BREAST RECONSTRUCTION POST MASTECTOMY

BREAST RECONSTRUCTION POST MASTECTOMY CLINICAL POLICY Policy Number: SURGERY 095.11 T2 Effective Date: January 1, 2016 Table of Contents CONDITIONS OF COVERAGE... BENEFIT CONSIDERATIONS... COVERAGE RATIONALE... DEFINITIONS... APPLICABLE CODES... BACKGROUND... REFERENCES... POLICY HISTORY/REVISION INFORMATION... Page 1 2 2 4 5 9 9 10 Related Policies: Refer to the Background section below for a list of related policies The services described in Oxford policies are subject to the terms, conditions and limitations of the Member's contract or certificate. Unless otherwise stated, Oxford policies do not apply to Medicare Advantage enrollees. Oxford reserves the right, in its sole discretion, to modify policies as necessary without prior written notice unless otherwise required by Oxford's administrative procedures or applicable state law. The term Oxford includes Oxford Health Plans, LLC and all of its subsidiaries as appropriate for these policies. Certain policies may not be applicable to Self-Funded Members and certain insured products. Refer to the Member's plan of benefits or Certificate of Coverage to determine whether coverage is provided or if there are any exclusions or benefit limitations applicable to any of these policies. If there is a difference between any policy and the Member s plan of benefits or Certificate of Coverage, the plan of benefits or Certificate of Coverage will govern. CONDITIONS OF COVERAGE Applicable Lines of Business/Products Benefit Type Referral Required (Does not apply to non-gatekeeper products) Authorization Required (Precertification always required for inpatient admission) Precertification with Medical Director Review Required Applicable Site(s) of Service (If site of service is not listed, Medical Director review is required) Special Considerations This policy applies to Oxford Commercial plan membership General benefits package No Yes 1,2 Yes 1 Inpatient, Office, Outpatient 1 Medical Director review is not required for reconstructive procedures following a mastectomy for cancer (or 1

Special Considerations (continued) prophylaxis) 2 Precertification is required for services covered under the Member's General Benefits package when performed in the office of a participating provider. For Commercial plans, precertification is not required, but is encouraged for out-ofnetwork services performed in the office that are covered under the Member's General Benefits package. If precertification is not obtained, Oxford may review for medical necessity after the service is rendered. BENEFIT CONSIDERATIONS Before using this guideline, please check the Member specific benefit document and any federal or state mandates, if applicable. Essential Health Benefits for Individual and Small Group: For plan years beginning on or after January 1, 2014, the Affordable Care Act of 2010 (ACA) requires fully insured non-grandfathered individual and small group plans (inside and outside of Exchanges) to provide coverage for ten categories of Essential Health Benefits ( EHBs ). Large group plans (both self-funded and fully insured), and small group ASO plans, are not subject to the requirement to offer coverage for EHBs. However, if such plans choose to provide coverage for benefits which are deemed EHBs (such as maternity benefits), the ACA requires all dollar limits on those benefits to be removed on all Grandfathered and Non-Grandfathered plans. The determination of which benefits constitute EHBs is made on a state by state basis. As such, when using this guideline, it is important to refer to the member specific benefit document to determine benefit coverage. COVERAGE RATIONALE Indications for Coverage Breast reconstruction is covered for Members who have a mastectomy with or without a diagnosis of cancer. Mastectomy includes partial (lumpectomy, tylectomy, quadrantectomy, and segmentectomy), simple, and radical. This benefit does not include aspirations, biopsy (open or core), excision of cysts, fibroadenomas or other benign or malignant tumors, aberrant tissue, duct lesions, nipple or areolar lesions, or treatment of gynecomastia. There is not a time frame in which the Member is required to have the reconstruction done post mastectomy under the Women s Health and Cancer Rights Act of 1998. In accordance with Federal and State mandates