NightOwl reimbursement

Payor reimbursement of NightOwl (US)



Always consult your payor organization with regards to local reimbursement policies. The information provided below is for information purposes only and does not guarantee any level of reimbursement by Ectosense.

Commercial payors

Most commercial insurers reimburse NightOwl tests as a test based on peripheral arterial tonometry (PAT) under CPT 95800 or G0400.
Clients that are familiar with the competing WatchPAT device from Itamar Medical can continue billing for the same.  

CPT 95800
Sleep study, unattended, simultaneous recording; heart rate, oxygen saturation, respiratory analysis (e.g., by airflow or peripheral arterial tone), and sleep time
G0400
Home sleep test (HST) with type iv portable monitor, unattended; minimum of 3 channels


Medicare

Medicare reimbursement is more complicated. 

The 4% desat rule

Whereas most commercial payors have adopted the AASM's recommended hypopnea scoring rule (1A, see below), Medicare requires the scoring of hypopnea by the alternative rule (1B, see below).
AASM Recommended Hypopnea Scoring (1A)
 Score a respiratory event as a hypopnea if ALL of the following criteria are met:

a. The peak signal excursions drop by ≥30% of pre-event baseline using nasal pressure (diagnostic study), PAP device flow (titration study), or an alternative hypopnea sensor (diagnostic study).
b. The duration of the ≥30% drop in signal excursion is ≥10 seconds.
c. There is a ≥3% oxygen desaturation from pre-event baseline and/or the event is associated with an arousal.

AASM Alternative Hypopnea Scoring (1B)
Score a respiratory event as a hypopnea if ALL of the following criteria are met:
a. The peak signal excursions drop by ≥30% of pre-event baseline using nasal pressure (diagnostic study), PAP device flow (titration study), or an alternative hypopnea sensor (diagnostic study).
b. The duration of the ≥30% drop in signal excursion is ≥10 seconds.
c. There is a ≥ 4% oxygen desaturation from pre-event baseline.


While HSATs based on Perpiheral Arterial Tonometry (PAT) have been widely used for Medicare, they do not record flow and their autoscoring model (which picks up on hypopneas) would technically not fall within the manual scoring guidelines of either the 1A or the 1B rule. 
The algorithms of PAT-based devices can be trained to provide an AHI output that is closer to either the 1A rule (3%) or to the 1B rule (4%). 
NightOwl currenlty only provides an output based on an algorithm that was trained to mimic the AASM-recommened 1A rule (3%). We expect to make available an algorithm that is tuned towards the 1B rule (4%) later in 2021, pending clearance by the FDA.

Local coverage articles (LCDs) for sleep testing

NightOwl falls within the scope of the local coverage articles that provide coverage for all devices based on peripheral arterial tone (PAT)

CMS PUB 100-03 NCD Chapter 1, Section 240.4.1 – Sleep Testing for Obstructive Sleep Apnea (OSA) finds that the evidence is sufficient to determine that the results of the sleep tests identified below can be used by a beneficiary’s treating physician to diagnose OSA.
[...]
  • Sleep testing devices measuring three or more channels that include actigraphy, oximetry, and peripheral arterial tone, are covered when used to aid the diagnosis of OSA in beneficiaries who have signs and symptoms indicative of OSA if performed unattended in or out of a sleep lab facility or attended in a sleep lab facility.

Local coverage articles (LCDs) for sleep therapy

The LCDs for PAP and OAT sleep therapy (L33718 and L33611) currently conflict with the sleep testing LCDs and restrict coverage to brand-name devices.
On Ectosense's request, the DME MACs have recently proposed new therapy LCDs that remove the inconsistencies with the testing LCDs. 
We expect that a new LCD will become effective between June and September of 2021.
DL33718 (OAT) 
DL33718 (PAP)

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