Clinical & Quality Management SODIUM HYALURONATE. Viscosupplementation. Policy Number: 2016M0010B Effective Date: April 1, 2016

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1 SODIUM HYALURONATE Viscosupplementation Policy Number: 2016M0010B Effective Date: April 1, 2016 Table of Contents: Page: Cross Reference Policy: POLICY DESCRIPTION 2 COVERAGE RATIONALE/CLINICAL CONSIDERATIONS 2 BACKGROUND 4 REGULATORY STATUS 6 CLINICAL EVIDENCE 8 APPLICABLE CODES 9 REFERENCES 11 POLICY HISTORY/REVISION INFORMATION 14 Knee Arthroplasty, 2015M0081A Hip Arthroplasty, 2015M0083A Radiofrequency Ablation for Chronic Spinal Pain, 2013M0019A Autologous chondrocyte Implantation to the Knee, 2015M0085A INSTRUCTIONS: Medical Policy assists in administering UCare benefits when making coverage determinations for members under our health benefit plans. When deciding coverage, all reviewers must first identify enrollee eligibility, federal and state legislation or regulatory guidance regarding benefit mandates, and the member specific Evidence of Coverage (EOC) document must be referenced prior to using the medical policies. In the event of a conflict, the enrollee's specific benefit document and federal and state legislation and regulatory guidance supersede this Medical Policy. In the absence of benefit mandates or regulatory guidance that govern the service, procedure or treatment, or when the member s EOC document is silent or not specific, medical policies help to clarify which healthcare services may or may not be covered. This Medical Policy is provided for informational purposes and does not constitute medical advice. In addition to medical policies, UCare also uses tools developed by third parties, such as the InterQual Guidelines, to assist us in administering health benefits. The InterQual Guidelines are intended to be used in connection with the independent professional medical judgment of a qualified health care provider and do not constitute the practice of medicine or medical advice. Other Policies and Coverage Determination Guidelines may also apply. UCare reserves the right, in its sole discretion, to modify its Policies and Guidelines as necessary and to provide benefits otherwise excluded by medical policies when necessitated by operational considerations. Page. 1 of 14

2 POLICY DESCRIPTION: This policy describes the use of hyaluronan-based preparations (also known as sodium hyaluronate) for the treatment of pain due to osteoarthritis of the knee. Products such as Hyalgan, Euflexxa, SYNVISC, and others, are viscoelastic fluid substances that help out in lubricating, protecting, and maintaining the health of articular cartilage. These products produce essentially the same therapeutic outcome when injected, by a doctor or other qualified healthcare professional, into the affected arthritic joint of individuals who have failed to get adequate relief from conservative/standard treatments, such as non-prescription pain relievers, exercise, and physical therapy. Currently, there is no curative therapy available for osteoarthritis, therefore the overall goals of this management are to reduce pain and prevent disability. COVERAGE RATIONALE / CLINICAL CONSIDERATIONS: A. Treatment with intra-articular injections of sodium hyaluronate, as a viscosupplementation therapy for the knee, are considered MEDICALLY NECESSARY for members with osteoarthritis of the knee, when administered according to U.S. Food and Drug Administration Labeled Indications*, and ALL of the following conditions are met: 1. The member has documented symptomatic osteoarthritis of the knee. Symptoms such as pain and knee stiffness, which interferes with the functions and activities of daily living such as ambulation, prolonged standing, and interrupting sleep. 2. Conservative, non-pharmacologic therapy, including physical therapy and simple analgesics (e.g., non-steroidal anti-inflammatory drugs, and/or topical capsaicin cream) has been attempted, and has not resulted in functional improvement after at least 3 months trial, or the member has been unable to tolerate conservative therapy because of adverse side effects. 3. The member has also failed to adequately respond to aspiration and injection of intra-articular corticosteroids. 4. There are no contraindications to the hyaluronan-based preparation injections (e.g., active joint infection, bleeding disorder). FDA Labeled Indications* Hyalgan Synvisc Euflexxa Supartz Orthovisc Synvisc One Gel-One Gel-Syn Genvisc 850 Monovisc approved for 5 injections approved for 3 injections approved for 3 injections approved for 3-5 injections approved for 3-4 injections approved as a single injection approved as a single injection approved for 3 injections approved for 3-5 injections approved as a single injection Page. 2 of 14

