BREAST RECONSTRUCTION POST MASTECTOMY

Transcription

1 COVERAGE DETERMINATION GUIDELINE BREAST RECONSTRUCTION POST MASTECTOMY Guideline Number: CDG Effective Date: January 1, 2016 Table of Contents COVERAGE RATIONALE... DEFINITIONS... APPLICABLE CODES... REFERENCES... HISTORY/REVISION INFORMATION... 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 s (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 Page Related Policies: Breast Repair/Reconstruction Not Following Mastectomy Cosmetic and Reconstructive Procedures DME, Orthotics, Ostomy Supplies, Medical Supplies and Repairs/Replacements Gender Dysphoria (Gender Identity Disorder) Treatment Pneumatic Compression Devices Prosthetic Devices, Wigs, Specialized, Microprocessor or Myoelectric Limbs Benefit Document Language Before using this guideline, please check enrollee s 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 1

2 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 specific benefit document to determine benefit coverage. Indications for Coverage Breast reconstruction is covered for 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 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 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 Gluteal Flap (GAP free flap) Refer to the Definitions Section of this Coverage Determination Guideline (CDG) for reconstruction procedure definitions. 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 complications may not be covered. 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 benefit document 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 enrollee specific benefit document for coverage. 2

3 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. (when covered these pumps are covered as Durable Medical Equipment) c. Compression Lymphedema sleeves are covered. (when covered, these sleeves are covered as a Prosthetic Device) 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 enrollee s state mandates and enrollee 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. If the reconstruction has been successfully completed post mastectomy and the enrollee chooses to enlarge their s for cosmetic reasons, this is considered a cosmetic service and is not a covered health service. 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 enrollee 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 a covered health service. 5. Revision of prior reconstructed due to normal aging does not meet the definition of a covered reconstructive health service. 6. Unproven services. DEFINITIONS Breast Reconstruction Steps: Step 1 - Creation of a mound: Reposition a woman s own muscle, fat and skin to create a mound. o TRAM FLAP the muscle, fat and skin from the lower abdomen is used to reconstruct the. o DIEP or SGAP FLAP the fat and skin but not muscle is used from the lower abdomen or buttocks to reconstruct the. 3

4 o 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. o Requires several office visits over 4-6 months to fill the device through an internal valve to expand the skin. o A second surgical procedure is needed to replace the expander. Surgical placement of a implant creates a mound. o May be used with a flap or alone following tissue expansion. o o Silicone and saline implants are available for reconstruction. Reconstruction alone may be done with an implant but usually a tissue expander is needed. Step 2 - Creation of a nipple and areola: Many different techniques are used. Tattooing may be used for the areola. 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 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 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) 4

5 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. "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 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 ) 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? Mastectomy Codes YES NO CPT Procedure Code 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 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 5

6 The following CPT codes do not meet criteria for post mastectomy (do not apply to reconstruction). CPT Procedure Code Biopsy of ; percutaneous, needle core, not using imaging guidance (separate procedure) Biopsy of ; open, incisional Excision of cyst, fibroadenoma, or other benign or malignant tumor, 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 radiological marker, open; single lesion Excision of 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 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,, trunk) (list separately in addition to code for primary procedure) Mastopexy Mammaplasty, augmentation; without prosthetic implant Mammaplasty, augmentation; with prosthetic implant Immediate insertion of prosthesis following mastopexy, mastectomy or in reconstruction 6

7 CPT Procedure Code 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 Preparation of moulage for custom implant Unlisted procedure, Code is covered only to achieve symmetry of the contralateral post mastectomy. CPT Procedure Code Reduction mammaplasty HCPCS Procedure Code L8600 Implantable prosthesis, silicone or equal Limited to specific diagnosis codes? YES NO 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, ICD-9 Diagnosis Code (Discontinued 10/01/15) Malignant neoplasm of nipple and areola of female Malignant neoplasm of central portion of female Malignant neoplasm of upper-inner quadrant of female Malignant neoplasm of lower-inner quadrant of female Malignant neoplasm of upper-outer quadrant of female Malignant neoplasm of lower-outer quadrant of female Malignant neoplasm of axillary tail of female Malignant neoplasm of other specified sites of female Malignant neoplasm of (female), unspecified site Malignant neoplasm of nipple and areola of male Secondary malignant neoplasm of 7

