Knowledge Base Article

Did You Know?

About Obstructive Sleep Apnea (OSA)

According to the National Library of Medicine (link), “Obstructive sleep apnea (OSA) is characterized by episodes of complete or partial collapse of the airway with an associated decrease in oxygen saturation or arousal from sleep. This disturbance results in fragmented, nonrestorative sleep. Other symptoms include loud, disruptive snoring, witnessed apneas during sleep, and excessive daytime sleepiness. OSA has significant implications for cardiovascular health, mental illness, quality of life, and driving safety.”

“The short-term prognosis of OSA with treatment is good but the long-term prognosis is guarded. The biggest problem is the lack of compliance with CPAP. Almost 50% of patients stop using CPAP within the first month. Many patients are at risk for adverse cardiac events and stroke. Those patients who do use CPAP regularly do have improved survival compared to those who do not. Further, OSA is also associated with pulmonary hypertension, hypercapnia, hypoxemia, and daytime sedation. In addition, there is a high risk of motor vehicle accidents in these individuals. The overall life expectancy of patients with OSA is lower than the general population.”

For patients not tolerating CPAP, Hypoglossal Nerve Stimulation (HNS) is one available alternative treatment strategy.

About the Inspire® Upper Airway Stimulation (UAS)

The position statement from the American Academy of Otolaryngology (AAO) (2016) states that:

“The AAO considers upper airway stimulation (UAS) via the hypoglossal nerve for the treatment of adult obstructive sleep apnea syndrome to be an effective second-line treatment of moderate to severe obstructive sleep apnea in patients who are intolerant or unable to achieve benefit with positive pressure therapy (PAP). Not all adult patients are candidates for UAS therapy and appropriate polysomnographic, age, BMI and objective upper airway evaluation measures are required for proper patient selection.”

Currently, the only FDA approved HNS is the Inspire® Upper Airway Stimulation (UAS) (Inspire® Medical Systems, Inc.). This system is comprised of:

• a stimulation lead that delivers mild stimulation to maintain multilevel airway patency during sleep,
• a breathing sensor lead that senses breathing patterns, and
• a generator that monitors breathing patterns.
• The system battery life for the implantable components is 7 to 10 years.

There are two external components, including:

• A patient sleep remote providing a noninvasive means for a patient to activate the generator, and
• A physician programmer allowing the physician to noninvasively interrogate and confiture the generator settings.

In June 2017, Inspire® Medical Systems, Inc. announced the FDA approval for the next-generation device, Inspire 3028 implantable pulse generator, which includes magnetic resonance (MR) conditional labeling to allow patients to undergo MRI safely. The Inspire 3028 device is 40% smaller and 18% thinner than the current Inspire neurostimulator which received FDA approval in April 2014. Patients can undergo MRI on the head and extremities if certain conditions and precautions are met (Inspire® Medical Systems, 2017). Additionally, the AHI range was extended from 20-65 event/hour to 15-65 events per hour.

Why it Matters?

In 2020, every Medicare Administrative Contractor (MAC) published a Local Coverage Determination (LCD) and related Billing and Coding Article (LCA) for HNS. In general, coverage guidance in each of the LCD’s includes the following statements:

“Notice: It is not appropriate to bill Medicare for services that are not covered (as described by this entire LCD) as if they are covered. When billing for non-covered services, use the appropriate modifier.

Compliance with the provisions in this policy may be monitored and addressed through post payment data analysis and subsequent medical review audits.”

In several of the MAC’s Response to Comments articles, 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.

In each instance, the MAC responded to this request by noting that failure of conservative therapy should be tried and failed and or not tolerated prior to a surgical approach and no change was made to the LCD.

Coding and Billing

Effective January 1, 2022, there are three new CPT codes related to implantation, revision, or removal of the HNS system:

• CPT 64582 (Open implantation of hypoglossal nerve stimulator array, pulse generator, and distal respiratory sensor electrode or electrode array).
• CPT 64583 (Revision or replacement of hypoglossal nerve stimulator array and distal respiratory sensor electrode or electrode array, including connections to existing pulse generator), and
• CPT 64584 (removal of hypoglossal nerve rose stimulator array pulse generator, and distal respiratory sensor electrode or electrode array).

First New RAC Issue in 2022

On June 7, 2022, the first approved RAC issue in 2022 was posted to the CMS Medicare Fee-for-Service Recovery Audit Program webpage (link):

• RAC Issue 0201: Hypoglossal Nerve Stimulation for Obstructive Sleep Apnea: Medical Necessity and Documentation Requirements.
• Review Type: Complex
• Provider Type: Outpatient Hospital, Ambulatory Surgical Center, and Professional Services
• Issue description: Hypoglossal nerve stimulation (HNS) is reasonable and necessary for the treatment of moderate to severe obstructive sleep apnea (OSA) when coverage criteria are met. Documentation will be reviewed to determine if HNS meets Medicare coverage criteria, applicable coding guidelines, and/or are medically reasonable and necessary.

What Can You Do?

As of June 13th, this newly approved RAC Issue has not been added to the list of issues being reviewed by any of the four Recovery Auditor Regions. If your hospital is providing this service, now is the time to review a few medical records against your MACs coverage requirements to ensure you are following the provisions of the policy and billing and coding article. The RAC issue includes a listing of each of the MACs LCDs and Billing and Coding Articles.

For those in the Palmetto MAC jurisdictions J and M, Palmetto has published an article (link) about HNS that includes links to a hypoglossal nerve stimulator checklist and their LCD.

You can also visit Inspire Medical System, Inc’s Inspire Sleep Apnea Innovations webpage (link). Information available for patients includes:

• Cost and Eligibility,
• Patient Stories,
• FAQ,
• Fee Events, and
• A four-question assessment to see if you qualify for this system.

Information available for Healthcare Professionals (link) includes:

• Indications/Contraindications,
• A Patient Experience Report,
• Reimbursement information (Hospital, Physician and Sleep Services Billing Guides),
• Training and Education Tools, and
• Digital Health Documents.