Latest Review Date: August 2024

Category:  Medical                                                                

POLICY:

FDA approved injectable implants/bulking agents (e.g. Radiesse®) may be considered medically necessary for the treatment of unilateral vocal cord paralysis.

Dermal fillers that are FDA approved for cosmetic purposes are considered not medically necessary, cosmetic and a contract exclusion.

FDA approved injectable dermal fillers (e.g., Sculptra®, Radiesse®) used to treat facial lipoatrophy are considered cosmetic and a contract exclusion.

DESCRIPTION OF PROCEDURE OR SERVICE:

Dermal Fillers for Cosmetic Purposes

Injectable fillers also referred to as injectable dermal or soft tissue fillers, are substances used to restore tissue volume loss caused by factors such as aging, lipoatrophy, injury or trauma. A wide variety of injectable fillers are available for clinical use, including products that break down over time (e.g., hyaluronic acid, collagen, calcium hydroxylapatite, and poly-L-lactic acid), products that remain indefinitely in tissue (e.g., polymethylmethacrylate microspheres, hydrogel polymers, and silicone), and autologous fat.

The majority of injectable fillers can be divided into the following categories:

• Calcium hydroxylapatite microsphere (e.g., Radiesse, Prolaryn)

• Collagen (e.g., Cosmoderm, Evolence, Fibrel, Zyplast, Zyderm)

• Poly-L-lactic acid (e.g., Sculptra)

• Hyaluronic acid (e.g., Restylane, Perlane, Juvederm Ultra, Elevess, Prevelle Silk, Teosyal, Revanesse Ultra, Hylaform B Gel, Captique, Artefill, Beletero Balance)

Vocal Cord Insufficiency

Under normal conditions, the mucosal vocal folds (vocal cords) open for breathing and close for voice vibration and swallowing. Loss of vocal fold closure due to paralysis, atrophy, or scar can affect voice, swallowing, and breathing. Injection of bulking agents has been reported for the treatment of vocal cord abnormalities. The objective of vocal fold injection augmentation (injection laryngoplasty) is to increase the size of the deficient vocal fold and reestablish symmetrical medial closure of both vocal folds.

Vocal fold paralysis occurs most frequently following surgery, and is a common complication of thyroid, cervical spine, esophagus, and lung surgeries. Examination on laryngoscopy shows impaired vocal fold motion, bowing of the fold, and incomplete glottis closure. Paresis refers to partial paralysis with preservation of gross mobility. The incidence of vocal fold paralysis has increased with the increase in thyroidectomy and anterior cervical discectomy and fusion. However, many cases of unilateral vocal fold insufficiency will spontaneously recover if left untreated.

Surgical interventions for vocal fold paralysis include laryngoplasty, arytenoid adduction, and laryngeal re-innervation. Vocal fold injection augmentation (injection laryngoplasty) for the temporary treatment of vocal fold insufficiency was first reported over a century ago using paraffin, although injection augmentation has become more commonly reported in the past 2 decades. Injection of a bulking agent into the paraglottic space results in medialization of the vocal fold, and can be approached through the cricothyroid membrane or through the mouth.

The objective of vocal fold injection augmentation for the treatment of vocal cord insufficiency is to increase the size of the deficient vocal fold and reestablish symmetrical medial closure of both vocal folds. Materials used for vocal fold augmentation include Teflon, calcium hydroxylapatite (Prolaryn™® Plus/Radiesse® Voice), carboxymethylcellulose (Prolaryn® Gel/Radiesse® Voice Gel), human collagen (CosmoPlast®), bovine collagen (Zyplast®), micronized dermis (Cymetra®), hyaluronic acid (Hylaform®, Restylane®), and autologous fat. All bulking agents cause some degree of inflammation. The duration of the inflammation varies according to the durability of the agent. Injection of bulking agents typically results in a transient increase in tissue volume, although Teflon, which has a high incidence of inflammation and granuloma formation, may result in a permanent increase in vocal fold volume.

KEY POINTS:

Literature review through July 25, 2024.

Summary of Evidence:

For individuals who have vocal fold insufficiency (e.g. paralysis, paresis, atrophy, or scar) who receive vocal fold injection augmentation, the evidence includes 1 randomized controlled trial (RCT) and systematic reviews of case series and cohort studies. Relevant outcomes are change in disease status, functional outcomes, quality of life, and treatment-related morbidity. Overall, the evidence is of low quality, with only 1 RCT in patients with unilateral vocal fold paralysis. This RCT showed a significant benefit of injection augmentation only in the first few months compared with observation, which could be related to the natural resolution of vocal fold paralysis over time. The systematic reviews have suggested comparable efficacy of vocal fold injection augmentation with surgical approaches, but interpretation is limited by a high potential for bias in the identified studies. Outcomes of the large case series and cohort studies have suggested a benefit in both objective and subjective outcomes related to the durability of the product injected.

