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L.2.01.422
Durolane (hyaluronic acid)
Euflexxa (sodium hyaluronate)
Gel-One (cross-linked hyaluronate)
Gelsyn-3 (sodium hyaluronate)
GenVisc 850 (sodium hyaluronate)
Hyalgan (sodium hyaluronate)
Hymovis (high molecular weight hyaluronan)
Monovisc (high molecular weight hyaluronan)
Orthovisc (high molecular weight hyaluronan)
Supartz FX (sodium hyaluronate)
Synojoynt (sodium hyaluronate)
Synvisc (Hylan G-F 20)
Synvisc One (Hylan G-F 20)
Triluron (sodium hyaluronate)
TriVisc
(sodium hyaluronate)
Visco-3 (sodium hyaluronate)
Intra-articular injection of hyaluronan has been proposed as a means of restoring the normal viscoelasticity of the synovial fluid in patients with osteoarthritis and reducing pain and improving function. This treatment may also be called viscosupplementation. Hyaluronan is a naturally occurring macromolecule that is a major component of synovial fluid and is thought to contribute to its viscoelastic properties. Chemical crosslinking of hyaluronan increases its molecular weight; cross-linked hyaluronans are referred to as hylans. In osteoarthritis, the overall length of hyaluronan chains present in cartilage and the hyaluronan concentration in the synovial fluid are decreased.
Most studies to date have assessed hyaluronan injections for knee osteoarthritis, the U.S. Food and Drug Administration-approved indication. Other joints (eg, hip, shoulder) are being investigated for intra-articular hyaluronan treatment of osteoarthritis.
Knee Osteoarthritis
Knee osteoarthritis is common, costly, and a cause of substantial disability. Among U.S. adults, the most common causes of disability are arthritis and rheumatic disorders.
Treatment
Currently, no curative therapy is available for osteoarthritis, and thus the overall goals of management are to reduce pain, disability, and the need for surgery.
The FDA has not approved intra-articular hyaluronan for joints other than the knee.
Durolane and Euflexxa may be considered medically necessary for treatment of painful osteoarthritis of the knee in patients who have insufficient pain relief from conservative nonpharmacologic therapy and simple analgesics.
Repeated courses of Durolane and Euflexxa injections may be considered medically necessary under the following conditions:
The use of intra-articular hyaluronan injections into joints other than the knee is considered investigational.
The following medications are not covered on any BCBSMS Formulary:
Gel-One
Gelsyn-3
GenVisc 850
Hyalgan
Hymovis
Monovisc
Orthovisc
Supartz FX
Synojoynt
Synvisc
Synvisc One
Triluron
TriVisc
Visco-3
Services related to delivery and/or administration of a medication determined to be not medically necessary will also be considered not medically necessary.
Federal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.
State Health Plan (State and School Employees) Participants
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Mental Health Disorders, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:
A. consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and
B. appropriate with regard to standards of good medical practice; and
C. not solely for the convenience of the Member, his or her Provider; and
D. the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.
For the definition of medical necessity, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.
Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
5/1998: Approved by Medical Policy Advisory Committee (MPAC).
8/2001: Reviewed by MPAC; Supartz added.
1/29/2001: HCPCS code added.
2/14/2002: Investigational definition added.
3/12/2002: New 2002 codes added, J7315 deleted.
5/1/2002: Type of Service and Place of Service deleted.
8/2002: Reviewed by MPAC; no changes.
3/13/2003: Code Reference section updated.
8/29/2003: Arthrease and Orthovisc added.
11/5/2003: Code Reference section reviewed, HCPCS J3490 deleted.
3/31/2004: Arthrease (Savient Pharmaceutical) and Orthovisc (Anika Therapeutics) have received FDA approval.
2/18/2005: Policy reviewed, Sources updated.
9/21/2005: Description revised to be consistent with BCBSA policy # 2.01.31.
12/13/2006: Policy reviewed, no changes.
1/2/2007: Code Reference section updated per the 2007 CPT/HCPCS revisions.
3/26/2007: Registered trademark symbols added.
