Clinical UM Guideline



Subject: Myringotomy and Tympanostomy Tube Insertion
Guideline #:  CG-SURG-46 Current Effective Date:    06/28/2017
Status: Reviewed Last Review Date:    05/04/2017

Description

This document addresses myringotomy and tympanostomy tube insertion, which are surgical procedures used to decompress and ventilate the middle ear when fluid builds up due to infection, trauma, or other conditions. Tympanostomy tubes are also known by other terms, including grommet, T-tube, ear tube, pressure equalization (PE) tube, vent, or myringotomy tube.

Clinical Indications

Medically Necessary:

The use of combined myringotomy and tympanostomy tube insertion is considered medically necessary for individuals who meet any of the following criteria:

  1. Children or adults with recurrent acute otitis media (AOM) (more than 3 episodes in 6 months or more than 4 episodes in 12 months) with or without otitis media with effusion (OME) who have middle ear effusion at the time of assessment for tube candidacy; or
  2. Children with unilateral or bilateral OME for greater than or equal to 3 months with hearing loss greater than 20 dB in one or both ears; or
  3. Children with recurrent AOM or OME of any duration when the child is at risk for speech, language, or learning delay or disorder from OM based on baseline sensory, physical, cognitive, or behavioral factors including, but not limited to, the following:
    1. Confirmed speech or language delay or disorder.
    2. Autism spectrum disorder or other pervasive developmental disorder.
    3. Syndromes (for instance, Down) or craniofacial disorders that include cognitive, speech, or language delays.
    4. Blindness or uncorrectable visual impairment.
    5. Cleft palate, with or without associated syndrome; or
  4. Children or adults with structural damage to the tympanic membrane (TM) or middle ear, such as cholesteatoma, chronic retraction of tympanic membrane or pars flaccida; or
  5. Children or adults with barotitis (barotrauma); or
  6. Children or adults with autophony due to patulous eustachian tube; or
  7. Children or adults with middle ear dysfunction due to head and neck radiation or skull base surgery; or
  8. Children or adults with a severe complication of acute otitis media including, but not limited to: meningitis, intracranial abscess, mastoiditis, or facial nerve paralysis; or
  9. Adults with OME greater than 3 months and continued symptoms of aural pressure or hearing loss; or
  10. Children or adults with persistent AOM despite at least 2 different courses of recommended empiric antibiotic therapy.

The use of myringotomy as a stand-alone procedure is considered medically necessary for individuals who meet one or more of the following criteria:

  1. Neonates with otitis media who are either:
    1. 16 or fewer weeks of age for full term infants; or
    2. Premature infant whose adjusted age (actual age – # weeks premature) is less than 16 weeks; or
  2. Individual with acute otitis media and an immunocompromising condition such as cancer chemotherapy or use of anti-rejection medications following a transplant; or
  3. Individual who meets criteria for tympanostomy and tube insertion but for whom tube insertion is not feasible due to the degree of ear inflammation.

Not Medically Necessary:

The use of myringotomy alone is considered not medically necessary when the criteria above have not been met and for all other indications.

The use of combined myringotomy and tympanostomy tube insertion is considered not medically necessary when the criteria above have not been met and for all other indications.

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.

CPT  
69420 Myringotomy including aspiration and/or eustachian tube inflation
69421 Myringotomy including aspiration and/or eustachian tube inflation requiring general anesthesia
69433 Tympanostomy (requiring insertion of ventilating tube), local or topical anesthesia
69436 Tympanostomy (requiring insertion of ventilating tube), general anesthesia
   
ICD-10 Procedure  
099500Z Drainage of right middle ear with drainage device, open approach
09950ZZ Drainage of right middle ear, open approach
099600Z Drainage of left middle ear with drainage device, open approach
09960ZZ Drainage of left middle ear, open approach
099700Z-099780Z Drainage of right tympanic membrane with drainage device
09970ZZ-09978ZZ Drainage of left tympanic membrane
099800Z-099880Z Drainage of right tympanic membrane, with drainage device
09980ZZ-09988ZZ Drainage of left tympanic membrane
   
ICD-10 Diagnosis  
  All diagnoses  
Discussion/General Information

According to the American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS), myringotomy is defined as a surgical procedure in which a small incision is made in the tympanic membrane (ear drum) for the purpose of draining fluid or providing short-term ventilation. The procedure is also used to relieve pressure caused by excessive buildup of fluid or to drain pus from the middle ear. It is most commonly done as a treatment for OME, but may also be considered as a treatment for ear trauma (including pressure-related barotrauma) and eustachian tube dysfunction in adults.

Tympanostomy is a companion procedure to myringotomy, and involves the insertion of a small tube into the eardrum through a myringotomy incision in order to keep the middle ear aerated for a prolonged period of time, and to prevent the accumulation of fluid in the middle ear. The procedure to place a tube involves myringotomy and is performed under local or general anesthesia. There are many different tube designs available on the market.  The most commonly used type is shaped like a grommet. When it is necessary to keep the middle ear ventilated for a very long period, a "T"-shaped tube may be used, as these "T-tubes" can stay in place for 2-4 years.

The use of myringotomy and tympanostomy tube insertion has become a widely used and accepted method of treating various middle ear conditions in children and adults.

The American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS) published a clinical practice guideline addressing the use of tympanostomy tubes in children (Rosenfeld, 2013). In this document they make the following recommendations:

The recommendations above (3 and 7) are based on high level evidence with a "preponderance of benefit over harm" (Gebhart, 1981; Gonzales, 1986; Mandel, 1989, 1992; Paradise, 2001, 2005; Rovers, 2001a, 2001b, 2005).

In another statement, the AAO-HNS reports the following which is based upon multiple observational studies (Broen, 1996; Iino, 1999; Sheahan, 2002):

From this statement, they offer the following option, despite acknowledging a moderate to low level of evidence supporting this statement (Hellstrom, 2011; Ponduri, 2009; Rosenfeld, 2011). The guideline panel agreed that tympanostomy tubes were a reasonable intervention for reducing middle ear effusion that would have resolved in normal risk children:

Statements 3, 6, 7, and 9 above are reiterated in the AAO-HNS clinical practice guideline addressing the treatment of otitis media with effusion published in 2016 (Rosenfeld, 2016).

The American Academy of Pediatrics (AAP) published their clinical practice guideline titled The Diagnosis and Management of Acute Otitis Media in 2013 (Lieberthal, 2013). This document includes the following Key Action Statement based on multiple studies (Casselbrant, 1992; Gebhart, 1981; Gonzales, 1986; Rosenfeld, 2000; Witsell, 2005):

In May 2013, the Agency for Healthcare Research and Quality (AHRQ) released a new comparative effectiveness review titled Otitis Media with Effusion: Comparative Effectiveness of Treatments (AHRQ, 2013). The conclusions of this review stated:

The use of myringotomy and tympanostomy tube insertion has become accepted as a treatment method for individuals with severe complication of acute otitis media such as meningitis, intracranial abscess, mastoiditis, or facial nerve paralysis. While there is little evidence addressing such treatment, there is wide agreement in the otolaryngology community supporting it. In such cases is it deemed prudent to use myringotomy and tympanostomy to prevent further progression of complications.

The American Academy of Pediatrics published their clinical guideline Otitis Media with Effusion in 2004. In this document they recommend that, "When a child becomes a surgical candidate, tympanostomy tube insertion is the preferred initial procedure."

The use of myringotomy alone is poorly studied in the medical literature. In most circumstances, there is no available evidence to demonstrate that the use of myringotomy without tube insertion has any incremental benefit over myringotomy with tube insertion for the treatment of OME or AOM; to the contrary, there is limited published literature indicating that it is inferior for these indications (Mandel, 1992). The use of tubes in conjunction with myringotomy in circumstances where myringotomy alone has been proposed adds longer-term benefits such as prolonged ventilation and drainage, and pressure release. Further, middle ear fluid cultures are generally considered unnecessary when planning or adjusting antibiotic choices, and could be accomplished via less invasive procedures, if required. However, there are some isolated circumstances where myringotomy alone may be warranted. Such circumstances may include when an individual's tympanic membrane is inflamed to the point where tube placement is not possible or in neonates when tube placement presents too great a risk. Other instances for myringotomy alone may be presented in individuals who are immunocompromised and who may present with advanced OM requiring immediate treatment or to obtain cultures to identify the infectious agent.

Definitions

Acute otitis media (AOM): Middle ear infection characterized by a history of acute onset of signs and symptoms, the presence of middle-ear effusion, and signs and symptoms of middle-ear inflammation.

Autophony: A condition characterized by an unusually loud hearing of a person's own voice and/or breathing.

Barotitis (barotrauma): Damage to the middle ear caused by pressure changes.

Intra-cranial complication: In this instance, a problem such as an infection inside the skull, that is related to the otitis media.

Mastoiditis: An infection of the mastoid bone of the skull.

Myringotomy: A surgical procedure that creates a small hole in the eardrum.

Otitis media with effusion (OME): An ear condition characterized by the accumulation of fluid in the middle ear.

Pars flaccida: A part of the ear drum.

Patulous eustachian tube: A condition where the eustachian tube that runs from the middle ear to the nasopharynx, which is normally closed, stays intermittently open.

Retraction of tympanic membrane: A condition in which a part of the eardrum lies deeper within the ear than normal.

Tympanostomy tube: A small type placed into a myringotomy incision to maintain the opening for prolong periods of time. Tympanostomy tubes are also known by other terms, including grommet, T-tube, ear tube, pressure equalization tube, vent, PE tube, or myringotomy tube.

Vestibular problems: Health conditions due to infection, inflammation, or damage to the vestibular system of the inner ear. This is usually characterized by balance problems.

References

Peer Reviewed Publications:

  1. Broen PA, Moller KT, Carlstrom J, et al. Comparison of the hearing histories of children with and without cleft palate. Cleft Palate Craniofac J. 1996; 33(2):127-133.
  2. Casselbrant ML, Kaleida PH, Rockette HE, et al. Efficacy of antimicrobial prophylaxis and of tympanostomy tube insertion for prevention of recurrent acute otitis media: results of a randomized clinical trial. Pediatr Infect Dis J. 1992; 11(4):278-286.
  3. Chowdhury CR, Ho JH, Wright A, et al. Prospective study of the effects of ventilation tubes on hearing after radiotherapy for carcinoma of nasopharynx. Ann Otol Rhinol Laryngol. 1988; 97(2 Pt 1):142-145.
  4. Gebhart DE. Tympanostomy tubes in the otitis media prone child. Laryngoscope. 1981; 91(6):849-866.
  5. Gonzalez C, Arnold JE, Woody EA, et al. Prevention of recurrent acute otitis media: chemoprophylaxis versus tympanostomy tubes. Laryngoscope. 1986; 96(12):1330-1334.
  6. Hellstrom S, Groth A, Jorgensen F, et al. Ventilation tube treatment: a systematic review of the literature. Otolaryngol Head Neck Surg. 2011; 145(3):383-395.
  7. Hornigold R, Morley A, Glore RJ, et al. The long-term effect of unilateral t-tube insertion in patients undergoing cleft palate repair: 20-year follow-up of a randomised controlled trial. Clin Otolaryngol. 2008; 33(3):265-268.
  8. Iino Y, Imamura Y, Harigai S, Tanaka Y. Efficacy of tympanostomy tube insertion for otitis media with effusion in children with Down syndrome. Int J Pediatr Otorhinolaryngol. 1999; 49(2):143-149.
  9. Ingels K, Rovers MM, van der Wilt GJ, Zielhuis GA. Ventilation tubes in infants increase the risk of otorrhoea and antibiotic usage. B-ENT. 2005; 1(4):173-176.
  10. Johnston LC, Feldman HM, Paradise JL, et al. Tympanic membrane abnormalities and hearing levels at the ages of 5 and 6 years in relation to persistent otitis media and tympanostomy tube insertion in the first 3 years of life: a prospective study incorporating a randomized clinical trial. Pediatrics. 2004; 114(1):e58-67.
  11. Kay DJ, Nelson M, Rosenfeld RM. Meta-analysis of tympanostomy tube sequelae. Otolaryngol Head Neck Surg. 2001; 124(4):374-380.
  12. Koopman JP, Reuchlin AG, Kummer EE, et al. Laser myringotomy versus ventilation tubes in children with otitis media with effusion: a randomized trial. Laryngoscope. 2004; 114(5):844-849.
  13. Le CT, Freeman DW, Fireman BH. Evaluation of ventilating tubes and myringotomy in the treatment of recurrent or persistent otitis media. Pediatr Infect Dis J. 1991; 10(1):2-11.
  14. Lous J, Ryborg CT, Thomsen JL. A systematic review of the effect of tympanostomy tubes in children with recurrent acute otitis media. Int J Pediatr Otorhinolaryngol. 2011; 75(9):1058-1061.
  15. Mandel EM, Rockette HE, Bluestone CD, et al. Myringotomy with and without tympanostomy tubes for chronic otitis media with effusion. Arch Otolaryngol Head Neck Surg. 1989; 115(10):1217-1224.
  16. Mandel EM, Rockette HE, Bluestone CD, et al. Efficacy of myringotomy with and without tympanostomy tubes for chronic otitis media with effusion. Pediatr Infect Dis J. 1992; 11(4):270-277.
  17. McCormick DP, Johnson DL, Baldwin CD. Early middle ear effusion and school achievement at age seven years. Ambul Pediatr. 2006; 6(5):280-287.
  18. Paradise JL, Campbell TF, Dollaghan CA, et al. Developmental outcomes after early or delayed insertion of tympanostomy tubes. N Engl J Med. 2005; 353(6):576-586.
  19. Paradise JL, Dollaghan CA, Campbell TF, et al. Language, speech sound production, and cognition in three-year-old children in relation to otitis media in their first three years of life. Pediatrics. 2000; 105(5):1119-1130.
  20. Paradise JL, Dollaghan CA, Campbell TF, et al. Otitis media and tympanostomy tube insertion during the first three years of life: developmental outcomes at the age of four years. Pediatrics. 2003a; 112(2):265-277.
  21. Paradise JL, Feldman HM, Campbell TF, et al. Early versus delayed insertion of tympanostomy tubes for persistent otitis media: developmental outcomes at the age of three years in relation to prerandomization illness patterns and hearing levels. Pediatr Infect Dis J. 2003b; 22(4):309-314.
  22. Paradise JL, Feldman HM, Campbell TF, et al. Effect of early or delayed insertion of tympanostomy tubes for persistent otitis media on developmental outcomes at the age of three years. N Engl J Med. 2001; 344(16):1179-1187.
  23. Paradise JL, Feldman HM, Campbell TF, et al. Tympanostomy tubes and developmental outcomes at 9 to 11 years of age. N Engl J Med. 2007; 356(3):248-261.
  24. Ponduri S, Bradley R, Ellis PE, et al. The management of otitis media with early routine insertion of grommets in children with cleft palate—a systematic review. Cleft Palate Craniofac J. 2009; 46(1):30-38.
  25. Rach GH, Zielhuis GA, van Baarle PW, van den Broek P. The effect of treatment with ventilating tubes on language development in preschool children with otitis media with effusion. Clin Otolaryngol Allied Sci. 1991; 16(2):128-132.
  26. Rosenfeld RM, Bhaya MH, Bower CM, et al. Impact of tympanostomy tubes on child quality of life. Arch Otolaryngol Head Neck Surg. 2000; 126(5):585-592.
  27. Rosenfeld RM, Jang DW, Tarashansky K. Tympanostomy tube outcomes in children at-risk and not at-risk for developmental delays. Int J Pediatr Otorhinolaryngol. 2011; 75(2):190-195.
  28. Rovers MM, Black N, Browning GG, et al. Grommets in otitis media with effusion: an individual patient data meta-analysis. Arch Dis Child. 2005; 90(5):480-485.
  29. Rovers MM, Krabbe PF, Straatman H, et al. Randomised controlled trial of the effect of ventilation tubes (grommets) on quality of life at age 1-2 years. Arch Dis Child. 2001a; 84(1):45-49.
  30. Rovers MM, Straatman H, Ingels K, et al. The effect of short-term ventilation tubes versus watchful waiting on hearing in young children with persistent otitis media with effusion: a randomized trial.  Ear Hear. 2001b; 22(3):191-199.
  31. Schilder AG, Van Manen JG, Zielhuis GA, et al. Long-term effects of otitis media with effusion on language, reading and spelling. Clin Otolaryngol Allied Sci. 1993; 18(3):234-241.
  32. Schilder AG. Assessment of complications of the condition and of the treatment of otitis media with effusion. Int J Pediatr Otorhinolaryngol. 1999; 49 Suppl 1:S247-251.
  33. Sheahan P, Blayney AW, Sheahan JN, Earley MJ. Sequelae of otitis media with effusion among children with cleft lip and/or cleft palate. Clin Otolaryngol Allied Sci. 2002; 27(6):494-500.
  34. Stenstrom R, Pless IB, Bernard P. Hearing thresholds and tympanic membrane sequelae in children managed medically or surgically for otitis media with effusion. Arch Pediatr Adolesc Med. 2005; 159(12):1151-1156.
  35. van Dongen TM, van der Heijden GJ, Venekamp RP, et al. A trial of treatment for acute otorrhea in children with tympanostomy tubes. N Engl J Med. 2014; 370(8):723-733.
  36. Witsell DL, Stewart MG, Monsell EM, et al. The Cooperative Outcomes Group for ENT: a multicenter prospective cohort study on the outcomes of tympanostomy tubes for children with otitis media. Otolaryngol Head Neck Surg. 2005; 132(2):180-188.
  37. Xu YD, Ou YK, Zheng YQ, et al. The treatment for postirradiation otitis media with effusion: a study of three methods. Laryngoscope. 2008; 118(11):2040-2043.

Government Agency, Medical Society, and Other Authoritative Publications:

  1. AHRQ. Otitis media with effusion: comparative effectiveness of treatments. May 2013. Available at: http://www.effectivehealthcare.ahrq.gov/ehc/products/387/1484/otitis-media-report-130504.pdf. Accessed on April 28, 2017.
  2. American Academy of Family Physicians; American Academy of Otolaryngology-Head and Neck Surgery; American Academy of Pediatrics Subcommittee on Otitis Media With Effusion. Otitis media with effusion. Pediatrics. 2004; 113(5):1412-1429.
  3. Browning GG, Rovers MM, Williamson I, et al. Grommets (ventilation tubes) for hearing loss associated with otitis media with effusion in children. Cochrane Database Syst Rev. 2010;(10):CD001801.
  4. Lieberthal AS, Carroll AE, Chonmaitree T, et al. The diagnosis and management of acute otitis media. Pediatrics. 2013; 131(3):e964-e999.
  5. Rosenfeld RM, Schwartz SR, Pynnonen MA, et al. Clinical practice guideline: Tympanostomy tubes in children. Otolaryngol Head Neck Surg. 2013; 149(1 Suppl):S1-35.
  6. Rosenfeld RM, Shin JJ, Schwartz SR, et al. Clinical practice guideline: Otitis media with effusion (update). Otolaryngol Head Neck Surg. 2016; 154(1 Suppl):S1-S41. 
Index

Ear tube
Grommet
Myringotomy tube
PE tube
Pressure equalization tube
T-tube
Vent

The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

History
Status Date

Action

Reviewed 05/04/2017 Medical Policy & Technology Assessment Committee (MPTAC) review. Updated formatting in Clinical Indications section. Updated References sections.
Reviewed 05/05/2016 MPTAC review. Updated Rationale and References sections.
Revised 11/05/2015 MPTAC review. Revised medically necessary statement criteria 1 to add "who have middle ear effusion at the time of assessment for tube candidacy". Removed ICD-9 codes from Coding section.
Revised 08/06/2015 MPTAC review. Revised medically necessary indications to address additional indications for myringotomy and tympanostomy tube placement and myringotomy alone. Updated Discussion and References sections.
Reviewed 05/07/2015 MPTAC review. Updated Discussion and References sections.
New 02/05/2015 MPTAC review. Initial document development.