Easy Choice Health Plan, Inc. Exactus Pharmacy Solutions, Inc. Harmony Health Plan of Illinois, Inc. Missouri Care, Incorporated WellCare Health Insurance of Arizona, Inc., operating in Hawai i as Ohana Health Plan, Inc. WellCare of Kentucky, Inc. WellCare Health Plans of Kentucky, Inc. WellCare Health Plans of New Jersey, Inc. WellCare of Connecticut, Inc. WellCare of Florida, Inc., operating in Florida as Staywell WellCare of Georgia, Inc. WellCare of Louisiana, Inc. WellCare of New York, Inc. WellCare of South Carolina, Inc. WellCare of Texas, Inc. WellCare Prescription Insurance, Inc. Windsor Health Plan, Inc. Viscosupplementation Policy Number: Original Effective Date: 1/8/2015 Revised Date(s): 1/7/2016 APPLICATION STATEMENT The application of the Clinical Coverage Guideline is subject to the benefit determinations set forth by the Centers for Medicare and Medicaid Services (CMS) Clinical Coverage Guideline page 1
National and Local Coverage Determinations and state-specific Medicaid mandates, if any. DISCLAIMER The Clinical Coverage Guideline is intended to supplement certain standard WellCare benefit plans. The terms of a member s particular Benefit Plan, Evidence of Coverage, Certificate of Coverage, etc., may differ significantly from this Coverage Position. For example, a member s benefit plan may contain specific exclusions related to the topic addressed in this Clinical Coverage Guideline. When a conflict exists between the two documents, the Member s Benefit Plan always supersedes the information contained in the Clinical Coverage Guideline. Additionally, Clinical Coverage Guidelines relate exclusively to the administration of health benefit plans and are NOT recommendations for treatment, nor should they be used as treatment guidelines. The application of the Clinical Coverage Guideline is subject to the benefit determinations set forth by the Centers for Medicare and Medicaid Services (CMS) National and Local Coverage Determinations and state-specific Medicaid mandates, if any. Note: Lines of business (LOB) are subject to change without notice; current LOBs can be found at www.wellcare.com select the Provider tab, then Tools and Clinical Guidelines. BACKGROUND Viscosupplementation therapy is part of the therapy used in the treatment of osteoarthritis of the knee. Osteoarthritis results from articular cartilage failure due to the complex interplay of genetic, metabolic, biochemical and biomechanical factors with a secondary component of inflammation. In most patients the initiating mechanism is damage to the articular cartilage either as a single large injury or a series of repeated smaller injuries. The primary symptom of osteoarthritis of the knee is pain however, because cartilage is aneural, significant radiographic findings are often noted in asymptomatic individuals imaged for other reasons. Synthetic hyaluronic preparations used as a viscosupplement are indicated for the treatment of pain in osteoarthritis of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics such as acetaminophen or non-steroidal anti-inflammatory drugs (NSAIDS). 1 Hyaluronic acid, a naturally occurring substance found in the synovial (joint) fluid, is injected into the knee joint and acts as a lubricant to enable bones to move smoothly over each other and as a shock absorber for joint loads. People with osteoarthritis ("wear-and-tear" arthritis) have a lower-than-normal concentration of hyaluronic acid in their joints. Viscosupplementation may be a therapeutic option for individuals with osteoarthritis of the knee; it has been shown to relieve pain in many patients who have not responded to other nonsurgical methods. The technique was first used in Europe and Asia, and approved by the FDA in 1997. Several preparations of hyaluronic acid are now commercially available. Immediate effects include: 2 Hyaluronic acid does not have an immediate pain-relieving effect. For the first 48 hours after the shot, you should avoid excessive weight bearing on the leg, such as standing for long periods, jogging or heavy lifting. You may notice a local reaction, such as pain, warmth, and slight swelling immediately after the shot. These symptoms generally do not last long. You may want to apply an ice pack to help ease them. Rarely, patients may develop a local allergy-like reaction in the knee. In these cases, the knee may become full of fluid, red, warm, and painful. If this occurs, contact your doctor immediately. Infection and bleeding are also very rare complications of this procedure. Long term effects include: 2 Over the course of the injections, you may notice that you have less pain in your knee. Hyaluronic acid does seem to have anti-inflammatory and pain-relieving properties. Effects may last for several months. Viscosupplementation may be effective in relieving the symptoms of arthritis, but has never been shown to reverse the arthritic process or re-grow cartilage. Hayes reported on the use of viscosupplementation for treatment of knee disorders after surgery. The success of