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Centers for Medicare & Medicaid Services

National Coverage Analysis (NCA) Tracking Sheet for Ultrasound Diagnostic Procedures (CAG-00309R)

Deltex Medical Group, manufacturer of the CardioQ esophageal Doppler monitor, has requested a reconsideration of the current NCD for ultrasound diagnostic procedures.  This NCD describes indications and limitations on coverage. Technologies are listed as either Category I (clinically effective, usually part of initial patient evaluation, may be an adjunct to radiologic and nuclear medicine diagnostic technique) or Category II (clinical reliability and efficacy not proven).  Medicare coverage is only extended to the procedures listed in Category I.  Techniques in Category II are considered experimental and are not covered.  Monitoring of cardiac output (Doppler) is placed in Category II.  Therefore, reimbursement for the use of esophageal Doppler monitoring to determine cardiac output and for hemodynamic management is not currently covered.

Deltex asserts in its request that the current NCD pre-dates the commercial availability of both the CardioQ and its predecessor devices (the EDM I and EDM II), much, if not all, of the validation data and all of the peer-reviewed, randomized controlled clinical trial data.  They request that esophageal Doppler monitoring should be covered in those patient groups that have been studied; specifically, ventilated patients in the ICU and operative patients with a need for intra-operative fluid optimization.  We are opening a National Coverage Analysis to determine if ultrasound monitoring of cardiac output is reasonable and necessary for Medicare beneficiaries.

Diagnostic Tests (other)
Inpatient Hospital Services
Physicians' Services
Requestor Name(s)Andy Hill (Deltex Medical Group)
Requestor Letter(s)View Letter
Formal Request Accepted and Review Initiated08/31/2006
Expected NCA Completion Date05/27/2007
Public Comment Period08/31/2006 - 09/30/2006
Proposed Decision Memo Released02/26/2007
Proposed Decision Memo Public Comment Period: 02/26/2007 - 03/28/2007 
Decision Memo Released05/22/2007
Comments for this NCA:View Public Comments
Lead Analyst(s)
  • LCDR Tara Turner, PharmD
Lead Medical Officer(s)
  • James Rollins, MD, MSHA, PhD

August 31, 2006

CMS opens this reconsideration of the NCD on Ultrasound Diagnostic Procedures.  The formal request is to remove the current non-coverage for cardiac output monitoring.  The initial 30-day public comment period begins with this posting date, and ends after 30 calendar days.  CMS considers all public comments, and is particularly interested in clinical studies and other scientific information relevant to the technology under review.

Instructions on submitting comments can be found at http://www.cms.hhs.gov/InfoExchange/02_publiccomments.asp#TopOfPage

February 26, 2007

CMS posts the Proposed Decision Memorandum  and opens a 30 day public comment period on the proposed decision.

May 22, 2007

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