8 ICD-9 Diagnosis Code (Discontinued 10/01/15) 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, ICD-10 codes will not be accepted for services provided prior to October 1, ICD-10 Diagnosis Code C Malignant neoplasm of nipple and areola, right female C Malignant neoplasm of nipple and areola, left female C Malignant neoplasm of nipple and areola, unspecified female C Malignant neoplasm of nipple and areola, right male C Malignant neoplasm of nipple and areola, left male C Malignant neoplasm of nipple and areola, unspecified male C Malignant neoplasm of central portion of right female C Malignant neoplasm of central portion of left female C Malignant neoplasm of central portion of unspecified female C Malignant neoplasm of central portion of right male C Malignant neoplasm of central portion of left male C Malignant neoplasm of central portion of unspecified male C Malignant neoplasm of upper-inner quadrant of right female C Malignant neoplasm of upper-inner quadrant of left female C Malignant neoplasm of upper-inner quadrant of unspecified female C Malignant neoplasm of upper-inner quadrant of right male C Malignant neoplasm of upper-inner quadrant of left male C Malignant neoplasm of upper-inner quadrant of unspecified male C Malignant neoplasm of lower-inner quadrant of right female C Malignant neoplasm of lower-inner quadrant of left female C Malignant neoplasm of lower-inner quadrant of unspecified female C Malignant neoplasm of lower-inner quadrant of right male C Malignant neoplasm of lower-inner quadrant of left male C Malignant neoplasm of lower-inner quadrant of unspecified male C Malignant neoplasm of upper-outer quadrant of right female C Malignant neoplasm of upper-outer quadrant of left female C Malignant neoplasm of upper-outer quadrant of unspecified female C Malignant neoplasm of upper-outer quadrant of right male C Malignant neoplasm of upper-outer quadrant of left male C Malignant neoplasm of upper-outer quadrant of unspecified male C Malignant neoplasm of lower-outer quadrant of right female C Malignant neoplasm of lower-outer quadrant of left female C Malignant neoplasm of lower-outer quadrant of unspecified female 8

9 ICD-10 Diagnosis Code C Malignant neoplasm of lower-outer quadrant of right male C Malignant neoplasm of lower-outer quadrant of left male C Malignant neoplasm of lower-outer quadrant of unspecified male C Malignant neoplasm of axillary tail of right female C Malignant neoplasm of axillary tail of left female C Malignant neoplasm of axillary tail of unspecified female C Malignant neoplasm of axillary tail of right male C Malignant neoplasm of axillary tail of left male C Malignant neoplasm of axillary tail of unspecified male C Malignant neoplasm of overlapping sites of right female C Malignant neoplasm of overlapping sites of left female C Malignant neoplasm of overlapping sites of unspecified female C Malignant neoplasm of overlapping sites of right male C Malignant neoplasm of overlapping sites of left male C Malignant neoplasm of overlapping sites of unspecified male C Malignant neoplasm of unspecified site of right female C Malignant neoplasm of unspecified site of left female C Malignant neoplasm of unspecified site of unspecified female C Malignant neoplasm of unspecified site of right male C Malignant neoplasm of unspecified site of left male C 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 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 Limited to place of service (POS)? Limited to specific provider type? Limited to specific revenue codes? REFERENCES YES YES YES NO NO NO 9

10 1. UnitedHealthcare Company Generic Certificate of Coverage UnitedHealthcare Company Generic Certificate of Coverage UnitedHealthcare Company Generic Certificate of Coverage American Society of Plastic Surgeons. Breast Reconstruction Procedures Steps. Available at: Accessed on September 3, GUIDELINE HISTORY/REVISION INFORMATION Date 01/01/2016 Action/ Added reference links to policies titled Gender Dysphoria (Gender Identity Disorder) Treatment and Pneumatic Compression Devices 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) Archived previous policy version CDG