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Medical Policy: 02.04.35
Original Effective Date: September 2011
Reviewed:
Revised:
Benefit Application
Benefit determinations are based on the applicable contract language in effect at the time the
services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary
based on contract, and individual member benefits must be verified. Wellmark determines medical
necessity only if the benefit exists and no contract exclusions are applicable. This medical
policy may not apply to FEP. Benefits are determined by the Federal Employee Program.
This Medical Policy document describes the status of medical technology at the time the document
was developed. Since that time, new technology may have emerged or new medical literature may
have been published. This Medical Policy will be reviewed regularly and be updated as scientific
and medical literature becomes available.
Description:
The American Cancer Society (ACS) reports in their Cancer Facts and Figures: An estimated 21,900 new cases of ovarian cancer are expected in the US in 2011. Ovarian cancer is the ninth most common cancer in women (not counting skin cancer) and ranks fifth as the cause of cancer death in women. About half of women diagnosed with ovarian cancer are age 60 and older. A woman’s risk of getting invasive ovarian cancer in her lifetime is about 1 in 71. Her lifetime chance of dying from ovarian cancer is about 1 in 95. Only 20% of ovarian cancers are diagnosed at an early stage. Finding the cancer early improves the chances it can be treated with success. About 9 out of 10 women treated for early ovarian cancer will live longer than 5 years after the cancer is found. Several large studies are underway to determine how best to find ovarian cancer in its earliest stages.
The mortality rate of ovarian cancer depends on three variables: 1) characteristics of the patient; 2) the biology of the tumor (grade, stage, and type); and 3) the quality of treatment (nature of staging, surgery and chemotherapy used). In particular, comprehensive staging and completeness of tumor resection appear to have a positive impact on patient outcome.
In 1997, the Society of Surgical Oncology first recommended ovarian cancer surgery and follow-up treatment be performed by physicians with ovarian cancer disease expertise. To date dozens of articles and several meta-analyses or systematic reviews have been published relevant to this recommendation looking at long-term outcomes, short-term outcomes, and process measures (types of treatment such as complete staging or tumor debulking). At least two meta-analyses have been performed concluding improved outcomes in patients with ovarian cancer when treated by gynecologic oncologists. Data are most convincing for patients with advanced stage disease. Median improvements in survival for patients treated by non-gynecologic oncologists versus gynecologic oncologists have been variable but impressive with increases recently reported to be up to 8 months (12 to 21 months). In at least some reports, important differences have also been observed showing improved survival in patients with early stage disease as well when treated by gynecologic oncologists.
Adult women presenting with an adnexal mass have an estimated 68% likelihood of having a benign lesion. About 6% have borderline tumors, 22%, invasive lesions, and 3%, metastatic disease. While a majority of patients can be treated without use of surgical oncology expertise, to date no existing diagnostic modalities have been identified to discriminate reliably between benign and malignant lesions. Referral guidelines were published by the American College of Obstetricians and Gynecologists (ACOG) and the Society of Gynecologic Oncologists (SGO) for women with pelvic masses that are suspicious for ovarian cancer who are being referred to gynecologic oncologists. In these guidelines, a decision to refer postmenopausal women was based on the presence of at least one of the following indicators: elevated CA 125, ascites, a nodular or fixed pelvic mass, evidence of abdominal or distant metastasis, or a family history of one or more first-degree relatives with ovarian or breast cancer. A decision to refer premenopausal women was based on at least one of the following: elevated CA 125, ascites, evidence of abdominal or distant metastasis, or a positive family history. A validation study has been performed based on these criteria, suggesting a high negative predictive value ([NPV} 90% or more) in both premenopausal and postmenopausal patients but a lower positive predictive value (as low as 34%).
OVA1™ (Vermillion, Inc., Fremont, CA) is a qualitative test that combines immunoassay results for five analytes (CA 125, prealbumin, apolipoprotein A-1, beta2 microglobulin, and transferrin) into a single numerical score. It is intended to be used in women with adnexal masses who are planning to have surgery by a non-gynecologic oncologist for disease considered benign using routine clinical and radiologic evaluation. In this patient subset, the test serves as an aid to further assess the likelihood that malignancy is present. Patients with positive results should be considered candidates for referral to a gynecologic oncologist for treatment. As described above, this treatment is likely to produce improved patient outcomes.
On July 16, 2009, the OVA1 test was cleared for market by the U.S. Food and Drug Administration (FDA) as a 510(k) submission. No predicate was identified, and the review decision was based on the de novo (automatic classification of class III devices) 510(k) review process. The intended use carried a boxed warning: “PRECAUTION: The OVA1™ test should not be used without an independent clinical/radiological evaluation and is not intended to be a screening test or to determine whether a patient should proceed to surgery. Incorrect use of the OVA1™ test carries the risk of unnecessary testing, surgery, and/or delayed diagnosis.”
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Prior Approval:
Not applicable
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Policy:
The proteomics-based OVA1™ test may be considered medically necessary as an aid to further assess the likelihood that malignancy is present when the physician’s (other than gynecologic oncologist) independent clinical and radiological preoperative evaluations do not indicate malignancy in a patient with an ovarian (adnexal) mass.
All other uses of the OVA1™ test are considered investigational including but not limited to:
- Screening for ovarian cancer
- Selecting patients for surgery for an adnexal mass
- Evaluation of patients with clinical or radiological evidence of malignancy
- Evaluation of patient with nonspecific signs or symptoms suggesting possible malignancy
- Postoperative testing and monitoring to assess surgical outcome and/or to detect recurrent malignant disease following treatment
The OVA1™ test has been analytically validated and clinical performance has been established in a prospective multi-center clinical trial. Extensive information about the trial is available through the posting of an FDA decision summary resulting from FDA clearance of the product in 2009. The use of the OVA1™ test clearly improves the diagnostic sensitivity and the preoperative detection of ovarian cancer. While the ability to triage patients for malignancy with an increased yield of true-positive results may be only one of many factors in decision making about where treatment should be delivered, it is a valuable piece of information that will contribute to better healthcare choices in dealing with a serious disease.
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Procedure Codes and Billing Guidelines:
- To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or ICD-9-CM diagnostic codes.
- 84999 Unlisted chemistry procedure
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Selected References:
- Bristow RE, Zahurak ML, Diaz-Montes TP et al. Impact of surgeon and hospital ovarian cancer surgical case volume on in-hospital mortality and related short-term outcomes. Gynecol Oncol 2009; 115(3):334-8.
- du Bois A, Rochon J, Pfisterer J et al. Variations in institutional infrastructure, physician specialization and experience, and outcome in ovarian cancer: a systematic review. Gynecol Oncol 2009; 112(2):422-36.
- Vernooij F, Heintz P, Witteveen E et al. The outcomes of ovarian cancer treatment are better when provided by gynecologic oncologists and in specialized hospitals: a systematic review. Gynecol Oncol 2007; 105(3):801-12.
- Giede KC, Kieser K, Dodge J et al. Who should operate on patients with ovarian cancer? An evidence-based review. Gynecol Oncol 2005; 99(2):447-61.
- Goff BA, Matthews BJ, Larson EH et al. Predictors of comprehensive surgical treatment in patients with ovarian cancer. Cancer 2007; 109(10):2031-42.
- Van Holsbeke C, Van Belle V, Leone FP et al. Prospective external validation of the “ovarian crescent sign” as a single ultrasound parameter to distinguish between benign and malignant adnexal pathology. Ultrasound Obstet Gynecol 2010; 36(1):81-7.
- Dearking AC, Aletti GD, McGree ME et al. How relevant are ACOG and SGO guidelines for referral of adnexal mass? Obstet Gynecol 2007; 110(4):841-8.
- Andersen MR, Goff BA, Lowe KA et al. Use of a symptom index, CA 125, and HE4 to predict ovarian cancer. Gynecol Oncol 2010; 116(3):378-83.
- U.S. Food and Drug Administration. 510(k) Substantial Equivalence Determination Decision Summary: OVA1™ Test (K081754). Available online at: http://www.accessdata.fda.gov/cdrh_docs/reviews/K081754.pdf. Last accessed August 2011
- Ueland F, DeSimone C, Seamon L et al. The OVA1 test improves the preoperative assessment of ovarian tumors. Gynecol Oncol 2010; 116(3 suppl 1):S23.
- Zhang Z, Chan DW. The road from discovery to clinical diagnostics: lessons learned from the first FDA-cleared in vitro diagnostic multivariate index assay of proteomic biomarkers. Cancer Epidemiol Biomarkers Prev 2010; 19(12):2995-9.
- Miller RW, Smith A, Desimone CP et al. Performance of the American College of Obstetricians and Gynecologists’ Ovarian Tumor Referral Guidelines with a Multivariate Index Assay. Obstet Gynecol. 2001; 117(6).
- ECRI Institute. OVA1 Test for Detection and Monitoring of Ovarian Cancer. Plymouth Meeting (PA): ECRI Institute; 2011 May 26. 5 p. [ECRI Hotline Response]. Available: http://www.ecri.org
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Policy History:
Date Reason Action
September 2011 Evidence review New policy
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drugs, etc. They are developed to
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*Current Procedural Terminology © 2010 American Medical Association. All Rights Reserved.
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