CurrentCareSourcePolicy N/A

Hyaluronic Acid Derivatives (Intraarticular) — Coverage Criteria for Knee Osteoarthritis

Defines prior-authorization criteria, dosing limits, and coverage exclusions for intraarticular hyaluronic acid derivative products used to treat knee osteoarthritis. Intended for clinicians and billing/authorization staff evaluating requests for these products.

Policy Summary

PayerCareSource

PolicyHyaluronic Acid Derivatives (Intraarticular) — Coverage Criteria for Knee Osteoarthritis

Policy CodePolicy N/A

Change TypeAnnual revision — no criteria changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization with radiologic confirmation and documentation of required prior therapies; ensure administration is by or under supervision of an appropriate specialist.

SourceLink

POLICY UPDATE CHANGES

Annual Revision with no criteria changes noted; review date updated.

One course per treated kneeAuthorization unit

≥ 6 monthsMinimum interval before repeat course

≥2Required conservative/pharmacologic therapy trials before initial approval

SpecialistProvider specialty required for administration

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Medical Necessity Criteria for Intraarticular Hyaluronic Acid — Knee OA

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):

A) Initial Therapy

Diagnosis of the knee to be treated is confirmed by radiologic evidence of knee osteoarthritis
Examples: x-ray, MRI, CT, ultrasound
ALL of the following
- a) Physical therapy
  - At least one course of physical therapy for knee osteoarthritis
- b) Pharmacologic therapies (must meet 'at least TWO' of the list)
  - Oral or topical nonsteroidal anti-inflammatory drug(s) [NSAID(s)]
    A trial of two or more NSAIDs (oral and/or topical) counts as one pharmacologic therapy
  - Acetaminophen
  - Tramadol
  - Duloxetine
- c) Intraarticular corticosteroids
  - At least TWO injections of intraarticular corticosteroids to the affected knee
The product is administered by or under the supervision of a physician specializing in rheumatology, orthopedic surgery, or physical medicine and rehabilitation (physiatrist)

B) Patient has already received one or more courses of a hyaluronic acid derivative in the same knee (repeat course)

At least 6 months have elapsed since the last injection with any hyaluronic acid derivative
Minimum interval for 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 response include reduced joint pain, tenderness, morning stiffness, or improved mobility
The product is administered by or under the supervision of a physician specializing in rheumatology, orthopedic surgery, or physical medicine and rehabilitation (physiatrist)

Dosing / Number of Injections per Course (one knee)

Approve ONE of the following dosing regimens depending on product:

ANY of the following

Durolane, Gel-One, Monovisc, Synvisc-One — One injection
Hymovis — Up to two injections given 1 week apart
Euflexxa, Gelsyn-3, sodium hyaluronate 1% injection (Teva), SynoJoynt, Synvisc, Triluron, TriVisc, Visco-3 — Up to three injections given 1 week apart
Orthovisc — Up to four injections given 1 week apart
GenVisc 850, Hyalgan, Supartz FX — Up to five injections given 1 week apart

Conditions Not Recommended for Approval

Coverage is not recommended in the following situations:

ALL of the following

Acute ankle sprain
Evidence is limited and role not established; not recommended
Osteoarthritis and other pathologic conditions involving joints other than the knee (e.g., hand, hip, ankle, shoulder, TMJ, adhesive capsulitis, subacromial impingement)
Safety and effectiveness in non-knee joints not established per prescribing information and guidelines
Pathologic conditions of the knee other than osteoarthritis (e.g., chondromalacia patellae, osteochondritis dissecans, patellofemoral syndrome, post-ACL reconstruction)
Intraarticular hyaluronic acid derivatives are indicated for knee osteoarthritis only; evidence insufficient for other knee conditions
Any circumstance not listed in the Recommended Authorization Criteria

Products Included and Coding Guidance

Products included in policy (by trade/generic name)mixedCovered

Durolane	sodium hyaluronate injection - Bioventus
Euflexxa	sodium hyaluronate injection - Ferring
Gel-One	sodium hyaluronate injection - Seikagaku/Zimmer
Gelsyn-3	sodium hyaluronate injection - Bioventus
GenVisc 850	sodium hyaluronate injection - OrthogenRx
Hyalgan	sodium hyaluronate injection - Fidia/Sanofi
Hymovis	high molecular weight viscoelastic hyaluronan injection - Fidia
Monovisc	high molecular weight hyaluronan injection - Anika
Orthovisc	high molecular weight hyaluronan injection - Anika
Supartz FX	sodium hyaluronate injection - Seikagaku/Bioventus

