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MP 2.04.62 Proteomics-based Testing Related to Ovarian Cancer

Medical Policy    
Subsection Last Review Status/Date
Reviewed with literature search/11:2014
Original Policy Date
Return to Medical Policy Index


Our medical policies are designed for informational purposes only and are not an authorization, or an explanation of benefits, or a contract. Receipt of benefits is subject to satisfaction of all terms and conditions of the coverage. Medical technology is constantly changing, and we reserve the right to review and update our policies periodically. 


More than 21,000 women in the United States are diagnosed each year with ovarian cancer and approximately 14,000 die of the disease.(1) The mortality rate depends on 3 variables: (1) characteristics of the patient; (2) biology of the tumor (grade, stage, type); and (3) quality of treatment (nature of staging, surgery and chemotherapy used).(2) 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 recommended ovarian cancer surgery and follow-up treatment be performed by physicians with ovarian cancer disease expertise.(3) To date, dozens of articles have been published on the application of this recommendation looking at long-term outcomes, short-term outcomes, and process measures (eg, types of treatment such as complete staging or tumor debulking). At least 2 meta-analyses have concluded that outcomes are better in patients with ovarian cancer when they are treated by gynecologic oncologists.(4,5) Data have been most convincing for patients with advanced-stage disease.

Adult women presenting with an adnexal mass have an estimated 68% likelihood of having a benign lesion.(6) About 6% have borderline tumors, 22%, invasive malignant lesions, and 3%, metastatic disease. Clinicians generally agree that women with masses that have a high likelihood of malignancy should undergo surgical staging by gynecologic oncologists. However, women with clearly benign masses do not require referral to a specialist. Criteria and tests that help differentiate benign from malignant pelvic masses are thus desirable.

In 2005, the American College of Obstetricians and Gynecologists and the Society of Gynecologic Oncologists jointly released referral guidelines that address criteria for referring women with pelvic masses that are suspicious for ovarian cancer to gynecologic oncologists.(7)
Separate criteria were developed for premenopausal and postmenopausal women. In premenopausal women, referral criteria included at least one of the following: elevated CA125 (>200 U/mL), ascites, evidence of abdominal or distant metastasis, or a positive family history. The referral criteria in postmenopausal women were similar, except that a lower threshold for an elevated CA125 test was used (35 U/mL) and nodular or fixed pelvic mass was an additional criterion.

Two proteomic tests have now been cleared by FDA with the intended use to triage patients with adnexal masses. A suggested use of the test is to identify women with a positive test who have a higher likelihood of malignant disease and may benefit from referral to a gynecologic-oncology specialist. Patients with positive results may be considered candidates for referral to a gynecologic oncologist for treatment.

Regulatory Status

On July 16, 2009, the OVA1TM test (Vermillion Inc., Fremont, CA) was cleared for market by FDA as a 510(k) submission. On September 1, 2011, the Risk of Ovarian Malignancy Algorithm (ROMATM test; Fujirebio Diagnostics Inc., Malvern, PA) was cleared by FDA as a 510(k) submission. Because the OVA1 test had been found to be a class II medical device by virtue of the July 2009 clearance, ROMA was found to be substantially equivalent to that predicate device. Intended use of OVA1 is as an aid to further assess the likelihood that malignancy is present when the physician’s independent clinical and radiological evaluation does not indicate malignancy. Intended use of ROMA is as an aid in assessing whether a premenopausal or postmenopausal woman who presents with an ovarian adnexal mass is at high or low likelihood of finding malignancy on surgery. Neither test is FDA-cleared as a screening or stand-alone diagnostic assay. FDA product code: ONX

Black Box Warning

On December 10, 2011, FDA published an amendment to the regulation for classifying ovarian adnexal mass assessment score test systems to restrict these devices so that a prescribed warning statement that addresses off-label risks be highlighted by a black box warning.(8) The warning is intended to mitigate the risk to health associated with off-label use as a screening test, stand-alone diagnostic test, or as a test to
determine whether or not to proceed with surgery.


