Notification



Notification Issue Date:



Medicare Advantage Policy

Title:External Breast Prosthesis
Policy #:MA05.033b

This policy is applicable to the Company’s Medicare Advantage products only. Policies that are applicable to the Company’s commercial products are accessible via a separate commercial policy database.


The Company makes decisions on coverage based on the Centers for Medicare and Medicaid Services (CMS) regulations and guidance, benefit plan documents and contracts, and the member’s medical history and condition. If CMS does not have a position addressing a service, the Company makes decisions based on Company Policy Bulletins. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable. Although the Medicare Advantage Policy Bulletin is consistent with Medicare’s regulations and guidance, the Company’s payment methodology may differ from Medicare.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.


This Policy Bulletin document describes the status of CMS coverage, medical terminology, and/or benefit plan documents and contracts at the time the document was developed. This Policy Bulletin will be reviewed regularly and be updated as Medicare changes their regulations and guidance, scientific and medical literature becomes available, and/or the benefit plan documents and/or contracts are changed.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's Evidence of Coverage.

A breast prosthesis is considered medically necessary and, therefore, covered for an individual who has had a mastectomy.

An external breast prosthesis garment, with mastectomy form (L8015) is considered medically necessary and, therefore, covered for use in the postoperative period prior to a permanent breast prosthesis or as an alternative to a mastectomy bra and breast prosthesis.

Breast prostheses, silicone or equal, with integral adhesive (L8031) have not been demonstrated to have a clinical advantage over those without the integral adhesive. Therefore, these items are considered not medically necessary and, therefore, not covered.

The medical necessity for the additional features of a custom-fabricated prosthesis (L8035) compared to a prefabricated silicone breast prosthesis has not been established. Therefore, a custom-fabricated prosthesis (L8035) is considered not medically necessary and, therefore, not covered.

A mastectomy bra (L8000) is considered medically necessary and, therefore, covered for an individual who has a covered mastectomy form (L8020) or silicone (or equal) breast prosthesis (L8030) when the pocket of the bra is used to hold the form/prosthesis.

A mastectomy sleeve (L8010) is not covered by Company because it is an item not covered by Medicare. Therefore, it is not eligible for reimbursement consideration.

An external breast prosthesis of the same type can be replaced at any time if it is lost or is irreparably damaged (this does not include ordinary wear and tear). An external breast prosthesis of a different type can be covered at any time if there is a change in the patient's medical condition necessitating a different type of item. The Company will pay for only one breast prosthesis per side for the useful lifetime of the prosthesis. Two prostheses, one per side, are allowed for those persons who have had bilateral mastectomies. More than one external breast prosthesis per side is considered not medically necessary and, therefore, not covered.

The useful lifetime expectancy for silicone breast prostheses is 2 years. The useful lifetime expectancy for a nipple prostheses is 3 months. For fabric, foam, or fiber filled breast prostheses, the useful lifetime expectancy is 6 months. Replacement sooner than the useful lifetime because of ordinary wear and tear is noncovered.

REQUIRED DOCUMENTATION

The Company may conduct reviews and audits of services to our members regardless of the participation status of the provider. Medical record documentation must be maintained on file to reflect the medical necessity of the care and services provided. These medical records may include but are not limited to: records from the professional provider’s office, hospital, nursing home, home health agencies, therapies, and test reports.

PRESCRIPTION (ORDER) REQUIREMENTS
Before submitting a claim to the Company, the supplier must have on file a timely, appropriate, and complete order for each item billed that is signed and dated by the professional provider who is treating the member. Requesting a provider to sign a retrospective order at the time of an audit or after an audit for submission as an original order, reorder, or updated order will not satisfy the requirement to maintain a timely professional provider order on file.

PROOF OF DELIVERY
Medical record documentation must include a contemporaneously prepared delivery confirmation or member’s receipt of supplies and equipment. The medical record documentation must include a copy of delivery confirmation if delivered by a commercial carrier and a signed copy of delivery confirmation by member/caregiver if delivered by the DME supplier/provider. All documentation is to be prepared contemporaneous with delivery and be available to the Company upon request.

