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Dermal Fillers and Bulking Agents for Vocal Cord Insufficiency

Policy Number: MP-216

Latest Review Date: September 2017

Category:  Medical                                                                

Policy Grade: C

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.

Artefill® is a dermal filler that is made of non-resorbable microspheres and is marketed as Polymethylmethacrylate with bovine collagen.  Because of the bovine source, this product requires allergy testing. The FDA approval (October 2006) is only for correction of nasolabial folds. This product duration is listed as permanent support structure for wrinkle correction. This product must be injected directly beneath the skin fold in the deep dermis.

Belotero Balance, FDA approved in 2011 for injection into facial tissue to smooth wrinkles and folds, especially around the nose and mouth (nasolabial folds).

Captique is dermal filler that is the same as the Hylaform but is not animal based; it comes from a bacterial source through fermentation.  Due to the bacterial source this makes Captique a stiffer form of dermal filler.  This filler was FDA approved November 2004 and is indicated for injection into the mid to deep dermis for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds) and duration of action is about 4 months.

CosmoDerm I Human Based C was FDA approved in 2003 for the injection into the superficial papillary dermis for correction of soft tissue contour deficiencies, such as wrinkles and acne scars.

Elevess or Cosmetic Tissue Augmentation Product (CTA) is indicated for injection into the mid to deep dermis for the correction of moderate to severe facial wrinkles and folds (such as nasolabial folds). Elevess was FDA approved December 2006.

Evolence was FDA approved June 27, 2008.  Evolence is indicated for correction of moderate-to-deep facial wrinkles and folds, such as nasolabial folds with duration of approximately 6 months. Porcine collagen is naturally occurring collagen filler that is derived from porcine tendons. 

Fibrel was FDA approved in 1998 for the correction of depressed cutaneous scars which are distendable by manual stretching of the scar borders.

Hylaform and Hylaform Plus, FDA approved in 2004 are hyaluronic acid products derived from an avian source, rooster combs.  They are similar in action to Restylane and Perlane but there needs to be aware of possible allergies to these avian proteins.  These products are indicated for injection into the mid to deep dermis for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds).

Juvederm Ultra XC and Juvederm Ultra Plus XC are non-animal stabilized hyaluronic dermal fillers that were FDA approved in June 2006. Juvederm Ultra Plus has a higher proportion of cross-linking of any of the hyaluronic acid fillers and thus has a smoother consistency. Indications are for injection into the mid to deep dermis for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds). The duration of the effects of the Juvederm products range from 6 to 12 months. FDA approved in 2010 for the addition of 0.3% Lidocaine into Juvederm Ultra and Juvederm Ultra Plus.

Juvederm Vollure XC, FDA approved in 2017 for the injection into the mid to deep dermis for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds) in adults over the age of 21.

Juvederm Volbella XC, FDA approved in 2016 for the injection into the lips for lip augmentation and for correction of perioral rhytids in adults over the age of 21.

Prevelle Silk was approved by the FDA in February 26, 2008 and is the only hyaluronic acid dermal filler that contains lidocaine.  The indications for Prevelle Silk are injection into mid to deep dermis for correction of moderate to severe facial wrinkles and folds.  The duration is approximately 6 months.

Perlane® injectable gel is biotechnologically engineered, non-immunogenic, stabilized hyaluronic acid gel particles.  The three-dimensional gel particles in Perlane are hydrophilic molecules, attracting and binding to water molecules as they degrade, helping to maintain volume augmentation for about 6 months. On May 2, 2007, Perlane was approved by the FDA for implantation into the deep dermis to superficial subcutis for the correction of moderate to severe facial folds and wrinkles, such as the nasolabial folds. Perlane is a Class III restricted medical device and should only be administered under the supervision of a licensed practitioner. Perlane has also been used for other facial issues that may include lip enhancement, chin augmentation, and softening acne scar.

Radiesse, hydroxylapatite, was FDA approved 2015 for the subdermal implantation for hand augmentation to correct volume loss in the dorsum of the hands. In March, 2007, the FDA approved Radiesse for vocal fold medialization. 

