We are living in a strange paradox in sleep medicine.
We ask innovators and manufacturers to invest in science. We require manufacturers to run rigorous trials and provide robust clinical data. We mandate U.S. Food and Drug Administration (FDA) clearance or De Novo authorization, Current Procedural Terminology (CPT) or Healthcare Common Procedure Coding System (HCPCS) codes.
And then, when they deliver, we still don’t pay for the therapy.
This is not theoretical. It is happening right now with multiple FDA-cleared sleep devices.
Real-world examples
Take eXciteOSA®, a daytime neuromuscular tongue stimulation device cleared by the FDA through the De Novo pathway for snoring and mild obstructive sleep apnea (OSA). It has regulatory clearance. It met safety and effectiveness standards. In 2024, it even received dedicated HCPCS codes E0492 and E0493. And yet, in practice, it is often billed under HCPCS A9270, a code that literally means “non-covered item or service.” Commercial payers frequently label it “investigational”. Approved. Coded. Unpaid.
Or consider iNAP®, an oral negative pressure therapy device cleared in 2022 by the FDA for OSA. Coding pathways exist through established durable medical equipment (DME) and suction-related HCPCS categories, but payer policies frequently still classify it as investigational.
This pattern is not new. Devices such as ApniCure® WinxTM Sleep Therapy System, ProventTM and Ebb® all achieved FDA clearance yet failed to achieve sustainable reimbursement and now no longer exist.
Approval is not access
The message is clear: FDA clearance plus a billing code does not equal reimbursement. That is the core problem.
And, to make matters worse, there is a dichotomy between device and pharmaceutical adoption. Device adoption requires navigating four distinct steps:
- FDA clearance or approval
- CPT or HCPCS coding
- Coverage determination
- Payment assignment
Any one of these can fail. Devices may receive codes with no assigned payment. They may fall into ambiguous benefit categories: not clearly durable medical equipment, not surgical, not pharmacy. The result is a coverage vacuum.
Manufacturers must then spend years navigating local coverage determinations (LCDs), fragmented commercial payer policies, and duplicative evidence demands that often exceed what the FDA already required for clearance.
Drugs face no comparable gauntlet.
After FDA approval, pharmaceuticals move into an established system: National Drug Codes (NDCs) are assigned, formularies are created and coverage—while managed—is expected. Medicare Part D plans must generally cover drugs within protected classes.1
For drugs, the conversation after FDA approval is typically, “How do we cover it?”
For devices, the conversation remains, “Prove more.”
A 2023 analysis found that only 44% of novel technologies reached meaningful coverage within a median of 5.7 years after FDA authorization.2 In contrast, approximately 90% of new drugs were adopted by at least one Medicare plan within the first year.3
This is not an argument against evidence.
It is an argument for alignment.
When “investigational” persists after approval
FDA clearance requires demonstration of safety and effectiveness within defined use parameters.4sup> Yet payers often require additional long-term or real-world data before even considering coverage, labeling devices investigational in the interim.
If FDA clearance is meaningful, reimbursement policy should reflect it.
If FDA clearance alone is insufficient, then the evidentiary bar for coverage should be explicit from the outset.
A high bar is manageable. An undefined bar is destabilizing.
Uncertainty deters investment and stifles innovation. Investors withdraw when the pathway to reimbursement is opaque. Capital shifts toward pharmaceuticals, where coverage pathways are more predictable.
Meanwhile, the clinical need is clear. Sleep disorders are linked to cardiovascular risk, metabolic disease, workplace accidents and reduced quality of life.5-7 Patients need effective, evidence-based treatment options, including non-pharmacologic therapies.
When those non-pharmacologic therapies are cleared but not covered, patients are not given choice; they are given fewer options and abandonment.
This is not a failure of science.
It is a failure of policy.
A path forward: alignment and transitional coverage
Greater alignment between the FDA, the Centers for Medicare and Medicaid Services (CMS) and commercial payers is essential.
One solution is earlier payer engagement during FDA pre-submission, allowing manufacturers to generate evidence that satisfies both regulatory and coverage requirements.
CMS’s Coverage with Evidence Development (CED) pathway was designed to bridge this gap, offering conditional reimbursement while additional data are collected.8
In theory, it balances access and evidence. In practice, however, it often delays both.
Of 27 devices that have entered the CED pathway, only four have exited with national coverage, taking 4-12 years to reach that mark.8
Lessons from sleep medicine
Hypoglossal nerve stimulation illustrates a more functional model. After FDA approval in 2014, coverage expanded gradually through Local Coverage Determinations, registry participation and real-world evidence (e.g., STAR and ADHERE).9-10 Over time, access followed data.
Newer technologies, like the Nidra Tonic Motor Activation (TOMAC) system, a wearable electrical stimulation device for moderate-to-severe restless leg syndrome (RLS), are now entering a similar pathway. FDA authorization was granted in 2023. A positive conditional recommendation by the American Academy of Sleep Medicine (AASM) Clinical Practice Guidelines followed in 2024 along with dedicated reimbursement codes (E0743/A4544). Ongoing registry-based evidence generation is now underway (THRIVE study) involving 325 patients intended to support broader payer adoption11. Whether coverage will follow remains uncertain.
From evidence to access
The device reimbursement gap is not a scientific problem. It is a systems problem. We have built a framework in which regulatory approval does not translate into patient access. We demand evidence, receive it and then delay coverage pending more evidence.
The consequences are predictable: delayed adoption, reduced innovation and fewer patient choices.
If we believe in evidence-based medicine, FDA authorization must carry real weight in coverage decisions. Transitional reimbursement models, structured registries and coordinated FDA–CMS alignment are not radical ideas, they are logical extensions of the system we already have.12
Reimbursement policy should not determine which innovations survive.
Sleep medicine — and the patients it serves — deserve better.
