Pulsed Electrical Stimulation Device for Osteoarthritis of the Knee
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Defines CareFirst coverage stance for pulsed electrical stimulation (PES) devices (e.g., BioniCare/BIO-1000) used to treat osteoarthritis of the knee for members covered under CareFirst plans.
No material clinical or coverage changes in this revision.
Coverage Determination
Coverage determination
Covered when ALL of the following are met
Policy statement from CareFirst
Regulatory rationale
Evidence limitations summarized in rationale
Mont et al. 4-year study limitations
Adjunctive status and lack of comparative evidence
External validity concerns and periodic literature surveillance with no change in conclusions
Pulsed electrical stimulation (PES) devices for treatment of osteoarthritis of the knee are excluded from coverage and considered experimental/investigational.
Use of PES devices for knee osteoarthritis is regarded as not medically necessary/experimental because available evidence is insufficient to demonstrate long‑term net health benefit or equivalence to established alternatives. Clinical studies have been small, short‑term, or nonrandomized, with inconsistent outcomes and limited data on meaningful measures such as joint swelling, range of motion, walking time, and delay of total knee replacement. Periodic literature surveillance (most recently through 2025) found no new evidence to change this conclusion.
Provider Requirements and Actions
Prior authorization required — verify before providing PES devices/services
Check the Prior Authorization Look-up tool (PAL) or call the CareFirst preauthorization number before providing services or devices to confirm whether prior authorization is required for the proposed PES device or related services.
- Use the PAL Tool: https://provider.carefirst.com/providers/medical/in-network-precertification-preauthorization.page
- Or call 1-866-773-2884 (1-866-PRE-AUTH)
No step therapy specified; FDA calls PES adjunctive but comparative evidence lacking
No step therapy protocols for PES devices are specified in this policy; the BIO-1000 is cleared by the FDA as an adjunctive therapy but the policy notes there are no comparative studies demonstrating equivalence to established alternatives.
- PES described by FDA clearance as “adjunctive” therapy
- Policy states insufficient evidence from comparative studies to show PES is as effective as alternatives
Confirm member contract and prior authorization requirements
Verify the member’s contract benefits and prior authorization requirements using CareFirst resources; specific contract provisions or exclusions take precedence over clinical criteria.
- Always check the member’s contract for benefits — contract supersedes clinical criteria
- For prior authorization requirements use the PAL Tool or call 1-866-773-2884
Denial risk — PES devices for OA knee considered experimental/investigational
Requests for pulsed electrical stimulation (PES) devices for treatment of osteoarthritis of the knee will be denied as experimental/investigational under this policy.
- Policy statement: PES devices for OA knee are considered experimental/investigational and not covered
Device Definition
Background and Evidence Summary
Pulsed electrical stimulation (PES) systems (for example, the BIO-1000/BioniCare) are wearable devices that deliver low‑amplitude monophasic pulsed electrical fields to the knee through skin‑contact applicators; they are intended as an adjunctive, symptomatic therapy that may be worn for multiple hours daily. Clinical evaluations have reported outcomes such as pain and physician global assessment, but trials have generally been small, of short duration, or nonrandomized; one longer nonrandomized study used historical controls and was subject to confounding. Overall, the evidence is inconsistent and does not adequately demonstrate sustained improvement in OA symptoms or prevention/delay of total knee replacement.
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