Clinical UM Guideline |
Subject: Lingual Frenotomy for Ankyloglossia-Related Feeding Difficulties | |
Guideline #: CG-SURG-122 | Publish Date: 10/01/2024 |
Status: New | Last Review Date: 08/08/2024 |
Description |
This document addresses lingual frenotomy for the treatment of ankyloglossia-related infant feeding difficulties. Ankyloglossia, or tongue-tie, occurs when the inferior lingual frenulum attaches to the bottom of the tongue in a location that restricts the tongue’s normal range of motion. This condition can interfere with speech, proper oral hygiene or newborn feeding. Lingual frenotomy (snipping of the frenulum) may be performed to enable the tongue’s normal range of motion. This document does not address ankyloglossia-related speech difficulties, labial frenulum abnormalities, or frenectomy or frenuloplasty procedures.
Note: Please see the following document for more information:
Clinical Indications |
Medically Necessary:
A lingual frenotomy is considered medically necessary for the treatment of ankyloglossia-related feeding difficulties when all the following criteria (1-4) are met:
Not Medically Necessary:
Lingual frenotomy for the treatment of ankyloglossia-related feeding difficulties is considered not medically necessary when the criteria above have not been met.
Coding |
The following codes for treatments and procedures applicable to this guideline are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.
When services may be Medically Necessary when criteria are met:
CPT |
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41010 | Incision of lingual frenum (frenotomy) |
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ICD-10 Diagnosis |
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P92.5 | Neonatal difficulty in feeding at breast |
Q38.1 | Ankyloglossia |
R63.30-R63.39 | Feeding difficulties |
When services are Not Medically Necessary:
For the procedure and diagnosis codes listed above when criteria are not met.
Discussion/General Information |
The lingual frenulum is a band of tissue that attaches to the underside of the tongue and to the floor of the mouth. The frenulum does not typically impede normal range of motion of the tongue. Ankyloglossia (tongue-tie) is a congenital anomaly in which the lingual frenulum is attached too near the tip of the tongue potentially resulting in restricted tongue movement which may interfere with breast and bottle feeding, speaking or effective oral hygiene. The prevalence of ankyloglossia is estimated to occur in approximately 4-11% of newborns. The rates of frenotomy to treat infant feeding difficulties have increased exponentially over the past two decades despite a paucity of randomized study demonstrating efficacy (O’Shea, 2017; Wei, 2023). Several validated tools for the evaluation of ankyloglossia severity exist in the published literature. Two widely-used and readily available tools are the Bristol Tongue Assessment Tool (BTAT; available here) and the Tongue-tie and Breastfed Babies (TABBY; available here) (Ingram, 2015; Ingram, 2019).
Frenotomy
In 2005, Hogan and colleagues published a randomized controlled trial (RCT) in which 57 infants with ankyloglossia experiencing feeding difficulties (40 breastfed and17 bottle fed) were enrolled and randomized to either 48 hours of intensive lactation consultant support (n=29; control) or immediate revision by frenotomy (n=28). Telephone follow-up with the infants’ lactating parent occurred at 24 hours, weekly for 4 weeks and lastly at 4 months. The average age at enrollment was a mean of 20 days, with breastfed infants averaging 1 week younger (18 days vs 24 days) compared to the control cohort. Of the 28 infants in the frenotomy arm, 27 improved and began to feed normally (1 remained on a nipple shield). Of the 29 infants in the control arm, only 1 improved with intensive lactation consultation (p<0.001). After 48 hours, the lactating parent of the 28 infants who had not improved in the control arm were offered cross-over to the frenotomy arm; all accepted, and 27 of 28 improved (96%) and began to feed normally. No complications were reported. Overall, 24 of the breastfeeding lactating parents enrolled in the study continued to breastfeed for 4 months (24/40, 60%). In this short-term, RCT cross-over study, frenotomy to treat ankyloglossia-related feeding difficulties in infants resulted in immediately improved and sustained feeding in 54/57 (95%) of infants. Given the premature cross-over, further investigation is warranted to determine if frenotomy provides sustained benefit compared to lactation consultation in infants with ankyloglossia experiencing feeding difficulties.
In 2008, Geddes and colleagues published results of a prospective cohort study in which 24 lactating parent/infant pairs experiencing persistent breastfeeding difficulty following lactation consultation were enrolled and underwent lingual frenotomy. The mean age of infants at enrollment was 33 days (± 28 days). Baseline ultrasounds were performed on each infant during breastfeeding to mechanically characterize their suckle and the rate of milk transfer. Milk transfer rate, maternal pain, and LATCH (latch, audible swallowing, type of nipple, comfort, and hold) scores were recorded before and after the frenotomy procedure. For each the 28 infants enrolled, milk intake (p<0.01), milk-transfer rate (p<0.01), LATCH score (p<0.05), and maternal pain scores (p<0.05) improved significantly post frenotomy. Two groups of infants were identified on ultrasound. All infants’ suckle pre-procedure inappropriately compressed the nipple (either at the tip or base) and all resolved or lessened post-procedure except 1 infant. The mean length of breastfeeding post-procedure was 11.3 months (range:5-24 months).