the following services are covered: Reconstruction of the on which the mastectomy was performed Surgery and reconstruction of the other to produce a symmetrical appearance, including nipple tattooing Prosthesis (Implanted and/or external) Treatment of physical complications of mastectomy, including lymphedema Various surgical techniques are used for reconstruction, including but not limited to: Insertion of FDA approved implants and tissue expanders Breast Implants and tissue expanders post mastectomy with or without skin substitutes, approved by the FDA, including but not limited to: Alloderm, Allomax or FlexHD are a covered benefit Transverse Rectus Abdominus Myocutaneous Flap (TRAM) Latissimus Dorsi Flap (LD) Deep Inferior Epigastric Perforator (DIEP) Flap 2

Gluteal Flap (GAP free flap) Refer to the Definitions section for reconstruction procedure definitions. If the original implant or reconstructive surgery was considered reconstructive surgery by Oxford, coverage may exist for removal, replacement and/or reconstruction. If the original implant or reconstructive surgery was considered reconstructive surgery under the Oxford benefit document, then removal of a ruptured prosthesis is treating a "complication arising from a medical or surgical intervention." Removal or replacement of an implant that is not ruptured and unassociated with local complications may not be covered. Additional Information: An in-network exception may be granted if there is not an in-network provider able to provide the requested reconstructive procedure. Refer to the Member specific benefit document and the In- Network Exceptions for Breast Reconstruction Surgery Following Mastectomy policy for information regarding coverage from non-network providers. Breast reconstruction may be covered under certain circumstances for the surgical treatment of gender dysphoria. Please refer to the member s specific benefit document for coverage determination. Treatments for complications post mastectomy 1. Lymphedema: a. Complex Decongestive Physiotherapy (CDP) is covered for the complication of lymphedema post mastectomy b. Lymphedema pumps when required are covered c. Compression Lymphedema sleeves are covered d. Elastic bandages and wraps associated with covered treatments for the complications of lymphedema 2. Treatment of a post operative infection(s). 3. Removal of a ruptured implant (either silicone or saline) is reconstructive for implants done post mastectomy. Placement of a new implant will be covered if the original implantation was done post mastectomy or for a covered reconstructive health service. Coverage Limitations and Exclusions Please refer to Member s state mandates and Member specific benefit documents. 1. Insertion of implants or reinsertion of implants for the purpose of improving appearance is a cosmetic procedure unless covered under a state or federal mandate. Note: If the reconstruction has been successfully completed post mastectomy and the Member chooses to enlarge their s for cosmetic reasons, this is considered a cosmetic service and is not covered. 2. Breast reconstruction or scar revision after biopsy or removal of a cyst with or without a biopsy usually does not meet the definition of a covered reconstructive health service. Refer to the Member s specific benefit documents and state mandates. 3. Tissue protruding at the end of a scar ( dog ear /standing cone), painful scars or donor site scar revisions must be reviewed to determine if the procedure meets reconstructive guidelines. 4. Liposuction other than to achieve symmetry during post mastectomy reconstruction is considered cosmetic and is not covered. 5. Revision of prior reconstructed due to normal aging does not meet the definition of a covered reconstructive health service. 6. Not medically necessary services. 3

