External Breast Prosthesis

Number: 0097

Table Of Contents

Policy
Applicable CPT / HCPCS / ICD-10 Codes
Background
References

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Policy

Scope of Policy

This Clinical Policy Bulletin addresses external breast prosthesis.

1. Medical Necessity

   1. Aetna considers external breast prosthesis medically necessary:

      1. Following a medically necessary mastectomy or lumpectomy; or
      2. For persons with gender dysphoria.

   2. Aetna considers the following medically necessary:

      1. Up to six breast prosthesis bras (mastectomy bras):

         1. Initially following a medically necessary mastectomy; or
         2. For members who have a medically necessary mastectomy form or silicone (or equal) breast prosthesis when the pocket of the bra is used to hold the form/prosthesis; or 
         3. For members with gender dysphoria; 

         Note: Some Aetna plans limit prosthetic coverage to an initial medically necessary prosthesis and do not cover replacement prostheses. Please check benefit plan descriptions for details. Under these plans, an initial external breast prosthesis and up to four initial breast prosthesis bras (mastectomy bras) are covered following a medically necessary mastectomy or for persons with gender dysphoria. For persons who have had a mastectomy, "initial" applies to a breast prosthesis and bras purchased within one year after the mastectomy is performed, not the first breast prosthesis prescribed after the member's Aetna coverage becomes effective.

      2. Up to six breast prosthesis bra (mastectomy bra) replacements every 12 months;
      3. An external breast prosthesis garment with mastectomy form for:
         
         
         1. Use in the post-operative period prior to a permanent breast prosthesis or as an alternative to a mastectomy bra and breast prosthesis; or
         2. Members with gender dysphoria; 
      4. Only one breast prosthesis per side for the useful lifetime of the prosthesis;
      5. Two breast prostheses, one per side, for:
         
         
         1. Members who have had bilateral mastectomies; or
         2. Members with gender dysphoria;
      6. One replacement silicone breast prostheses every 24 months:
         
         
         1. For fabric, foam, or fiber-filled breast prostheses, replacements are considered medically necessary every 6 months;
         2. Replacements of nipple prostheses are considered medically necessary every 3 months;
         3. The medical necessity of more frequent replacements must be documented. 

         Note: Some Aetna plans limit coverage to an initial breast prosthesis and do not cover replacement prostheses.  Please check benefit plan descriptions for details.

      7. Three gradient compression lymphedema sleeves ("mastectomy sleeves") initially per affected arm, then two replacements every six months. Note: The Women's Health and Cancer Rights Act (WHCRA) of 1998 (Public Law #105-277) mandates that all insurance companies provide coverage for breast "prostheses and physical complications of mastectomy including lymphedemas."

   3. Aetna considers the following not medically necessary:

      1. A breast prosthesis, silicone or equal, with integrated adhesive is considered not medically necessary because it has not been demonstrated to have a clinical advantage over those without the integrated adhesive;

         Note: The additional features of a custom-fabricated breast prosthesis, compared to a pre-fabricated silicone breast prosthesis, are not considered medically necessary.

      2. External breast prosthesis for the management of developmental breast asymmetry;
      3. More than one external breast prosthesis.

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Table:

Applicable CPT / HCPCS / ICD-10 Codes

Code	Code Description
Other CPT codes related to the CPB:
19300-19303 19305-19307	Mastectomy procedures
HCPCS codes covered if selection criteria are met:
A4280	Adhesive skin support attachment for use with external breast prosthesis, each
A6522	Gradient compression garment, arm, padded, for nighttime use, each
A6523	Gradient compression garment, arm, padded, for nighttime use, custom, each
A6549	Gradient compression stocking/sleeve, not otherwise specified
A6574	Gradient compression arm sleeve and glove combination, custom, each
A6575	Gradient compression arm sleeve and glove combination, each
A6576	Gradient compression arm sleeve, custom, medium weight, each
A6577	Gradient compression arm sleeve, custom, heavy weight, each
A6578	Gradient compression arm sleeve, each
A6584	Gradient compression wrap with adjustable straps, not otherwise specified
A6588	Gradient pressure wrap with adjustable straps, arm, each
L8000	Breast prosthesis, mastectomy bra, without integrated breast prosthesis form, any size, any type
L8001	Breast prosthesis, mastectomy bra, with integrated breast prosthesis form, unilateral, any size, any type
L8002	Breast prosthesis, mastectomy bra, with integrated breast prosthesis form, bilateral, any size, any type
L8010	Breast prosthesis, mastectomy sleeve
L8015	External breast prosthesis garment, with mastectomy form, post mastectomy
L8020	Breast prosthesis, mastectomy form
L8030	Breast prosthesis, silicone or equal
L8032	Nipple prosthesis, prefabricated, reusable, any type, each
L8033	Nipple prosthesis, custom fabricated, reusable, any material, any type, each
L8039	Breast prosthesis, not otherwise specified
S8422	Gradient pressure aid (sleeve), custom made, medium weight
S8423	Gradient pressure aid (sleeve), custom made, heavy weight
S8424	Gradient pressure aid (sleeve), ready made
HCPCS codes not covered for indications listed in the CPB:
L8031	Breast prosthesis, silicone or equal, with integral adhesive
L8035	Custom breast prosthesis, post mastectomy, molded to patient model
ICD-10 codes covered if selection criteria are met:
C50.011 - C50.919	Malignant neoplasm of breast
C79.81	Secondary malignant neoplasm of breast
D05.01 - D05.99	Carcinoma in situ of breast
F64.0 - F64.9	Gender identity disorders [gender dysphoria]
N60.11 - N60.19	Diffuse cystic mastopathy [severe fibrocystic disease]
Z85.3	Personal history of malignant neoplasm of breast
Z90.10 - Z90.13	Acquired absence of breast and nipple
ICD-10 codes not covered for indications listed in the CPB:
N64.89	Other specified disorders of breast [management of developmental breast asymmetry]

