Notification



Notification Issue Date:



Medicare Advantage Policy

Title:Removal of Breast Implants
Policy #:MA11.076c

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.

MEDICALLY NECESSARY

The removal of breast implant(s) is considered medically necessary and, therefore, covered for the following indications:
  • Documented broken or failed implants
  • Extrusion
  • Infection or rejection
  • Siliconoma or granuloma
  • Interference with diagnosis of breast cancer
  • Surgical treatment of breast cancer
  • Painful capsular contracture with disfigurement

NONCOVERED

Requests for removal of breast implant(s) that do not meet the medical necessity criteria listed in this policy are considered cosmetic services. Services that are cosmetic are not covered by the Company because cosmetic services are not covered by Medicare. Therefore, they are not eligible for reimbursement consideration.

Subsequent surgery to improve, correct, or further alter the appearance of a body part that has previously undergone a cosmetic surgical procedure is considered a revision of a previously performed cosmetic procedure. Under most circumstances, cosmetic services are not covered by the Company because cosmetic services are not covered by Medicare. Therefore, they are not eligible for reimbursement consideration.

However, reconstruction or replacement of an implant requiring removal for any of the above indications that was originally placed for reconstruction of a traumatic or surgically created breast deficit will be covered as medically necessary.

WOMEN'S HEALTH AND CANCER RIGHTS ACT (WHCRA)

The Women's Health and Cancer Rights Act (WHCRA) was enacted as a federal mandate in October 1998. The federal mandate addresses reconstructive breast surgery following a mastectomy, and requires coverage for:

(1) All stages of reconstruction of the breast on which the mastectomy has been performed;
(2) Surgery and reconstruction of the other breast to produce a symmetrical appearance; and
(3) Prostheses and physical complications of mastectomy, including lymphedemas.

REQUIRED DOCUMENTATION

The individual's medical record must reflect the medical necessity for the care 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.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the service.
Policy Guidelines

This policy is consistent with Medicare's coverage determination. The Company's payment methodology may differ from Medicare.

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable Evidence of Coverage, the removal of breast implant(s) 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

Implanted breast prostheses are silicone shells filled with saline and/or silicone gel. The implantation can be either for medically necessary indications (e.g., reconstruction following mastectomy, surgery/trauma) or for cosmetic reasons. Reconstructive treatment is defined as any medical or surgical service designed to restore bodily function or to correct a deformity that has resulted from trauma or the treatment of disease. Cosmetic services are those provided to improve an individual's physical appearance, from which no significant improvement in physiologic function can be expected. Emotional and/or psychological improvement alone does not constitute improvement in physiologic function.

Complications can occur with breast implants that may require removal of the implant. Examples of complications include infection, extrusion (implant exposure at the surface of the skin), rupture, and contracture. Research evidence reveals that the incidence of microbial contamination of the luminal saline of the implant is unlikely. Normal saline is a physiologic solution consistent with an organism's normal functioning.

A contracture occurs when the capsule surrounding a breast implant tightens. Extreme cases can cause the breast to feel hard and painful. Disfigurement may also result if the capsule surrounding one implant contracts and the other does not, or if the capsule contracts unevenly. Contractures have been graded according to the Baker Classification as follows:
  • Baker Grade I: Augmented breast feels as soft as a normal breast.
  • Baker Grade II: Breast is less soft, and the implant can be palpated but is not visible.
  • Baker Grade III: Breast is firm, palpable, and the implant (or its distortion) is visible.
  • Baker Grade IV: Breast is hard, painful, cold, tender, and distorted.
    (US Food and Drug Administration [FDA], 2004)

References

American Society of Plastic Surgeons (ASPS). Breast Implant Safety. [BreastImplantSafety.org Web site]. Available at: http://www.breastimplantsafety.org. [The link to this reference is no longer active on the ASPS Web site]. Accessed February 20, 2017.

American Society of Plastic Surgeons (ASPS). Practice Parameter. Treatment principles of silicone breast implants. [ASPS Web site]. 03/01/05. Available at: http://www.plasticsurgery.org/for-medical-professionals/advocacy/key-issues/breast-procedures.html. [The link to this reference is no longer active to the public on the ASPS Web site]. Accessed February 20, 2017.

Brown MH, Markus YM, Belchetz B, et al. Microbial growth in saline breast implants and saline tissue expanders (Abstract). Plastic Reconstr Surg. 2002;109(7):2242-2244.

Chung KC, Wilkins EG, Beil RJ JR, et al. Diagnosis of silicone gel breast implant rupture by ultrasonography. Plast Reconstr Surg. 1996;97(1):104-109.

Ferguson JH. Silicone breast implants and neurologic disorders. Report of the Practice Committee of the American Academy of Neurology. Neurology. 1997;48(6):1504-1507.

Gabriel SE, O'Fallon WM, Kurland LT, et al. Risk of connective-tissue diseases and other disorders after breast implantation. N Engl J Med. 1994;330(24):1697-1702.

Gherardini G, Zaccheddu R, Basoccu G. Trilucent breast implants: voluntary removal following the Medical Device Agency recommendation. Report on 115 consecutive patients. Plast Reconstr Surg. 2004;113(3):1024-1027.

Hennekens CH, Lee IM, Cook NR, et al. Self-reported breast implants and connective-tissue disease in female health professionals. A retrospective cohort study. JAMA. 1996;275(8):616-621.

Marotta JS, Goldberg EP, Habal MB, et al. Silicone gel breast implant failure: evaluation of properties of shells and gels for explanted prostheses and meta-analysis of literature rupture data. Ann Plast Surg. 2002;49(3):227-247.

