CurrentCareSourcePolicy N/A

Hyaluronic Acid Derivatives (Intraarticular) — Medical Benefit Coverage Criteria

Defines prior authorization, coverage criteria, dosing, and situations not recommended for intraarticular hyaluronic acid derivative injections for knee osteoarthritis for CareSource medical benefit members in North Carolina.

Policy Summary

PayerCareSource

PolicyHyaluronic Acid Derivatives (Intraarticular) — Medical Benefit Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateOct 9, 2024

Key ActionObtain prior authorization and verify radiologic confirmation of knee osteoarthritis and prior conservative therapies before approval.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

one courseauthorization units

≥6 mominimum interval

2 injHymovis dosing

up to 5 injGenVisc/Hyalgan/Supartz FX dosing

NCapplicable state

Recommended Authorization Criteria

Policy Summary

PayerCareSource

PolicyHyaluronic Acid Derivatives (Intraarticular) — Medical Benefit Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateOct 9, 2024

Key ActionObtain prior authorization and verify radiologic confirmation of knee osteoarthritis and prior conservative therapies before approval.

SourceLink

On This Page

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Initial and Repeat Therapy Criteria

Covered when ALL of the following are met for initial therapy (A) or repeat therapy (B):

Diagnosis of the knee to be treated is confirmed by radiologic evidence of knee osteoarthritis (X-ray, MRI, CT, or ultrasound).

Examples of radiographic evidence include X-ray, MRI, CT scan, or ultrasound.

Initial therapy prerequisites (A)

Nonpharmacologic: At least one course of physical therapy for knee osteoarthritis OR oral or topical NSAID(s).
Examples of topical NSAIDs include diclofenac solution or diclofenac gel.
Pharmacologic: At least two of: tramadol, acetaminophen, duloxetine, or other listed pharmacologic therapies (trial of two or more NSAIDs, oral and/or topical, counts as one pharmacologic therapy).
Examples of oral NSAIDs include naproxen, ibuprofen, celecoxib.

Provider specialty: Product is administered by or under the supervision of a physician specializing in rheumatology, orthopedic surgery, or physical medicine and rehabilitation (physiatrist).

Repeat therapy prerequisites (B): For repeat course: prescriber documents prior response to previous hyaluronic acid derivative therapy for knee osteoarthritis; at least 6 months have elapsed since the last hyaluronic acid injection; and the product is administered by or under the supervision of a specified specialist.At least 6 months since last hyaluronic acid injection

Examples of response include reduced joint pain, tenderness, morning stiffness, or improved mobility.

Use of intraarticular hyaluronic acid derivatives for acute ankle sprain, osteoarthritis or other pathologic conditions involving joints other than the knee (for example: hand, hip, ankle, shoulder, temporomandibular joint [TMJ], adhesive capsulitis, subacromial impingement) is not recommended for approval. The prescribing information notes that the safety and effectiveness of injections into non‑knee joints have not been established, and current guideline recommendations (e.g., American College of Rheumatology) do not support use in hand or hip osteoarthritis. Small trials of other joint indications have produced inconsistent or negative results and additional data are needed to determine any role for these products outside the knee.

Intraarticular hyaluronic acid derivatives for joints other than the knee are specifically not recommended due to an absence of established safety and effectiveness in those indications. Guideline statements and limited trials in hand, hip, ankle, shoulder, and other non‑knee joints do not provide sufficient evidence to support routine use, and approval for non‑knee joints is therefore discouraged.

Provider Requirements and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is recommended for medical benefit coverage of intraarticular hyaluronic acid derivative products for knee osteoarthritis. Approval is provided when the patient meets the documented Criteria and Dosing; extended approvals allowed if the patient continues to meet criteria. Because of the specialized evaluation and administration, these products must be administered by or under the supervision of a physician specializing in rheumatology, orthopedic surgery, or physical medicine and rehabilitation (physiatrist). Requests for doses or regimens outside those documented will be reviewed case-by-case by a clinician. Previous therapies noted as [verification of therapies required] must be verified by a clinician in the Coverage Review Department.

Prior authorization recommended for medical benefit coverage
Administration must be by or under supervision of specified specialists (rheumatology, orthopedic surgery, physiatry)
Requests outside documented doses/regimens considered case-by-case

Documentation Required

Therapy Prerequisites and Required Clinical Documentation

Patients must have radiologic confirmation of osteoarthritis of the knee (examples: X-ray, MRI, CT, ultrasound) for the knee to be treated. Documentation must verify that the patient has tried conservative nonpharmacologic therapy and specified pharmacologic therapies as described in the criteria: at least one course of physical therapy AND at least two pharmacologic modalities (examples include trials of oral/topical NSAIDs, tramadol, acetaminophen, duloxetine). When the criteria indicate [verification of therapies required], the Coverage Review clinician must confirm prior therapies.

Radiologic evidence of knee osteoarthritis required (X-ray, MRI, CT, ultrasound)
At least one course of physical therapy for knee osteoarthritis
At least two pharmacologic therapies (oral/topical NSAIDs, tramadol, acetaminophen, duloxetine) — trial of two or more NSAIDs counts as one pharmacologic therapy
Verification of prior therapies required when noted

Documentation Required

Response Documentation for Retreatment

For repeat (retreatment) requests, the prescriber must attest that the patient had a response to the prior course of hyaluronic acid derivative therapy for knee osteoarthritis and now requires additional therapy. Examples of response include reduced joint pain, decreased tenderness, reduced morning stiffness, or improved mobility. Additionally, at least 6 months must have elapsed since the last injection with any hyaluronic acid derivative before a repeat course is approved.

Prescriber attestation of clinical response to prior hyaluronic acid therapy required for retreatment
Document examples of response: reduced pain, less tenderness, reduced morning stiffness, improved mobility
Minimum interval of 6 months since last hyaluronic acid injection for repeat course

Denial Risk

Denial Risk for Non‑Knee or Non‑Indicated Conditions

Requests for hyaluronic acid derivative injections for joints or conditions not listed in the Recommended Authorization Criteria (for example: hand, hip, shoulder, ankle, TMJ, adhesive capsulitis, subacromial impingement, non-osteoarthritis knee conditions such as chondromalacia patellae or post-ACL reconstruction) are not recommended for approval and may be denied due to insufficient evidence of safety and effectiveness.

Non-knee joints (hand, hip, shoulder, ankle, TMJ) — not recommended
Non-osteoarthritis knee conditions (e.g., chondromalacia patellae, osteochondritis dissecans, patellofemoral syndrome, post-ACL reconstruction) — not recommended
Coverage not recommended for circumstances not listed in the Recommended Authorization Criteria

Definitions and Therapy Courses

Course of therapy — Number of injections by product

Single-injection productsDurolane, Gel-One, Monovisc, Synvisc-One — one injection per treated knee per course

Two-injection productHymovis — up to two injections given 1 week apart per treated knee per course

Three- or four-injection productsEuflexxa, Gelsyn-3, sodium hyaluronate 1% injection, SynoJoynt, Synvisc, Triluron, TriVisc, Visco-3 — up to three injections (some products three or four as specified like Orthovisc)

Orthovisc dosingOrthovisc — up to three or four injections given 1 week apart per treated knee per course

Five-injection productsGenVisc 850, Hyalgan, Supartz FX — up to five injections given 1 week apart per treated knee per course

Radiologic evidence — Imaging confirmation required

Required imaging confirmationRadiologic evidence of knee osteoarthritis via X-ray, MRI, CT, or ultrasound is required to confirm the diagnosis of the knee to be treated

Documentation requirementRadiologic confirmation must be provided as part of clinical documentation for authorization

Diagnosis linkageImaging must confirm osteoarthritis of the specific knee proposed for injection

OpenPayer

Hyaluronic Acid Derivatives (Intraarticular) — Medical Benefit Coverage Criteria

Recommended Authorization Criteria

Coding and Retreatment Rules

Provider Requirements and Prior Authorization

Clinical Background

Definitions and Therapy Courses