All uses of the OVA1 and ROMA tests are investigational, including but not limited to

  1. preoperative evaluation of adnexal masses to triage for malignancy, or
  2. screening for ovarian cancer, or
  3. selecting patients for surgery for an adnexal mass, or
  4. evaluation of patients with clinical or radiologic evidence of malignancy, or
  5. evaluation of patients with nonspecific signs or symptoms suggesting possible malignancy, or
  6. postoperative testing and monitoring to assess surgical outcome and/or to detect recurrent malignant disease following treatment.



Policy Guidelines

OVA1 and ROMA tests are combinations of several separate lab tests and involve a proprietary algorithm for determining risk (ie, they are what the American Medical Association’s CPT calls “Multianalyte Assays with Algorithmic Analyses” [MAAAs]).

Effective 1/1/13, there are specific CPT category I MAAA codes for these tests:

81500 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.

81503 Oncology (ovarian), biochemical assays of five proteins (CA-125, apoliproprotein A1, beta-2 microglobulin, transferrin and prealbumin), utilizing serum, algorithm reported as a risk score – is specific to OVA1.

CPT instructs that these codes cannot be reported with the component tests (i.e., codes 86304 and 86305 cannot be reported with 81500, and codes 82172, 82232, 83695, 83700, 84134, 84466, and 86304 cannot be reported with 81503).

Prior to 2013, these tests would most likely be reported using an unlisted CPT code such as 84999 unlisted chemistry procedure or 86849 unlisted immunology procedure.

According to one national laboratory’s website, prior to 2013, they reported 83001 (Gonadotropin; follicle stimulation hormone [FSH]) and 83002 (Gonadotropin; luteinizing hormone [LH]), in addition to 84999 for OVA1, as those additional services are used “to help determine menopausal status so that the appropriate reference range can be applied.”

Benefit Application
BlueCard/National Account Issues

State or federal mandates (e.g., FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity. 


This policy was originally created in 2010 and was updated regularly with searches of the MEDLINE database. Most recently, the literature was reviewed through September 25, 2014. The literature review focuses on the following 3 issues related to evaluation of diagnostic tests.

Assessment of a diagnostic technology typically focuses on 3 parameters: (1) technical performance; (2) diagnostic performance (sensitivity, specificity, and positive and negative predictive values) in appropriate populations of patients; and (3) demonstration that the diagnostic information can be used to improve patient outcomes (clinical utility).

Technical performance is typically assessed with 2 types of studies, those that compare test measurements with a criterion standard and those that compare results taken with the same device on different occasions (test-retest).

Diagnostic performance is evaluated by the ability of a test to accurately diagnose a clinical condition in comparison with the criterion standard. The sensitivity of a test is the ability to detect a disease when the condition is present (true positive), while specificity indicates the ability to detect patients who are suspected of disease but who do not have the condition (true negative). Evaluation of diagnostic performance, therefore, requires independent assessment by the 2 methods in a population of patients who are suspected of disease but who do not all have the disease.

Clinical utility involves assessing the data linking use of a test to improvement in patient management and/or health outcomes. While in some cases, tests can be evaluated adequately using technical and diagnostic performance. When a test identifies a new or different group of patients with a disease; randomized trials are needed to demonstrate impact of the test on the net health outcome.

Technical Performance

Descriptions of the developmental process for the OVA1 test have been published in U.S. Food and Drug Administration (FDA) documents and in a perspective by Fung in 2010.(9-11) Candidate biomarkers were selected based on initial studies using mass spectroscopy but were converted to standard immunoassays to improve analytical performance. Seven final markers were evaluated, none of which individually appeared to be highly specific for malignant ovarian disease. However, the choice of 5 of these (CA125, prealbumin, apolipoprotein A-I, β2-microglobulin, transferrin) produced a composite profile that did appear to have discriminatory ability. The test, as cleared by FDA, is performed on a blood sample, which is to be sent to a reference laboratory for testing using the 5 immunoassays previously described. Results of the 5 determinations are entered manually into an Excel® spreadsheet used by the OvaCalc software. This software contains an algorithm that combines the 5 discrete values into a single unitless numeric score from 0.0 to 10.0.

