RetiredUnitedHealthcarePolicy CSLA2025D0081G

Intra-articular sodium hyaluronate (hyaluronan) injections for knee osteoarthritis

This UnitedHealthcare Medical Benefit Drug Policy governs coverage and medical necessity criteria for intra-articular sodium hyaluronate (hyaluronan) products for treatment of knee osteoarthritis for the state of Louisiana and related product selection rules.

Policy Summary

PayerUnitedHealthcare

PolicyIntra-articular sodium hyaluronate (hyaluronan) injections for knee osteoarthritis

Policy CodePolicy CSLA2025D0081G

Change TypeRetired (state-specific)

Effective DateJul 1, 2025

Next Review Date

Key ActionPrior authorization is required for initial and continued intra-articular sodium hyaluronate injections; document diagnosis, prior conservative therapy (≥3 months) or intolerance, dosing per FDA labeling, and for reauthorization show positive clinical response and ≥6 months since prior course.

SourceLink

POLICY UPDATE CHANGES

Retired policy; Louisiana plan membership disenrolled on Apr. 1, 2026.

07/01/2025 routine review; no content changes.

knee OA onlyFDA-labeled indication emphasized

6 monthsInitial/continuation authorization

multipleProducts referenced

LA onlyApplies to

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State-specific retirement

Coverage and Medical Necessity Criteria

Initial Therapy

Covered when ALL of the following are met:

Initial authorization criteria: Diagnosis of knee osteoarthritis; and the member has not responded adequately to conservative therapy (e.g., physical therapy, NSAIDs, acetaminophen, topical capsaicin, or intra-articular steroids) after at least 3 months or is intolerant to such therapy; and the member reports pain which interferes with functional activities (e.g., ambulation, prolonged standing); and the pain is attributed to degenerative joint disease/primary osteoarthritis of the knee; and there are no contraindications to the injections (e.g., active joint infection, bleeding disorder); and dosing is in accordance with U.S. FDA approved labeling; and initial authorization is for a single injection course once per joint for 6 months.

Continuation Therapy

Covered when ALL of the following are met:

Reauthorization criteria: Diagnosis of knee osteoarthritis; and documentation of positive clinical response to prior hyaluronan injections (e.g., significant pain relief was achieved with the prior course); and pain has recurred; and at least 6 months have passed since the prior course of treatment for the respective joint; and dosing is in accordance with U.S. FDA approved labeling; and continuing authorization is for a single injection course once per joint for 6 months.

Preferred Product Step Criteria

Coverage for listed non-preferred hyaluronan products is medically necessary when EITHER of the following are met:

Option A: Both of the following: (1) history of a trial of adequate dose and duration of two of the following preferred products: Durolane, Euflexxa, Gelsyn-3; and (2) physician attests that, in their clinical opinion, the clinical response would be expected to be superior to that experienced with two of the preferred products.

Option B: Both of the following: (1) history of failure, contraindication, or intolerance to two of the following: Durolane, Euflexxa, Gelsyn-3; and (2) physician attests that the same failure, contraindication, or intolerance would not be expected to occur with the requested non-preferred product.

Includes instruction: 'Physician attests...' as required documentation.

Not Medically Necessary / Cosmetic

Unproven indications: Intra-articular injections of sodium hyaluronate are unproven and not medically necessary for indications other than knee osteoarthritis, including but not limited to hip osteoarthritis, temporomandibular joint osteoarthritis, and temporomandibular joint disc displacement.

Cosmetic uses: Hyaluronic acid gel preparations to improve the skin's appearance, contour, or reduce depressions due to acne, scars, injury, or wrinkles are considered cosmetic and are not covered.

Knee Osteoarthritis (Initial/Repeat therapy)

Knee osteoarthritis — summary of evidence

Knee OA evidence: Multiple randomized controlled trials and comparative studies (including a 660‑patient multicenter RCT) demonstrate similar pain relief across various HA products with small differences in local adverse events; systematic reviews report small statistically significant effects on function in some populations but variable clinical significance and insufficient evidence to conclude delay or avoidance of total knee replacement.