Restylane, Refyne, Restylane Defyne, 2016 approval, is indicated for injection into the mid-to-deep dermis for the correction of moderate to severe facial wrinkles and folds (such as nasolabial fold) in patients over the age of 21. Restylane Defyne is indicated for injection into the mid-to-deep dermis for the correction of moderate to severe deep facial wrinkles and folds (such as nasolabial fold) in patients over the age of 21.

Sculptra™ is an injectable implant that contains microparticles of poly-L-lactic acid.  It is a biocompatible, biodegradable, synthetic polymer from the alpha-hydroxy-acid family. In August 2004, the FDA approved Sculptra™ as injectable filler to correct facial fat loss in HIV patients.  Sculptra™ works by temporarily adding volume to facial tissue and restoring a smoother, fuller appearance to the face.  The initial treatment series may consist of 4 to 5 injection sessions conducted at approximately 2-week intervals.  Repeat treatments may be needed to maintain the effect which may range from several months to about a year. On July 29, 2009, the FDA approved Sculptra Aesthetic for correction of shallow to deep nasolabial fold contour deficiencies and other facial wrinkles which are treated with the appropriate injection technique in healthy patients.

Zyderm I is FDA approved for the correction of contour deformities of the dermis in non-weight bearing areas and was extremely effective for correction of fine lines and shallow scars, with results often lasting 3 months.  Other uses were for rhytides, deeper nasolabial folds and marionette lines but the effect only lasted about 2 months.  There were issues with this product that included allergies to bovine collagen, lack of longer lasting results and disappointing results for its uses.

Zyderm II and Zyplast were FDA approved with hopes of improving on the Zyderm I issues.  Zyplast was indicated by the FDA approval for the correction of contour deficiencies of soft tissue and seemed to work well but some of the same issues existed with frequency of treatments, skin allergy testing and the poor response of deeper rhytides and folds. 

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.

In a multicenter survey, the ratio of office-based procedures in the awake patient to operating room procedure with general anesthesia increased from 1:9 in 2003 to 1:1 by 2008. Two advances are proposed to account for the increase in office-based procedures: the availability of easier-to-inject materials, and the development of video-chip laryngoscopy. In addition to the need for only local anesthetic, office-based procedures allow immediate assessment of voice and adjustment if needed. The ease of an office-based procedure has expanded the indications for vocal fold augmentation to include patients whose condition does not warrant the inconvenience and risk of general anesthetic, as an interim treatment when paralysis is expected to be temporary, as an aid to diagnosis or to determine benefit for surgical treatment and as adjunctive augmentation after laryngeal framework surgery.

 

Policy:

Effective for dates of service on or after March 3, 2011:

Radiesse™, Sculptra™, and other FDA approved injectable implant devices 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 implant device used to treat facial lipoatrophy is considered cosmetic and a contract exclusion.

 

Key Points:

This evidence review was created in January 2005 with a review of the literature of the MEDLINE database through June 13, 2016.

A search of the literature identified 2 systematic reviews of level III and IV studies that compared injection augmentation to other interventional techniques. In addition, 1 small randomized controlled trial (RCT), several small prospective studies, and large case series were identified. Following is a summary of key literature to date.

Efficacy of Vocal Fold Injection Augmentation

Systematic Reviews

A 2013 meta-analysis by Shen et al compared voice-related QOL after injection augmentation with calcium hydroxylapatite (Prolaryn Plus/Radiesse Voice) to voice-related QOL after medialization thyroplasty with silicone. Twenty-four (total N=544 patients) studies met the inclusion criteria of case series, cohort studies, or RCTs that assessed voice-related quality of life and had at least 1 month of follow-up. Selected were 10 studies on injection augmentation with calcium hydroxyapatite and 14 on medialization laryngoplasty. Fourteen studies were retrospective. Study sample sizes ranged from 5 to 59 patients. No RCTs were identified. Improvements from baseline in the Voice Handicap Inventory scores were 38.20 for medialization thyroplasty and 36 for injection augmentation (p=NS). Improvements from baseline in maximum phonatory time were 6.23 for medialization thyroplasty and 5.60 for injection augmentation (p=NS). Interpretation of this meta-analysis is limited by the lack of prospective comparative studies and potential for selection bias.

