CurrentmhnPolicy CP.PHAR.05

Hyaluronate Derivatives

Coverage and prior authorization criteria for hyaluronate derivative injections (various branded sodium hyaluronate/hyaluronic acid products) primarily for osteoarthritis of the knee; applies to commercial, HIM (medical benefit), and Medicaid lines of business governed by Centene-affiliated health plans.

Policy Summary

Payermhn

PolicyHyaluronate Derivatives

Policy CodePolicy CP.PHAR.05

Change TypeNo material change

Effective Date10.01.08

Next Review Date

Key ActionSubmit documentation (office chart notes, lab results, or other clinical information) demonstrating the member meets all approval criteria.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

multiplebrands listed for PA

6 monthsapproval interval

≥4 weeksrequired NSAID trial

single-useformulation note

J7318–J7332billing codes listed

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Initial Therapy — Osteoarthritis of the Knee

Initial Approval — Osteoarthritis of the Knee (must meet ALL):

ALL of the following

Diagnosis of osteoarthritis (OA) of the knee supported by imaging (e.g., X-ray, MRI).
Prescribed by or in consultation with a rheumatologist, orthopedist, physiatrist, or sports medicine physician.
Inadequate response to physical therapy as directed by a physical therapist.
Failure of a ≥ 4-week trial of one of the following, unless all are contraindicated or clinically significant adverse effects are experienced: (a) oral non-steroidal anti-inflammatory drug (NSAID) at continuous therapeutic (prescription strength) dosing; OR (b) topical NSAID if member is ≥ 75 years old or unable to take oral NSAIDs. (Prior authorization may be required for topical NSAIDs).
Trial of at least one intra-articular glucocorticoid injection with a documented positive but inadequate response (examples include inadequate pain relief, frequent need for rescue medications such as NSAIDs or opioids, inability to increase activity levels, or steroid-induced hyperglycemia), unless contraindicated or history of intolerance. (Prior authorization may be required for intra-articular glucocorticoids).
If request is for a product other than Euflexxa, Monovisc, Orthovisc, Synvisc, or Synvisc One: failure of two of the following, unless clinically significant adverse effects are experienced or all are contraindicated: (a) Euflexxa; (b) Monovisc or Orthovisc; (c) Synvisc or Synvisc One. ^For Illinois HIM requests, the step therapy requirements above do not apply as of 1/1/2026 per IL HB 5395.
Member does not have any of the following: (a) coexistent active inflammatory arthritis other than OA (e.g., rheumatoid arthritis, spondylitis, gouty arthritis) in the targeted knee; AND (b) history of total knee arthroplasty in the targeted knee.
Dose does not exceed one treatment cycle per knee for a 6 month period.

Continuation Therapy — Osteoarthritis of the Knee

Continuation Therapy — Continued Therapy for Osteoarthritis of the Knee (must meet ALL):

ALL of the following

Member meets one of the following: (a) currently receiving medication via the benefit or has previously met initial approval criteria; OR (b) member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B).
Member is responding positively to therapy as evidenced by one or more of the following: decrease in pain symptoms (e.g., improvement in Visual Analog Scale for pain); improvement in ambulation or range of motion; improvement in stiffness; decrease in rescue pain medication use.
Member has not had total knee arthroplasty in the targeted knee.
If request is for a product other than Euflexxa, Monovisc, Orthovisc, Synvisc, or Synvisc One: failure of two of the following, unless clinically significant adverse effects are experienced or all are contraindicated: (a) Euflexxa; (b) Monovisc or Orthovisc; (c) Synvisc or Synvisc One. ^For Illinois HIM requests, the step therapy requirements above do not apply as of 1/1/2026 per IL HB 5395.

Non‑FDA approved indications not addressed in this policy are not authorized unless there is sufficient documentation of efficacy and safety per applicable off‑label use policies (e.g., CP.CPA.09, HIM.PA.154, CP.PMN.53) or evidence of coverage documents.

There is no data to suggest efficacy of hyaluronate derivatives in patients who have had total knee arthroplasty in the targeted knee.

Use of hyaluronate derivatives in joints other than the knee is not supported by the evidence and is not appropriate for coverage (e.g., ankle, hip studies show no consistent benefit).

