Medical Review Criteria Breast Surgeries

Medical Review Criteria Breast Surgeries Subject: Breast Surgeries Authorization: Prior authorization is required for the following procedures requested for members enrolled in HPHC commercial (HMO, POS, or PPO) products: Breast Reconstruction Breast Implant Removal Inverted Nipple Repair Reduction Mammoplasty/Breast Reduction Prior authorization is not required for mastectomy procedures including prophylactic mastectomy. Note: In accordance with MA Chapter 233 (An Act Relative to HIV-Associated Lipodystrophy Syndrome Treatment), HPHC covers treatments to correct or repair disturbances of body composition caused by HIV associated lipodystrophy syndrome for any member enrolled in any HPHC plan delivered, issued or renewed within the commonwealth. Medical record documentation from a treating provider must confirm that the treatment is medically necessary for correcting, repairing or ameliorating the effects of HIV associated lipodystrophy syndrome. Policy and Coverage Criteria: Harvard Pilgrim Health Care (HPHC) covers medically necessary breast surgeries including mastectomy, breast reconstruction, reduction mammoplasty, breast implant removal, and inverted nipple repair. Mastectomy (including prophylactic mastectomy) is covered when the PCP or attending provider determines that the procedure is medically necessary. Post-mastectomy/post-lumpectomy breast reconstruction, and surgical and reconstructive procedures to the contralateral breast, are covered in accordance with the Women s Health & Cancer Rights Act of 1998 (i.e., to repair or restore appearance of one or both breasts, and/or for physical complications [e.g., lymphedema] of all stages of mastectomy or lumpectomy). Reconstructive procedures unrelated to mastectomy or lumpectomy are covered when HPHC determines a requested procedure is reasonable and medically necessary for the individual member. Removal of breast implants is covered when HPHC determines the procedure is reasonable and medically necessary for the individual member. (HPHC does not cover the removal of intact breast implants solely for a suspected benefit for prophylaxis against auto-immune disease, connective tissue disease or breast cancer, or because an intact implant has shifted as these indications are considered investigational and unproven.) Criteria used to review requests for gynecomastia surgery are described in HPHC s Gynecomastia Surgeries Medical Review Criteria. Breast Reconstruction Harvard Pilgrim Health Care (HPHC) considers Post-Mastectomy/Post-Lumpectomy Reconstruction including Breast Reduction, Augmentation, and/or Implant Use as medically necessary when documentation confirms Breast Surgeries Page 1 of 6

procedure is requested to repair or restore the appearance of one or both breasts, or for physical complications (e.g., lymphedema) after ANY of the following: 1. Any stage of mastectomy, lumpectomy or excisional biopsy including evaluation and treatment of ANY of the following: Breast cyst Benign or malignant breast mass Aberrant breast tissue Duct lesion Nipple or areolar lesion 2. Excision of chest wall tumor (including ribs) with or without plastic reconstruction. Reconstruction of the contra-lateral breast is considered as medically necessary when documentation demonstrates that procedure is necessary for the repair of breast asymmetry caused by mastectomy or medically necessary lumpectomy. HPHC considers reconstruction of the affected breast as medically necessary when documentation (including photographs*) confirms ANY of the following: Significant breast asymmetry (i.e., at least a 2-cup difference in breast size) in a female member who has reached physical maturity (age 16 years or older); Severe disfigurement resulting from surgical complications, trauma, disease, or Poland Syndrome. * Mailed or emailed photo documentation is required. Faxed photos of poor quality cannot be used to make a determination of medical necessity. HPHC considers reconstruction after removal of breast implants as medically necessary when documentation confirms ANY of the following: Original implants were inserted following an authorized breast reconstruction procedure; Prior to the implant removal, the member met HPHC s Medical Review Criteria for breast reconstruction (above). Reconstruction after removal of breast implants in other situations, is considered cosmetic and not covered (even if HPHC determines removal of the breast implant is medically necessary). Breast Implant Removal Harvard Pilgrim Health Care (HPHC) considers Post-Mastectomy/Post-Lumpectomy Implant Removal as medically necessary when documentation confirms procedure is requested to repair or restore the appearance of one or both breasts, or for physical complications after ANY stage of mastectomy, lumpectomy or excisional biopsy Harvard Pilgrim Health Care (HPHC) considers removal of a silicone or saline breast implant, with or without capsulectomy/capsulotomy, as medically necessary when documentation confirms ANY of the following: Implant interferes with breast cancer screening Removal is needed to facilitate breast cancer treatment Removal is required to treat a persistent or recurrent infection (local or systemic) that is secondary to the breast implant, and refractory to medical management including antibiotics Removal is required to treat a capsular contracture (Baker Grade III-IV) that is causing pain and is refractory to medical management. Removal of a ruptured silicone breast implant (intracapsular or extracapsular rupture) when rupture is confirmed by diagnostic imaging (e.g., MRI or other conclusive study). Breast Surgeries Page 2 of 6