In 2011, Buryk and colleagues published results of a 12-month, single-blinded RCT conducted to determine whether frenotomy for infants with ankyloglossia improved maternal nipple pain and infants’ ability to breastfeed. Neonates diagnosed with ankyloglossia who experienced persistent difficulty breastfeeding were randomized to either a frenotomy (n=30 infants) or a sham procedure (n=28 infants). The mean age at time of enrollment was 6 days with no significant difference in age between study arms. Breastfeeding and maternal nipple pain were assessed preintervention and postintervention using validated self-report questionnaire tools. Follow-up occurred at 2 weeks, 2 months, 6 months and 12 months of age. At the 2-week follow-up, lactating parents of infants in the sham group were given the option to cross-over to the frenotomy group. Following the frenotomy, both arms demonstrated statistically significantly decreased pain scores with the frenotomy group improving significantly more than the sham arm (p<0.001). Breastfeeding scores improved significantly in the frenotomy arm (p=0.029) whereas no change was demonstrated in the sham arm. No complications were reported. All but 1 parent in the sham group elected to have the procedure performed at 2 weeks of age, which precluded long-term comparison between the study arms. Breastfeeding improvement scores continued to improve through 2 months and then plateaued. This RCT demonstrated immediate improvement in breastfeeding scores following a frenotomy.
In 2014, Emond and colleagues published results of a single-blind, RCT conducted to determine if early frenotomy was better than standard breastfeeding support for infants diagnosed with ankyloglossia and feeding difficulties. The primary outcome of interest was breastfeeding improvement (LATCH score) at 5 days. Infants (n=107) diagnosed with mild-moderate ankyloglossia and a LATCH score of less than or equal to 8 were enrolled and randomized to frenotomy (n=53) or the control arm (n=52) and evaluated at day 5 and at 8 weeks post-procedure. At day 5 the frenotomy arm demonstrated improvement in self-reported breastfeeding self-efficacy and there was a 15.5% increase in bottle feeding in the comparison group compared with a 7.5% increase in the frenotomy group. However, the primary objective of improvement in LATCH score at day 5 was not met. At day-5, 44 of 52 in the comparison group requested to cross-over to the frenotomy group; by week-8 just 12% (n=6) were breastfeeding without a frenotomy. At 8 weeks, further comparison between groups was precluded by the high proportion of the control arm who elected to cross-over to the intervention arm. Throughout the study period, no adverse events were reported. In this RCT, early frenotomy did not result in an objective improvement in breastfeeding but was associated with improved self-efficacy.
In 2015, Francis and colleagues published results of a systematic review of surgical and nonsurgical treatments for infants diagnosed with ankyloglossia. A total of 29 studies reporting breastfeeding effectiveness outcomes were chosen for inclusion (5 RCTS, 1 retrospective cohort, and 23 case series). Four RCTs reported improvements in breastfeeding efficacy by using either maternally reported or observer ratings, whereas 2 RCTs found no improvement. While lactating parents consistently self-reported improved effectiveness after frenotomy procedures, outcome measures used were heterogeneous and short-term; no study effectively assessed mid- and long-term outcomes of frenotomy. None of the studies addressed nonsurgical interventions, longer-term breastfeeding, objective growth outcomes, or frenotomy compared with conservative breastfeeding interventions (e.g., lactation consultation). The study authors concluded, “A small body of evidence suggests that frenotomy may be associated with lactating parent-reported improvements in breastfeeding, and potentially in nipple pain, but with small, short-term studies with inconsistent methodology, strength of the evidence is low to insufficient.”
In 2017, Ghaheri and colleagues published results of a prospective cohort study aimed to determine the impact of frenotomy on breastfeeding impairment. Lactating parent and infants (0-12 weeks of age) with persistent breastfeeding difficulties and ankyloglossia and/or tethered maxillary labial frenula were enrolled. Participants completed preoperative, 1-week, and 1-month postoperative surveys consisting of the Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF), visual analog scale (VAS) for nipple pain severity, and the revised Infant Gastroesophageal Reflux Questionnaire (I-GERQ-R). Breastmilk intake was measured preoperatively and 1 week postoperatively in a subset of the study sample (n=60). A total of 237 lactating parent/infant pairs were enrolled after self-electing laser lingual frenotomy and/or maxillary labial frenectomy. Isolated posterior ankyloglossia was identified in 78% of enrolled infants. A total of 178 (75%) infants underwent surgical revision of both the lingual and labial frenulum, 1 received only labial frenotomy and 58 (25%) received lingual frenotomy alone. A total of 8 (3%) infants received a second lingual frenotomy for lack of improvement following the first procedure. Significant postoperative improvements were reported between mean preoperative scores compared to 1-week and 1-month scores of the BSES-SF (p<0.001), the I-GERQ-R (p<0.001 [for lingual frenotomy alone and both procedures]), and VAS pain scale (p<0.001). Average breastmilk intake improved 155% (3.0 to 4.9 mL/min; p=<0.001). No complications were reported. In this cohort study, significant improvement in breastfeeding outcomes were demonstrated 1 week following labial and lingual revision for breastfeeding difficulties and were sustained through 1-month follow-up.