In 2015, Siu et al published a systematic review of interventions for unilateral vocal fold paralysis (UVFP). Meta-analysis could not be performed due to variability in outcome measures. Included were 17 studies that compared injection augmentation, medialization thyroplasty, arytenoid adduction, and/or laryngeal reinnervation. The investigators identified 7 level III and IV comparative studies that compared injection augmentation to other techniques; all but 1 study compared injection augmentation to medialization thyroplasty. The total number of subjects was not fully described, although review of the included studies indicates that many studies had small sample sizes. All treatments improved perceptual, acoustic, quality of life (QOL), and laryngoscopic outcomes, but injection augmentation was not permanent. Interpretation of these data is limited by the lack of prospective comparative studies and potential for selection bias.

Randomized Controlled Trials

Pei et al reported a small RCT with 29 patients to determine whether injection augmentation with a temporary bulking agent would lead to healing with long-term improvement in function and QOL. Patients with UVFP confirmed by laryngoscopy were treated with a single hyaluronate injection or remained under observation in this open-label trial. Assessments at 1, 3, and 6 months after injection included quantitative laryngeal electromyography, vidolaryngostroboscopy, Voice Outcome Survey, laboratory voice analysis, and 36-Item Short-Form Health Survey (SF-36). The control group was evaluated at baseline and 6 months. At 1-month follow-up, there was improvement in all outcomes in the injection group, which persisted through 6 months. However, comparison with the observation group at 6 months showed no significant differences between groups, except for SF-36 mental health scores. These results suggest that while vocal fold injection augmentation may be associated with short-term improved outcomes, most patients will have spontaneous recovery by 6 months.

Observational Studies

In an article published in 2003 by Karpenko et al, Cymetra was used as injection for unilateral vocal cord paralysis. The goal was to demonstrate that injections for glottal incompetence would lead to long term improvement in voice quality and glottal gap closure. Ten patients were in the study and underwent injection of Cymetra into the thyroarytenoid muscle. Significant improvements were identified in maximum phonation time, relative glottal area, and subjective judgment of glottal competency. The results were not maintained at the 3-month study interval. No significant change in quantitative or subjective voice quality was noted for the study group during the investigation. Resorption of Cymetra was thought to play a significant role in contributing to these findings.

Kimura et al (2008) reported on 275 patients who had received vocal fold injection augmentation with bovine collagen (Atelocollagen).Treatment was performed for patients with glottis insufficiency that was not likely to recover spontaneously and who refused general anesthesia, admission to the hospital, or neck incision. Follow-up for at least 3 months (mean, 20 months; range, 3-120 months) on 155 (56%) patients showed no long-term local or systemic reaction. Results of this study are difficult to interpret because of the large percentage (44%) of patients who were not included in the report.

In 2010, Tan and Woo reported on their 10-year experience with injection augmentation of the vocal fold. They performed 381 injections with micronized dermis in 344 patients for vocal cord paralysis (n=216), scar (n=51), atrophy (n=42), sulcus (n=22), and other causes (e.g., Parkinson disease, multiple sclerosis; n=13). The operative and postoperative complication rate was 1.05%, although 29% of injections had premature absorption (mean, 14.7 months). In 159 patients with follow-up beyond 1 year, 14% of patients had more than 1 injection, and 20% of patients who had received injection augmentation went on to open surgical procedures.

In 2016, Francis et al reported on 633 patients seen at authors’ tertiary laryngology center and had confirmed UVFP following laryngoscopy. Over 75% of UVFP cases resulted from surgery. Forty-six percent of patients were managed by observation and supportive care, 28% were successfully treated by injection augmentation, 22% had surgical treatment with laryngoplasty, and 4% had injection augmentation followed by laryngoplasty.

