Does Q5168 require prior authorization?

No, Q5168 does not require prior authorization (high confidence). Covered without prior authorization.

What is the Medicare reimbursement rate for Q5168?

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

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`Q5168`, Injection, ranibizumab-leyk (nufymco), biosimilar, 0.1 mg

HCPCS/CPT

Prior Authorization

No Prior Auth Required

Covered without prior authorization (high confidence)

Medicare Pricing

Work RVU

0.00

Facility

N/A

Non-Facility

N/A

Documentation Required

Initial therapy requires diagnosis, maximum 12 intravitreal VEGF/dual VEGF-Ang-2 inhibitor doses per year per eye, and authorization for up to 12 months.
Coverage determinations for off-label use require supporting peer-reviewed literature, specialty consultant advice as indicated, and reference to accepted standards of medical practice; documentation of these sources must be provided for review.

Provider requests to add an off-label use must be submitted in writing with supporting data consisting of either at least two Phase III trials demonstrating safety and effectiveness, or if no Phase III evidence exists, at least two large Phase II trials from different centers or other overwhelming Phase II evidence for rare diseases.

Specific drug approvals require condition-specific documentation (e.g., biopsy confirmation for dense deposit disease, diagnosis of HHT with AVMs for bevacizumab, documentation of refractory status for infliximab uses, pretreatment evaluation and prior therapy failure for endometriosis).

Key Coverage Criteria

Initial therapy for ophthalmologic VEGF/Ang-2 inhibitors requires (1) diagnosis, (2) intravitreal VEGF or dual VEGF/Ang-2 inhibitor administration limited to 12 doses per year per eye, and (3) authorization for a maximum of 12 months.
Eylea (aflibercept) is proven and medically necessary for diabetic macular edema, diabetic retinopathy, macular edema following retinal vein occlusion, neovascular age-related macular degeneration, and retinopathy of prematurity.
NGS covers leuprolide acetate (LHRH analog) as palliative treatment of advanced breast carcinoma in premenopausal and perimenopausal women.
A drug use is covered if it is an FDA-approved labeled indication or is a medically accepted off-label indication supported by one of the accepted compendia at the specified levels (AHFS-DI supportive; NCCN Category 1 or 2A; Micromedex DrugDex Class I/IIa/IIb or Clinical Pharmacology supportive; Lexi-Drugs Evidence Level A) or by articles or LCDs published by National Government Services (NGS).
Off-label uses in anti-cancer chemotherapeutic regimens are covered when they meet the Medicare definition of a medically accepted indication per the Medicare Benefit Policy Manual (Pub 100-02, Ch.15, §50.4.5).
Medicare pays for an FDA-approved injectable drug when it was injected on or after the FDA approval date, is reasonable and necessary for the individual patient, and all other coverage requirements are met.

5 Active Policies

NGS-J6-L33394, Drugs and Biologicals, Coverage of, for Label and Off-Label Uses

NGS-JK-L33394, Drugs and Biologicals, Coverage of, for Label and Off-Label Uses

UHC-POL-ophthalmologic-vegf-inhibitors, Ophthalmologic Vascular Endothelial Growth Factor (VEGF) Inhibitors

UMR-POL-UMR-ophthalmologic-vegf-inhibitors, Ophthalmologic Vascular Endothelial Growth Factor (VEGF) Inhibitors

SUREST-POL-SUREST-ophthalmologic-vegf-inhibitors, Ophthalmologic Vascular Endothelial Growth Factor (VEGF) Inhibitors

`Q5168`, Injection, ranibizumab-leyk (nufymco), biosimilar, 0.1 mg

Prior Authorization

Medicare Pricing

Documentation Required

Key Coverage Criteria

5 Active Policies

Related Codes

Have a follow-up question?

Q5168, Injection, ranibizumab-leyk (nufymco), biosimilar, 0.1 mg

Prior Authorization

Medicare Pricing

Documentation Required

Key Coverage Criteria

5 Active Policies

Related Codes

Have a follow-up question?

`Q5168`, Injection, ranibizumab-leyk (nufymco), biosimilar, 0.1 mg