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Homocysteine is an amino acid found in the blood, which has been evaluated as a potential marker of cardiovascular disease (CVD) in the general population and as a potential risk marker for people with CVD. The association between homocysteine-lowering interventions and risk of CVD has also been examined.
Homocysteine is a sulfur-containing amino acid that is rapidly oxidized in plasma into homocystine and cysteine-homocysteine disulfide. Measurement of total plasma homocysteine is the sum of homocysteine and its oxidized forms. The laboratory test is referred to as either homocysteine or homocystine.
Plasma levels of homocysteine have been actively researched as a risk factor for cardiovascular disease, initially based on the observation that patients with hereditary homocystinuria, an inborn error of metabolism associated with high plasma levels of homocysteine, had a markedly increased risk of cardiovascular disease. Subsequently, prospective epidemiologic studies were conducted to determine if an elevated plasma level of homocysteine was an independent risk factor for cardiovascular disease and could be used to improve current risk prediction models.
Interest in homocysteine as a potentially modifiable risk factor has been stimulated by the epidemiologic finding that levels of homocysteine are inversely correlated with levels of folate. This finding has raised the possibility that treatment with folic acid might lower homocysteine levels and, in turn, reduce the risk of CVD. Therefore, homocysteine has potential utility both as a risk predictor and as a target of treatment.
Determination of homocysteine concentration may be offered as a component of a comprehensive cardiovascular risk assessment that may include evaluation of small-density lipoproteins, subclassification of high-density lipoproteins, evaluation of lipoprotein (A), high-sensitivity C-reactive protein, and genotyping of apolipoprotein E.
Several homocysteine test systems have been cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process. These include the liquid-stable 2-part homocysteine reagent test by Catch Inc. (Maple Valley, WA) in 2006. Catch Inc. was purchased by Axis-Shield (Scotland) in 2010 and the Catch-branded products were phased out in 2011. The test is indicated for the in vitro quantitative determination of total homocysteine in serum and plasma to assist in diagnosing and treating patients with suspicion of homocystinuria and hyperhomocysteinemia. Other homocysteine test systems cleared for marketing by FDA include the Homocysteine Enzymatic Assay (Roche Diagnostics, Indianapolis, IN) in 2012, the Diazyme Enzymatic Homocysteine Assay (Diazyme Laboratories, Poway, CA) in 2012, the A/C Automatic Enzymatic Hcy [Homocysteine] Assay (AntiCancer Inc., San Diego, CA) in 2008, and the Teco Enzymatic Homocysteine Assay (Teco Diagnostics, Anaheim, CA) in 2007.
POLICYMeasurement of plasma levels of homocysteine is considered investigational in the screening, evaluation, and management of patients for cardiovascular disease.
Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
POLICY HISTORY2/2001: Approved by Medical Policy Advisory Committee (MPAC)
7/11/2001: Code Reference section updated
2/13/2002: Investigational definition added
5/8/2002: Type of Service and Place of Service deleted
8/8/2002: CPT code 82172 description revised, hyperlink added
3/31/2005: Reviewed by MPAC, Lipoprotein-associated phospholipase A2 (Lp-PLA2) is considered investigational, CPT code 82172 Note in Code Reference section “Apolipoprotein B (apo B) and Apolipoprotein E (apo E) testing is considered investigational. Apolipoprotein A (apo A) is covered. See Measurement of Small Low Density Lipoprotein (LDL) Particles medical policy.” deleted
5/12/2005: Code Reference section reviewed, ICD-9 diagnosis code 272.0-272.9, 410-414, 440.0-440.9, V12.50-V12.59, V17.3-V17.4, V77.91, V81.0-V81.2 deleted non-covered codes
5/9/2006: Policy reviewed, no changes
1/3/2007: Code reference section updated per the 2007 CPT/HCPCS revisions
4/4/2007: Policy reviewed, and updated. Homocysteine, apolipoprotein B (apo B), apolipoprotein E, and lipoprotein-associated phospholipase A2 (Lp-PLA2) separated into individual policies. Previously addressed in combination in the Tests used for Screening, Diagnosis, and Management of Dyslipidemia and Cardiovascular Disease policy
4/24/2009: Policy reviewed, no changes.
06/21/2011: Policy reviewed; no changes.
05/09/2012: Policy reviewed; no changes.
09/03/2013: Policy reviewed; no changes.
06/09/2014: Policy reviewed; description updated. Policy statement unchanged.
07/30/2015: Code Reference section updated for ICD-10.
09/11/2015: Policy reviewed; no change in policy statement. Investigative definition updated in Policy Guidelines section.
01/19/2016: Policy description updated regarding homocysteine test systems. Policy statement unchanged.
06/06/2016: Policy number added.
SOURCE(S)Blue Cross Blue Shield Association Policy # 2.04.23
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.