3 B. Additional series of injections for members who have responded to previous series are considered MEDICALLY NECESSARY under the following circumstances: 1. Significant improvement in pain and functional capacity was achieved as a result of the previous injections. 2. Pain has recurred. 3. At least 6 months have passed since the prior course of treatment. C. Intra-articular injections of sodium hyaluronate are considered MEDICALLY NECESSARY for temporomandibular joint (TMJ) disc displacement and osteoarthritis. D. Treatment with sodium hyaluronate preparations is considered EXPERIMENTAL AND INVESTIGATIONAL for any indication not listed above, including but not limited to: Pain due to osteoarthritis in any joint other than the knee or TMJ Any other form of arthritis (including rheumatoid arthritis) Patello-femoral syndrome Chondromalacia of the knee/patella Following total or partial knee joint replacement Facet joint arthropathy Osteochondritis dissecans Because the clinical evidence of safety and/or efficacy of viscosupplementation for these indications has not been established in published, peer-reviewed medical literature. Treatment with hyaluronic acid gel preparations to improve the skin's contour and/or reduce depressions due to acne, scars, injury or wrinkles is considered COSMETIC and not MEDICALLY NECESSARY. The use of sodium hyaluronate preparations to improve the skin's contour and/or reduce depressions in the skin due to acne, scars, injury or wrinkles improves physical appearance but does not remove or improve a functional impairment of the skin. Clinical Considerations: Intra-Articular Hyaluronan Injections Instructions: Synvisc, Euflexxa Gel-Syn requiring a series of 3 injections, for osteoarthritis of the knee, is limited to 6 injections in 6 months (3 injections per knee). Synvisc-One requiring only one (1) injection for osteoarthritis of the knee is limited to 96 units/mg in 6 months (48 units/mg per knee). Gel-One and Monovisc requiring only one (1) injection for osteoarthritis of the knee, is limited to 2 prefilled syringes in 6 months (one syringe per knee). Orthovisc requiring a series of 4 injections for osteoarthritis of the knee, is limited to 4 injections 8 injections in 6 months (4 injections per knee). Supartz, Hyalgan, and Genvisc 850 requiring a series of 5 injections for osteoarthritis of the knee, is limited to 10 injections in 6 months (5 injections per knee). The vial and syringes are for single use only. The product should be used immediately upon opening and any unused portion should be discarded. Page. 3 of 14

4 Continuation of Therapy: There has been at least six months since the last treatment cycle, AND There is objective evidence documented in the medical record to support significant improvement in pain and functional status as a result of viscosupplementation. Contraindications: Do not inject sodium hyaluronate into the knees of patients with infections or skin diseases in the area of the injection site or joint. Do not administer to patients with known allergies to avian or avian-derived products (including eggs, feathers, or poultry). Do not administer to patients with known hypersensitivity (allergy) to hyaluronate preparations. Potential Adverse Effects: The most common adverse events considered to be related to viscosupplementation injections were pain, joint swelling, joint effusion and arthralgia. BACKGROUND: Osteoarthritis of the knee is a disease in which the elastoviscous properties of the synovial fluid in the knee joint becomes diminished, resulting in less protection and shock absorption. These changes are partly due to a reduction in the concentration and size of hyaluronic acid molecules that are naturally present in synovial fluid. Sodium hyaluronate, also referred to as hyaluronic acid (HA) or hyaluronan, is a viscoelastic substance that occurs naturally in synovial fluid and is thought to play an important role in lubricating, protecting, and maintaining the health of articular cartilage. Sodium hyaluronate preparations are used as an intra-articular treatment for relief of pain associated with osteoarthritis (OA), with the potential for disease modification through improvement of synovial fluid quality and/or quantity. Hyaluronic acid preparations have been approved by the FDA as a device for the treatment of pain in osteoarthritis of the knee in patients who have not responded to exercise, physical therapy and nonprescription analgesics. Hyaluronic acid gels have also been approved by the FDA for treatment of wrinkles and other facial contouring disorders. Seven preparations of intra-articular hyaluronan have been approved by the U.S. Food and Drug Administration (FDA) as an alternative to NSAID therapy in the treatment of osteoarthritis of the knee (Synvisc, Synvisc-One, Hyalgan, Supartz, OrthoVisc, Gel-One and Euflexxa ). With the exception of Euflexxa, these products are manufactured from rooster combs. Euflexxa is the only no-avian derived hyaluronan approved in the United States. As new hyaluronans are developed and approved by the FDA for the treatment of pain associated with osteoarthritis of the knee or shoulder they will be added to this policy. These materials are classified by the FDA as devices. Synvisc, Synvisc-One TM (Hylan G-F 20): A cross-linked preparation of hyaluronan, Hylan G-F 20 is a viscosupplementation drug injected into knee joints to increase the elastoviscous properties of arthritic joint (synovial) fluid, while at the same time slowing its egress from the joint. Two formulations of Hylan GF-20 are currently available: 1) Synvisc is administered once-weekly for a total of 3 intra- Page. 4 of 14

