CurrentCareSourcePolicy N/A

Durolane (sodium hyaluronate) — medical benefit coverage (Arkansas PASSE)

Defines medical-benefit coverage, prior authorization, site-of-service, clinical criteria, and quantity limits for Durolane (sodium hyaluronate) for osteoarthritis of the knee for CareSource members in Arkansas PASSE.

Policy Summary

PayerCareSource

PolicyDurolane (sodium hyaluronate) — medical benefit coverage (Arkansas PASSE)

Policy CodePolicy N/A

Change TypeMinor — no material changes

Effective DateJan 1, 2022

Next Review DateN/A

Key ActionObtain prior authorization and document radiologic confirmation of knee osteoarthritis (Kellgren-Lawrence ≥2), prescriber specialty, prior intra‑articular corticosteroid trial, and trials of non‑pharmacologic therapies and analgesics.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

J7318Billing/HCPCS code

1 inj (60 mg)Quantity limit

Office/OutpatientSite(s) of service

≥40Min age

6 moApproval period

Coverage Criteria for Durolane (sodium hyaluronate)

inv-01: Initial Therapy

Covered when ALL of the following are met for knee osteoarthritis

Initial authorization criteria: Member is >= 40 years old

Initial authorization criteria: Prescribed by an orthopedic surgeon, interventional pain physician, rheumatologist, physiatrist (PM&R), or sports medicine subspecialist

Initial authorization criteria: Diagnosis of knee osteoarthritis confirmed by radiologic evidence (Kellgren-Lawrence grade >= 2)

Initial authorization criteria: Prior intra-articular corticosteroid injection with efficacy < 4 weeks

Policy Summary

PayerCareSource

PolicyDurolane (sodium hyaluronate) — medical benefit coverage (Arkansas PASSE)

Policy CodePolicy N/A

Change TypeMinor — no material changes

Effective DateJan 1, 2022

Next Review DateN/A

SourceLink

On This Page

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Initial authorization criteria: Weight loss attempts or lifestyle modification when BMI > 30

Initial authorization criteria: Sufficient trial (e.g., 2–3 months) of non-pharmacologic therapies (bracing/orthotics, physical/occupational therapy)

Initial authorization criteria: Trial and failure of at least 3 simple analgesic therapies (acetaminophen, NSAIDs, oral or topical salicylates)

Initial authorization criteria: Not using medication for hip or shoulder related conditions (knee-specific indication)

Initial authorization criteria: Dosage: Inject 60 mg every 6 months

inv-02: Continuation Therapy / Reauthorization

Reauthorization requires ALL of the following

Reauthorization criteria: Documented significant relief achieved with the initial course of treatment

Reauthorization criteria: Initial course of treatment has been completed for 6 months or longer

Reauthorization criteria: Member continues to meet all initial approval criteria

This policy covers Durolane (sodium hyaluronate) only for intra-articular viscosupplementation of the knee. Use of the medication for non-knee joints is excluded — specifically, the member must not be using Durolane for hip- or shoulder-related conditions. Coverage and prior authorization criteria are written to apply to radiographically confirmed osteoarthritis of the knee (Kellgren-Lawrence grade >= 2) and to a member population aged 40 years or older who meet the other listed clinical and trial requirements.

CareSource considers Durolane not medically necessary for multiple non-knee indications due to insufficient evidence of superior efficacy. The policy lists the following specific not medically necessary uses: refractory interstitial cystitis, arthropathy disorder of the shoulder, intravitreal tamponade, keratoconjunctivitis sicca, subacromial impingement, and syndrome of the shoulder.

Coding and Radiographic Criteria

Covered HCPCS CodeHCPCSCovered

J7318

Durolane (sodium hyaluronate)

inv-06: Radiographic severity — Kellgren-Lawrence grade >= 2

Radiographic severityKellgren-Lawrence grade >= 2

ContextRequired radiologic evidence for diagnosis of knee osteoarthritis for initial and reauthorization approvals

Source guidanceUsed to confirm osteoarthritis of the knee on imaging (Kellgren-Lawrence scale)

Provider Actions, Documentation, and Authorization

Prior Authorization

Prior authorization required

Prior authorization required for Durolane (sodium hyaluronate) when billed under the medical benefit. Durolane is a preferred product; prior authorization must be obtained before coverage is approved.

Billing code: J7318
Benefit type: Medical; Site of service: Office/Outpatient Hospital
Quantity limit: 1 injection (60 mg) per 6 months

Step Therapy

Required prior trials

Required prior trials and prerequisites before initial approval. All listed trials/attempts must be documented and met.

Age: Member must be ≥ 40 years old
Prescriber specialty: Orthopedic surgeon, interventional pain physician, rheumatologist, physiatrist (PM&R), or sports medicine subspecialist
Radiologic confirmation: Osteoarthritis of the knee with Kellgren-Lawrence grade ≥ 2
Prior intra-articular corticosteroid injection(s) with efficacy < 4 weeks
For members with BMI > 30: documentation of weight loss attempts or lifestyle modification attempts to promote weight loss
Non-pharmacologic therapies: documented sufficient trial (e.g., 2–3 months) of bracing/orthotics and physical/occupational therapy
Analgesic therapies: trial of at least 3 simple analgesic therapies (acetaminophen, NSAIDs, oral or topical salicylates)
Site limitation: Member must not be using medication for hip or shoulder related conditions
Dosage limit: 60 mg injection every 6 months

Documentation Required

Required documentation

Documentation required with the prior authorization request. Include clinical and objective evidence to support medical necessity.

Member age and BMI (if applicable)
Prescriber name and specialty (must be in allowed specialty list)
Radiologic report confirming osteoarthritis of the knee (Kellgren-Lawrence grade ≥ 2)
Details of prior intra-articular corticosteroid injection(s) including date(s) and duration of efficacy (< 4 weeks)
Documentation of weight loss or lifestyle modification attempts when BMI > 30
Documentation of trials and outcomes for non-pharmacologic therapies (dates and duration, e.g., 2–3 months)
Documentation of trials and outcomes for at least 3 simple analgesic therapies
Statement that medication is being requested for knee OA and not for hip or shoulder conditions

Denial Risk

Denial triggers

Denial triggers — requests will be denied if authorization criteria are not met or required documentation is missing.

Member < 40 years of age
Prescriber not in allowed specialty list
No radiologic confirmation of knee OA or Kellgren-Lawrence grade < 2
No documented prior intra-articular corticosteroid trial or corticosteroid trial had efficacy ≥ 4 weeks
Missing documentation of required non-pharmacologic or analgesic therapy trials
Request for use in conditions considered not medically necessary (e.g., refractory interstitial cystitis, shoulder arthropathy, intravitreal tamponade, keratoconjunctivitis sicca, subacromial impingement)

Definitions and Radiologic Confirmation

inv-12: Radiologic confirmation — Kellgren-Lawrence scale grade 2 or greater.

DefinitionRadiologic confirmation: Kellgren-Lawrence scale grade 2 or greater.

UseRequired for initial authorization and reauthorization of Durolane for knee osteoarthritis.

DocumentationRadiology report or imaging demonstrating Kellgren-Lawrence grade ≥2 must be included with prior authorization request.

Initial Therapy Criteria

inv-13: Initial Therapy

Initial authorization criteria

Initial: Age >= 40

Initial: Prescriber specialty: orthopedic surgeon, interventional pain physician, rheumatologist, physiatrist (PM&R), or sports medicine subspecialist

Initial: Radiologic confirmation of knee osteoarthritis (Kellgren-Lawrence grade >= 2)

Initial: Prior intra-articular corticosteroid injection with efficacy duration < 4 weeks

Initial: If BMI > 30: weight loss attempts or lifestyle modification documented

Initial: Sufficient trial (e.g., 2–3 months) of non-pharmacologic therapies (bracing/orthotics, physical/occupational therapy) documented

Initial: Failure of at least 3 simple analgesic therapies (acetaminophen, NSAIDs, oral or topical salicylates) documented

Initial: Indication limited to knee (not hip or shoulder)

Initial: Dosage permitted: 60 mg injected every 6 months; initial approval duration: 6 months

Continuation / Reauthorization Criteria

inv-14: Reauthorization

Reauthorization criteria for continued coverage

Reauthorization: Documented significant relief from the initial treatment course

Reauthorization: Initial course completed for 6 months or longer

Reauthorization: Member continues to meet all initial authorization criteria

Reauthorization approval duration: additional 6 months when criteria met

Step Therapy Requirements

Required prior therapies (step 1)	Failure definition / notes
Prior intra‑articular corticosteroid injection(s)	Lack of efficacy: symptom relief lasting < 4 weeks
Weight loss attempts or lifestyle modifications (only if BMI > 30)	Documentation of attempts to lose weight or modify lifestyle
Sufficient trial of non‑pharmacologic therapies (e.g., 2–3 months of bracing/orthotics, physical/occupational therapy)	Trial duration example: 2 to 3 months
Trial and failure of at least 3 simple analgesic therapies (acetaminophen, NSAIDs, oral or topical salicylates)	Document trials of ≥3 simple analgesics without adequate symptom control

Quantity Limits

inv-16: Durolane (sodium hyaluronate) — quantity limit per injection: 1 (60 mg)

Quantity limit per injection1 injection (60 mg)

Dose intervalInject 60 mg every 6 months (dosage allowed)

Billing codeHCPCS J7318 (Durolane)

Allowed Site(s) of Service

Note

Site of care — office permitted

Durolane is covered when administered in allowed outpatient settings under the medical benefit.

Allowed sites of service: office and outpatient hospital

Note

Site of care — infusion center permitted

Durolane is covered when administered in allowed outpatient settings under the medical benefit.

Allowed sites of service: office and outpatient hospital (includes infusion center settings billed under the medical benefit)

Background

Durolane (sodium hyaluronate) is described in this policy as an intra-articular viscosupplement used for the treatment of osteoarthritis of the knee. The policy references guideline-based and evidence sources to support coverage decisions and specifies clinical prerequisites for use, including radiologic confirmation (Kellgren-Lawrence grade >= 2), required prior trials, and documentation of benefit on reauthorization.