DESCRIPTION
Adult women presenting with an adnexal mass have an estimated 68% likelihood of having a benign lesion, 6% have borderline tumors, 22% invasive lesions, and 3% metastatic disease. Although the majority of these individuals can be treated without the use of the gynecologic oncology expertise, there is clearly a segment of this population that would be well-served by specialized care. Enhanced diagnostic reliability (i.e discriminating between benign and malignant masses )in the pre-operative decision-making process will appropriately triage those individuals who would benefit from the gynecologic oncology specialties.
A proteomic test has been developed for use in women with adnexal masses considered to be benign based on routine clinical and radiological evaluations, with a plan for surgery by a non-gynecological oncologist. In this patient subset, the test serves to estimate the risk that there is actually an underlying malignant process and therefore adjust the pre-operative plan of care accordingly.
The proteome is the entire set of proteins expressed by a genome, cell, tissue or organism. Proteomics is the global analysis of gene expression used to identify, quantitate, and characterize specific proteins.
This test, (e.g., OVA1 ) is a qualitative serum test that combines immunoassay results for 5 analytes (CA 125, prealbumin, apolipoprotein A-1, beta2 microglobulin, and transferrin) into a single numerical score. Patients with positive results should be considered candidates for referral to a oncological gynecologist. According to ACOG, It has been well-established that women with ovarian cancer whose care is managed by a physician who has advanced training and expertise in the treatment of women with gynecologic cancer, such as a gynecologic oncologist, have improved overall survival rates as compared with those treated without such collaboration.
POLICY
Proteomics-based testing (e.g., OVA1) when used to assess an adnexal mass for possibility of malignancy is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Proteomics-based testing (e.g., OVA1) for all other uses including but not limited to the following is considered investigational:
Screening for ovarian cancer
Evaluation of individuals with clinical or radiological evidence of malignancy
Evaluation of individuals with nonspecific signs or symptoms suggesting possible malignancy
Post-operative testing and monitoring to assess surgical outcome and/or to detect recurrent malignant disease following treatment
Any device utilized for this procedure must have FDA approval specific to the indication, otherwise it will be considered investigational.
Policies with similar titles: Analysis of Proteomic Patterns in Serum for Early Detection of Cancer
MEDICAL APPROPRIATENESS
Proteomics - based testing for the evaluation of an ovarian (adnexal) mass is considered medically appropriate if ALL of the following are met:
Mass is suggestive of a benign lesion (based on clinical and radiological evaluation)
Individual is 18 years or older
Current treatment plan is for surgical intervention
Results of the test will guide future plan of care
Individual has not yet been referred to a gynecologic oncologist
IMPORTANT REMINDER
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
ADDITIONAL INFORMATION
In the 2009 FDA submission the OVA1TM carried the precautionary statement that it is not intended to be used as a screening test or to determine whether a patient should proceed to surgery. No controlled studies were found in the published literature that validate the use of proteomics-based testing as a screening tool for ovarian cancer.
SOURCES
American Association of Clinical Chemistry. (2010) The diagnostic dilemma of ovarian cancer. Clinical Laboratory News 36 (7) retrieved December 28, 2010 from http://www.aacc.org/publications/cln/2010/july/Pages/CoverStory2.aspx.
American College of Obstetricians and Gynecologists. (2007). Management of adnexal masses. Obstetrics and Gynecology, 110 (1), 201-214.
BlueCross BlueShield Association. Medical Policy reference Manual. (4:2010). Proteomics - based testing for the evaluation of ovarian (adnexal) masses (2.04.62). Retrieved December 16, 2010 from Blue Web. (13 articles and/or guidelines reviewed)
Ueland, F. (2008). A biomarker for risk stratification of ovarian tumors. Retrieved December 28, 2010 from http://www.touchendocrinology.com/articles/biomarker-panel-risk-stratification-ovarian-tumors (Level 5 Evidence - Independent)
U.S. Food and Drug Administration. (2009, September). Substantial equivalent determination decision summary: OVA1TM test. K081754. Retrieved December 28, 2010 from http://www.accessdata.fda.gov/cdrh_docs/reviews/K081754.pdf.
ORIGINAL EFFECTIVE DATE: 5/14/2011
MOST RECENT REVIEW DATE: 5/14/2011
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Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
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