HCPCS (Healthcare Common Procedure Coding System) Codes
Code Description
J7326 Hyaluronan or derivative, Gel-One, for intra-articular injection, per dose
Coding and Billing for Gel-One Cross-Linked Hyaluronate
• Prior authorization/pre-determination is suggested prior to administration of Gel-One Cross-Linked Hyaluronate. The payer will want to review the product indications, dosage, route of administration and medical necessity.
• It is recommended providers bill for Gel-One showing both the J7326 HCPCS code and the NDC as reflected on the sample CMS-1500 claim form below. The following qualifiers are to be used when entering supplemental information for the billing of Gel-One.
Gel-One Hyaluronate is an injectable hyaluronate gel approved for the treatment of osteoarthritis (OA) of the knee that does not respond to other conservative treatments. It is the first low-volume viscosupplement available in a single-injection formula.
Unlike other viscosupplement treatments, highly purified Gel-One Hyaluronate requires only 3mL for safe, effective and complete treatment with no reports of pseudosepsis (severe acute inflammatory responses) in the pre-market clinical study.
N4 National Drug Codes (NDC)
ML Milliliter
To enter supplemental information, begin at 24A on the CMS-1500 claim form by entering the qualifier and then the information. Do not enter a space between the qualifier and the number/code/information. Do not enter hyphens or spaces within the number/code. Add the supplemental information in the following order: qualifier, NDC code, one space, unit/basis of measurement qualifier, quantity. The number of digits for the quantity is limited to eight digits before the decimal and three digits after the decimal. If entering a whole number, do not use a decimal. Do not use commas.
Coverage Rationale Medical Necessity Plans
Coverage for Durolane, Euflexxa, and Gelsyn-3 is contingent on criteria in the Diagnosis-Specific Criteria section. Prior authorization is not required.
Coverage for Gel-One, GenVisc 850, Hyalgan, Hymovis, Monovisc, Orthovisc, Supartz, Synojoynt, Synvisc or Synvisc-One, Triluron, TriVisc, or Visco-3 is contingent on Medical Necessity Criteria and Diagnosis-Specific Criteria. In order to continue coverage, members already on these products will be required to change therapy to Durolane, Euflexxa, or Gelsyn-3 unless they meet the criteria below.
Medical Necessity Criteria (for Medicare reviews, refer to the CMS section**)
Treatment with Gel-One, GenVisc 850, Hyalgan, Hymovis, Monovisc, Orthovisc, Supartz, Synojoynt, Synvisc or Synvisc-One, Triluron, TriVisc, or Visco-3 is medically necessary for the indications specified in this policy when one the criteria below are met:
Both of the following:
- History of a trial of adequate dose and duration of Durolane, Euflexxa, and Gelsyn-3, resulting in minimal clinical response; and
- Physician attests that, in their clinical opinion, the clinical response would be expected to be superior than experienced with Durolane, Euflexxa, and Gelsyn-3.
or Both of the following: - History of failure, contraindication, or intolerance to Durolane, Euflexxa, and Gelsyn-3; and *Physician attests that, in their clinical opinion, the same failure, contraindication, or intolerance would not be expected to occur with Gel-One, GenVisc 850, Hyalgan, Hymovis, Monovisc, Orthovisc, Supartz, Synojoynt, Synvisc or SynviscOne, Triluron, TriVisc, or Visco-3.
Non-Medical Necessity Plans
Any sodium hyaluronate product is to be approved contingent on the coverage criteria in the Diagnosis-Specific Criteria section.
Diagnosis-Specific Criteria
Initial Authorization (sodium hyaluronate naïve patients)
Intra-articular injections of sodium hyaluronate are proven and medically necessary when all of the following are met:
- Diagnosis of knee osteoarthritis; 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 member reports pain which interferes with functional activities (e.g., ambulation, prolonged standing); and
- The pain is attributed to degenerative joint disease/primary osteoarthritis of the knee; and
- There are no contraindications to the injections (e.g., active joint infection, bleeding disorder); and
- Dosing is in accordance with the US FDA approved labeling as shown in the table below; and
- Initial authorization is for a single injection course once per joint for 6 months.
Reauthorization/Continuation
Repeated courses of intra-articular hyaluronan injections may be considered when all of the following are met:
- Diagnosis of knee osteoarthritis; and
- Documentation of positive clinical response to therapy (e.g., significant pain relief was achieved with the prior course of injections); and
- Pain has recurred; and
- At least 6 months have passed since the prior course of treatment for the respective joint; and
- Dosing is in accordance with the US FDA approved labeling as shown in the table below; and
- Continuing authorization is for a single injection course once per joint for 6 months.
Documentation Requirements
Benefit coverage for health services is determined by the member specific benefit plan document and applicable laws that may require coverage for a specific service. The documentation requirements outlined below are used to assess whether the member meets the clinical criteria for coverage but do not guarantee coverage of the service requested.
CPT J7326 DESCRIPTION
Osteoarthritis is the most common form of arthritis. Pathologically in the knee, osteoarthritis is characterized by deterioration and loss of articular cartilage, subchondral sclerosis and osteophyte formation. Since there are no curative therapies for osteoarthritis at this time, the overall goals of existing therapies are to reduce pain, prevent disability, and postpone the need for total knee replacement surgery. Various non-pharmacologic (e.g., weight loss, physical therapy) and pharmacologic (e.g., acetaminophen, non-steroidal anti-inflammatory [NSAIDs], intraarticular injections of corticosteroids, intra-articular hyaluronates) treatment modalities are utilized.
