National Medical Policy

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National Medical Policy
Subject:                  Breast Reconstructive Surgery

Policy Number:            NMP492

Effective Date*: February 2013

Updated:                  April 2013



               This National Medical Policy is subject to the terms in the
                                  IMPORTANT NOTICE
                              at the end of this document

              The Centers for Medicare & Medicaid Services (CMS)
      For Medicare Advantage members please refer to the following for coverage
                                guidelines first:

Use    Source                                Reference/Website Link
X      National Coverage Determination       Breast Reconstruction:
       (NCD)                                 http://www.cms.gov/medicare-coverage-
                                             database/details/ncd-
                                             details.aspx?NCDId=64&ncdver=1&SearchType
                                             =Advanced&CoverageSelection=Both&NCSelecti
                                             on=NCA%7cCAL%7cNCD%7cMEDCAC%7cTA%7
                                             cMCD&ArticleType=Ed%7cKey%7cSAD%7cFAQ
                                             &PolicyType=Final&s=5%7c6%7c66%7c67%7c4
                                             4&KeyWord=breast+reconstruction&KeyWordLo
                                             okUp=Doc&KeyWordSearchType=Exact&kq=tru
                                             e&bc=IAAAABAAAAAAAA%3d%3d&

       National Coverage Manual Citation
X      Local Coverage Determination          Cosmetic and Reconstructive Surgery; Plastic
       (LCD)*                                Surgery: http://www.cms.gov/medicare-
                                             coverage-database/search/advanced-
                                             search.aspx

X      Article (Local)*                      Cosmetic vs. Reconstructive Surgery:
                                             http://www.cms.gov/medicare-coverage-
                                             database/search/advanced-search.aspx

       Other
       None                                  Use Health Net Policy

Instructions
 Medicare NCDs and National Coverage Manuals apply to ALL Medicare members
    in ALL regions.



Breast Reconstructive Surgery Apr 13                                                1
     Medicare LCDs and Articles apply to members in specific regions. To access your
     specific region, select the link provided under "Reference/Website" and f ollow the
     search instructions. Enter the topic and your specific state to find the coverage
     determinations for your region. *Note: Health Net must follow local coverage
     determinations (LCDs) of Medicare Administration Contractors (MACs) located
     outside their service area when those MACs have exclusive coverage of an item
     or service. (CMS Manual Chapter 4 Section 90.2)
     If more than one source is checked, you need to access all sources as, on
     occasion, an LCD or article contains additional coverage information than
     contained in the NCD or National Coverage Manual.
     If there is no NCD, National Coverage Manual or region specific LCD/Article,
     follow the Health Net Hierarchy of Medical Resources for guidance.

Current Policy Statement (Refer to HN NMP 169 Cosmetic and
Reconstructive Surgery and HN NMP 323 Lymphedema and Venous
Stasis Ulcer Treatments for additional information) and/or state
mandates.

*Note  Women's Health & Cancer Rights Act of 1998 (WHCRA) is a federal law that
provides protections to patients who choose to have breast reconstruction in
connection with a mastectomy. In accordance with WHCRA, all stages of
reconstruction of the breast on which a mastectomy was performed, surgery and
reconstruction of the other breast to produce symmetrical appearance, prostheses
and treatment of physical complications of the mastectomy, including lymphedema
are considered medically necessary.

Health Net, Inc. considers reconstructive breast surgery medically necessary after a
mastectomy or a lumpectomy which results in a significant deformity. Medically
necessary procedures include any of the following:

1.   Implantation of U.S. Food and Drug Administration (FDA)-approved internal
     breast prosthesis;
2.   The use of tissue expanders;
3.   Use of AlloDerm Regenerative Tissue Matrix, FlexHD Acelluar Hydrated Dermis,
     AlloMax, NeoForm Dermis;
4.   Tissue/muscle reconstruction procedures (e.g. flaps);
5.   Oncoplastic reconstruction;
6.   Reconstructive surgical revisions;
7.   Breast reconstruction of the affected breast, including reconstruction of the
     nipple and areolar complex;
8.   Tattooing in conjunction with reconstructive breast surgery post-mastectomy;
9.   Removal of a breast implant, periprosthetic capsulotomy or capsulectomy is
     considered medically necessary when documentation in the patient's record
     indicates any of the following mechanical complications of breast prosthesis:

              Ruptured implant
               Implant extrusion
              Painful capsular contracture with disfigurement
               Infection or inflammatory reaction due to breast prosthesis
               Siliconoma
               Granuloma
               Interference with diagnosis of breast cancer
9.   Autologous fat/graft transfer (e.g., lipoinjection, lipofilling, lipopodeling) post-
     mastectomy, when no native breast tissue is present.



Breast Reconstructive Surgery Apr 13                                                        2
Health Net considers breast reconstructive surgery to correct breast asymmetry in
the nondiseased, unaffected, or contralateral breast, medically necessary only in the
following situations:

1.   Surgical correction due to a medically necessary mastectomy or a medically
     necessary lumpectomy that results in a significant deformity;
2.   Repair of breast asymmetry due to trauma.
3.   Breast implant for Poland's syndrome (congenital absence of breast).
4.   Pectus excavatum repair when documented functional impairment exists (i.e.,
     decreased cardiac output and/or abnormal pulmonary function during exercise)
     or when future cardiovascular compromise is anticipated.

Not Medically Necessary/Investigational
Health Net, Inc. considers the following not medically necessary when used in
association with breast reconstruction procedures, since there is a lack of
randomized, controlled, prospective studies (list may not be all inclusive):

1.   Permacol
2.   Radiesse

Note: Breast reconstruction services following mastectomy and lumpectomy is
available to both females and males. In addition, a diagnosis of breast cancer is not
required for breast reconstruction services, and the timing of reconstructive services
is not a factor.

Codes Related To This Policy
NOTE:
The codes listed in this policy are for reference purposes only. Listing of a code in
this policy does not imply that the service described by this code is a covered or non-
covered health service. Coverage is determined by the benefit documents and
medical necessity criteria. This list of codes may not be all inclusive.

On October 1, 2014, the ICD-9 code sets used to report medical diagnoses and
inpatient procedures will be replaced by ICD-10 code sets. Health Net National
Medical Policies will now include the preliminary ICD-10 codes in preparation for this
transition. Please note that these may not be the final versions of the codes and
that will not be accepted for billing or payment purposes until the October 1, 2014
implementation date.

ICD-9 Codes (not an inclusive list)
 170.4-175.9     Malignant neoplasm of breast
 198.41          Secondary malignant neoplasm of breast
 610.1           Diffuse cystic mastopathy [severe fibrocystic disease]
 757.6           Specified anomalies of breast (absence)
 V10.3           Personal history of malignant neoplasm of breast
 V45.71          Acquired absence of breast [following medically necessary
                 mastectomy or lumpectomy resulting in significant deformity]

ICD-10 Codes (not an inclusive list)
C50                  Malignant neoplasm of breast
N60.1                Diffuse cystic mastopathy(fibrocystic disease)
Q83                  Congenital malformations of the breast
Z85.3                Personal history of malignant neoplasm of breast
Z90.1                Acquired absence of breast(s)



Breast Reconstructive Surgery Apr 13                                                     3
CPT Codes (not an inclusive list)
11920          Tattooing, intradermal introduction of insoluble opaque pigments to
               correct color defects of skin, including micropigmentation; 6.0 sq
               cm or less
11921          Tattooing, intradermal introduction of insoluble opaque pigments to
               correct color defects of skin, including micropigmentation; 6.1 to
               20.0 sq cm
11970          Replacement of tissue expander with permanent prosthesis
11971          Removal of tissue expander(s) without insertion of prosthesis
19318          Reduction mammaplasty
19324          Mammaplasty, augmentation; without prosthetic implant
19325          Mammaplasty, augmentation; with prosthetic implant
19328          Removal of intact mammary implant
19330          Removal of mammary implant material
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/areola reconstruction
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          Breast reconstruction with transverse rectus abdominis
               myocutaneous flap (TRAM), single pedicle, including closure of
               donor site; 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