Details of the algorithm appear proprietary, but development is described as an empiric process, based on use of banked samples from academic partners, on a small prospective study of samples from Europe and using a designated subset of samples from the clinical study used to support submission to FDA. It appears at an undisclosed point in the developmental process as a result of interaction with FDA;
separate cutpoints were developed for premenopausal and postmenopausal women.

A similar developmental process was described for ROMA by Moore et al.(12) They studied 9 biomarkers and chose human epididymis secretory protein 4 (HE4) and CA125 because these markers in tandem produced the best performance. The algorithm developed was subsequently modified to include menopausal status and was independently validated.(13) Again, separate cutoffs were used for premenopausal and postmenopausal women.

The OVA1 is a qualitative serum test that combines immunoassay results for the 5 analytes previously described (CA125, prealbumin, apolipoprotein A-I, 2-microglobulin, transferrin) into a single numerical score. Analytical performance for the test demonstrated good test precision (coefficient of variation [CV] range, 1%-7.4%, depending on the sample levels studied) and good reproducibility (CV range, 2.8%-
8.9%). The test appears linear, reagent and samples stable, and there was no observed interference evaluating common endogenous substances (eg, hemoglobin, bilirubin).

The ROMA test is also a qualitative serum test that combines 2 analytes HE4 EIA and the ARCHITECT CA125, along with menopausal status into a numerical score. Analytical performance for the ROMA also exhibited good precision with a total CV ranging from 0.49% to 7.72%, depending on both sample values and menopausal status. The reproducibility of the test was acceptable, with a CV that ranged from 0.98% to 25.9%, with highest values observed in patients with low scores, as expected. The reagents are variably stable, and users are instructed to follow package inserts for stability on each analyte used. The test was unaffected by interference with hemoglobin, bilirubin, lipids, or human antimouse antibodies. However, high levels of rheumatoid factor (>500 IU/mL) did appear to cause elevations in test values, and testing in patients with elevated rheumatoid factor is not recommended.

Diagnostic Performance

OVA1 Test

Diagnostic performance of the OVA1 test was evaluated in a prospective, double-blind clinical study using 27 enrollment sites.(11) The study was supported by the commercial sponsor of the test. Patients underwent a complete clinical evaluation before surgical intervention, and only patients with adnexal masses who had a planned surgical intervention were included. The study enrolled a total of 743 patients, with 146 subjects used in the training set and 516 in the testing set. Seventy-four patients were excluded because of missing information or samples. The final prevalence of cancer in the population was 27%. Using pathologic diagnosis as the criterion standard, test performance, when combined with presurgical assessment for benign disease, was as follows in the hands of nongynecologic oncologists (see Table 1).

Table 1. Diagnostic Performance of OVA1 


Clinical assessment alone

Clinical assessment with OVA1







Positive predictive value



Negative predictive value



a Confidence intervals not provided.

No additional studies evaluating the diagnostic performance of the OVA1 test were identified in literature updates.

ROMA Algorithm

In 2014, Wang et al published a meta-analysis of studies evaluating the diagnostic accuracy of the ROMA algorithm and comparing it to the performance of single markers HE4 and CA125.(14) To be included in the meta-analysis, studies had to investigate both HE4 and CA125 or calculate ROMA, include women with ovarian cancer and benign gynecologic disease, use pathology diagnosis as the reference standard, and collect blood samples before treatment was initiated. A total of 32 studies met these inclusion criteria; 6 of these were conducted in the United States. Findings of the overall pooled analysis of diagnostic accuracy are presented in Table 2.

Table 2. Diagnostic Performance of ROMA Compared with HE4 and CA125: MEta-Analysis Findings


No. Studies

Sensitivity, % (95% CI)

Specificity, % (95% CI)



85.3 (81.2 to 88.6)

82.4 (77.4 to 86.5)



76.3 (72.0 to 80.1)

93.6 (90.0 to 95.9)



79.2 (74.0 to 83.6)

82.1 (76.6 to 86.5)


HE4: human epididymis secretory protein 4.

