Commercial

Medical Policy

Notification

Intra-Articular Injection of Hyaluronan for the Treatment of Osteoarthritis

Notification Issue Date:

This policy has been identified for the HCPCS code update, effective 07/01/2020.

The following HCPCS code has been added to this policy:

J7333 Hyaluronan or derivative, visco-3, for intra-articular injection, per dose

The following HCPCS code has revised narrative in this policy:
FROM: J7321 Hyaluronan or derivative, Hyalgan, Supartz or Visco-3, for intra-articular injection, per dose
TO: J7321 Hyaluronan or derivative, hyalgan or supartz, for intra-articular injection, per dose

Title:

Intra-Articular Injection of Hyaluronan for the Treatment of Osteoarthritis

Policy #:

11.14.07z

Policy

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.

MEDICALLY NECESSARY

INITIAL SERIES
Single or bilateral injections of hyaluronan are considered medically necessary and, therefore, covered when all of the following criteria are met:

The individual is symptomatic. Symptoms may include pain that interferes with activities of daily living such as ambulation and prolonged standing, or pain interrupting sleep, crepitus, and/or knee stiffness.

The clinical diagnosis is supported by radiologic evidence of osteoarthritis of the knee such as joint space narrowing, subchondral sclerosis, osteophytes, and sub-chondral cysts.

If appropriate, other diagnoses have been excluded by appropriate evaluation and management services and laboratory and imaging studies (i.e., the pain and functional disability is not considered likely to be due to a diagnosis other than osteoarthritis of the knee).

The individual has failed at least three months of conservative therapy. Conservative therapy is defined as:

Nonpharmacologic therapy (such as but not limited to home exercise program, education, weight loss, physical therapy if indicated); and

Non-narcotic analgesics (e.g., acetaminophen) or nonsteroidal anti-inflammatory drugs (NSAIDS), if not contraindicated.

The individual has failed to respond to aspiration of the knee when effusion is present and intra-articular corticosteroid injection therapy when inflammation is a significant component of the individual's symptoms and intra-articular corticosteroids are not contraindicated.

REPEAT SERIES
A repeat series of injections with hyaluronan is considered medically necessary and, therefore, covered for those individuals who have responded to the first series and meet the following requirements:

Symptoms have recurred AND,

At least six months have elapsed since the prior series of injections AND,

There was significant improvement in pain and functional capacity achieved with the prior series of injections using a standardized assessment tool OR,

There is significant reduction in the doses of NSAID medications taken or reduction in the number of intra-articular steroid injections to the knees during the six-month period following the injection(s).

COMPANY-DESIGNATED PREFERRED PRODUCTS

Although there are many brands of viscosupplement on the market for the treatment of osteoarthritis of the knee, there is no reliable evidence of the superiority of any one brand of viscosupplement compared to other brands. The Company has designated Monovisc®, Orthovisc®, Synvisc®, and Synvisc-One® as preferred products.

These products are less costly and at least as likely to produce equivalent therapeutic results as non-preferred products, which include but are not limited to Durolane®, Euflexxa®, Gel-One®, Hyalgan®, Hymovis®, Gelsyn-3™ (formerly Gel-Syn™), GenVisc 850®, Triluron™, TriVisc™, Supartz®, Synojoynt™, and Visco-3™.

For individuals who meet the above medical necessity criteria, use of the Company-designated preferred products Monovisc®, Orthovisc®, and a Synvisc® product (either Synvisc® or Synvisc-One®), is considered medically necessary and, therefore, covered.

NON-PREFERRED PRODUCTS

For individuals who meet the above medical necessity criteria, use of non-preferred products, which include but are not limited to Durolane®, Euflexxa®, Gel-One®, Hyalgan®, Hymovis®, Gelsyn-3™ (formerly Gel-Syn™), GenVisc 850®, Triluron™, TriVisc™, Supartz®, Synojoynt™, and Visco-3™ is considered medically necessary and, therefore, covered in at least one the following instances*:

The individual has a documented contraindication, or documented non-response, to all preferred products (Monovisc®, Orthovisc®, and a Synvisc® product [either Synvisc® or Synvisc-One®]).
The individual is currently receiving or has previously received a non-preferred product for intra-articular hyaluronan injection of the knee.