Facial lipodystrophy syndrome (LDS) is characterized by a localized loss of fat from the face, resulting in excessively sunken cheeks. The condition may occur as a side effect of antiretroviral therapy used in the HIV infection treatment regimen. Facial LDS can be socially stigmatizing and may impact patients’ adherence to highly active antiretroviral therapy (HAART), psychological health, and quality of life (QoL), including feelings of distress, depression, anxiety, social isolation, and career barriers. Although new HAART medications are associated with less severe facial LDS, the prevalence of HIV facial LDS among treated individuals exceeds 50%. Treatment of HIV facial LDS is linked to improvement in the QoL of patients in health perception, mental health, social function, and emotional status (Jagdeo, et al., 2015). The FDA has approved two dermal fillers, Sculptra® and Radiesse® that are indicated for facial lipoatrophy, a component of HIV LDS.

Practice Guidelines and Position Statements

American Academy of Otolaryngology-Head and Neck Surgery

The American Academy of Otolaryngology-Head and Neck Surgery (AAOHNS) published guidelines in 2013 on improving voice outcomes after thyroid surgery. AAOHNS made a strong recommendation for identifying the recurrent laryngeal nerve(s) during thyroid surgery, and recommendations to examine and document voice and vocal fold mobility both before and after surgery. AAOHNS recommended that if patients have voice change or abnormal vocal fold mobility after surgery, surgeons should provide counsel on options for rehabilitation. Vocal fold injection medialization is described as a temporary intervention that may reduce the need for later surgical reconstruction.

In a 2018 practice guideline on dysphonia (hoarseness), the AAO-HNS stated clinicians should advocate for surgery as a therapeutic option for patients with dysphonia with conditions amenable to surgical intervention, such as suspected malignancy, symptomatic benign vocal fold lesions that do not respond to conservative management, or glottic insufficiency. This surgery includes vocal fold injection medialization using bulking agent.

In 2019 the American Laryngological Association (ALA) published a guideline on vocal fold injection augmentation. The group stated the procedure is indicated for glottal insufficiency due to unilateral vocal fold paralysis or paresis, vocal fold atrophy, vocal fold scar, sulcus vocalis, or loss of the soft tissue of the vocal folds. It is contraindicated for the individuals with the following:

• Unstable cardiopulmonary status

• Allergy to any injectable materials including local anesthetic

• Poor exposure of the endolarynx due to a prolapsing arytenoid

• Severe supraglottic constriction, poorly defined anatomic landmarks of the neck

Relative contraindications:

• Individuals with a large posterior glottal gap or large interarytenoid defects that require laryngeal framework surgery

• Individuals being treated with anticoagulation medications

National Institute for Health and Care Excellence

The U.K.’s National Institute for Health and Care Excellence (NICE) provided guidance in 2005 on collagen injection for vocal cord augmentation. NICE concluded that collagen injection is efficacious for short-term symptom relief and there were no major safety concerns.

U.S. Preventive Services Task Force Recommendations

Not applicable.

KEY WORDS:

Sculptra®, poly-L-lactic acid, injectable implant, lipoatrophy, HIV, collagen, Zyderm® I, Zyderm® II, Zyplast®, CosmoDerm I®, CosmoDerm II®, CosmoPlast®, porcine collagen, bovine collagen, Evolence®, hyaluronic acid, Restylane®, Perlane®, Juvederm®, Juvederm® Ultra, Juvederm® Ultra Plus, Hylaform®, Hylaform® Plus, Captique, Puragen and Puragen Plus, Prevelle® Silk, Silk Voice®, Artefil®, Radiesse®, Elevess, Sculptra® Aesthetic, synthetic polymer, unilateral vocal cord paralysis, Coaptite®, Juliesse™, Prolaryn® Plus/Radiesse® Voice, carboxymethylcellulose (Prolaryn® Gel/Radiesse® Voice Gel), human collagen, micronized dermis (Cymetra®), hyaluronic acid (Hylaform®, Restylane®), Juvederm® Vollure XC, Juvederm® Volbella XC, Refyne, Restylane® Defyne, Belotero Balance®, Artefill®, Fibrel, Evolence®, glottal insufficency

APPROVED BY GOVERNING BODIES:

Multiple bulking agents have been approved by the U. S. Food and Drug Administration (FDA) through the 510(k) process for the treatment of unilateral vocal cord paralysis. Manufacturers including but not limited to,Sofregen Medical (Medford, MA), Cytophil (East Troy, WI), Coapt Systems (Palo Alto, CA) and Bioform Medical (San Mateo, CA). According to the FDA, the product code dedicated to bulking agents for vocal cord medialization is MIX.

The Radiesse® Laryngeal Implant (calcium hydroxylapatite) (BioForm Medical Inc.) obtained clearance from the FDA through the 510(k) approval process, as substantially equivalent to the predicate device on March 1, 2007. According to the FDA, the Radiesse® Laryngeal Implant is indicated for vocal fold medialization and treatment of vocal fold insufficiency that can be improved by injection of a soft-tissue bulking agent. The Radiesse® Laryngeal Implant is intended to augment the size of the displaced or deformed vocal fold so that it may meet the opposing vocal fold at the midline for improved phonation. Vocal fold insufficiency associated with serious aspiration difficulties may be an urgent indication for a Radiesse® Laryngeal Implant (FDA, 2007). In February 2010, Merz Aesthetics Inc. acquired BioForm Medical Inc. Merz Aesthetics Inc. manufactures Radiesse® Laryngeal Implant under the names Radiesse® Voice and Radiesse® Voice Injectable Implant (Merz Aesthetics Inc., 2012).

The FDA 510(k) documents refer to Prolaryn products above using their original product names. Prolaryn Plus was originally cleared as the Radiesse Laryngeal Implant (Bioform Medical, Inc., Franksville, WI, USA), and Prolaryn Gel was originally cleared for marketing as the Laryngeal Augmentation Implant (Bioform, Inc.).

On, November 8, 2018, the FDA cleared the Silk Voice® (Sofregen Medical, Inc.) synthetic polymer for vocal fold medialization and vocal fold insufficiency.

SCULPTRA® (FDA approved July 2009) is indicated for use in immune-competent people as a single regimen for correction of shallow to deep nasolabial fold contour deficiencies and other facial wrinkles in which deep dermal grid pattern (cross-hatch) injection technique is appropriate.

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits.  Group-specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply

FEP contracts: Special benefit consideration may apply.  Refer to member’s benefit plan

CURRENT CODING:

CPT Codes:

HCPCS:

REFERENCES:

1. American Academy of Dermatology (AAD). Fillers: Overview. 2023. Available at URL address: www.aad.org/public/diseases/cosmetic-treatments/fillers
2. American Academy of Otolaryngology Head and Neck Surgery. Vocal Cord (Fold) Paralysis. 2023. Available at URL address: www. enthealth.org/conditions/vocal-cord-fold-paralysis/
3. American Academy of Otolaryngology-Head and Neck Surgery. Clinical Practice Guideline: Hoarseness (Dysphonia). 2018.
4. American Laryngological Association. Injection Augmentation. 2019. Available at: www.alahns.org/wpcontent/uploads/CLC/57. CLC Injection-Augmentation.pdf.
5.  Barclay, Laurie. Guideline Issued for Evaluation and Management of Hoarseness. 2023. Available at URL address: www.medscape.org/viewarticle/708571571
6. Carruthers J, Humphrey S. Injectable soft tissue fillers: Overview of clinical use. In: UpToDate, Dover JS, Colwell AS (Eds). Literature review current through March 2024. Last updated May 10, 2022.
7. DeFatta RA, Chowdhury FR, Sataloff RT. Complications of injection laryngoplasty using calcium hydroxylapatite. J Voice. 2012 Sep;26(5):614-8. doi: 10.1016/j.jvoice.2011.08.005. Epub 2011 Nov 6.
8. Francis DO, Williamson K, Hovis K, Gelbard A, Merati AL, Penson DF, Netterville JL, Garrett CG. Effect of injection augmentation on need for framework surgery in unilateral vocal fold paralysis. Laryngoscope. 2016 Jan;126(1):128-34. doi: 10.1002/lary.25431. Epub 2015 Jul 7.
9. Hirano S, Sugiyama Y, Kaneko M, Mukudai S, Fuse S, Hashimoto K. Intracordal Injection of Basic Fibroblast Growth Factor in 100 Cases of Vocal Fold Atrophy and Scar. Laryngoscope. 2021 Sep;131(9):2059-2064. doi: 10.1002/lary.29200. Epub 2020 Oct 27.
10. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
11. Jagdeo J, Ho D, Lo A, et al. A systematic review of filler agents for aesthetic treatment of HIV facial lipoatrophy (FLA). J Am Acad Dermatol. 2015 Dec;73(6):1040-54.e14.
12. Mallur PS, Rosen CA. Vocal fold injection: review of indications, techniques, and materials for augmentation. Clin Exp Otorhinolaryngol. 2010 Dec;3(4):177-82. doi: 10.3342/ceo.2010.3.4.177. Epub 2010 Dec 22.
13. Pei YC, Fang TJ, Hsin LJ, Li HY, Wong AM. Early hyaluronate injection improves quality of life but not neural recovery in unilateral vocal fold paralysis: an open-label randomized controlled study. Restor Neurol Neurosci. 2015;33(2):121-30. doi: 10.3233/RNN-140439.
14. Siu J, Tam S, Fung K. A comparison of outcomes in interventions for unilateral vocal fold paralysis: A systematic review. Laryngoscope. 2016 Jul;126(7):1616-24. doi: 10.1002/lary.25739. Epub 2015 Oct 20.
15. U.S Food and Drug Administration. FDA-Approved Dermal Fillers. 2020. Available at URL address: www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/CosmeticDevices/WrinkleFillers/ucm227749.htm.
16. U.S Food and Drug Administration. Hoang, A. (n.d.). www.accessdata.fda.gov/cdrh_docs/pdf18/K180631.pdf      
17. U.S. Food and Drug Administration. Radiesse laryngeal implant. Summary of safety and effectiveness. 510(k) No. K070090. Silver Springs, MD: FDA; March 1, 2007.       
18. U.S. Food and Drug Administration Center for Devices and Radiological Health.  Sculptra-p030050/S039, 2023. Available at URL address: www.fda.gov/medical-devices/recently-approved-devices/sculptra-p030050s039
19. Wang CC, Wu SH, Tu YK, Lin WJ, Liu SA. Hyaluronic Acid Injection Laryngoplasty for Unilateral Vocal Fold Paralysis-A Systematic Review and Meta-Analysis. Cells. 2020 Nov 5;9(11):2417. doi: 10.3390/cells9112417.

