BlueCross and BlueShield of Montana Medical Policy/Codes
Scintigraphy of Acute Deep Venous Thrombus
Chapter: Radiology
Current Effective Date: August 27, 2013
Original Effective Date: August 27, 2013
Publish Date: May 27, 2013
Revised Dates: This policy is no longer scheduled for routine literature review and update.
Description

Deep vein thrombosis (DVT) is a common occurrence. It is estimated that in the United States approximately five million patients experience one or more episodes of DVT each year, resulting in over 500,000 cases of pulmonary embolism and 100,000 deaths.  Prompt treatment of acute thrombus is considered essential to initiate anticoagulation or thrombolytic therapy to prevent the serious consequences of pulmonary embolus.  Radiographic evaluation of deep venous thrombus is performed both in symptomatic patients and in asymptomatic patients at high risk of venous thrombus, i.e., after orthopedic surgery.  Contrast venography is considered the gold standard of diagnosis, but this invasive procedure is not routinely used.  Duplex ultrasonography is probably the most common noninvasive technique used, followed by impedance plethysmography. Ultrasonography is thought to have excellent sensitivity and specificity in the thigh, but poor diagnostic accuracy below the knee.  Both of the above techniques provide indirect evidence of thrombus by imaging an alteration in blood flow and thus cannot distinguish between acute and chronic thrombus.

Direct detection of acute venous thrombus has been investigated using intravenously injected radiolabeled synthetic peptides that bind with high affinity to receptors expressed on activated platelets.  In 1999, the Food and Drug Administration (FDA) approved the radiopharmaceutical peptide apcitide (AcuTect™) for use in the scintigraphic imaging of acute venous thrombosis in the lower extremities in patients who have signs and symptoms of acute thrombophlebitis. Apcitide binds to glycoprotein IIb/IIIa fibrinogen receptors, which are expressed on the surface of activated platelets, thus making the radiopharmaceutical specific for acute, not chronic thrombus.

Policy

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.

Medically Necessary

BCBSMT may consider scintigraphic imaging of acute deep venous thrombus in the lower extremities medically necessary in patients with signs and symptoms of acute deep venous thrombus.

Investigational

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

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.

Rationale for Benefit Administration

This medical policy was developed through consideration of peer reviewed medical literature, FDA approval status, accepted standards of medical practice in Montana, Technology Evaluation Center evaluations, and the concept of medical necessity. BCBSMT reserves the right to make exceptions to policy that benefit the member when advances in technology or new medical information become available.

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.

Rationale

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.

Coding

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. 

ICD-9 Codes

451.11, 451.19, 453.40, 453.41, 453.42

Procedural Codes: 78456
References
  1. Carretta, R.F., Vand Streek, P., et al.  Nuclear Exam Rivals Venography for Clots Diagnostic Imaging (1998 June) 85-86.
  2. AcuTect package insert.  Diatide, Inc. Londonderry, New Hampshire.
  3. Taillefer, R., Therasse, E., et al.  Comparison of early and delayed scintigraphy with 99Tc-apcitide and correlation with contrast-enhanced venography in detection of acute deep vein thrombosis.  Journal of Nuclear Medicine (1999 December) 40(12): 2029-35.
  4. Morimoto, Y., Sugimoto, T., et al.  Clinical assessment of vascular thrombosis using indium-111 platelet scintigraphy.  Angiology (2000 January) 51(1): 61-8.
  5. Taillefer, R., Edell, S., et al.  Acute thromboscintigraphy with (99m) To-apcitide:  results of the phase 3 multicenter clinical trial comparing 99Tc-apcitide scintigraphy with contrast venography for imaging acute DVT.  Multicenter Trial Investigators.  Journal of Nuclear Medicine (2000 July) 41(7):1214-23.
  6. Morimoto, Y., Sugimoto, T., et al.  Diagnosis of deep vein thrombus using platelet scintigraphy.  Annals of Thoracic Cardiovascular Surgery (2001 June) 7(3): 138-42.
  7. Scintigraphy of Acute Deep Venous Thrombus.  Chicago, Illinois:  Blue Cross Blue Shield Association Medical Policy Reference Manual (2003 March) Radiology 6.01.22.
History
May 2013  New 2013 BCBSMT medical policy.  Scintigraphic imaging of acute deep venous thrombus in the lower extremities may be considered medically necessary in patients with signs and symptoms of acute deep venous thrombus.
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Scintigraphy of Acute Deep Venous Thrombus