Clinical Policy Title: Ear tubes (tympanostomy)

Clinical Policy Title: Ear tubes (tympanostomy) Clinical Policy Number: 11.03.05 Effective Date: January 1, 2015 Initial Review Date: September 17, 2014 Most Recent Review Date: September 21, 2016 Next Review Date: September 2017 Policy contains: Ventilation tubes. Myringotomy. Tympanostomy tubes. Grommets. Otitis media with effusion. Related policies: CP# 11.03.04 Tonsillectomy and/or adenoidectomy in children up to 12 years old ABOUT THIS POLICY: AmeriHealth Caritas Iowa has developed clinical policies to assist with making coverage determinations. AmeriHealth Caritas Iowa s clinical policies are based on guidelines from established industry sources, such as the Centers for Medicare & Medicaid Services (CMS), state regulatory agencies, the American Medical Association (AMA), medical specialty professional societies, and peer-reviewed professional literature. These clinical policies along with other sources, such as plan benefits and state and federal laws and regulatory requirements, including any state- or plan-specific definition of medically necessary, and the specific facts of the particular situation are considered by AmeriHealth Caritas Iowa when making coverage determinations. In the event of conflict between this clinical policy and plan benefits and/or state or federal laws and/or regulatory requirements, the plan benefits and/or state and federal laws and/or regulatory requirements shall control. AmeriHealth Caritas Iowa s clinical policies are for informational purposes only and not intended as medical advice or to direct treatment. Physicians and other health care providers are solely responsible for the treatment decisions for their patients. AmeriHealth Caritas Iowa s clinical policies are reflective of evidence-based medicine at the time of review. As medical science evolves, AmeriHealth Caritas Iowa will update its clinical policies as necessary. AmeriHealth Caritas Iowa s clinical policies are not guarantees of payment. Coverage policy AmeriHealth Caritas Iowa considers the use of ear tubes to be clinically proven and, therefore, medically necessary when either of the following criteria is met: Uni- or bilateral chronic otitis media with effusion (OME), with symptoms of at least three months duration and with documentation of vestibular, behavioral or school performance problems; ear discomfort; or reduced quality of life (QoL). Chronic bilateral OME greater than three months with hearing difficulty, documented by a hearing test. Adenoidectomy may or may not also be performed in addition to ear tube surgery, refer to policy #11.03.04 (Tonsillectomy and/or Adenoidectomy in children up to 12 years old). Limitations: 1

AmeriHealth Caritas Iowa considers the use of ear tubes to be investigational and, therefore, not medically necessary in the following circumstances: In children or adults with a single OME episode < three months duration (date of onset or diagnosis, whichever is known). In children or adults with recurrent acute otitis media (AOM) who do not have effusion in either ear at the time of assessment. In children 6 months old or less (Rosenfeld, 2013: table below). Background There are 2.2 million new cases of OME diagnosed in the U.S. annually, affecting 50 to 90 percent of children by age five (Rosenfeld, 2004). About four episodes of new-onset OME per child occur annually, with a mean duration of 17 days (Mandel, 2008). Although many cases resolve routinely, at least 25% of OME episodes persist for over three months (Rosenfeld, 2003). Chronic cases of OME, defined as those persisting for over three months are frequently associated with hearing loss, vestibular problems, poor school performance, behavioral problems, ear discomfort, recurrent otitis media, or reduced quality of life (Rosenfeld, 2013). Surgery, including the insertion of ear tubes, is among the various options for treating children with OME. Children with chronic OME who do not receive tubes should be re-evaluated every six months until effusion is no longer present, significant hearing loss is detected or structural abnormalities (tympanic membrane or middle ear) are detected. Recurrent otitis media (OM) or OME of any duration may put children at risk for speech, language or hearing problems. Ear tubes are tiny cylinders placed through the eardrum (tympanic membrane) to allow air into the middle ear. They also may be called tympanostomy tubes, myringotomy tubes, ventilation tubes, pressure-equalization (PE) tubes or grommets. These tubes can be made out of various materials and may have a coating intended to reduce the possibility of infection. There are two basic types of ear tubes: short-term and long-term. Short-term tubes are smaller and typically stay in place for six months to a year before being extruded on their own. Long-term tubes are larger and have flanges that secure them in place for longer. Long-term tubes may fall out on their own but removal by an otolaryngologist may be necessary. Ear tubes are often recommended when a person experiences repeated middle ear infection (acute otitis media) or has hearing loss caused by the persistent presence of middle ear fluid OME. These conditions occur commonly in children, but may also affect teenagers and adults; they can lead to speech and balance problems, hearing loss or changes in the structure of the eardrum. Less common conditions that may warrant the placement of ear tubes are malformation of the eardrum or Eustachian tube, Down syndrome, cleft palate and barotrauma (injury to the middle ear caused by a reduction of air pressure usually seen with altitude changes in flying and scuba diving). 2

