Frenectomy or Frenotomy for Ankyloglossia

Number: 0116

Policy

Aetna considers lingual or labial frenectomy, frenotomy, or frenuloplasty medically necessary for ankyloglossia when newborn feeding difficulties or childhood articulation problems exist.

Aetna considers prophylactic frenectomy, frenotomy or frenuloplasty to promote speech development experimental and investigational because the effectiveness of this approach has not been established.

Background

Ankyloglossia, or tongue-tie, exists when the inferior lingual frenulum attaches to the bottom of the tongue and restricts its movement.  This condition can impair the normal mobility of the tongue and interfere with speech or newborn feeding.

If the tongue can touch the anterior dentition, mobility is adequate for the development of normal speech.  However, in situations where the inferior lingual frenulum significantly impedes tongue excursion, a frenulectomy may be performed in order to free the tongue.

An assessment by the National Institute for Health and Clinical Excellence (NICE, 2005) concluded that “[c]urrent evidence suggests that there are no major safety concerns about division of ankyloglossia (tongue-tie) and limited evidence suggests that this procedure can improve breastfeeding”.

A position statement by the Canadian Paediatric Society (Rowan-Legg, et al., 2011) found: "Associations between tongue-tie and breastfeeding problems in infants have been inconsistent, and are a longstanding source of controversy in the medical community. Definitions of ankyloglossia vary, and management suggestions are not based on randomized controlled trials. ... Based on current available evidence, frenotomy cannot be recommended. If, however, the association between significant tongue-tie and major breastfeeding problems is clearly identified and surgical intervention is deemed necessary, frenotomy should be performed by a clinician experienced with the procedure and with appropriate analgesia."

Aras and colleagues (2010) compared the tolerance of lingual frenectomy with regard to a local anesthesia requirement as well as post-surgical discomfort experienced by patients operated on with diode laser or erbium:yttrium-aluminium-garnet (Er:YAG) laser.  A total of 16 referred patients with tongue mobility complaints were included in this study.  A GaAlAs laser device with a continuous wavelength of 808 nm was used in the diode group.  Frenulums were incised by applying 2 W of laser power.  The Er:YAG laser device with a continuous wavelength of 2,940 nm was used in the Er:YAG group.  Frenulums were incised by applying 1 W of laser power.  The acceptability of the lingual frenectomy without local anesthesia and the degree of the post-surgical discomfort were evaluated.  Although the majority of patients (n = 6) could be operated on without local anesthesia in the Er:YAG group, all patients could not be operated on without local anesthetic agent in the diode group.  There were no differences between the 2 groups with regard to pain, chewing, and speaking on the 1st or 7th day after surgery, whereas patients had more pain in the Er:YAG group than in the diode group the first 3 hrs after surgery.  The authors concluded that these findings indicate that only the Er:YAG laser can be used for lingual frenectomy without local anesthesia, and there was no difference between the 2 groups regarding the degree of the post-surgical discomfort except in the first 3 hrs.  Thus, these results indicate that the Er:YAG laser is more advantageous than the diode laser in minor soft-tissue surgery because it can be performed without local anesthesia and with only topical anesthesia.

Buryk et al (2011) noted that ankyloglossia has been associated with a variety of infant-feeding problem and that frenotomy commonly is performed for relief of ankyloglossia.  The investigators conducted a randomized, single-blinded, controlled trial to determine whether frenotomy for infants with ankyloglossia improved maternal nipple pain and ability to breastfeed. A secondary objective was to determine whether frenotomy improved the length of breastfeeding. Over a 12-month period, neonates who had difficulty breastfeeding and significant ankyloglossia were assigned to either a frenotomy (30 infants) or a sham procedure (28 infants) and breastfeeding was assessed by a preintervention and postintervention nipple-pain scale and the Infant Breastfeeding Assessment Tool. Study subjects were followed two weeks post=procedure and at regularly scheduled follow-ups over a 1-year period. The infants in the sham group were given a frenotomy before or at the 2-week follow-up if it was desired. Both groups demonstrated statistically significantly decreased pain scores after the intervention, but the frenotomy group improved significantly more than the sham group (P < .001). Breastfeeding scores significantly improved in the frenotomy group (P = .029) without a significant change in the control group. All but 1 parent in the sham group elected to have the procedure performed when their infant reached 2 weeks of age, which prevented additional comparisons between the 2 groups. The investigators demonstrated immediate improvement in nipple-pain and breastfeeding scores, despite a placebo effect on nipple pain, which they state provides convincing evidence for those seeking a frenotomy for infants with signficant ankyloglossia.

