CurrentPremera BluecrossPolicy N/A

5.01.633 Intraarticular Corticosteroids

Defines medical necessity criteria, documentation, coding, and utilization limits for Zilretta (extended-release triamcinolone acetonide) administered intra-articularly for moderate to severe osteoarthritis pain of the knee; covers medical-benefit management and states investigational status for other indications.

Policy Summary

PayerPremera Bluecross

Policy5.01.633 Intraarticular Corticosteroids

Policy CodePolicy N/A

Change TypeAdministrative revision (removed non-formulary exception reference)

Effective DateJun 1, 2026

Next Review Date

Key ActionProviders must document that all medical necessity criteria are met (age ≥18, confirmed knee OA, no prior Zilretta in requested knee, prior therapy trials) and submit medical records for review; initial authorization may be approved up to 1 month.

SourceLink

POLICY UPDATE CHANGES

06/01/26 Annual Review, approved May 25, 2026. Removed reference to non-formulary exception reviews.

06/01/23 New policy effective for dates of service on or after September 1, 2023, added coverage criteria and HCPCS code J3304 for Zilretta.

05/01/25 Annual Review clarified FDA dosing/administration note and non-formulary exception authorization duration.

1Covered drug (Zilretta) indication

1HCPCS code listed

1Lifetime injections allowed per knee

Coverage Summary

This policy covers Zilretta (triamcinolone acetonide extended‑release), an intra‑articular, extended‑release corticosteroid formulation studied for knee osteoarthritis pain. Trials demonstrated a statistically significant reduction in pain versus placebo (primary endpoint: weekly mean Average Daily Pain at week 12; LS mean reduction -3.12 for Zilretta vs -2.14 for placebo; p < 0.0001).

Effective date: 2026-06-01; Last review: 2026-05-25. The coverage stance is mixed: Zilretta is covered only for a specific population and conditions—moderate to severe knee osteoarthritis when conservative therapies have failed—with defined documentation, coding (HCPCS J3304), and utilization limits (single 32 mg injection per knee per lifetime).

Threshold summary

Age>= 18 years

Minimum age18+

Dose per injection32 mg (single-dose intra-articular)

Prior oral NSAID trial duration3 months (inadequate response or intolerance)

Prior intra-articular corticosteroid injectionsAt least 2 injections of methylprednisolone acetate, triamcinolone, betamethasone, or dexamethasone in the requested knee

Lifetime injections allowed per knee1

Medical Necessity for Zilretta (intra-articular, knee)

Zilretta may be considered medically necessary when ALL of the following are met:

ALL of the following

Individual is aged 18 years or older>= 18 years
Supported by policy age consideration
Confirmed diagnosis of osteoarthritis of the knee
Has not received prior treatment with Zilretta in the requested knee
Prior conservative therapies
- Required therapies (both required)

Investigational / Not Medically Necessary

Use of Zilretta is considered investigational when not meeting the above criteria or for other indications:

ANY of the following

Use of Zilretta for all other indications is considered investigational
Re-authorization or additional injections following administration of one injection are considered investigational
Future re-authorization after one injection is investigational

Re‑authorization or additional intra‑articular injections after the single approved dose are considered investigational and are not approved. Providers should be aware that requests for repeat injections beyond the one 32 mg injection per knee per lifetime are subject to denial under the policy.

Coding

HCPCS - ZilrettaHCPCSCovered

J3304

Injection, triamcinolone acetonide, preservative-free, extended-release, microsphere formulation (Zilretta), 1 mg

Provider Actions / Billing Impact

Prior Authorization

Prior authorization required for Zilretta

Prior authorization is required. Providers must document that all medical necessity criteria are met (age ≥18, confirmed knee OA, no prior Zilretta in the requested knee, prior therapy trials) and submit medical records for review. Initial authorization may be approved for up to 1 month.

HCPCS J3304

Documentation Required

Required medical record documentation

Office visit notes and submitted medical records must support medical necessity and include the following elements to support coverage determination.

Diagnosis
Relevant history

Background & Evidence

Zilretta is an extended‑release formulation of triamcinolone acetonide intended for intra‑articular administration for knee osteoarthritis. Randomized trials demonstrated pain reduction versus placebo (week 12 ADP LS mean reduction -3.12 vs -2.14; p < 0.0001). The policy scope is limited to use for moderate to severe knee osteoarthritis after failure or intolerance of specified conservative therapies.

Key evidence

RCT primary endpointSignificant reduction in weekly mean Average Daily Pain at week 12 vs placebo (LS mean reduction -3.12 for Zilretta vs -2.14 for placebo; p < 0.0001)

Term	Definition
Mild knee osteoarthritis	Individuals with low or intermittent knee pain with mostly well-preserved joint function and quality of life.
Moderate/severe knee osteoarthritis	Individuals with constant pain which significantly impairs functionality, daily activity, and quality of life.

Revision History

06/01/23added

Material: New policy created (approved May 9, 2023) effective for dates of service on or after September 1, 2023; added coverage criteria for Zilretta and added HCPCS code J3304.

05/01/25clarified

Clarified that medications listed are subject to the product's FDA dosing and administration prescribing information and clarified non-formulary exception review authorizations may be approved up to 12 months.

06/01/26revisedLatest

Administrative revision: removed reference to non-formulary exception reviews; no clinical policy statement changes noted.