Notification



Notification Issue Date:



Medical Policy Bulletin


Title:Intra-Articular Injection of Hyaluronan for the Treatment of Osteoarthritis

Policy #:11.14.07t

This policy is applicable to the Company’s commercial products only. Policies that are applicable to the Company’s Medicare Advantage products are accessible via a separate Medicare Advantage policy database.


The Company makes decisions on coverage based on Policy Bulletins, benefit plan documents, and the member’s medical history and condition. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable.

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.

This Medical Policy Bulletin document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy Bulletin will be reviewed regularly and be updated as scientific and medical literature becomes available. For more information on how Medical Policy Bulletins are developed, go to the About This Site section of this Medical Policy Web site.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's benefit contract.

MEDICALLY NECESSARY

The intra-articular injection of hyaluronan is considered medically necessary and, therefore, covered for the treatment of osteoarthritis when all of the following medical necessity criteria are met:
  • The individual has documented symptomatic osteoarthritis of the knee.
  • The individual reports pain that interferes with functional activities (e.g., ambulation or prolonged standing).
  • There is adequate documentation that the individual does not have functional improvement after a trial period of at least three months of conservative treatments such as exercise, physical therapy, medication (e.g., nonsteroidal anti-inflammatory drugs [NSAIDs]), and injection of intra-articular corticosteroids; or the individual is unable to tolerate conservative treatment due to adverse side effects; or because such therapy is contraindicated because of other medical conditions.
  • The intra-articular hyaluronan product is approved by the US Food and Drug Administration (FDA) for intra-articular injection of the knee.

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 Orthovisc®, Synvisc®, and Synvisc-One® as its preferred products.

These products are less costly and at least as likely to produce equivalent therapeutic results as the 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®, and TriVisc™.

For individuals who meet the above medical necessity criteria, use of the Company-designated preferred products, 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: Euflexxa®, Gel-One®, Hyalgan®, Hymovis®, Monovisc®, Supartz®, Gelsyn-3 (formerly Gel-Syn™), GenVisc 850®, Visco-3™, Durolane®, or TriVisc) 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 both preferred products (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.

*Requests for the use of 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™, 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

ADDITIONAL COURSES OF TREATMENT
Additional intra-articular injections of hyaluronan for the treatment of osteoarthritis of the knee for individuals who have responded to a previous course of treatment may be given individual consideration for coverage when both of the following criteria are met:
  • At least six months must have elapsed since the prior injection or series of injections before another series can be administered regardless of whether the same product or a different product is used or whether a different technique of administration is used.
  • The individual's medical record must objectively document one of the following outcomes during the 6-month period following the injection:
    • significant improvement in pain and functional capacity of the joint
    • significant reduction in the doses of non-steroidal anti-inflammatory drugs [NSAIDs]
    • significant reduction in the number of intra-articular steroid injections

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®, or TriVisc), is considered not medically necessary and, therefore, not covered (with the exception of a documented contraindication to the preferred products (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

DOCUMENTATION GUIDELINES

For additional courses of treatment, the medical record should document all of the following criteria:
  • Reduction in the requirement for medication(s) or adaptive equipment
  • Improvement in pain and function, as described by improved tolerance of activities, such as walking
  • Improvement in physical findings, such as measured improved range of motion, improved strength, or reduced inflammation

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®, and TriVisc .

Description

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)

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.
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US Food and Drug Administration (FDA). Center for Devices and Radiological Health. Sodium Hyaluronate for Injection. Gel-Syn™. [prescribing information]. Thousand Oaks, CA; 08/01/16. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf11/P110005b.pdf and https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma_template.cfm?id=p110005s002 . Accessed February 2, 2018.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. Sodium Hyaluronate for Injection. GenVisc 850®. [prescribing information]. Doylestown, PA; 08/01/16. Available at: https://google2.fda.gov/search?q=Gen-visc&client=FDAgov&site=FDAgov&lr=&proxystylesheet=FDAgov&requiredfields=-archive%3AYes&output=xml_no_dtd&getfields=*. Accessed February 2, 2018.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health.
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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]. 08/01/16. Available at: https://google2.fda.gov/search?q=hymovis&client=FDAgov&site=FDAgov&lr=&proxystylesheet=FDAgov&requiredfields=-archive%3AYes&output=xml_no_dtd&getfields=* . Accessed February 2, 2018.

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]. 08/01/16. Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P090031 . Accessed February 2, 2018.

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]. 08/01/16. Available at: https://google2.fda.gov/search?q=orthovisc&client=FDAgov&site=FDAgov&lr=&proxystylesheet=FDAgov&requiredfields=-archive%3AYes&output=xml_no_dtd&getfields=*. Accessed February 2, 2018.

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]. 08/01/16. Available at: https://google2.fda.gov/search?q=supartz&client=FDAgov&site=FDAgov&lr=&proxystylesheet=FDAgov&requiredfields=-archive%3AYes&output=xml_no_dtd&getfields=*. Accessed February 2, 2018.

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]. 08/01/16. Available at: https://google2.fda.gov/search?q=synvisc&client=FDAgov&site=FDAgov&lr=&proxystylesheet=FDAgov&requiredfields=-archive%3AYes&output=xml_no_dtd&getfields=*. Accessed February 2, 2018.

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]. 08/01/16. Available at: https://google2.fda.gov/search?q=synvisc&client=FDAgov&site=FDAgov&lr=&proxystylesheet=FDAgov&requiredfields=-archive%3AYes&output=xml_no_dtd&getfields=*. Accessed February 2, 2018.

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]. 08/01/16. Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P980044S027 . Accessed February 2, 2018.

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

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

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD -10 Diagnosis Code Number(s)

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

M17.9 Osteoarthritis of knee, unspecified




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, 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



Revenue Code Number(s)

N/A

Coding and Billing Requirements


Cross References


Policy History

Revisions from 11.14.07t
01/01/2019This 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
04/09/2018This 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:
01/01/2018This 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:
11/22/2017This 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: 01/01/2019
Version Issued Date: 01/03/2019
Version Reissued Date: N/A

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