Response to Comments: Hypoglossal Nerve Stimulation for Treatment of Obstructive Sleep Apnea (DL38528).

Considerations for updates to the LCD language

1. Drug Induced Sleep Endoscopy (DISE) Training
   • Consistent with other MAC LCDs for HGNS therapy, request ‘Grandfathering’ implanters who were certified to perform DISE & Implants prior to final LCD implementation date
2. Device Interaction statement not reflective of FDA approved labeling
3. Clarification of language around Limitation for ‘Active Psychiatric Disease’

Recommendations for DISE Policy Language
A ‘Grandfathering’ clause be added to the LCD to accept certification for implanters who were trained and certified prior to the publication of a Final LCD. Some physicians have been performing HGNS implants for over 5 years and have been certified to perform DISE under criteria different than proposed in the Draft LCDs, yet with excellent outcomes. We request that a clause be added that states: ‘Physicians who were certified by the FDA approved manufacturer prior to publication of the Final LCD will not be required to re-certify and shall have documentation of DISE training certification to submit to this contractor if necessary.’

Recommendations for Language related to Device Interaction
Current Proposed LCD states: “Beneficiaries with an implantable device could experience unintended interaction with the HGNS implant system…”
Inspire recommends removing this statement
Rationale: Extensive testing was performed and submitted to the FDA for review, ensuring that there is no deleterious device interaction with other implantable devices such as pacemakers, defibrillators, or other implantable neurostimulation devices. FDA did not add a contraindication or warning statement to the IDE Approval for Inspire’s HGNS system.

Recommendation for Language related to ‘Active Psychiatric Disease’
Current Proposed LCD has a benefit Limitation for:
“Active Psychiatric Disease”
Recommend that this limitation/statement be clarified to state:
“An active, serious mental illness that reduces the ability to carry out Activities of Daily Living (ADLs) and would interfere with the patient's ability to operate the HNS and report problems to the attending provider.”
Kathy Sherwood Senior Vice President, Global Market Access, Inspire Medical Systems, Inc.

Thank you for your comments. In regards to the request for a “grandfathering” clause, WPS 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.

In regards to the safety of the device and potential interaction with other devices, the policy will remain unchanged, as the language is consistent with the STAR criteria and the FDA approval. Future literature supporting the safety of the device can be submitted with a reconsideration request to make changing to the current LCD language.

In regards to the language “Active Psychiatric Disease,” the language in the final policy will be clarified to state active psychiatric care that is poorly controlled. The decision should be made by the attending provider as to whether the condition of the patient is such that the patient can operate the HNS and report problems to the attending provider.

I am writing on behalf of the American Association of Oral and Maxillofacial Surgeons. Many of our members are trained to treat obstructive sleep apnea. I have received a few inquiries related to recent LCDs for hypoglossal nerve stimulation. Can you provide any details on the process for developing this LCD, specifically the provider qualifications?
Patricia Serpico, CPC, Manager, Health Policy, Quality & Reimbursement, American Association of Oral and Maxillofacial Surgeons

Thank you for your inquiry. The process of LCD creation and reconsideration was developed as part of the 21st Century Act and outlined in CR10901. The process includes review of medical literature, creation of a draft LCD, an open meeting to allow for public comment on the draft LCD, a possible contractor advisor committee meeting (CAC) to allow for peer selected medical society state representative comments and the comment period to which you responded. Review of literature and comments received during this process help develop the final version of the LCD. In regards to the LCD direction on provider qualifications, this was determined from literature such as the STAR trial as well as recommendations from subject matter experts (SME).

The American Academy of Sleep Medicine (AASM) appreciates the opportunity to comment on the Proposed Local Coverage Determination (LCD) for Hypoglossal Nerve Stimulation for the Treatment of Obstructive Sleep Apnea (OSA), as the proposed LCD will directly impact AASM member reimbursements. The comments included in this response reflect the opinions of our over 9,000 individual members and 2,500 accredited sleep centers, providing sleep medicine services to the Medicare population.

History/Background and/or General Information
The hypoglossal nerve passes and branches within the tongue (not over the tongue muscles) and innervates (not supplies into) the tongue. Additionally, the early trials for hypoglossal nerve stimulation were limited not by unselective activation but by arousals triggered by stimulation. We urge WPS to update this section to include more accurate information.

Covered Indications
CPAP failure or intolerance. AASM urges WPS to include CPAP refusal or non-acceptance as a possible indication, provided that consultation was performed with a sleep expert AND the surgeon qualified for implantation (if they are not the same). There are patients who will agree to undergo PAP home treatment post lab titration or who refuse PAP treatment despite urging by the provider. As long as a conversation about RBAs and limitations of hypoglossal nerve stimulation takes place with a sleep expert and surgeon,
and that in their judgement the therapy is appropriate, it should also be allowed.

Limitations
AASM recommends that the term ‘active psychiatric disease’ be clarified, as it is not clear which disorders are considered psychiatric disease and it is also unclear what would be considered ‘active’. AASM recommends that those with psychotic disorders be excluded, including patients with borderline personality and bipolar disorder. However, other disorders (e.g., depression/anxiety, obsessive compulsive disorder) should not be contraindicated, if they are actively being treated by a medical professional.
Uncontrolled hypertension
While we agree and acknowledge that hypertension be assessed and controlled as best as possible for implantation procedure safety, exclusion of this group may forgo treatment for those whose sleep apnea needs management most. AASM, therefore, recommends that hypertension be removed from the list of exclusions.

Drug Induced Sleep Endoscopy
AASM does not agree with the DISE scoring requirement as per manufacturer’s validation service. The inconsistency is not necessarily remedied by this process and the manufacturer is an interested party. We recommend that the implanting surgeon be required to demonstrate CME or other course /education in sleep endoscopy rather than the above. DISE interpretation for complete circular collapse is still a bit more subjective and the second opinion service’s opinion may not necessarily be “more valid.”

Thank you for your consideration of these comments. The AASM appreciates the Agency’s efforts to develop Local Coverage Determinations in order to guide reimbursement for evidence-based care. We encourage WPS to adopt the changes to the Proposed LCD, as outlined in this letter.
Kelly A. Carden, MD, MBA American Academy of Sleep Medicine President

Thank you for your comments. In regards to the addition of “CPAP refusal or non-acceptance as a possible indication” there will be no changes made to the LCD at this time. Prior to a surgical intervention, there should be adequate trial of conservative treatments with documentation of failure or intolerance.

In regards to “active psychiatric disease”, see response to comment #1.
In regards to uncontrolled hypertension, 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.

In regards to the DISE scoring requirement the request is considered but there will be no change in the LCD language at this time as peer reviewed articles were not submitted. A formal reconsideration request can be made with supporting literature to make potential changes to the LCD.