Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Obstructive Sleep Apnea (OSA)

Treatment: procedure codes - 64568 and 0466T (treatment hypoglossal nerve stimulation or Inspire upper airway stimulation system)

The insurer denied coverage for procedure codes - 64568 and 0466T (treatment hypoglossal nerve stimulation or Inspire upper airway stimulation system).

The denial is overturned.

 According to the documentation submitted, this is the case of a patient whose medical history includes chronic rhinitis and congestion, sleep apnea, asthma, and migraines. The patient underwent a sleep endoscopy. According to the procedure notes, the patient has a history of obstructive breathing with possible base of tongue collapse, and he does not tolerate continuous positive airway pressure (CPAP). Endoscopy examination showed that the patient had nasal septal deviation with turbinate enlargement. There was evidence of palate obstruction. During sleep apnea, there was also lateral pharyngeal closure in the hypopharynx and oropharynx. There was a severe amount of base of tongue collapse during sleep endoscopy. There was no evidence of laryngeal involvement. The patient tolerated the procedure well. 

Treatment options for OSA include weight loss, Positive airway pressure treatment (CPAP, BiPAP [Bilevel Positive Airway Pressure], etc), dental appliances and upper airway surgery. All of these treatments are effective.  PAP [Positive Airway Pressure] treatment is the best studied, and when used properly, effectively treats OSA symptoms. There also appears to be an improvement in overall health outcomes, although a recent study questions that. However, less than 50% (percent) of patients who are prescribed CPAP are compliant with it.  

A new treatment, hypoglossal nerve stimulation, has become available for the treatment of OSA. It is promoted as an alternative to PAP in patients who are unable to tolerate CPAP.  It has been shown to be effective as a treatment for selected patients with OSA who CPAP intolerant are.  The device was approved by the Food and Drug Administration (FDA). The literature does demonstrate a sustained clinical symptomatic benefit from the device up to 36 months after implantation (ref #4). It is too soon to know about the potential long-term benefits on health-related outcomes such as cardiovascular events, hypertension or motor vehicle accidents. However, the data about CPAP in this regard are far from conclusive. 

Almost every article about the use of hypoglossal nerve stimulation uses the term "selected patients". This refers to the criteria applied in the studies and are reflected in the FDA approval letter (Ref #1) and are listed on the inspire website (ref #2).
 
Criteria include:

1)	Body Mass index (BMI) < 32 (Note this criteria is not on the FDA letter but is quoted in almost every study).
2)	Apnea-Hypopnea Index (AHI) between 15-65.
3)	Central and mixed apneas < 25% of AHI. 
4)	Appropriate anatomy by sleep endoscopy.
5)	Failure to effectively use CPAP. 

In this case, the patient appears to meet every one of the criteria cited in the literature. The sleep study shows an AHI 17. BMI is 28. Only 2% Central apneas are noted. 

It would appear that the Inspire device is a good choice for this patient. He has tried CPAP for years without success. He is not obese, so weight loss is not likely to help. 
In summary, the literature would support the use of the hypoglossal nerve stimulator in this case as the patient falls within the recommended criteria for patient selection. 

The inspire system is likely to be more beneficial than any other standard treatments and the adverse risks are not increased over other treatments.
 
The carrier's denial of procedure codes - 64568 and 0466T (treatment hypoglossal nerve stimulation or Inspire upper airway stimulation system) for obstructive sleep apnea should be overturned.