BREAST RECONSTRUCTION POST MASTECTOMY

COVERAGE DETERMINATION GUIDELINE BREAST RECONSTRUCTION POST MASTECTOMY Guideline Number: CDG.003.02 Effective Date: May 1, 2014 Table of Contents COV...
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COVERAGE DETERMINATION GUIDELINE

BREAST RECONSTRUCTION POST MASTECTOMY Guideline Number: CDG.003.02 Effective Date: May 1, 2014 Table of Contents COVERAGE RATIONALE.......................................... DEFINITIONS…………………………………………..... APPLICABLE CODES................................................ REFERENCES........................................................... HISTORY/REVISION INFORMATION………………...

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Related Coverage Determination Guidelines: • Breast Repair/Reconstruction Not Following Mastectomy • Cosmetic and Reconstructive Procedures • DME, Orthotics, Ostomy Supplies, Medical Supplies and Repairs/Replacements • Prosthetic Devices and Wigs

INSTRUCTIONS FOR USE This Coverage Determination Guideline provides assistance in interpreting certain standard UnitedHealthcare benefit plans. When deciding coverage, the enrollee specific document must be referenced. The terms of an enrollee’s document (e.g., Certificates of Coverage (COCs), Schedules of Benefits (SOBs), or Summary Plan Descriptions (SPDs), and Medicaid State Contracts) may differ greatly from the standard benefit plans upon which this guideline is based. In the event of a conflict, the enrollee's specific benefit document supersedes these guidelines. All reviewers must first identify enrollee eligibility, any federal or state regulatory requirements and the plan benefit coverage prior to use of this guideline. Other coverage determination guidelines and medical policies may apply. UnitedHealthcare reserves the right, in its sole discretion, to modify its coverage determination guidelines and medical policies as necessary. This Coverage Determination Guideline does not constitute medical advice. UnitedHealthcare may also use tools developed by third parties, such as the MCG™ Care Guidelines, to assist us in administering health benefits. The MCG™ Care Guidelines are intended to be used in connection with the independent professional medical judgment of a qualified health care provider and do not constitute the practice of medicine or medical advice. COVERAGE RATIONALE Plan Document Language Before using this guideline, please check enrollee’s specific plan 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 enrollee’s specific plan document to determine benefit coverage. Breast Reconstruction Post Mastectomy: Coverage Determination Guideline (Effective 05/01/2014)

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Indications for Coverage Some states require benefit coverage for services that UnitedHealthcare considers cosmetic procedures, such as repair of external congenital anomalies in the absence of a functional impairment. Please refer to enrollee’s plan specific documents. 1. Enrollees 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 breast tissue, duct lesions, nipple or areolar lesions, or treatment of gynecomastia. •

There is not a time frame in which the enrollee is required to have the reconstruction done post mastectomy under the Women’s Health and Cancer Rights Act of 1998.

2. In accordance with Federal and State mandates the following are covered: •

All stages of reconstruction of the breast on which the mastectomy was performed



Surgery and reconstruction of the other breast to produce a symmetrical appearance, including nipple tattooing



Prosthesis (Implanted or external)



Treatment of physical complications of mastectomy, including lymphedema

Surgical Breast Reconstruction Procedures are covered after a mastectomy: 1.

Various surgical techniques are used for breast reconstruction, including but not limited to: a. b.

c. d. e. f.

Insertion of FDA approved breast 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 Gluteal Flap (GAP free flap)

Refer to the Definitions Section of this Coverage Determination Guideline (CDG) for breast reconstruction procedure definitions. Additional Information: A gap exception may be granted if there is not an in-network provider able to provide the requested reconstructive procedure. Refer to the enrollee specific plan document for information regarding coverage from non-network providers. 2. If the original implant or reconstructive surgery was considered reconstructive surgery under the UnitedHealthcare benefit document, coverage may exist for removal, replacement, and/or reconstruction. If the original implant or reconstructive surgery was considered reconstructive surgery under the UnitedHealthcare 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 breast complications may not be covered. Breast Reconstruction Post Mastectomy: Coverage Determination Guideline (Effective 05/01/2014)

