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Jan 31, 2009 05:21AM
You might also want to check out your carrier's policy regarding a breast MRI. If you cannot locate it on the website (usually under a physician tab/icon under a general link for Medical Policies - and you'll probably have to search), call the customer service center and ask them to direct you to the location of the written policy.
Here is the policy for BCBS of Oklahoma:
Magnetic Resonance Imaging (MRI) of the Breast (BMRI)
ILLINOIS: Illinois Joint Committee on Administrative Rules of the Administrative Code, Title 50: Insurance, Section 2016.30 - Required Coverage for Reconstructive Surgery Following Mastectomy
NEW MEXICO: None
TEXAS: 1997 Texas Department of Insurance (TIC Article 21.53I) Statute/Rule
FEDERAL (applies to all Plans): Federal Law Women's Health and Cancer Rights Act (WHCRA) of 1998 (Title IX)
Each benefit plan or contract defines which services are covered, which are excluded, and which are subject to dollar caps or other limits. Members and their providers have the responsibility for consulting the member's benefit plan or contract to determine if there is any exclusion or other benefit limitations applicable to this service or supply. If there is a discrepancy between a Medical Policy and a member's benefit plan or contract, the benefit plan or contract will govern.
Magnetic Resonance Imaging (MRI) of the Breast (BMRI) may be considered medically necessary as an alternative to screening mammography in the following:
* Patients considered to have a family history suggestive of hereditary breast cancer (multiple first-and/or second-degree relatives with breast, ovarian, or colon cancer; OR
* Patients with a known BRCA-1 or BRCA-2 mutation; OR
* To screen the contralateral breast in patients who have known breast cancer.
BMRI may be considered medically necessary for diagnosis or detection in the following:
* To evaluate the breast in patients with adenocarcinoma involving axillary nodes but with mammographically normal breast; OR
* To determine ipsilateral tumor extent, and/or the presence of contralateral disease, in patients with newly diagnosed, clinically present localized breast cancer; OR
* Before and after completion of neoadjuvant chemotherapy, to evaluate chemotherapeutic response and the extent of residual disease prior to surgical treatment; OR
* To further evaluate suspicious clinical findings or imaging results that remain indeterminate after primary screening test results (mammography, breast ultrasound, biopsy) and physical examination are inconclusive for breast carcinoma or when these studies cannot be performed; OR
* To evaluate suspected breast cancer recurrence in patients who have undergone post-mastectomy tissue reconstruction with tissue transfer flaps or implants; OR
* To evaluate suspected breast cancer recurrence in patients with a prior history of breast cancer and inconclusive mammography, ultrasound and clinical findings.
BMRI is considered experimental, investigational and unproven for all other indications, including but not limited to:
* As a screening technique in average risk patients; OR
* As a screening technique for the detection of breast cancer when sensitivity of mammography is limited (such as, dense breasts, breast implants); OR
* For evaluation of low-suspicion findings on conventional testing not indicated for immediate biopsy and referred for short-interval follow-up; OR
* To diagnose a suspicious breast lesion in order to avoid biopsy; OR
* To further characterize indeterminate breast lesions identified by clinical exam, mammography or ultrasound when a biopsy can be performed; OR
* For evaluation of residual tumor in patients with positive margins after lumpectomy; OR
* To differentiate cysts from solid breast lesions; OR
* MRI of the breast that does not use scanners equipped with breast coils, regardless of the clinical indications.
BMRI to identify the status of a breast implant (regardless of breast implant age) placed for cosmetic reasons or for augmentation unrelated to breast cancer may be considered a cosmetic exclusion and will be subject to benefit limitations.
CPT Codes: HCPCS Codes:
ICD-9 Diagnosis Codes: ICD-9 Procedure Codes:
174.0, 174.1, 174.2, 174.3, 174.4, 174.5, 174.6, 174.8, 174.9, 175.0, 175.9, 196.3, 198.81, 233.0, 611.72, 996.54, V10.3, V16.0, V16.3, V16.41
MRI is the use of a magnetic field and radio waves (instead of radiation) to produce detailed, computer-generated pictures of organs, body areas, or the entire body.
BMRI can be performed using magnetic resonance (MR) scanners and intravenous MR contrast agents. Specialized breast coils are used to enhance the test outcome, which allows for bilateral breast imaging and greater differentiation of varying breast tissue. The patient is in a prone position with the breasts hanging through a cutout in the table. When MRI-guided biopsy of a lesion is planned, the patient may be positioned on her side to permit easier access to the breast for biopsy. The MRI-guided breast biopsy is accomplished using MRI-guide compatible needles and localization equipment. BMRI may also be called magnetic resonance mammography (MRM).
Regarding risks of inheriting the susceptibility to breast cancer and use of BMRI, patients are evaluated for alterations or mutations in two genes, BRCA-1 and BRCA-2. These patients are of families suspected or confirmed as:
* Having hereditary breast cancer,
* Occurring at an early age,
* In multiple generations or multiple first-degree relatives,
* Occurring bilaterally, and
* Occurring in a pattern suggesting an autosomal dominant pattern of inheritance (consistent with a high probability of harboring the breast cancer gene).