DEFINTIONS Breast Reconstruction Steps: STEP 1: Creation of a mound: Reposition a woman s own muscle, fat and skin to create a mound. TRAM Flap - the muscle, fat and skin from the lower abdomen is used to reconstruct the. DIEP or SGAP Flap the fat and skin but not muscle is used from the lower abdomen or buttocks to reconstruct the. LATISSIUMS DORSI Flap the muscle, fat and skin from the back are used to reconstruct the may also need a implant. Tissue expansion is used to stretch the skin to provide coverage for a implant to create a mound. Requires several office visits over 4-6 months to fill the device through an internal valve to expand the skin. A second surgical procedure is needed to replace the expander. Surgical placement of a implant creates a mound. May be used with a flap or alone following tissue expansion. Silicone and saline implants are available for reconstruction. Reconstruction alone may be done with an implant but usually as tissue expander is needed. STEP 2: Creation of a nipple and areola: Many different techniques are used. Tattooing may be used for the areola. Deep Inferior Epigastric Perforator (DIEP) Flap: The DIEP flap technique uses abdominal skin and subcutaneous tissue while sparing the rectus abdominus muscle. Blood vessels, called deep inferior epigastric perforators (DIEP), with the overlying skin and fat supplied by them, are removed from the lower abdomen and transferred to the chest to reconstruct a after mastectomy. Gluteal Artery Perforator (GAP) Free Flap: Superior Gluteal Artery Perforator (S-GAP) Flap: The superior gluteal artery perforator flap involves microsurgical transfer of skin and fat from the buttock without muscle sacrifice. The flap is vascularized by one single perforator originating from the superior gluteal artery. Inferior Gluteal Artery Perforator (I-GAP) Free Flap: The IGAP is harvested using the same microsurgical, muscle-sparing techniques as the DIEP and S-GAP flaps. Latissimus Dorsi Flap (LD): The LD flap moves muscle (and skin if required) from the back to reconstruct the. It may be transferred as a free tissue transfer or rotated into place as a pedicle flap to reconstruct the. Mastectomy: Mastectomy includes partial (lumpectomy, tylectomy, quadrantectomy, and segmentectomy), simple, and radical. A mastectomy does not include aspirations, biopsy (open or core), excision of cysts, fibroadenomas or other benign or malignant tumors, aberrant tissue, duct lesions, nipple or areolar lesions, and treatment of gynecomastia. "Stacked" DIEP Flap: This procedure allows for incorporation of more abdominal fatty tissue than conventional TRAM procedures or unilateral DIEP flap procedures. 4

Superficial Inferior Epigastric Artery (SIEA) Flap: Replaces the skin and soft tissue removed at mastectomy with skin and fatty tissue harvested from the abdomen. Transverse Rectus Abdominus Myocutaneous (TRAM) Flap: The surgeon takes muscle and overlying lower abdominal tissue and moves it to the chest area. TRAM flap may be done as either a pedicle flap or a free flap. Women's Health and Cancer Rights Act of 1998, 713 (a): "In general - a group health plan, and a health insurance issuer providing health insurance coverage in connection with a group health plan, that provides medical and surgical benefits with respect to a mastectomy shall provide, in case of a participant or beneficiary who is receiving benefits in connection with a mastectomy and who elects reconstruction in connection with such mastectomy, coverage for (1) reconstruction of the on which the mastectomy has been performed; (2) surgery and reconstruction of the other to produce symmetrical appearance; and (3) prostheses and physical complications all stages of mastectomy, including lymphedemas in a manner determined in consultation with the attending physician and the patient." APPLICABLE CODES The Current Procedural Terminology (CPT ) codes and Healthcare Common Procedure Coding System (HCPCS) codes listed in this policy are for reference purposes only. Listing of a service code in this policy does not imply that the service described by this code is a covered or noncovered health service. Coverage is determined by the member specific benefit document and applicable laws that may require coverage for a specific service. The inclusion of a code does not imply any right to reimbursement or guarantee claims payment. Other policies and coverage determination guidelines may apply. This list of codes may not be all inclusive. Mastectomy CPT Codes CPT Code 19301 Mastectomy, partial (eg, lumpectomy, tylectomy, quadrantectomy, segmentectomy) 19302 Mastectomy, partial (eg, lumpectomy, tylectomy, quadrantectomy, segmentectomy); with axillary lymphadenectomy 19303 Mastectomy, simple, complete 19304 Mastectomy, subcutaneous 19305 Mastectomy, radical, including pectoral muscles, axillary lymph nodes 19306 