Medicare will consider viscosupplementation therapy for the knee via intra-articular injections of hyaluronic preparations medically reasonable and necessary when ALL of the following conditions are met:
• The patient 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 patient has failed at least three months of conservative therapy. Conservative therapy is defined as:
o Nonpharmacologic therapy (such as but not limited to home exercise program, education, weight loss, physical therapy if indicated); and
o If not contraindicated, simple analgesics and NSAIDS.
• The patient has failed to respond to aspiration of the knee and intra-articular corticosteroid injection therapy when inflammation is a significant component of the patient’s symptoms and intra-articular corticosteroids are not contraindicated.
• Drugs and biologicals approved for marketing by the FDA are considered safe and effective when used for indications specified on the labeling. The labeling lists the safe and effective, i.e., medically reasonable and necessary dosage and frequency. Therefore, doses and frequences that exceed the accepted standard of recommended dosage and/or frequency, as described in the package insert, are considered not reasonable and necessary and therefore, not subject to coverage.
• Intra-articular injections of other therapeutic agents, such as corticosteroids, should not be performed in the same knee during the course of viscosupplementation therapy.
• If the first course of treatment produces relief, subsequent courses of treatment may be reasonable if symptoms return. Subsequent courses of treatment will be allowed six (6) months after the last injection of a previous course of treatment.
• Per the FDA package insert, the effectiveness of Monovisc™ has not been established for more than one course of treatment.
• Viscosupplementation of joints other than the knee(s) will be considered not reasonable and necessary and will not be subject to coverage.
• Treatment for diagnoses other than those included in the "ICD-9 Codes that Support Medical Necessity" section of this LCD will not be covered.
• Imaging procedures (e.g., 20611, 77012, 77021, 76881, 76882 or 76942) performed routinely for the purpose of visualization of the knee to provide guidance for needle placement will not be covered. Flouroscopy may be medically necessary and allowed if documentation supports that the presentation of the patient’s affected knee on the day of the procedure makes needle insertion problematic. No other imaging modality for the purpose of needle guidance and placement will be covered.
• Arthrography to provide needle guidance for knee injections will not be covered. (See Utilization Guidelines).
• Coverage of viscosupplementation therapy of the knee assumes that knee arthroplasty is not being considered as a current treatment option.
• Viscosupplementation will not be covered:
o When the diagnosis is anything other than osteoarthritis
o For intra-articular injection in joints other than the knee
o As the initial treatment of osteoarthritis of the knee
o When failure of/or contraindication to conservative therapy and/or corticosteroid injections are not documented in the medical record
o When the dose and treatment regimen exceeds those approved under the FDA label
o When a repeat series of injections is initiated prior to six months after completion of the previous course of treatment
o When a repeat series of injections is administered when there was no symptomatic/functional improvement evidenced from the previous series of injections
o For topical application of hyaluronate preparations
Group 1 Paragraph
Group 1 Codes
20610 Drain/inj joint/bursa w/o us
J7321 Hyalgan/supartz inj per dose
J7323 Euflexxa inj per dose
J7324 Orthovisc inj per dose
J7325 Synvisc or Synvisc-One
J7327 Monovisc inj per dose
ICD-9 Codes that Support Medical Necessity
Group 1 Paragraph
For HCPCS codes J7321, J7323, J7324,J7325,J7326, and J7327:
Group 1 Codes
715.16 OSTEOARTHROSIS LOCALIZED PRIMARY INVOLVING LOWER LEG
715.26 OSTEOARTHROSIS LOCALIZED SECONDARY INVOLVING LOWER LEG
715.36 OSTEOARTHROSIS LOCALIZED NOT SPECIFIED WHETHER PRIMARY OR SECONDARY INVOLVING LOWER LEG
715.96 OSTEOARTHROSIS UNSPECIFIED WHETHER GENERALIZED OR LOCALIZED INVOLVING LOWER LEG