May 22, 2007 -- The Centers for Medicare & Medicaid Services (CMS) announced today a decision to provide coverage for Doppler monitoring of cardiac output in certain settings. CMS has determined that the current evidence is adequate to revise its longstanding Ultrasound Diagnostic Procedures National Coverage Determination and remove the past noncoverage of this diagnostic test in these settings.

"Today's decision reflects CMS' commitment to using evidence-based approaches to provide Medicare beneficiaries with reasonable and necessary medical technologies as they evolve through innovation in the marketplace," said CMS Acting Administer Leslie V. Norwalk, Esq. "As we developed this decision, we used the best available medical evidence -- in the form of randomized controlled clinical trials -- to re-evaluate our position on this important non-invasive method of caring for patients in intensive care situations."

CMS will amend the National Coverage Determination (NCD) "Ultrasound Diagnostic Procedures" at section 220.5 of the NCD manual by adding "Monitoring of cardiac output (Esophageal Doppler) for ventilated patients in the ICU and operative patients with a need for intra-operative fluid optimization" to the list of covered uses.
Cardiac output refers to the volume of blood ejected from the heart over a period of time. For patients undergoing surgery or those in the intensive care units (ICUs), cardiac output monitoring is used to guide intravenous fluid replacement and pharmacologic therapy to maintain adequate flow of blood to the patient's organs.

In contrast to other techniques for measuring cardiac output, the probe of the esophageal Doppler can be inserted within minutes, requires minimal technical skill, and is not associated with major complications.

CMS was asked to reconsider its longstanding NCD on ultrasound diagnostic procedures. Deltex Medical Group, manufacturer of the CardioQ esophageal Doppler monitor, asserted in its reconsideration request that the existing NCD pre-dated the commercial availability of both the CardioQ and its predecessor devices, much, if not all, of the validation data and all of the peer-reviewed, randomized controlled clinical trial data.

CMS' decision is effective today, and is available online at https://www.cms.hhs.gov/mcd/viewdecisionmemo.asp?id=196.

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