External Breast Prostheses

For any item to be covered by Medicare, it must 1) be eligible for a defined Medicare benefit category, 2) be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, and 3) meet all other applicable Medicare statutory and regulatory requirements.

The purpose of a Local Coverage Determination (LCD) is to provide information regarding “reasonable and necessary” criteria based on Social Security Act § 1862(a)(1)(A) provisions.

In addition to the “reasonable and necessary” criteria contained in this LCD there are other payment rules, which are discussed in the following documents, that must also be met prior to Medicare reimbursement:

• The LCD-related Standard Documentation Requirements Article, located at the bottom of this policy under the Related Local Coverage Documents section.
• The LCD-related Policy Article, located at the bottom of this policy under the Related Local Coverage Documents section.
• Refer to the Supplier Manual for additional information on documentation requirements.
• Refer to the DME MAC web sites for additional bulletin articles and other publications related to this LCD.

For the items addressed in this LCD, the “reasonable and necessary” criteria, based on Social Security Act § 1862(a)(1)(A) provisions, are defined by the following coverage indications, limitations and/or medical necessity.

A breast prosthesis is covered for a beneficiary who has had a mastectomy. (Refer to the ICD-10 code list in the LCD-related Policy Article for applicable diagnoses.)

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

A mastectomy bra (L8000) is covered for a beneficiary who has a covered mastectomy form (L8020) or silicone (or equal) breast prosthesis (L8030, L8031) when the pocket of the bra is used to hold the form/prosthesis.

An external breast prosthesis of a different type can be covered at any time if there is a change in the beneficiary’s medical condition necessitating a different type of item.

The Medicare program will cover one breast prosthesis per side for the useful lifetime of the prosthesis. Two prostheses, one per side, are covered for those beneficiaries who have had bilateral mastectomies. More than one external breast prosthesis per side will be denied as not reasonable and necessary.

The medical necessity for the additional features of a custom fabricated prosthesis (L8035) compared to a prefabricated silicone breast prosthesis has not been established, and therefore, if an L8035 breast prosthesis is billed, it will be denied as not reasonable and necessary.

GENERAL

A Standard Written Order (SWO) must be communicated to the supplier before a claim is submitted. If the supplier bills for an item addressed in this policy without first receiving a completed SWO, the claim shall be denied as not reasonable and necessary.

For Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) base items that require a Written Order Prior to Delivery (WOPD), the supplier must have received a signed SWO before the DMEPOS item is delivered to a beneficiary. If a supplier delivers a DMEPOS item without first receiving a WOPD, the claim shall be denied as not reasonable and necessary. Refer to the LCD-related Policy Article, located at the bottom of this policy under the Related Local Coverage Documents section.

For DMEPOS base items that require a WOPD, and also require separately billed associated options, accessories, and/or supplies, the supplier must have received a WOPD which lists the base item and which may list all the associated options, accessories, and/or supplies that are separately billed prior to the delivery of the items. In this scenario, if the supplier separately bills for associated options, accessories, and/or supplies without first receiving a completed and signed WOPD of the base item prior to delivery, the claim(s) shall be denied as not reasonable and necessary.

An item/service is correctly coded when it meets all the coding guidelines listed in CMS HCPCS guidelines, LCDs, LCD-related Policy Articles, or DME MAC articles. Claims that do not meet coding guidelines shall be denied as not reasonable and necessary/incorrectly coded.

Proof of delivery (POD) is a Supplier Standard and DMEPOS suppliers are required to maintain POD documentation in their files. Proof of delivery documentation must be made available to the Medicare contractor upon request. All services that do not have appropriate proof of delivery from the supplier shall be denied as not reasonable and necessary.

