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INDEX:
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

Effective Date: 06/01/2012 Title: OVA1, Test for Ovarian Cancer
Revision Date: 10/01/2015 Document: BI355:00
CPT Code(s): 81503, 82172, 82232, 84134, 84466, 86304
Public Statement

Effective Date:

a)    This policy will apply to all services performed on or after the above Revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

OVA-1 requires pre-authorization.

The OVA-1 test is a blood test that combines several other tests into a single score.  This test is covered only for certain women planning to undergo surgery for a pelvic mass that appears to be benign.  The test is indicated only if a positive test would lead to referral to a gynecologic oncologist prior to surgery.

If this test does not meet standards for medical necessity, the patient may be responsible for the entire cost of the test.


Medical Statement

The proteomics-based OVA1™ test is covered 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 who meets ALL of the following criteria:

1)    Older than 18 years;

2)    Adnexal, presumed ovarian, mass present;

3)    Surgery is planned for treatment of the mass;

4)    The patient has not been referred to a gynecologic oncologist;

5)    A positive test would lead to referral to a gynecologic oncologist prior to surgery.

Codes Used In This BI:

81503             Oncology (ovarian), biochemical assays of five proteins

82172             Assay of apolipoprotein

82232             Assay of beta-2 protein

84134             Assay of prealbumin

84466             Assay of transferring

86304             Immunoassay tumor ca 125


Limits

OVA1™ is considered investigational for any other use, including screening for ovarian cancer, selecting patients with an adnexal mass for surgery, evaluation of patients with clinical or radiological evidence of malignancy, or detection of recurrent malignant disease following surgery.


Background

The OVA1™ test (Vermillion, Inc., Fremont, CA) 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. 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.  This test will be covered only for this patient subset.

In 2009, it was estimated that more than 21,000 women in the U.S. were diagnosed with ovarian cancer and more than 14,000 died of this disease (Bristow, 2009).  The mortality rate 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) (du Bois, 2009).   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 (Hoskins, 1997).  To date dozens of articles and several meta-analyses or systemic 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 is 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) (Tingulstad, 2003).  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 (Giede, 2005).

 

A recent systematic review of 198 studies addressing the role of specialty treatment by gynecologic oncologists and evaluation of other practice related factors (type of hospital, surgical volume, etc.) was more guarded in its analysis (duBois, 2009).  This review noted that not all reports confirmed these findings of improved performance based on sub-specialty. It also noted that in some reports only patients presenting with certain stages of disease (in most cases advanced stage although in some cases early stage) were studied and found to exhibit treatment differences. Nevertheless, this review also concluded that the use of sub-specialists and better education of treatment options for both primary care physicians and patients was warranted.

 

In an analysis of predictors of comprehensive surgical treatment (meticulous and extensive disease staging, efforts at debulking of the tumor with removal of all visible lesions, lymphadenectomy) in patients with ovarian cancer, Goff et al. observed that comprehensive treatment was linked not only to physician factors but also to a number of simple demographic factors including age, race, insurance status and geographic location (urban versus rural) (Goff, 2007). Optimization of treatment for ovarian cancer may clearly be complicated by these factors.

 

Adult women presenting with an adnexal mass have an estimated 68% likelihood of having a benign lesion (Van Holsbeke, 2010).  About 6% have borderline tumors, 22% invasive lesions, and 3% metastatic disease.

 

Obviously 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. Recent publications have appeared describing the use of CA 125 with a symptom index (Anderson, 2009), the use of an “ovarian crescent sign” on ultrasound (Van Holsbeke, 2010), and the use of three-dimensional ultrasound (Alcazar, 2009) to provide increased diagnostic reliability in this decision-making process, but all of these appear to require further validation before being considered for routine clinical use.

 

The OVA1™ is a new proteomic test that has been developed specifically to triage patients thought to have benign adnexal masses with planned treatment by a non-gynecologic-oncologist physician. 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.

 

Regulatory Status

 

On July 16, 2009, the Vermillion OVA1™ test was cleared for market by the FDA as 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 OVA1TM 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.”


Reference

A recipe for proteomics diagnostic test development: the OVA1™ test from biomarker discovery to FDA clearance. Clin Chem 2010; 56(2):327-9.

ACOG Committee Opinion: number 280, December 2002. (2002) The role of the generalist obstetrician-gynecologist in the early detection of ovarian cancer. Obstet Gynecol 2002; 100(6):1413-6.

Alcazar JL, Rodriguez D.(2009) Three-dimensional power Doppler vascular sonographic sampling for predicting ovarian cancer in cystic-solid and solid vascularized masses. J Ultrasound Med 2009; 28(3):275-81.

Andersen MR, Goff BA, Lowe KA et al.(2009) Combining a symptom index with CA 125 to improve detection of ovarian cancer. Cancer 2009; 113(3):484-9.

Andersen MR, Goff BA, Lowe KA et al.(2010) Use of a Symptom Index, CA125, and HE4 to predict ovarian cancer. Gynecol Oncol 2010; 116(3):378-83.

Bristow RE, Zahurak ML, Diaz-Montes TP et al.(2009) 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.

Dearking AC, Aletti GD, McGree ME et al. (2007) How relevant are ACOG and SGO guidelines for referral of adnexal mass? Obstet Gynecol 2007; 110(4):841-8.

du Bois A, Rochon J, Pfisterer J et al.(2009) Variation in institutional infrastructure, physician specialization and experience, and outcome in ovarian cancer: a systematic review. Gynecol Oncol 2009; 112(2):422-36.

Giede KC, Kieser K, Dodge J et al.(2005) 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. (2007) Predictors of comprehensive surgical treatment in patients with ovarian cancer. Cancer 2007; 109(10):2031-42.

Hoskins W, Rice L, Rubin S. (1997) Ovarian cancer surgical practice guidelines. Oncology 1997; 11(6):896-904.

Muller CY. (2010) Doctor, should I get this new ovarian cancer test-OVA1? Obstet Gynecol 2010; 116(2 Pt 1):246-7.

Tingulstad S, Skjeldestad FE, Hagen B. (2003) The effect of centralization of primary surgery on survival in ovarian cancer patients. Obstet Gynecol 2003; 102(3):499-505.

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 May 2010.

Ueland F, DeSimone C, Seamon L et al. (2010) The OVA1 test improves the preoperative assessment of ovarian tumors. Gynecol Oncol 2010; 116(3 suppl 1):S23.

Van Holsbeke C, Van Belle V, Leone F et al. (2010) 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 [E-pub ahead of print].

Vernooij F, Heintz P, Witteveen E et al. (2007) 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.

Zhang Z, Chan DW. (2010) 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.

 


Application to Products
This policy applies to all health plans administered by QualChoice, both those insured by QualChoice and those that are self-funded by the sponsoring employer, unless there is indication in this policy otherwise or a stated exclusion in your medical plan booklet. Consult the individual plan sponsor Summary Plan Description (SPD) for self-insured plans or the specific Evidence of Coverage (EOC) for those plans insured by QualChoice. In the event of a discrepancy between this policy and a self-insured customer’s SPD or the specific QualChoice EOC, the SPD or EOC, as applicable, will prevail. State and federal mandates will be followed as they apply.
Changes: QualChoice reserves the right to alter, amend, change or supplement benefit interpretations as needed.
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