TheraBionic P1 device coverage (coverage criteria)
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Governs prior authorization and coverage determination for the TheraBionic P1 intrabuccal RF EMF device for Connecticut Medicaid (HUSKY) enrollees; applies to providers requesting coverage under HUSKY A, B, C, and D.
No material clinical or coverage changes in this revision.
Coverage Determination
Not Medically Necessary / Investigational
Coverage determination summary
Applies to all indications including, but not limited to, advanced hepatocellular cancer.
The use of the TheraBionic P1 device is designated investigational and therefore not medically necessary for the treatment of any condition. This investigational status explicitly includes, but is not limited to, treatment of advanced hepatocellular carcinoma. Coverage determinations will follow the Connecticut Department of Social Services definition of Medical Necessity and be made on an individual, case-by-case basis.
Rationale: there is insufficient evidence in peer‑reviewed, published medical literature to establish the safety and clinical efficacy of the TheraBionic P1 system for any indication. Because the available evidence does not meet the standards required to demonstrate medical benefit, the device is designated investigational and will not be considered medically necessary for coverage.
HCPCS / Billing Codes
| E0767 | Intrabuccal, systemic delivery of amplitude modulated, radiofrequency electromagnetic field device, for cancer treatment, includes all accessories |
Provider Responsibilities & Prior Authorization
Prior authorization required for TheraBionic P1 (HCPCS E0767)
Prior authorization is required for the TheraBionic P1 device (HCPCS E0767) for individuals covered under HUSKY A, B, C, and D, effective for requests on or after May 1, 2025.
- HCPCS code: E0767 — Intrabuccal, systemic delivery of amplitude modulated, radiofrequency electromagnetic field device, for cancer treatment, includes all accessories
- Requests are reviewed in accordance with procedures for reviewing durable medical equipment
Step therapy — none specified
No step therapy requirements are specified for the TheraBionic P1 device; there are no limitations applicable.
- Limitations: N/A
Submit case-specific documentation for review
Coverage determinations are made based on review of requested and/or submitted case-specific information following the procedures used for durable medical equipment reviews.
- Provide full case-specific clinical documentation with the prior authorization request for review.
Supporting references may be submitted with requests
Supporting clinical literature, FDA device information, and cited publications may be submitted with requests as part of the case-specific information.
- Examples: peer-reviewed publications, ClinicalTrials.gov entries, and the FDA TheraBionic P1 device page.
Investigational device — denial risk
Use of the TheraBionic P1 device is considered investigational and therefore not medically necessary for the treatment of any condition; requests for this device may be denied on that basis.
- Policy stance: investigational / not medically necessary due to insufficient peer-reviewed evidence of safety and clinical efficacy.
Requests reviewed under DME procedures — prior authorization required
Prior authorization requests for the TheraBionic P1 device are reviewed under durable medical equipment review procedures; lack of prior authorization may result in denial of coverage.
- Authorization is effective for requests on or after May 1, 2025 for HUSKY A, B, C, and D.
- Payment is subject to the member having active coverage and benefits at time of service.
Device Background
Background: the TheraBionic P1 System is a handheld, battery‑operated radiofrequency electromagnetic field generator with an intrabuccal antenna that emits amplitude‑modulated frequencies intended to affect cancer cell division. The device has been proposed for cancer treatments, but based on the current peer‑reviewed literature the evidence is considered insufficient to establish safety and clinical efficacy for clinical use in HUSKY enrollees.
Definitions
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