REFILL REQUIREMENTS

For DMEPOS items and supplies provided on a recurring basis, billing must be based on prospective, not retrospective use. For DMEPOS products that are supplied as refills to the original order, suppliers must contact the beneficiary, and document an affirmative response, prior to dispensing the refill and not automatically ship on a pre-determined basis, even if authorized by the beneficiary. This shall be done to ensure that the refilled item remains reasonable and necessary, existing supplies are expected to end, and to confirm any changes or modifications to the order. Contact with the beneficiary or designee regarding refills must take place no sooner than 30 calendar days prior to the expected end of the current supply. For delivery of refills, the supplier must deliver the DMEPOS product no sooner than 10 calendar days prior to the expected end of the current supply. This is regardless of which delivery method is utilized.

For all DMEPOS items that are provided on a recurring basis, suppliers are required to have contact with the beneficiary or caregiver/designee and document an affirmative response, prior to dispensing a new supply of items. Suppliers must not deliver refills without a refill request and an affirmative response from a beneficiary. Items delivered without a valid, documented refill request will be denied as not reasonable and necessary.

Suppliers must not dispense a quantity of supplies exceeding a beneficiary's expected utilization. Suppliers must stay attuned to changed or atypical utilization patterns on the part of their clients. Suppliers must verify with the treating practitioner that any changed or atypical utilization is warranted.

Regardless of utilization, a supplier must not dispense more than a three (3) month quantity at a time.

Clinical Background

Breast cancer is one of the most common cancers in women in the United States, accounting for about 30% of all new cancers in women each year.¹ Based on cases from 2018–2022, the age-adjusted rate of new cases of female breast cancer was approximately 130 per 100,000 women per year.² In 2022, there were an estimated 4 million women living with breast cancer in the United States.² Breast cancer mainly occurs in middle-aged and older women, with a median age at the time of breast cancer diagnosis of 63 years.² Between 2014 to 2023, age-adjusted death rates for breast cancer have fallen on average 1.2% each year and the 5-year survival rate is now 91.7%.²

Treatment options for breast cancer include surgery, radiation, chemotherapy, hormone therapy, and targeted therapy. Most women with breast cancer undergo some form of surgery, primarily lumpectomy, also known as breast-conserving surgery, or mastectomy, which involves removal of the entirety of the breast tissue.^3,4 While some women may be able to undergo mastectomy with immediate reconstruction, some may not have reconstruction completed until months or years later; additionally, many women never have reconstruction surgery and are treated with mastectomy alone.⁵ Post-mastectomy, women may develop biomechanical issues such as postural asymmetry due to a loss of breast weight leading to uneven body weight distribution and changes in the body’s center of gravity, particularly if the breast tissue removal is unilateral.^6-9

An external breast prosthesis (EBP) is a type of artificial breast form and represents a non-surgical alternative to breast reconstruction after mastectomy.¹⁰ Most prostheses are made from silicone, but can also be made from lightweight foam or fiberfill, or may be filled with polypropylene beads.^11,12 Properly weighted EBP, typically made from silicone gel, may help to provide balance and correct postural asymmetry.^9,11 A breast prosthesis can either be worn in a specially designed pocket in a post-mastectomy bra, or attached directly to the skin of the chest wall using either a separate adhesive skin support or an adhesive material integrated into the back surface of the prosthetic itself.^10,13 Silicone external breast prostheses that adhere to the chest wall bear their own weight and can help avoid the strain to the shoulder and back that may be caused by the weight of a silicone EBP held in a post-mastectomy bra pocket.¹⁴ The availability of different materials and attachment methods results in a range of available EBP types for patients to consider; factors such as age, lifestyle and preferences can influence which EBP an individual chooses.¹⁵

At the time of this literature analysis, EBP, including silicone breast prostheses without integral adhesive, are covered for Medicare beneficiaries who have undergone a mastectomy.¹⁶ Separate adhesive skin supports for use with non-adhesive EBP are also covered; however, breast prostheses, silicone or equal, with integral adhesive are denied as not reasonable and necessary.^16,17 The focus of this analysis is to determine whether the use of breast prostheses, silicone or equal, with integral adhesive compared to conventional (non-adhesive) breast prosthesis used with or without separate adhesive skin support is medically reasonable and necessary to improve health and quality of life outcomes in beneficiaries who have undergone a mastectomy.