6/14/2007: Code Reference section updated per quarterly HCPCS and Category III revisions.
12/19/2007: Code Reference section updated per the 2008 CPT/HCPCS revisions.
1/15/2008: Policy description updated. POLICY section rewritten for clarity. Added repeated courses of intra-articular hyaluronan injections may be considered medically necessary if there was significant pain relief with the prior course, and at least six months have passed since the course to POLICY section. Osteoarthritis added to policy title.
3/27/2008: Reviewed and approved by MPAC.
10/15/2009: Policy reviewed, no changes.
12/15/2009: Coding Section revised for 2010 CPT4 and HCPCS revisions.
12/30/2010: Policy description and statement unchanged. FEP verbiage added to the Policy Exceptions section. Deleted outdated references from the Sources section.
05/17/2011: Policy reviewed; no changes.
03/02/2012: Policy reviewed; no changes.
05/13/2013: Policy description updated to add information regarding the single-dose cross-linked hyaluronate Gel-One®. Code Reference section updated to remove deleted HCPCS code J7322 and to add HCPCS code J7326. Removed ICD-9 procedure code 81.92 from the Code Reference section.
12/31/2014: Code Reference section updated to revise the description of the following CPT code: 20610. Effective 1/1/15. Added the following new 2015 CPT code: 20611. Added the following new 2015 HCPCS code: J7327.
08/28/2015: Medical policy revised to add ICD-10 codes.
06/06/2016: Policy number L.2.01.422 added. Policy Guidelines updated to add medically necessary and investigative definitions.
10/19/2016: Policy description updated regarding products. Policy statements unchanged. Code Reference section updated to add HCPCS codes J7328 and Q9980.
12/30/2016: Code Reference section updated to add new 2017 HCPCS codes J7320 and J7322.
12/22/2017: Code Reference section updated to revise description for HCPCS code J7321 effective 01/01/2018.
05/11/2018: Policy description updated to add information regarding intra-articular hyaluronan injections for osteoarthritis and FDA-approved treatments. Policy statements unchanged. Code Reference section updated to remove deleted HCPCS code Q9980.
12/20/2018: Code Reference section updated to add new HCPCS codes J7318 and J7329, effective 01/01/2019.
09/17/2019: Code Reference section updated to add new HCPCS codes J7331 and J7332, effective 10/01/2019.
06/29/2020: Code Reference section updated to revise code description for HCPCS code J7321 and to add new HCPCS code J7333, effective 07/01/2020.
03/30/2021: Code Reference section updated to revise code description for HCPCS code J7321, effective 04/01/2021.
06/11/2021: Policy description updated regarding knee osteoarthritis and treatments. Policy statements unchanged. Policy Guidelines updated to change "Nervous/Mental Conditions" to "Mental Health Disorders" and "Medically Necessary" to "medical necessity."
11/08/2022: Policy reviewed. Policy statements unchanged. Code Reference section updated to remove deleted HCPCS code J7333.
02/01/2023: Policy Exceptions updated to add the following: State Health Plan (State and School Employees): The prescription drug(s) in this medical policy may be covered under a prescription drug benefit plan administered by the State Health Plan’s Pharmacy Benefit Manager. Please perform a formulary drug search at https://www.dfa.ms.gov/cvs-caremark and submit any required Prior Authorization Requests for coverage determination to the Plan’s Pharmacy Benefit Manager. Services related to delivery and/or administration of a medication determined to be not medically necessary will also be considered not medically necessary. Services related to delivery and/or administration of a self-administered drug are not covered.
07/01/2023: Policy Exceptions updated regarding State Health Plan (State and School Employees) Participants.
10/31/2023: Policy reviewed; no changes.
05/06/2024: Policy description updated regarding products. Policy statements unchanged.