HCPCS Codes (not an all inclusive list)
 L8600        Implantable breast prosthesis, silicone or equal
 Q4100        Skin substitute, not otherwise specified
 Q4116        Skin substitute, alloderm, per square centimeter
 Q4128        Flex HD, Allopatch HD, Or Matrix HD, Per Square Centimeter




Breast Reconstructive Surgery Apr 13                                                 4
Scientific Rationale  Update April 2013
Autologous fat grafting (AFG) is used as an adjunct to standard breast reconstruction
following mastectomy or breast-conserving surgery (lumpectomy or partial
mastectomy). Autologous fat grafting consists of 3 phases - harvesting of fat tissue
(e.g. lower abdomen, back, or thighs), processing, and application of the graft to the
surgical site. Fat harvesting is similar to classic liposuction.

In 2009, the American Society of Plastic Surgeons (ASPS) Executive Committee
approved Guiding Principles that did not provide specific recommendations for the
clinical use of fat grafts, citing a lack of strong data and literature. The review of the
scientific evidence by the Task Force indicated that there were no reports suggesting
an increased risk of malignancy associated with fat grafting and limited data
suggested that fat grafts may not interfere with radiologic imaging for breast cancer
detection.

In 2011, a joint ASPS & American Society for Aesthetic Plastic Surgery (ASAPS)
Position Statement: Stem Cells and Fat Grafting, addressed concerns regarding stem
cells and fat grafting in clinical practice. They noted that standard fat grafting
procedures which do transfer some stem cells naturally present within the tissue
should be described as a fat grafting procedure, not a stem cell procedure. They
stated that the marketing and promotion of stem cell procedures in aesthetic surgery
is not adequately supported by clinical evidence. A substantial body of clinical data
to assess plastic surgery applications of stem cell therapies still needs to be
collected. Until further evidence is available, stem cell therapies in aesthetic and
reconstructive surgery should be conducted within clinical studies under Institutional
Review Board approval, including compliance with all guidelines for human medical
studies.

2012 Post-Mastectomy Fat Graft/Fat Transfer (ASPS) Guiding Principles, provides
recommendations regarding fat transfer to the post-mastectomy breast with no
native breast tissue present. Per the ASPS, "An evaluation of available literature on
autologous fat grafting following mastectomy with no remaining native breast tissue
indicates that the body of evidence is comprised mostly of case series, and when
combined, the studies provide consistent evidence, thus resulting in grade B
recommendations. A grade B recommendation encourages clinicians to employ the
available information while remaining cognizant of newer, evidence-based findings.
The existing evidence suggests autologous fat grafting as an effective option in
breast reconstruction following mastectomy while demonstrating moderate to
significant aesthetic improvement. In addition, the available evidence also cites
autologous fat grafting as a useful modality for alleviating post mastectomy pain
syndrome. Furthermore, the evidence suggests autologous fat grafting as a viable
option for improving the quality of irradiated skin present in the setting of breast
reconstruction."

ASPS GUIDING PRINCIPLES
1. Aesthetic Outcome: Studies indicate that breast cancer patients undergoing fat
   grafting as an adjunct to post-mastectomy breast reconstruction experience
   moderate to significant aesthetic improvement, particularly for volume, contour
   and superomedial fullness. The evidence also suggests that cosmetic outcome is
   significantly enhanced after serial fat grafting and that, overall, patients are
   satisfied with aesthetic results.
2. Breast Cancer Recurrence: Evidence suggests that in post-mastectomy breast
   reconstruction patients, fat grafting does not increase the risk of breast cancer
   recurrence. As surveillance is integral for the management of any breast cancer
   patient, fat grafting to post-mastectomy reconstructed breasts does not delay

Breast Reconstructive Surgery Apr 13                                                     5
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