Device-Aided Continuous Dopamine Infusion • Medical Necessity & Prior Authorization

Duopa (PEG-J Pump) & Vyalev (24-Hr Subcutaneous Infusion) — Medical Necessity Checklist

Billing & Coverage Codes: Duopa: HCPCS J7340 (Carbidopa 5 mg / Levodopa 20 mg Enteral Suspension per 100 mL) + External Infusion Pump DME • Vyalev: NDC 00074-0501-xx (Foscarbidopa / Foslevodopa Subcutaneous Solution)

Important Policy Notice — Not a Guarantee of Approval: Clinical coverage criteria change periodically and your health plan's official Evidence of Coverage and clinical policy determination are final. This checklist summarizes published CMS and commercial payer policies for educational preparation and is never a guarantee of approval.

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Plain-English Clinical Documentation Checklist

What Your Neurologist / Care Team Must Document in the Chart Note

Because Duopa and Vyalev cost $85,000–$130,000+ per year at list price, Medicare and commercial insurers require strict documentation that oral medications can no longer control the patient's daily 'OFF' periods:

1Prescribed by (or in consultation with) a neurologist or movement-disorder specialist for a confirmed diagnosis of advanced levodopa-responsive Parkinson's disease.

2Documented persistent, disabling motor fluctuations with typically ≥ 2.5 to 3+ hours per day of 'OFF' time (or severe troublesome dyskinesia) despite optimized oral carbidopa/levodopa dosing (typically ≥ 4–5 doses/day).

3Documented trial, inadequate response, intolerance, or contraindication to at least TWO classes of oral adjunctive Parkinson's medications: (1) Dopamine Agonist (pramipexole, ropinirole, rotigotine), (2) MAO-B Inhibitor (rasagiline, selegiline), and/or (3) COMT Inhibitor (entacapone).

4For Duopa specifically: gastroenterology clearance and confirmed placement (or scheduled placement) of a percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) tube.

5For Vyalev specifically: confirmation that the patient or a trained family caregiver can safely manage daily subcutaneous cannula site rotation and pump cartridge changes.

6For Re-Authorization (typically required every 6–12 months): chart documentation showing measurable clinical reduction in daily 'OFF' hours compared to baseline.

Published Clinical Policy Citations

CMS Medicare & Major Commercial Payer Policies

Medicare Part B DMEPOS (Duopa HCPCS J7340) & Medicare Part D (Vyalev)Verified Oct 2026

CMS Medicare Benefit Policy Manual Ch. 15 § 110.3 (External Infusion Pumps) & Part D Specialty Prior Authorization Criteria

Duopa is covered under the Part B Durable Medical Equipment external infusion pump benefit for advanced levodopa-responsive PD with severe motor fluctuations; Vyalev is covered under Part D Specialty formulary/exception criteria (subject to the $2,100 annual Part D cap).

View Official Source Policy (https://www.cms.gov/medicare-coverage-database/)

Anthem / Blue Shield / UHC / Aetna / Cigna Specialty Pharmacy PoliciesVerified Oct 2026

Commercial Specialty Drug Clinical Criteria — Duopa (carbidopa/levodopa enteral) & Vyalev (foscarbidopa/foslevodopa)

Requires prescription by a neurologist, confirmed levodopa responsiveness, persistent OFF time despite oral carbidopa/levodopa plus ≥ 2 adjunctive drug classes, and no concurrent non-selective MAO inhibitor use.

View Official Source Policy (https://www.anthem.com/ca/provider/policies/clinical-guidelines/)

Other Parkinson's Medical Necessity Checklists

DBS Surgery (CPT 61885 / 61867)DaTscan SPECT (CPT 78803 + A9584)PT / OT / Speech & LSVT (CPT 97110, 97535, 92507)Home Health Care (CPT 99349 / G0151 / G0153)Brand Parkinson's Drugs Prior Auth