In 2021, Slagter and colleagues published results from a prospective, cohort study which enrolled 175 consecutive individuals who reported problems with infant breastfeeding and reflux related to a tongue-tie or lip-tie. Study participants underwent frenotomy and were followed for up to 6 months to assess the impact on breastfeeding efficacy, nipple pain and reflux symptoms. At month 1, all 175 participants completed the subjective assessment questionnaires and at month 6, 145 study participants remained available for follow-up. Based on the study questionnaires (VAS, BSES-SF and I-GERQ-R), frenotomy resulted in a significant improvement in nipple pain scores and reflex at 1 week (p<0.001). At 1 month, the BSES-SF and I-GERQ-R remained significant (p<0.001 and p=0.001, respectively). At study end (6 months), only the I-GERQ-R remained significantly improved (0.001). Stratifying by type of tie (lip or tongue) did not diminish the significance of reported improvements. At 1 month, 8 participants underwent a second frenotomy for persistent or recurrent symptoms. No post-operative complications were reported. At 6 months, 61% (n=88) of participants available for follow-up (n=145)were still breastfeeding. This study demonstrates a reasonable improvement in clinically meaningful breastfeeding outcomes in both the immediate and medium-term timeframe following frenotomy for ankyloglossia.
In 2021, Visconti and colleagues publishes a systematic review with the objective of determining the effect of frenotomy for ankyloglossia on breastfeeding and speech outcomes in infants and children 12 and younger. Studies reporting outcomes on breastfeeding infants and children with speech delays were chosen for inclusion. A total of 5 studies (3 RCTs and 2 prospective cohorts) met the inclusion criteria for infants who had received a frenotomy for breastfeeding difficulties (n=731). The review concluded that frenotomy for ankyloglossia was effective for reducing nipple pain and improving maternal self-efficacy during breastfeeding, but noted that ankyloglossia diagnosis and assessment tools were inconsistent across the studies. A total of 2 studies were included assessing the effect of frenotomy for ankyloglossia to treat speech delays; study authors concluded that the evidence in this setting is “currently inconclusive due to lack of objective data and research quality. Overall, the review also revealed inconsistent definitions of ankyloglossia severity, standardised outcome measures and research protocols.”
In 2024, Cordray and colleagues published results from a meta-analysis of RCTs and cohort studies that used validated measures of efficacy for breastfeeding outcomes; a total of 21 studies (4 RCTS, 17 cohort studies) met inclusion criteria (n=1993). Breastfeeding self-efficacy, nipple pain and infant reflux improved significantly post-frenotomy (5-10 days; p<0.001 for each outcome) and were sustained to 1 month (p<0.001; p<0.001; p=0.002, respectively). Based on LATCH score results, breastfeeding quality improved significantly immediately post-frenotomy (5-7 days; p=0.01). Study authors conclude,
This systematic review and meta-analysis showed that breastfeeding self-efficacy, maternal pain, infant latch, and infant gastroesophageal reflux significantly improve after frenotomy in mother-infant dyads with breastfeeding difficulties and ankyloglossia. Providers should offer frenotomy to improve breastfeeding outcomes in symptomatic mother-infant dyads who face challenges associated with ankyloglossia.
Expert Evaluation and Conservative Management
In 2018, Dixon and colleagues published results of a cohort study which sought to characterize the impact of programmatic intervention to evaluate the diagnosis and treatment of frenotomy in newborn infants with suspected ankyloglossia. The primary objective was to improve breastfeeding support to avoid unnecessary surgical intervention when possible. Expert breastfeeding review and assessment of lingual function were employed using a validated method, the Bristol Tongue-tie Assessment Tool (BTAT). An educational program was developed to support the introduction of a new clinical pathway which included seminars and online information for healthcare professionals and the general public to enhance breastfeeding support when feeding difficulties were present. Following the programmatic intervention, the rate of frenotomy reduced from 11.3% to 3.5% over a 2-year period. Feeding methods were not different before or after surgery between infants who received a frenotomy and those who did not. The study authors concluded, “establishing consistent multidisciplinary assessment of tongue-tie in infants with feeding difficulties led to a marked reduction in frenotomy intervention rate.” This study demonstrates the importance of expert assessment and lactation support as part of a comprehensive evaluation when determining the appropriateness of surgical intervention for ankyloglossia.