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Background

This policy is supported by Durable Medical Equipment Medicare Administrative Contractor (DME MAC) policy.

"Breast prosthesis, mastectomy bra, without integrated breast prosthesis form, any size, any type" describes a bra with pockets that are intended to hold a mastectomy form or breast prosthesis held adjacent to the chest wall.  These do not include an integrated breast prosthesis. They may be constructed of any material (e.g., cotton, polyester or other materials), with any type or location of closure, any size, with or without integrated structural support (e.g., underwire).

"Breast prosthesis, mastectomy bra, with integrated breast prosthesis form, unilateral, any size, any type" and "Breast prosthesis, mastectomy bra, with integrated breast prosthesis form, bilateral, any size, any type" describe a bra with integrated breast prosthesis, either unilateral or bilateral, respectively.  They may be constructed of any material (e.g., cotton, polyester or other materials), with any type or location of closure, any size, with or without integrated structural support (e.g., underwire).

"External breast prosthesis garment, with mastectomy form, post mastectomy" describes a camisole type undergarment with polyester fill used post mastectomy.

A custom fabricated prosthesis is one which is individually made for a specific patient starting with basic materials. "Custom breast prosthesis, post mastectomy, molded to patient model" describes a molded-to-patient-model custom breast prosthesis.  It is a particular type of custom fabricated prosthesis in which an impression is made of the chest wall and this impression is then used to make a positive model of the chest wall.  The prosthesis is then molded on this positive model.

Developmental Breast Asymmetry

Suhail et al (2023) stated that about 25 % of women are affected by breast asymmetry as a consequence of abnormal breast development, which can result in significant emotional distress.  Despite this, there is currently no widely accepted approach for managing this prevalent condition.  In a systematic review, these investigators examined the available evidence on the management of developmental breast asymmetry.  They carried out a comprehensive search in Medline, Embase, and CENTRAL databases for primary clinical studies reporting on the management of developmental breast asymmetry from 1962 to November 2022.  The primary outcome measures were long-term aesthetic outcomes and patient-reported outcomes (PROs).  A total of 11 case series and 2 cohort studies were included, comprising a total of 1,237 patients with a mean age of 26.5 years (range of 14 to 65 years); 12 studies (92 %) addressed asymmetry via surgical interventions, using various augmentation and reduction procedures, whereas 1 study (8 %) utilized external prostheses.  Meta-analysis of the data was not deemed to be possible because of heterogeneity of data; a narrative synthesis of the literature was provided.  The authors concluded that there is no consensus on how to manage developmental breast asymmetry.  In addition, there is a lack of consistency in the classification of patients with developmental breast asymmetry and in the reporting of outcomes, highlighting the need for a consensus.  Moreover, these researchers stated that further investigations outlining long-term aesthetic and PROs are needed to understand which procedures provide optimal outcomes.  Furthermore, external breast prosthesis is a promising non-surgical alternative, and further studies into its effectiveness are needed.

The authors stated that this review had 2 main drawbacks.  First, the conclusions were limited by the scarcity of primary studies on this topic and the lack of level 1 evidence.  These findings were primarily based on retrospective observation studies such as case series and cohort studies, which were susceptible to bias.  Second, the variation in the classification and reporting of outcomes following symmetrizing procedures, deeming meta-analysis of the data was not possible.  These investigators stated that a consensus in this area is needed to facilitate better comparison of outcomes in future studies evaluating results of breast symmetrization procedures.

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References