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Aetna Aetna
Clinical Policy Bulletin:
Myringotomy and Tympanostomy Tube
Number: 0418


Policy

Aetna considers myringotomy and tympanostomy tube (also known as ventilation tube and grommet) insertion medically necessary for any of the following indications: 

  1. Autophony due to patulous eustachian tube; or 
  2. Barotitis media control; or
  3. Cholesteatoma; or
  4. Chronic retraction of tympanic membrane or pars flaccida; or
  5. Complications of otitis media such as meningitis, facial nerve paralysis, coalescent mastoiditis, or brain abscess; or
  6. Otitis media with effusion after 3 months or longer and bilateral hearing impairment (defined as 20 dB hearing threshold level or worse in both ears) (tympanostomy tube); or 
  7. Recurrent episodes of acute otitis media (more than 3 episodes in 6 months or more than 4 episodes in 12 months) (tympanostomy tube); or
  8. Severe otalgia in acute otitis media (myringotomy); or 
  9. To obtain a culture (diagnostic tympanocentesis/myringotomy) of the middle ear fluid prior to beginning or changing antimicrobial therapy (this may be necessary in situations such as otitis media that has failed to respond to appropriate antimicrobial therapy, or for otitis media in individuals or neonates who are immunocompromised). 

Note: OtoScan laser-assisted myringotomy (also called tympano-laserostomy, laser-assisted tympanostomy [LAT] or OtoLAM) is considered to be as effective as traditional myringotomy and is safe.  The same selection criteria apply to both laser myringotomy and the traditional myringotomy.

Tympanostomy tube insertion is considered not medically necessary for children with a single episode of otitis media with effusion (OME) of less than 3 months’ duration

Tympanostomy tube insertion is considered not medically necessary for children with recurrent acute otitis media (AOM) who do not have middle ear effusion in either ear at the time of assessment for tube candidacy.

Aetna considers myringotomy and tympanostomy tube insertion experimental and investigational for all other indications because its effectiveness for indications other than the ones listed above has not been established.

Aetna considers the use of (i) phosphorylcholine-coated tympanostomy tube and (ii) vancomycin-coated tympanostomy tube experimental and investigational because their effectiveness has not been established.

Aetna considers the EarPopper device for the treatment of otitis media with effusion and all other conditions (e.g., eustachian tube dysfunction and negative pressure as a consequence of elevation changes from airline travel, diving, and sinusitis surgery, etc.) experimental and investigational because of insufficient evidence of its effectiveness.



Background

A myringotomy is an incision of the tympanic membrane to allow ventilation of the middle ear, drainage of middle ear fluid, or to obtain cultures from an infected middle ear.  In children with middle-ear effusions, initial treatment often consists of observation or antibiotic therapy even though recent evidence indicated that the benefit of antibiotics for otitis media with effusion (Lous et al, 2005) and acute otitis media (Schilder et al, 2004) is limited.  Most cases of otitis media with effusion resolve spontaneously within 3 months of onset.

An alternative to myringotomy with tube placement is a new tympanostomy procedure by CO2 laser without ventilation tubes, (also called tympanolaserostomy or laser-assisted tympanostomy [LAT]).  OtoLAM™ (ESC Medical Systems, Needham, MA) is performed with a computer-driven laser and a video monitor to pinpoint the exact location for the hole.  It programs the precise size of the hole into the computer.  The laser then takes just 1/10 of a second to create the opening, without damaging surrounding skin or structures in the ear.  The hole stays open for several weeks and this provides ventilation of the middle ear without the need for tube placement.  Studies showed that the CO2 laser was especially effective in vaporizing the tympanic membrane, especially when there was fluid behind the tympanic membrane to protect the promontory.  Laser myringotomies maintain patency slightly longer than that produced by cold-knife myringotomy (3 to 6 weeks versus 48 to 72 hours) but have not been proven to be more efficacious in the management of effusion than simple myringotomy.  A randomized controlled study (n = 208) found that laser myringotomy is safe but less effective than ventilation tube in the treatment of chronic otitis media with effusion (Koopman et al, 2004).