*Non-preferred products that do not meet either of these conditions are considered not medically necessary and, therefore, not covered.

LIMITATIONS OF ADMINISTRATION

Viscosupplementation injections can be given in a single knee joint or bilaterally.

A course of treatment for a single knee is composed of one of the following:

One intra-articular injection of Synvisc-One®, Gel-One®, Monovisc®, or Durolane®
Two intra-articular injections of Hymovis®, each injection administered one week apart
Three intra-articular injections of Euflexxa®, Gelsyn-3™ (formerly Gel-Syn™), Synvisc®, Visco-3™, Synojoynt™, Triluron™ or TriVisc™, each injection administered one week apart
Three to four intra-articular injections of Orthovisc®, each injection administered one week apart
Five intra-articular injections of Hyalgan®, GenVisc 850®, or Supartz®, each injection administered one week apart

NOT MEDICALLY NECESSARY

When the above medical necessity criteria for intra-articular injection of hyaluronan into the knee are not
met, the service is considered not medically necessary and, therefore, not covered because the available published peer-reviewed literature does not support its use in the treatment of illness or injury.

For individuals receiving their first course of hyaluronan into the knee (treatment-naive), use of non-preferred products, which include, but are not limited to Euflexxa®, Gel-One®, Hyalgan®, Hymovis®, Monovisc®, Supartz®, Gelsyn-3™ (formerly Gel-Syn™), GenVisc 850®, Visco-3™, Durolane®, Triluron™, Synojoynt™or TriVisc™, is considered not medically necessary and, therefore, not covered (with the exception of a documented contraindication to the preferred products (Monovisc®, Orthovisc®, and a Synvisc® product [either Synvisc® or Synvisc-One®]) because more cost-effective alternatives are available.

EXPERIMENTAL/INVESTIGATIONAL

The intra-articular injection of hyaluronan into any joint other than the knee is considered experimental/investigational and, therefore, not covered unless the indication is supported as an accepted off-label use, as defined in the Company medical policy on off-label coverage for prescription drugs and biologics.

BILLING REQUIREMENTS

When the individual presents for an injection of a hyaluronan agent only, it is not appropriate for the provider to report an evaluation and management (E/M) service.

For Synvisc® and Synvisc-One®, providers must use the Healthcare Common Procedure Coding System (HCPCS) code J7325 and follow the below requirements:

Synvisc® is administered by intra-articular injection once a week (one week apart) for a total of three injections. Providers must bill 16 units of HCPCS code J7325 for each injection of Synvisc®.
Synvisc-One® is administered as one single intra-articular injection. Providers must bill 48 units of HCPCS code J7325 for the single injection of Synvisc-One®.

Inclusion of a code in this policy does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

REQUIRED DOCUMENTATION

The individual's medical record must reflect the medical necessity for the care provided. These medical records may include but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the service.

Guidelines

ADMINISTRATION

The FDA has approved the following preparations of intra-articular hyaluronan in the treatment of osteoarthritis of the knee:

Synvisc® (hylan G-F 20)
Synvisc-One® (hylan G-F 20)
Orthovisc® (high-molecular-weight hyaluronan)
Hyalgan® (sodium hyaluronate)
Supartz®(sodium hyaluronate)
Euflexxa® (1% sodium hyaluronate)
Gel-One® (hyaluronic acid)
Monovisc® (high molecular-weight hyaluronan)
Gelsyn-3™ [formerly Gel-Syn™] (sodium hyaluronate)
GenVisc 850® (sodium hyaluronate)
Hymovis® (high-molecular-weight viscoelastic hyaluronan)
Visco-3™ (sodium hyaluronate)
Durolane® (hyaluronic acid)
TriVisc™ (sodium hyaluronate)
Triluron™ (sodium hyaluronate)
Synojoynt™ (sodium hyaluronate)

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, the intra-articular injection of hyaluronan for the treatment of osteoarthritis of the knee is covered under the medical benefit of the Company’s products when the medical necessity criteria in this medical policy are met.

