TL;DR: The Centers for Medicare & Medicaid Services modified NCD 65, its osteogenic stimulators coverage policy, with an effective date of January 9, 2026. Here's what billing teams need to know.
This update touches a policy that governs both electrical and ultrasonic bone growth stimulators — devices billed under the durable medical equipment benefit. The CMS osteogenic stimulators coverage policy under NCD 65 Medicare sets specific clinical thresholds your claims must meet. Miss those thresholds, and you're looking at a claim denial. This post covers every coverage criterion, the non-covered exclusions, and the billing guidelines your team needs before January 9, 2026.
Quick-Reference Table
| Field | Detail |
|---|---|
| Payer | CMS (Centers for Medicare & Medicaid Services) |
| Policy | Osteogenic Stimulators |
| Policy Code | NCD 65 |
| Change Type | Modified |
| Effective Date | January 9, 2026 |
| Impact Level | High |
| Specialties Affected | Orthopedic surgery, neurosurgery, spine surgery, DME suppliers, orthopedic billing |
| Key Action | Audit all pending and future osteogenic stimulator claims against the updated NCD 65 medical necessity and documentation criteria before January 9, 2026 |
CMS Osteogenic Stimulators Coverage Criteria and Medical Necessity Requirements 2026
The real issue with NCD 65 is documentation. The coverage criteria are specific — and CMS enforces them strictly. If your supporting records don't line up with the timeline and imaging requirements below, your reimbursement is at risk.
The CMS osteogenic stimulators coverage policy covers two device types: electrical stimulators and ultrasonic stimulators. The rules for each differ. Know which device you're billing before you look at coverage criteria.
Electrical Osteogenic Stimulators
CMS covers both noninvasive and invasive (implantable) electrical stimulators. Each has its own set of nationally covered indications.
Noninvasive electrical stimulators are covered for four indications:
| # | Covered Indication |
|---|---|
| 1 | Nonunion of long bone fractures |
| 2 | Failed fusion — but only after a minimum of nine months has elapsed since the last surgery |
| 3 | Congenital pseudarthroses |
| 4 | As an adjunct to spinal fusion surgery (effective July 1, 1996) for patients at high risk of pseudarthrosis — specifically those with a previously failed spinal fusion at the same site, or those undergoing a multiple-level fusion involving three or more vertebrae (e.g., L3–L5, L4–S1) |
The nonunion threshold matters here. CMS defines nonunion of a long bone fracture as fracture healing that has ceased for three or more consecutive months before treatment begins. You need serial radiographs to prove it. That means at least two sets of images, each covering multiple views of the fracture site, separated by a minimum of 90 days. One set of X-rays won't cut it.
Also: the six-month clock still applies. Under the September 15, 1980 criterion, nonunion is only recognized after six or more months have passed without fracture healing. The April 1, 2000 update added the serial radiograph requirement on top of that — both standards apply together.
Invasive (implantable) electrical stimulators are covered for:
| # | Covered Indication |
|---|---|
| 1 | Nonunion of long bone fractures |
| 2 | As an adjunct to spinal fusion surgery (effective July 1, 1996) — same high-risk pseudarthrosis criteria as the noninvasive device |
The same six-month and serial radiograph documentation rules apply to invasive stimulators for nonunion claims.
Ultrasonic Osteogenic Stimulators
Ultrasonic stimulators have a narrower covered indication. Effective January 1, 2001, CMS covers them as medically reasonable and necessary for the treatment of nonunion fractures.
One firm restriction: ultrasonic osteogenic stimulators cannot be used at the same time as any other noninvasive osteogenic device. If a patient is already on a noninvasive electrical stimulator, billing for a concurrent ultrasonic device creates a medical necessity problem. Your documentation needs to show the devices aren't running concurrently.
Whether this update represents a prior authorization change, your Medicare Administrative Contractor may apply additional local rules on top of NCD 65. Check with your MAC before assuming NCD 65 alone governs your region's requirements.
CMS Osteogenic Stimulators Exclusions and Non-Covered Indications
The policy doesn't cover these scenarios. Bill them and you'll face a claim denial.
Failed fusion under nine months: A noninvasive electrical stimulator for failed fusion is not covered if fewer than nine months have passed since the last surgery. Document the surgery date in your records. CMS will look for it.
Nonunion without sufficient documentation: Nonunion claims without serial radiographs — at least two sets, 90 days apart — will not meet the medical necessity threshold. Single imaging studies don't qualify.
Nonunion before six months: CMS does not recognize nonunion until at least six months have passed without fracture healing. Claims filed before that window closes are not covered.
Concurrent noninvasive device use with ultrasonic stimulators: Billing an ultrasonic stimulator concurrently with another noninvasive osteogenic device falls outside coverage. This is an explicit restriction in the policy.