CONSUMABLE SUPPLIES
The durable medical equipment (DME) supplier must monitor the quantity of accessories and supplies an individual is actually using. Contacting the individual regarding replenishment of supplies should not be done earlier than approximately seven days prior to the delivery/shipping date. Dated documentation of this contact with the individual is required in the individual’s medical record. Delivery of the supplies should not be done earlier than approximately five days before the individual would exhaust their on-hand supply.

If required documentation is not available on file to support a claim at the time of an audit or record request, the durable medical equipment (DME) supplier may be required to reimburse the Company for overpayments.
Policy Guidelines

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable Evidence of Coverage, an external breast prosthesis is covered under the medical benefits of the Company’s Medicare Advantage products when the medical necessity criteria listed in this medical policy are met.

Description

An external breast prosthesis is an artificial breast form that can be worn after a mastectomy. It is made from several different types of material (such as silicone gel, foam, and fiberfill) that are of similar weight and feel to natural breast tissue. Some prostheses adhere directly to the chest area, while others fit into pockets of mastectomy bras to hold the prosthesis in place.
References

Evidence of Coverage.

Noridian Healthcare Solutions. Local Coverage Article(A52478) : External breast prosthesis. Original: 10/01/2015. (Revised: 01/01/2017). Available at: https://med.noridianmedicare.com/documents/2230703/7218263/External+Breast+Prostheses/21376e51-3234-486a-8cc5-ec4a3b766e97. Accessed December 13, 2017.

Noridian Healthcare Solutions. Local Coverage Determination (LCD)(L33317) : External breast prosthesis. Original: 10/01/2015. (Revised: 01/01/2017). Available at: https://med.noridianmedicare.com/documents/2230703/7218263/External+Breast+Prostheses/21376e51-3234-486a-8cc5-ec4a3b766e97. Accessed December 13, 2017.



Coding

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD -10 Diagnosis Code Number(s)

A BREAST PROSTHESIS IS MEDICALLY NECESSARY FOR AN INDIVIDUAL WHO HAS HAD A MASTECTOMY WHEN REPORTED WITH THE FOLLOWING DIAGNOSIS CODES

C50.011 Malignant neoplasm of nipple and areola, right female breast
C50.012 Malignant neoplasm of nipple and areola, left female breast
C50.019 Malignant neoplasm of nipple and areola, unspecified female breast
C50.111 Malignant neoplasm of central portion of right female breast
C50.112 Malignant neoplasm of central portion of left female breast
C50.119 Malignant neoplasm of central portion of unspecified female breast
C50.211 Malignant neoplasm of upper-inner quadrant of right female breast
C50.212 Malignant neoplasm of upper-inner quadrant of left female breast
C50.219 Malignant neoplasm of upper-inner quadrant of unspecified female breast
C50.311 Malignant neoplasm of lower-inner quadrant of right female breast
C50.312 Malignant neoplasm of lower-inner quadrant of left female breast
C50.319 Malignant neoplasm of lower-inner quadrant of unspecified female breast
C50.411 Malignant neoplasm of upper-outer quadrant of right female breast
C50.412 Malignant neoplasm of upper-outer quadrant of left female breast
C50.419 Malignant neoplasm of upper-outer quadrant of unspecified female breast
C50.511 Malignant neoplasm of lower-outer quadrant of right female breast
C50.512 Malignant neoplasm of lower-outer quadrant of left female breast
C50.519 Malignant neoplasm of lower-outer quadrant of unspecified female breast
C50.611 Malignant neoplasm of axillary tail of right female breast
C50.612 Malignant neoplasm of axillary tail of left female breast
C50.619 Malignant neoplasm of axillary tail of unspecified female breast
C50.811 Malignant neoplasm of overlapping sites of right female breast
C50.812 Malignant neoplasm of overlapping sites of left female breast
C50.819 Malignant neoplasm of overlapping sites of unspecified female breast
C50.911 Malignant neoplasm of unspecified site of right female breast
C50.912 Malignant neoplasm of unspecified site of left female breast
C50.919 Malignant neoplasm of unspecified site of unspecified female breast
C79.81 Secondary malignant neoplasm of breast
D05.00 Lobular carcinoma in situ of unspecified breast
D05.01 Lobular carcinoma in situ of right breast
D05.02 Lobular carcinoma in situ of left breast
D05.10 Intraductal carcinoma in situ of unspecified breast
D05.11 Intraductal carcinoma in situ of right breast
D05.12 Intraductal carcinoma in situ of left breast
D05.80 Other specified type of carcinoma in situ of unspecified breast
D05.81 Other specified type of carcinoma in situ of right breast
D05.82 Other specified type of carcinoma in situ of left breast
D05.90 Unspecified type of carcinoma in situ of unspecified breast
D05.91 Unspecified type of carcinoma in situ of right breast
D05.92 Unspecified type of carcinoma in situ of left breast
I97.2 Postmastectomy lymphedema syndrome
Z85.3 Personal history of malignant neoplasm of breast
Z90.10 Acquired absence of unspecified breast and nipple
Z90.11 Acquired absence of right breast and nipple
Z90.12 Acquired absence of left breast and nipple
Z90.13 Acquired absence of bilateral breasts and nipples