Safety of Vocal Fold Injection Augmentation

Inflammatory reactions and implant malposition/migration are potential complications of vocal fold injection augmentation. In 2012, DeFatta et al reported complications of injection augmentation with calcium hydroxylapatite (Prolaryn Plus/Radiesse Voice). Sixteen patients had injection augmentation of 22 vocal folds. Mucosal waves were evaluated when possible before and post-injection with strobovideolaryngoscopy, and implant location was examined used computed tomography in patients suspected of having implant malposition. Ten major complications were identified that affected mucosal vibration, and there was confirmed implant malposition/migration for 6 implants. These 6 implants were at least partially removed, with foreign body reaction and granulation tissue formation identified with histologic analysis. The authors commented on the ease of injection with a 25-gauge needle, but also the potential for migration, with this high viscosity (similar to water) product.

Dermal Fillers

The Vega Study, from France, was a 96-week open-label, non-comparative, single-center study in 50 HIV patients.  Patients had a mean age of 45 years, 84% were Caucasian, and 98% were male.  Most patients had 4 to 5 injection sessions.  The results showed all patients experienced increases in skin thickness in the treatment area in weeks 8 to 96 during the study and the changes persisted for up to 2 years.  The results also showed 3% had bruising, 30% had hematoma, and 52% had a nodule at the injection site.

The Chelsea and Westminster (C&W) Study, from England, was a 24 week, open-label, single-center, randomized study in 30 HIV patients.  Patients were randomized to the delayed treatment group (treatment delayed by 12 weeks) or immediate treatment group, and received 12 or 24 weeks, respectively, of follow up.  The immediate treatment group received injections on day one and at weeks 2 and 4.  The delayed treatment group received injections at weeks 12, 14, and 16.  The results showed all patients had significant changes from baseline in mean skin thickness in the areas treated.  A mean increase in dermal thickness of approximately 4 to 6 mm was observed in both groups 12 weeks after the initiation of treatment.  The adverse events at the injection site included 38% with bruising, 10% with discomfort, 10% with erythema, 10% with inflammation, and 31% with a nodule.

The Apex 002 Study and the Blue Pacific Study were 2, single-center, open-label, 12-month investigator-initiated studies in the U.S. in HIV positive patients with facial lipoatrophy.  There were 99 pts in each study, and the majority was Caucasian males.  Patients received up to 6 injection sessions at 3 to 6 week intervals and were followed for one year.  The adverse events for the Apex study included discomfort in 19%, edema in 3%, bruising in 1%, and injection site papule in 6%.  The adverse events for the Blue Pacific Study included bruising in 30%, edema in 17%, discomfort in 15%, and erythema in 3% and injection site papule in 13%.

The final results of the U.S. Studies have not been published.  The long-term safety and effectiveness beyond 2 years have not been investigated.  The uses of poly-L-lactic acid injectable implant devices for the treatment of other diseases/conditions (e.g., facial wrinkles and folds due to ageing) have not been done in the U.S.

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 small (N=29) 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. Key issues that need to be addressed include the durability of the procedure, whether there is benefit as a temporary treatment while awaiting resolution of symptoms, and whether there is utility of the procedure for diagnosis or to determine the efficacy of surgery. The evidence is insufficient to determine the effects of the technology on health outcomes.

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

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, 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

 

Approved by Governing Bodies:

In January 2002, Coaptite™ Laryngeal Augmentation System was cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process (K013243). FDA determined that this device was substantially equivalent to existing devices for use as an injectable, space-occupying implant for vocal fold medialization and augmentation.

In December 2003, Laryngeal Augmentation Implant was cleared for marketing by FDA through the 510(k) process (K033398). FDA determined that this device was substantially equivalent to Coaptite Laryngeal Augmentation System as a space-filling material for soft tissue augmentation in laryngeal procedures for vocal fold medialization and augmentation.

In April 2006, Juliesse™ Laryngeal Implant was cleared for marketing by FDA through the 510(k) process (K060815). FDA determined that this device was substantially equivalent to Radiesse™ Voice Gel Injectable Laryngeal Augmentation Implant for use in in surgical reconstructions as a space-occupying material in laryngeal surgical procedures for vocal fold medialization and augmentation.

In March 2007, Radiesse™ Injectable Laryngeal Augmentation Implant was cleared for marketing by FDA through the 510(k) process (K070090). FDA determined that this device was substantially equivalent to Juliesse™ Laryngeal Implant and the Coaptite™ Laryngeal Augmentation System as a space-filling material for soft tissue augmentation in laryngeal procedures for vocal fold medialization and augmentation.