Step Therapy / Product Selection

Product step therapy requirement	IL HIM exemption (per IL HB 5395)
For requests for a product other than Euflexxa, Monovisc, Orthovisc, Synvisc, or Synvisc One: failure of two of the following comparator groups is required unless clinically significant adverse effects occur or all are contraindicated: (a) Euflexxa; (b) Monovisc or Orthovisc; (c) Synvisc or Synvisc One.
Illinois HIM requests are exempt from the step therapy requirements as of 1/1/2026 per Illinois HB 5395 (step therapy bypass added in 4Q 2025 annual review).

Historical step therapy and policy changes	Notes
4Q 2021: added allowable treatment number per duration to initial and continued criteria (treatment-cycle limits).
4Q 2022–4Q 2024: periodic HCPCS updates (e.g., updated J7321 description, removed J7333) and minor template/line-of-business adjustments; HIM line revised to medical benefit (02.12.24).
4Q 2025: added step therapy bypass for Illinois HIM per IL HB 5395 (effective for HIM requests as of 1/1/2026); P&T approval recorded 11.25.

Coding

HCPCS Codes (selected list beginning)HCPCS

J7318

Hyaluronan or derivative, Durolane, for intra-articular injection, 1 mg

HCPCS Codes (complete list in document)HCPCS

J7320	Hyaluronan or derivative, GenVisc 850, for intra-articular injection, 1 mg
J7321	Hyaluronan or derivative, Hyalgan, Supartz, or VISCO-3, for intra-articular injection, per dose
J7322	Hyaluronan or derivative, Hymovis, for intra-articular injection, 1 mg
J7323	Hyaluronan or derivative, Euflexxa, for intra-articular injection, per dose
J7324	Hyaluronan or derivative, Orthovisc, for intra-articular injection, per dose
J7325	Hyaluronan or derivative, Synvisc or Synvisc-One, for intra-articular injection, 1 mg
J7326	Hyaluronan or derivative, Gel-One, for intra-articular injection, per dose
J7327	Hyaluronan or derivative, Monovisc, for intra-articular injection, per dose
J7328	Hyaluronan or derivative, Gelsyn-3, for intra-articular injection, 0.1 mg
J7329	Hyaluronan or derivative, Trivisc, for intra-articular injection, 1 mg

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Provider Actions & Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required for the hyaluronate derivatives listed below when billed to the medical benefit. For Health Insurance Marketplace (HIM), these products are excluded from the pharmacy benefit and should not be authorized under pharmacy criteria; HIM requests should be reviewed under the medical benefit criteria in this policy. Providers must submit supporting clinical documentation (e.g., office/chart notes, imaging, lab results) demonstrating that the member meets all approval criteria. Inclusion of HCPCS or other codes in this policy is informational only and does not guarantee coverage — verify current professional coding guidance before submitting claims.

Prior authorization required for: sodium hyaluronate (Euflexxa, Gelsyn-3, GenVisc 850, Hyalgan, Supartz FX, Synojoynt, Triluron, TriVisc, VISCO-3), hyaluronic acid (Durolane), cross-linked hyaluronate (Gel-One), hyaluronan (Hymovis, Orthovisc, Monovisc), and hylan polymers A and B (Synvisc, Synvisc One).
For HIM: hyaluronate derivatives are excluded from the pharmacy benefit and must be reviewed under the medical benefit; do not approve under pharmacy criteria.
Providers must submit office chart notes, imaging, labs, or other clinical information to support that all approval criteria are met.
Codes (e.g., HCPCS J7318) are informational only; inclusion does not guarantee coverage — confirm coding prior to claim submission.

Denial Risk

Non‑Covered Indications / Off‑Label Use

Requests for uses that are not FDA‑approved and not specifically addressed in this policy will not be authorized unless sufficient off‑label documentation is provided per applicable off‑label use policies. Refer to CP.CPA.09 for commercial, HIM.PA.154 for HIM medical benefit, and CP.PMN.53 for Medicaid for requirements and evidence standards when requesting coverage for non‑FDA indications.

Non‑FDA approved indications require supporting evidence per referenced off‑label use policies.
Absent sufficient documentation of efficacy and safety, non‑covered indications will be denied.

