Does J7356 require prior authorization?

Yes, J7356 requires prior authorization (medium confidence). Conditional coverage; review criteria to confirm PA need.

What is the Medicare reimbursement rate for J7356?

Medicare facility rate: N/A. Non-facility rate: N/A. Work RVU: 0.00.

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`J7356`, Injection, foscarbidopa 0.25 mg/foslevodopa 5 mg

HCPCS/CPT

Prior Authorization

Prior Auth Required

Conditional coverage; review criteria to confirm PA need (medium confidence)

Medicare Pricing

Work RVU

0.00

Facility

N/A

Non-Facility

N/A

Documentation Required

A Standard Written Order (SWO) must be communicated to the supplier before claim submission and a signed Written Order Prior to Delivery (WOPD) must be received before delivery of DMEPOS base items that require WOPD.

Proof of delivery (POD) documentation must be maintained by the supplier and be made available to the Medicare contractor upon request; claims without appropriate POD will be denied.

For insulin pump coverage, document C-peptide testing (meeting specified thresholds), beta cell autoantibody positivity, comprehensive diabetes education completion, prior multiple daily injection regimen (≥3 injections/day for ≥6 months) with self-adjustments, and documented glucose self-testing frequency (average ≥4 times/day for 2 months prior to initiation or ≥4 times/day during the month prior to Medicare enrollment if previously on a pump).

For inotropic therapy coverage, document failure of guideline-directed medical therapy (GDMT), cardiologist evaluation with training in advanced HF, documented symptomatic improvement on the selected inotropic drug at discharge, and planned three-month re-evaluations by the prescribing provider or heart failure team.

Claims for blinatumomab must document indication, cycle count consistent with coverage (≤9 or ≤4 cycles as applicable), and units of service not exceeding 875 UOS (25 vials) per month; follow related Policy Article coding guidance for UOS reporting.

Suppliers must document that drugs were actually dispensed to the beneficiary, must be licensed in the state where they are physically located, and must meet all applicable federal, state, and local laws to bill for infusion drugs.

Key Coverage Criteria

External infusion pumps (HCPCS E0779, E0780, E0781, E0791) are covered for administration of deferoxamine for treatment of chronic iron overload.
External infusion pumps are covered for administration of anticancer chemotherapy for unresectable primary hepatocellular carcinoma or unresectable colorectal cancer or when the beneficiary refuses surgical excision of the tumor.
External infusion pumps are covered for administration of morphine for intractable cancer pain.
Continuous subcutaneous insulin infusion (pump E0784) is covered for diabetes mellitus when the beneficiary meets either criterion A (C-peptide/autoantibody evidence of insulin deficiency) or B (prior successful insulin pump use before Medicare enrollment) and either criterion C (prior multiple daily injection program with documented deficiencies) or D (prior pump use with documented glucose testing).
External ambulatory insulin infusion pumps that incorporate non-adjunctive CGM dose adjustment are described by HCPCS combination E0784 + E2103 and are covered only if the beneficiary meets all insulin pump criteria and all CGM criteria in Glucose Monitors LCD L33822.
External ambulatory insulin infusion pumps with integrated adjunctive CGM receiver functionality are described by HCPCS combination E0784 + E2102 and are covered only if the beneficiary meets all insulin pump criteria and all CGM criteria in Glucose Monitors LCD L33822 (claims on/after 4/1/2022).

5 Active Policies

ARKBLUE-FOSCARBIDOPA-WITH-FOSLEVODOPA-E-G-VYALEV-C5C479DD2A, Foscarbidopa with foslevodopa (e.g., Vyalev)

HEALTHPARTNERS-CC-ENTRY-281805, Advanced Parkinson’s disease infusions: foscarbidopa and foslevodopa (Vyalev), apomorphine Hcl (Onapgo)

MULTI

POINT32HEALTH-MDMNG-14251, Vyalev (foscarbidopa/foslevodopa)

MULTI

HEALTHNET_OR-HNOR-CARBIDOPA-LEVODOPA-ER-CAPSULES-CREXONT-RYTARY-ENTERAL-SU-94186A93C0, Carbidopa-Levodopa ER Capsules (Crexont, Rytary), Enteral Suspension (Duopa), IR Tablets (Dhivy), Foscarbidopa/Foslevodopa (Vyalev); CP.PMN.238

L33794, External Infusion Pumps

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J7356, Injection, foscarbidopa 0.25 mg/foslevodopa 5 mg