1–10 of 17

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Prior Authorization, Documentation, and Denial Risks

Prior Authorization

Prior authorization recommended

Prior authorization is recommended for medical benefit coverage of intraarticular hyaluronic acid products for knee osteoarthritis; approvals are issued per the policy’s Recommended Authorization Criteria and the dosing regimens specified. Requests for doses outside the established dosing documented in this policy will be reviewed on a case‑by‑case basis by a clinician (e.g., Medical Director or Pharmacist).

Documentation Required

Documentation of prior therapies required

When the criteria note '[verification of therapies required]', previous therapy must be verified by a clinician in the Coverage Review Department. Providers must document trials as specified in the criteria, including courses of physical therapy, the required pharmacologic therapies (e.g., NSAIDs, acetaminophen, tramadol, duloxetine), or at least two intraarticular corticosteroid injections to the affected knee.

Documentation Required

Radiologic confirmation required

Radiologic evidence confirming the diagnosis of knee osteoarthritis must be provided for the knee to be treated; examples of acceptable imaging include x‑ray, magnetic resonance imaging (MRI), computed tomography (CT) scan, or ultrasound.

Denial Risk

Denial risk for non-knee joints or non-OA knee conditions

Requests for hyaluronic acid injections for joints other than the knee, or for knee pathologic conditions other than osteoarthritis, are not recommended for approval and are at risk of denial.

Documentation Required

Provider specialty requirement for administration

Product administration must be performed by or under the supervision of a physician who specializes in rheumatology, orthopedic surgery, or physical medicine and rehabilitation (physiatrist).

Key Clinical Thresholds and Authorization Units

Minimum interval for repeat courseAt least 6 months since last hyaluronic acid injection in the same knee

One course per treated kneeAuthorization unit

≥ 6 monthsMinimum interval before repeat course

2 or more prior therapiesRequired conservative/pharmacologic therapy trials before initial approval

Administered by specialistProvider specialty required for administration

Clinical Background

Intraarticular hyaluronic acid derivatives are intended to restore the normal properties of synovial fluid—specifically its viscosity and elasticity—to reduce pain related to knee osteoarthritis in patients who have not responded adequately to conservative nonpharmacologic therapy and simple analgesics (e.g., acetaminophen).

Overall evidence supporting efficacy is limited and guideline recommendations are conditional; professional guidelines note a conditional recommendation against routine use but acknowledge that viscosupplementation may be considered when other alternatives have been exhausted and that benefits may extend beyond 12 weeks in some patients.

Retreatment data are limited, but published product experience and studies generally report data on repeat courses. In many cases a minimum interval of at least 6 months was required or had elapsed prior to administration of a repeat course; therefore repeat courses are typically allowed only after ≥ 6 months since the prior hyaluronic acid injection in the same knee.

This policy is reviewed annually; document history indicates routine annual revisions with no criteria changes (review dates include 09/27/2023 and 10/09/2024).

Defined Terms

Course of therapyThe set number of injections per product administered to one knee as specified in the dosing section (e.g., one injection for Durolane; up to five for GenVisc 850).

Response to prior hyaluronic acid therapyPrescriber-reported improvement such as reduced joint pain, tenderness, morning stiffness, or improved mobility.

Policy Updates

2024-10-09Annual revisionLatest

Annual revision with no criteria changes; review date updated to 10/09/2024.

2023-09-27Annual revision

Annual revision with no criteria changes; review date recorded as 09/27/2023.

Policy Summary

PayerCareSource

PolicyHyaluronic Acid Derivatives (Intraarticular) — Coverage Criteria for Knee Osteoarthritis

Policy CodePolicy N/A

Change TypeAnnual revision — no criteria changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization with radiologic confirmation and documentation of required prior therapies; ensure administration is by or under supervision of an appropriate specialist.

SourceLink

On This Page

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

Criteria will be updated as new published data are available

These situations are not recommended for approval based on available evidence and prescribing information.