However, services that are identified in this policy as experimental/investigational or not medically necessary are not eligible for coverage or reimbursement by the Company.

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

The FDA has approved the following preparations of intra-articular hyaluronan in the treatment of osteoarthritis of the knee: Synvisc®, Synvisc-One®, Orthovisc®, Hyalgan®, Hymovis®, Supartz®, Euflexxa®, Monovisc®, Gelsyn-3™ (formerly Gel-Syn™), GenVisc 850®, Gel-One®, Visco-3™, Durolane®, Triluron™,Synojoynt™ and TriVisc™ .

Description

Various polymers derived from hyaluronic acid have been approved and marketed as implanted prosthetic devices. Clinical studies of sodium hyaluronate and hylan G-F-20 have demonstrated that injection of these agents into the joint space of osteoarthritic knees is sometimes marginally more effective than placebo procedures in reduction of pain and improvement in functional capacity in some individuals. These marginal beneficial results are more pronounced with the larger molecular weight compound hylan G-F20. There are no data indicating that these agents reverse or retard the osteoarthritic process in the injected joints. The long-term effects of repeated injections are unknown.

Synthetic and naturally occurring hyaluronic-acid derivatives are administered intra-articularly. The mechanism(s) of action are not known. There is some evidence for an anti-inflammatory effect, a short-term lubricant effect, an analgesic effect by directly buffering the synovial nerve endings, and a stimulating effect on synovial lining cells leading to the production of normal hyaluronic acid. They have become a treatment option for individuals with osteoarthritis who have failed to respond, or had a contraindication, to conservative therapy such as analgesics and NSAIDs.

Osteoarthritis is the most common form of arthritis and is characterized by hypertrophy of bone and degradation of cartilage. Individuals with osteoarthritis typically have joint pain, stiffness, and loss of range of motion, factors can impact mobility and the performance of activities of daily living. The causes of osteoarthritis are not well understood; however, biomechanical stresses, biochemical changes, and genetic factors are all thought to be important in its pathogenesis. The overall goal of managing osteoarthritis is to reduce pain and prevent disability because there is currently no curative therapy available for osteoarthritis.

Viscosupplementation is a procedure in which hyaluronan (also known as hyaluronic acid) is injected into a joint as a means of restoring the normal viscoelasticity of the synovial fluid in individuals with osteoarthritis. Viscosupplementation has become an important treatment option for individuals with osteoarthritis who have failed to respond to conservative non-pharmacologic therapy (e.g., physical therapy), pharmacologic therapy (e.g., nonsteroidal anti-inflammatory drugs [NSAIDs], acetaminophen), and intra-articular injection of corticosteroids.

To date, the majority of studies have assessed hyaluronan for osteoarthritis of the knee. Additionally, hyaluronan's use in the treatment of osteoarthritis of the knee is the only US Food and Drug Administration (FDA)--approved indication. The FDA has approved the following preparations of intra-articular hyaluronan in the treatment of osteoarthritis of the knee; these preparations have demonstrated equivalent therapeutic results when used for the treatment of osteoarthritis of the knee:

Synvisc® (hylan G-F 20)
Synvisc-One® (hylan G-F 20)
Orthovisc® (high-molecular-weight hyaluronan)
Hyalgan® (sodium hyaluronate)
Supartz® (sodium hyaluronate)
Euflexxa® (1% sodium hyaluronate)
Gel-One® (hyaluronic acid)
Monovisc® (high-molecular-weight hyaluronan)
Gelsyn-3™ [formerly Gel-Syn™] (sodium hyaluronate)
GenVisc 850® (sodium hyaluronate)
Hymovis® (high-molecular-weight viscoelastic hyaluronan)
Visco-3™ (sodium hyaluronate)
Durolane® (hyaluronic acid)
TriVisc™ (sodium hyaluronate)
Triluron™ (sodium hyaluronate)
Synojoynt™(sodium hyaluronate)

Intra-articular injection of hyaluronan is currently being investigated for the treatment of osteoarthritis of other joints, including the hip, shoulder, ankle, foot, and hand. Current evidence on these uses is limited, consisting of case series and small randomized controlled trials. The available data is limited with inconsistent outcomes.

