CurrentCareSourcePolicy N/A

UTILIZATION MANAGEMENT MEDICAL POLICY

Defines prior authorization recommendation, coverage criteria, dosing/number of injections per product, approved indications (knee osteoarthritis), and situations not recommended for approval for hyaluronic acid derivative intraarticular products under the medical benefit.

Policy Summary

PayerCareSource

PolicyUTILIZATION MANAGEMENT MEDICAL POLICY

Policy CodePolicy N/A

Change TypeAnnual Revision — No criteria changes

Effective DateOct 9, 2024

Next Review Date

Key ActionPrior Authorization is recommended for medical benefit coverage; approvals follow the listed criteria and dosing and requests outside policy will be reviewed case-by-case by a clinician.

SourceLink

POLICY UPDATE CHANGES

Annual Revision, Summary of Changes = No criteria changes.

1Covered Indication (knee osteoarthritis)

≥6 monthsMinimum interval for retreatment

MultipleProducts listed

SeveralNot recommended for use in other joints

Coverage Summary

Policy quick facts and thresholds

Minimum interval for retreatment>= 6 months since last hyaluronic acid injection

Covered IndicationOsteoarthritis of the knee (FDA‑approved indication)

Products listedMultiple (e.g., Euflexxa, Durolane, Gel‑One, Monovisc, Hymovis, Orthovisc, Synvisc, Supartz FX, Gen Visc 850, etc.)

Dose per kneeDose listed is for one knee; each knee treated requires a syringe or vial

Not recommended for use in other jointsUse not recommended for joints other than the knee (e.g., hand, hip, ankle, shoulder, TMJ, adhesive capsulitis, subacromial impingement)

Medical Necessity Criteria

FDA-Approved Indication - Osteoarthritis of the Knee

Approve one course of therapy per treated knee if the patient meets ONE of the following (A or B):

ANY of the following

A) Initial Therapy
- Diagnosis of the knee to be treated is confirmed by radiologic evidence of knee osteoarthritis
  Examples: X-ray, MRI, CT scan, ultrasound
- Patient has tried at least TWO of the following modalities of therapy for osteoarthritis
  - Non-pharmacologic
    At least one course of physical therapy for knee osteoarthritis
    Oral or topical nonsteroidal anti-inflammatory drug(s) [NSAID(s)]
    Examples of oral NSAIDs include naproxen, ibuprofen, celecoxib; topical examples include diclofenac formulations
  - Pharmacologic therapies
    Tramadol (Ultram/XR, generic)
    Acetaminophen
    Duloxetine (Cymbalta, generic)
- The product is administered by or under the supervision of a physician specializing in rheumatology, orthopedic surgery, or physical medicine and rehabilitation (physiatrist)
- At least TWO injections of intraarticular corticosteroids to the affected knee
  This appears in document but placement ambiguous; included as required per initial therapy text
B) Repeat Course
- According to the prescriber, the patient had a response to the previous course of hyaluronic acid derivative therapy for osteoarthritis of the knee and now requires additional therapy
  Examples of a response include reduced joint pain, tenderness, morning stiffness, improved mobility
- At least 6 months have elapsed since the last injection with any hyaluronic acid derivative>= 6 months since last hyaluronic acid injection
- The product is administered by or under the supervision of a physician specializing in rheumatology, orthopedic surgery, or physical medicine and rehabilitation (physiatrist)

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Coding / Product List

Listed product names (drug list)mixed

Euflexxa	sodium hyaluronate injection (Ferring)
Durolane	sodium hyaluronate injection (Bioventus)
Gel-One	sodium hyaluronate injection (Seikagaku/Zimmer)
Gen Visc 850	sodium hyaluronate injection (OrthogenRx)
Gelsyn-3	sodium hyaluronate injection (Bioventus)
Monovisc	high molecular weight hyaluronan injection (Anika)
Hymovis	high molecular weight viscoelastic hyaluronan injection (Fidia)
Orthovisc	high molecular weight hyaluronan injection (Anika)
Sodium hyaluronate 1% injection	Teva
Supartz FX	sodium hyaluronate injection (Seikagaku/Bioventus)

1–10 of 16

1/2

Dose listed is for one knee; if two knees are treated, each knee requires a syringe or vial of product.

Provider Actions / Authorization & Documentation

Prior Authorization

Prior authorization recommended

Prior authorization is recommended for medical benefit coverage; approvals are provided for the number of injections noted in the dosing section. Requests for doses outside of the established policy will be considered on a case-by-case basis by a clinician.

Documentation Required

Verification of prior therapies

Verification of prior therapies (for example, trials of the listed pharmacologic and nonpharmacologic therapies) is required and will be performed by a clinician in the Coverage Review Department when noted in the criteria.

Documentation Required

Radiologic confirmation required

Diagnosis of the knee to be treated must be confirmed by radiologic evidence (examples include X-ray, MRI, CT scan, ultrasound).

Billing Rule

Dose per knee

The dose listed in the dosing section is for one knee. If two knees are being treated, each knee requires its own syringe or vial of product.

Documentation Required

Administration provider specialty

The product must be administered by or under the supervision of a physician specializing in rheumatology, orthopedic surgery, or physical medicine and rehabilitation (physiatrist).

Background, Evidence & Definitions

Hyaluronic acid derivatives treat pain related to knee osteoarthritis by restoring the normal properties (viscosity and elasticity) of synovial fluid. Products vary by source (avian/rooster or chicken comb–derived versus non-avian) and by number of injections per course. Retreatment data are limited; in many cases at least 6 months was required or had elapsed before a repeat course.

Label	Value
Guideline stance	ACR (2019) conditional recommendation against routine use; OARSI (2019) conditional recommendation for use in knee OA

Definitions

TermCourse

DefinitionThe number of injections per product as listed under Dosing (varies by product)

OpenPayer

UTILIZATION MANAGEMENT MEDICAL POLICY

Coverage Summary

Medical Necessity Criteria

Conditions Not Recommended for Approval

Coding / Product List

Provider Actions / Authorization & Documentation

Background, Evidence & Definitions

Revision History