This policy uses coverage criteria developed solely based on applicable Medicare statutes, regulations, NCDs, LCDs, CMS manuals and other applicable Medicare coverage documents.
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. Such symptoms may include pain which interferes with the 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, 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 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: 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.
*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
A series is defined as a set of injections for each joint and each treatment. The frequency of injection(s) applies to the initial series and repeat series as follows:
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™, Synojoynt™, Triluron™ 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 drug.