Removal of a ruptured saline implant is not considered medically necessary in the absence of other complications. When criteria for the removal of a unilateral breast implant are met, removal of the contralateral implant is authorized only if the procedure independently meets implant removal criteria (above). Reduction Mammoplasty Harvard Pilgrim Health Care (HPHC) considers reduction mammoplasty following a mastectomy or lumpectomy as medically necessary when documentation confirms procedure is requested to repair or restore the appearance of one or both breasts, or for physical complications (e.g., lymphedema) after ANY of the following: o Any stage of mastectomy, lumpectomy or excisional biopsy including evaluation and treatment of ANY of the following: Breast cyst Benign or malignant breast mass Aberrant breast tissue Duct lesion Nipple or areolar lesion HPHP considers reduction mammoplasty unrelated to mastectomies or lumpectomies as medically necessary when documentation confirms the presence of severe breast hypertrophy in a female aged 16 years or older who has reached physical maturity and ALL the following criteria are met: 1. The member s physical symptoms are significant and persistent, 2. Symptoms are directly attributable to or significantly exacerbated by breast hypertrophy rather than other possible causes; 3. The member s symptoms show BOTH of the following: have interfered with activities of daily living for at least six months, and are unrelieved despite conservative management (e.g., NSAIDS, support wear, physical therapy, optimal medical treatment) and Are ANY of the following: o Shoulder, upper back, or neck pain, o Ulnar nerve palsy, o Significant arthritic changes in the cervical or upper thoracic spine, o Skin inflammation at the inframammary fold; 4. The amount of breast tissue expected to be removed from each breast can reasonably be expected to improve the patient s symptoms, and meets or exceeds the amounts outlined in the Table for Reduction Mammoplasty Criteria (guidelines). 5. In cases of breast asymmetry, bilateral reduction mammoplasty may be authorized when the amount of breast tissue expected to be removed from the larger breast meets criteria. **HPHC reserves the right to request the post-operative pathology report to confirm the amount of breast tissue that was removed from each breast. Exclusions: Harvard Pilgrim Health Care (HPHC) considers listed breast surgeries as not medically necessary for all other indications. In addition, HPHC does not cover: Cosmetic procedures (e.g., mastopexy, correction of inverted nipple) that are not part of an authorized post-mastectomy breast reconstruction procedure; Removal of intact breast implants solely for a suspected benefit for prophylaxis against auto-immune disease, connective tissue disease or breast cancer; Breast Surgeries Page 3 of 6

Removal of an intact breast implant solely because it has shifted. Guidelines: Table for Reduction Mammoplasty Criteria The individual s body surface area (BSA) is calculated using the DuBois & DuBois Formula, BSA (m 2 ) = 0.007184 x (height 0.725 x weight 0.425 ) where height is in centimeters and weight is in kilograms. Member s body surface area (M 2 ) Weight (in grams) of Tissue to Be Removed 1.35-1.44 150 1.45-1.54 200 1.55-1.64 250 1.65-1.74 300 1.75-1.84 350 1.85-1.89 400 1.90-1.99 450 2.00-2.04 500 2.05-2.09 550 2.10-2.14 600 2.15-2.19 650 2.20-2.24 700 2.25-2.29 800 2.30-2.34 900 2.35-2.39 950 2.40-2.44 1050 2.45-2.49 1150 2.50-2.54 1250 2.55 1350 Grade Grade I Grade II Grade III Grade IV Baker Grading System for Capsular Contracture: Definition Breast is soft without palpable thickening Breast is a little firm but no visible changes in appearance Breast is firm and has visible distortion in shape Breast is hard and has severe distortion or malposition in shape; pain/discomfort may be associated with this level of capsule contracture Coding: Codes are listed below for informational purposes only, and do not guarantee member coverage or provider reimbursement. The list may not be all-inclusive. Deleted codes and codes which are not effective at the time the service is rendered may not be eligible. CPT Code Description 19316 Mastopexy Breast Surgeries Page 4 of 6

