Notification



Notification Issue Date:



Medicare Advantage Policy

Title:Injectable Dermal Fillers
Policy #:MA05.021a

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.

Sculptra® (injectable poly-L-lactic acid) and Radiesse® (calcium hydroxylapatite) injectable dermal fillers are covered for the treatment of facial lipodystrophy syndrome (LDS) in individuals with human immunodeficiency virus (HIV) when all of the following criteria are met:
  • Facial LDS is caused by the use of antiretroviral agents in the treatment of HIV.
  • Facial LDS is a significant contributor to the individual's diagnosis of clinical depression.

Injectable dermal fillers that are used for all other indications are considered noncovered. Injectable fillers that are not approved by the FDA for the treatment of LDS are considered noncovered.

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.
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, injectable dermal fillers are covered under the medical benefits of the Company’s Medicare Advantage products when the medical necessity criteria listed in this policy are met.

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

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]. Available at: http://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=338&ncdver=1&DocID=250.5&bc=gAAAABAAAAAA& Accessed May 08, 2019.

Galderma Laboratories, L.P. Sculptra aesthetic (injectable poly-L-lactic acid). 2017. [Web site]. Available at: https://www.sculptraaesthetic.com/. Accessed on May 08, 2019.

National Institute for Clinical Excellence (NICE). Collagen injection for vocal cord augmentation: Interventional procedure guidance 130. 06/2005. [NICE Web site]. Available at: https://www.nice.org.uk/guidance/ipg130. Accessed on May 08, 2019.

US Food and Drug Administration (FDA) Cosmetic Devices. Dermal fillers approved by the Center for Devices and Radiological Health. [FDA Web site]. Available at: https://www.fda.gov/medical-devices/cosmetic-devices/dermal-fillers-approved-center-devices-and-radiological-health#approved. Accessed on May 08, 2019.


US Food and Drug Administration (FDA) Medical Devices Advisory Committee, General and Plastic Surgery Devices Panel. Panel meeting summary, November 18-19, 2008. [FDA Web site]. Available at: https://wayback.archive-it.org/7993/20170405193134/https:/www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/GeneralandPlasticSurgeryDevicesPanel/ucm125405.htm. Accessed on May 08, 2019.

US Food and Drug Administration (FDA). Radiesse injectable implant: Instructions for use. [FDA Web site]. Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf5/p050037c.pdf. Accessed on May 08, 2019.



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)

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



HCPCS Level II Code Number(s)



MEDICALLY NECESSARY

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 0.1 M


Revenue Code Number(s)

N/A

Coding and Billing Requirements






Policy History

MA05.021a
06/05/2019The policy has been reviewed and reissued to communicate the Company’s continuing position on injectable dermal fillers.
10/10/2018This policy has been reissued in accordance with the Company's annual review process.
01/01/2017The following HCPCS code has been deleted from this policy:
  • C9800 Dermal injection procedure(s) for Facial Lipodystrophy Syndrome (LDS) and provision of Radiesse or Sculptra dermal filler, including all items and supplies

MA05.021
03/04/2015This policy was reviewed and reissued in accordance with the Company's Policy Confirmation Review track. The intent of this policy remains unchanged.
01/01/2015This is a new policy.





Version Effective Date: 01/01/2017
Version Issued Date: 01/03/2017
Version Reissued Date: 06/05/2019