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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 Additional Information: • Lymphedema pumps are covered as Durable Medical Equipment • Compression Lymphedema sleeves are covered as Prosthetic Refer to the CDGs titled DME, Orthotics, Ostomy Supplies, Medical Supplies and Repairs/Replacements and Prosthetic Devices and Wigs. . 2. Treatment of a post-operative infection 3. Removal of a ruptured breast implant (either silicone or saline) is reconstructive for implants done post-mastectomy. Placement of a new breast implant will be covered if the original implantation was done post-mastectomy or for a covered reconstructive health service. Medical Necessity Plans: Use the criteria above when applicable. Coverage Limitations and Exclusions Please refer to enrollee’s state mandates and plan specific documents. 1. Insertion of breast implants or reinsertion of breast implants for the purpose of improving appearance is a cosmetic procedure unless covered under a state or federal mandate. •

If the breast reconstruction has been successfully completed post mastectomy and the enrollee chooses to enlarge their breasts for cosmetic reasons, this is considered a cosmetic service and is not a covered health service.

2. Breast reconstruction or scar revision after breast 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 enrollee’s plan specific 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 breast symmetry during post mastectomy reconstruction is considered cosmetic and is not a covered health service. 5. Revision of prior reconstructed breast due to normal aging does not meet the definition of a covered reconstructive health service.

Breast Reconstruction Post Mastectomy: Coverage Determination Guideline (Effective 05/01/2014)

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6. Unproven services. For ASO plans with SPD language other than fully-insured Generic COC language: Please refer to the enrollee’s plan specific SPD for coverage. DEFINITIONS Cosmetic Procedures (California Only): procedures or services are performed to alter or reshape normal structures of the body in order to improve the Covered Person's appearance 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 breast 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 breast. It may be transferred as a free tissue transfer or rotated into place as a pedicle flap to reconstruct the breast. 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 breast tissue, duct lesions, nipple or areolar lesions, and treatment of gynecomastia Reconstructive Procedures: Reconstructive procedures when the primary purpose of the procedure is either to treat a medical condition or to improve or restore physiologic function. Reconstructive procedures include surgery or other procedures which are associated with an Injury, Sickness or Congenital Anomaly. The primary result of the procedure is not a changed or improved physical appearance. Procedures that correct an anatomical Congenital Anomaly without improving or restoring physiologic function are considered Cosmetic Procedures. The fact that a Covered Person may suffer psychological consequences or socially avoidant behavior as a result of an Injury, Sickness or Congenital Anomaly does not classify surgery (or other procedures done to relieve such consequences or behavior) as a reconstructive procedure. (2011 Generic COC) Reconstructive Procedures (California Only): Reconstructive procedures to correct or repair abnormal structures of the body caused by congenital defects, developmental abnormalities, trauma, infection, tumors, or disease. Reconstructive procedures include surgery or other procedures which are associated with an Injury, Sickness or Congenital Anomaly. The primary result of the procedure is not a changed or improved physical appearance for cosmetic purposes only, but rather to improve function and/or to create a normal appearance, to the extent possible. Stages of Breast Reconstruction:

Breast Reconstruction Post Mastectomy: Coverage Determination Guideline (Effective 05/01/2014)

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• •

One-stage immediate breast reconstruction may be done at the same time as the mastectomy. After the general surgeon removes the breast tissue, a plastic surgeon places a breast implant where the breast tissue was removed to form the breast mound. Two-stage immediate or two-stage delayed reconstruction is done if the skin and chest wall tissues inadequate for immediate reconstruction. An implanted tissue expander, like a balloon, is placed beneath the skin and chest muscle. Through a tiny valve beneath the skin, the surgeon injects a salt-water solution at regular intervals to fill the expander over time. After the skin over the breast area has stretched enough, the expander is usually removed in a second operation, and a permanent implant is put in its place. Some expanders are left in place as the final implant.

