249 Proteomics-based Testing for the Evaluation of Ovarian ...

Medical Policy Proteomics-based Testing for the Evaluation of Ovarian Masses

Table of Contents

Policy: Commercial Policy: Medicare Authorization Information

Coding Information Description Policy History

Information Pertaining to All Policies References

Policy Number: 249

BCBSA Reference Number: 2.04.62

Related Policies

Analysis of Proteomic Patterns for Early Detection of Cancer, #536

Policy Commercial Members: Managed Care (HMO and POS), and Indemnity Medicare HMO BlueSM and Medicare PPO BlueSM Members

All uses of the OVA1 and ROMA tests are INVESTIGATIONAL, including but not limited to Preoperative evaluation of adnexal masses to triage for malignancy, or Screening for ovarian cancer, or Selecting patients for surgery for an adnexal mass, or Evaluation of patients with clinical or radiologic evidence of malignancy, or Evaluation of patients with nonspecific signs or symptoms suggesting possible malignancy, or Postoperative testing and monitoring to assess surgical outcome and/or to detect recurrent malignant

disease following treatment.

Prior Authorization Information Commercial Members: Managed Care (HMO and POS)

This is NOT a covered service.

Commercial Members: PPO, and Indemnity

This is NOT a covered service.

Medicare Members: HMO BlueSM

This is NOT a covered service.

Medicare Members: PPO BlueSM

This is NOT a covered service.

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CPT Codes / HCPCS Codes / ICD-9 Codes

The following codes are included below for informational purposes. Inclusion or exclusion of a code does not constitute or imply member coverage or provider reimbursement. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage as it applies to an individual member.

Providers should report all services using the most up-to-date industry-standard procedure, revenue, and diagnosis codes, including modifiers where applicable.

CPT Codes

CPT Description

Codes

81500 81503

81504

Oncology (ovarian), biochemical assays of two proteins (CA-125 and HE4), utilizing serum, with menopausal status, algorithm reported as a risk score ? is specific to the ROMA test. Oncology (ovarian), biochemical assays of five proteins (CA-125, apoliproprotein A1, beta-2 microglobulin, transferrin and pre-albumin), utilizing serum, algorithm reported as a risk score ? is specific to OVA1. Oncology (tissue of origin), microarray gene expression profiling of > 2000 genes, utilizing formalin-fixed paraffin-embedded tissue, algorithm reported as tissue similarity scores

ICD-9 Diagnosis Codes

Investigational for all diagnoses.

Description

The OVA1TM test 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 nongynecologic 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. This treatment is likely to produce improved patient outcomes.

The OVA1TM test from Vermillion, Inc. is considered medically necessary for the further evaluation of ovarian (adnexal) masses when independent clinical and radiologic preoperative evaluations do not indicate malignancy. All other uses of the OVA1TM test are considered investigational regardless of the commercial name, the manufacturer or FDA approval status except as noted in the policy statement.

Summary

The OVA1 test has been analytically validated and clinical performance has been established in a prospective multi-center clinical trial. The plan for this trial (although not the trial itself) has been described in the peer-reviewed literature, and a brief summary of results has appeared in a single abstract.

Extensive information about the trial is available through the posting of an FDA decision summary resulting from FDA clearance of the product in 2009. Use of the OVA1 test clearly improves the diagnostic sensitivity and the preoperative detection of ovarian cancers. This increase in the identification of malignancies should result in more early referrals to gynecological oncologists with resulting improvement in clinical outcomes. Thus, use of the OVA 1 test is considered medically necessary as part of the preoperative evaluation of patients with ovarian masses by non-gynecologic oncologists whose initial evaluation does not indicate the mass is malignant.

All other uses of this test, including use as a screening tool for ovarian cancer, are considered investigational.

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Policy History

Date

Action

2/2014 1/2014 6/2013

11/20114/2012 9/2011

7/2011

12/1/2010

New references added from BCBSA National medical policy. Updated to add new CPT code 81504. BCBSA National medical policy review. Policy statement changed to investigational for all indications. Effective 6/1/2013. Medical policy ICD 10 remediation: Formatting, editing and coding updates. No changes to policy statements. Reviewed - Medical Policy Group - Urology, Obstetrics and Gynecology. No changes to policy statements. Reviewed - Medical Policy Group - Hematology and Oncology. No changes to policy statements. Medical policy 249 effective 12/1/2010.

