The Centers for Medicare and Medicaid Services is amending its diagnostic ultrasound policy to allow coverage of Doppler monitoring of cardiac output in ventilated patients in intensive care and operative patients with a need for intraoperative fluid optimization.
The agency said that new studies had come to light that led it to reverse its previous decision against national coverage of the monitoring.
“As we developed this decision, we used the best available medical evidence—in the form of randomized controlled clinical trials—to reevaluate our position on this important noninvasive method of caring for patients in intensive care situations,” CMS Acting Administrator Leslie V. Norwalk said in a statement.
Deltex Medical Group PLC, the Chichester, England-based company that makes the monitoring equipment, petitioned CMS last year to revisit its coverage decision. According to Deltex, the earlier CMS decision was made before its device, the CardioQ, was commercially available. The CardioQ was approved by the Food and Drug Administration under the 510(k) process in 2003.
CMS agreed with Deltex that there was now sufficient evidence to support coverage. The agency found a number of prospective, randomized studies showing that when compared with standard cardiac output (CO) monitoring, patients managed with the less invasive esophageal Doppler monitoring “had adequate CO, shorter hospital length of stays … and, generally, decreased complications.”
The CardioQ system uses a disposable ultrasound probe inserted into the patient's esophagus. It determines circulating blood volume, a crucial measure during surgery or for ventilated patients in the ICU. The measure is used to guide intravenous fluid replacement and drug therapy.