CurrentCentenePolicy CP.PHAR.05

Hyaluronate Derivatives (PDF)

Policy governs medical-benefit coverage and prior authorization criteria for hyaluronate derivatives used to treat knee osteoarthritis (and addresses other/ off-label uses and contraindications), for Commercial, HIM-Medical Benefit, and Medicaid lines of business.

Policy Summary

PayerCentene

PolicyHyaluronate Derivatives (PDF)

Policy CodePolicy CP.PHAR.05

Change TypeAnnual review and coding/step therapy updates

Effective Date10.01.08

Next Review Date

Key ActionProvider must submit documentation (office chart notes, imaging, claims history, prior trial evidence) showing the member meets all approval criteria; prior authorization may be required for topical NSAIDs and intra-articular glucocorticoids.

SourceLink

POLICY UPDATE CHANGES

Added step therapy bypass for Illinois HIM per IL HB 5395 (effective 2026-01-01 noted in policy).

Added physiatrist to specialist prescriber options.

Updated HCPCS code description for J7321 and removed J7333.

Updated HCPCS code description revised for J7322 on 2026-01-06.

YesFDA approved indication

MultipleListed products

6 monthsApproval duration

>=4 weeks

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Coverage Summary

Coverage stance: covered_with_criteria. Scope: Medical-benefit coverage and prior authorization criteria for hyaluronate derivatives to treat knee osteoarthritis for Commercial, HIM-Medical Benefit, and Medicaid. Subject: Hyaluronate derivatives (intra-articular viscosupplementation). Effective date: 2008-10-01; Last review: 2026-01-06.

Key thresholds: No more than one treatment cycle per knee per 6 months; Failure of a ≥ 4-week trial of an oral NSAID at continuous therapeutic (prescription strength) dosing (or topical NSAID if ≥ 75 years old or unable to take oral NSAIDs); step therapy for products other than Euflexxa, Monovisc, Orthovisc, Synvisc, and Synvisc One (two-agent failure) unless contraindicated — Illinois HIM requests are exempt from step therapy per IL HB 5395 effective 2026-01-01.

Key Policy Thresholds & Stats

Treatment frequencyNo more than one treatment cycle per knee per 6 months

NSAID trial duration≥ 4 weeks of continuous therapeutic (prescription-strength) oral NSAID dosing (topical NSAID acceptable if ≥75 y or oral NSAIDs contraindicated)

Approval duration / retreatment intervalApproval duration: 6 months; continued therapy requires ≥6 months since last treatment cycle

Listed hyaluronate productsMultiple (e.g., Euflexxa, Monovisc, Orthovisc, Synvisc/Synvisc One, Durolane, Gel-One, GenVisc 850, Gelsyn-3, Hyalgan, Hymovis, Triluron, TriVisc, Synojoynt)

Treatment cycles vary by productExamples: Euflexxa 3 injections; Monovisc 1 injection; Gel-One 1 injection; Durolane 1 injection; GenVisc 3–5 injections

Initial Therapy Criteria — Osteoarthritis of the Knee

Initial Therapy Criteria — Other Diagnoses / Indications

Continuation Therapy Criteria — Osteoarthritis of the Knee

Continuation Therapy — Other Diagnoses / Indications

Diagnoses / Indications Not Authorized

Provider Actions & Authorization Requirements

Prior Authorization

Prior authorization required

Prior authorization required. Provider must submit documentation (office chart notes, imaging, claims history, prior trial evidence) supporting that the member meets all approval criteria. Note: prior authorization may be required for topical NSAIDs and for intra-articular glucocorticoids.

Documentation Required

Document glucocorticoid response

Documented positive but inadequate response to at least one intra-articular glucocorticoid injection is required. Examples of acceptable documentation are provided in Appendix D (e.g., inadequate pain relief, frequent need for rescue medications, decreased activity, steroid-induced hyperglycemia).

Documentation Required

Imaging confirmation

Applicable Codes

HCPCS codes for hyaluronate derivatives (informational)HCPCS

J7318	Hyaluronan or derivative, Durolane, for intra-articular injection, 1 mg
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 or hymovis one, 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

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Clinical Evidence & Guidelines

Evidence summary: The policy cites major osteoarthritis guidelines including OARSI (2014 and 2019) and the 2019 ACR/Arthritis Foundation guideline as referenced sources for practice guidance. Randomized controlled trials in non-knee joints (ankle and hip) are noted to show mixed or no benefit — for example, ankle RCTs reported no superiority over saline and ankle reviews were heterogeneous, and a multicenter randomized placebo-controlled trial in hip OA found hyaluronic acid was not more effective than placebo at 3 months.

Background context: Hyaluronate derivatives are FDA-indicated for treatment of pain in knee osteoarthritis after inadequate response to conservative therapy and simple analgesics; this policy therefore focuses on knee OA and references the guideline and trial evidence described above to define appropriate use.

Quick Evidence & Updates

Guidelines citedOARSI 2014 & 2019 and ACR/Arthritis Foundation 2019 referenced

RCT evidence notesAnkle/hip RCTs showed mixed or no benefit (e.g., DeGroot 2012 ankle; Richette hip trial showed no benefit)

Regulatory/legislative updateIllinois HIM step therapy bypass added per IL HB 5395 (effective 1/1/2026)

Background & Definitions

Background: Hyaluronate derivatives are FDA-indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and to simple analgesics (e.g., acetaminophen).

The policy lists multiple branded hyaluronate products (e.g., Euflexxa, GenVisc 850, Hyalgan, Supartz FX, Synvisc, Synvisc One, Durolane, Gel-One, Monovisc, Orthovisc, Hymovis, Gelsyn-3, Synojoynt, Triluron, TriVisc, VISCO-3) and establishes medical necessity criteria, contraindications, dosing/treatment cycles, and references to clinical evidence and guidelines.

Definitions: OA = Osteoarthritis.

Definitions: NSAID = Non-steroidal anti-inflammatory drug.

Revision History

07.10.25policy_revision

4Q 2025 annual review added step therapy bypass for Illinois HIM per IL HB 5395; references reviewed and updated. P&T Approval Date = 11.25. (Marked material change in BRIEF.)

12.04.24policy_revision

Added physiatrist to specialist prescriber options (non-material).

07.19.24policy_revision

4Q 2024 annual review: updated HCPCS code description for J7321 and removed J7333 (non-material).