HCPCS Level II Code Number(s)



MEDICALLY NECESSARY

A4280 Adhesive skin support attachment for use with external breast prosthesis, 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

L8015 External breast prosthesis garment, with mastectomy form, post mastectomy

L8020 Breast prosthesis, mastectomy form

L8030 Breast prosthesis, silicone or equal, without integral adhesive

L8032 Nipple prosthesis, prefabricated, reusable, any type, each

L8039 Breast prosthesis, not otherwise specified


NOT MEDICALLY NECESSARY

L8031 Breast prosthesis, silicone or equal, with integral adhesive

L8033 Nipple prosthesis, custom fabricated, reusable, any material, any type, each

L8035 Custom breast prosthesis, post mastectomy, molded to patient model


NOT COVERED

L8010 Breast prosthesis, mastectomy sleeve


Revenue Code Number(s)

N/A

Coding and Billing Requirements

HCPCS code L8000 describes a bra with pockets that are intended to hold a mastectomy form or breast prosthesis held adjacent to the chest wall. Bras coded L8000 do not include an integrated breast prosthesis (for bras with integrated breast prosthesis, see codes L8001 and L8002). Products described by code L8000 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).

HCPCS codes L8001 and L8002 describe a bra with integrated breast prosthesis, either unilateral or bilateral. Products described by codes L8001 and L8002 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).

HCPCS code L8015 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. HCPCS code L8035 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.

HCPCS code A4280 should be used when billing for an adhesive skin support that attaches an external breast prosthesis directly to the chest wall.





Policy History

MA05.033b
01/01/2020This policy has been identified for the annual HCPCS code update effective 01/01/2020.

The following HCPCS code has been revised in this policy:

Changed from: L8032 Nipple prosthesis, reusable, any type, each

Changed to: L8032 Nipple prosthesis, prefabricated, reusable, any type, each


The following HCPCS code has been added to this policy as not medically necessary:

L8033 Nipple prosthesis, custom fabricated, reusable, any material, any type, each

MA05.033a
02/13/2019This policy has been reissued in accordance with the Company's annual review process.
02/07/2018This version of the policy will become effective 02/07/2018. Revised policy number MA05.033a was issued as a result of the department's annual review process to communicate the Company’s continuing position on External Breast prostheses.

MA05.033
02/15/2017The policy has been reviewed and reissued to communicate the Company’s continuing position on External Breast prostheses.

Existing durable medical equipment documentation requirements, in accordance with Medicare, are now included with examples.
02/03/2016The policy has been reviewed and reissued to communicate the Company’s continuing position on External Breast prostheses.

Existing durable medical equipment documentation requirements, in accordance with Medicare, are now included with examples.
06/24/2015The policy has been reviewed and reissued to communicate the Company’s continuing position on External Breast prostheses.

Existing durable medical equipment documentation requirements, in accordance with Medicare, are now included with examples.
01/01/2015This is a new policy.







Version Effective Date: 01/01/2020
Version Issued Date: 12/30/2019
Version Reissued Date: N/A