Steehler and colleagues (2012) measured maternal breast feeding benefit after infant frenotomy.  In addition, these researchers examined if timing of neonatal/infant frenotomy affects outcome.  Medical records of neonates and infants suspected to have ankyloglossia between April 2006 and February 2011 were reviewed.  Patient demographic data were compiled.  A telephone survey was conducted to gather data on this cohort of patients.  Neonatal and infant consultations (n = 367) were performed for feeding difficulties due to suspected ankyloglossia, 302 of these infants underwent frenotomy for ankyloglossia.  A total of 91 mothers agreed to participate in a follow-up telephone survey regarding the intervention.  Results showed that 80.4 % of mothers strongly believed the procedure benefited their child's ability to breast-feed, and 82.9 % of mothers were able to initiate/resume breast-feeding after the procedure was performed.  The belief that frenotomy significantly benefitted an infant's ability to feed significantly differed in patients that had the procedure performed in the first week of life (86 %) as compared to infants that had the procedure performed after the first week of life (74 %) (p < 0.003).  The authors concluded that based on maternal observations, when frenotomy is performed on neonates with ankyloglossia and feeding difficulties in the first week of life, there is more benefit than when it is performed after the first week of life.  The population of patients with ankyloglossia is predominantly male with a high familial/genetic correlation associated with the phenotypic trait.  They stated that frenotomy for ankyloglossia demonstrated a high degree of maternal satisfaction; is well-tolerated and has been shown to improve breast-feeding and decrease pain and difficulty associated with breast-feeding.

O'Callahan et al (2013) evaluated the effect of office-based frenotomy on reversing breast-feeding difficulties among infants with problematic ankyloglossia, and examined characteristics associated with anterior and posterior ankyloglossia.  Mothers of infants who underwent a frenotomy for ankyloglossia from December 2006 through March 2011 completed a post-intervention web-based survey about breast-feeding difficulties they experienced before and after the frenotomy.  Maternal-infant dyads had been referred from health providers to a primary care practice for assessment of ankyloglossia.  Infants were subsequently classified as having no ankyloglossia, anterior (Type I or Type II) or posterior (Type III or Type IV).  There were 311 infants evaluated for ankyloglossia and 299 (95 %) underwent a frenotomy.  Most infants were classified as having Type III (36 %) or IV (49 %) ankyloglossia compared to only 16 % with anterior (Type I and Type II combined).  Differences by classification type were found for gender (p = 0.016), age (p = 0.017), and maxillary tie (p = 0.005).  Among survey respondents (n = 157), infant latching significantly improved (p < 0.001) from pre- to post-intervention for infants with posterior ankyloglossia.  Both the presence and severity of nipple pain decreased from pre- to post-intervention among all classifications (p < 0.001).  Additionally, 92 % of respondents breast-fed exclusively post-intervention.  The mean breast-feeding duration of 14 months did not differ significantly by classification.  The authors concluded that breast-feeding difficulties associated with ankyloglossia in infants, particularly posterior, can be improved with a simple office-based procedure in most cases.  

Toner et al (2014) determined parental satisfaction and cost-effectiveness of having a frenotomy performed in the office setting versus in the operating room under general anesthesia.  After obtaining IRB approval at The Children's Hospital of Philadelphia (CHOP), these investigators performed a retrospective chart review of patients having a frenotomy in the office between 2003 and 2008.  A total of 55 patients met the criteria and 25 were consented and their parents interviewed.  All participants reported an improvement in feeding within 1 day and up to 2 weeks following the procedure.  Parents also reported being somewhat satisfied to very satisfied with having the frenotomy performed in the office versus under general anesthesia.  There were no complications reported.  Performing the frenotomy in the office provided patients with satisfaction as well as cost savings.  The surgical fee for a frenotomy in the office was $850 and was the same as if the procedure was performed in the operating room.  Performing a frenotomy under general anesthesia included extra cost that consisted of an anesthesia fee of $500 to $900 and hospital charges ranging from $500 to $8,000.  The authors concluded that performing the frenotomy in the office on their 25 patients resulted in a cost savings of more than $240,000 and the avoidance of general anesthesia in the first few weeks of life.  They stated that office frenotomy should be considered in children with ankyloglossia who present with difficulty nursing in the first week of life.