Mastectomy, radical, including pectoral muscles, axillary and internal mammary lymph nodes (Urban type operation) Mastectomy, modified radical, including axillary lymph nodes, with or 19307 without pectoralis minor muscle, but excluding pectoralis major muscle CPT is a registered trademark of the American Medical Association. The following CPT codes do not meet criteria for post mastectomy (do not apply to reconstruction). CPT Code Biopsy of ; percutaneous, needle core, not using imaging 19100 guidance (separate procedure) 19101 Biopsy of ; open, incisional Excision of cyst, fibroadenoma, or other benign or malignant tumor, 19120 aberrant tissue, duct lesion, nipple or areolar lesion (except 19300), open, male or female, one or more lesions Excision of lesion identified by preoperative placement of 19125 radiological marker, open; single lesion Excision of lesion identified by preoperative placement of 19126 radiological marker, open; each additional lesion separately identified by a preoperative radiological marker (List separately in addition to 5

CPT Code code for primary procedure) 21555 Excision tumor, soft tissue of neck or thorax; subcutaneous 21556 Excision tumor, soft tissue of neck or thorax; deep, subfascial, intramuscular Breast Reconstruction Post Mastectomy CPT Codes CPT Code Tattooing, intradermal introduction of insoluble opaque pigments to 11920 correct color defects of skin, including micropigmentation; 6.0 sq cm or less Tattooing, intradermal introduction of insoluble opaque pigments to 11921 correct color defects of skin, including micropigmentation; 6.1 to 20.0 sq cm Tattooing, intradermal introduction of insoluble opaque pigments to correct color defects of skin, including micropigmentation; each 11922 additional 20.0 sq cm, or part thereof (List separately in addition to code for primary procedure) 11970 Replacement of tissue expander with permanent prosthesis 11971 Removal of tissue expander(s) without insertion of prosthesis Application of skin substitute graft to trunk, arms, legs, total wound 15271 surface area up to 100 sq cm; first 25 sq cm or less wound surface area Application of skin substitute graft to trunk, arms, legs, total wound surface area up to 100 sq cm; each additional 25 sq cm wound 15272 surface area, or part thereof (List separately in addition to code for primary procedure) Implantation of biologic implant (eg, acellular dermal matrix) for soft 15777 tissue reinforcement (ie,, trunk) (List separately in addition to code for primary procedure) 19316 Mastopexy 19324 Mammaplasty, augmentation; without prosthetic implant 19325 Mammaplasty, augmentation; with prosthetic implant Immediate insertion of prosthesis following mastopexy, 19340 mastectomy or in reconstruction 19350 Nipple/areola reconstruction Breast reconstruction, immediate or delayed, with tissue expander, 19357 including subsequent expansion Breast reconstruction with latissimus dorsi flap, without prosthetic 19361 implant 19364 Breast reconstruction with free flap 19366 Breast reconstruction with other technique 19367 19368 19369 Breast reconstruction with transverse rectus abdominis myocutaneous flap (TRAM), single pedicle, including closure of donor site Breast reconstruction with transverse rectus abdominis myocutaneous flap (TRAM), single pedicle, including closure of donor site; with microvascular anastomosis (supercharging) Breast reconstruction with transverse rectus abdominis myocutaneous flap (TRAM), double pedicle, including closure of donor site 19380 Revision of reconstructed 19396 Preparation of moulage for custom implant 19499 Unlisted procedure, The code below is covered only to achieve symmetry of the contralateral post mastectomy 6

