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DESCRIPTIONAutoantibodies directed against cyclic citrullinated proteins (anti-CCP) are found in many patients with rheumatoid arthritis (RA). Citrullination refers to the post-translational modification of the amino acid arginine to citrulline by the enzyme peptidylarginine deiminase (PAD). The physiologic role of citrullination is unclear, however it has been shown to occur during apoptosis, and is thought to play a role in the degradation of intracellular proteins by unfolding protein molecules and thereby exposing them to degradation enzymes. PAD enzymes can be found in monocytes and macrophages associated with inflammation, including in the synovial fluid of patients with active RA. In patients with RA and active joint inflammation, levels of anti-CCP are higher in the synovial fluid than in the peripheral circulation. Anti-CCP found in the serum is thought to be a result of diffusion of these antibodies from the synovial fluid into the general circulation.
Autoantibodies against CCP have been recognized and measured for several decades, by means of the anti-perinuclear factor (APF) and the anti-keratin antibody (AKA). However, these older tests were performed by a cumbersome immunofluorescence assay and were not commonly used in routine clinical practice. Following the recognition that APF and AKA activity were entirely dependent upon citrullination, attention turned toward measuring anti-CCP antibodies. Serum Anti-CCP levels are currently measured using an enzyme-linked immunosorbent assay (ELISA). The first generation of anti-CCP testing (CCP1) used citrullinated proteins derived from human filaggrin. This method of testing was expensive and difficult to standardize, since it required purification of sufficient quantities of the human antigen. The second generation of anti-CCP testing (CCP2) uses a synthetic peptide antigen, thus making the test cheaper and easy to standardize. CCP2 is currently the only commercially available method for testing for anti-CCP antibodies.
The INOVA Diagnostics QUANTA Lite™ CCP IgG ELISA and the Axis-Shield Diagnostics Diastat™ anti-CCP ELISA test received 510(k) marketing clearance from the U.S. Food and Drug Administration (FDA) in 2002 for use as an aid in the diagnosis of rheumatoid arthritis. According to the FDA statement for the Diastat, “autoantibody levels represent one parameter in a multi-criterion diagnostic process, encompassing both clinical and laboratory based assessments.” Additional anti-CCP tests have received 510(k) marketing clearance since 2002.
POLICYMeasurement of anti-CCP may be considered medically necessary when used as part of the diagnostic work-up for rheumatoid arthritis up to two (2) times per calendar year.
Measurement of anti-CCP is considered investigational when used to monitor disease activity and/or treatment response.
Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Nervous/Mental Conditions, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:
A. consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and
B. appropriate with regard to standards of good medical practice; and
C. not solely for the convenience of the Member, his or her Provider; and
D. the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.
For the definition of Medically Necessary, “standards of good 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. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.
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 HISTORY4/25/2007: Policy Added
7/19/2007: Reviewed and approved by the Medical Policy Advisory Committee (MPAC)
1/7/2009: Policy reviewed, no changes
3/26/2009: Reviewed by the Medical Policy Advisory Committee (MPAC) and policy statement updated to include medically necessary when used as a part of the diagnostic workup for rheumatoid arthritis.
4/3/2009: Code reference section updated. 86200 moved to covered table. ICD-9 diagnosis codes range 714.0-714.9 added to covered table.
02/08/2010: Code Reference section updated to add ICD-9 Diagnosis Code 719.49 to the covered table.
11/17/2010: Added ICD-9 codes 719.40-719.48 and 719.50-719.59 to the Covered Codes table.
09/23/2011: Policy reviewed; no changes.
04/24/2013: Policy reviewed; no changes.
08/18/2015: Medical policy revised to add ICD-10 codes.
06/06/2016: Policy number added. Policy Guidelines updated to add medically necessary and investigative definitions.
SOURCE(S)Blue Cross Blue Shield Association Policy # 2.01.78
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.
The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.