Prophylactic Frenotomy to Promote Speech Development

Webb et al (2013) reviewed the outcomes of tongue-tie division procedures in patients with ankyloglossia with the goal of:

1. deriving clinically oriented insights into the effect of tongue-tie division procedures, and
2. identifying needs in knowledge to stimulate further research.  Medline, Embase, and Cochrane databases were searched without any limitations, for studies published between 1966 and June 2012. 

Studies were included (level 4 evidence or above) if subjects of any age had ankyloglossia and underwent tongue-tie release.  Outcome measures of interest were any subjective or objective measures of breast-feeding and speech outcomes, or reports of adverse events.  In all, 378 abstracts were generated from the literature searches; 20 studies met the criteria for data extraction and analysis.  Of those, 15 studies were observational and 5 were randomized controlled trials (RCTs).  Tongue-tie division provided objective improvements in the following: LATCH scores (3 studies); SF-MPQ index (2 studies); IBFAT (1 study); milk production and feeding characteristics (3 studies); and infant weight gain (1 study).  Subjective improvements were also noted in maternal perception of breast-feeding (14 studies) and maternal pain scores (4 studies).  No definitive improvements in speech function were reported.  The only significant adverse events were recurrent tongue-ties that required repeat procedures.  The authors concluded that ankyloglossia is a well-tolerated procedure that provides objective and subjective benefits in breast-feeding; however, there was a limited number of studies available with quality evidence.  Moreover, they stated that there are no significant data to suggest a causative association between ankyloglossia and speech articulation problems.

Brookes and Bowley (2014) noted that tongue-tie or ankyloglossia is a congenital variation characterized by a short lingual frenulum that may result in restriction of tongue movement and thus impact on function.  Tongue tie division (frenotomy) in affected infants with breast-feeding problems yields objective improvements in milk production and breast-feeding characteristics, including objective scoring measures, weight gain and reductions in maternal pain.  For the majority of mothers, frenotomy appears to enhance maintenance of breast-feeding.  Tongue tie division is a safe procedure with minimal complications.  The commonest complication is minor bleeding.  Recurrence leading to re-division occurs with rates of 0.003 to 13 % reported; this appears to be more common with posterior than anterior ties.  The authors stated that there are limited reports indicating that prophylactic frenotomy may promote subsequent speech development; however, evidence is currently insufficient to condone this practice and further good quality research into this area is needed.

Chinnadurai et al (2015) reviewed literature on feeding, speech, and social outcomes of treatments for infants and children with ankyloglossia.  Medline, PsycINFO, Cumulative Index of Nursing and Allied Health Literature, and Embase were searched.  Two reviewers independently assessed studies against predetermined inclusion/exclusion criteria; 2 investigators independently extracted data on study populations, interventions, and outcomes and assessed study quality.  Two RCTs, 2 cohort studies, and 11 case series assessed the effects of frenotomy on feeding, speech, and social outcomes.  Bottle-feeding and social concerns, such as ability to use the tongue to eat ice cream and clean the mouth, improved more in treatment groups in comparative studies.  Supplementary bottle-feedings decreased over time in case series.  Two cohort studies reported improvement in articulation and intelligibility with treatment.  Other benefits were unclear.  One RCT reported improved articulation after Z-frenuloplasty compared with horizontal-to-vertical frenuloplasty.  Numerous non-comparative studies reported speech benefits post-treatment; however, studies primarily discussed modalities, with outcomes including safety or feasibility, rather than speech.  These researchers included English-language studies, and few studies addressed longer-term speech, social, or feeding outcomes; non-surgical approaches, such as complementary and alternative medicine; and outcomes beyond infancy, when speech or social concerns may arise.  The authors concluded that data are currently insufficient for assessing the effects of frenotomy on non-breast-feeding outcomes that may be associated with ankyloglossia.

