CurrentMass General Brigham Health PlanPolicy 096

Medical Necessity Guidelines — IB-Stim (PENFS)

Clinical medical necessity guidelines for use of the IB-Stim percutaneous electrical nerve field stimulator system, describing coverage criteria and requirements for Mass General Brigham Health Plan members across product lines.

Policy Summary

PayerMass General Brigham Health Plan

PolicyMedical Necessity Guidelines — IB-Stim (PENFS)

Policy CodePolicy 096

Change TypeReformatted policyupdated prior authorization and code list

Effective DateAug 1, 2025

Next Review Date

Key ActionObtain prior authorization (use code 64999) for Mass General Brigham ACO, OneCare, and SCO members before IB-Stim placement.

SourceLink

POLICY UPDATE CHANGES

Updated prior authorization table and added variation for OneCare and SCO members.

Reformatted policy and updated code list.

Ages 11-18ACO pediatric coverage

Not coveredCommercial/QHP stance

≤120 hrs/wkDosage limit

RequiredPrior auth

Coverage Criteria for IB-Stim (PENFS)

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Requests will be denied for members with the following clinical or device-related contraindications. Do not proceed with implantation or use if the member has a cardiac pacemaker, a bleeding disorder such as hemophilia, active psoriasis vulgaris at the intended implantation site, or any infected areas of skin at the implantation site. Also exclude members with a documented history of sensitivity to compound benzoin tincture.

Coverage varies by product line. For Mass General Brigham ACO members the IB‑Stim percutaneous electrical nerve field stimulator may be covered when all ACO medical necessity criteria are met and prior authorization is obtained (use code 64999). For OneCare and Senior Care Options (SCO) members, prior authorization is also required and ACO criteria apply. For Commercial and Qualified Health Plan members and for Medicare Advantage members, IB‑Stim PENFS is considered not covered / experimental or investigational based on limited evidence and conditional guideline recommendations.

Provider Actions, Prior Authorization, and Denial Rules

Prior Authorization

Prior authorization required for ACO, OneCare, and SCO members

Prior authorization is required for Mass General Brigham ACO members (use CPT code 64999). OneCare and SCO members also require prior authorization and follow the Mass General Brigham ACO medical necessity criteria.

Use CPT 64999 for prior authorization requests for ACO members.

Step Therapy

Required prior therapies — trial of ≥3 interventions

Member must have persistent symptoms despite trials of at least three of the specified interventions.

Behavioral modification
Educational interventions or psychotherapy (coping mechanisms such as relaxation, distraction, or guided imagery)
Dietary changes or trigger avoidance
Pharmacologic interventions

Documentation Required

Required clinical documentation for ACO prior authorization

For Mass General Brigham ACO coverage, submit documentation that demonstrates the member's age (11–18), diagnosis meeting IBS or functional dyspepsia criteria, decreased functioning due to symptoms, prior trials and failures of at least three specified interventions, and that the skin at the implantation site is healthy, clean, and intact.

Member age: 11–18 years
Diagnosis meeting the policy definitions for pediatric IBS or functional dyspepsia
Evidence of decreased functioning (e.g., school absence, avoidance of activities) due to abdominal symptoms
Documentation of trials and inadequate response to at least three interventions listed in policy
Clinical note confirming healthy, clean, intact skin at intended implantation site

Denial Risk

Coverage exclusions by product — Medicare Advantage and Commercial/QHP denied

Requests for IB-Stim (PENFS) for Medicare Advantage members and for Commercial and Qualified Health Plan members will be denied as not covered or considered experimental/investigational.

Medicare Advantage: service is not covered per Mass General Brigham Health Plan guidance using CMS policy sources
Commercial and Qualified Health Plans: service is considered experimental/investigational and not covered

Denial Risk

Clinical and safety exclusion triggers for denial

Deny requests if the member does not meet the ACO age or diagnostic criteria, has not failed the required prior therapies, or if exclusionary clinical/safety conditions are present (e.g., cardiac pacemaker, hemophilia, psoriasis vulgaris, infected skin at implantation site, or history of sensitivity to compound benzoin tincture).

Age outside 11–18 years
Diagnosis does not meet defined IBS or functional dyspepsia criteria
Lack of documentation of failure of ≥3 required interventions
Unhealthy, unclean, or non-intact skin at implantation site
Presence of exclusionary conditions: cardiac pacemaker, hemophilia, psoriasis vulgaris, infected skin at implantation site, or sensitivity to compound benzoin tincture

Definitions

Irritable bowel syndrome (IBS) — pediatric (diagnostic summary)

Core symptom frequency and durationRecurrent abdominal pain on average at least 1 day per week in the last 3 months with symptom onset at least 6 months ago

Associated features (need ≥2)Related to defecation; change in stool frequency; change in stool form

Required functional impactDecreased functioning (e.g., school absence, avoidance of activities, social avoidance) despite prior interventions

Functional dyspepsia (diagnostic summary)

Structural evaluation requirementUpper endoscopy shows no evidence of structural disease likely to explain symptoms

Key symptom criteria (need ≥1)Bothersome postprandial fullness; early satiation; epigastric pain; or epigastric fullness

Context of functional impairmentSymptoms must be associated with decreased functioning and persistent despite prior interventions

64567	Percutaneous electrical nerve field stimulation, cranial nerves, without implantation.
64999	Unlisted procedure, nervous system

OpenPayer

Medical Necessity Guidelines — IB-Stim (PENFS)

Coverage Criteria for IB-Stim (PENFS)

Coding and Dosage Information

Provider Actions, Prior Authorization, and Denial Rules

Background

Definitions

Policy Revision History