Families at high risk for harboring a BRCA-1 or BRCA-2 mutation are those in which the incidence of breast cancer is found in first- or second-degree relatives, about half the family members are affected. The susceptibility may be transmitted through the maternal or paternal side of the family. The identification of BRCA-1 and BRCA-2 mutation makes it possible to test for abnormalities in these genes and gain information on the future risk of cancer. When faced with the risk of inheriting the susceptibility to cancer, patients with a positive test, a family history of breast cancer, or family members having a confirmed mutation of the BRAC-1 or BRAC-2 gene, may consider management options, such as BMRI.
This policy regarding BMRI as a screening and/or diagnostic (detection) tool was primarily based upon several Blue Cross Blue Shield Association (BCBSA) Technology Evaluation Center (TEC) Assessments (BCBSA TEC Assessment).
For patients who are at high genetic risk for breast cancer - based on 2003 BCBSA TEC Assessment:
* When applied to high genetic-risk patients, the evidence appears to show at least equivalent performance for MRI in terms in sensitivity in detecting breast cancer compared to mammography. In the studies reviewed, MRI detected 100% of cancer cases, while mammography detected 33%.
* When applied to average-risk patients, the direct benefit of MRI screening among this population has not been proven. Because the prevalence of breast cancer is extremely low in average-risk patients, screening with a test such as MRI that has inferior specificity would result in lower positive-predictive values and many more false-positive results. Compared with mammography, there would be greater numbers of workups, biopsies, and morbidity if MRI screening were to be applied to average-risk women.
For patients who have breast characteristics limiting the sensitivity of mammography - based on 2004 BCBSA TEC Assessment:
* When applied to patients with or without a prior history of breast cancer, evidence is insufficient to draw conclusions on the effects of adjunctive BMRI on health outcomes.
* When applied to patients in the average-risk population, the incremental effects of adjunctive BMRI screening are uncertain.
* When the sensitivity of mammography is limited in patients after breast conservation therapy, there may be improvements in sensitivity with BMRI; however, more prospective studies are needed to confirm this.
For patients who have breast cancer and desire screening of the contralateral breast - based on 2004 BCBSA TEC Assessment:
* Several BMRI studies were conducted at various times before, during, and after treatment of breast cancer. Most studies reported that contralateral cancers detected on BMRI were not detected by conventional testing, whereas in some cases BMRI was done to evaluate suspicious findings in the contralateral breast. Four of five studies reported a 4% to 9% prevalence of cancer in the contralateral breast using MRI, with one study reporting a higher 24%. The positive predictive variable ranged from 20% to 80% and specificity ranged from 76% to 97%.
* A larger study of 212 patients with negative findings on mammograms on the asymptomatic contralateral breast found 12 cancers (5%) on BMRI. However the positive predictive variable was 20% and specificity of 76%.
* When the positive predictive variables and specificity for BMRI have not been well established, more confirmatory studies are necessary to support the use of BMRI in screening the contralateral breast.
Diagnostic or Detection Uses:
For patients who have a suspected breast implant rupture which had been originally placed for cosmetic reasons or augmentation (unrelated to breast cancer augmentation or reconstruction), whether clinical conditions appear or not, BMRI is not a covered benefit, as the initial breast implant placement was a cosmetic augmentation procedure. All services relating to the post-cosmetic augmentation procedure, including, but not limited to BMRI, are not a covered benefit.
For patients who have a suspected breast implant rupture which had been originally placed for breast reconstruction resulting from a mastectomy due to breast cancer, accidental injury, or trauma, BMRI would be considered a covered benefit as mandated by Federal Legislation.
For patients who have a suspected occult breast primary tumor with axillary nodal adenocarcinoma when there is a negative mammography and physical examination - based on 2004 BCBSA TEC Assessment:
* The adjunctive use of BMRI allows patients to avoid the morbidity of mastectomy in a substantial portion of patients (approximately 25% - 61%) compared to the risk of an unnecessary biopsy estimated at 8%.
* The use of positive BMRI findings to guide breast conserving therapy instead of presumptive mastectomy appears to offer substantial benefit of breast conservation in true-positive BMRI.
For patients who have posteriorly located tumors and determination of chest wall involvement is required - based on clinical studies:
* The available prospective study of 19 patients with posteriorly located breast tumors suspected to involve the pectoralis major muscle based on either mammography or clinical examination, the presence of abnormal enhancement within the pectoralis major muscle on BMRI was 100% sensitive and specific for identifying five tumors that actually had invaded the chest wall. In the available studies, the results of the BMRI were compared with surgical and pathological findings. Prior to the BMRI and based on clinical examination, thirteen of the 19 were thought to be fixed on the chest wall. When based on mammography, twelve of the 19 were thought to have pectoral muscle involvement.
* The available evidence from two other studies reported four cases in which BMRI was able to determine involvement of the chest wall with 100% accuracy. Given the high level of diagnostic accuracy for BMRI, as compared with reference standard and conventional alternative techniques, the evidence is considered sufficient to permit conclusions that BMRI improves net health outcomes.
