Sodium Hyaluronate (for Louisiana Only)

Coverage Summary

This policy is a state-specific medical benefit drug policy that applies only to UnitedHealthcare Community Plan members in Louisiana. It addresses coverage of intra-articular sodium hyaluronate (hyaluronic acid) products, defines preferred and non-preferred products, and specifies diagnosis‑specific authorization requirements. The policy’s covered indication is knee osteoarthritis and coverage for initial treatment requires all listed criteria in the Diagnosis‑Specific Criteria (including symptom-related functional impairment, attribution to degenerative knee OA, and failure or intolerance of conservative therapy for at least 3 months) as well as dosing consistent with U.S. FDA labeling. Initial authorization is for a single injection course per joint for 6 months, and repeated courses require documentation of prior positive response with at least 6 months between courses. The policy also includes preferred product criteria and notes product‑specific coverage conditions. This version is effective July 1, 2025 and the revision history notes a routine review with no content changes; the policy is specific to Louisiana and should be applied consistent with federal, state, or contractual requirements that may govern coverage.

Surface thresholds and quick facts

Conservative therapy duration>= 3 months

Minimum interval between courses>= 6 months

Effective dateJuly 1, 2025

Policy numberCSLA2O25D0081G

Coverage stancemixed

Preferred Product Exception Criteria

Treatment with GenVisc 850, Hyalgan, Supartz, Visco-3, Hymovis, Orthovisc, Synvisc or Synvisc-One, Gel-One, Monovisc, Triluron, TriVisc, or Synojoynt is medically necessary for the indications specified in this policy when one of the criteria below are met:

ANY of the following

Option 1
- History of a trial of adequate dose and duration of two of the following:
- Durolane
- Euflexxa
- Gelsyn-3

Diagnosis-Specific Criteria — Initial Authorization

Intra-articular injections of sodium hyaluronate are proven and medically necessary when ALL of the following are met:

ALL of the following

Diagnosis of knee osteoarthritis; and
The member reports pain which interferes with functional activities (e.g., ambulation, prolonged standing); and
The member has not responded adequately to conservative therapy which may include physical therapy or pharmacotherapy (e.g., non-steroidal anti-inflammatory drugs [NSAIDs], acetaminophen and/or topical capsaicin cream) or injection of intra-articular steroids and such therapy has not resulted in functional improvement after at least 3 months; or the member is unable to tolerate conservative therapy because of adverse side effects; and
The pain is attributed to degenerative joint disease/primary osteoarthritis of the knee; and

Diagnosis-Specific Criteria — Reauthorization / Continuation

Prior Authorization

Reauthorization requirements — documentation needed for repeat courses

For repeat courses, submit documentation of prior positive clinical response to the prior injection course, confirm at least 6 months have passed since the prior course for the same joint, document recurrence of pain, and indicate planned dosing consistent with U.S. FDA labeled regimen; continuing authorization is for a single injection course once per joint for 6 months.

Contraindications, Not Medically Necessary & Cosmetic Exclusions

Denial Risk

Denial risk for not covered indications and cosmetic uses

Claims for sodium hyaluronate for temporomandibular joint osteoarthritis, hip osteoarthritis, temporomandibular joint disc displacement, or for skin contouring/wrinkle/acne/scar treatments are considered not medically necessary or cosmetic and may be denied.

Product Dosing / FDA Labeled Regimens

Billing Rule

Dosing must follow FDA labeling

Dosing for each product must align with the U.S. FDA labeled course per joint as listed in the policy (product-specific injection counts per treatment course).

Applicable Codes

Procedure CPT codes (reference)CPT

20605	Arthrocentesis, aspiration and/or injection, intermediate joint or bursa; without ultrasound guidance
20606	Arthrocentesis, aspiration and/or injection, intermediate joint or bursa; (text in source truncated/incomplete)
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

J-codes / drug HCPCSHCPCS

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
J7329	Hyaluronan or derivative, Trivisc, for intra-articular injection, 1 mg
J7331	Hyaluronan or derivative, Synojoynt, for intra-articular injection, 1 mg
J7332	Hyaluronan or derivative, Triluron, for intra-articular injection, mg (dose text in source truncated)

Diagnosis codes referencedICD-10

M13.0	Polyarthritis, unspecified
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
M17.4	Other bilateral secondary osteoarthritis of knee
M17.5	Other unilateral secondary osteoarthritis of knee

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Products / package inserts cited (informational)mixed

Synvisc	Hylan G-F 20; cited package insert (Sept 2014)
Synvisc-One	Single injection hylan product
Euflexxa	Sodium hyaluronate; cited package insert (Feb 2022)
Hyalgan	Sodium hyaluronate; cited package insert (Aug 2017)
Supartz	Sodium hyaluronate; cited package insert (Apr 2015)
Orthovisc	High molecular weight hyaluronan; cited package insert (June 2005)
Gel-One	Single injection HA; cited package insert (2011)
Gelsyn-3	3-injection HA; cited package insert (Feb 2016)
Monovisc	Single injection HA; cited package insert (Dec 2013)
GenVisc 850	HA product; cited package insert (Nov 2019)

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Provider Actions & Submission Requirements

Prior Authorization

Initial authorization requirements

For initial authorization (sodium hyaluronate–naive patients), submit documentation of: diagnosis of knee osteoarthritis; pain that interferes with functional activities; at least 3 months of conservative therapy without functional improvement (or documented intolerance/contraindication); attribution of pain to primary degenerative knee OA; planned dosing consistent with U.S. FDA labeling; initial authorization is for a single injection course once per joint for 6 months.

Documentation Required

Reference federal/state/contractual requirements

When deciding coverage, reference federal, state, or contractual benefit plan requirements because they may differ from this policy; in the event of conflict, contractual requirements govern.

Clinical Evidence Summary

Randomized and nonrandomized studies of hyaluronic acid injection laryngoplasty for unilateral vocal fold paralysis (UVFP) show potential short‑ to medium‑term clinical benefit but are limited by small sample sizes, incomplete follow‑up, and variable study quality. Lau et al. (2010) was a small RCT comparing small‑ versus large‑particle HA and suggested a trend toward greater durability with larger‑particle products, but follow‑up was incomplete. Prospective series (for example Gotxi‑Erezuma 2017 and Miaskiewicz 2016) report significant improvements in voice measures (VHI, GRBAS, MDVP) and low complication rates, with some patients requiring repeat injections. A Cochrane review (Lakhani et al. 2012) concluded that there is currently insufficient high‑quality evidence to recommend specific injectable materials for UVFP and that more randomized trials are needed. Product‑specific reports and reviews (Salinas & Chhetri 2014) note durability of approximately 4–6 months for some cross‑linked, larger‑particle preparations, and explicitly state that use of dermal HA products such as Restylane and Hylan b Gel for laryngeal injection is considered off‑label.

Professional society guidance is cautious about routine use of intra‑articular hyaluronic acid for osteoarthritis. The American College of Rheumatology (ACR) conditionally recommends intra‑articular corticosteroid injections over other IA injections including HA; ACR conditionally recommends against IA HA in knee and first CMC joint OA (but allows its use in shared decision‑making when other interventions fail) and strongly recommends against HA for hip OA. The American Academy of Orthopaedic Surgeons (AAOS) evidence‑based guidelines (2nd and 3rd editions) do not support routine use of viscosupplementation for knee osteoarthritis.

Background & Definitions

Sodium hyaluronate (hyaluronic acid, HA) is a normal synovial fluid component used as an intra‑articular viscosupplement to lubricate joints and absorb shock. Commercial HA products differ by molecular weight and cross‑linking and may be derived from bacterial fermentation or avian sources. FDA approval for the IA HA devices is limited to treatment of pain from osteoarthritis of the knee (with product‑specific labeled dosing regimens); several dermal HA products are FDA‑approved for cosmetic skin contouring. The policy notes that evidence for use of IA HA in other joints or indications (for example hip, TMJ, shoulder, ankle, or cosmetic skin contouring) is limited, inconsistent, or inconclusive, and such uses are generally considered unproven or cosmetic and not medically necessary under this policy.

Term	Definition
Initial authorization	Authorization for a single injection course once per joint for 6 months for sodium hyaluronate-naive patients
Continuing authorization	Authorization for a single injection course once per joint for 6 months for re-treatment when reauthorization criteria met
UVFP	Unilateral vocal fold paralysis
IL	Injection laryngoplasty
VHI	Voice Handicap Index

Revision History

07/01/2025routine reviewLatest

Archived previous policy version CSLA2024DOO81F noted in revision history; no content changes.