11/01/2024: Added list of products to the top of the policy. Policy description revised to remove products. Revised policy statement to specify that Durolane and Euflexxa may be considered medically necessary for treatment of painful osteoarthritis of the knee in patients who have insufficient pain relief from conservative nonpharmacologic therapy and simple analgesics. Added statement that the following medications are not covered: Gel-One, Gelsyn-3, GenVisc 850, Hyalgan, Hymovis, Monovisc, Orthovisc, Supartz FX, Synojoynt, Synvisc, Synvisc One, Triluron, TriVisc, and Visco-3. Added that services related to delivery and/or administration of a medication determined to be not medically necessary will also be considered not medically necessary. Sources updated. Code Reference section updated to move the following HCPCS codes from the Covered Codes table to the Not Covered/Non-Formulary Codes table: J7320, J7321, J7322, J7324, J7325, J7326, J7327, J7328, J7329, J7331, and J7332. Effective 01/01/2025.
12/02/2025: Policy reviewed and approved by the Pharmacy & Therapeutics (P&T) Committee. Sources updated.
Blue Cross Blue Shield Association policy # 2.01.31
Durolane prescribing information. Bioventus LLC. Last accessed September 2025.
Euflexxa prescribing information. Ferring Pharmaceuticals Inc. July 2016. Last accessed September 2025.
Gel-One product information. Zimmer Biomet. Last accessed September 2025.
Gelsyn-3 prescribing information. Bioventus LLC. Last accessed September 2025.
GenVisc 850 prescribing information. Avanos Medical, Inc. Last accessed September 2025.
Hyalgan prescribing information. Fidia Pharma USA INC. August 2017. Last accessed September 2025.
Hymovis prescribing information. Fidia Pharma USA Inc. October 2015. Last accessed September 2025.
Monovisc prescribing information. Anika Therapeutics, Inc. Last accessed September 2025.
Orthovisc prescribing information. Anika Therapeutics, Inc. Last accessed September 2025.
Supartz FX prescribing information. Bioventus LLC. March 2016. Last accessed September 2025.
Synojoint product information. Arthrex, Inc. Last accessed September 2025.
Synvisc prescribing information. Genzyme Corporation. Last accessed September 2025.
Synvisc-One prescribing information. Genzyme Corporation. Last accessed September 2025.
Triluron prescribing information. Fidia Pharma USA Inc. July 2019. Last accessed September 2025.
Trivisc prescribing information. Avanos Medical, Inc. Last accessed September 2025.
Visco-3 prescribing information. Zimmer Biomet. Last accessed September 2025.
This may not be a comprehensive list of procedure codes applicable to this policy.
The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.
Code Number | Description | ||
CPT-4 | |||
20610 | Arthrocentesis, aspiration and/or injection; major joint or bursa (eg, shoulder, hip, knee, subacromial bursa); without ultrasound guidance | ||
20611 | Arthrocentesis, aspiration and/or injection, major joint or bursa (eg, shoulder, hip, knee, subacromial bursa); with ultrasound guidance, with permanent recording and reporting | ||
HCPCS | |||
J7318 | Hyaluronan or derivative, Durolane, for intra-articular injection, 1 mg | ||
J7323 | Hyaluronan or derivative, Euflexxa, for intra-articular injection, per dose | ||
ICD-9 Procedure | ICD-10 Procedure | ||
ICD-9 Diagnosis | ICD-10 Diagnosis | ||
715.16 | Osteoarthrosis, localized, primary | M17.0 - M17.12 | Primary osteoarthritis of knee (code range) |
715.26 | Osteoarthrosis, localized, secondary | M17.2 - M17.5 | Secondary osteoarthritis of knee (code range) |
715.36715.96 | Osteoarthrosis, localized, not specified whether primary or secondaryOsteoarthrosis, unspecified whether generalized or localized | M17.9 | Osteoarthritis of knee, unspecified |
Not Covered/Non-Formulary
Code Number | Description |
CPT-4 | |
HCPCS | |
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 |
J7324 | Hyaluronan or derivative, Orthovisc, for intra-articular injection, per dose |
J7325 | Hyaluronan or derivative, Synvisc or Synvisc-One, for intra-articular, 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 |
ICD-10 Procedure | |
ICD-10 Diagnosis |
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