Notification



Notification Issue Date:



Medical Policy Bulletin


Title:Injectable Dermal Fillers

Policy #:05.00.62h

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.

Radiesse® (injectable calcium hydroxylapatite) is considered medically necessary for unilateral vocal cord paralysis. All other uses of Radiesse® (injectable calcium hydroxylapatite) are not covered by the Company because they are considered a cosmetic service. Services that are cosmetic are a benefit contract exclusion for all products of the Company. Therefore, they are not eligible for reimbursement consideration.

Injectable dermal fillers, such as but not limited to, autologous fat transfer, Sculptra® (injectable poly-L-lactic acid), autologous cellular product (azficel-T, laVív), human collagen (CosmoDerm, CosmoPlast), hyaluronic acid (Restylane, Restylane L, Juvederm, Captique, Belotero Balance, Prevelle Silk, Hydrelle), modified hyaluronic acid from avian source (Hylan B Gel), bovine collagen (Zyplast, Zyderm), human collagen from human tissue (Cymetra), and polymethyl methacrylate [PMMA] microsphere-enhanced bovine collagen (Artefill) are not covered by the Company because they are considered a cosmetic service. Services that are cosmetic are a benefit contract exclusion for all products of the Company. Therefore, they are not eligible for reimbursement consideration.

Services performed due to recent trauma and/or accident and intended to restore a member to a pre-trauma and/or pre-accident state may be eligible for coverage, except when a specific benefit contract exclusion exists.

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.

All requests for injectable dermal fillers require review by the Company and must include a letter of medical necessity from the professional provider stipulating that facial LDS caused by antiretroviral HIV treatment is a significant contributor to the diagnosis of clinical depression.
Guidelines

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, injectable dermal fillers that do not meet the medical necessity criteria listed in this policy are considered cosmetic services. Services that are cosmetic are a benefit contract exclusion for all products of the company. Therefore, they are not eligible for reimbursement consideration.

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

The Center for Devices and Radiological Health (CDRH) of the FDA granted premarket approval for Sculptra® (injectable poly-L-lactic acid) on August 3, 2004, and for Radiesse® (calcium hydroxylapatite) on December 22, 2006, for the treatment of HIV-associated facial lipoatrophy. On March 01, 2007, the FDA granted an additional approval to Radiesse® for vocal fold medialization and vocal fold insufficiency.

The FDA has also approved numerous other injectable dermal (wrinkle) filler, volume-producing agents localized to the face to smooth wrinkles and folds; correct contour deficiencies; and augment lips.

The FDA has not approved injectable dermal (wrinkle) filler, volume-producing agents to:
  • Augment (increase volume of) or alter the shape of facial features such as cheeks and nose
  • Increase breast size (breast augmentation)
  • Increase buttocks size
  • Rejuvenate hands or feet
  • Implant into bone, tendon, ligament, or muscle


Description

Dermal fillers vary from biologic to synthetic materials, and from absorbable to nonabsorbable compounds. In general, dermal fillers are volume-producing agents that are approved for injection into the dermal layers for the correction of moderate-to-severe wrinkles, contour deficiencies, folds, and depressions.

Dermal fillers include human fat and medical device implants approved for medical use by the Food and Drug Administration (FDA). Autologous fat transfer is the removal of fat from one part of the body and transferring it somewhere else on the body. The FDA has approved a multitude of injectable dermal fillers and volume-producing agents for treatment localized to the face in order to create a smoother appearance. The agents include, but are not limited to, autologous cellular product (azficel-T, laVív), human collagen (CosmoDerm, CosmoPlast), hyaluronic acid (Restylane, Restylane L, Juvederm, Captique, Belotero Balance, Prevelle Silk, Hydrelle), bovine collagen (Zyplast, Zyderm), human collagen from human tissue (Cymetra), microscopic plastic beads and polymethyl methacrylate [PMMA] microsphere-enhanced bovine collagen (Artefill), calcium hydroxylapatite [CaHA] (Radiesse®), and Poly-L-Lactic Acid (PLLA) (Sculptra Aesthetic). In addition, Restylane and Restylane L Injectable Gels are approved for lip augmentation in those over the age of 21 years.

The FDA has also granted approval to two dermal fillers, Sculptra® and Radiesse®, to address facial lipoatrophy, which is a component of lipodystrophy syndrome (LDS) in individuals with human immunodeficiency virus (HIV). LDS is associated with a triad of complications, including lipoatrophy (localized loss of subcutaneous fat); lipodystrophy (regionalized fat accumulation); and metabolic abnormalities (insulin resistance, hypercholesterolemia, and hypertriglyceridemia). Facial LDS is often characterized by a localized loss of fat from the face, resulting in facial abnormalities such as excessively sunken cheeks. Facial LDS may occur as a side effect of medicinal (antiretroviral) therapies that individuals receive as part of an HIV infection treatment regimen. Facial LDS may occur by itself and should not be confused with HIV wasting, which may also occur in the face. HIV wasting affects muscle rather than subcutaneous fat and is not a part of LDS. Individuals with facial LDS may experience adverse psychological conditions, such as depression, and stop their HIV treatments in an attempt to halt or reverse this complication.

Sculptra® (injectable poly-L-lactic acid) is a biodegradable, biocompatible synthetic polymer that is injected below the surface of the skin in individuals with HIV and facial LDS. It works by inducing the synthesis and deposition of the body's own collagen to create a smoother, fuller appearance of underlying dermal tissues. Injections are administered in a series that may last for a year or more, and they do not correct the underlying cause of the facial fat loss. There is no literature providing evidence that Sculptra® improves the physiological functioning of the eyes, nose, mouth, or chin.

Radiesse® (injectable calcium hydroxylapatite [CaHA]) is a semi-solid, cohesive implant, whose principle component is synthetic CaHA suspended in a gel for injection below the skin in individuals with HIV and facial LDS. Small particles of CaHA act as a scaffold for collagen growth, which promotes volume replacement to folds and sunken facial areas. In a clinical study, the treatment lasted for one year after the first treatment session in all individuals. As with Sculptra®, there is no literature providing evidence that Radiesse® improves the physiological functioning of the eyes, nose, mouth, or chin. Additionally, in 2007, the FDA approved Radiesse® for vocal fold medialization.

The vocal cords are two elastic bands of muscle tissue in the larynx. Vocal cord paralysis is a condition which involves immobilization of the vocal cords; this may be unilateral (affect one side) or bilateral (affect both sides). The potential causes of unilateral vocal cord paralysis are broad, and can include latrogenic injury, vagal nerve injury, tumors or thoracic diseases, or systemic causes (infections, inflammatory disease, neurologic problems,). While the pathogenesis of unilateral vocal cord paralysis is poorly understood, it may impact an individual’s voice, swallowing or the airway function. Examination of unilateral vocal cord paralysis may include auditory-perceptual evaluation of voice, aucustic measurements, intensity measures or laryngoscopy; and medical management may include voice therapy, medialization (paralyzed vocal fold is placed toward the midline), or medialization via injectables. In 2005, the National Institute for Health and Clinical Excellence (NICE) concluded collagen injection for vocal cord augmentation to be safe and efficacious in patients requiring short-term symptom relief; however, long term safety and efficacy data were lacking.

Repetitive injections with both Sculptra®, and Radiesse® may be necessary to maintain the therapeutic treatment effect in individuals with HIV and facial LDS.

The use of injectable dermal fillers has aesthetic applications. For example, these products provide volume for wrinkles around the eyes, cheeks, lips, and neck, thereby improving appearance. Cosmetic services are those provided to improve an individual's physical appearance, from which no significant improvement in physiological function can be expected. Emotional and/or psychological improvement alone does not constitute improvement in physiological function.
References


Carruthers A, Liebeskind M, Carruthers J, et al. Radiograhic and computed tomographic studies of calcium hydroxylapatite for the treatment of HIV-associated facial lipoatrophy and correction of nasolabial folds. Dermatol Surg.2008;34 Suppl 1:S78-84. Available at: http://www.ncbi.nlm.nih.gov/pubmed/18547186. Accessed January 26, 2015.

Centers for Medicare & Medicaid Services (CMS). National Coverage Determination (NCD). 250.5: Dermal Injections for the Treatment of Facial Lipodystrophy Syndrome (LDS). [CMS Web site]. July 6, 2010. Available at: http://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=338&ncdver=1&IsPopup=y&NCAId=234&NcaName=Dermal+injections+for+the+treatment+of+facial+lipodystrophy+syndrome+(FLS)&bc=AAAAAAAACAAAAA%3D%3D& Accessed January 26, 2015

Centers for Medicare & Medicaid Services (CMS). CMS Manual System. Transmittal 2105. [CMS Web site]. November 24, 2010. Available at: http://www.cms.gov/transmittals/downloads/R2105CP.pdf. Accessed January 26, 2015

Comite SL, Liu JF, Balasubramanian S, et al. Treatment of HIV-associated facial lipoatrophy with Radiance FN™ (Radiesse). Derm Online Journal.2004;10(2):2. Available at: http://dermatology.cdlib.org/102/therapy/HIV/comite.html. Accessed January 26, 2015

FDA, Center for Devices and Radiological Health. Office of Device Evaluation General and Plastic Surgery Devices Panel, Public Advisory Committee Meeting November 18, 2008:. [FDA Web site]. Available at:http://www.fda.gov/ohrms/dockets/ac/08/briefing/2008-4391b1-01%20-%20FDA%20Executive%20Summary%20Dermal%20Fillers.pdf. Accessed January 26, 2015.

FDA Medical Devices: Cosmetic Devices. Approved Wrinkle fillers. June 7, 2012. Available at: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/CosmeticDevices/WrinkleFillers/ucm227749.html. Accessed January 26, 2015.

FDA, Center for Devices and Radiological Health Listing of all approved wrinkle filler devices. August 3, 2012 [FDA Web site]. Available at: http://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm?start_search=1&Search_Term=lmh&Approval_Date_From=&Approval_Date_To=&sort=approvaldatedesc&PAGENUM=10 Accessed January 26, 2015

Hanke CW, Rohrich RJ, Busso M, et al. Facial Soft-Tissue Fillers conference: Assessing the State of the Science. J Am Acad Dermatol. 2011;64(4 Suppl):S66-85.

Levy RM, Redbord KP, Hanke CW. Treatment of HIV lipoatrophy and lipoatrophy of aging with poly-L-lactic acid: a prospective 3-year follow-up study. J Am Acad Dermatol. 2008;59(6):923-33.

National Institute for Clinical Excellence (NICE). Collagen injection for vocal cord augmentation. Interventional Procedure Guidance 130. London, UK: NICE; June 2005. Available at: http://www.nice.org.uk/guidance/ipg130/resources/ipg130-collagen-injection-for-vocal-cord-augmentation-information-for-people-considering-the-procedure-and-for-the-public-2. Accessed January 26, 2015.

Sturm LP, Cooter RD, Mutimer KL, Graham JC, Maddern GJ. A systematic review of permanent and semipermanent dermal fillers for HIV-associated facial lipoatrophy. AIDS Patient Care STDS. 2009;23(9): 699-714.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. Sculptra (injectable poly-L lactic acid). Premarket approval letter. [FDA Web site]. 08/03/04. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf3/P030050S002a.pdf. Accessed January 26, 2015.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. Radiesse®. Summary of safety and effectiveness. [FDA Web site]. 12/22/06. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf5/P050037b.pdf. Accessed January 26, 2015.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. Radiesse®. Premarket approval letter. [FDA Web site]. 12/22/06. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf5/p050052a.pdf Accessed January 26, 2015.

US Food and Drug Administration (FDA). Instructions for use. Radiesse®. [FDA Web site]. Available at: http://www.fda.gov/ohrms/dockets/ac/06/briefing/2006-4233b1_10.pdf. Accessed January 26, 2015.

US Food and Drug Administration (FDA). Radiesse laryngeal implant. 510(k) Summary of safety and effectiveness. [FDA Web site]. March 1, 2007. Available at:http://www.accessdata.fda.gov/cdrh_docs/pdf7/K070090.pdf. Accessed January 26, 2015.

Valeant Pharmaceuticals International, Inc. ©2012. Sculptra®. Available at: http://www.sculptra.us/. Accessed January 26, 2015.





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)

THE FOLLOWING CODES REPRESENT INJECTABLE DERMAL FILLERS USED AS A COSMETIC SERVICE:
11950, 11951, 11952, 11954


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)

B20 Human immunodeficiency virus [HIV] disease

B97.35 Human immunodeficiency virus, type 2 [HIV 2] as the cause of diseases classified elsewhere

E88.1 Lipodystrophy, not elsewhere classified

J38.01 Paralysis of vocal cords and larynx, unilateral



HCPCS Level II Code Number(s)



G0429 Dermal filler injection(s) for the treatment of facial lipodystrophy syndrome (LDS) (e.g., as a result of highly active antiretroviral therapy)

Q2026 Injection, Radiesse, 0.1 ML

Q2028 Injection, Sculptra, 0.5 MG

THE FOLLOWING CODE REPRESENTS OTHER INJECTABLE DERMAL FILLERS:

J3590 Unclassified Biologics


Revenue Code Number(s)

N/A

Coding and Billing Requirements



Policy History

Policy #05.00.62h
10/10/2018This policy has been reissued in accordance with the Company's annual review process.


Effective 10/05/2017 this policy has been updated to the new policy template format.


Version Effective Date: 01/01/2017
Version Issued Date: 01/03/2017
Version Reissued Date: 10/11/2018

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Independence Blue Cross is an independent licensee of the Blue Cross and Blue Shield Association, serving the health insurance needs of Philadelphia and southeastern Pennsylvania.