5 articular injections, and 2) Synvisc-One is administered in a single intra-articular injection. Trials have indicated that both compounds appear to result in a small but statistically significant improvement in reducing pain and increasing levels of mobility in the majority of individuals treated, as compared with placebo, and may even slow down deterioration of joints. Hyalgan (sodium hyaluoronate): It is usually given as weekly intra-articular injections administered for up to 5 weeks, for a total of 5 injections. Some patients may benefit with a total of 3 injections. Noticeable improvements usually occur beginning at week 5 after treatment initiation, and symptom relief may last for 6 months. Hyalgan should not be used to treat joint dysfunction. Supartz (sodium hyaluronate): It is indicated for the treatment of pain in OA of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy (e.g., physical therapy) and simple analgesics (e.g., acetaminophen). Supartz is administered by an injection onceweekly for a total of 5 injections. Euflexxa (sodium hyaluronate): It is a gel-like, elastic, sterile product containing natural, highly purified hyaluronan (1% sodium hyaluronate). Unlike some other hyaluronan products, Euflexxa does not come from bird-derived sources. It is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics (e.g., acetaminophen). Gel-One (hyaluronic acid): Gel-One is a sterile, transparent and viscoelastic hydrogel composed of cross-linked hyaluronate, a derivative of highly purified sodium hyaluronate (hyaluronan) extracted from chicken combs. Indication is for patients who have failed to respond adequately to nonpharmacological therapy, NSAIDs or analgesics (e.g., acetaminophen), alternative practices and procedures include removal of excess fluid from the knee, followed by intra-articular injection of corticosteroid, exercise, physical therapy, weight loss and avoidance of activities that cause joint pain. For patients who have failed the above treatments, surgical interventions such as arthroscopic surgery and total knee replacement are also alternative treat. Gel-One is designed as a single injection treatment to reduce pain associated with osteoarthritis of the knee for up to 13 weeks. Side effects may include pain in the knee at the injection site, stiffness, fluid, swelling or warmth in or around the knee, and changes walking, such as limping. OrthoVisc (High Molecular Weight Hyaluronan): It is a sterile, non-pyrogenic, clear viscoelastic solution consisting of sodium hyaluronate in physiologic saline and contained in a single-use syringe. The hyaluronic acid of OrthoVisc is extracted from rooster combs. Indication is for patients with osteoarthritis (OA) of the knee, who have failed to respond adequately to conservative nonpharmacologic therapy and to simple analgesics. OrthoVisc is injected once weekly for 3 to 4 weeks, for a total of 3 to 4 injections. Note: There is a lack of reliable evidence that any one brand of viscosupplement is superior to other brands for medically necessary indications. There are also a lack of studies demonstrating that persons who fail to respond to one brand of viscosupplement will respond to other brands of viscosupplements. Therefore, hyaluronic acid preparations for the treatment of pain due to osteoarthritis of the knee are deemed therapeutically equivalent. These products can be expected to produce essentially the same therapeutic outcome and toxicity. There is a lack of evidence in the peer-reviewed published medical literature on the impact of fluoroscopic guidance in improving clinical outcomes of viscosupplementation injections of the knee. There are no Page. 5 of 14