Mentor Corporation. Saline-Filled Breast Implant Surgery: Making an Informed Decision. [US Food and Drug Administration (FDA) Web site]. 2009. Available at: http://www.fda.gov/downloads/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/ucm064453.pdf. Accessed February 02, 2018.

National Research Center (NRC) for Women & Families. Breast Implants: A research and regulatory summary. [NRC Web site]. July 2012. Available at: http://www.center4research.org/2010/03/breast-implants-a-research-and-regulatory-summary/. Accessed February 02, 2018.

Netscher DT, Weizer G, Malone RS, et al. Diagnostic value of clinical examination and various imaging techniques for breast implant rupture as determined in 81 patients having implant removal. South Med J. 1996;89(4):397-404.

Novitas Solutions, Inc. Local Coverage Determination (LCD). L35090: Cosmetic and Reconstructive Surgery. [Novitas Solutions Web site]. Original: 10/01/2015. (Revised: 04/14/2017). Available at: https://www.cms.gov/medicare-coverage-database/details/lcd-details.aspx?LCDId=35090&ver=36&Date=12%2f31%2f2015&DocID=L35090&bc=iAAAAAgBAAAA&. Accessed February 02, 2018.

Peters W, Smith D, Fornasier V, et al. An outcome analysis of 100 women after explantation of silicone gel breast implants. Ann Plast Surg. 1997;39(1):9-19.

Samuels JB, Rohrich RJ, Weatherall PT, et al. Radiographic diagnosis of breast implant rupture: current status and comparison of techniques. Plast Reconstr Surg. 1995;96(4):865-877.

Sanchez-Guerrero J, Colditz GA, Karlson EW, et al. Silicone breast implants and the risk of connective-tissue diseases and symptoms. N Engl J Med. 1995;332(25):1666-1670.

Siggelkow W, Klosterhalfen B, Klinge U, et al. Analysis of local complications following explantation of silicone breast implants. Breast. 2004;13(2):122-128.

Silverman BG, Brown SL, Bright RA, et al. Reported complications of silicone gel breast implants: an epidemiologic review. Ann Intern Med. 1996;124(8):744-756.

Song JW, Kim HM, Bellfi LT, et al. The effect of study design biases on the diagnostic accuracy of magnetic resonance imaging for detecting silicone breast implant ruptures: a meta-analysis. Plast Reconstr Surg. 2011;127(3):1029-1044.

Spear SL, Howard MA, Boehmler JH, et al. The infected or exposed breast implant: management and treatment strategies. Plast Reconstr Surg. 2004;113(6):1634-1644.

Thomas WO III, Harper LL, Wong SW, et al. Explantation of silicone breast implants. Am Surg. 1997;63(5):421-429.

US Department of Labor; Employee Benefits Security Administration. Fact Sheet: Women’s Health and Cancer Rights Act. [US Department of Labor Web site]. Available at: https://www.dol.gov/sites/default/files/ebsa/about-ebsa/our-activities/resource-center/fact-sheets/whcra.pdf. Accessed February 02, 2018.

US Department of Labor; Employee Benefits Security Administration. Your rights after a mastectomy. [US Department of Labor Web site]. August 2017. Available at:

https://www.dol.gov/sites/default/files/ebsa/about-ebsa/our-activities/resource-center/publications/your-rights-after-a-mastectomy.pdf. Accessed February 02, 2018.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. Breast Implants home page. [FDA Web site]. 09/17/13 (Page updated 03/21/2017). Available at: http://www.fda.gov/medicaldevices/productsandmedicalprocedures/implantsandprosthetics/breastimplants/default.htm. Accessed February 02, 2018.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. Breast Implants: Local Complications and Adverse Outcomes. [FDA Web site]. Available at: https://www.fda.gov/downloads/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/UCM548169.pdf. Accessed February 02, 2018.



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)

19328, 19330, 19370, 19371


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)

See Attachment A


HCPCS Level II Code Number(s)

N/A


Revenue Code Number(s)

N/A

Coding and Billing Requirements


Cross References

Attachment A: Removal of Breast Implants
Description: ICD-10-CM codes







Policy History

Revisions from MA11.076c:
04/25/2018The policy has been reviewed and reissued to communicate the Company’s continuing position on the removal of breast implants.
03/29/2017The policy has been reviewed and reissued to communicate the Company’s continuing position on removal of breast implants
10/01/2016This policy has been identified for the ICD-10 code update, effective 10/01/2016.
Deleted:
T85.81XA, T85.81XD, T85.81XS, T85.82XA, T85.82XD, T85.82XS, T85.83XA, T85.83XD, T85.83XS, T85.84XA, T85.84XD, T85.84XS


Added:
T85.818A, T85.818D, T85.818S, T85.828A, T85.828D, T85.828S, T85.838A, T85.838D, T85.838S, T85.848A, T85.848D, T85.848S

Revisions from MA11.076b
03/30/2016This version of the policy will become effective on 04/06/2016.

This policy was updated to delineate the Company's coverage criteria for the Removal of Breast Implants.

Revisions from MA11.076a
11/04/2015This version of the policy will become effective on 11/18/2015.

The intent of this policy remains unchanged; however, the policy has been updated to further clarify coverage criteria for removal of breast implants.

Revisions from MA11.076
01/01/2015This is a new policy.




Version Effective Date: 10/01/2016
Version Issued Date: 10/01/2016
Version Reissued Date: 04/25/2018