| Clinical UM Guideline |
| Subject: Myringotomy and Tympanostomy Tube Insertion | |
| Guideline #: CG-SURG-46 | Publish Date: 04/07/2021 |
| Status: Reviewed | Last Review Date: 02/11/2021 |
| 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:
The use of myringotomy as a stand-alone procedure is considered medically necessary for individuals who meet one or more of the following criteria:
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.
When services may be Medically Necessary when criteria are met:
| CPT |
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| 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 |
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| ICD-10 Procedure |
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| 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 |
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| ICD-10 Diagnosis |
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| All diagnoses |
When services are Not Medically Necessary:
For the procedure codes listed above when criteria are not met or for situations designated in the Clinical Indications section as not medically necessary.
| 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 their only recommendation against a tympanostomy in the AAO-HNS guideline, they state the following based on one randomized controlled trial (RCT) and several systematic reviews (Casselbrant, 1992; Hellstrom, 2011; Lous, 2012):
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):
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 it is 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.”
In 2017, Steele and others published the results of a meta-analysis investigating the effectiveness of tympanostomy tubes in children with chronic otitis media with effusion and recurrent acute otitis media. The analysis involved 54 publications, with 29 studies describing the results of 16 RCTs and another 24 studies reporting the results of 24 non-randomized controlled trials. The authors reported that children with chronic otitis media with effusion who were treated with tympanostomy tubes had a net decrease in mean hearing threshold vs. watchful waiting of 9.1 dB at 1 to 3 months and 0.0 dB at 12 to 24 months. They noted that children with recurrent acute otitis media may have fewer episodes after placement of tympanostomy tubes. Finally, they found that adverse events are associated with tympanostomy tube placement are poorly defined and reported. They concluded,
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 tube 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:
Government Agency, Medical Society, and Other Authoritative Publications:
| 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 | 02/11/2021 | Medical Policy & Technology Assessment Committee (MPTAC) review. Reformatted Coding section. |
| Reviewed | 02/20/2020 | MPTAC review. Updated References section. |
| Reviewed | 03/21/2019 | MPTAC review. Updated References section. |
| Reviewed | 05/03/2018 | MPTAC review. The document header wording updated from “Current Effective Date” to “Publish Date.” Updated References section. |
| Reviewed | 05/04/2017 | 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. |
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