mp-216 - Medical Policies - Alabama
Dermal Fillers and Bulking Agents for Vocal Cord Insufficiency
Policy Number: MP-216
Latest Review Date: August 2021
Policy Grade: C
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.
Poly-L-lactic acid, (Sculptra™), an injectable filler used to treat facial lipoatrophy is considered cosmetic and a contract exclusion.
DESCRIPTION OF PROCEDURE OR SERVICE:
Dermal Fillers for Cosmetic Purposes
Dermal fillers are products that are injected or placed into the dermis. There are also subdermal fillers and those placed underneath the dermis in the subcutis. They can be injected into areas with fine lines and wrinkles. Bovine collagen was the first FDA-approved dermal filler in the United States for more than a decade.
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.
Literature review through July 2021.
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.
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.
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
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, Artefil, Radiesse, Elevess, Sculptra Aesthetic, Perlane, unilateral vocal cord paralysis, Coaptite™, Juliesse™, Prolaryn™ Plus/Radiesse™ Voice, carboxymethylcellulose (Prolaryn™ Gel/Radiesse™ Voice Gel), human collagen (CosmoPlast®), bovine collagen (Zyplast®), 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).
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.
Coverage is subject to member’s specific benefits. Group specific policy will supersede this policy when applicable.
ITS: Home Policy provisions apply
FEP contracts: FEP does not consider investigational if FDA approved. Will be reviewed for medical necessity.
|31513||Laryngoscopy, indirect; with vocal cord injection|
|31570||Laryngoscopy, direct, with injection into vocal cord(s), therapeutic;|
|31571||With operating microscope or telescope|
|31574||Laryngoscopy, flexible; with injection(s) for augmentation (e.g., percutaneous, transoral), unilateral|
|G0429||Dermal filler injection(s) for the treatment of facial lipodystrophy syndrome (LDS) (e.g., as a result of highly active antiretroviral therapy)|
|L8607||Injectable bulking agent for vocal cord medialization, 0.1ml, includes shipping and necessary supplies|
|Q2026||Injection, Radiesse, 0.1 ml|
|Q2028||Injection, Sculptra, 0.5mg|
Cymetra, Injectable, 1cc
- American Academy of Dermatology (AAD). Fillers: Overview. © 2018. Accessed on March 15, 2019. Available at URL address: https://www.aad.org/public/diseases/cosmetic-treatments/fillers
- American Academy of Otolaryngology Head and Neck Surgery. Fact sheet: Vocal Cord Paralysis: Patient Health Information. © 2019. Last reviewed August 2018. Accessed January 02, 2020. Available at URL address: http://www.entnet.org/content/vocal-cord-paralysis
- American Osteopathic College of Dermatology. Dermatologic Disease Database. Dermal Fillers. www.aocd.org/skin/dermatologic_diseases/dermal-fillers.html. Accessed March 5, 2009.
- Bader RS and Johnson DL. Dermal fillers. emedicine, October 23, 2008. emedicine.medscape.com/article/1125066-print. Accessed March 5, 2009.
- Barclay Laurie. Guideline issued for evaluation and management of hoarseness. cme.medscape.com/viewarticle/708571.
- Brunings J. Uber eine neue behandlungsmethode der rekurranslahmung. Verhandl Ver Dtsch Laryngol. 1911;18:93-151.
- Carrol T, Rosen CA. Long-term Results of Calcium Hydroxylapatite (CaHA) Vocal Fold Injection for Glottal Incompetence; Combined Otolaryngology Spring Meeting, ALA Section; 2010 Apr 28-May 2; Las Vegas, NV, USA.
- Chandrasekhar SS, Randolph GW, Seidman MD, et al. Clinical practice guideline: improving voice outcomes after thyroid surgery. Otolaryngol Head Neck Surg, 2013 14 8(6 Suppl)S1-37. //oto.sagepub.com/content/148/6_suppl/S1.full.pdf+html. Accessed January 02, 2020.
- DeFatta RA, Chowdhury FR, Sataloff RT. Complications of injection laryngoplasty using calcium hydroxylapatite. J Voice. Sep 2012; 26(5):614-618.
- Francis DO, Williamson K, Hovis K, et al. Effect of injection augmentation on need for framework surgery in unilateral vocal fold paralysis. Laryngoscope. Jan 2016; 126(1):128-134.