FDA regulates human cells and tissues intended for implantation, transplantation, or infusion through the Center for Biologics Evaluation and Research, under Code of Federal Regulation (CFR) title 21, parts 1270 and 1271. Micronized dermis and human collagen are included in these regulations.

The FDA is aware that unapproved versions of Juvederm, such as Juvederm Ultra 2, 3, and 4 are being sold and distributed in the U.S., including by online retailers. Juvederm is a prescription device that should only be injected and sold by or on the prescription of a licensed health care provider. The FDA is warning health care providers and patients not to use any Juvederm Ultra 2, 3 or 4, because these products are not approved for use in the U.S. As such, the safety and effectiveness of these products cannot be assured.

 

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: FEP does not consider investigational if FDA approved.  Will be reviewed for medical necessity

 

Current Coding: 

CPT codes:

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

HCPCS:

G0429             Dermal filler injection(s) for the treatment of facial lipodystrophy

                        syndrome (LDS) (e.g., as a result of highly active antiretroviral therapy)

J3490              Unclassified drugs

L8607             Injectable bulking agent for vocal cord medialization, 0.1ml, includes

                        shipping and necessary supplies (Effective January 1, 2016)

Q2026             Injection, Radiesse, 0.1 ml

Q2027             Injection, Sculptra, 0.1 ml

Q4112                 ; Cymetra, Injectable, 1cc 

Previous Coding: 

C9742             Laryngoscopy, flexible fiberoptic, with injection into vocal cord(s),

                        therapeutic, including diagnostic laryngoscopy, if performed

                        (Deleted December 31, 2016)

 

References:

  1. American Osteopathic College of Dermatology.  Dermatologic Disease Database.  Dermal Fillers. www.aocd.org/skin/dermatologic_diseases/dermal-fillers.html.  Access éd March 5, 2009.

  2. Bader RS and Johnson DL.  Dermal fillers.  emedicine, October 23, 2008.  emedicine.medscape.com/article/1125066-print.  Accessed March 5, 2009.

  3. Barclay Laurie.  Guideline issued for evaluation and management of hoarseness.  cme.medscape.com/viewarticle/708571.

  4. Brunings J. Uber eine neue behandlungsmethode der rekurranslahmung. Verhandl Ver Dtsch Laryngol. 1911;18:93-151.

  5. 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.

  6. 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.

  7. DeFatta RA, Chowdhury FR, Sataloff RT. Complications of injection laryngoplasty using calcium hydroxylapatite. J Voice. Sep 2012; 26(5):614-618.

  8. 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.

  9. 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.

  10. 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.

  11. Mallur PS, Rosen CA. Vocal Fold Injection: Review of Indications, Techniques, and Materials for Augmentation. Clin Exp Otorhinolarygol, 2010 December; 3(4): 177-182.

  12. 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.

  13. 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.

  14. Mosby’s Drug Consult 2004.  Poly-L-lactic acid, www.home.mdconsult.com/das/drug/body/326943814/1/4049.html.

  15. National Institute for Health and Care Excellence. Collagen injection for vocal cord augmentation (IPG130). 2005; //www.nice.org.uk/guidance/ipg130.

  16. 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.

  17. Rosen CA, Gartner-Schmidt J, et al. Vocal Fold Augmentation with Calcium Hydroxylapatite: Twelve-month Report. Laryngoscope. 2009 May; 119(5): 1033-1041.

  18. Sculptra Aesthetic Prescribing Information.  www.sculptraesthetic.com/welcome/hcp.aspx.  Accessed August 3, 2009.

  19. Schwartz SR, Cohen SM, Dailey SH, et al.  Clinical practice guideline:  Hoarseness (Dysphonia).  Otolaryngology-Head and Neck Surgery 2009; 141: S1-S31.

  20. 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.

  21. 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.

  22. 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.

  23. 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.

  24. U.S. Food and Drug Administration Center for Devices and Radiological Health.  Sculptra-p030050, www.fda.gov/cdrh/pdf3/p030050.html.

  25. 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.

  26. 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

  27. 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.

 

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.

 

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.