Trials commonly use WOMAC and VAS outcomes; some hylan preparations showed a trend toward higher local adverse events on repeat cycles.

Non‑knee Joint Osteoarthritis and TMJ

Shoulder, hip, ankle, and TMJ — evidence statements

Shoulder OA/rotator cuff pathology: Systematic reviews and randomized trials report pain and functional improvements after intra‑articular HA for glenohumeral osteoarthritis and rotator cuff pathology, but substantial heterogeneity and similar improvements in control groups suggest possible placebo effects; further RCTs are needed to define efficacy and optimal dosing.

Hip OA: Evidence for hip OA is mixed: small prospective studies report benefit but larger multicenter placebo RCTs have not shown superiority over placebo; VA/DoD guidance does not recommend IA hyaluronate for hip OA; overall data are insufficient to support routine use.

Ankle OA: Small RCTs and case series provide inconsistent results and are of low quality; Cochrane and systematic reviews conclude evidence is insufficient to recommend routine use for ankle OA and NICE guidance advises against offering IA hyaluronan for OA generally.

Temporomandibular joint (TMJ) disorders:

Rheumatoid Arthritis

Rheumatoid arthritis (RA)

RA evidence: Biologic rationale is uncertain and evidence is limited: small RCTs and meta‑analyses for knee RA suggest possible benefit for pain and inflammation but studies are few, small, and subject to bias; pilot trials in foot/ankle RA show short‑term functional improvement but larger confirmatory trials are needed.

Injection laryngoplasty

Glottic insufficiency / unilateral vocal fold paralysis (UVFP)

Intracordal HA injection: Multiple small randomized and prospective series report improvements in glottal closure, objective voice measures, and quality of life after hyaluronic acid injection laryngoplasty; benefits are often observed at 1 and 6 months and many patients have sustained improvement with some requiring repeat injections; durability for some cross‑linked HA products is approximately 4–6 months.

Evidence quality is limited and Cochrane review found insufficient high‑quality randomized data to favor specific injectable materials.

Evidence summaries and guideline context

Clinical evidence and professional society guidance summarized (not an explicit coverage decision in these chunks):

Osteoarthritis IA HA: Professional societies (AAOS, ACR) generally do not recommend routine viscosupplementation for knee osteoarthritis and recommend against IA hyaluronic acid for hip OA; however, FDA has approved multiple product‑specific intra‑articular HA regimens for patients who have failed conservative therapy.

AAOS does not support viscosupplementation for knee OA; ACR conditionally recommends against HA for knee and first CMC OA but allows shared decision‑making; FDA labeling lists specific product regimens.

Injection laryngoplasty with HA: Controlled and observational studies report improved voice‑related outcomes and temporary benefit (approx. 4–6 months) with some HA products used for injection laryngoplasty, but overall randomized evidence is limited and insufficient to recommend specific injectable materials.

Cochrane review identified insufficient high‑quality randomized trials; some small RCTs suggest particle size may affect durability.

Intra-articular sodium hyaluronate is not supported for non‑knee joint osteoarthritis and related disorders where evidence is insufficient. Specifically, injections for hip osteoarthritis, temporomandibular joint (TMJ) osteoarthritis, and TMJ disc displacement are considered unproven and not medically necessary due to inadequate evidence of efficacy. Additionally, hyaluronic acid gel preparations used to improve skin appearance, contour, depressions (e.g., acne or scar-related), or wrinkles are cosmetic and are not covered.

Use of sodium hyaluronate following total or partial joint replacement is explicitly unstudied: there are no clinical trials evaluating intra‑articular hyaluronate in persons after joint arthroplasty, and thus this use lacks evidence to support clinical benefit.

Procedures that inject sodium hyaluronate for the purpose of skin contouring, filling depressions, or reducing wrinkles are cosmetic in nature. Because these interventions address appearance rather than functional impairment, they are considered cosmetic and are not covered under this policy.

This policy was retired for Louisiana plan membership effective April 1, 2026; members in the Louisiana plan were disenrolled from this policy on that date.

This policy addresses intra‑articular (IA) hyaluronan (sodium hyaluronate) and limits supported use to knee osteoarthritis. IA hyaluronan is considered unproven and not medically necessary for indications other than knee osteoarthritis. The policy also clarifies that HA gel preparations for skin aesthetic purposes are cosmetic and not covered.

The National Institute for Health and Care Excellence (NICE) guidance cited in this policy recommends that intra‑articular hyaluronan injections should not be offered for management of osteoarthritis. This position reflects NICE's assessment of the evidence and is invoked here as part of the context for non‑knee OA indications.

Professional society guidance is consistent with limited endorsement of viscosupplementation. The American College of Rheumatology (ACR) conditionally recommends against intra‑articular hyaluronic acid for knee and first CMC OA and strongly recommends against its use for hip OA, while allowing shared decision‑making in select knee cases. The American Academy of Orthopaedic Surgeons (AAOS) does not support routine viscosupplementation for knee osteoarthritis and in its latest guideline does not recommend hyaluronic acid injections for routine treatment of symptomatic knee OA.

Applicable Codes and Operational Coding Rules

Applicable CPT CodesCPT

20605	Arthrocentesis, aspiration and/or injection, intermediate joint or bursa; without ultrasound guidance.
20606	Arthrocentesis, aspiration and/or injection, intermediate joint or bursa; with ultrasound guidance; with permanent recording and reporting.
20610	Arthrocentesis, aspiration and/or injection, major joint or bursa; without ultrasound guidance.
20611	Arthrocentesis, aspiration and/or injection, major joint or bursa; with ultrasound guidance, with permanent recording and reporting.

Applicable HCPCS/J-codesHCPCS

J3490	Unclassified drugs.
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, 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.

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Applicable ICD-10 CodesICD-10

M17.0	Bilateral primary osteoarthritis of knee.
M17.10	Unilateral primary osteoarthritis, unspecified knee.
M17.11	Unilateral primary osteoarthritis, right knee.
M17.12	Unilateral primary osteoarthritis, left knee.
M17.2	Bilateral post-traumatic osteoarthritis of knee.
M17.30	Unilateral post-traumatic osteoarthritis, unspecified knee.
M17.31	Unilateral post-traumatic osteoarthritis, right knee.
M17.32	Unilateral post-traumatic osteoarthritis, left knee.
M17.4	Other bilateral secondary osteoarthritis of knee.
M17.5	Other unilateral secondary osteoarthritis of knee.

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Covered/Referenced Proceduresmixed

affected codes

Document references intra‑articular and intracordal HA injections; specific CPT/HCPCS codes not listed in this document section.

FDA product classificationmixed

MOZ	FDA product code for acid, hyaluronic, intraarticular

inv-22: Minimum conservative therapy duration

Minimum conservative therapy durationAt least 3 months of conservative therapy (e.g., physical therapy, NSAIDs, acetaminophen, topical capsaicin, or intra-articular steroids) without functional improvement prior to initiating intra‑articular sodium hyaluronate — unless the member is intolerant to such therapy.

Documentation requiredProvider must document the type and duration of conservative therapies tried and either lack of functional improvement after ≥3 months or documented intolerance/contraindication.

ExceptionsShorter durations acceptable when member is unable to tolerate conservative therapy due to adverse effects (document intolerance).

inv-23: Minimum interval between courses

Minimum interval between courses

Provider Requirements, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for initial and continued intra-articular sodium hyaluronate injections. Confirm prior authorization requirements with the member's plan before treatment as plan terms may vary.

