Local Coverage Article Response to Comments

Response to Comments: Hypoglossal Nerve Stimulation for the Treatment of Obstructive Sleep Apnea


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Article ID
Article Title
Response to Comments: Hypoglossal Nerve Stimulation for the Treatment of Obstructive Sleep Apnea
Article Type
Response to Comments
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Article Text

The evidence related to hypoglossal nerve stimulation (HNS) for treatment of obstructive sleep apnea was presented at the Contractor Advisory Committee (CAC) meeting on June 13, 2019. The advice of the CAC members and Subject Matter Experts was considered in the development of the proposed policy. The following are the comment summaries and contractor responses for the Proposed Local Coverage Determination (LCD) L38307 (Hypoglossal Nerve Stimulation for the Treatment of Obstructive Sleep Apnea) which was posted for comment on 10/30/2019 and presented at the October 29, 2019 Open Meeting. All comments were reviewed and incorporated into the final LCD where applicable.

Response To Comments


Several commenters requested a removal or clarification of the Limitation statement “Active psychiatric illness” because it is a vague description with the potential of disqualifying patients who are actively under the care of a mental health professional, and have adequate control of their symptoms.

A more correct term might be a serious mental illness that reduces the ability to carry out daily life and would interfere with the patient’s ability to operate the HNS and report problems to the attending provider. This decision would made by the treating physician(s). After further review, the language in the final policy will be clarified to state active psychiatric care that is poorly controlled.


A couple of commenters asked for clarification of the limitation regarding beneficiaries with implantable devices that could experience unintended interaction with the HNS implant system. Comments included a recent publication that suggested there are no adverse interactions with cardiac implantable devices, and no reports of adverse findings with concurrent use of both devices.

Thank you for the literature and your comments The literature received revealed a small sample size. CGS expects that additional literature regarding the safety and efficacy of this service will be forthcoming. Until additional literature is received no change will be made to the policy as the language is consistent with the STAR criteria and the FDA approval.


Several comments were received regarding the training required for the Drug Induced Sleep Endoscopy (DISE), to determine the presence of complete concentric collapse (CCC).


Thank you for the comment. No peer reviewed articles were submitted with this request. There was a consensus among the subject matter experts (SMEs) that the second party review is appropriate and the 15 procedures was a conservative but good number, allowing for greater success with implantation. Should data be forthcoming and demonstrates that similar results are being obtained on the first 5-10, it may be submitted through the reconsideration process. 


Several comments were received that requested the language be clarified under Shared Decision Making (SDM). Several stated it was not clear if the referring physician would need to document the implant is appropriate for the patient and similar documentation would be needed from the implanting provider. In addition, there were issues with questioning why one specialist would need referrals from other specialists regarding this procedure.

Thank you for your comments. Shared decision making (SDM), by definition, is between the provider and the patient and does not mean between the various providers. The language in the final policy will be clarified to indicate that SDM is between the attending providers and the patient, and not between multiple providers.


Several commenters indicated the Provider Specialties section address the limitation of allowing only board certified Otolaryngologists for implantation. Comments also submitted pointed to the evaluation, referral, and post implant evaluation should be performed by board eligible or certified sleep physicians. They suggested that post implant should remain the responsibility of the implanting physician. In addition, a comment was submitted that noted in some geographical areas, Neurosurgeons who perform similar nerve stimulation surgeries, should be allowed to implant the device, and ENT Head and Neck surgeons are often implanter partners for Sleep physician referrers.

Thank you for the comments. The Subject Matter Experts (SME) that provided input for this service at the CAC Meeting agreed with the provider specialty limitation. They agreed that all providers performing this service and the follow-up care should meet specified educational requirements. In the original Star trial and follow-up through five years, all the implanting surgeons were ENT, and approved per the FDA criteria. There was no documentation submitted with the comment to support the commenters’ recommendation for inclusion of additional specialty providers.


One comment received requested that current physicians who were certified on DISE and completed implant training by the FDA approved manufacturer prior to the date of this final LCD, be grandfathered as a certified implanter and have LCD language that addresses this population.

CGS appreciates your comments and agrees. Providers that underwent FDA approved device manufacturer DISE training prior to the date of this LCD, shall be deemed to meet the criteria for satisfactory performance of DISE without further documentation. All such providers shall maintain certification of completion of this training, supply proof of training by manufacturer, and DISE results should be made available upon request.


A couple of commenters requested that CPAP refusal or non-acceptance should be included with CPAP failure or intolerance as criteria. The refusal/non-acceptance should be clearly documented along with conversations of the benefits of CPAP and the limitations of HNS.

Thank you for your comments. Failure of conservative therapy should be tried and failed and or not tolerated prior to a surgical approach. No change at this time.


One commenter requested the Limitation of tonsil size be removed stating there is no evidence for this restriction.

Thank you for your comment. Pronounced anatomical abnormalities were used as exclusion criteria on the STAR trial. Tonsil size of 3 or 4 (tonsils visible beyond the pillars or extending midline) was presented as such an example. No peer review data was submitted to validate this claim and was not recommended by any of our Subject Matter Experts (SMEs) during our evidentiary CAC. The reconsideration process is always open for appropriate data to be presented after the LCD is finalized.


Several providers commented on vague language regarding Limitations. Several examples included the following: neuromuscular disease, uncontrolled HTN, pregnancy planning. It was suggested that additional clarifications are warranted.

The items in the Limitations are those found in the STAR criteria and serve as a reference for criteria of those patients that have been studied for HNS implantation. Evidence to support a change in the limitations was not submitted with the comments. The reconsideration process is available once the policy becomes effective with the submission of full-text peer reviewed articles.


One commenter corrected the anatomy of the hypoglossal nerve.

Thank you for your comment. Description to be changed.


One commenter raised the issue that the LCD requires utilizing only an accredited sleep study facility and noted that home studies are allowed with documentation of medical necessity for home study.(refer to L35050).

Thank you for your comment. Refer to LCD L35050 which allows for home sleep studies if patient meets the criteria. No change to be made at this time.


One commenter suggested that the LCD was requiring a formal referral from a sleep medicine physician to an Otolaryngologist for implanting of HNS. In addition, it was pointed out that it did not seem necessary for the implanting physician to document the additional conversations with multiple providers regarding the surgery.

Thank you for your comments. The LCD is requiring SDM between the patient and the treating physician (specifically the implanting provider); this does not refer to provider and provider consultations. Both physicians are required to have conversations regarding risks and benefits with the patient ( SDM). See Comment/Response #5.


One commenter stated endoscopy studies, during sleep and wake, is a standard of otolaryngologist training and should not require further certification by a third party including an FDA approved manufacturer.

Thank you for the comment. There is evidence to support the training and there was no additional evidence presented to the contrary. There is no evidence that DISE training is part of a general training program for Otolaryngologists. SME’s, including otolaryngologists, agreed with the Company approved training.


Another comment addressed the fact that attending physicians are not able to be board certified until they are in practice for a year. This would restrict access to trained implanting otolaryngologists.

Thank you for the comment and Board eligible otolaryngologists have been added to the final LCD.


One comment stated the policy should not require fellowship training; residency in otolaryngology should be sufficient training in my opinion.

Fellowship training is not required.


One provider recommends that the criteria for hypoglossal nerve stimulation surgery include the failure of CPAP and Oral Appliance Therapy with a Mandibular Advancement Device and states there evidence to support both of these treatment modalities.

Thank you for your comments. The LCD does require documentation of failed CPAP in addition to the other coverage criteria. Regarding the recommendation of adding the Oral Appliance Therapy with a Mandibular Advancement Device to coverage criteria, evidence to support this change was not submitted with the comments. The reconsideration process is available once the policy becomes effective with the submission of full-text peer reviewed articles.

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