LCD Reference Article Response To Comments Article

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

A57967

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Contractor Information

Contractor Name	Contract Type	Contract Number	Jurisdiction	States
National Government Services, Inc.	MAC - Part A	06101 - MAC A	J - 06	Illinois
National Government Services, Inc.	MAC - Part B	06102 - MAC B	J - 06	Illinois
National Government Services, Inc.	MAC - Part A	06201 - MAC A	J - 06	Minnesota
National Government Services, Inc.	MAC - Part B	06202 - MAC B	J - 06	Minnesota
National Government Services, Inc.	MAC - Part A	06301 - MAC A	J - 06	Wisconsin
National Government Services, Inc.	MAC - Part B	06302 - MAC B	J - 06	Wisconsin
National Government Services, Inc.	A and B and HHH MAC	13101 - MAC A	J - K	Connecticut
National Government Services, Inc.	A and B and HHH MAC	13102 - MAC B	J - K	Connecticut
National Government Services, Inc.	A and B and HHH MAC	13201 - MAC A	J - K	New York - Entire State
National Government Services, Inc.	A and B and HHH MAC	13202 - MAC B	J - K	New York - Downstate
National Government Services, Inc.	A and B and HHH MAC	13282 - MAC B	J - K	New York - Upstate
National Government Services, Inc.	A and B and HHH MAC	13292 - MAC B	J - K	New York - Queens
National Government Services, Inc.	A and B and HHH MAC	14111 - MAC A	J - K	Maine
National Government Services, Inc.	A and B and HHH MAC	14112 - MAC B	J - K	Maine
National Government Services, Inc.	A and B and HHH MAC	14211 - MAC A	J - K	Massachusetts
National Government Services, Inc.	A and B and HHH MAC	14212 - MAC B	J - K	Massachusetts
National Government Services, Inc.	A and B and HHH MAC	14311 - MAC A	J - K	New Hampshire
National Government Services, Inc.	A and B and HHH MAC	14312 - MAC B	J - K	New Hampshire
National Government Services, Inc.	A and B and HHH MAC	14411 - MAC A	J - K	Rhode Island
National Government Services, Inc.	A and B and HHH MAC	14412 - MAC B	J - K	Rhode Island
National Government Services, Inc.	A and B and HHH MAC	14511 - MAC A	J - K	Vermont
National Government Services, Inc.	A and B and HHH MAC	14512 - MAC B	J - K	Vermont

Article Information

General Information

Article ID
A57967

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

Article Type
Response to Comments

Original Effective Date
04/01/2020

Retirement Date
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Article Guidance

Article Text

As an important part of Medicare Local Coverage Determination (LCD) development, National Government Services solicits comments from the provider community and from members of the public who may be affected by or interested in our LCDs. The purpose of the advice and comment process is to gain the expertise and experience of those commenting.

We would like to thank those who suggested changes to the LCD for Hypoglossal Nerve Stimulation for Treatment of Obstructive Sleep Apnea. The official notice period for the final LCD begins on February 13, 2020 and the final determination will become effective for services rendered on or after April 1, 2020.