Step Therapy

Step Therapy Requirement (IL HIM Bypass)

Step therapy requires failure of two preferred comparator products (see policy criteria) prior to approval of a non‑preferred hyaluronate product, unless contraindicated or clinically significant adverse effects are documented. For requests under Illinois Health Insurance Marketplace (IL HIM), the step therapy requirement is bypassed effective 01/01/2026 per IL HB 5395 — IL HIM requests should not be denied for lack of step therapy failure after that date.

Standard step therapy: prior failure of two of the following unless contraindicated or adverse effects: Euflexxa; Monovisc or Orthovisc; Synvisc or Synvisc One.
Illinois HIM: step therapy bypass effective 01/01/2026 per IL HB 5395 — do not enforce the two‑product failure requirement for IL HIM requests dated on/after this effective date.

Billing Rule

HCPCS Coding and Claim Submission Reminder

HCPCS and other coding listed in this policy are provided for informational purposes. Inclusion or exclusion of codes does not guarantee coverage or payment. Providers should reference the most up‑to‑date professional coding guidance prior to claim submission.

Example HCPCS: J7318 = Hyaluronan or derivative, Durolane, for intra‑articular injection, 1 mg.
Coding guidance may change over time; verify codes and descriptors before billing.

Site of Care / Product Handling

Prior Authorization

HIM benefit handling: excluded from pharmacy benefit — apply medical benefit criteria

For Health Insurance Marketplace (HIM) members, coverage of hyaluronate derivatives under the pharmacy benefit is excluded; these agents should be reviewed under the medical benefit and the criteria in this policy applied for medical benefit authorization.

Do not submit PA under the HIM pharmacy benefit; route requests for HIM members to medical benefit review.
Document LOB (HIM) on the request to ensure correct benefit handling.

Documentation Required

Office/infusion center: syringes and vials are single‑use, pre‑filled (one injection/one knee)

All syringes and vials are single‑use (one injection per knee) and syringes are pre‑filled; providers must follow single‑use administration per product labeling when scheduling and billing procedures.

Plan procedures and billing for one injection per knee per labeled syringe/vial.
Refer to product availability table for syringe/vial volumes and per‑injection dosing.

Definitions

OA — definition

DefinitionOsteoarthritis (OA): degenerative joint disease abbreviated as 'OA' in this policy (Appendix A).

Typical requirementDiagnosis of OA of the knee must be supported by imaging (e.g., X‑ray, MRI) per initial approval criteria.

Coverage contextHyaluronate derivatives are indicated for pain from OA of the knee in patients who have failed non‑pharmacologic therapy and simple analgesics.

NSAID — definition

DefinitionNSAID: non‑steroidal anti‑inflammatory drug (abbreviated 'NSAID' in Appendix A).

Therapy requirementInitial therapy requires failure of a ≥4‑week trial of an oral prescription‑strength NSAID (or topical NSAID if ≥75 years or unable to take oral NSAIDs).

Prior authorization notePrior authorization may be required for topical NSAIDs as noted in criteria.

Treatment cycle — definition / notes

DefinitionTreatment cycle: total number of injections per cycle per knee (varies by product; defined in section V Dosage and Administration).

Per-product examplesExamples — Durolane: 1 injection per treatment cycle; Euflexxa: 3 injections; GenVisc 850: 3–5 injections; TriVisc: 3 injections; Monovisc: 1 injection (per label equivalence notes).

Both kneesIf treating both knees, double the number of injections per treatment cycle (treatment cycle measured per knee).

Revision History

2025-07-10policy_revisionLatest

Added step therapy bypass for Illinois HIM per Illinois HB 5395 (documented in 4Q 2025 annual review).

2024-12-04policy_revision

Added physiatrist to the list of specialist prescribers.

2024-07-19policy_revision

4Q 2024 annual review: updated HCPCS code description for J7321 and removed J7333; references reviewed and updated.

2024-02-12policy_revision

Revised HIM line of business to HIM medical benefit because hyaluronates are excluded from the HIM pharmacy benefit.

2024-05-07policy_revision

Removed specialty prescriber exception for New Mexico Community Care.

2021-07-20policy_revision

4Q 2021 annual review: added allowable treatment number per duration to initial and continued criteria; references reviewed and updated.

OpenPayer

Hyaluronate Derivatives

Coverage Criteria

Initial Therapy

Continuation / Renewal Criteria