Notification



Notification Issue Date:



Medical Policy Bulletin


Title:Removal of Breast Implants

Policy #:11.08.14k

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


The Company makes decisions on coverage based on Policy Bulletins, benefit plan documents, and the member’s medical history and condition. 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.

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 Medical Policy Bulletin document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy Bulletin will be reviewed regularly and be updated as scientific and medical literature becomes available. For more information on how Medical Policy Bulletins are developed, go to the About This Site section of this Medical Policy Web site.



Policy

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

INDICATIONS FOR REMOVAL OF SILICONE GEL-FILLED BREAST IMPLANT(S)

MEDICALLY NECESSARY
The removal of silicone gel-filled breast implant(s) is considered medically necessary and, therefore, covered for the following indications:
  • Documented implant rupture
  • Extrusion
  • Infection or rejection
  • Siliconoma or granuloma
  • Baker Class IV contracture (breast is hard, painful, cold, tender, and distorted)
  • Interference with diagnosis of breast cancer
  • Surgical treatment of breast cancer
  • Baker Class III contracture (breast is firm, palpable, and the implant [or its distortion] is visible) only when the implant(s) was placed as part of a medically necessary reconstructive procedure
  • Individuals diagnosed with breast implant-associated anaplastic large cell lymphoma (BIA-ALCL)

When the above criteria for removal of a silicone gel-filled breast implant are met unilaterally AND the implant was originally placed for a medically necessary indication (e.g., chest wall deformities such as Pectus Excavatum or Poland’s Syndrome, repair of breast asymmetry due to a medically necessary mastectomy or lumpectomy, repair of breast asymmetry due to trauma), then removal of the implant in the contralateral breast is considered medically necessary to achieve breast symmetry, and is therefore covered when both implants are removed at the same time.

In addition, when a individual has been diagnosed with unilateral breast implant--associated anaplastic large cell lymphoma (BIALCL), removal of both implants (affected and the contralateral breast) is considered medically necessary and is therefore covered regardless of why the implants were originally placed.

BENEFIT CONTRACT EXCLUSION
The removal of silicone gel-filled breast implant(s) for any other indication is considered cosmetic and therefore a benefit contract contract exclusion for all products of the Company.

Services that are cosmetic are a benefit contract exclusion for all products of the Company. 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 considered benefit contract exclusions. Individual benefits must be verified.

INDICATIONS FOR REMOVAL OF SALINE-FILLED BREAST IMPLANT(S)

MEDICALLY NECESSARY
The removal of saline-filled breast implant(s) is considered medically necessary and, therefore, covered for the following indications:
  • Extrusion
  • Infection or rejection
  • Siliconoma or granuloma
  • Baker Class IV contracture (breast is hard, painful, cold, tender, and distorted)
  • Interference with diagnosis of breast cancer
  • Surgical treatment of breast cancer
  • Baker Class III contracture (breast is firm, palpable, and the implant [or its distortion] is visible), only when the implant(s) was placed as part of a medically necessary reconstructive procedure
  • Individuals diagnosed with breast implant-associated anaplastic large cell lymphoma (BIA-ALCL)

When the above criteria for removal of a saline-filled breast implant are met unilaterally AND the implant was originally placed for a medically necessary indication (e.g., chest wall deformities such as Pectus Excavatum or Poland’s Syndrome, repair of breast asymmetry due to a medically necessary mastectomy or lumpectomy, repair of breast asymmetry due to trauma), then removal of the implant in the contralateral breast is considered medically necessary to achieve breast symmetry, and is therefore covered when both implants are removed at the same time.

In addition, when a individual has been diagnosed with unilateral breast implant-associated anaplastic large cell lymphoma (BIALCL), removal of both implants (affected and the contralateral breast) is considered medically necessary and is therefore covered regardless why the implants were originally placed.

BENEFIT CONTRACT EXCLUSION
The removal of saline-filled breast implant(s) for any other indication is considered cosmetic and therefore a benefit contract contract exclusion for all products of the Company.


Services that are cosmetic are a benefit contract exclusion for all products of the Company. 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 considered benefit contract exclusions. Individual benefits must be verified.

