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FDA Expands Indications for the Inspire Upper Airway Stimulation (UAS) System

Published on 

Wednesday, June 14, 2023

 | Documentation 
 | Medicare Coverage 

Did You Know?
According to the American Lung, about 10 to 30% of adults in the U.S. may have sleep apnea and your risk increases with age and weight. One relatively new treatment for this condition is Hypoglossal Nerve Stimulation (HNS).

Effective January 1, 2022, there were three new CPT codes related to implantation, revision, or removal of the HNS system. A few months later, on June 7, 2022, the first RAC approved issue in 2022 was RAC Issue 0201 (Hypoglossal Nerve Stimulation for Obstructive Sleep Apnea: Medical Necessity and Documentation Requirements). You can read more about this in a related MMP article.

The affected CPT code for RAC Issue 0201 is 64582 (open implantation of hypoglossal nerve neurostimulator array, pulse generator and distal respiratory sensor electrode or electrode array). The following table highlights the place of service, volume and claims paid in CY 2022 for this CPT code.  

Place of Service

Procedure Volume

SumCPT Paid

Inpatient Hospital

113

$28,771.66

Outpatient Hospital

5,962

$2,702,754.78

Ambulatory Surgery Center (ASC)

958

$4,486,802.84

Overall Totals

7,033

$7,218,329.28

Data Source: RealTime Medicare Data (RTMD) CY 2022 Medicare Fee-For-Service nationwide paid claims.

 

Why It Matters?

Medicare Administrative Contractors (MACs) have published Local Coverage Determinations (LCDs) and related coding and billing articles for this procedure. Currently, two of the indications are a body mass index (BMI) less than 35 kg/m2, and a polysomnography (PSG) demonstrating an apnea-hypopnea index (AHI) of 15 to 65 events per hour within 24 months of initial consultation for HNS implant.

 

In the U.S. Food & Drug Administration’s June 9, 2023 FDA Roundup, they announced they have approved an expanded indication for the Inspire Medical Systems’ Inspire Upper Airway Stimulation (UAS) System to include an updated AHI and BMI threshold.

 

“The safety and effectiveness data available now increased the AHI baseline to 100 and a BMI level of 40 for adults with moderate to severe Obstructive Sleep Apnea (OSA).”

 

What Can I Do?

With this device being on the RAC approved issue list you should:

  • Be mindful of the timing of the FDA’s expanded indications in the event you receive a request for records for dates of service on or after June 9, 2023.
  • Watch for updated indication information in your MACs related LCD.
  • Share this information with key stakeholders.

 

Resources

American Lung Association article Learn About Sleep Apnea at https://www.lung.org/lung-health-diseases/lung-disease-lookup/sleep-apnea/learn-about-sleep-apnea

 

FDA Roundup: June 9, 2023: https://www.fda.gov/news-events/press-announcements/fda-roundup-june-9-2023

Article Author: Beth Cobb, RN, BSN, ACM, CCDS
Beth Cobb, RN, BSN, ACM, CCDS, is the Manager of Clinical Analytics at Medical Management Plus, Inc. Beth has over twenty-five years of experience in healthcare including eleven years in Case Management at a large multi-facility health system. In her current position, Beth is a principle writer for MMP’s Wednesday@One weekly e-newsletter, an active member of our HIPAA Compliance Committee, MMP’s Education Department Program Director and co-developer of MMP’s proprietary Compliance Protection Assessment Tool.

This material was compiled to share information.  MMP, Inc. is not offering legal advice. Every reasonable effort has been taken to ensure the information is accurate and useful.