For patients who have suspicious breast lesions and further characterization is desired - based on 2000, 2001, and 2004 BCBSA TEC Assessments:
* The available studies addressed a group of patients who have breast lesions of sufficient suspicion to warrant recommendation to undergo biopsy for diagnosis. Therefore, BMRI results are assumed to have an impact on the decision whether or not to undergo definitive biopsy, considered the gold standard.
* The available evidence did not show that this use of BMRI would improve health outcomes. Considering the relative ease of breast biopsy, the sensitivity of BMRI would have to be virtually 100% to confidently avoid biopsy. While BMRI performs well, it is clear that the sensitivity is not 100%. False negative results tend to occur, particularly in certain subcategories, such as ductal carcinoma in situ, but invasive carcinomas may fail to enhance on MR, leading to false negative findings as well. The potential harm to health outcomes of failing to diagnose breast cancer or at least delaying the diagnosis of breast cancer is of significant concern.
For patients who have low-suspicion findings on conventional testing not indicated for immediate biopsy and referred for short-interval follow-up:
* The available evidence suggests that adjunctive BMRI may be very sensitive and specific in patients with low-suspicion findings on conventional testing and may provide a useful method to select patients for biopsy or to avoid prolonged short-interval follow-up. However, none of the available studies use prospective methods in the appropriate patient population to directly compare the sensitivity and specificity of short-interval mammographic follow-up with BMRI and to determine the effects of adjunctive BMRI on cancer detection rate and biopsy rate.
* Well-designed prospective confirmatory studies would be necessary to permit conclusions regarding the effect this adjunctive use of BMRI has on health outcomes.
For patients who have clinically localized breast cancer and preoperative mapping to identify multicentric disease is desired - based on 2000 and 2004 BCBSA TEC Assessments:
* The available multiple studies confirm BMRI has a better sensitivity for identifying multicentric breast tumors compared to mammography and/or ultrasound. Approximately 2% to 15% of patients otherwise eligible for breast conserving therapy may have multicentric disease seen on BMRI. BMRI is primarily used to identify multicentric breast tumors that have not been detected on conventional testing using mammography, clinical exam, or ultrasound.
* The effect on health outcomes of multicentric disease detected only on BMRI has not been established. If BMRI information is used to guide mastectomy, then the potential benefit of breast conservation will be decreased. The effects of multicentric disease on locoregional occurrence and survival have not been established after either breast conserving therapy with whole-breast radiation or modified radical mastectomy.
For patients who have locally advanced breast cancer and require preoperative tumor mapping before and after completion of neoadjuvant chemotherapy - based on 2004 BCBSA TEC Assessment:
* Compared with conventional methods of evaluating tumor size and extent (such as mammography, clinical exam, or ultrasound), BMRI provides an estimation of tumor size and extent that is at least as good as or better than that based on alternatives. One clinical trial found BMRI to be 100% sensitive and specific for defining residual tumor after chemotherapy. Conversely, mammography achieved 90% sensitivity and 57% specificity, and clinical examination was only 50% sensitive and 86% specific.
* Using BMRI instead of conventional methods to guide surgical decision-making regarding the use of breast conserving therapy versus mastectomy would be at least as beneficial and may more frequently lead to the appropriate surgical procedure.
For patients who have locally advanced breast cancer and require evaluation of response during neoadjuvant chemotherapy - based on 2004 BCBSA TEC Assessment:
* The available evidence is limited to a few small studies with inconsistencies in outcome measures, reporting, and use of statistical comparisons. A total of six studies, including a total of 206 patients, performed BMRI during the course of chemotherapy. BMRI outcomes for response to chemotherapy were based on either reduction in tumor size or reduction in contrast enhancement. Three studies reported negative-predictive value (ability to predict a nonresponsive tumor) results of 38%, 83%, and 100%. However, the two lower estimates were from prospective studies, while the highest estimate was from a retrospective review.
* Results are not consistent, and there is insufficient evidence to determine whether BMRI can reliably predict lack of response to neoadjuvant chemotherapy. Ongoing clinical trials are pending.
For patients who have positive surgical margins after lumpectomy and require evaluation of residual tumor - based on clinical studies:
* Seven studies evaluated the diagnostic performance of BMRI to determine the presence of residual disease after prior biopsy or lumpectomy. Histopathology on re-excision was used as the reference standard. Most of these studies, including a single prospective study, reported poor sensitivity and specificity of BMRI for detection of residual disease. Two studies that reported more favorable results have methodological concerns that limit the influence of reported results. Three of the studies were conducted in the same institution and accrued patients during similar time periods, so overlap of reported patients may exist.
* The available evidence is not sufficient to permit conclusions whether BMRI improves net health outcomes when used to identify the presence and/or extent of residual disease after lumpectomy and prior to re-excision.
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MED207.110bu, Genetic Testing for Inherited Mutations or Susceptibility to Cancer or Other Conditions
SUR716.009, Breast Implant, Removal and/or Insertion
Title: Effective Date:
Magnetic Resonance Imaging (MRI) of the Breast (BMRI) 01-01-2007
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