19318 Unilateral reduction mammoplasty 19324 Mammoplasty, augmentation; without prosthetic implant 19325 With prosthetic implant 19328 Removal of intact mammary implant 19330 Removal of mammary implant material 19355 Correction of Inverted Nipple 19340 Immediate insertion of breast prosthesis following mastopexy, mastectomy or in reconstruction 19342 Delayed insertion of breast prosthesis following mastopexy, mastectomy or in reconstruction 19350 Nipple/areolar reconstruction 19355 Correction of inverted nipples 19357 Breast reconstruction, immediate or delayed, with tissue expander, including subsequent expansion 19361 Breast reconstruction with latissimus dorsi flap, with or without prosthetic implant 19364 Breast reconstruction with free flap 19366 Breast reconstruction with other technique 19367 Breast reconstruction with transverse rectus abdominis myocutaneous flap (TRAM), single pedicle, including closure of donor site 19368 With microvascular anastomosis (supercharging) 19369 Breast reconstruction with transverse rectus abdominis myocutaneous flap (TRAM), double pedicle, including closure of donor site 19370 Open periprosthetic capsulotomy, breast 19371 Periprosthetic capsulectomy, breast 19380 Revision of reconstructed breast 19396 Preparation of moulage for custom breast implant 19499 Unlisted procedure, breast Billing Guidelines: Member s medical records must document that services are medically necessary for the care provided. Harvard Pilgrim Health Care maintains the right to audit the services provided to our members, regardless of the participation status of the provider. All documentation must be available to HPHC upon request. Failure to produce the requested information may result in denial or retraction of payment. References: 1. American Society of Plastic Surgeons (ASPS). Practice Parameter. Treatment Principles of Silicone Breast Implants. March 2005. Available at: http://www.plasticsurgery.org/documents/medical-professionals/healthpolicy/evidence-practice/treatmentprinciplesofsiliconebreastimplants.pdf. 2. Breast Reconstruction for Deformities Unrelated to Cancer Treatment: ASPS Recommended Insurance Coverage Criteria for Third-Party Payers): http://www.plasticsurgery.org/documents/medical- professionals/health-policy/insurance/breast-reconstruction-for-deformities-unrelated-to-cancer- Treatment.pdf 3. Contralateral prophylactic mastectomy. UpToDate.com/login [via subscription only]. Accessed August 1, 2017. 4. Local Coverage Determination for Cosmetic and Reconstructive Surgery (L34698). https://www.cms.gov/medicare-coverage-database/details/lcddetails.aspx?lcdid=34698&ver=21&doctype=active&bc=aaiaaaaaaaaaaa%3d%3d&. Accessed November 17, 2017. 5. Overview of breast reconstruction. UpToDate.com/login [via subscription only]. Accessed August 1, 2017. Breast Surgeries Page 5 of 6

6. Overview of breast reduction. UpToDate.com/login [via subscription only]. Accessed August 1, 2017. 7. Reduction mammoplasty - the sliding scale revisited. Ann Plastic Surg, Jan 1999; 42(1) 109-108. 8. Reduction Mammoplasty: ASPS Recommended Insurance Coverage Criteria for Third-Party Payers (accessed 5/18/15): http://www.plasticsurgery.org/documents/medical-professionals/healthpolicy/insurance/reduction_mammaplasty_coverage_criteria.pdf 9. Reduction mammoplasty: cosmetic or reconstructive procedure. Schnur, Paul L, et al., "Reduction Mammoplasty: Cosmetic or Reconstructive Procedure?" Ann Plastic Surg. Sept 1991; 27 (3): 232-7. Relevant Mandates: U.S. Women's Health and Cancer Right Act of 1998 Maine Title 24-A MRSA 4237 NH RSA 417-D:2-b MA Chapter 223 Summary of Changes Date Changes 11/17 Updated for style guide 10/16 Added language to support mandate for HIV associated lipodystrophy 5/16 Minor formatting edits. Updated references 6/15 Reformatted, minor language changes. Add coding profile. Add ASPS documents to references. Delete coverage for repair of inverted nipple unless part of an authorized post-mastectomy breast reconstruction procedure. Approved by Medical Review Committee: 12/12/17 Reviewed/Revised: 9/02, 10/03, 10/04, 12/05, 1/06, 2/07, 2/08, 3/08, 4/09, 4/10, 5/11, 4/12, 4/13, 6/14, 6/15; 5/16; 10/16; 11/17 Initiated: 7/01 Breast Surgeries Page 6 of 6