Spinal fusion with fewer than three vertebral levels: Coverage as an adjunct to spinal fusion surgery applies only to multiple-level fusion — meaning three or more vertebrae. A two-level fusion doesn't qualify under the high-risk pseudarthrosis indication.
Coverage Indications at a Glance
| Indication | Device Type | Status | Notes |
|---|---|---|---|
| Nonunion of long bone fractures | Noninvasive electrical | Covered | Six months without healing + serial radiographs (2 sets, 90 days apart) required |
| Nonunion of long bone fractures | Invasive (implantable) electrical | Covered | Same six-month and serial radiograph requirements apply |
| Nonunion fractures | Ultrasonic | Covered | Effective January 1, 2001; cannot be used concurrently with other noninvasive devices |
| Failed fusion (9+ months post-surgery) | Noninvasive electrical | Covered | Minimum nine months must have passed since last surgery |
| Failed fusion (under 9 months post-surgery) | Noninvasive electrical | Not Covered | Time threshold not met |
| Congenital pseudarthroses | Noninvasive electrical | Covered | No additional time or imaging requirements specified |
| Adjunct to spinal fusion — high-risk pseudarthrosis, previously failed fusion | Noninvasive electrical, invasive electrical | Covered | Effective July 1, 1996; must document prior failure at same site |
| Adjunct to spinal fusion — multiple-level fusion (3+ vertebrae) | Noninvasive electrical, invasive electrical | Covered | Effective July 1, 1996; must involve three or more vertebral levels |
| Adjunct to spinal fusion — fewer than 3 vertebral levels, no prior failure | Noninvasive or invasive electrical | Not Covered | Doesn't meet multiple-level or high-risk criteria |
| Concurrent ultrasonic + other noninvasive device | Ultrasonic | Not Covered | Explicit prohibition in policy |
CMS Osteogenic Stimulators Billing Guidelines and Action Items 2026
Osteogenic stimulator billing lives and dies on documentation timing. These are the steps your billing team and DME suppliers need to take before January 9, 2026.
| # | Action Item |
|---|---|
| 1 | Audit your open osteogenic stimulator claims for documentation completeness. Pull every claim for an electrical or ultrasonic bone growth stimulator that's pending or recently submitted. Check that each file includes the serial radiograph sets — minimum two studies, each with multiple views, separated by at least 90 days. Missing images equal medical necessity failures. |
| 2 | Verify the six-month nonunion threshold in your records. For every nonunion claim, confirm the fracture date in the record and calculate whether six or more months have elapsed without healing. Document this calculation explicitly in the chart note or supporting file. |
| 3 | Confirm surgery dates for all failed fusion claims. For noninvasive electrical stimulator claims tied to failed fusion, your records must show that at least nine months have passed since the last surgery. Pull the operative report and timestamp it against the stimulator order date. |
| 4 | Flag spinal fusion adjunct claims for vertebral level count. For any claim using the high-risk pseudarthrosis indication, your documentation must identify three or more vertebral levels involved in the fusion — or confirm a prior failed fusion at the same site. A two-level fusion claim without documented prior failure at that site won't hold up under NCD 65. |
| 5 | Check for concurrent device billing on ultrasonic stimulator claims. If a patient is receiving ultrasonic osteogenic stimulation, verify they are not simultaneously using another noninvasive osteogenic device. If concurrent use exists in the record, you have a coverage policy violation. Resolve it before the claim goes out. |
| 6 | Contact your MAC for prior authorization requirements specific to your region. NCD 65 is the national floor. Your Medicare Administrative Contractor may require prior authorization or have a local coverage determination that adds criteria on top of NCD 65. Don't assume national coverage is the whole picture. |
| 7 | Update your billing guidelines documentation templates before January 9, 2026. If your DME intake forms or physician order templates don't capture the required imaging dates, surgery dates, and vertebral level counts, fix them now. The effective date is January 9, 2026 — that's your deadline. |
If your practice sees high volume of spine or orthopedic cases and you're not certain how this update applies to your payer mix, talk to your compliance officer before January 9, 2026.
| 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 |
CPT, HCPCS, and ICD-10 Codes for Osteogenic Stimulators Under NCD 65
The policy data provided for NCD 65 does not include specific CPT or HCPCS codes. This is not unusual for an NCD — billing teams typically use HCPCS Level II E-codes for DME equipment claims, but those codes are not enumerated in this version of the policy document.
Work with your DME billing team or MAC to confirm the correct HCPCS codes for:
- Noninvasive electrical bone growth stimulators
- Invasive (implantable) electrical bone growth stimulators
- Ultrasonic bone growth stimulators
Your MAC's local coverage determination or associated billing and coding article will list the applicable HCPCS codes and any diagnosis code requirements. Check your MAC's website directly, or search your internal charge master for the device category.
Do not submit claims without confirmed HCPCS code assignments. And do not invent or assume codes based on similar device categories — osteogenic stimulator billing has a history of audit attention, and incorrect coding compounds documentation problems fast.
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