Product Description

External breast prostheses with integral adhesive (also known as self-supporting, attachable, stick-on, or contact external breast prostheses) are often made of silicone, or other similar material, and include an adhesive surface integrated into the back surface of the prosthesis itself. This integrated adhesive holds the breast prosthesis in position against the skin of the chest wall without the need for a separate adhesive skin support.

Food and Drug Administration (FDA) Approval

External breast prostheses used with adhesive are Class I devices that fall under the FDA product code KCZ, are regulated under 21 CFR 878.3800, and are 510(K) exempt.

See: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?id=KCZ

Evidence Questions

The development of an assessment in support of Medicare coverage decisions is based on the same general question for almost all requests: “Is the evidence sufficient to conclude that the application of the technology under study will improve final health outcomes for Medicare beneficiaries?”

The formulation of specific questions for the assessment recognizes that the effect of an intervention can depend substantially on how it is delivered, to whom it is applied, the alternatives with which it is being compared, and the setting where it is used. In order to appraise the net health outcomes of external breast prostheses, silicone or equal, with integral adhesive, the DME MACs sought to address the following questions:

1. In Medicare beneficiaries who use EBP post-mastectomy, are there differences in biomechanical outcomes (e.g., shoulder strain, back/neck pain, spinal asymmetry, postural stability) between EBP with integral adhesive and conventional (non-adhesive) breast prosthesis used with or without separate adhesive skin support?
2. In Medicare beneficiaries who use EBP post-mastectomy, are there differences in prosthetic tolerance outcomes (e.g., comfort, adverse effect) between EBP with integral adhesive and conventional (non-adhesive) breast prosthesis used with or without separate adhesive skin support?
3. In Medicare beneficiaries who use EBP post-mastectomy, are there differences in quality of life (QoL) outcomes between EBP with integral adhesive and conventional (non-adhesive) breast prosthesis used with or without separate adhesive skin support?

Literature Analysis

Studies evaluating EBP with integral adhesive

An observational, questionnaire-based study by Münstedt et al,¹⁸ enrolling 78 participants (55 participants included in the analysis; mean age: 56 years) who had undergone a unilateral mastectomy due to breast cancer, investigated the potential benefits of a self-supporting EBP with integral adhesive on self-concept (i.e., self-perception) assessed using the Frankfurt Self-Concept Scale (FSKN) and body image assessed using the Frankfurt Body Concept Scale (FKKS). Most participants noted that self-supporting EBP use allowed participants to have a more positive feeling about life (76.4%), to consider breast reconstruction less (66.7%), to be more self-assured (65.5%), and to be more active (65.5%). Additionally, 33.3% of participants who had reported having back pain noted improvement in their pain with the use of a self-supporting EBP. Participants who reported experiencing more psychological effects from a mastectomy showed significantly more improvements in the subscales that examined body self-acceptance and body acceptance by others compared to participants who experienced fewer psychological effects (difference in improvement: p = 0.029 and p = 0.027, respectively). Skin tolerability was considered good by most participants, with only 16.4% of participants reporting some irritations, and no severe irritations being reported. Limitations of this study include the potential for selection bias due to lack of randomization, lack of a comparator group, high dropout rate (20%), potential lack of generalizability to the Medicare population due to the mean age of participants, and the potential for response bias due to reliance on patient-reported outcome measures.

Studies evaluating EBP without integral adhesive used with separate adhesive skin support or unclear mechanism of adhesion

A 12-week, single-center, randomized crossover study by Qiu et al,¹⁹ including 30 participants (mean age: 48.5 years) who had undergone a unilateral mastectomy due to breast cancer, evaluated the effects of adhesive EBP (unclear adhesive mechanism) compared to conventional (non-adhesive) EBP on physical and psychological domains, as well as QoL, assessed using objective evaluations of scar and skin condition, a study-designed survey to evaluate comfort and practicality of EBP, the Quality of Life Instruments for Cancer Patients: Breast Cancer (QLICP-BR), and a body image scale. At 6 weeks, the intervention group (wearing the adhesive EBP) was significantly more likely to choose self-adhesive EBP (p = 0.033) and indicated that this type of EBP seemed more part of their body compared to conventional EBP (p = 0.046). The control group (wearing the conventional EBP) was significantly more likely to complain of shoulder and back discomfort at the end of the 6 weeks (p = 0.028). The type of EBP the study groups used was then switched. At 12 weeks, there was no between group difference in EBP choice (i.e., participants in both study groups preferred the self-adhesive EBP), and the control group (while wearing the adhesive EBP) also noted that the adhesive EBP seemed more part of their body (p = 0.040). There were no between group differences in QoL, body image, or skin rash, redness, or ulceration at 6 or 12 weeks. Limitations of this study include the small sample size from a single center, potential lack of generalizability to the Medicare population due to the mean age of participants, and the potential for response bias due to reliance on patient-reported outcome measures. Additionally, it is not clear if the studied adhesive EBP used an integral or separate adhesive skin support; if a separate adhesive skin support was required, the comparison would result in indirect evidence based on the defined evidence questions.

A 9-month, multi-center, randomized crossover study by Thijs-Boer et al,¹⁴ enrolling 101 participants (91 participants provided complete follow-up data; mean age: 54.3 years, range: 26–81 years) who had undergone a unilateral mastectomy due to breast cancer, evaluated patient preference and satisfaction of adhesive EBP fixed in position by a Velcro skin strip compared to conventional non-adhesive EBP assessed using study-designed questionnaires. Additionally, EBP tolerance was evaluated by inspection of the skin for the presence of lesions. Compared to conventional EBP, adhesive EBP were significantly less likely to cause neck and shoulder discomfort (p = 0.022) and were more likely to be regarded as part of the body (p = 0.00); however, conventional EBP were significantly easier to apply (p = 0.00) and caused less patient reported local itch or irritation (p = 0.00) compared to adhesive EBP. During the study, two (2) participants were observed to have developed a rash under the adhesive strip. Both types of prostheses were comparable in terms of overall satisfaction, and 59.3% of the participants preferred the adhesive prosthesis at the end of the study. Limitations of this study include the unclear methodology (specifically the lack of transparency related to the randomization process), the potential lack of generalizability to the Medicare population due to the mean age of participants, and the potential for response bias due to reliance on patient-reported outcome measures. Additionally, the adhesive EBP studied required separate adhesive skin supports, resulting in indirect evidence based on the defined evidence questions.

A single-center, randomized study by Münstedt et al,²⁰ enrolling 72 participants [67 participants were included in the final analysis; study group: n = 33, mean age (SD): 53 (5.64) years; control group: n = 34, mean age (SD): 53 (6.42) years] who had undergone a unilateral mastectomy due to breast cancer, investigated the potential benefits of adhesive EBP (unclear adhesive mechanism) compared to conventional (non-adhesive) EBP on self-concept (i.e., self-perception) assessed using the FSKN. Psycho-social issues after mastectomy and the importance of EBP after mastectomy were evaluated using a questionnaire. With the use of adhesive EBP, there was a significant improvement in the FSKN subscale that evaluated participants’ ability and confidence in communication with others, interrelationships, and life in the social environment (p = 0.027). There were also positive trends in the FSKN subscales that evaluated cognition, emotions, and opinions about others. Participants noted that use of an adhesive EBP made them think less about breast reconstruction and that the adhesive EBP felt more like part of their body. The adhesive was reported to be tolerated well, and most participants would recommend adhesive EBP to others. Six months after the end of the study, 50% of participants used adhesive EBP exclusively, 41% used both conventional and adhesive EBP depending on the event, and 9% returned to exclusive use of a conventional EBP. Limitations of this study include the potential for selection bias as initial eligibility was based on the return of a questionnaire by participants, the unclear methodology (specifically the lack of transparency related to randomization process), the potential lack of generalizability to the Medicare population due to the mean age of participants, and the potential for response bias due to the use of patient-reported outcome measures. Additionally, it is not clear if the studied adhesive EBP used an integral or separate adhesive skin support; if a separate adhesive skin support was required, the comparison would result in indirect evidence based on the defined evidence questions.

Evidence Based Guidelines

No relevant evidence-based guidelines were identified.

Professional Society Recommendations

No relevant professional society recommendations were identified.

Conclusion

External breast prostheses are artificial breast forms and represent a non-surgical alternative to breast reconstruction after mastectomy. The focus of this analysis was to determine if the use of EBP with integral adhesive is associated with differential effects on biomechanical, prosthesis tolerance, and QoL outcomes compared to conventional (non-adhesive) breast prosthesis used with or without separate adhesive skin support in patients who have undergone a mastectomy for breast cancer.

Based on the best available evidence, self-supporting EBP with integral adhesive were well tolerated and led to a more positive feeling about life, a reduction in consideration of breast reconstruction surgery, and an increase in feelings of self-assurance. External breast prostheses with integral adhesive may also lead to an improvement in back pain in some patients compared to baseline. When compared to conventional (non-adhesive) EBP, participants using EBP with separate adhesive skin support or EBP with unclear adhesive mechanism were less likely to experience shoulder, back or neck discomfort. Additionally, studies that employed objective evaluation of EBP tolerance did not find significant differences in the rates of skin rash, redness, or ulceration with the use of adhesive compared to a non-adhesive EBP. Finally, there was no differential effect on QoL based on the type of EBP utilized. No studies directly comparing EBP with integral adhesive to EBP without integral adhesive used with separate adhesive skin support were identified; therefore, there is no evidence to support that the mechanism of EBP adhesion would alter the findings of the analyzed studies.

As a result of this analysis, the External Breast Prostheses Local Coverage Determination will be updated to remove the not reasonable and necessary (R&N) determination that states “[b]reast prostheses, silicone or equal, with integral adhesive (L8031) have not been demonstrated to have a clinical advantage over those without the integral adhesive.” Removal of the not R&N determination will provide beneficiaries who have undergone mastectomy with another EBP option based on individual preferences.

DOCUMENTATION REQUIREMENTS

Section 1833(e) of the Social Security Act precludes payment to any provider of services unless "there has been furnished such information as may be necessary in order to determine the amounts due such provider." It is expected that the beneficiary's medical records will reflect the need for the care provided. The beneficiary's medical records include the treating practitioner’s records, hospital records, nursing home records, home health agency records, records from other healthcare professionals and test reports. This documentation must be available upon request.


GENERAL DOCUMENTATION REQUIREMENTS

In order to justify payment for DMEPOS items, suppliers must meet the following requirements:

• SWO
• Medical Record Information (including continued need/use if applicable)
• Correct Coding
• Proof of Delivery

Refer to the LCD-related Standard Documentation Requirements article, located at the bottom of this policy under the Related Local Coverage Documents section for additional information regarding these requirements.

Refer to the Supplier Manual for additional information on documentation requirements.

Refer to the DME MAC web sites for additional bulletin articles and other publications related to this LCD.


POLICY SPECIFIC DOCUMENTATION REQUIREMENTS

Items covered in this LCD have additional policy-specific requirements that must be met prior to Medicare reimbursement.

Refer to the LCD-related Policy article, located at the bottom of this policy under the Related Local Coverage Documents section for additional information.


Miscellaneous


Appendices


Utilization Guidelines
Refer to Coverage Indications, Limitations and/or Medical Necessity

N/A

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2. National Cancer Institute Surveillance, Epidemiology, and End Results Program. Cancer Stat Facts: Female Breast Cancer. https://seer.cancer.gov/statfacts/html/breast.html. Accessed January 7, 2026.
3. National Breast Cancer Foundation. Surgery. https://www.nationalbreastcancer.org/breast-cancer-surgery/. Accessed January 7, 2026.
4. American Cancer Society. Surgery and other procedures for breast cancer. https://www.cancer.org/cancer/types/breast-cancer/treatment/surgery-for-breast-cancer.html. Last revised October 14, 2025. Accessed January 7, 2026.
5. Hojan K. Does the weight of an external breast prosthesis play an important role for women who undergone mastectomy? Reports of practical oncology and radiotherapy : journal of Greatpoland Cancer Center in Poznan and Polish Society of Radiation Oncology. 2020;25(4):574-578.
6. Malicka I, Barczyk K, Hanuszkiewicz J, Skolimowska B, Woźniewski M. Body posture of women after breast cancer treatment. Ortopedia, traumatologia, rehabilitacja. 2010;12(4):353-361.
7. Serel S, Tuzlalı ZY, Akkaya Z, Uzun Ç, Kaya B, Bayar S. Physical Effects of Unilateral Mastectomy on Spine Deformity. Clinical breast cancer. 2017;17(1):29-33.
8. Mangone M, Bernetti A, Agostini F, et al. Changes in Spine Alignment and Postural Balance After Breast Cancer Surgery: A Rehabilitative Point of View. BioResearch open access. 2019;8(1):121-128.
9. Xie H, Lan X, Wang Y, et al. Impact of wearing external breast prosthesis on body posture of patients after unilateral mastectomy: a randomized controlled trial. Frontiers in oncology. 2025;15:1456562.
10. American Cancer Society. Breast Reconstruction Alternatives. https://www.cancer.org/cancer/types/breast-cancer/reconstruction-surgery/breast-reconstruction-alternatives.html. Last Revised May 5, 2025. Accessed January 7, 2026.
11. Johns Hopkins Medicine. Post-mastectomy Prothesis. https://www.hopkinsmedicine.org/health/treatment-tests-and-therapies/postmastectomy-prosthesis. Accessed January 7, 2026.
12. Breast Cancer Now. Types of Breast Prosthesis. https://breastcancernow.org/about-breast-cancer/life-after-treatment/your-body-after-breast-cancer-treatment/breast-prosthesis/types-of-breast-prosthesis. Accessed January 7, 2026.
13. Kiefer C. Presenting All the Choices: Teaching Women About Breast Prosthetics. https://www.medscape.com/viewarticle/408954_3?form=fpf. Accessed January 7, 2026. 2001.
14. Thijs-Boer FM, Thijs JT, van de Wiel HB. Conventional or adhesive external breast prosthesis? A prospective study of the patients' preference after mastectomy. Cancer nursing. 2001;24(3):227-230.
15. Zheng L, Zhou B, Liang R, Yip J. The use of external breast prostheses in post-operative care for women after breast cancer mastectomy: A scoping review. Textile Research Journal. 2025(Jul;95(13-14)):1757-1768.
16. Centers for Medicare & Medicaid Services. External Breast Prostheses Local Coverage Determination L33317. https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=33317&ver=34&bc=0. Accessed January 7, 2026.
17. Centers for Medicare & Medicaid Services. External Breast Prostheses - Policy Article A52478. https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleId=52478&ver=26. Accessed January 7, 2026.
18. Münstedt K, Schüttler B, Milch W, et al. Epicutaneous breast forms. A new system promises to improve body image after mastectomy. Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer. 1998;6(3):295-299.
19. Qiu J, Tang L, Huang L, Hou S, Zhou J. Physical and psychological effects of different temperature-controlled breast prostheses on patients with breast cancer during rehabilitation: a randomized controlled study (CONSORT). Medicine. 2020;99(13):e19616.
20. Münstedt K, Milch W, Reimer C. Breast forms after mastectomy—patient's issues. Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer. 1995;3(6):428-431.

• Other (Request for Coverage by a Manufacturer)