Viscosupplements contain hyaluronate. Hyaluronates are also referred to as hyaluronic acid or hyaluronan. 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 patients. These marginal beneficial results are more pronounced with the larger molecular weight compound hylan G-F20. There is 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.
Advantage and Elite/ProMedica Medicare Plan
Medical Policy updated to refer Product Lines Elite/ProMedica Medicare Plan and Advantage to the Magellan MRx Prescription Drug Benefits/Prior Authorizations. The Viscosupplementations will continue to be billed to the medical benefit. Refer to Prescription Drug Benefits/Prior Authorizations https://www.paramounthealthcare.com/services/providers/prior-authorizationcriteria/magellan-mrx
COVERAGE CRITERIA
HMO, PPO, Individual Marketplace
The use of viscosupplementation (C9465, (C9465, J7318-J7329)) is considered not medically necessary for osteoarthritis of the knee and for all other indications.
Note:
Ultrasound guidance, fluoroscopic guidance and knee arthrography for viscosupplement injections is considered experimental and investigational because it has not been established that this approach will improve health outcomes.
CODING/BILLING INFORMATION
The appearance of a code in this section does not necessarily indicate coverage. Codes that are covered may have selection criteria that must be met. Payment for supplies may be included in payment for other services rendered.
Length of Authorization
Coverage will be provided for 12 months and may be renewed.
Billing Guideline
Hyaluronate injections are considered medically necessary for OA of the knee(s)† when all of the following criteria are met:
Gel-One and Synvisc/Synvisc-One are the preferred agents for Commercial and Medicare members.
Documented symptomatic OA of the knee.
- Trial and failure of conservative therapy (including physical therapy, pharmacotherapy [e.g., nonsteroidal anti-inflammatory drugs (NSAIDs), acetaminophen (up to 1 g 4 times/day) and/or topical capsaicin cream]) has been attempted and 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.
- Member has failed to adequately respond to aspiration and injection of intra-articular steroids.
- Member reports pain which interferes with functional activities (e.g., ambulation, prolonged standing).
- No contraindications to the injections (e.g., active joint infection, bleeding disorder).
- Failed trial of Gel-One AND Synvisc/Synvisc-One prior to using Sodium Hyaluronate, Orthovisc,
Euflexxa, Supartz Fx, Hyalgan, Hymovis, Monovisc, Synojoynt, Triluron, TriVisc, Visco-3, Gelsyn-3 and Durolane††.
† FDA Approved Indication(s); not acoveredbenefitforMedicaidmembers
†† Both Commercial AND Medicare members are subject to this step therapy Renewal Criteria Coverage may be renewed when all of the following criteria are met:
- Medical record demonstrates reduction in dose of NSAIDS (or other analgesics or anti- inflammatory medication) during the 12-month period following the previous series of injections
- The medical record objectively documents significant improvement in pain and functional capacity as the result of the previous injections
- Absence of unacceptable toxicity from the previous injections
- Patient must have trial and failure of Gel-One AND Synvisc/Synvisc-One before using Sodium Hyaluronate, Orthovisc, Euflexxa, Supartz Fx, Hyalgan, Monovisc, Synojoynt, Triluron, TriVisc, Visco-3, Gelsyn-3 and Durolane.††
Dosage/Administration
Product Dose
Euflexxa 20mg once weekly x 3 doses
Gel-One 30mg x 1 dose
Gelsyn-3 16.8 mg once weekly x 3 doses
Hyalgan 20mg once weekly x 5 doses
Hymovis 24mg once weekly x 2 doses
Monovisc 88mg x 1 dose
Orthovisc 30mg once weekly x 3 or 4 doses
Sodium Hyaluronate 1% 20 mg once weekly x 3 doses
Supartz FX 25mg once weekly x 5 doses
Synvisc 16mg once weekly x 3 doses
Synvisc-One 48mg x 1 dose
Trivisc 25mg once weekly x 3 doses
Durolane 60mg (3mL) x 1 dose
Triluron 20 mg once weekly x 3 doses
Synojoynt 1% once weekly x 3 doses
Quantity Limitations
- Euflexxa: Maximum 6 injections per 180 days
- Gel-One: Maximum 2 injection per 180 days
- Gelsyn-3: Maximum 6 injections per 180 days
- Hyalgan: Maximum 10 injections per 180 days
- Hymovis: Maximum 4 injections per 180 days
- Monovisc: Maximum 2 injections per 180 days
- Orthovisc: Maximum 8 injections per 180 days
- Supartz Fx: Maximum 10 injections per 180 days
- Sodium Hyaluronate 1%: Maximum 6 injections per 180 days
- Synvisc: Maximum 6 injections per 180 days
- Synvisc-One: Maximum 2 injection per 180 days
- Trivisc: Maximum 3 injections per 180 days
- Durolane: Maximum 2 injections per 180 days
- Triluron: Maximum 3 injections per 180 days
- Synojoynt: Maximum 3 injections per 180 days