Prior authorization required for initial course and reauthorization per plan terms
Initial authorization: single injection course once per joint for 6 months (see dosing/labeling)
Reauthorization: single injection course once per joint for 6 months, ≥6 months since prior course and documentation of positive clinical response

Prior Authorization

Prior Authorization for Non‑Knee Joints

Non‑knee joint injections (e.g., shoulder, ankle, hip, TMJ) have limited and sometimes conflicting evidence of benefit. Prior authorization may be required and coverage is generally considered unproven for indications other than knee osteoarthritis.

Hip osteoarthritis, temporomandibular joint osteoarthritis, and other non‑knee indications: insufficient evidence

Background and Scope

Sodium hyaluronate, also known as hyaluronic acid or hyaluronan, is a natural component of synovial fluid used via intra‑articular injection to supplement joint lubrication and viscoelastic properties. Products vary by molecular weight, cross‑linking and formulation; several branded preparations have FDA‑labeled regimens for treatment of knee osteoarthritis in patients who have not responded to conservative therapy.

Definitions and Key Terms

inv-43: Sodium hyaluronate / hyaluronic acid (HA) definition

Definition of sodium hyaluronate / HAA component of normal synovial fluid used for intra‑articular injections to supplement or replace synovial HA; commercially prepared HA products differ by molecular weight, cross‑linkage, and source (bacterial fermentation or avian-derived).

Product variabilityHA products vary in molecular weight and cross‑linking and may be derived from bacterial fermentation or extracted from avian products, which can affect properties and durability.

FDA device classificationHA preparations for knee OA are approved as devices (MOZ product code) and act mechanically to lubricate rather than via systemic absorption.

inv-44: Conservative therapy

Conservative therapy definedNon-surgical measures including physical therapy, NSAIDs, acetaminophen, topical capsaicin, or intra‑articular steroid injection with at least a 3‑month trial (unless intolerant).

Policy Revision History

2026-04-01retirementLatest

Policy retired for Louisiana plan membership; Louisiana membership disenrolled effective Apr. 1, 2026.

2025-07-01routine_review

Routine review completed; no content changes to the clinical policy statements.

Policy Summary

PayerUnitedHealthcare

PolicyIntra-articular sodium hyaluronate (hyaluronan) injections for knee osteoarthritis

Policy CodePolicy CSLA2025D0081G

Change TypeRetired (state-specific)

Effective DateJul 1, 2025

Next Review Date

SourceLink

On This Page

Systematic reviews identified few high‑quality RCTs; some studies show improvement in pain and function but findings are inconsistent and optimal dosing and treatment schedules remain unclear.

At least 6 months must have passed since the prior course of intra‑articular hyaluronate for the same joint before reauthorization.

Reauthorization requirementDocumentation of positive clinical response to the prior course and recurrence of pain required for repeat course authorization.

Authorization durationContinuing authorization is for a single injection course once per joint for 6 months.

inv-24: Pain score thresholds used in trials

Example trial pain threshold (hip trials)Some trials used visual analog scale (VAS) thresholds for inclusion — e.g., VAS > 40 mm as reported in Richette et al. and other hip studies.

Knee trial outcomes measuresKnee RCTs commonly report baseline and follow-up pain using WOMAC pain subscore and VAS measures for eligibility and outcome assessment.

Documentation suggestionWhen available, include baseline and follow‑up pain scores (WOMAC, VAS) in prior authorization/continuation documentation to demonstrate response or recurrence.

inv-25: FDA-labeled injection regimens

Product-specific FDA-labeled regimens (examples)Durolane — 1 injection per course; Euflexxa — 3 injections per course; Hyalgan — 5 injections per course; Synvisc One — single injection per course; Gel-One — single injection per course; Monovisc — single injection per course; GenVisc 850 — 3 to 5 injections per course.

Labeling requirement for dosingDosing and number of injections must follow the U.S. FDA approved labeling for each product when administered.

Provider documentationDocument the specific HA product and the regimen (number of injections) per FDA labeling when requesting authorization.

Providers should expect individual review for non‑knee joint IA hyaluronate requests

Prior Authorization

PA for Device‑Labeled Regimens

When coverage refers to product‑specific, FDA‑labeled regimens (e.g., single‑injection vs multi‑injection products), prior authorization is required to verify dosing and product selected meet policy criteria.

Examples: Durolane (1 injection), Euflexxa (3 injections), Hyalgan (5 injections), etc.
PA required when requesting product outside preferred product criteria or non‑labeled dosing

Note

Confirm Plan‑Specific Prior Authorization

Confirm prior authorization and benefit coverage with the member's federal, state, or contractual plan. Plan terms govern in the event of conflict and may impose additional requirements.

Check applicable federal/state/contractual benefit plan terms before submitting PA
UnitedHealthcare reserves the right to modify policies; providers must verify current plan requirements

Documentation Required

Documentation: Diagnosis and Conservative Therapy

Providers must document the diagnosis of knee osteoarthritis and that the member had an adequate trial of conservative therapy for at least 3 months or had intolerance/contraindication to such therapy.

Document diagnosis of knee OA and attribution of pain to primary degenerative joint disease
Document trial of conservative therapy (e.g., PT, NSAIDs, acetaminophen, topical capsaicin, or IA steroids) for ≥3 months OR intolerance/contraindication

Documentation Required

Required Clinical Outcome Documentation

Required clinical outcome documentation should be provided to support positive response for reauthorization and may include standardized pain or function measures.

Examples of acceptable outcome measures: WOMAC, VAS, Constant score, Lequesne index, functional assessments
Document magnitude of improvement, duration of benefit, and recurrence of symptoms prior to reauthorization

Note

Check Federal/State/Contractual Plan Terms

Providers should verify federal, state, or contractual benefit plan terms and retain documentation of coverage decisions. In conflicts, those terms govern over this policy.

Reference applicable benefit plan terms when determining coverage
Retain supporting documentation in the medical record for audits or appeals

Step Therapy

Preferred Product Trial Requirements

Preferred product criteria require a trial of two listed preferred products (Durolane, Euflexxa, Gelsyn‑3) by history of adequate dose/duration or documentation of failure, intolerance, or contraindication before coverage of other branded products is considered.

Trial of two preferred products at adequate dose and duration OR documented failure/intolerance/contraindication to two preferred products
If switching due to failure/intolerance, physician must attest that same issue would not be expected with the requested product

Step Therapy

Step Therapy Expectations

Step therapy expectations: conservative therapy is expected prior to IA hyaluronate given modest or equivocal benefit in some studies. Authorization typically requires evidence of stepwise trials.

Expect trial of non‑pharmacologic (e.g., exercise, PT) and simple analgesics before IA HA
Document duration and response to prior conservative treatments to satisfy step therapy requirements

Documentation Required

Conservative Therapy Preferred Before HA

Conservative therapy (exercise programs and simple analgesics) is preferred prior to considering intra‑articular hyaluronate injections. IA hyaluronate is indicated only after inadequate response or intolerance to conservative measures.

Conservative measures include physical therapy, home exercise, weight loss, NSAIDs, acetaminophen, topical agents
IA hyaluronate should be considered when these measures have not provided functional improvement after ≥3 months or are not tolerated

Note

Interaction with Third‑Party Utilization Tools

This policy may be used alongside third‑party utilization management tools (e.g., InterQual). Providers must comply with any additional rules or criteria as implemented by those tools.

UnitedHealthcare may use InterQual® or similar criteria to assist in benefit administration
Follow third‑party tool requirements in addition to this policy when applicable

Denial Risk

Denial Risk for Insufficient Documentation

Lack of documentation of prior adequate conservative therapy (≥3 months), absence of a diagnosis of knee osteoarthritis, or missing documentation of contraindications/intolerances may result in denial of coverage.

Denial risk if no adequate trial or documentation of conservative therapy
Denial risk if diagnosis of knee OA is not documented or if contraindications are not addressed

Denial Risk

Postoperative Joint Replacement — Lack of Evidence

There is no evidence from clinical trials to support use of sodium hyaluronate after total or partial joint replacement. Requests for postoperative viscosupplementation may be denied due to lack of supporting evidence.

No clinical trials evaluate HA use following total or partial joint replacement
Postoperative joint replacement use is unproven and may be denied

Note

Coverage Determinations and Plan Requirements

Coverage determinations must reference and be consistent with applicable federal, state, or contractual benefit plan requirements. If there is a conflict between this policy and plan terms, the plan terms prevail.

In the event of conflict, federal/state/contractual benefit plan terms govern
Providers must follow plan‑specific rules and document reliance on plan language when applicable

Purpose of trialConservative therapy must be attempted and documented to demonstrate lack of functional improvement prior to IA hyaluronate use for knee OA.

Documentation expectationsProviders should document types of conservative treatments tried, duration (≥3 months), and reasons for intolerance if applicable.

inv-45: Viscosupplementation / intra‑articular hyaluronate

DefinitionViscosupplementation (intra‑articular hyaluronate) is injection of HA or crosslinked hylan into a joint to restore viscoelastic properties of synovial fluid and potentially reduce pain and improve function in OA.

Intended effectHA acts mechanically as a lubricant and shock absorber in the joint; multiple product formulations approved for knee OA aim to supplement synovial fluid.

Regulatory statusSeveral HA preparations are FDA‑approved as devices for knee OA with product‑specific labeled regimens and dosing.

inv-46: Injection laryngoplasty (IL) / intracordal HA

Definition of injection laryngoplasty (IL) / intracordal HAOffice‑based or LEMG/EMG‑guided injection of hyaluronic acid into the vocal fold to medialize the cord and improve glottic closure and voice quality in unilateral vocal fold paralysis or glottic insufficiency.

Typical techniqueProcedures may be performed in the office setting (LEMG‑guided) with 1.0 mL injections reported in multiple series and trials.

Expected outcomesStudies report improvements in glottal closure measures, voice metrics (e.g., VHI), and quality of life; some patients require repeat injections while many achieve durable benefit over months.

inv-47: IA hyaluronate

Shorthand definitionIA hyaluronate = intra‑articular (IA) hyaluronate/hyaluronic acid (viscosupplementation) used to treat pain from knee osteoarthritis.

Usage contextRefers specifically to intra‑articular administration into synovial joints for viscosupplementation purposes, most commonly the knee.

Regulatory noteIA hyaluronate products are approved by FDA as devices under product code MOZ for knee OA patients who have failed conservative therapy.

inv-48: Injection laryngoplasty (IL)

Injection laryngoplasty (IL) with HA for UVFP/glottic insufficiencyInjection laryngoplasty using hyaluronic acid is an office‑based or EMG/LEMG‑guided procedure to medialize the vocal fold and improve voice in unilateral vocal fold paralysis (UVFP); clinical series and small RCTs report improved voice outcomes and QOL.

Durability and repeat treatmentsSome patients achieve long-term benefit from a single injection, while others require 2–3 injections; reported follow‑up in series extends to months to years for many patients.

Evidence limitationsEvidence consists of small RCTs and observational series; Cochrane review identified insufficient high‑quality randomized data to recommend specific injectable materials.

inv-49: AAOS guideline

AAOS guideline referenceAAOS Clinical Practice Guideline Summary: Management of Osteoarthritis of the Knee (Nonarthroplasty), Third Edition (Brophy RH, Fillingham YA).

Context of guidelineAAOS guidance is cited in the policy background and evidence summaries regarding professional society positions on viscosupplementation for knee OA.

Use in policyThe guideline is referenced to contextualize professional society recommendations when assessing evidence and coverage stance for IA hyaluronate.