"Stacked" DIEP Flap: This procedure allows for incorporation of more abdominal fatty tissue than conventional TRAM procedures or unilateral DIEP flap procedures. 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 breast reconstruction in connection with such mastectomy, coverage for (1) reconstruction of the breast on which the mastectomy has been performed; (2) surgery and reconstruction of the other breast 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 ) and Healthcare Common Procedure Coding System (HCPCS) codes listed in this guideline are for reference purposes only. Listing of a service code in this guideline does not imply that the service described by this code is a covered or noncovered health service. Coverage is determined by the enrollee 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. ®

CPT is a registered trademark of the American Medical Association. Limited to specific procedure codes?

YES

NO

Mastectomy Codes ®

CPT Procedure Code 19301 19302 19303 19304 19305

Description Mastectomy, partial (eg, lumpectomy, tylectomy, quadrantectomy, segmentectomy); Mastectomy, partial (eg, lumpectomy, tylectomy, quadrantectomy, segmentectomy); with axillary lymphadenectomy Mastectomy, simple, complete Mastectomy, subcutaneous Mastectomy, radical, including pectoral muscles, axillary lymph nodes

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®

CPT Procedure Code 19306 19307

Description Mastectomy, radical, including pectoral muscles, axillary and internal mammary lymph nodes (urban type operation) Mastectomy, modified radical, including axillary lymph nodes, with or without pectoralis minor muscle, but excluding pectoralis major muscle

®

The following CPT codes do not meet criteria for post mastectomy (do not apply to breast reconstruction). ®

CPT Procedure Code 19100 19101 19120 19125

19126

21555 21556

Description Biopsy of breast; percutaneous, needle core, not using imaging guidance (separate procedure) Biopsy of breast; open, incisional Excision of cyst, fibroadenoma, or other benign or malignant tumor, aberrant breast tissue, duct lesion, nipple or areolar lesion (except 19300), open, male or female, one or more lesions Excision of breast lesion identified by preoperative placement of radiological marker, open; single lesion Excision of breast lesion identified by preoperative placement of radiological marker, open; each additional lesion separately identified by a preoperative radiological marker (list separately in addition to code for primary procedure) Excision, tumor, soft tissue of neck or anterior thorax, subcutaneous; less than 3 cm Excision, tumor, soft tissue of neck or anterior thorax, subfascial (eg, intramuscular); less than 5 cm

Breast Reconstruction Post Mastectomy ®

CPT Procedure Code 11920

11921

11922 11970 11971 15271

15272

15777 19316 19324

Description Tattooing, intradermal introduction of insoluble opaque pigments to correct color defects of skin, including micropigmentation; 6.0 sq cm or less Tattooing, intradermal introduction of insoluble opaque pigments to 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 additional 20.0 sq cm, or part thereof (list separately in addition to code for primary procedure) Replacement of tissue expander with permanent prosthesis Removal of tissue expander(s) without insertion of prosthesis Application of skin substitute graft to trunk, arms, legs, total wound 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 surface area, or part thereof (list separately in addition to code for primary procedure) Implantation of biologic implant (eg, acellular dermal matrix) for soft tissue reinforcement (ie, breast, trunk) (list separately in addition to code for primary procedure) Mastopex Mammaplasty, augmentation; without prosthetic implant

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®

CPT Procedure Code 19325 19340 19350 19357 19361 19364 19366 19367

19368

19369 19380 19396 19499

Description Mammaplasty, augmentation; with prosthetic implant Immediate insertion of breast prosthesis following mastopexy, mastectomy or in reconstruction Nipple/areola reconstruction Breast reconstruction, immediate or delayed, with tissue expander, including subsequent expansion Breast reconstruction with latissimus dorsi flap, without prosthetic implant Breast reconstruction with free flap Breast reconstruction with other technique 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 Revision of reconstructed breast Preparation of moulage for custom breast implant Unlisted procedure, breast

Code 19318 is covered only to achieve symmetry of the contralateral breast post mastectomy. ®

CPT Procedure Code 19318 HCPCS Procedure Code L8600 Limited to specific diagnosis codes? ICD-9 Diagnosis Code 174.0 174.1 174.2 174.3 174.4 174.5 174.6 174.8 174.9 175.0 198.81 233.0 V10.3 V45.71 V51.0

Description Reduction mammaplasty Description Implantable breast prosthesis, silicone or equal YES

NO

Description Malignant neoplasm of nipple and areola of female breast Malignant neoplasm of central portion of female breast Malignant neoplasm of upper-inner quadrant of female breast Malignant neoplasm of lower-inner quadrant of female breast Malignant neoplasm of upper-outer quadrant of female breast Malignant neoplasm of lower-outer quadrant of female breast Malignant neoplasm of axillary tail of female breast Malignant neoplasm of other specified sites of female breast Malignant neoplasm of breast (female), unspecified site Malignant neoplasm of nipple and areola of male breast Secondary malignant neoplasm of breast Carcinoma in situ of breast Personal history of malignant neoplasm of breast Acquired absence of breast and nipple Encounter for breast reconstruction following mastectomy

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ICD-10 Codes In preparation for the transition from ICD-9 to ICD-10 medical coding on October 1, 2015*, a sample listing of the ICD-10 CM and/or ICD-10 PCS codes associated with this policy has been provided below for your reference. This list of codes may not be all inclusive and will be updated to reflect any applicable revisions to the ICD-10 code set and/or clinical guidelines outlined in this policy. *The effective date for ICD-10 code set implementation is subject to change. ICD-10 Diagnosis Code (Effective 10/01/15) C50.011 C50.012 C50.019 C50.021 C50.022 C50.029 C50.111 C50.112 C50.119 C50.121 C50.122 C50.129 C50.211 C50.212 C50.219 C50.221 C50.222 C50.229 C50.311 C50.312 C50.319 C50.321 C50.322 C50.329 C50.411 C50.412 C50.419 C50.421 C50.422 C50.429 C50.511 C50.512 C50.519 C50.521 C50.522 C50.529

Description

Malignant neoplasm of nipple and areola, right female breast Malignant neoplasm of nipple and areola, left female breast Malignant neoplasm of nipple and areola, unspecified female breast Malignant neoplasm of nipple and areola, right male breast Malignant neoplasm of nipple and areola, left male breast Malignant neoplasm of nipple and areola, unspecified male breast Malignant neoplasm of central portion of right female breast Malignant neoplasm of central portion of left female breast Malignant neoplasm of central portion of unspecified female breast Malignant neoplasm of central portion of right male breast Malignant neoplasm of central portion of left male breast Malignant neoplasm of central portion of unspecified male breast Malignant neoplasm of upper-inner quadrant of right female breast Malignant neoplasm of upper-inner quadrant of left female breast Malignant neoplasm of upper-inner quadrant of unspecified female breast Malignant neoplasm of upper-inner quadrant of right male breast Malignant neoplasm of upper-inner quadrant of left male breast Malignant neoplasm of upper-inner quadrant of unspecified male breast Malignant neoplasm of lower-inner quadrant of right female breast Malignant neoplasm of lower-inner quadrant of left female breast Malignant neoplasm of lower-inner quadrant of unspecified female breast Malignant neoplasm of lower-inner quadrant of right male breast Malignant neoplasm of lower-inner quadrant of left male breast Malignant neoplasm of lower-inner quadrant of unspecified male breast Malignant neoplasm of upper-outer quadrant of right female breast Malignant neoplasm of upper-outer quadrant of left female breast Malignant neoplasm of upper-outer quadrant of unspecified female breast Malignant neoplasm of upper-outer quadrant of right male breast Malignant neoplasm of upper-outer quadrant of left male breast Malignant neoplasm of upper-outer quadrant of unspecified male breast Malignant neoplasm of lower-outer quadrant of right female breast Malignant neoplasm of lower-outer quadrant of left female breast Malignant neoplasm of lower-outer quadrant of unspecified female breast Malignant neoplasm of lower-outer quadrant of right male breast Malignant neoplasm of lower-outer quadrant of left male breast Malignant neoplasm of lower-outer quadrant of unspecified male

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ICD-10 Diagnosis Code (Effective 10/01/15) C50.611 C50.612 C50.619 C50.621 C50.622 C50.629 C50.811 C50.812 C50.819 C50.821 C50.822 C50.829 C50.911 C50.912 C50.919 C50.921 C50.922 C50.929 C79.81 D05.00 D05.01 D05.02 D05.10 D05.11 D05.12 D05.80 D05.81 D05.82 D05.90 D05.91 D05.92 Z42.1 Z85.3 Z90.10 Z90.11 Z90.12 Z90.13

Description

breast Malignant neoplasm of axillary tail of right female breast Malignant neoplasm of axillary tail of left female breast Malignant neoplasm of axillary tail of unspecified female breast Malignant neoplasm of axillary tail of right male breast Malignant neoplasm of axillary tail of left male breast Malignant neoplasm of axillary tail of unspecified male breast Malignant neoplasm of overlapping sites of right female breast Malignant neoplasm of overlapping sites of left female breast Malignant neoplasm of overlapping sites of unspecified female breast Malignant neoplasm of overlapping sites of right male breast Malignant neoplasm of overlapping sites of left male breast Malignant neoplasm of overlapping sites of unspecified male breast Malignant neoplasm of unspecified site of right female breast Malignant neoplasm of unspecified site of left female breast Malignant neoplasm of unspecified site of unspecified female breast Malignant neoplasm of unspecified site of right male breast Malignant neoplasm of unspecified site of left male breast Malignant neoplasm of unspecified site of unspecified male breast Secondary malignant neoplasm of breast Lobular carcinoma in situ of unspecified breast Lobular carcinoma in situ of right breast Lobular carcinoma in situ of left breast Intraductal carcinoma in situ of unspecified breast Intraductal carcinoma in situ of right breast Intraductal carcinoma in situ of left breast Other specified type of carcinoma in situ of unspecified breast Other specified type of carcinoma in situ of right breast Other specified type of carcinoma in situ of left breast Unspecified type of carcinoma in situ of unspecified breast Unspecified type of carcinoma in situ of right breast Unspecified type of carcinoma in situ of left breast Encounter for breast reconstruction following mastectomy Personal history of malignant neoplasm of breast Acquired absence of unspecified breast and nipple Acquired absence of right breast and nipple Acquired absence of left breast and nipple Acquired absence of bilateral breasts and nipples

Limited to place of service (POS)?

YES

NO

Limited to specific provider type?

YES

NO

Limited to specific revenue codes?

YES

NO

REFERENCES None Breast Reconstruction Post Mastectomy: Coverage Determination Guideline (Effective 05/01/2014)

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GUIDELINE HISTORY/REVISION INFORMATION Date • •

05/01/2014

• • •

Action/Description Added reference link to CDGs titled: o Breast Reconstruction Not Following Mastectomy o Cosmetic and Reconstruction Procedures Revised coverage rationale/indications for coverage: o Updated/expanded coverage criterion #2 for surgical breast reconstruction procedures to indicate: - If the original implant or reconstructive surgery was considered reconstructive surgery under the UnitedHealthcare benefit document, coverage may exist for removal, replacement, and/or reconstruction; if the original implant or reconstructive surgery was considered reconstructive surgery under the UnitedHealthcare 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 breast complications may not be covered o Removed definition of “Reconstructive Procedures for California Plans”; this definition is provided in the Definitions section of the policy Revised definitions; removed definition of “Reconstructive Procedures (2001 Generic Certificate of Coverage)” Updated list of applicable ICD-10 codes (preview draft effective 10/01/15); changed tentative effective date of ICD-10 code set implementation from “10/01/14” to “10/01/15” Archived previous policy version CDG.003.01

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