Prior authorization required; InterQual criteria will be used

Prior authorization is required; Fallon will apply InterQual® CP: Procedures, Stereotactic Introduction Subcortical Electrodes (InterQual criteria in effect on the date of service) to determine medical necessity effective 08/01/2024. Medtronic Activa HDE considerations for patients ≥7 years are reviewed case-by-case for members <18 years.

• InterQual® CP: Procedures, Stereotactic Introduction Subcortical Electrodes is the referenced criteria set.
• Effective for dates of service on or after August 1, 2024, Fallon Health will use InterQual® Criteria for DBS.

Obtain prior authorization for DBS procedures and device implantation/revision

Prior authorization is required for DBS procedure and device codes; submissions must include the clinical indication, prior medical therapy trials, and documentation of multidisciplinary evaluation and provider/facility experience.

• Procedure and device CPT codes listed in the policy (e.g., 61863–61868, 61880, 61885–61888 and programming/analysis codes) require prior authorization.
• Include documentation of prior medical therapy trials and multidisciplinary team evaluation.
• Provider/facility criteria and experience must be documented per the policy.

Follow Medicare and MassHealth rules for authorization and medical necessity

Authorization and medical necessity determinations follow applicable CMS NCDs/LCDs for Medicare Advantage members and MassHealth medical necessity guidelines for MassHealth members; NaviCare and PACE follow Medicare then MassHealth/Interdisciplinary Team rules as described.

• Fallon complies with CMS NCDs/LCDs and Medicare statutes/regulations for Medicare Advantage determinations.
• Fallon generally follows MassHealth Medical Necessity Guidelines for MassHealth members and follows Medicare then MassHealth for NaviCare members.
• PACE members require authorization by the interdisciplinary team.

Document trial and failure or intolerance of optimal medical therapy

Document that optimal conservative medical therapy was tried and either failed or was not tolerated prior to DBS consideration; examples include oral medications and botulinum toxin where applicable.

• Document trials of relevant oral medications (anticholinergics, benzodiazepines, baclofen) and botulinum toxin when applicable.
• State that therapies were ineffective or not tolerated and provide dates/dosing where possible.

Show dystonia is refractory to medical therapy (document specific failed trials)

For dystonia candidates, document failed trials of appropriate medical therapies (anticholinergics, benzodiazepines, botulinum toxin, baclofen, neuroleptics and/or intrathecal baclofen) demonstrating refractory dystonia prior to DBS referral.

• All patients in pediatric series were described as poorly responsive or refractory to medical therapy with failed trials of listed agents.
• Specify which agents were tried, duration, and responses.

Step therapy not specified — check member benefit plan

This policy does not specify a formal step therapy program; coverage and any step requirements depend on the member's benefit plan terms and applicable mandates.

• Check the member's Evidence of Coverage for plan-specific exclusions or limitations that may affect authorization.
• If benefit plan conflicts with policy, the benefit plan provisions govern.

Include diagnosis criteria, severity scales, therapy response, and provider/facility qualifications

Provide documentation demonstrating diagnosis criteria and severity scales (e.g., Fahn‑Tolosa‑Marin tremor scale, Hoehn and Yahr or UPDRS III for PD), prior optimal medical therapy and response, and evidence the provider and facility meet required training and experience.

• For ET/tremor-dominant PD, include Fahn‑Tolosa‑Marin score showing level 3 or 4 in the extremity intended for treatment.
• For PD, document L-dopa responsiveness and severity (Hoehn & Yahr or UPDRS III).
• Document neurosurgeon and operative team training, movement disorder physician involvement, and facility imaging/OR/support services.

Submit pre- and post-programming rating scales and video documentation

Provide pre- and post-programming standardized dystonia rating scales (e.g., Barry‑Albright, Burke‑Fahn‑Marsden) and video documentation when available; note that initial programming often requires ≥2 hours and follow-up sessions are typically scheduled every 2–4 weeks for 6–12 months.

• Complete standardized rating scales and video prior to the first programming session and periodically thereafter.
• Document duration of programming sessions (initial session often ≥2 hours) and planned follow-up schedule.

Use and document implantable neurostimulator L-codes

When billing for implanted devices, use the listed L-codes for implantable neurostimulator devices (L8679, L8681, L8686–L8689) and document device codes and any applicable ICD coding consistent with policy guidance.

• Device L-codes listed in the policy must be used for implantable neurostimulator pulse generators and related external components.
• Document the specific device L-code(s) and ensure procedural CPT coding is consistent with device implantation or replacement guidance.

Coverage exclusions that will trigger denial if present

Coverage is denied for excluded indications including non‑idiopathic Parkinson's disease or Parkinson's Plus syndromes, significant cognitive impairment or psychiatric/substance abuse that interfere with benefit, structural lesions causing the movement disorder, prior movement disorder surgery in the affected basal ganglion, or significant comorbidities contraindicating DBS.

• DBS is not covered for non‑idiopathic PD or Parkinson's Plus syndromes.
• Cognitive impairment, current psychosis, alcohol or drug abuse, structural lesions, prior movement disorder surgery in affected basal ganglion, and significant comorbidities are exclusions.

Document age, refractory status, disability and consistent coding to avoid denial

Ensure documentation shows the patient meets generally accepted criteria (e.g., age ≥7 years for pediatric HDE consideration, dystonia refractory to medical treatment, and significant disability); missing age, therapy failure, disability, or inconsistent procedure/device coding may lead to denial.

• Pediatric GPi DBS under HDE requires age ≥7 years (requests for ≥7 and <18 reviewed case-by-case).
• Document specific failed therapies, level of disability, and consistent CPT/HCPCS coding to support medical necessity.

Verify member benefit plan for exclusions or limitations

Coverage may be denied or limited if the member's benefit plan excludes the service or contains other limitations; always verify the member's Evidence of Coverage as plan provisions govern when discrepant with this policy.

• Consult the product's Evidence of Coverage for exclusions or benefit limitations.
• Applicable state mandates or federal mandates may override plan provisions where specified.