WOMEN'S HEALTH AND CANCER RIGHTS ACT (WHCRA)

The Women's Health and Cancer Rights Act 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

To support the medical necessity of the removal of a breast implant, the medical record documentation must include:
  • Documentation of the original indication for implantation and the type of implant, either silicone gel-filled or saline-filled
  • Reason for the implant removal and the results of any mammogram, ultrasound, and/or magnetic resonance imaging (MRI) as appropriate

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.
Guidelines

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, the removal of breast implant(s) is covered under the medical benefits of the Company's 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 do 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)
    Breast implant--associated anaplastic large cell lymphoma (BIA-ALCL) is another complication that that can occur with breast implants. BIA-ALCL has been reported most commonly in individuals with a history of a textured breast implant. BIA-ALCL is not a cancer of the breast tissue itself, but of the scar envelope that the body naturally forms around a breast implant, called the capsule. Symptoms of BIA-ALCL include a swelling of the breast that develops over several years after insertion of textured breast implants, or a lump in the breast or lymph node in the armpit. Less common symptoms include overlying skin rash, fever, and weight loss. Treatment of BIA-ALCL follows standardized guidelines established by the National Comprehensive Cancer Network (NCCN). The US Food and Drug Administration [FDA] does not recommend removal of implants for individuals that are not having symptoms. For confirmed BIA-ALCL, current NCCN recommendations call for total capsulectomy, removal of the implant, as well as excision of any masses.

    COSMETIC SERVICES

    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 do not constitute improvement in physiologic function.
    References


    American Society of Plastic Surgeons (ASPS). BIA-ALCL Resources. [ASPS Web site]. 06/06/19. Available at: https://www.plasticsurgery.org/for-medical-professionals/health-policy/bia-alcl-physician-resources. Accessed April 17, 2020.

    American Society of Plastic Surgeons (ASPS). Breast implants: what patients need to know. [ASPS Web site]. 08/05/19. Available at: https://www.plasticsurgery.org/patient-safety/breast-implant-safety. Accessed April 17, 2020.

    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 April 17, 2020.

    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.

    Clemens MW, Jacobsen ED, Horwitz SM. 2019 NCCN Consensus Guidelines on the Diagnosis and Treatment of Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). Aesthetic Surgery Journal. 2019;39(S1):S3-S13.

    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 August 1, 2019.

    National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology -T-Cell Lymphomas. v.1.2020. [NCCN Web site]. Available at: https://www.nccn.org/professionals/physician_gls/pdf/t-cell.pdf. Accessed April 17, 2020.

    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/breast-implants-research-regulatory-summary/. Accessed April 17, 2020.

    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 Article (LCA). A56587: Cosmetic and Reconstructive Surgery. [Novitas Solutions Web site]. Original: 05/30/2019. (Revised: 01/01/20). Available at: https://www.cms.gov/medicare-coverage-database/details/article-details.aspx?articleId=56587&ver=21&Keyword=reconstructive&KeywordSearchType=Or&Date=&PolicyType=Both&ArticleType=BC%7cSAD%7cRTC%7cReg&Cntrctr=323*1&KeyWordLookUp=Doc&SearchType=Advanced&CoverageSelection=Both&kq=true&search_id=&service_date=&bc=IAAAABAAAAAA&. Accessed April 17, 2020.

    Novitas Solutions, Inc. Local Coverage Determination (LCD). L35090: Cosmetic and Reconstructive Surgery. [Novitas Solutions Web site]. Original: 10/01/2015. (Revised: 11/07/2019). Available at: https://www.cms.gov/medicare-coverage-database/details/lcd-details.aspx?LCDId=35090&ver=69&Keyword=reconstructive&KeywordSearchType=Or&Date=&PolicyType=Both&ArticleType=BC%7cSAD%7cRTC%7cReg&Cntrctr=323*1&KeyWordLookUp=Doc&SearchType=Advanced&CoverageSelection=Both&kq=true&bc=IAAAABAAAAAA&. Accessed April 17, 2020.

    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 April 17, 2020.

    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 April 17, 2020.

    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 April 17, 2020.

    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://wayback.archive-it.org/7993/20170112132504/http://www.fda.gov/downloads/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/UCM259894.pdf . Accessed April 17, 2020.

    US Food and Drug Administration (FDA). Center for Devices and Radiological Health. The FDA Requests Allergan Voluntarily Recall Natrelle BIOCELL Textured Breast Implants and Tissue Expanders from the Market to Protect Patients: FDA Safety Communication. [FDA Web site]. Available at: https://www.fda.gov/medical-devices/safety-communications/fda-requests-allergan-voluntarily-recall-natrelle-biocell-textured-breast-implants-and-tissue. Accessed April 17, 2020.

    US Food and Drug Administration (FDA). Center for Devices and Radiological Health. Questions and Answers about Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). [FDA Web site]. Available at: https://www.fda.gov/medical-devices/breast-implants/questions-and-answers-about-breast-implant-associated-anaplastic-large-cell-lymphoma-bia-alcl. Accessed April 17, 2020.



    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 11.08.14k:
    06/08/2020This version of the policy will become effective 06/08/2020. This policy has been updated in consideration of recommendations of the US Food and Drug Administration (FDA) and 2019 National Comprehensive Cancer Network (NCCN) Consensus Guidelines on the Diagnosis and Treatment of Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). In addition, criteria were added to address the removal of a breast implant in the contralateral breast.

