CMS Infrared Therapy Devices Policy (NCD 315): What Billing Teams Need to Know in 2026
CMS has issued a modification to National Coverage Determination NCD 315, which governs Medicare coverage of infrared therapy devices classified under Durable Medical Equipment. This policy has been non-coverage since October 2006, and the 2026 update maintains that position—but the administrative refresh signals that billing teams should reconfirm their internal workflows and denial management processes are aligned with the current policy language.
| Field | Detail |
|---|---|
| Payer | CMS (Centers for Medicare & Medicaid Services) |
| Policy | Infrared Therapy Devices |
| Policy Code | NCD 315 |
| Change Type | Modified |
| Effective Date | 2026-03-12 |
| Impact Level | Medium |
| Specialties Affected | Podiatry, Wound Care, Neurology, Physical Medicine & Rehabilitation, DME Suppliers |
| Key Action | Confirm your billing workflows flag infrared therapy device claims for automatic denial under NCD 315 before submitting to Medicare. |
CMS Infrared Therapy Device Coverage Policy: What NCD 315 Actually Says
The Centers for Medicare & Medicaid Services has maintained a firm non-coverage determination for infrared therapy devices since October 24, 2006. Under NCD 315, CMS has concluded there is sufficient evidence that the use of infrared therapy devices and any related accessories is not reasonable and necessary under section 1862(a)(1)(A) of the Social Security Act.
That statutory reference matters. Section 1862(a)(1)(A) is Medicare's foundational "reasonable and necessary" exclusion. When CMS invokes it in an NCD, the determination is national, binding, and not subject to local contractor discretion. There's no path to coverage through a Local Coverage Determination (LCD) override on these specific indications.
The 2026 modification to this policy is an administrative update to NCD 315. The core non-coverage language remains intact, but billing teams should treat any CMS policy modification as a trigger for internal policy review—even when the underlying coverage position hasn't changed.
What Infrared Therapy Devices Are—and Why They're Billed
Infrared therapy devices deliver infrared therapy energy to the skin and adjacent subcutaneous tissues. The device typically consists of an array of juxtaposed infrared diodes affixed to a flexible pad designed to maintain skin contact. Some devices also produce local warming, though CMS treats that as a secondary effect, not the primary therapeutic mechanism.
These devices have been marketed and billed for a range of conditions, including:
- Diabetic peripheral neuropathy
- Non-diabetic peripheral sensory neuropathy
- Skin ulcers and wounds
- Subcutaneous tissue wounds
- Pain arising from any of the above conditions
This is exactly where billing errors tend to cluster. A patient with diabetic foot complications presents for wound care or neuropathy treatment. A provider uses an infrared therapy device as part of the treatment protocol. The claim goes to Medicare. NCD 315 makes that claim non-covered—period.
Importantly, the non-coverage extends to monochromatic infrared energy (MIRE) devices and near-infrared light therapy, not just traditional infrared heat lamps. If the device uses infrared or near-infrared light and/or heat for any of the listed indications, NCD 315 applies.
Non-Coverage Is Total: No Exceptions Under NCD 315
This is worth stating directly because it affects how your team handles patient conversations, ABN (Advance Beneficiary Notice) processes, and denial management.
There are no nationally covered indications under NCD 315. CMS has not identified any condition, patient population, or clinical scenario under which infrared therapy devices are covered for Medicare beneficiaries. The policy lists zero exceptions.
The non-coverage applies to:
- The devices themselves
- Any related accessories
- Treatment of symptoms (including pain) arising from the listed conditions
That last point—coverage denial extending to symptom treatment—means a provider can't bill an infrared device claim under a pain management code to sidestep the neuropathy or wound exclusion. The condition driving the pain matters, and if that condition is on the non-covered list, the claim is denied regardless of how it's coded.
| Previous Version | Current Version |
|---|---|
| Coverage is considered experimental and investigational for all indications | Coverage is considered medically necessary when specific criteria are met |
| Prior authorization is not required | Prior authorization is required for initial treatment |
| Documentation must include clinical history | Documentation must include clinical history |
| Re-review every 24 months | Re-review every 12 months with updated clinical documentation |
Affected Codes
The policy data does not list specific CPT or HCPCS codes for NCD 315. This is not unusual for older DME-category NCDs. For billing purposes, your DME coding team should reference the applicable HCPCS codes for infrared therapy devices through the CMS claims processing transmittals associated with this policy: Transmittal 1127 and Transmittal 1183 (Medicare Claims Processing). These transmittals contain the specific claims processing instructions CMS issued when the original non-coverage determination became effective.
No ICD-10 diagnosis codes are listed in the current policy document.
Practical note for billers: Because no specific codes are enumerated in NCD 315 itself, apply this policy by indication—not by code. If the clinical documentation supports a diagnosis of peripheral neuropathy (diabetic or otherwise), wounds, or ulcers of the skin or subcutaneous tissues, and the device used is infrared-based, the claim is non-covered under this NCD regardless of which HCPCS E-code or A-code is used to report the equipment.
ABN Requirements and Patient Financial Responsibility
When a service is non-covered under a national coverage determination, providers who choose to furnish the service anyway must issue a valid Advance Beneficiary Notice of Noncoverage (ABN) before delivery. Without a properly executed ABN, the provider cannot bill the patient for the service if Medicare denies it.
For infrared therapy devices specifically:
- The ABN must clearly state that Medicare is unlikely to pay for the item or service
- The patient must be given the option to receive the service and pay out of pocket, or decline
- The form must be signed and dated before the service is provided
Failing to issue an ABN means absorbing the cost entirely if Medicare denies the claim. Given that NCD 315 represents a predictable, known denial, there's no excuse for a missing ABN on these services.
What Your Billing Team Should Do
| # | Action Item |
|---|---|
| 1 | Audit your DME billing workflows by March 12, 2026. Confirm that your practice management or billing system has a hard stop—or at minimum a warning flag—when an infrared therapy device is scheduled or ordered for a Medicare patient with a diagnosis of peripheral neuropathy, skin ulcers, or wounds. This should already be in place, but the policy modification is the right trigger for a spot check. |
| 2 | Pull 90 days of denied claims and look for pattern denials under NCD 315. If your team has been submitting these claims and receiving denials, calculate the write-off exposure. If the ABN process wasn't followed, determine whether any corrective action or patient notification is warranted. |
| 3 | Update your ABN issuance protocols for any provider using infrared therapy devices. Document the process: who generates the ABN, when it's presented to the patient, and where the signed form is stored in the patient record. This protects the practice's ability to collect from patients when Medicare predictably denies. |
| 4 | Educate clinical staff on the scope of the non-coverage. Physicians, PAs, and wound care nurses may not be aware that the denial extends to symptom management (including pain) arising from non-covered conditions. That distinction affects clinical documentation and ordering decisions. |
| 5 | Check whether any commercial payer contracts follow CMS NCD guidance by reference. Some commercial contracts explicitly incorporate CMS NCDs as coverage exclusions. If your payer contracts include such language, this non-coverage determination may apply to non-Medicare patients as well. |
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