The Agency for Healthcare Research and Quality (AHRQ)’s report on “Treatments for ankyloglossia and ankyloglossia with concomitant lip-tie” (Francis et al, 2015) systematically reviewed the literature on surgical and non-surgical treatments for infants and children with ankyloglossia and ankyloglossia with concomitant lip-tie.  The authors searched MEDLINE (PubMed), PsycINFO, Cumulative Index of Nursing and Allied Health Literature (CINAHL) and Embase (Excerpta Medica Database), as well as the reference lists of included studies and recent systematic reviews.  They conducted the searches between September 2013 and August 2014.  These researchers included studies of interventions for ankyloglossia published in English.  Two investigators independently screened studies against predetermined inclusion criteria and independently rated the quality of included studies.  They extracted data into evidence tables and summarized them qualitatively.  These investigators included 58 unique studies comprising 6 RCTs (3 good, 1 fair, 2 poor quality), 3 cohort studies (all poor quality), 33 case-series, 15 case-reports, and 1 unpublished thesis.  Most studies assessed the effects of frenotomy on breast-feeding-related outcomes; 4 RCTs reported improvements in breast-feeding efficacy using either maternally reported or observer ratings, while 2 RCTs using observer ratings found no improvement.  Mothers consistently reported improved breast-feeding effectiveness after frenotomy, but outcome measures were heterogeneous and short-term.  Future studies could provide additional data to confirm or change the measure of effectiveness; thus, the authors considered the strength of evidence (SOE; confidence in the estimate of effect) to be low at this time.  Furthermore, this literature is characterized by:

1. a lack of details about the surgical procedure,
2. co-interventions allowed variably in control groups, and
3. diversity of provider settings. 

Pain outcomes improved for mothers of frenotomized infants compared with control in 1 study of 6-day old infants; but not in studies of infants a few weeks older.  Given these inconsistencies and the small number of comparative studies and participants, the SOE is low for an immediate reduction in nipple pain; 3 studies with significant limitations reported improvements in other feeding outcomes with frenotomy, and 4 poor-quality studies reported some improvements in speech articulation but mixed results related to overall speech sound production; 3 poor-quality comparative studies noted some improvements in social concerns and gains in tongue mobility in treated participants.  Strength of evidence for all of these outcomes was insufficient; SOE was moderate for minor and short-term bleeding following surgery and insufficient for other harms (re-operation, pain). The authors concluded that a small body of evidence suggested that frenotomy may be associated with improvements in breast-feeding as reported by mothers, and potentially in nipple pain, but with small short-term studies, inconsistently conducted, SOE was generally low to insufficient.  Comparative studies reported improvements in some measures of speech, but assessment of outcomes was inconsistent.  They stated that few studies addressed tongue mobility and self-esteem issues; research is lacking on non-surgical interventions, as well as on outcomes other than breast-feeding, particularly speech and dental outcomes.  They noted that future research is needed on a range of issues, including prevalence and incidence of ankyloglossia and problems with the condition; the field is currently challenged by a lack of standardized approaches to assessing and studying the problems of infants with ankyloglossia.

Ghaheri and colleagues (2018) noted that lingual frenotomy improves patient-reported outcome measures, including infant reflux and maternal nipple pain, and prolongs the nursing relationship; however, many mother-infant dyads continue to experience breast-feeding difficulty despite having had a frenotomy.  These investigators examined how incomplete release of the tethered lingual frenulum may result in persistent breast-feeding difficulties.  They carried out a 1-group, observational, prospective cohort study.  The sample consisted of breast-feeding mother-infant (0 to 9 months of age) dyads (n = 54) after the mothers self-elected completion lingual frenotomy and/or maxillary labial frenectomy following prior lingual frenotomy performed elsewhere.  Participants completed surveys pre-operatively, 1-week post-operatively, and 1-month post-operatively consisting of the Breastfeeding Self-Efficacy Scale-Short-Form (BSES-SF), VAS for nipple pain severity, and the Revised Infant Gastroesophageal Reflux Questionnaire (I-GERQ-R).  Significant post-operative improvements were reported between mean pre-operative scores compared with 1-week and 1-month scores of the BSES-SF, F(2) = 41.2, p < 0.001; the I-GERQ-R, F(2) = 22.7, p < 0.001; and VAS pain scale, F(2) = 46.1, p < 0.001.  The authors demonstrated that besides nipple pain, measures of infant reflux symptoms and maternal breast-feeding self-confidence could improve following full release of the lingual frenulum.  Additionally, a patient population was identified that could benefit from increased scrutiny of infant tongue function when initial frenotomy failed to improve breast-feeding symptoms.