6 published peer-reviewed clinical studies demonstrating improved outcomes of viscosupplementation of the knee when administered with fluoroscopic guidance. REGULATORY STATUS: 1. U.S. FOOD AND DRUG ADMINISTRATION (FDA): Effective 01/01/2015: Hyalurons are approved by the FDA as devices under the Pre-Market Approval (PMA) process. However, National Government Services will use criteria found in Local Coverage Determination (LCD) "Coverage of Drugs and Biologicals for Label and Off-Label Uses" (Available at: or ) to expand coverage to offlabel indications based on the American Hospital Formulary Services (AHFS), Clinical Pharmacology, NCCN Drugs and Biologics Compendium and/or Thomson Micromedex DrugDex compendium. Viscosupplementation with hyaluronans will only be covered for osteoarthritis of the knee or shoulder joint when: There is radiological evidence to support the diagnosis of osteoarthritis; and There is adequate documentation that simple pharmacologic therapy (e.g., aspirin), or exercise and physical therapy has been tried and the patient has failed to respond satisfactorily. The following products have received FDA approval and are limited to osteoarthritis of the knee. Sodium hyaluronate (Hyalgan, Supartz, Euflexxa, Monovisc, Gel-Syn ) 1. Hyalgan - (20mg/2 ml). The intra-articular injections are given once weekly for a total of five injections. 2. Supartz - (25mg/2.5 ml). The intra-articular injections are given once a week for a total of five weeks. 3. Euflexxa - (20mg/injection) a three-injection treatment regimen in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics. 4. Monovisc - (88mg/4 ml). The intra-articular injection is given once. 5. Gel-Syn - (16.8mg/2mL). The intra-articular injections are given once weekly for three weeks. High molecular weight hyaluronan (Orthovisc ) 1. Orthovisc (30mg/2ml). The intra-articular injections are administered weekly for three - four weeks. Hyaluronic acid (Gel-One ) 1. Gel-One (30 mg/3 ml) for intra-articular injections. The intra-articular injections are given once. Hylan G-F 20 (Synvisc, Synvisc-One ) 1. Synvisc - (16mg/2ml). The intra-articular injections are given once weekly for a total of three weeks 2. Synvisc-One - (48mg/6ml). The intra-articular injections are given once per six months. Page. 6 of 14

7 Limitations: A one-time repeat series of injections for patients who have responded to the first series may be given individual consideration for coverage provided that the drug is administered in accordance with FDA-approved indications and under the following circumstances: Significant improvement in knee or shoulder pain and known improvement in functional capacity resulted from the first series of injections which has been documented in the record; and At least six (6) months have elapsed since the prior series of injections. The dose and frequency of administration should be consistent with the FDA approved labeling. It is expected that an injection (Synvisc-One, Gel-One ) or course of the injections (Synvisc, Hyalgan, Supartz, Euflexxa, Orthovisc, Gel-Syn ) will not be repeated within six months time. Contraindications: Do not administer to patients with known allergies to avian or avian-derived products (including eggs, feathers, or poultry). Do not administer to patients with known hypersensitivity (allergy) to hyaluronate preparations. Do not inject sodium hyaluronate into the knees of patients with infections or skin diseases in the area of the injection site or joint. None of the hyaluronic acid preparations are approved for use in joints other than the knee. Additional information (product code MOZ) is available at: Accessed December 16, Euflexxa. P Rockville, MD: FDA. October 11, Available at: Gel-One (hyaluronan). P FDA. November 27, Available at: Gel-Syn. P Rockville, MD: FDA. May 9, Available at: Hyalgan. P Rockville, MD: FDA. May 28, Available at Monovisc. P Bedford, MA: FDA. February 25, Available at: Orthovisc. P Rockville, MD: FDA. February 4, Available at: Supartz. P Rockville, MD: FDA. January 24, Available at: Synvisc. P Rockville, MD: FDA August 8, Available at: Synvisc-One (hylan G-F 20) P940015S012b FDA February 26, Available at: Page. 7 of 14