Each year, more than half a million ear tube surgeries are performed on children, making it the most common childhood surgery performed with anesthesia. The average age for ear tube insertion is 1 to 3 years old. Inserting ear tubes may: Reduce the risk of future ear infection. Restore hearing loss caused by middle ear fluid. Improve speech and balance problems. Improve behavior and sleep problems caused by chronic ear infections. Complications may include: Failure to resolve ear infections. Thickening of the eardrum over time, which affects hearing in a small percentage of patients. Persistent perforation after the tube falls out of the eardrum. Chronic ear drainage: the most common complication, occurring in 10 percent to 15 percent. Searches Need for further and more aggressive surgery (such as tonsil, adenoid, sinus or ear surgery). Infection. Hearing loss. Scarring of the eardrum. Possible need to keep the ear dry and to use ear plugs. Foreign-body reaction to the tube itself for example, an allergic reaction to the tube material (rare). AmeriHealth Caritas Iowa searched PubMed and the databases of: UK National Health Services Centre for Reviews and Dissemination. Agency for Healthcare Research and Quality Guideline Clearinghouse and evidence-based practice centers. The Centers for Medicare & Medicaid Services (CMS). Searches were conducted on August 10, 2016, using the terms "ear tubes" and ear infections [MeSH]. We included: Systematic reviews, which pool results from multiple studies to achieve larger sample sizes and greater precision of effect estimation than in smaller primary studies. Systematic reviews use predetermined transparent methods to minimize bias, effectively treating the review as a scientific endeavor, and are thus rated highest in evidence-grading hierarchies. Guidelines based on systematic reviews. 3

Economic analyses, such as cost-effectiveness, and benefit or utility studies (but not simple cost studies), reporting both costs and outcomes sometimes referred to as efficiency studies which also rank near the top of evidence hierarchies. Findings Despite the frequency of ear tube insertion, there was no clinical practice guideline on indications for surgery, with the exception of an expert panel representing 19 institutions (Rosenfeld, 2013). Effectiveness of ear tubes in the treatment of OME has been addressed in numerous peer-reviewed articles. Following a review of 59 studies for the Agency for Healthcare Research and Quality (Berkman, 2013), researchers from Research Triangle Park NC conducted a systematic review of 41 studies to compare outcomes of various types of surgery for OME (Wallace, 2014). Major findings, which found that ear tubes reduced OME and improved hearing (but also had some associated harms), included: Ear tubes decreased time with OME and improved hearing, compared to watchful waiting or myringotomy (or both) Adenoidectomy alone, as adjunct to myringotomy or combined with ear tubes, reduced OME and improved hearing, compared to watchful waiting or myringotomy Ear tubes and watchful waiting did not differ in language, cognitive, or academic outcomes Otorrhea and tympanosclerosis were more common in ears with tubes Adenoidectomy increased risk of postsurgical hemorrhage Another meta-analysis of 10 articles (n=71,353) assessed outcomes of primary tympanostomy tube placement (TT) and adenoidectomy (AD) in children with recurrent OM, OME, or otorrhea. Repeated TT for children undergoing primary AD (17.2%) was significantly lower than those undergoing primary TT (31.8%); no difference existed for when only children under age four were included. TT insertion for those infants within 9 months of evaluation showed no difference in 48 developmental measures at age 9-11, when compared with those infants who had delayed insertion (Mikals, 2014). Other meta-analyses found mixed results. One documented that one in three children with tympanostomy tubes inserted would not have an acute otitis media episode for the following six months (Lous, 2011). Another, using the Cochrane Database of Systematic Reviews, found that tympanoplasty reduced hearing problems in the first six months post surgery, but that natural resolutions achieved the same gains thereafter (Browning, 2010) which matched results of an earlier meta-analysis (Kay, 2001). The extensive evidence on ear tube insertion continues to be used in professional guidelines. In 2013, the American Academy of Pediatrics and the American Academy of Family Physicians issued a guideline on uncomplicated acute OM in children age 6 months to 12 years (Lieberthal, 2013). Another recent guideline recommended no ear tube insertion for any child under six months (Rosenfeld, 2013). 4

Perhaps the most comprehensive guideline on the topic was created in 2004, and updated in 2016, by the American Academy of Otolaryngology-Head and Neck Surgery, American Academy of Pediatrics, and American Academy of Family Physicians. The more recent version included an additional four new clinical practice guidelines, 20 new systematic reviews, and 49 Randomized Controlled Trials (Rosenfeld, 2016), not included in the earlier version (Rosenfeld, 2004). Policy updates: This update produced four (4) new professional society guidelines and six (6) new peer-reviewed references, each of which has been included in this policy. The additional information from these sources has been incorporated into the Findings and Summary of Clinical Evidence sections. Summary of clinical evidence: Citation Mikals (2014) Comparison of outcomes of various types of surgery for otitis media Wallace (2014) Content, Methods, Recommendations Repeat tympanostomy tubes (TT) for children undergoing primary adenoidectomy (Ad) was 17.2%, vs. 31.8% for primary TT (no difference for age <4) 391 infants < age 3 evaluated for middle-ear effusion assigned to undergo insertion of TT within 9 mos. No difference between the 391 infants at age 9-11 vs. group who had delayed insertion, for 48 developmental measures (reading, spelling, writing, calculation) Comparing effectiveness of surgical strategies to manage OME Systematic review of 41 studies Ad alone or combined with tubes reduced OME and improved hearing Tubes and watchful waiting not different in language, cognitive, academic outcomes Adenoidectomy increased risk of postsurgical hemorrhage Rosenfeld (2013) Tympanostomy tubes in children Guidelines and systematic reviews, 2005 2012., 113 studies Tubes should not be inserted in children with a single OME episode < 3 months duration (date of onset or diagnosis, whichever is known). Tubes should be offered to 1) chronic bilateral OME > 3 mos with hearing difficulty; 2) Uni- or bilateral chronic OME with symptoms > 3 mos. and documentation of vestibular, behavioral or school problems; ear discomfort; or reduced quality of life. Surveillance of chronic OME: children who do not receive tubes should be re-evaluated every six months until effusion is no longer present, significant hearing loss is detected, or middle ear abnormalities are detected. No tube insertion in children with recurrent AOM with no effusion in either ear 5

Lous (2011) Effect of tympanostomy tubes on children with recurrent otitis media Browning (2010) Grommets for hearing loss associated with otitis media with effusion in children McDonald (2008/2011) Grommets for recurrent otitis media in children RCTs (five total) children with insertion of tympanostomy tubes One of three children have no acute otitis media episodes six months post-surgery. 10 RCTs (grommets vs. no grommets), n=1728 Grommets beneficial in first 6 months (hearing differences), not at 12/18 months No effects on language or speech development, behavior or quality of life 2 RCTs, n=1480 (tubes vs. antibiotics or other control), children < 16 Grommets effective in maintaining a disease-free state for the first 6 months after insertion. Further research is needed for periods beyond 6 months. Possible adverse effects of surgical insertion should be weighed vs. benefits. Glossary Ear tubes Also termed pressure equalization tubes (PE tubes), tympanostomy tubes, myringotomy tubes or ventilation tubes. These are synonyms for the colloquially used ear tubes. Middle ear The portion of the ear between the external ear and the oval window of the inner ear. It contains the three small bones (ossicles) that transmit vibrations of the eardrum to the fluids and membranes of the inner ear. Myringotomy Incision of tympanic membrane to allow ventilation of the middle ear, drainage of middle ear fluid, or obtain cultures from an infected middle ear. Otitis media with effusion Inflammation of the middle ear with accumulation of fluid, commonly known as glue ear. Otoscopy Examination of the ear with an instrument (otoscope) to ensure the passage to the eardrum is clear and the tympanic membrane free of perforations. Tinnitus Ringing in the ears. Tympanometry Examination of the inner ear/eardrum by creating vibrations of air in the ear canal. 6

Tympanostomy Insertion of ear tubes. Otorrhea Postoperative ear discharge. References Professional society guidelines/other: Effective Health Care. Otitis media with effusion: comparative effectiveness of Treatments. Comparative Effectiveness Review No. 101. 2013. http://effectivehealthcare.ahrq.gov/ehc/products/387/1485/otitismedia-executive-130504.pdf. Accessed October 7, 2014. Lieberthal AS, Carroll AE, Chonmaitree T, et al. The diagnosis and management of acute otitis media. Pediatrics. 2013; 131(3):e964-e999. National Collaborating Centre for Women s and Children s Health. Surgical management of otitis media with effusion in children. London (UK): National Institute for Health and Clinical Excellence (NICE). 2008/assess as up-to-date.2011. (NICE clinical guideline; no.60.0). Rosenfeld RM, Culpepper L, Doyle KJ, et al. Clinical practice guideline: otitis media with effusion. Otolaryngol Head Neck Surg. 2004;130(5 Suppl):S95 118. 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. 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. http://oto.sagepub.com/content/154/1_suppl/s1.full. Accepted December 1, 2015. Accessed August 10, 2016. Peer-reviewed references: Abrams H, Chisolm T H, McArdle R. A cost-utility analysis of adult group audiologic rehabilitation: are the benefits worth the cost. J Rehabil Res Dev. 2002; 39: 549 57. Berkman ND, Wallace IF, Steiner MJ, et al. Otitis media with effusion: comparative effectiveness of treatments. Rockville MD: Agency for Healthcare Research and Quality; May 2013. Report No. 13- EHC091-EF. Browning GG, Rovers MM, Williamson I, Lous J, Burton MJ. Grommets (ventilation tubes) for hearing loss associated with otitis media with effusion in children. Cochrane DB Syst Rev. October 6, 2010. http://onlinelibrary.wiley.com/doi/10.1002/14651858.cd001801.pub3/full. Accessed August 11, 2016. 7

Iino Y, Imamura Y, et al. Efficacy of tympanostomy tube insertion for otitis media with effusion in children with Down syndrome. Int J Pediatr Otorhinolaryngol. 1999; 49: 143 49. Kay DJ, Nelson M, et al. Meta-analysis of tympanostomy tube sequelae. Otolaryngol Head Neck Surg. 2001; 124(4): 374 80. Kujala T, Alho OP, et al. Quality of life after surgery for recurrent otitis media in a randomized controlled trial. Pediatr Infect Dis J. 2014; 33: 715 19. Kujala T, Alho OP, et al. Tympanostomy with and without adenoidectomy for the prevention of recurrences of acute otitis media: a randomized controlled trial. Pediatr Infect Dis J 2012; 31: 565 69. Lous J, Ryborg CT, et al. A systematic review of the effect of tympanostomy tubes in children with recurrent acute otitis media. Int J Pediatr Otorhinolaryngol 2011; 75: 1058 61. Mandel EM, Doyle WJ, Winther B, Alper CM. The incidence, prevalence and burden of OM in unselected children aged 1-8 years followed by weekly otoscopy through the common cold season. Int J Pediatr Otorhinolaryngol. 2008;72:491 99. McDonald S, Langton CD, Nunez DA. Grommets (ventilation tubes) for recurrent acute otitis media in children. Cochrane DB Syst Rev. October 8, 2008; assessed as up-to-date. 2011. http://onlinelibrary.wiley.com/doi/10.1002/14651858.cd004741.pub2/full. Accessed August 11, 2016. Mikals SJ, Brigger MT. Adenoidectomy as an adjuvant to primary tympanostomy tube placement: a systematic review and meta-analysis. JAMA Otolaryngol Head Neck Surg. 2014;140(2):95 101. Moualed D, Masterson L, Kumar S, Donnelly N. Water precautions for preventions of infection in children with ventilator tubes (grommets). Cochrane DB Syst Rev. January 1, 2016. http://onlinelibrary.wiley.com/doi/10.1002/14651858.cd010375.pub2/full. Accessed August 11, 2016. Popova D, Varbanova S, et al. Comparison between myringotomy and tympanostomy tubes in combination with adenoidectomy in 3-7-year-old children with otitis media with effusion. Int J Pediatr Otorhinolaryngol.2010; 74: 777 80. Rosenfeld RM, Kay D. Natural history of untreated otitis media. Laryngoscope. 2003;113:1645 57. Stachler RJ, Chandrasekhar SS, Archer SM, et al. American Academy of Otolaryngology-Head and Neck Surgery. Clinical practice guideline: sudden hearing loss. Otolaryngol Head Neck Surg. 2012; 143 (3 Suppl):S1 35. 8

Vaile L, Wlliamson T, Waddell A, Taylor JG. Interventions for ear discharge associated with grommets. Cochrane DB Syst Rev. http://onlinelibrary.wiley.com/doi/10.1002/14651858.cd001933.pub2/full. April 19, 2006. Accessed August 11, 2016. Wallace IF, Berkman ND, Lohr KN, Harrison MF, Kimple AJ, Steiner MJ. Surgical treatments for otitis media with effusion: a systematic review. Pediatrics. 2014;133(2):296 311. Clinical trials: Searched clinicaltrials.gov on June 10, 2016 using terms ear tubes. Open Studies. 47 studies found, three (3) relevant. Norwegian University of Science and Technology. Follow-up After Middle Ear Tube Ventilation Tube Insertion: Who and Where? Clinicaltrials.gov website. https://clinicaltrials.gov/ct2/show/nct02831985?term=ear+tubes&recr=open&rank=7. Last updated July 11, 2016. Accessed August 11, 2016. Tel-Aviv Sourasky Medical Center. The Effect of Tympanostomy Tube Insertion on Sleep in Children with Chronic Otitis Media with Effusion. Clinicaltrials.gov website. https://clinicaltrials.gov/ct2/show/nct02477735?term=ear+tubes&recr=open&rank=31. Last updated June 17, 2015. Accessed August 11, 2016. Vastra Gotaland Region. A Comparison of Surgical and a New Non-Surgical Treatment Methods for Secretory Otitis Media in Children. ClinicalTrials.gov website. https://clinicaltrials.gov/ct2/show/nct02546518?term=ear+tubes&recr=open&rank=5. Last updated March 14, 2016. Accessed August 11, 2016. CMS National Coverage Determinations (NCDs): No NCD was identified at the writing of this policy. Local Coverage Determinations (LCDs): No LCD was identified at the writing of this policy. Commonly submitted codes Below are the most commonly submitted codes for the service(s)/item(s) subject to this policy. This is not an exhaustive list of codes. Providers are expected to consult the appropriate coding manuals and bill accordingly. CPT Code Description Comment 69424 Ventilating tube removal requiring anesthesia 9

69433 Tympanostomy (requiring insertion of ventilation tube), local or topical anesthesia. 69436 Tympanostomy (requiring insertion of ventilation tube), general anesthesia. ICD-10 Code Description Comment H65.20 Chronic serous otitis media, unspecified ear H65.21 Chronic serous otitis media, right ear H65.22 Chronic serous otitis media, left ear H65.23 Chronic serous otitis media, bilateral H65.30 Chronic mucoid otitis media, unspecified ear H65.31 Chronic mucoid otitis media, right ear H65.32 Chronic mucoid otitis media, left ear H65.33 Chronic mucoid otitis media, bilateral H65.411 Chronic allergic otitis media, right ear H65.412 Chronic allergic otitis media, left ear H65.413 Chronic allergic otitis media, bilateral H65.419 Chronic allergic otitis media, unspecified ear H65.491 Other chronic nonsuppurative otitis media, right ear H65.492 Other chronic nonsuppurative otitis media, left ear H65.493 Other chronic nonsuppurative otitis media, bilateral H65.499 Other chronic nonsuppurative otitis media, unspecified ear HCPCS Level II N/A Description Comment 10