Campbell (2018) stated that tongue-tie (ankylglossia) occurs when there is an anterior attachment near the tip of the tongue resulting in restricted tongue movement.  It is reported to be a cause of poor breast-feeding in infants and nipple pain in breast-feeding mothers.  This investigator examined if frenotomy is safe and effective in improving ability to feed orally among infants.  Frenotomy may correct the restriction of tongue movement and allow improved breast-feeding and reduced maternal nipple pain.  Randomized, quasi-randomized, cluster-randomized controlled trials that compared frenotomy verses no frenotomy or frenotomy verses sham procedure were included in the review.  Participants were infants with ankylglossia experiencing feeding problems, or whose breast-feeding mothers were experiencing nipple pain.  A total of 5 studies (n = 302) met the inclusion criteria.  Pooled analysis of 2 studies showed no change following frenotomy (MD -0.1, 95 % CI: -0.6 to 0.5 units on a 10-point feeding scale).  A 3rd study showed objective improvement on a 12-point feeding scale (MD 3.5, 95 % CI: 3.1 to 4.0 units of a 12-point feeding scale).  Pooled analysis of 3 studies (n = 212) showed a reduction in maternal pain scores following frenotomy (MD -0.7, 95 % CI: -1.4 to -0.1 units on a 10-point pain scale).  These studies had serious methodological shortcomings.  The author concluded that investigators did not find a consistent positive effect on infant breast-feeding following frenotomy.  A short-term reduction in breast pain was found among breast-feeding mothers; small trial numbers and methodological issues meant no definitive benefit for frenotomy in infants with tongue-tie could be proved.

Use of Topical Anesthetics Before Lingual Frenotomy

Ovental and associates (2014) stated that the Food and Drug Administration (FDA) has said that oral preparations containing benzocaine should only be used in infants under strict medical supervision, due to the rare, but potentially fatal, risk of methemoglobinemia.  These investigators determined the analgesic effect of topical application of benzocaine prior to lingual frenotomy in infants with symptomatic ankyloglossia.  They hypothesized that the duration of crying immediately following frenotomy with topical benzocaine would be shorter than with no benzocaine.  This RCT compared the length of crying after lingual frenotomy in term infants who did, or did not, receive topical application of benzocaine to the lingual frenulum prior to the procedure.  These researchers recruited 21 infants to this study.  Crying time was less than 1 minute in all of the subjects.  The average length of crying in the benzocaine group was not significantly different from  the length of crying in the control group (21.6 ± 13.6 versus 13.1 ± 4.0 seconds; p = 0.103).  The authors concluded that contrary to their hypothesis, infants who were treated with topical benzocaine did not benefit from topical analgesia in terms of crying time.  They stated that the use of benzocaine for analgesia prior to lingual frenotomy in term infants should therefore be discouraged.

In a randomized study, Shavit and colleagues (2017) examined the comparative effectiveness of 2 topical anesthetics in controlling the pain associated with frenotomy in young infants.  A total of 42 infants who were referred for frenotomy were randomly allocated to receive the topical anesthetic gel 2 % tetracaine or 20 % benzocaine applied prior to frenotomy.  Frenotomies were videotaped.  The primary outcome measure was the Neonatal Facial Coding System (NFCS) score; secondary outcome measures included cry duration and a visual analog scale (VAS) assessed by the parents.  The 2 groups were comparable with regard to weight, age, gender, previous painful experience, and last feeding time.  Median NFCS scores prior to frenotomy in the tetracaine and the benzocaine groups were 4.5 (IQR: 0.75 to 10.2) and 3.5 (IQR: 0 to 9.5), respectively (p = 0.89, 95 % confidence interval [CI]: -3 to 4).  During frenotomy, median NFCS score increased to 28 (IQR: 24.5 to 30.25) in the tetracaine group (p < 0.0001, median difference [MD] -22, 95 % CI: -24.5 to -19), and to 28 (IQR: 26-30) in the benzocaine group (P < 0.0001, median difference -23, 95% CI -27 to -17). Mean cry durations in the tetracaine and the benzocaine groups were 69.4 seconds and 63.9 seconds, respectively (P = 0.32, 95 % CI: -47 to 15), and mean VAS scores were 57.2 and 58.2, respectively (p = 0.89, 95 % CI: -15.2 to 13.4).  The authors concluded that these topical anesthetics appeared ineffective in controlling the pain associated with frenotomy.  They stated that clinicians should continue to search for an effective treatment for this procedure.

