Caption Health Secures NTAP Authorization From Centers For Medicare And Medicaid Services For AI-Guided Ultrasound Platform

Expands access to key diagnostic tool for Medicare patients in the hospital

Caption Health, the leader in AI-guided ultrasound, announced that the Centers for Medicare and Medicaid Services (CMS) have approved new technology add-on payments (NTAP) for the Caption Guidance™ AI-based software platform for Medicare patients receiving in-patient care. Cases eligible for NTAP will have a newly created ICD-10 procedure code corresponding to Caption Guidance™.  The NTAP designation is awarded to new medical technologies and services which are expected to substantially improve the diagnosis or treatment of Medicare beneficiaries, and will go into effect October 1, 2021. Caption Guidance’s Breakthrough Designation from the FDA addresses the NTAP innovation and clinical efficacy requirements, and a subsequent application met the cost criterion to receive the NTAP designation.

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The additional reimbursement covers Caption Guidance ultrasound acquisitions for 461 separate diagnostic resource groups (DRGs), including heart failure, stroke, and other common cardiac issues for inpatient care. With NTAP, hospitals would be eligible for an additional payment – up to a maximum amount – in cases where the costs of using this innovative technology exceed the payment under the corresponding DRG. Depending on the DRG and the hospital’s costs, the additional payment could be significant for the hospital.

This NTAP decision comes at a time when the US healthcare system is experiencing an aging population, increasing rates of chronic disease, and a shortage of clinicians.  According to the Kaiser Family Foundation, there were approximately 62.0 million Medicare beneficiaries in 2020. For critically ill patients, a study in the Journal of the Intensive Care Society has shown that point-of-care ultrasounds (POCUS) changed patient management in 47% of cases. Caption Guidance enables more healthcare providers to capture diagnostic-quality ultrasound images throughout the care process.

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Caption AI, which includes Caption Guidance, is the first and only FDA-cleared AI imaging acquisition and guidance software for cardiac ultrasound, and was eligible for this NTAP pathway because of its Breakthrough Device status from the FDA. In studies, including one published in JAMA Cardiology earlier this year, more than 90% of the images acquired using Caption AI were of sufficient diagnostic quality to assess LV size, LV function, RV size and pericardial effusion. Caption AI is also being utilized by the United States Naval Medical Research Center for the second phase of its COVID-19 Health Action Response for Marines (CHARM) study.

“With the NTAP approval, America’s vulnerable senior population will have greater access to innovative AI-based guidance and interpretation technologies from Caption, which means ultrasound testing can be utilized as needed,  offering the potential to positively impact treatment and outcomes,” said Steve Cashman, CEO of Caption Health. “We are on a mission to expand access to ultrasound diagnosis, and have already made strides through enabling a broader set of care team members to acquire diagnostic quality ultrasound studies. This NTAP designation helps to build upon that.”

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