viscosupplementation in treating OA of the knee prior to knee surgery led to the investigation of this technique for reducing pain and hastening recovery following surgery for various knee conditions, including ACL strains, OA of the knee, meniscal tears, and cartilage damage. ACL repair, partial meniscectomy, and most of the surgical techniques for OA of the knee or cartilage damage may be performed via minimally invasive arthroscopic techniques under regional or general anesthesia, may require a short hospital stay, and typically are followed by rehabilitation and physical therapy. Rehabilitation protocols generally focus on early mobilization and weight bearing, but the degree to which either is allowed varies with the surgery performed. Physical therapy begins during the hospital stay and continues for several weeks or months. In the early rehabilitation period, patients may use Clinical Coverage Guideline page 2
walking aids and/or a brace that is adjustable for RO. 3 Viscosupplementation may be administered immediately or shortly after surgery but does not in itself require hospitalization. It may be performed on an outpatient basis, involves the administration of a local anesthetic or fluoroscopic guidance, and is prescribed and administered by a licensed physician such as an orthopedic surgeon, an interventional pain physician, or a rheumatologist. Viscosupplementation also may be administered by any physician or healthcare professional qualified to perform intra-articular injections. 3 As supported by the American Academy of Orthopaedic Surgeons (AAOS), viscosupplementation of the knee is intended to relieve knee pain and improve knee function by normalizing the elastoviscous content of synovial fluid in knees afflicted by OA. Postoperative viscosupplementation for knee conditions is intended to reduce the duration of pain and hasten the recovery of knee function by replacing HA that may have been lost during knee surgery. Before injecting an endogenous HA product, any effusion or excess fluid present in the knee joint capsule is removed by aspiration. 3 American Academy of Orthopaedic Surgeons Recommendations In 2013, the AAOS released an update to the clinical practice guideline (CPG) for osteoarthritis of the knee. One significant recommendation change from the 2008 CPG pertains to the issue of viscosupplementation. The 2008 CPG included an inconclusive recommendation regarding the use of intra-articular hyaluronic acid (HA) injections that was largely the motivating factor for the expedited update of the CPG. The 2013 edition states: We cannot recommend using hyaluronic acid (HA) for patients with symptomatic OA of the knee. The AAOS states that a strong rating was not given based on supporting evidence from 3 high-quality and 11 moderate-quality research studies that met the inclusion criteria. 4 Limitations of viscosupplementation therapy for the knee include: 1 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. Viscosupplementation of joints other than the knee(s). Treatment for diagnoses other than those included in the ICD-9 Codes noted in the Coding Section below. Imaging procedures 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. Coverage of viscosupplementation therapy of the knee assumes that knee arthroplasty is not being considered as a current treatment option. Highlights of the AAOS recommendations for viscosupplementation therapy for the knee include: 5 For those with symptomatic osteoarthritis of the knee should participate in self-management programs, strengthening, low-impact aerobic exercises, and neuromuscular education; and engage in physical activity consistent with national guidelines. Recommendation: Strong. Weight loss for patients with symptomatic osteoarthritis of the knee and a BMI 25. Recommendation: Moderate. Use of nonsteroidal anti-inflammatory drugs (NSAIDs; oral or topical) or Tramadol for patients with symptomatic osteoarthritis of the knee. Recommendation: Strong. Clinical Coverage Guideline page 3
The AAOS issued does not recommend the following for those with symptomatic osteoarthritis of the knee: 5 Acupuncture (Recommendation: Strong) Lateral wedge insoles (Recommendation: Moderate) Use of glucosamine and chondroitin (Recommendation: Strong) Use of needle lavage (Recommendation: Moderate) Arthroscopy with lavage and/or debridement (Recommendation: Strong) Hyaluronic acid (Recommendation: Strong) The AAOS was unable to recommend for or against the following for those with symptomatic OA of the knee: 5 Use of physical agents (including electrotherapeutic modalities) Manual therapy Use of a valgus directing force brace (medial compartment unloader) Use of acetaminophen, opioids, or pain patches Use of intraarticular (IA) corticosteroids Growth factor injections and/or platelet rich plasma The AAOS was unable to recommend for or against arthroscopic partial meniscectomy in patients with OA of the knee with a torn meniscus. Providers might perform a valgus producing proximal tibial osteotomy in patients with symptomatic medial compartment osteoarthritis of the knee. In the absence of reliable evidence, the AAOS opinion is not to use the free-floating (un-fixed) interpositional device in patients with symptomatic medial compartment osteoarthritis of the knee. Repeat Treatments Limited evidence exists to support the efficacy of repeated viscosupplementation treatment. The Food and Drug Administration (FDA) received evidence that included two studies. The first, an uncontrolled study, examined patients receiving 5 weekly injections of viscosupplementation repeated every 6 months for 30 months, for a total of 25 injections. 