Findings were similar when diagnostic performance in premenopausal women and postmenopausal women were evaluated separately. ROMA had similar or higher sensitivity than HE4 and CA125, and HE4 had the highest specificity.

The study with the largest sample size was published by Karlsen et al in 2012.15 The study included 1218 women presenting with pelvic masses. Before diagnosis, HE4 and CA125 levels were obtained, and ROMA and the Risk of Malignancy Index (RMI; an index consisting of ultrasound findings, menopausal status, CA125 levels) were calculated. At a fixed sensitivity of 94.4%, the specificity of ROMA was 76.5% and the specificity of RMI was 81.5%. At a fixed specificity of 75%, the sensitivity of ROMA was 94.8% and the sensitivity of RMI was 96.0%. Accuracy of ROMA and RMI were not compared statistically, but appeared to be similar. In another study, Kaijser et al evaluated 360 women with pelvic masses who were scheduled for surgery.(16) The study compared the diagnostic accuracy of ROMA and an ultrasound-based prediction model (LR2) developed by the International Ovarian Tumor Analysis (IOTA) Study. Histology was used as the reference standard. The overall performance of LR2 (94% sensitivity, 82% specificity) was significantly better than ROMA (84% sensitivity, 80% specificity).

Clinical Utility

The ideal study design to evaluate clinical utility of proteomics-based testing would be a randomized controlled trial comparing patient management decisions (eg, referral patterns) and/or health outcomes (eg, mortality) in patients managed with the tests with those managed according to best current clinical practices. No randomized or nonrandomized studies with these comparisons were identified.

A TEC Assessment was completed in 2012 on “Multi-analyte testing for the evaluation of adnexal masses.”(17) The Assessment included evaluation of both the OVA1 and ROMA tests in regards to their impact on health outcomes. The following conclusions were made:

“The evidence regarding the effect of OVA1 and ROMA and effects on health outcomes is indirect and based on studies of diagnostic performance of the tests in patients undergoing surgery for adnexal masses. Although the studies show improvements in sensitivity and worsening of specificity with the use of the tests in conjunction with clinical assessment, there are problems in concluding that this results in improved health outcomes. The clinical assessment performed in the studies is not well characterized. Although OVA1 improves sensitivity, specificity declines so much that most patients test positive. ROMA does not improve the sensitivity of testing to a great extent. Underlying these issues is uncertainty regarding whether there would be actual health benefits based on altering patient referral based on these tests…Whether use of OVA1 or ROMA improves the net health outcome or is as beneficial as other diagnostic strategies has not been demonstrated. Referring all patients to a physician with expertise in staging and debulking ovarian cancer is a reasonable clinical alternative with no harm.”

In 2014, Kaijser et al published a study that did not directly evaluate clinical utility but that provides relevant information.(18) It was a retrospective cohort study that included 101 newly diagnosed cases of biopsy-proven invasive ovarian cancer. Blood samples obtained before treatment were analyzed; HE4 and CA125 levels were measured and the ROMA algorithm was calculated. Median overall survival in the study cohort was 3.7 years. In a multivariate analysis controlling for confounding variables, neither HE4 levels nor ROMA were independently associated with progression-free survival (PFS) or disease-specific survival (DSS). For example, for ROMA and the outcome of PFS, the adjusted hazard ratio (HR) for each 10% increase in risk was 0.98 (95% confidence interval, 0.88 to 1.11). Patients were not prospectively
managed according to their HE4 levels or ROMA score and thus the actual impact of these tests on PFS and DSS cannot be determined from this study.

Clinical Input Received From Physician Specialty Societies and Academic Medical Centers

While the various physician specialty societies and academic medical centers may collaborate with and make recommendations during this process, through the provision of appropriate reviewers, input received does not represent an endorsement or position statement by the physician specialty societies or academic medical centers, unless otherwise noted. Results of clinical input in 2012 revealed mixed support for the use of this test as a tool for triaging patients with an adnexal mass. Reviewers agreed that
the evidence was insufficient to determine the impact of these tests on referral patterns. For indications other than triaging patients with an adnexal mass, there was a lack of support for use of these tests.