In 2023, Knight and colleagues published results from an unblinded, multicenter, RCT to primarily investigate whether frenotomy was clinically effective in increasing continuation of breastfeeding at 3 months in infants with breastfeeding difficulties diagnosed with ankyloglossia. The study’s primary outcome was breastmilk feeding at 3 and 6 months and key secondary outcomes included lactating parent’s pain, exclusive breastfeeding, frenotomy, adverse events and maternal anxiety and depression. A total of 169 infants (up to 10 weeks of age) were enrolled and randomized to frenotomy with breastfeeding support (n=80) or breastfeeding support alone (n=89). The trial was prematurely halted due to the COVID-19 pandemic impacting breastfeeding support services, slow recruitment and crossover between arms. Adverse events were reported for 3 infants after surgery [bleeding (n=1), salivary duct damage (n=1), accidental cut to the tongue and salivary duct damage (n=1)], resulting in a complication rate of approximately 2% (1/50) in this study population. This study demonstrates there is a level of risk, albeit likely low, with frenotomy as an interventional surgical procedure. The authors concluded:
The statistical power of the analysis was extremely limited due to not achieving the target sample size and the high proportion of infants in the breastfeeding support arm who underwent frenotomy. This trial does not provide sufficient information to assess whether frenotomy in addition to breastfeeding support improves breastfeeding rates in infants diagnosed with tongue-tie.
Authoritative Guidance
In 2017, a Cochrane Systematic Review was published entitled “Frenotomy for tongue-tie in newborn infants.” The primary objective was determination of whether frenotomy is safe and effective in improving the ability to feed among infants 3 months of age or younger diagnosed with ankyloglossia feeding difficulties. Secondary objectives included determining severity of ankyloglossia indicated for frenotomy, ideal age at time of frenotomy and characterizing the severity of feeding difficulties indicated for frenotomy. A total of five RCTs met inclusion criteria (n=302). No adverse effects were reported following frenotomy in any study. Serious methodological shortcomings were noted and included limited sample sizes, a lack of blinding in most, and every study offered frenotomy to controls early in the study. As a result, none of the studies were able to demonstrate the effect of frenotomy on long-term breastfeeding. The study authors concluded,
Frenotomy reduced breastfeeding mothers’ nipple pain in the short term. Investigators did not find a consistent positive effect on infant breastfeeding. Researchers reported no serious complications, but the total number of infants studied was small. The small number of trials along with methodological shortcomings limits the certainty of these findings. Further randomised controlled trials of high methodological quality are necessary to determine the effects of frenotomy.
In 2020, the American Academy of Otolaryngology–Head and Neck Surgery (AAO-HNS) published the following guidance: “Clinical Consensus Statement: Ankyloglossia in Children.” In it, the following statements were listed which reached expert consensus:
In 2022, the American Academy of Pediatric Dentistry (AAPD) published guidance entitled, “Policy on Management of the Frenulum in Pediatric Patients.” In it the following policy statement can be found:
AAPD recognizes that causes other than ankyloglossia are more common for breastfeeding difficulties and that, while frenulotomy for an infant with ankyloglossia can lead to an improvement in breastfeeding, not all infants with ankyloglossia require surgical intervention. Due to the broad differential diagnosis, a team-based approach including consultation with other specialists can aid in treatment planning. Further randomized controlled trials and other prospective studies of high methodological quality are necessary to determine the indications and long-term effects of frenulotomy/frenulectomy.
In 2024, the American Academy of Pediatrics (AAP) published a clinical guidance report entitled, ‘Identification and Management of Ankyloglossia and its Effect on Breastfeeding in Infants” (Thomas, 2024). In the report, the importance of pediatricians partnering with lactation specialists is emphasized in addition to a careful review of the breastfeeding parent and infant perinatal history, including,
Perform a complete infant physical examination with special attention to:
Definitions |
Ankyloglossia: A condition that impairs tongue movement due to a restrictive lingual frenulum.
Bristol Tongue Assessment Tool (BTAT; available here): An evaluation tool used to determine the severity of ankyloglossia, the tool is scored from a minimum of 0 to a maximum of 8.
Lingual frenulum: A band of tissue which connects the tongue's tip to the bottom of the mouth.
Tongue-tie and Breastfed Babies (TABBY; available here): An evaluation tool modified from the BTAT and used to determine the severity of ankyloglossia, the tool is scored from a minimum of 0 to a maximum of 8.
References |
Peer Reviewed Publications:
Government Agency, Medical Society, and Other Authoritative Publications:
Websites for Additional Information |
History |
Status | Date | Action |
New | 08/08/2024 | Medical Policy & Technology Assessment Committee (MPTAC) review. Initial document development. |
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