There may be additional indications contained in the Policy section of this document due to evaluation of criteria highlighted in the Company’s off-label policy, and/or review of clinical guidelines issued by leading professional organizations and government entities.

References

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US Food and Drug Administration (FDA). Center for Devices and Radiological Health. Sodium Hyaluronate for Injection. GenVisc 850®. [prescribing information]. Doylestown, PA; 05/20/25. Available at: https://genvisc850.com/professionals/assets/info.pdf. Accessed August 01, 2025.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health.
Hyalgan®. Premarket approval letter. [FDA Web site]. 06/28/24. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P950027S015. Accessed August 01, 2025.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health.
Hymovis®. Premarket approval letter, summary of safety and effectiveness, and labeling. [FDA Web site]. 04/09/25. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P150010S001. Accessed August 01, 2025.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. Monovisc®. Premarket approval letter, summary of safety and effectiveness, and labeling. [FDA Web site]. 08/08/23. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P090031S008. Accessed August 01, 2025.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. Orthovisc®. Premarket approval letter, summary of safety and effectiveness, and labeling. [FDA Web site]. 11/08/22. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P030019S023. Accessed August 01, 2025.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. Supartz™. Premarket approval letter, summary of safety and effectiveness, and labeling. [FDA Web site]. 07/22/25. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P980044S051. Accessed August 01, 2025.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health.
Synvisc®. Premarket approval letter, summary of safety and effectiveness, and labeling. [FDA Web site]. 01/02/25. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P940015S043. Accessed August 01, 2025.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. Synvisc-One®. Premarket approval letter, summary of safety and effectiveness, and labeling. [FDA Web site]. 01/02/25. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P940015S044. Accessed August 01, 2025.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. Visco-3™. Premarket approval letter, summary of safety and effectiveness, and labeling. [FDA Web site]. 07/22/25. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P980044S051. Accessed August 01, 2025.

Van den Bekerom MP, Lamme B, Sermon A, et al. What is the evidence for viscosupplementation in the treatment of patients with hip osteoarthritis? Systematic review of the literature. Arch Orthop Trauma Surg. 2008;128(8):815-823.

Witteveen AG, Hofstad CJ, Kerkhoffs GM. Hyaluronic acid and other conservative treatment options for osteoarthritis of the ankle. Cochrane Database Syst Rev.
2015 (10):CD010643.

Zhang W, Moskowitz RW, Nuki G, et al. OARSI recommendations for the management of hip and knee osteoarthritis, Part II: OARSI evidence-based, expert consensus guidelines. Osteoarthritis Cartilage.2008;16(2):137-162.

Zhang W, Nuki G, Moskowitz RW, et al. OARSI recommendations for the management of hip and knee osteoarthritis: part III: changes in evidence following systematic cumulative update of research published through January 2009. Osteoarthritis Cartilage.2010;18(4):476-499.

Coding

CPT Procedure Code Number(s)

N/A

ICD - 10 Procedure Code Number(s)

N/A

ICD - 10 Diagnosis Code Number(s)

M17.0 Bilateral primary osteoarthritis of knee

M17.11 Unilateral primary osteoarthritis, right knee

M17.12 Unilateral primary osteoarthritis, left knee

M17.2 Bilateral post-traumatic osteoarthritis of 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

HCPCS Level II Code Number(s)

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 or hymovis one, 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
J7328 Hyaluronan or derivative, GELSYN-3, for intra-articular injection, 0.1 mg
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, 1 mg

Revenue Code Number(s)

N/A

MPMiscCodesNarrativesPub

Coding and Billing Requirements

Cross Reference

Policy History

Revisions From 11.14.07z:

01/01/2026

This policy has been identified for the HCPCS code update, effective 01/01/2026.