Summary of Evidence

The OVA1 and ROMA tests have both been analytically validated and clinical performance has been reported in prospective multicenter clinical studies. Changes in the observed sensitivity and negative predictive value of testing compared with clinical assessment has been small and of uncertain diagnostic value. Studies on the diagnostic accuracy of these tests compared with other diagnostic tools have had mixed findings, but do not report that ROMA is superior to other risk prediction tools that use standard clinical information or single markers. No studies have been performed that directly evaluated the impact on patient management eg, referral patterns, and no studies have evaluated the impact on health outcomes. Clinical input from academic medical centers and specialty societies did not show consensus that this test improved outcomes when used as a tool to triage patients with adnexal masses. As a result of the evidence and clinical input, these tests are considered investigational pending more information about their performance and impact on outcomes.

Practice Guidelines and Position Statements

The American Congress of Obstetricians and Gynecologists (ACOG) addressed the use of the OVA1 test in their guidelines on the role of the obstetrician-gynecologist in the early detection of epithelial ovarian cancer, last updated in 2011.19 In May, 2013, the Society for Gynecologic Oncology endorsed the ACOG guideline.(20) This document included the following statements:

  • The OVA1 test appears to improve the predictability of ovarian cancer in women with pelvic masses
  • This is not a screening test, but may be useful for evaluating women with a pelvic mass
  • Clinical utility is not yet established

The National Institute for Health and Care Excellence issued guidance in 2011 on the recognition and management of ovarian cancer.(21) These guidelines made the following recommendations:

  • The evidence suggests that the combination of HE4 and serum CA125 is more specific, but less sensitive than either marker in isolation.
  • There was no evidence to suggest that multiple tumor markers were much better than the two marker combination of serum CA125 and HE4.
  • The routine use of CA125 is recommended; the data on other serum markers is not substantial enough to recommend their use

The National Comprehensive Cancer Network (NCCN) guideline on ovarian cancer (v3.2014) includes the following statement(22):

“It has been suggested that specific biomarkers (serum HE4 and CA125) along with an algorithm (Risk of Ovarian Malignancy Algorithm [ROMA]) may be useful for determining whether a pelvic mass is malignant or benign. The FDA has approved the use of HE4 and CA125 for estimating the risk of ovarian cancer in women with a pelvic mass. Currently, the NCCN Panel does not recommend the use of these biomarkers for determining the status of an undiagnosed pelvic mass.”

U.S. Preventive Services Task Force Recommendations
In 2012, The U.S. Preventive Services Task Force recommended against screening women for ovarian cancer (D recommendation).(23) The task force has not addressed proteomics-based testing related to ovarian cancer.

Medicare National Coverage
There is no national coverage determination (NCD). In the absence of an NCD, coverage decisions are left to the discretion of local Medicare carriers.


  1. Surveillance Epidemology and End Results (SEER) Program. SEER Stat Fact Sheets: Ovary Cancer. Accessed October 7, 2014.
  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. Feb 2009;112(2):422-436. PMID 18990435
  3. Hoskins W, Rice L, Rubin S. Ovarian cancer surgical practice guidelines. Society of Surgical Oncology practice guidelines. Oncology (Williston Park). Jun 1997;11(6):896-900, 903-894. PMID 9189944
  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. Jun 2007;105(3):801-812. PMID 17433422
  5. Giede KC, Kieser K, Dodge J, et al. Who should operate on patients with ovarian cancer? An evidence-based review. Gynecol Oncol. Nov 2005;99(2):447-461. PMID 16126262
  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. Jul 2010;36(1):81-87. PMID 20217895
  7. Im SS, Gordon AN, Buttin BM, et al. Validation of referral guidelines for women with pelvic masses. Obstet Gynecol. Jan 2005;105(1):35-41. PMID 15625139
  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. PMID
  9. Fung ET. A recipe for proteomics diagnostic test development: the OVA1 test, from biomarker discovery to FDA clearance. Clin Chem. Feb 2010;56(2):327-329. PMID 20110452
  10. U.S. Food and Drug Administration (FDA). 510(k) substantial equivalence determination decision summary: ROMA™ test – K103358. Accessed August 21,2014.
  11. U.S. Food and Drug Administration (FDA). 510(k) Substantial Equivalence Determination Decision Summary:OVA1™ Test (K081754). Accessed August 21, 2014.
  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. Feb 2008;108(2):402-408. PMID 18061248
  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. Aug 2011;118(2 Pt 1):280-288. PMID 21775843
  14. Wang J, Gao J, Yao H, et al. Diagnostic accuracy of serum HE4, CA125 and ROMA in patients with ovarian cancer: a meta-analysis. Tumour Biol. Jun 2014;35(6):6127-6138. PMID 24627132
  15. 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. Nov 2012;127(2):379-383. PMID 22835718
  16. 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. May 2013;129(2):377-383. PMID 23360924
  17. Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Multi-analyte testing for the evaluation of adnexal masses. TEC Assessment Program. 2012; Volume 27, Tab 8. PMID
  18. Kaijser J, Van Belle V, Van Gorp T, et al. Prognostic Value of Serum HE4 Levels and Risk of Ovarian Malignancy Algorithm Scores at the Time of Ovarian Cancer Diagnosis. Int J Gynecol Cancer. Sep 2014;24(7):1173-1180. PMID 24987915
  19. American College of Obstetricians and Gynecologists (ACOG). The Role of the Obstetrician Gynecologist in the Early Detection of Epithelial Ovarian Cancer. Accessed August 21, 2014.
  20. Society of Gynecologic Oncologists. Multiplex Serum Testing for Women with Pelvic Mass (May 2013).
    Accessed August 21, 2014.
  21. National Center for Clinical Excellence (NICE). The recognition and initial management of ovarian cancer 2011; Accessed August 21, 2014.
  22. National Comprehensive Cancer Network (NCCN). Ovarian Cancer v3.2014. Accessed August 21, 2014.
  23. U.S. Preventive Services Task Force. Screening for Ovarian Cancer. 2012; Accessed September 25, 2014.  




CPT  81500 Oncology (ovarian), biochemical assays of two proteins (CA-125 and HE4), utilizing serum, with menopausal status, algorithm reported as a risk score
  81503 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
ICD-9-CM Diagnosis 220 Benign neoplasm of ovary
  236.2 Neoplasm of uncertain behavior, ovary
  239.5 Neoplasn of unspecified nature, other genitourinary organs (includes ovary)
  789.33, 789.34 Abdominal or pelvic swelling, mass or lump, left upper quadrant and right upper quadrant codes
ICD-10-CM (effecitve 10/1/15) D27.0-D27.9 Benign neoplasm of ovary, code range
   D39.10-D39.12 Neoplasm of uncertain behavior, ovary, code range
   D49.5 Neoplasm of unspecified nature, of other genitourinary organs (includes ovary)
  R19.01,R19.02 Right upper quadrant abdominal swelling, mass and lump and left upper quadrant abdominal swelling, mass and lump codes
ICD-10-PCS (effective 10/1/15)    Not applicable. ICD-10-PCS codes are only used for inpatient services. There are no ICD procedure codes for laboratory tests.



Protemic-based testing, ovarian

Policy History


Date Action Reason
04/08/10 Add to Medicine section New policy
4/14/11 Replace policy Policy updated with literature search. References 9-11 and 16, 17 added; reference 13 updated. No changes to policy statements
11/8/12 Replace policy Policy updated with literature search, 2012 TEC Assessment, and results of clinical vetting. References 7, 13 and 17-28 were added to the policy. ROMA™ testing was added to the policy and policy statement changed to investigational for all indications. New CPT codes added to policy.
11/14/13 Replace policy Policy updated with literature search through September 30, 2013. References 14, 15 and 20 added; other references renumbered or removed. No change to policy statement. Title changed to Proteomic-based Testing Related to Ovarian Cancer.
11/13/14 Replace policy Policy updated with literature review through September 25, 2014. References 1, 14, 18, and 23 added. Policy statement unchanged. Policy title changed to “Proteomics-Based Testing Related to Ovarian Cancer”.


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