- Guidance “Drip Laryngeal Anesthesia” – Tips and Pearls. White Paper on Injection Techniques. [Personal Communication]. http://www.radiesse-voice.com/docs/ML00113.pdf Accessed December 2019.
- Hayes Health Technology Brief. Radiesse Voice Injectable Implant (Merz Aesthetics Inc.) for Treatment of Glottic Insufficiency Including Vocal Cord Paralysis). Annual Review October 15, 2015. Archived Jan 03, 2017.
- IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
- Karpenko AN and Meleca RJ. Cymetra injection for unilateral vocal fold paralysis. Ann Otol Rhinol Laryngol, November 2003, Vol. 112, No. 11, pp. 927-934.
- Kimura M, Nito T, Sakakibara K, et al. Clinical experience with collagen injection of the vocal fold: a study of 155 patients. Auris Nasus Larynx. Mar 2008; 35(1):67-75.
- Mallur PS, Rosen CA. Vocal Fold Injection: Review of Indications, Techniques, and Materials for Augmentation. Clin Exp Otorhinolarygol, 2010 December; 3(4): 177-182.
- Morgan JE, Zraick RI, et al. Injection Versus Medialization Laryngolplasty for the Treatment of Unilateral Vocal Fold Paralysis. Laryngoscope, 2007 Nov; 117(11): 2068-74.
- Mosby’s Drug Consult 2004. Poly-L-lactic acid, www.home.mdconsult.com/das/drug/body/326943814/1/4049.html.
- Moyle, GJ, et al. A randomized open-label study of immediate versus delayed polylactic acid injections for the cosmetic management of facial lipoatrophy in persons with HIV infection, HIV Medicine, March 2004; 5(2): pp. 82-87.
- National Institute for Health and Care Excellence. Collagen injection for vocal cord augmentation (IPG130). 2005; //www.nice.org.uk/guidance/ipg130.
- Pei YC, Fang TJ, Hsin LJ, et al. 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):121-130.
- Rosen CA, Gartner-Schmidt J, et al. Vocal Fold Augmentation with Calcium Hydroxylapatite: Twelve-month Report. Laryngoscope. 2009 May; 119(5): 1033-1041.
- Rosen CA., Performing Radiesse™ Trans-Oral Vocal Cord Fold Augmentation InjectionVia Flexible Nasopharyngoscopic
- Schwartz SR, Cohen SM, Dailey SH, et al. Clinical practice guideline: Hoarseness (Dysphonia). Otolaryngology-Head and Neck Surgery 2009; 141: S1-S31.
- Sculptra Aesthetic Prescribing Information. www.sculptraesthetic.com/welcome/hcp.aspx. Accessed August 3, 2009.
- Shen T, Damrose EJ, Morzaria S. A meta-analysis of voice outcome comparing calcium hydroxylapatite injection laryngoplasty to silicone thyroplasty. Otolaryngol Head Neck Surg. Feb 2013; 148(2):197-208.
- Siu J, Tam S, Fung K. A comparison of outcomes in interventions for unilateral vocal fold paralysis: A systematic review. Laryngoscope. Jul 2016; 126(7):1616-1624.
- Sulica L, Rosen CA, Postma GN, et al. Current practice in injection augmentation of the vocal folds: indications, treatment principles, techniques, and complications. Laryngoscope. Feb 2010; 120(2):319-325.
- Tan M, Woo P. Injection laryngoplasty with micronized dermis: a 10-year experience with 381 injections in 344 patients. Laryngoscope. Dec 2010; 120(12):2460-2466.
- U.S Food and Drug Administration. Dermal Fillers Approved by the Center for Devices and Radiological Health. //www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/CosmeticDevices/WrinkleFillers/ucm227749.htm. Assessed August 2018
- U.S. Food and Drug Administration (FDA). Executive Summary: Dermal Filler Devices. Food and Drug Administration Center for Devices and Radiological Health Office of Device Evaluation General and Plastic Surgery Devices Panel Public Advisory Committee Meeting, November 18, 2008.
- U.S. Food and Drug Administration Center for Devices and Radiological Health. Sculptra-p030050, www.fda.gov/cdrh/pdf3/p030050.html.
- Valantin, MA, et al. Polylactic acid implants (New-Fill) to correct facial lipoatrophy in HIV-infected patients: Results of the open-label study VEGA, AIDS, November 2003; 17(7): 2471-2477.
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.
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.