CPT Code 19318 Reduction mammoplasty CPT is a registered trademark of the American Medical Association. Applicable HCPCS Code HCPCS Code L8600* Implantable prosthesis, silicone or equal *Refer to policies: Durable Medical Equipment, Orthotics, Ostomy Supplies, Medical Supplies, and Repairs/Replacements Prosthetic Devices, Wigs, Specialized, Microprocessor or Myoelectric Limbs Applicable ICD-9 Codes (Discontinued 10/01/15) The following list of codes is provided for reference purposes only. Effective October 1, 2015, the Centers for Medicare & Medicaid Services (CMS) implemented ICD-10-CM (diagnoses) and ICD- 10-PCS (inpatient procedures), replacing the ICD-9-CM diagnosis and procedure code sets. ICD-9 codes will not be accepted for services provided on or after October 1, 2015. ICD-9 Procedure Code (Discontinued 10/01/15) 174.0 Malignant neoplasm of nipple and areola of female 174.1 Malignant neoplasm of central portion of female 174.2 Malignant neoplasm of upper-inner quadrant of female 174.3 Malignant neoplasm of lower-inner quadrant of female 174.4 Malignant neoplasm of upper-outer quadrant of female 174.5 Malignant neoplasm of lower-outer quadrant of female 174.6 Malignant neoplasm of axillary tail of female 174.8 Malignant neoplasm of other specified sites of female 174.9 Malignant neoplasm of (female), unspecified site 175.0 Malignant neoplasm of nipple and areola of male 198.81 Secondary malignant neoplasm of 233.0 Carcinoma in situ of V10.3 Personal history of malignant neoplasm of V45.71 Acquired absence of and nipple V51.0 Encounter for reconstruction following mastectomy ICD-10 Codes ICD-10-CM (diagnoses) and ICD-10-PCS (inpatient procedures) must be used to report services provided on or after October 1, 2015. ICD-10 codes will not be accepted for services provided prior to October 1, 2015 ICD-10 Diagnosis Code C50.011 Malignant neoplasm of nipple and areola, right female C50.012 Malignant neoplasm of nipple and areola, left female C50.019 Malignant neoplasm of nipple and areola, unspecified female C50.021 Malignant neoplasm of nipple and areola, right male C50.022 Malignant neoplasm of nipple and areola, left male C50.029 Malignant neoplasm of nipple and areola, unspecified male C50.111 Malignant neoplasm of central portion of right female C50.112 Malignant neoplasm of central portion of left female C50.119 Malignant neoplasm of central portion of unspecified female C50.121 Malignant neoplasm of central portion of right male C50.122 Malignant neoplasm of central portion of left male C50.129 Malignant neoplasm of central portion of unspecified male 7

ICD-10 Diagnosis Code C50.211 Malignant neoplasm of upper-inner quadrant of right female C50.212 Malignant neoplasm of upper-inner quadrant of left female C50.219 Malignant neoplasm of upper-inner quadrant of unspecified female C50.221 Malignant neoplasm of upper-inner quadrant of right male C50.222 Malignant neoplasm of upper-inner quadrant of left male C50.229 Malignant neoplasm of upper-inner quadrant of unspecified male C50.311 Malignant neoplasm of lower-inner quadrant of right female C50.312 Malignant neoplasm of lower-inner quadrant of left female C50.319 Malignant neoplasm of lower-inner quadrant of unspecified female C50.321 Malignant neoplasm of lower-inner quadrant of right male C50.322 Malignant neoplasm of lower-inner quadrant of left male C50.329 Malignant neoplasm of lower-inner quadrant of unspecified male C50.411 Malignant neoplasm of upper-outer quadrant of right female C50.412 Malignant neoplasm of upper-outer quadrant of left female C50.419 Malignant neoplasm of upper-outer quadrant of unspecified female C50.421 Malignant neoplasm of upper-outer quadrant of right male C50.422 Malignant neoplasm of upper-outer quadrant of left male C50.429 Malignant neoplasm of upper-outer quadrant of unspecified male C50.511 Malignant neoplasm of lower-outer quadrant of right female C50.512 Malignant neoplasm of lower-outer quadrant of left female C50.519 Malignant neoplasm of lower-outer quadrant of unspecified female C50.521 Malignant neoplasm of lower-outer quadrant of right male C50.522 Malignant neoplasm of lower-outer quadrant of left male C50.529 Malignant neoplasm of lower-outer quadrant of unspecified male C50.611 Malignant neoplasm of axillary tail of right female C50.612 Malignant neoplasm of axillary tail of left female C50.619 Malignant neoplasm of axillary tail of unspecified female C50.621 Malignant neoplasm of axillary tail of right male C50.622 Malignant neoplasm of axillary tail of left male C50.629 Malignant neoplasm of axillary tail of unspecified male C50.811 Malignant neoplasm of overlapping sites of right female C50.812 Malignant neoplasm of overlapping sites of left female C50.819 Malignant neoplasm of overlapping sites of unspecified female C50.821 Malignant neoplasm of overlapping sites of right male C50.822 Malignant neoplasm of overlapping sites of left male C50.829 Malignant neoplasm of overlapping sites of unspecified male C50.911 Malignant neoplasm of unspecified site of right female C50.912 Malignant neoplasm of unspecified site of left female C50.919 Malignant neoplasm of unspecified site of unspecified female C50.921 Malignant neoplasm of unspecified site of right male C50.922 Malignant neoplasm of unspecified site of left male C50.929 Malignant neoplasm of unspecified site of unspecified male C79.81 Secondary malignant neoplasm of D05.00 Lobular carcinoma in situ of unspecified D05.01 Lobular carcinoma in situ of right D05.02 Lobular carcinoma in situ of left 8