6 A second study 7 examined the effectiveness of viscosupplementation in 108 patients, 14 of whom received repeat injections within 4 to 8 months due to pain recurrence, 6 of whom completed 12 month follow-up. In addition, the National Institute for Health and Clinical Excellence states that evidence suggests pain relief is found beneficial for up to 3 months after a series of 3 to 5 injections. The findings note that the effect size is generally small. Current evidence is limited to uncontrolled case series; improvements following repeat treatment may be due to the natural history of the condition and placebo effects. 8 American College of Rheumatology 9,10 The American College of Rheumatology (ACR) recommends: The use of intra-articular hyaluronic acid injection for the treatment of osteoarthritis of the knee in adults, in accordance with the ACR 2012 OA guidelines. Hyaluronic acid injection is clinically indicated for management of osteoarthritis in patients who are not good candidates or who do not respond to other treatment options. The ACR supports patient access to appropriate therapies including hyaluronic acid injection. POSITION STATEMENT Applicable To: Medicaid Medicare Clinical Coverage Guideline page 4
Exclusions Viscosupplementation is considered experimental and investigational for any indications not listed above. These include, but are not limited to: Chondromalacia patellae Facet joint arthropathy Osteochondritis dissecans Patellofemoral arthritis Patellofemoral syndrome Plantar nerve entrapment syndrome For use in joints other than the knee Active synovitis Ultrasound guidance for viscosupplement injections is considered experimental and investigational due to a lack of efficacy supporting improved health outcomes. In addition, intra-articular polynucleotides in the treatment of knee osteoarthritis is considered experimental and investigational due to a lack of proven efficacy. In addition, viscosupplementation will not be covered for any of the following: 1 When the diagnosis is anything other than osteoarthritis (e.g., TMJ). For intra-articular injection in joints other than the knee. As the initial treatment of osteoarthritis of the knee. When failure of/or contraindication to conservative therapy and/or corticosteroid injections are not documented in the medical record. When the dose and treatment regimen exceeds those approved under the FDA label. When a repeat series of injections is initiated prior to six months after completion of the previous course of treatment. When a repeat series of injections is administered when there was no symptomatic/functional improvement evidenced from the previous series of injections. For topical application of hyaluronate preparation. After the second course of therapy. Coverage Viscosupplementation therapy for the knee via intra-articular injections of hyaluronic preparations is considered medically necessary when all of the following conditions are met: 1 Member is symptomatic. 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; Clinical diagnosis is supported by radiologic evidence of osteoarthritis of the knee such as joint space narrowing, subchondral sclerosis, osteophytes and sub-chondral cysts OR if radiologic evidence is not available, member shall have documented symptomatic osteoarthritis of the knee according to American College of Rheumatology (ACR) clinical and laboratory criteria which includes the necessity for the member to meet five (5) or more of the following: o Bony enlargement o Bony tenderness o Crepitus (noisy, grating sound) on active motion o Erythrocyte sedimentation rate (ESR) less than 40 mm/hr o Less than 30 minutes of morning stiffness o No palpable warmth of synovium o Over 50 years of age Clinical Coverage Guideline page 5