POLICY HISTORY:

Medical Policy Group, January 2005 (1)

Medical Policy Administration Committee, January 2005

Available for comment February 14-March 30, 2005

Medical Policy Group, January 2006 (1)

Medical Policy Group, January 2007 (1)

Medical Policy Group, January 2008 (1)

Medical Policy Group, March 2009 (1)

Medical Policy Administration Committee, April 2009

Available for comment April 3-May 18, 2009

Medical Policy Group, August 2009 (1)

Medical Policy Group, September 2009 (1)

Medical Policy Administration Committee, October 2009

Available for comment October 2, November 16, 2009

Medical Policy Update, July 2010 (1): August, 2010 Added Perlane to policy as not covered.

Medical Policy Group, April 2011 (1): Update to Description, Policy, Key Points, Key Words Coding  and References to include coverage for unilateral vocal cord paralysis

Medical Policy Administration Committee Meeting, April 2011

Available for comment April 13 – May 30, 2011

Medical Policy Group, October 2013 (1): Removed ICD-9 Diagnosis codes; no change to policy statement.

Medical Policy Group, November 2014: 2015 Annual Coding update.  Added HCPCS code C9742 to current coding.

Medical Policy Group November 2015: 2016 Annual Coding Update.  Added HCPCS code L8607 to current coding.

Medical Policy Group, December 2016: 2017 Annual Coding Update.  Created previous coding section and moved deleted HCPCS code C9742 to this section.

Medical Policy Group, September 2017 (6): Updates to Title, Description, Key Points, Key Words, Governing Bodies, Removed old policy statement from 2009, coding section and References.

Medical Policy Group, January 2020: Updates to Description, Key Points, Governing Bodies, Key Words (glottal insufficiency), Coding (31513, corrected Q2028) and References. No change to policy intent.

Medical Policy Group, August 2021 (5): Updates to Key Points, and References. No change to Policy Statement.

Medical Policy Group, July 2022 (5): Minor update to Key Points. No change to Policy Statement.

Medical Policy Group, July 2023 (9):  Updates to Key Points, Benefit Application and References. Reviewed by consensus. There is no new published peer-reviewed literature available that would alter the coverage statement in this policy.

Medical Policy Group, August 2024 (9): Changed the title to Dermal Fillers and Bulking Agents. Updates to Description, Key Points, Key Words (silk voice, synthetic polymer), Approved by Governing Bodies and References. Policy statement updated to include clarification of FDA approved injectable dermal fillers when used for the treatment of facial lipoatrophy.

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.