Information Pertaining to All Blue Cross Blue Shield Medical Policies

Click on any of the following terms to access the relevant information: Medical Policy Terms of Use Managed Care Guidelines Indemnity/PPO Guidelines Clinical Exception Process Medical Technology Assessment Guidelines

References

1. 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.

2. 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.

3. Hoskins W, Rice L, Rubin S. Ovarian cancer surgical practice guidelines. Society of Surgical Oncology practice guidelines. Oncology (Williston Park) 1997; 11(6):896-900, 03-4.

4. 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.

5. 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.

6. 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.

7. Im SS, Gordon AN, Buttin BM et al. Validation of referral guidelines for women with pelvic masses. Obstet Gynecol 2005; 105(1):35-41.

8. Medical Devices: Ovarian adnexal mass assessment score test system; Labeling; Black box restrictions. 21 CFR Part 866, Federal Register 2011;76(251):82128-82123.

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

10. U.S. Food and Drug Administration (FDA). 510(k) substantial equivalence determination decision summary: ROMATM test ? K103358. Available online at: . Last accessed October, 2013.

11. U.S. Food and Drug Administration (FDA). 510(k) Substantial Equivalence Determination Decision Summary: OVA1TM Test (K081754). Available online at: . Last accessed October, 2013.

12. Moore RG, Brown AK, Miller MC et al. The use of multiple novel tumor biomarkers for the detection of ovarian carcinoma in patients with a pelvic mass. Gynecol Oncol 2008; 108(2):402-8.

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13. Moore RG, Miller MC, Disilvestro P et al. Evaluation of the diagnostic accuracy of the risk of ovarian malignancy algorithm in women with a pelvic mass. Obstet Gynecol 2011; 118(2 Pt 1):280-8.

14. Karlsen MA, Sandhu N, Hogdall C et al. Evaluation of HE4, CA125, risk of ovarian malignancy algorithm (ROMA) and risk of malignancy index (RMI) as diagnostic tools of epithelial ovarian cancer in patients with a pelvic mass. Gynecol Oncol 2012; 127(2):379-83.

15. Kaijser J, Van Gorp T, Van Hoorde K et al. A comparison between an ultrasound based prediction model (LR2) and the risk of ovarian malignancy algorithm (ROMA) to assess the risk of malignancy in women with an adnexal mass. Gynecol Oncol 2013; 129(2):377-83.

16. Van Gorp T, Veldman J, Van Calster B et al. Subjective assessment by ultrasound is superior to the risk of malignancy index (RMI) or the risk of ovarian malignancy algorithm (ROMA) in discriminating benign from malignant adnexal masses. Eur J Cancer 2012;48(11):1649-56.

17. Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Multi-analyte testing for the evaluation of adnexal masses. TEC Assessments 2012; Volume 27, Tab C.

18. American College of Obstetricians and Gynecologists Committee on Gynecologic Practice. Committee Opinion No. 477: the role of the obstetrician-gynecologist in the early detection of epithelial ovarian cancer. Obstetrics and Gynecology 2011; 117(3):742-6.

19. American College of Obstetricians and Gynecologists (ACOG). The Role of the Obstetrician Gynecologist in the Early Detection of Epithelial Ovarian Cancer. Available online at: %20Gynecologic%20Practice/The%20Role%20of%20the%20Obstetrician%20Gynecologist%20in% 20the%20Early%20Detection%20of%20Epithelial%20Ovarian%20Cancer.aspx. Last accessed October, 2013.

20. Society of Gynecologic Oncologists. Multiplex Serum Testing for Women with Pelvic Mass (May 2013). Available online at: . Last accessed October, 2013.

21. National Center for Clinical Excellence (NICE). The recognition and initial management of ovarian cancer 2011. Available online at: . Last accessed October, 2013.

22. National Comprehensive Cancer Network (NCCN). Available online at: . Last accessed October, 2013.

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