Frenuloplasty for Ankyloglossia

A frenuloplasty can also be used for ankyloglossia. It is not certain whether it gives a better result. Suter and Bornstein (2010) systematically reviewed the diagnostic criteria, indications, and need for treatment of ankyloglossia (tongue-tie), as well as the various treatment options for patients in different age groups. The MEDLINE databases and the Cochrane Library were searched according to well-defined criteria, resulting in 64 included articles. The evidence regarding the classifications of tongue-tie, epidemiologic data, inheritance, breastfeeding problems, impaired tongue mobility, speech disorders, malocclusion, gingival recessions, therapy, and complications due to surgery was analyzed in detail. The authors found that different classifications for ankyloglossia have been proposed but not uniformly accepted. Breastfeeding problems in neonates could be associated with a tongue-tie, but not enough controlled trials have been performed to identify an ideal treatment option. In children and adults with ankyloglossia, limitations in tongue mobility are present, but the individual degree of discomfort, as well as the severity of an associated speech problem, are subjective and difficult to categorize. There is no evidence supporting the development of gingival recessions because of ankyloglossia. Frenotomy, frenectomy, and frenuloplasty are the main surgical treatment options to release/remove an ankyloglossia. Becauseof of the limited evidence available, no specific surgical method can be favored. The authors concluded that the lack of an accepted definition and classification of ankyloglossia makes comparisons between studies almost impossible. Because almost no controlled prospective trials for surgical interventions in patients with tongue-ties are present in the literature, no conclusive suggestions regarding the method of choice can be made. It also remains controversial which tongue-ties need to be surgically removed and which can be left to observation.

Labial Frenectomy or Frenotomy for Ankyloglossia

Rarely, a labial frenum can result in ankyloglossia (Bahedura, et al., 2016). Ghaheri, et al. (2017) examined lingual and labial frenectomy and breast feeding. Some of the infants had a lingual frenectomy and some had a labial frenectomy. Only one infant had only a labial frenectomy, so no conclusions can be reached about the contribution of the labial frenectomy to breast feeding. 

A labial frenectomy is related to development of a midline diastema (front tooth gap). The latter may be an aesthetic or malocclusion problem (Huang & Creath, 1995). Komori, et al. (2017) noted that: “Most frenulum abnormalities occur in the lingual or maxillary labial frenulum. In the lingual frenulum, adhesion to the proglossis impairs tongue movement, causing problems, such as suckling, articulation, and speech disorders. In the maxillary labial frenulum, high adhesion to the alveolar portion causes diastema of the dentition and eruption site abnormalities in the central incisors . . . .  The disorders caused by maxillary labial frenulum abnormalities include diastema and abnormal central incisor position, onset of dental caries and periodontal disease due to the retention of food residue, and movement and cosmetic impairment of the upper lip. However, if no functional disorders, such as the above mentioned are clearly noted, it is best to take a conservative approach with regular follow-up observation.” 

Table: CPT Codes / HCPCS Codes / ICD-10 Codes

Code	Code Description
Information in the [brackets] below has been added for clarification purposes.   Codes requiring a 7th character are represented by "+":
CPT codes covered if selection criteria are met:
40806	Incision of labial frenum (frenotomy)
40819	Excision of frenum, labial or buccal (frenumectomy, frenulectomy, frenectomy)
41010	Incision of lingual frenum (frenotomy)
41115	Excision of lingual frenum (frenectomy)
41520	Frenoplasty (surgical revision of frenum, e.g., with Z-plasty)
HCPCS codes covered if selection criteria are met:
D7960	Frenulectomy (frenectomy or frenotomy) - separate procedure
ICD-10 code covered if selection criteria are met:
P92.0 - P92.9	Feeding problems of newborn
Q38.1	Ankyloglossia

The above policy is based on the following references: