Prior authorization is recommended. To authorize, call Blue Cross and Blue Shield of Montana (BCBSMT) Customer Service at 1-800-447-7828 or fax your request to the Medical Review Department at 406-441-4624. A retrospective review will be performed if services are not prior authorized.
BCBSMT considers scintigraphic imaging of the lower extremities for screening asymptomatic patients at risk of acute deep venous thrombus experimental, investigational and unproven.
Federal mandate prohibits denial of any drug, device or biological product fully approved by the FDA as investigational for the Federal Employee Program (FEP). In these instances coverage of these FDA-approved technologies are reviewed on the basis of medical necessity alone.
The purpose of medical policy is to guide coverage decisions and is not intended to influence treatment decisions. Providers are expected to make treatment decisions based on their medical judgment. BCBSMT recognizes the rapidly changing nature of technological development and welcomes provider feedback on all medical policies.
When using this policy to determine whether a service, supply or device will be covered, please note that member contract language will take precedence over medical policy when there is a conflict.
The following data are based on the package insert of AcuTect.
Two multicenter clinical studies included 243 patients with signs and symptoms of acute thrombus who underwent evaluation with scintigraphic imaging compared with contrast venography, considered the gold standard. The primary outcome of the studies was agreement between the interpretations of the blindly read scintigraphic and contrast venography studies. The criterion for efficacy end point was pre-set at 75% agreement, with the lower limit of the 95% confidence interval being 60%. This agreement rate took into account the blind read variability of venography due to the adverse impact of the reader being blinded to the clinical information on the patient. The agreement rate between the results of scintigraphy versus venography met this criterion.
It should be noted that the FDA-labeled indications are limited to symptomatic patients, and the data presented to the FDA focused on symptomatic patients. There are no data regarding the use of scintigraphic imaging in asymptomatic patients. Asymptomatic patients may represent a large percentage of patients undergoing imaging for DVT as a “rule out” test. For example, prior to hospital discharge after orthopedic procedures such as arthroplasties, many asymptomatic patients may undergo Doppler ultrasonography to rule out the presence of a thrombus. Data regarding this application of the scintigraphic imaging have not been published. The FDA labeling also states “How negative AcuTect images should be used in the diagnostic evaluation or therapeutic management of patients with suspected acute venous thrombosis has not been studied.”
In addition, no data are available regarding the diagnostic performance of scintigraphic imaging compared with Duplex ultrasonography; a more commonly used diagnostic technique than contrast venography. Therefore, it is not known whether the evaluation of DVT is improved by routinely performing both ultrasonography and scintigraphic imaging. Some imaging protocols suggest the use of scintigraphic imaging in the setting of indeterminate or nondiagnostic ultrasonography in symptomatic patients.
A search of the MEDLINE Database through (2002 through September 2006) identified no new clinical trials that would alter the conclusions reached above.
Disclaimer for coding information on Medical Policies
Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.
The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers. Only the written coverage position in a medical policy should be used for such determinations.
Benefit coverage determinations based on written Medical Policy coverage positions must include review of the member’s benefit contract or Summary Plan Description (SPD) for defined coverage vs. non-coverage, benefit exclusions, and benefit limitations such as dollar or duration caps.