PARTNERSHIP HEALTHPLAN OF CALIFORNIA GUIDELINE / PROCEDURE Guideline/Procedure Number: MPUG3112 Guideline/Procedure Title: Breast Magnetic Resonance Imaging (MRI) Guidelines Lead Department: Health Services ☒External Policy ☐ Internal Policy Next Review Date: 02/18/2016 Last Review Date: 02/18/2015 Original Date: 02/15/2012 Applies to: ☒ Medi-Cal ☒ Healthy Kids ☐ Employees Reviewing Entities: ☒ IQI ☐P&T ☒ QUAC ☐ OPERATIONS ☐ EXECUTIVE ☐ COMPLIANCE ☐ DEPARTMENT ☐ BOARD ☐ COMPLIANCE ☐ FINANCE ☒ PAC Approving Entities: ☐ CEO ☐ COO ☐ CREDENTIALING Approval Signature: Robert Moore, MD, MPH ☐ DEPT. DIRECTOR/OFFICER Approval Date: 02/18/2015 I. RELATED POLICIES: A. MCUP3108 BRCA – Gene Sequence Analysis B. MCUP3041 – TAR Review Process II. IMPACTED DEPTS: A. Health Services B. Claims C. Member Services III. DEFINITIONS: A. N/A IV. ATTACHMENTS: A. N/A V. PURPOSE: The following guidelines are used to assess appropriateness of breast magnetic resonance imaging (MRI). VI. GUIDELINE / PROCEDURE: A. Breast MRI is more sensitive but less specific than mammography. B. Breast MRI is useful in screening asymptomatic women with a high risk of developing breast cancer, specifically the following groups: 1. Women with known BRCA1 or BRCA2 gene mutations (ACS) 2. Women with a first-degree relative with a BRCA1 or BRCA2 mutation (ACS) 3. Women with two first-degree relatives with breast cancer, or one first-degree relative with bilateral breast cancer, or one first-degree relative with pre-menopausal breast cancer (InterQual) 4. Women with other specific genetic conditions putting them at high risk for breast cancer 5. There is controversy over whether breast MRI is useful in screening women with a history of radiation to the chest 6. There is controversy over whether breast MRI is useful in screening women with a >20% lifetime risk of breast cancer using the Gail model C. Breast MRI is useful in identifying a primary breast tumor in women who are found to have metastatic cancer in axillary lymph nodes when mammograms are normal. Page 1 of 3 Guideline/Procedure Number: MPUG3112 Lead Department: Health Services Guideline/Procedure Title: Breast Magnetic Resonance Imaging ☒ External Policy (MRI) Guidelines ☐ Internal Policy Next Review Date: 02/18/2016 Original Date: 02/15/2012 Last Review Date: 02/18/2015 ☒ Healthy Kids ☐ Employees Applies to: ☒ Medi-Cal D. Breast MRI is useful to assess possible rupture of silicone breast implants. E. Breast MRI is useful in the situation of planning breast conserving treatment following neoadjuvant chemotherapy. F. Breast MRI might be useful in pre-operative evaluation to assess risk of contralateral cancer in women at high risk (young age, dense breasts, large tumor size, infiltrating ductal carcinoma). It has not been shown useful in women at lower risk. G. Breast MRI is probably not useful in further characterizing non-specific abnormal findings on screening mammography. H. Breast MRI is not useful in routine screening of women who have an average risk of developing breast cancer I. For women who are candidates for breast MRI screening, it should be done once a year along with annual mammograms. J. Notes: 1. Most recent USPSTF guideline on breast cancer screening applies only to average-risk women (Nov 2009) and makes no recommendation one way or the other on breast MRI. 2. The American College of Radiology guidelines (2008) are more permissive, and encourage breast MRI more widely for screening asymptomatic women with increased risk and for screening the contralateral breast in newly diagnosed breast cancer. K. Criteria for breast MRI approval: If any of the following questions are answered yes, breast MRI can be approved: 1. Does the woman have a known BRCA1 or BRCA2 gene mutation? 2. Does the woman have a first-degree relative with a BRCA1 or BRCA2 gene mutation? 3. Does the woman have two first-degree relatives with breast cancer? 4. Does the woman have one first-degree relative with bilateral breast cancer? 5. Does the woman have one first-degree relative with pre-menopausal breast cancer? 6. Does the woman have another genetic condition putting her at increased risk for breast cancer? 7. Did the woman have chest radiation for any condition earlier in her life? 8. Does the woman have metastatic cancer from an unknown primary in her axillary lymph nodes? 9. If the woman has silicone breast implants, is there concern they may have ruptured? L. If the answer to all nine questions is no, breast MRI will not be approved. M. If there are other factors or concerns that may be generating the request for breast MRI, including for women with current breast cancer, with abnormal mammograms, or with abnormalities on breast examination, the TAR will be submitted to the Chief Medical Officer or Physician Designee for review. VII. REFERENCES: A. The Lancet, “MRI for breast cancer screening, diagnosis, and treatment,” Nov 19, 2011, pp 1804-1811. B. Annals of Internal Medicine, “Screening for Breast Cancer: U.S. Preventive Services Task Force Recommendation Statement,” Nov 17, 2009, pp. 716-726. C. Annals of Internal Medicine, “Systematic Review: Using Magnetic Resonance Imaging to Screen Women at High Risk for Breast Cancer,” Nov 9, 2008, pp. 671-679. Page 2 of 3 Guideline/Procedure Number: MPUG3112 Lead Department: Health Services Guideline/Procedure Title: Breast Magnetic Resonance Imaging ☒ External Policy (MRI) Guidelines ☐ Internal Policy Next Review Date: 02/18/2016 Original Date: 02/15/2012 Last Review Date: 02/18/2015 ☒ Healthy Kids ☐ Employees Applies to: ☒ Medi-Cal D. “ACR Practice Guideline for the Performance of Contrast-Enhanced Magnetic Resonance Imaging (MRI) of the Breast,” Revised 2008. E. “Breast MRI Implementation Update,” Kaiser Permanente practice guideline, July 2, 2007. F. CA: A Cancer Journal for Clinicians, “American Cancer Society guidelines for breast screening with MRI as an adjunct to mammography,” Mar-Apr 2007. Pp. 75-89. VIII. DISTRIBUTION: A. PHC Departmental Directors B. PHC Provider Manual IX. POSITION RESPONSIBLE FOR IMPLEMENTING PROCEDURE: Senior Director, Health Services X. REVISION DATES: Medi-Cal 02/18/15 Healthy Kids 02/18/15 PREVIOUSLY APPLIED TO: PartnershipAdvantage: MPUG3112 - 02/15/2012 to 01/01/2015 Healthy Families: MPUG3112 - 02/15/2012 to 03/01/2013 ********************************* In accordance with the California Health and Safety Code, Section 1363.5, this policy was developed with involvement from actively practicing health care providers and meets these provisions: Consistent with sound clinical principles and processes Evaluated and updated at least annually If used as the basis of a decision to modify, delay or deny services in a specific case, the criteria will be disclosed to the provider and/or enrollee upon request The materials provided are guidelines used by PHC to authorize, modify or deny services for persons with similar illnesses or conditions. Specific care and treatment may vary depending on individual need and the benefits covered under PHC. Page 3 of 3