ICD-10 Diagnosis Code D05.10 Intraductal carcinoma in situ of unspecified D05.11 Intraductal carcinoma in situ of right D05.12 Intraductal carcinoma in situ of left D05.80 Other specified type of carcinoma in situ of unspecified D05.81 Other specified type of carcinoma in situ of right D05.82 Other specified type of carcinoma in situ of left D05.90 Unspecified type of carcinoma in situ of unspecified D05.91 Unspecified type of carcinoma in situ of right D05.92 Unspecified type of carcinoma in situ of left Z42.1 Encounter for reconstruction following mastectomy Z85.3 Personal history of malignant neoplasm of Z90.10 Acquired absence of unspecified and nipple Z90.11 Acquired absence of right and nipple Z90.12 Acquired absence of left and nipple Z90.13 Acquired absence of bilateral s and nipples BACKGROUND Breast reconstruction is the rebuilding of a. It involves using autologous tissue or prosthetic material to construct a natural-looking. Often this includes the reformation of a natural-looking areola and nipple. This procedure involves the use of implants or relocated flaps of the patient's own tissue. Breast reconstruction is achieved through several plastic surgery techniques that attempt to restore a to near normal shape, appearance and size. This policy addresses reconstructive procedures following a mastectomy and treatments of complications post mastectomy. For information regarding repair/reconstruction not following a mastectomy, refer to the policy titled Breast Repair/ Reconstruction (Not Following Mastectomy). For additional information, please refer to the following related policies: In-Network Exceptions for Breast Reconstruction Surgery Following Mastectomy Breast Repair/ Reconstruction (Not Following Mastectomy) Cosmetic and Reconstructive Procedures Breast Reduction Surgery Gynecomastia Durable Medical Equipment, Orthotics, Ostomy Supplies, Medical Supplies, and Repairs/Replacements Pneumatic Compression Devices Prosthetic Devices, Wigs, Specialized, Microprocessor or Myoelectric Limbs Gender Dysphoria (Gender Identity Disorder) Treatment REFERENCES The foregoing Oxford policy has been adapted from an existing UnitedHealthcare national policy that was researched, developed and approved by UnitedHealthcare Coverage Determination Committee. [CDG.003.05, Effective 01/01/2016] 1. American Society of Plastic Surgeons. Breast Reconstruction Procedures Steps. Available at: http://www.plasticsurgery.org. Accessed on September 3, 2015. 2. Federal Mandate: The Women's Health and Cancer Rights Act of 1998. (Reconstructive Breast Surgery). September 9, 2002, Revision Date July 16, 2007. 9

POLICY HISTORY/REVISION INFORMATION Date 01/01/2016 Action/ Revised conditions of coverage/special considerations; added language to indicate: o Precertification is required for services covered under the Member's General Benefits package when performed in the office of a participating provider o For Commercial plans, precertification is not required, but is encouraged for out-of-network services performed in the office that are covered under the Member's General Benefits package; if precertification is not obtained, Oxford may review for medical necessity after the service is rendered Revised coverage rationale/indications for coverage; o Updated list of services covered in accordance with federal/state mandate; replaced prosthesis (implanted or external) with prosthesis (Implanted and/or external) o Added language to indicate reconstruction may be covered under certain circumstances for the surgical treatment of gender dysphoria (refer to the enrollee specific benefit document for coverage determination) Updated supporting information to reflect the most current background information and references Archived previous policy version SURGERY 095.10 T2 10