Response To Comments

Number	Comment	Response
1	Two specialty societies combined their comments and applauded the explicitly covered indications for age, body mass index (BMI), timing of polysomnography (PSG) relative to hypoglossal nerve (HGN) surgery, and predominance of obstructive events (versus central apneas). However, concern was expressed that prior to determination of PAP failure, sleep testing performed under the supervision of an American Academy of Sleep (AASM) accredited facility occur, noting the STAR clinical trials defined hypopneas using 4% oxygen desaturations rather than arousals or >/= 3% desaturations, thereby missing a baseline of undertreated OSA.	We appreciate the positive comments. Requirements for physicians supervising sleep testing are provided in Local Coverage Article: Polysomnography and Sleep Studies – Medical Policy Article (A53019). The sleep laboratory or testing facility must be affiliated with a hospital or be under the direction and control of a physician (MD/DO), even though the diagnostic test may be performed in the absence of direct physician supervision. The laboratory physician director must be/have: Board-certified in sleep medicine (ABSM, i.e., Diplomate of, or board-eligible for, the American Board of Sleep Medicine; or A diplomate or board-eligible for an American Board of Medical Specialties (ABMS) approved board; or Completed residency or fellowship training by an ABMS member board and has completed all the requirements for subspecialty certification in sleep medicine except the examination itself, and only until the time of reporting of the first examination for which the physician is eligible; or An active staff member of a sleep center or laboratory accredited by the American Academy of Sleep Medicine (AASM), the Accreditation Commission for Health Care, Inc. or The Joint Commission (formerly the Joint Commission on Accreditation of Healthcare Organizations (JCAHO); or Completed training and certification from the National Board for Respiratory Care (NBRC) Inc. The literature we found did not require a PSG to determine PAP failure. Most studies used a 4% oxygen desaturation rather than 3% in their determination of OSA and arousals were not always reported.
2	One professional society sent corrected information for hypoglossal nerve anatomy and also stated early trials for hypoglossal nerve stimulation were limited not by unselective activation but by arousals triggered by stimulation.	Nerve anatomy will be corrected in the final LCD. The history of HGN stimulation for OSA prior to that included in the draft will not be augmented.
3	A request was received 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).”	The current draft states, “Beneficiary has documentation that demonstrates CPAP failure (defined as AHI greater than 15 despite CPAP usage) or CPAP intolerance (defined as less than 4 hours per night, 5 nights per week or the CPAP has been returned including shared decision making that the patient was intolerant of CPAP despite consultation with a sleep expert.” The language will be maintained.
4	One professional society requested Home Sleep Study (HSS) results be allowed for determination of degree of OSA, CPAP effectiveness, etc.	The CMS National Coverage Determination (NCD) Sleep Testing for Obstructive Sleep Apnea (OSA) 240.4.1 provides for home sleep studies in some instances. For determining the degree of OSA, e.g., the AHI, the effect of CPAP, and other measurements required for HGN eligibility, the study must be performed in a free-standing or hospital sleep lab facility. All of the HGN UAS studies had the initial sleep study performed in such facilities. A few allowed home studies to determine later follow-up.
5	One professional society objected to tonsil size 3 or 4 per standardized tonsillar hypertrophy grading scale as an exclusion.	The tonsil size exclusion has been in most if not all HGN UAS studies and will be maintained in the LCD.
6	Failure of Oral Appliance Therapy with a Mandibular Advancement Device was requested to be added as eligibility for HGN UAS.	The Durable Medical Equipment Medicare Administrative Contractors have local coverage determinations providing coverage for medically necessary mandibular devices to treat OSA. We would anticipate the sleep physician prescribing such a device if indicated.
7	The manufacturer noted that “the FDA did not add a contraindication or warning statement to the IDE Approval for Inspire’s HGNS system.” Therefore, it was requested that the following statement be removed: “Beneficiaries with an implantable device could experience unintended interaction with the HGNS implant system.”	In the interests of patient safety, the current language specifying magnetic resonance imaging for Models 3024 and 3028 will be maintained as well as the guidance to check with Manufacturer Guidelines for more information and updates.
8	Commenters were concerned that some of the beneficiary limitations were inappropriate or too vague. Examples: Neuromuscular disease Active psychiatric disease Uncontrolled hypertension Plan to become pregnant Any condition or procedure that has compromised neurological control of the upper airway Hypoglossal nerve palsy Moderate-to-severe pulmonary artery hypertension	Changes or lack thereof in the final LCD: “affecting the respiratory system” will be added An active, serious mental illness that is poorly controlled and 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 physician The draft LCD language, “Persistent uncontrolled hypertension despite medication use” will be maintained No change; studies have not included pregnant beneficiaries or those planning to become pregnant No change. The board-certified or –eligible sleep physician would be expected to detect such condition or procedure No change No change
9	One specialty society felt physician training and certification using drug induced sleep endoscopy (DISE) to detect complete concentric collapse of the palate was unnecessary because it was a standard component of otolaryngologists’ training. The society also objected to the requirement for cadaver-based training stating “otolaryngology training now allows residents to learn this procedure in real-time on live patients as they learn all the other surgeries that they perform.”	No evidence was provided that such training occurs especially for the detection of complete concentric palatal collapse. In addition, the manufacturer requires this training and certification to acquire the device for patient use. Otolaryngology residency curricula were not provided nor was there evidence provided to support competency without such training. In addition, the manufacturer requires this training and certification to acquire the device for patient use.
10	The same specialty society asked that the evaluation, referral, and post-implant evaluation should be performed by a board-certified or -eligible sleep physician or otolaryngologist. Two other professional societies supported evaluation by a board-certified or –eligible sleep physician evaluating the patient to determine that he or she cannot tolerate CPAP despite multiple adjustments and hypoglossal nerve stimulation implantation is an appropriate consideration.	The draft LCD requires evaluation by a board-eligible or certified sleep non-operating physician and a board-eligible or certified otolaryngologist. No data were provided to support a change in this requirement. The contractor continues to believe that the requirement is in the best interests of the beneficiary.
11	Comments about shared decision making suggested some thought that it was between the referring sleep physician and the operating otolaryngologist.	Shared decision making (SDM), by definition, is between the patient and the physician. The patient should be given sufficient information to decide what treatment to choose. Beneficiaries need to know the chance of success of decreasing AHI, symptom relief, and relieving OBS as found in the literature and for the treating and operating physician and surgeons. The final LCD will be clarified that SDM is not between providers.
12	The manufacturer requested language grandfathering implanters who were trained and certified prior to the publication of the draft LCD.	We agree that physicians who have undergone FDA-approved device manufacturer DISE training and certification prior to the effective date of this LCD shall be deemed to meet the criteria for satisfactory performance of DISE. The physician must maintain records of completed training and certification which should be available on request.
13	There were several comments regarding implanting physician specialty and certification. One state medical society stated no board certification should be required. Board-eligibility for otolaryngologists just finishing their training and not yet eligible for certification was requested by other medical specialty societies.	Board-eligibility in otolaryngology will be added to the final LCD.

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

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