The following HCPCS code has revised narrative in this policy:

FROM: J7322 Hyaluronan or derivative, Hymovis, for intra-articular injection, 1 mg

TO: J7322 Hyaluronan or derivative, hymovis or hymovis one, for intra-articular injection, 1 mg

Revisions From 11.14.07y:

12/01/2025

This version of the policy will become effective 12/01/2025.

This policy has been updated to be consistent with the US Food and Drug Administration (FDA) labeling, Novitas Solutions, Inc. Local Coverage Determination (LCD) L35529 recommendations.

The below unspecified laterality diagnosis codes have been removed from the policy coding table:

M17.10, M17.30, M17.5, M17.9

Revisions From 11.14.07x:

10/16/2024	This policy has been reissued in accordance with the Company's annual review process.
06/28/2023	This policy has been reissued in accordance with the Company's annual review process.
07/27/2022	This policy has been reissued in accordance with the Company's annual review process.
07/28/2021	This policy has been reissued in accordance with the Company's annual review process.
04/01/2021	This policy has been identified for the HCPCS code update, effective 04/01/2021. The following HCPCS code has been removed from this policy: J7333 Hyaluronan or derivative, visco-3, for intra-articular injection, per dose The following HCPCS code has been revised in this policy: FROM: J7321 Hyaluronan or derivative, hyalgan or supartz, for intra-articular injection, per dose TO: J7321 Hyaluronan or derivative, Hyalgan, Supartz or Visco-3, for intra-articular injection, per dose

Revisions From 11.14.07w:

12/18/2020

This policy has been reissued in accordance with the Company's annual review process.

Revisions From 11.14.07v:

07/01/2020

Revisions From 11.14.07u:

01/01/2020

This policy has been updated to be consistent with the US Food and Drug Administration (FDA) labeling, Novitas Solutions, Inc. Local Coverage Article (LCA).A55036, andNovitas Solutions, Inc. Local Coverage Determination (LCD).L35427recommendations This policy was updated to communicate The Company’s preferred and non -preferred agents. Monovisc® was added as new preferred agent.
The following HCPCS codes have been added to this policy:

J7331 Hyaluronan or derivative, synojoynt, for intra-articular injection, 1 mg
J7332 Hyaluronan or derivative, triluron, for intra-articular injection, 1 mg

Revisions From 11.14.07t:

01/01/2019

This policy has been identified for the HCPCS code update, effective 01/01/2019.

The following HCPCS codes have been added to this policy:
J7318 Hyaluronan or derivative, durolane, for intra-articular injection, 1 mg
J7329 Hyaluronan or derivative, trivisc, for intra-articular injection, 1 mg

The following HCPCS codes have been removed from this policy:
C9465 Hyaluronan or derivative, Durolane, for intra-articular injection, per dose
J3490 Unclassified drugs

Revisions From 11.14.07s:

04/09/2018

This policy has undergone a routine review and the medical necessity criteria have been revised to reflect the United States Food and Drug Administration (FDA) labeling and drug compendia (i.e., Micromedex,Lexicomp).Novitas Solutions, Inc. Local Coverage Article (LCA).A55036, andNovitas Solutions, Inc. Local Coverage Determination (LCD).L35427

The following HCPCS code was added for Durolane:
C9465 Hyaluronan or derivative, Durolane, for intra-articular injection, per dose

Revisions From 11.14.07r:

01/01/2018

This policy has been identified for the HCPCS code update, effective 01/01/2018.

The following HCPCS code has been removed from this policy: J3490
The following HCPCS narrative has been revised in this policy: J7321

Revisions From 11.14.07q:

11/22/2017

This policy has been reissued in accordance with the Company's annual review process.

Effective 10/05/2017 this policy has been updated to the new policy template format.

Version Effective Date:

1/2/2026

Version Issued Date:

1/2/2026

Version Reissued Date: