Does J9201 require prior authorization?

Yes, J9201 requires prior authorization (high confidence). At least one active policy explicitly requires prior authorization.

What is the Medicare reimbursement rate for J9201?

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

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`J9201`, Injection, gemcitabine hydrochloride, not otherwise specified, 200 mg

HCPCS/CPT

Prior Authorization

Prior Auth Required

At least one active policy explicitly requires prior authorization (high confidence)

Medicare Pricing

Work RVU

0.00

Facility

N/A

Non-Facility

N/A

Documentation Required

Documentation of chart notes or medical record documentation of no response to BCG.

Key Coverage Criteria

Coverage of injectable oncology medications is based on NCCN Compendium Categories of Evidence and Consensus (1, 2A, 2B = proven/medically necessary; 3 = unproven/not medically necessary); if NCCN is unavailable, base decisions on FDA labeling.
Authorization up to 12 months for treatment of BCG-unresponsive NMIBC with CIS (with or without papillary tumors) when the drug is used as a single agent inserted intravesically and given once every 3 weeks for up to 6 months, followed by once every 12 weeks for up to 18 months.

Coverage is provided for injectable oncology medications listed in the NCCN Compendium with Categories of Evidence and Consensus of 1, 2A, or 2B as proven and medically necessary; categories with 3 are unproven and not medically necessary.

Coverage is provided for injectable oncology medications listed in the NCCN Compendium with Categories of Evidence and Consensus of 1, 2A, or 2B as proven and medically necessary; Category 3 is unproven and not medically necessary. If NCCN has no compendium, coverage determinations are based on FDA labeling.

Indication: Drug prescribed within FDA-approved dosing regimen.

11 Active Policies

ARKBLUE-GEMCITABINE-BRANDED-INTRAVENOUS-INFUSION-E-G-AVG-BEC867C987, Gemcitabine branded intravenous infusion (e.g., Avgemsi)

BCBSM-2204883-3961826568, INLEXZO (GEMCITABINE)

HEALTHPARTNERS-CC-ENTRY-287010, Oncology - gemcitabine intravesical system (Inlexzo)

MULTI

BCBSNJ-DRUGS-197-9A2A0DDA05, Gemcitabine in sodium chloride injection (Infugem)

MODA-INLEXZO-F154055AA2, Inlexzo (gemcitabine)

EVICORE-HPLAN-CIGNA-729A536F50C8, Q3 - 2026 Cigna MedOnc Master Drug List.pdf

SUREST-POL-SUREST-oncology-medication-clinical-coverage-policy, Oncology Medication Clinical Coverage

EVICORE-HPLAN-HEALTH_PARTNERS_PLANS-4BC80209CCC5, Q3 - 2026 Jefferson Health Plans MedOnc Master Drug List

BCBSTN-4104c817d2, Gemcitabine (Inlexzo) intravesical system

UHC-POL-oncology-medication-clinical-coverage-policy, Oncology Medication Clinical Coverage

UMR-POL-UMR-oncology-medication-clinical-coverage-policy, Oncology Medication Clinical Coverage

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J9201, Injection, gemcitabine hydrochloride, not otherwise specified, 200 mg