In an update of the 1994 clinical practice guideline Otitis Media With Effusion in Young Children, developed by the AHCPR, the American Academy of Family Physicians, American Academy of Otolaryngology-Head and Neck Surgery, and the American Academy of Pediatrics Subcommittee on otitis media with effusion (2004) recommended that clinicians should manage children with otitis media with effusion (OME, aged 2 months through 12 years) who are not at risk with watchful waiting for 3 months from the date of effusion onset (if known), or from the date of diagnosis (if onset is unknown).  Children with persistent OME who are not at risk should be re-examined at 3- to 6-month intervals until the effusion is no longer present, significant hearing loss is identified, or structural abnormalities of the eardrum or middle ear are suspected.  When a child becomes a surgical candidate, tympanostomy tube insertion is the preferred initial procedure.  Candidates for surgery include children with OME lasting 4 months or longer with persistent hearing loss or other signs and symptoms, recurrent or persistent OME in children at risk regardless of hearing status, and OME and structural damage to the tympanic membrane or middle ear.  The tube usually remains in place for several months, although it may be rejected sooner or remain in place for years.  Adenoidectomy should not be performed unless a distinct indication exists (nasal obstruction, chronic adenoiditis); repeat surgery should consist of adenoidectomy plus myringotomy, with or without tube insertion.  Furthermore, tonsillectomy alone or myringotomy alone should not be used to treat OME (Rosenfeld et al, 2004).

A Cochrane review (Lous et al, 2005) stated that the most common medical treatment options for OME include the use of decongestants, mucolytics, steroids, anti-histamines and antibiotics.  The effectiveness of these therapies, however, has not been established.  Surgical treatment options include grommet (ventilation or tympanostomy tube) insertion, adenoidectomy or both.  Moreover, the benefits of grommets in children appear small.  The effect of grommets on hearing diminished during the first year.  Potentially adverse effects on the tympanic membrane are common after grommet insertion.  Thus, an initial period of watchful waiting seems to be an appropriate management strategy for most children with OME.  Randomised controlled studies are needed before more detailed conclusions about the effectiveness of grommets can be drawn.

In a multi-center, randomized controlled study (n = 395), Paradise et al (2005) concluded that in otherwise healthy children younger than 3 years of age who have persistent middle-ear effusion within the duration of effusion (9 months) that these patients were studied, prompt insertion of tympanostomy tubes does not improve developmental outcomes at 6 years of age.

In a "follow-up" study, Paradise et al (2007) examined tympanostomy tubes and developmental outcomes at 9 to 11 years of age.  These researchers enrolled 6,350 infants soon after birth and evaluated them regularly for middle-ear effusion.  Before 3 years of age, 429 children with persistent effusion were randomly assigned to undergo the insertion of tympanostomy tubes either promptly or up to 9 months later if effusion persisted.  They assessed literacy, attention, social skills, and academic achievement in 391 of these children at 9 to 11 years of age.  Mean (+/- SD) scores on 48 developmental measures in the group of children who were assigned to undergo early insertion of tympanostomy tubes did not differ significantly from the scores in the group that was assigned to undergo delayed insertion.  These measures included the Passage Comprehension subtest of the Woodcock Reading Mastery Tests (mean score, 98 +/- 12 in the early-treatment group and 99 +/- 12 in the delayed-treatment group); the Spelling, Writing Samples, and Calculation subtests of the Woodcock-Johnson III Tests of Achievement (96 +/- 13 and 97 +/- 16; 104 +/- 14 and 105 +/- 15; and 99 +/- 13 and 99 +/- 13, respectively); and inattention ratings on visual and auditory continuous performance tests.  The authors concluded that in otherwise healthy young children who have persistent middle-ear effusion, as defined in this study, prompt insertion of tympanostomy tubes does not improve developmental outcomes up to 9 to 11 years of age.

In an editorial that accompanied the study by Paradise and associates, Berman (2007) stated that the consistency of the findings of Paradise et al during prolonged follow-up periods provided convincing evidence that persistent middle-ear effusion in otherwise normal children does not cause developmental impairments.

Allen (2007) conducted a retrospective chart review to determine if intravenous access is necessary during the performance of myringotomy with tube insertion.  The study included 50 pediatric patients divided equally into 2 groups: group 1, who did not have intravenous access established before the procedure, and group 2, who did have intravenous access established.  To be enrolled, patients in both groups had to be less 12 years of age or younger, have an American Society of Anesthesiologists physical status classification of P1 or P2, and had to have undergone no adjunctive procedure with the myringotomy.  Induction time was significantly shorter in group 1 (average: 6.96 +/- 2.72 mins) than in group 2 (average: 9.80 +/- 3.82 mins; p = 0.004).  Operating time and total operating room time were not significantly different between the 2 groups.  Additionally, 24 of 25 patients in group 1 had their pain managed with acetaminophen or no medication at all, while 9 of 25 group 2 patients received acetaminophen and 13 received intravenous pain medication.  Interestingly, no patients in group 1 required anti-emetics, whereas 4 patients in group 2, who were given intravenous or intramuscular narcotics, received anti-emetic medications.  These findings indicate that myringotomy with tube insertion can be safely accomplished without establishing intravenous access.  Induction times and time under general anesthesia were significantly increased when intravenous access was obtained.  The findings also suggest that acetaminophen provides adequate post-operative pain control in this patient population and that the use of intravenous or intramuscular narcotics increases the risk of post-operative nausea.

Spielmann et al (2008) stated that there is a paucity of evidence to guide the post-operative follow-up of patients undergoing middle-ear ventilation tube insertion for the first time.  This study was undertaken to identify current practice at the authors' institution and to inform subsequent change in their follow-up procedure.  Two cycles of data collection and analysis were performed.  All pediatric patients undergoing ventilation tube insertion for the first time were identified.  Patients who had previously undergone ventilation tube insertion or additional procedures such as adenoidectomy or tonsillectomy were excluded.  The first data collection period comprised all of the year 2000, and the second 18 months over 2003 to 2004.  A minimum of 20 months' follow-up was allowed for.  Data regarding clinical findings and audiometry were recorded at each follow-up appointment.  A total of 50 patients meeting the criteria for inclusion in the first cohort were identified.  There were a total of 156 appointments between surgery and data collection (a mean of 3.12 per child).  A total of 113 (72 %) appointments lead to no medical intervention.  The only statistically significant difference between patients requiring further ventilation tube insertion (n = 10) and those not requiring further treatment during the study period (n = 40) was the average hearing threshold (p < 0.01).  These findings prompted a change in the post-operative regime; all patients undergoing ventilation tube insertion were subsequently seen at 3 months for a pure tone audiogram, and further review depended on clinical and audiometric findings.  Records for 84 children were identified and collected for the second cohort, there were a total of 154 appointments (a mean of 1.83 per child).  In only 18 appointments (12 %) were normal findings and hearing recorded and children given a further review appointment.  Sixteen of 29 (55 %) children with abnormal clinical findings (otorrhea, tube blockage or extrusion) required some form of intervention (p < 0.05).  Twenty-six had a mean hearing threshold worse than 20 dB at first review.  Nineteen (73 %) required further intervention of some sort (p < 0.01).  The authors concluded that these findings demonstrated that the vast majority of review appointments resulted in no clinical intervention.  Thus, these investigators question the need for regular follow-up in this patient group.  Twenty per cent (10 of 50 and 18 of 84) of the patients required further ventilation tube insertion within the study periods.  This is consistent with rates reported in the literature.  Children with abnormal clinical findings or a mean hearing threshold greater than 20 dB were significantly more likely to require further intervention.  The authors recommended one post-operative review with audiometry, 3 months after surgery.  At this initial appointment, further review should be offered to those children with poor hearing, early extrusion, blockage or infection, as they are more likely to require further ventilation tube insertion.

In a Cochrane review on grommets (ventilation tubes) for recurrent acute otitis media in children, McDonald et al (2008) concluded that ventilation tubes have a significant role in maintaining a "disease-free" state in the first 6 months after insertion.  They stated that more research is needed to investigate the effect beyond 6 months.  Furthermore, clinicians should consider the possible adverse effects of grommet insertion before surgery is undertaken.

Hornigold et al (2008) noted that between July 1984 and March 1987, all children that underwent repair for primary cleft palate at the Queen Victoria Hospital were enrolled in a clinical trial.  Those found to have OME at time of surgery had a t-tube inserted into 1 randomized ear, while the other ear received no treatment.  The object of the study was to re-assess patients from the original trial to discover the impact of the unilateral t-tube 20 years later.  A total of 22 patients were identified as potential study participants.  Of this group, 14 were contactable and 7 agreed to participate in the follow-up study.  Main outcome measures were persistent symptomatology, otoscopy, pure tone audiometry and tympanometry.  Follow-up results were compared within the original treatment groups from the primary study, on an intention-to-treat basis.  Otoscopically the ears were normal in 2 of the 7 treated ears compared with 4 of the 7 non-treated ears.  All the other ear ears had various types of chronic otitis media.  Four of the 7 had hearing of greater than 10 dB in the treated ear compared with the non-treated ear.  The authors concluded that these findings would indicate need for caution in the use of t-tubes in the cleft population and raises the question of long-term follow-up to assess for secondary cholesteatoma.

In a systematic review, Ponduri et al (2009) examined if early routine grommet insertion in children with cleft palate has a beneficial effect on hearing and speech and language development compared with conservative management.  The main outcome measure was the effect of early routine grommet placement on the degree of conductive hearing loss.  Secondary outcome measures included differences in hearing level, possible side effects, speech and language development, and quality of life.  These researchers identified 368 citations for review.  From a review of the titles, 34 potentially relevant papers were selected.  Of these, 18 studies met the inclusion criteria, including 8 case series, 6 historical cohort studies, 3 prospective cohort studies, and 1 randomized trial.  Most studies were either small or of poor quality or both.  The results of the studies were contradictory, with some studies suggesting early placement of grommets was beneficial and others reporting there was no benefit.  The authors concluded that there is currently insufficient evidence on which to base the clinical practice of early routine grommet placement in children with cleft palate.

Campbell and colleagues (2009) stated that primary ciliary dyskinesia is an autosomal recessively inherited group of disorders of ciliary ultra-structure.  Otolaryngologists are frequently involved in the management of some of the most common symptoms of primary ciliary dyskinesia including chronic rhinitis, sinusitis, and otitis media with effusion.  A dilemma for otorhinolaryngologists is whether ventilation tubes are of benefit in children with primary ciliary dyskinesia and otitis media with effusion and what effective alternatives exist.  The authors addressed this issue via a literature review and case presentation.  An extensive review of the literature was undertaken and a discussion of the advantages and disadvantages of ventilation tubes in the management of otitis media with effusion in these children was presented and compared with that of the general population.  These investigators presented a case of a 9-month old boy with Kartagener's syndrome and chronic bilateral otitis media with effusion to illustrate their findings.  Eight papers were identified, all with small study numbers.  The main outcome measures were hearing, otorrhea and tympanic membrane structural changes.  The natural history of otitis media with effusion and hearing loss in primary ciliary dyskinesia appears to be fluctuant into adulthood.  Thus, otitis media with effusion in primary ciliary dyskinesia does not resolve by the age of 9 years, regardless of treatment, as previously assumed.  Ventilation tube insertion improves hearing in primary ciliary dyskinesia, but may lead to a higher rate of otorrhea when compared to the general population.  Tympanic membrane changes were clinically insignificant.  The patient eventually underwent successful insertion of bilateral ventilation tubes with a marked improvement in hearing and language with minimal otorrhoea.  The authors concluded that the highest level of evidence found for the management of otitis media with effusion in children with primary ciliary dyskinesia was level IV.  Currently, the evidence is inconclusive and conflicting.  While these findings are promising, clearly higher quality research on a larger number of patients is required to definitively evaluate the management options for otitis media with effusion in these children.

Methicillin-resistant staphylococcus aureus (MRSA) infections and colonization in children have increased in recent years.  Moreover, bacterial biofilm formation has been implicated in the high incidence of persistent otorrhea following tympanostomy tube insertion.  It has been suggested that the tube material may be an important factor in the persistence of such otorrhea.  Development of MRSA otorrhea after tympanostomy tube placement is a growing concern.  Jang and associates (2010) evaluated the effect of using vancomycin and chitosan coated tympanostomy tubes on the incidence of MRSA biofilm formation in-vitro.  Three sets each of vancomycin-coated silicone tubes (n = 5), commercial silver oxide-coated silicone tubes (n = 5) and uncoated tympanostomy tubes (as controls; n = 5) were compared as regards resistance to MRSA biofilm formation after in vitro incubation.  Scanning electron microscopy showed that the surfaces of the silver oxide-coated tubes supported the formation of thick biofilms with crusts, comparable to the appearance of the uncoated tubes.  In contrast, the surface of the vancomycin-coated tympanostomy tubes was virtually devoid of MRSA biofilm.  The authors concluded that vancomycin-coated tympanostomy tubes resist MRSA biofilm formation.  They noted that pending further study, such tubes show promise in assisting the control of MRSA biofilm formation.

In a prospective, randomized, double-blind controlled trial, Hong et al (2011) compared the post-operative complication rates of phosphorylcholine-coated fluoroplastic tympanostomy tubes versus uncoated fluoroplastic tympanostomy tubes.  A total of 240 children with recurrent acute otitis media and chronic otitis media with effusion were randomized to receive a phosphorylcholine-coated tube in one ear and an uncoated tube in the other.  Post-operatively, patients were assessed at 2 weeks and 4, 8, 12, 18, and 24 months to ascertain the incidence of otorrhea, tube lumen blockage, and early extrusion.  Out of 240 children, 5 withdrew and 16 were lost to early follow-up.  The mean age was 43.8 months.  There were no statistically significant differences in the incidence of post-operative otorrhea, tube blockage, and extrusion.  The authors concluded that phosphorylcholine-coated fluoroplastic ventilation tubes do not offer any advantages over uncoated standard fluoroplastic tympanostomy tubes.

The EarPopper is a non-invasive device for treating conditions such as otitis media with effusion, middle ear effusion, aerotitis/barotitis and eustachian tube dysfunction, without the need for surgery or antibiotics.  It delivers a constant, regulated stream of air into the nasal cavity through the nostril with a 1-oz infant nasal syringe equipped with a plastic tip.  During the moment of swallowing, the air is diverted up the eustachian tube clearing and ventilating the middle ear.  The EarPopper relieves the negative ear pressure allowing any accumulated fluids to drain.  The Australia and New Zealand Horizon Scanning Network's assessment on "EarPopper™ for the treatment of otitis media in children" (2007) deemed this technology as "yet to emerge"; and it does not receive approval from the Australian Therapeutic Goods Administration.  The assessment noted that the evidence suggested that the EarPopper™ may provide a safe and effective treatment option in the short-term with minimal clinical impact on health practitioners as it can be used at home; and recommended that this technology be monitored.

An Agency for Healthcare Research and Quality’s report on “Otitis media with effusion: Comparative effectiveness of treatments” (AHRQ, 2012) stated that “Though not in widespread use, the technique of autoinflation [which is what EarPopper tries to accomplish] has been used as a treatment for OME.  The goal of autoinflation is to use either a Valsalva maneuver or external device to equalize middle ear and oropharyngeal pressure, essentially transiently opening the Eustachian tube.  A 2006 Cochrane Collaboration study included six RCTs examining the use of autoinflation versus no treatment for hearing loss associated with OME.  Studies included children, adults, and special populations and concluded that the evidence for the use of autoinflation in the short-term was favorable; however, given the small number of studies and lack of long-term follow-up, the long-term effects could not be determined”.

The American Academy of Otolaryngology-Head & Neck Surgery's clinical practice guideline on "Tympanostomy tubes in children" (Rosenfeld et al, 2013) provided the following recommendations:

  • Clinicians should not perform tympanostomy tube insertion in children with a single episode of OME of less than 3 months’ duration
  • Clinicians should obtain an age-appropriate hearing test if OME persists for 3 months or longer (chronic OME) or prior to surgery when a child becomes a candidate for tympanostomy tube insertion
  • Clinicians should offer bilateral tympanostomy tube insertion to children with bilateral OME for 3 months or longer (chronic OME) and documented hearing difficulties
  • Clinicians should re-evaluate, at 3- to 6-month intervals, children with chronic OME who did not receive tympanostomy tubes until the effusion is no longer present, significant hearing loss is detected, or structural abnormalities of the tympanic membrane or middle ear are suspected
  • Clinicians should not perform tympanostomy tube insertion in children with recurrent acute otitis media (AOM) who do not have middle ear effusion in either ear at the time of assessment for tube candidacy
  • Clinicians should offer bilateral tympanostomy tube insertion to children with recurrent AOM who have unilateral or bilateral middle ear effusion at the time of assessment for tube candidacy
  • Clinicians should determine if a child with recurrent AOM or with OME of any duration is at increased risk for speech, language, or learning problems from otitis media because of baseline sensory, physical, cognitive, or behavioral factors
  • In the perioperative period, clinicians should educate care-givers of children with tympanostomy tubes regarding the expected duration of tube function, recommended follow-up schedule, and detection of complications
  • Clinicians should not encourage routine, prophylactic water precautions (use of earplugs, headbands; avoidance of swimming or water sports) for children with tympanostomy tubes.

Youssef and Ahmed (2013) compared long-term follow-up results of laser versus classical myringotomy with ventilation tube insertion over 5 years.  A total of 86 patients with bilateral OME were divided into 2 groups: (i) laser myringotomy group and (ii) myringotomy with ventilation tube insertion group, with follow-up in hearing results and recurrence rates over 5 years.  The mean patency time of myringotomy in laser group was 23 days, while the mean patency time of the ventilation tubes ears was 4.0 months in myringotomy group.  Twelve patients in laser group (13.9 %) showed a recurrent OME compared to 9 patients in myringotomy group (10.4 %).  The authors concluded that laser fenestration is a less effective alternative to myringotomy and tube placement.  The recurrence rates after both procedures did not show statistical significance over long follow-up.  It might be considered as an effective alternative to classical surgery and ideal for short-term ventilation.

 
CPT Codes / HCPCS Codes / ICD-9 Codes
CPT codes covered if selection criteria are met:
69420
69421
69424
69433
69436
CPT codes not covered for indications listed in the CPB:
69401
Other CPT codes related to the CPB:
31000 - 31230
31231 - 31297
42820 - 42821
42830 - 42836
ICD-9 codes covered if selection criteria are met:
381.00 - 381.4 Nonsuppurative otitis media
381.7 Patulous Eustachian tube
382.00 - 382.9 Suppurative and unspecified otitis media
384.22 Attic perforation of tympanic membrane [Pars flaccida]
385.30 - 385.33 Cholesteatoma of middle ear and mastoid
993.0 Barotrauma, otitic
Other ICD-9 codes related to the CPB:
320.0 -322.9 Meningitis
324.0 Intracranial abscess
351.0 Bell's palsy
381.81 Dysfunction of Eustachian tube [not covered for EarPopper]
383.00 - 383.9 Mastoiditis and related conditions
388.40 Abnormal auditory perception, unspecified
388.70 - 388.72 Otalgia
389.00 - 389.9 Hearing loss


The above policy is based on the following references:
  1. American Academy of Otolaryngology - Head and Neck Surgery (AAO-HNS). Clinical Indicators Myringotomy. Alexandria, VA: AAO-HNS; 2001. Available at: http://www.entnet.org/indicators/myringotomy.html. Accessed June 11, 2001.
  2. Stool SE, Berg AO, Berman S, et al. Otitis media with effusion in young children. Clinical Practice Guideline, Number 12. AHCPR Publication No. 94-0622. Rockville, MD: Agency for Health Care Policy and Research (AHCPR); July 1994.
  3. Freemantle N, Sheldon TA, Song F, Long A.  The treatment of persistent glue ear in children. Effective Health Care. York, UK: Centre for Reviews and Dissemination (CRD); 1992;1(4).
  4. Forzley GJ. Myringotomy. In: Procedures for Primary Care Physicians. JL Pfenninger, ed. Mosby-Year Book, Inc; 1994:188-191.
  5. Conseil d'Evaluation des Technologies de la Sante du Quebec (CETS). Variations in rates of tonsillectomy, adenoidectomy and myringotomy in Quebec. Report CETS 96-1 RE. Montreal, QC:CETS; 1996.
  6. New Zealand Health Technology Assessment (NZHTA). Screening programmes for the detection of otitis media with effusion and conductive hearing loss in pre-school and new entrant school children: A critical appraisal of the literature. NZHTA Report 3. Christchurch, New Zealand: NZHTA; 1998.
  7. Alberta Heritage Foundation for Medical Research (AHFMR). OtoScan laser assisted myringotomy (OtoLAM). Techscan. Edmonton, AB: AHFMR; November 1999.
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