Knowledge Base Article

MMP’s Medicare Compliance Assessment Tool (MedCAT) combines current Medicare Fee-for-Service (FFS) review targets (i.e., MAC, RAC, SMRC) with hospital specific Medicare FFS paid claims data made possible through a collaboration with RealTime Medicare Data (RTMD).

In general, MedCAT Minute articles spotlight current contractor review activities. The focus of this article is RAC Issue 0210: Hypoglossal Nerve Stimulation (HNS) for Obstructive Sleep Apnea (OSA).

Background

For patients with OSA who are unable to tolerate CPAP, HNS is one available alternative treatment strategy. The American Academy of Otolaryngology (AAO) (2016) position statement indicates 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.” ¹

Medicare Coverage Guidance

In 2020, each 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.

RAC Issue 0210: Hypoglossal Nerve Stimulation for Obstructive Sleep Apnea: Medical Necessity and Documentation Requirements

RAC Issue 0210 was approved for review by CMS on June 7, 2022.

• 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 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.
• Affected Code: CPT 64582
  • Note: This CPT code was effective on January 1, 2022.
• Applicable Policy References: The related National Coverage Determination (NCD) 2401.4.1 Sleep Testing for OSA and each of the MACs LCD and related Billing and Coding Articles are included in this section of the RAC Issue.

By July 1, 2022, all RACs had added this issue to their list of issues that they would review for all three listed provider types.

Meeting Medical Necessity and Documentation Gaps

Palmetto GBA, the Jurisdiction J MAC, has published an article highlighting requirements to meet criteria for HNS and indications when HNS would not be reasonable and necessary.

Meeting Medical Necessity

• Beneficiary is 22 years of age or older,
• Body mass index (BMI) is less than 35 kg/m2,
• A polysomnography (PSG) demonstrating an AHI of 15 to 65 events per hour within 24 months of initial consultation for HNS implant,
• Beneficiary has predominantly obstructive events (defined as central and mixed apneas less than 25 percent of the total AHI), and
• Shared Decision-Making (SDM) between the beneficiary, sleep physician and qualified otolaryngologist.
  • Note, Palmetto advises the reader to refer to an HNS checklist for remaining criteria.

   

  Examples from Palmetto’s list of indications that when present would make HNS Not Reasonable and Necessary  

• Beneficiaries with central and mixed apneas that make up more than one-quarter of total AHI,
• BMI 35 kg/m2 or greater,
• Hypoglossal-nerve palsy, or
• Persistent uncontrolled hypertension despite medication use.

   

  Documentation Gaps

  Examples of recurring documentation gaps MMP has identified for HNS includes:  

• No drug induced sleep endoscopy procedure report in the medical record,
• No shared decision-making notes by the sleep physician in the medical record, and
• No descriptive documentation of the patient failing CPAP therapy prior to progressing to HNS as a second-line therapy in the medical record.

FDA Expands Indications for Inspire Upper Airway Stimulation

On June 8, 2023, the FDA approved the expansion of the indications for the Inspire Airway Stimulation (UAS) system to include people with OSA who have an upper limit baseline apnea-hypopnea index (AHI) of 100 (increase from ≤ 65 to ≤100) and increased the upper limit for recommended BMI to 40.²

Currently, Inspire’s proprietary Inspire therapy is the first and only FDA-approved neurostimulation technology that provides a safe and effective treatment for moderate to severe obstructive sleep apnea. ³

As of March 13, 2024, none of the MACs have adopted the expanded indications in their coverage policy.

Moving Forward

• For hospitals, ASCs, and Physicians performing HNS procedures identify applicable coverage policies for your MAC jurisdiction and review a sample of medical records against the coverage requirements to confirm you are following the provisions and/or identify any documentation gaps.
• Share your findings with key stakeholders at your facility, and
• Check your MACs website periodically to see if they have adopted the FDA’s expanded indications for this procedure.

Resources

¹First Coast Local Coverage Determination L38398: Hypoglossal Nerve Stimulation for the Treatment of Obstructive Sleep Apnea, https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=38398&ver=6#:~:text=In%202016%2C%20the%20American%20Academy,UAS)%20via%20the%20hypoglossal%20nerve

²FDA Inspire Upper Airway Stimulation – P130008/S090 Overview, Content current as of 07/13/2023, https://www.fda.gov/medical-devices/recently-approved-devices/inspire-upper-airway-stimulation-p130008s090