepsis.

The Steripath® Initial Specimen Diversion Device® is currently in use in hundreds of healthcare systems and hospitals across the country and has demonstrated clinical and cost-effectiveness in 20 studies, reporting sustained results of zero or near-zero blood culture contamination rates, up to a 31% reduction in vancomycin days of therapy, and as much as a 12-fold decrease in false-positive CLABSIs over extended periods of time.^3-10

This extensive data demonstrating the clinical performance of Steripath validates that patient harm resulting from false-positive sepsis diagnoses can be prevented. Magnolia Medical is committed to working with the federal government to ensure all patients nationwide are protected from the implications of false-positive sepsis test results.

About Magnolia Medical Technologies

Magnolia Medical Technologies develops, manufactures, and markets innovative blood and bodily fluid collection devices to facilitate significant improvements in the accuracy, consistency, and predictability of critical laboratory tests. Magnolia Medical invented and patented the Initial Specimen Diversion Technique (ISDT™) and Device (ISDD®) for blood culture collection and contamination prevention. The company has amassed an intellectual property portfolio, including more than 100 issued method, apparatus, and design patents with more than 70 additional patent applications pending. For more information, visit www.magnolia-medical.com.

References:

Indicated to reduce the frequency of blood culture contamination when contaminants are present, compared to standard method controls without diversion.
Data on file.
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