o o o Rheumatoid factor less than 1:40 titer (agglutination method) Synovial fluid signs (clear fluid of normal viscosity and WBC less than 2000/mm3) Radiographic evidence 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; Member has failed at least 3 months of conservative therapy* which can include any two of the following: o Two (2) courses of unique oral or topical analgesics; OR o Two (2) intra-articular steroid injections; OR o Formal physical therapy followed by home based exercise therapy. Documentation of member participation in a weight loss program as well as evidence of education and counseling regarding weight loss / nutritional counseling; No contraindications exist. This includes, but is not limited to active joint infection, bleeding disorder, skin infections at the injection site. One additional injections is considered medically necessary and will be authorized for members who have responded to previous series and when the following criteria is met: A minimum of 6 months has passed since the previous set of injections; Member s medical record shows a reduction in the dose of NSAIDS (or other analgesics or antiinflammatory medication) during the 3-month period following the previous set of injections*; The medical record objectively documents significant improvement in pain and functional capacity as the result of the previous injections. CODING * Change in dosage is not required if the member requires medications for a comorbid medical condition in addition to knee OA. Covered CPT Codes 20610 Arthrocentesis, aspiration and/or injection; major joint or bursa (e.g., should, hip, knee joint, subacromial bursa) Non-Covered CPT Codes 20611 Arthrocentesis, aspiration and/or injection; major joint or bursa (e.g., should, hip, knee joint, subacromial bursa); with ultrasound guidance 76942 Ultrasonic guidance for needle placement, imaging supervision and interpretation, and applicable HCPCS codes Covered HCPCS * Codes J7321 Hyaluronan or derivative, Hyalgan or Supartz, for intra-articular injection, per dose [knee only] J7323 Hyaluronan or derivative, Euflexxa, for intra-articular injection, per dose [knee only] [least cost medically necessary brands] J7324 Hyaluronan or derivative, Orthovisc, for intra-articular injection, per dose [knee only] [least cost medically necessary brands] J7325 Hyaluronan or derivative, Synvisc, or Synvisc-One for intra-articular injection, 1 mg [knee only] J7326 Hyaluronan or derivative, Gel-One, for intra-articular injection, per dose J7327 Hyaluronan or derivative, Monovisc, for intra-articular injection, per dose Clinical Coverage Guideline page 6
J7328 Hyaluronan or derivative, Gel-Syn, for intra-articular injection, 0.1 mg Covered ICD-9-CM Diagnosis Codes 715.16 Osteoarthrosis, localized, primary, lower leg [knee only] 715.26 Osteoarthrosis, localized, secondary, lower leg [knee only] 715.36 Osteoarthrosis, localized, not specific whether primary or secondary, lower leg [knee only] 715.96 Osteoarthrosis, unspecified whether generalized or localized, lower leg [knee only] Non-Covered ICD-9-CM Diagnosis Codes - All other diagnoses are non-covered Covered ICD-10-CM Diagnosis Codes M17.0 M17.9 Osteoarthritis of knee Non-Covered ICD-10-CM Diagnosis Codes - All other diagnoses are non-covered *Current Procedural Terminology (CPT ) 2016 American Medical Association: Chicago, IL. REFERENCES 1. Viscosupplementation therapy for knee (L29005). Centers for Medicare and Medicaid Services Web site. http://www.cms.hhs.gov/mcd/search.asp. Published February 16, 2009 (revised August 13, 2012). Accessed December 21, 2015. 2. Viscosupplementation treatment for arthritis. American Academy of Orthopaedic Surgeons Web site. http://orthoinfo.aaos.org/topic.cfm?topic=a00217. Published March 2014. Accessed December 21, 2015. 3. Postoperative intra-articular viscosupplementation for treatment of knee conditions. Hayes Directory Web site. http://www.hayesinc.com. Published November 1, 2013 (updated September 24, 2015). Accessed December 21, 2015. 4. AAOS approves updated OA Knee CPG. American Academy of Orthopaedic Surgeons Web site. http://www.aaos.org/news/aaosnow/jun13/cover1.asp. Published June 2013. Accessed December 21, 2015. 5. Treatment of osteoarthritis of the knee (2nd ed.). American Academy of Orthopaedic Surgeons Web site. http://www.aaos.org/research/guidelines/treatmentofosteoarthritisofthekneeguideline.pdf. Published May 2013. Accessed December 21, 2015. 6. Scali JJ. Intra-articular hyaluronic acid in the treatment of osteoarthritis of the knee: A long term study. Eur J Rheumatol Inflamm. 1995;15(1):57-62. 7. Kotz R, Kolarz G. Intra-articular hyaluronic acid: Duration of effect and results of repeated treatment cycles. Am J Orthop. 1999;28(11 suppl):5-7. 8. National Institute for Health and Clinical Excellence (NICE). Osteoarthritis. The Care and Management of Osteoarthritis in Adults. NICE Clinical Guideline 59. London, UK: NICE; February 2008. 9. Intra-Articular hyaluronic acid injection in osteoarthritis of the knee. American College of Rheumatology Web site. www.rheumatology.org. Published 2014. Accessed December 21, 2015. 10. Hochberg MC, Altman RD, April KT, Benkhalti M, Guyatt G, McGowan J, et al. American College of Rheumatology 2012 recommendations for the use of nonpharmacologic and pharmacologic therpaies in osteoarthritis of the hand, hip and knee. American College of Rheumatology Web site. https://www.rheumatology.org/practice/clinical/guidelines/acr_2012_oa_guidelines.pdf. Published April 2012. Accessed December 21, 2015. MEDICAL POLICY COMMITTEE HISTORY AND REVISIONS Date Action 1/7/2016 Approved by MPC. No changes. 1/8/2015 Approved by MPC. New. Clinical Coverage Guideline page 7