    The following indication was added to this policy for the removal silicone gel-filled and saline-filled breast implant(s):
    • Individuals diagnosed with breast implant--associated anaplastic large cell lymphoma (BIA-ALCL)
    The following criteria were added to the policy for the removal of silicone gel-filled breast implants to address the contralateral (unaffected) breast:
    • When the above criteria for removal of a silicone gel-filled breast implant are met unilaterally AND the implant was originally placed for a medically necessary indication (e.g., chest wall deformities such as Pectus Excavatum or Poland’s Syndrome, repair of breast asymmetry due to a medically necessary mastectomy or lumpectomy, repair of breast asymmetry due to trauma), then removal of the implant in the contralateral breast is considered medically necessary to achieve breast symmetry, and is therefore covered when both implants are removed at the same time.
    • In addition, when a individual has been diagnosed with unilateral breast implant-associated anaplastic large cell lymphoma (BIALCL), removal of both implants (affected and the contralateral breast) is considered medically necessary and is therefore covered regardless of why the implants were originally placed.

    The following criteria were added to the policy for the removal of saline-filled breast implants to address the contralateral (unaffected) breast:
    • When the above criteria for removal of a saline-filled breast implant are met unilaterally AND the implant was originally placed for a medically necessary indication (e.g., chest wall deformities such as Pectus Excavatum or Poland’s Syndrome, repair of breast asymmetry due to a medically necessary mastectomy or lumpectomy, repair of breast asymmetry due to trauma), then removal of the implant in the contralateral breast is considered medically necessary to achieve breast symmetry, and is therefore covered when both implants are removed at the same time.
    • In addition, when a individual has been diagnosed with unilateral breast implant-associated anaplastic large cell lymphoma (BIALCL), removal of both implants (affected and the contralateral breast) is considered medically necessary and is therefore covered regardless why the implants were originally placed.

    The following ICD- 10CM codes have been added to this policy:

    C84.60 Anaplastic large cell lymphoma, ALK-positive, unspecified site
    C84.61 Anaplastic large cell lymphoma, ALK-positive, lymph nodes of head, face, and neck
    C84.62 Anaplastic large cell lymphoma, ALK-positive, intrathoracic lymph nodes
    C84.63 Anaplastic large cell lymphoma, ALK-positive, intra-abdominal lymph nodes
    C84.64 Anaplastic large cell lymphoma, ALK-positive, lymph nodes of axilla and upper limb
    C84.65 Anaplastic large cell lymphoma, ALK-positive, lymph nodes of inguinal region and lower limb
    C84.66 Anaplastic large cell lymphoma, ALK-positive, intrapelvic lymph nodes
    C84.67 Anaplastic large cell lymphoma, ALK-positive, spleen
    C84.68 Anaplastic large cell lymphoma, ALK-positive, lymph nodes of multiple sites
    C84.69 Anaplastic large cell lymphoma, ALK-positive, extranodal and solid organ sites
    C84.70 Anaplastic large cell lymphoma, ALK-negative, unspecified site
    C84.71 Anaplastic large cell lymphoma, ALK-negative, lymph nodes of head, face, and neck
    C84.72 Anaplastic large cell lymphoma, ALK-negative, intrathoracic lymph nodes
    C84.73 Anaplastic large cell lymphoma, ALK-negative, intra-abdominal lymph nodes
    C84.74 Anaplastic large cell lymphoma, ALK-negative, lymph nodes of axilla and upper limb
    C84.75 Anaplastic large cell lymphoma, ALK-negative, lymph nodes of inguinal region and lower limb
    C84.76 Anaplastic large cell lymphoma, ALK-negative, intrapelvic lymph nodes
    C84.77 Anaplastic large cell lymphoma, ALK-negative, spleen
    C84.78 Anaplastic large cell lymphoma, ALK-negative, lymph nodes of multiple sites
    C84.79 Anaplastic large cell lymphoma, ALK-negative, extranodal and solid organ sites
    Z48.3 Aftercare following surgery for neoplasm

    REVISIONS FROM 11.08.14j:
    10/01/2018This version of the policy will become effective 10/01/2018. The following ICD-10 codes have been added to the policy: T81.40XA, T81.40XD, T81.40XS, T81.41XA, T81.41XD, T81.41XS, T81.42XA, T81.42XD, T81.42XS, T81.43XA, T81.43XD, T81.43XS, T81.44XA, T81.44XD, T81.44XS, T81.49XA, T81.49XD, T81.49XS. The following ICD-10 codes have been termed from the policy:T81.4XXA, T81.4XXD, T81.4XXS.

    REVISIONS FROM 11.08.14i:
    04/25/2018This policy has undergone a routine review, and no revisions have been made.


    Effective 10/05/2017 this policy has been updated to the new policy template format.
    Version Effective Date: 06/08/2020
    Version Issued Date: 06/08/2020
    Version Reissued Date: N/A

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