8 Above pdfs accessed December 16, Skin Contouring (including acne, scars and wrinkle treatments) The FDA has approved several products containing a transparent hyaluronic acid gel to improve the contours of the skin. These products are used to treat acne, scars and wrinkles on the skin by temporarily adding volume to facial tissue and restoring a smoother appearance to the face. Devices include: Restylane injectable gel received PMA approval March 25, Perlane injectable gel received PMA approval May 2, Hylaform received PMA approval April 22, Juvéderm 24HV, Juvéderm 30 & Juvéderm 30HV Gel Implants received PMA approval June 2, CENTERS FOR MEDICARE AND MEDICAID SERVICES (CMS): No National Coverage Determination (NCD) for sodium hyaluronate for the treatment of osteoarthritis was identified. Local Coverage Determination (LCD) L33394: In order to meet the requirement that the use of the drug is reasonable and necessary for the treatment of disease, the drugs must be safe and effective. Drugs approved for marketing by the Food and Drug Administration (FDA) are considered safe and effective when used for indications specified on the labeling. Therefore, Medicare pays for the use of a FDAapproved drug, if: It was injected on or after the date of the FDA's approval; It is reasonable and necessary for the individual patient; and All other applicable coverage requirements are met. Available at: &bc=iaaaaagaaaaaaa%3d%3d&. Accessed December 16, MINNESOTA DEPARTMENT OF HUMAN SERVICES (DHS): Minnesota DHS does not have a policy statement regarding sodium hyaluronate for the treatment of osteoarthritis in its Provider Manual or other specific provider references. CLINICAL EVIDENCE: Numerous randomized controlled trials have investigated the utility of sodium hyaluronate for osteoarthritis of the knee, as well as for temporomandibular joint arthritis and disc displacement. SUMMARY: Increase in viscoelasticity of synovial fluid after sodium hyaluronate injection has not been demonstrated in patients with rheumatoid arthritis, and it has not been determined whether sodium hyaluronate is protective in joints affected by rheumatoid arthritis. Further studies are needed to determine the safety and durability of such treatment for patello-femoral syndrome and chondromalacia of the knee and whether it significantly delays the need for more invasive treatment, e.g. surgery, joint replacement or arthroplasty. There are no clinical studies evaluating the use of sodium hyaluronate in persons following Page. 8 of 14

9 total or partial knee joint replacement surgery. There is moderate to strong evidence from a number of randomized, double-blind, placebo-controlled clinical trials that intraarticular hyaluronic acid (HA) can relieve pain and increase functional activity in patients with osteoarthritis (OA) of the knee who have failed or cannot tolerate conservative therapy. The treatment effect is similar in magnitude to that provided by corticosteroids, suggesting that HA could be an option for patients who have failed steroid therapy or in whom steroid therapy might be contraindicated. There is also some promising evidence from a small number of studies that the treatment effect of intraarticular HA is similar to that provided by conventional exercise programs. There is promising but scarce evidence suggesting that HA may also have disease-modifying effects; additional well-designed studies are necessary to clarify the disease-modifying potential of intraarticular HA for the treatment of OA. There is also some positive evidence from randomized, controlled trials suggesting that treatment with intraarticular HA may provide pain relief and improve movement in patients with disc displacement and/or OA of the temporomandibular joint (TMJ), and that the effect may be similar to that provided by corticosteroids. The evidence related to intraarticular HA for hip OA is conflicting and limited; several randomized trials reported a positive effect, while one placebo-controlled trial failed to demonstrate a benefit. No important safety issues were reported in the reviewed studies. Data regarding the long-term benefits beyond one year or any adverse effects of repeated treatments is limited. There is only a small subset of this body of literature documents outcomes of viscosupplementation when administered as a component of a postsurgical treatment plan. Results of the available studies fail to provide sufficient evidence that Synvisc injection benefits patients who have ankle arthritis. All of the studies found that this procedure provided statistically significant reductions in pain and the two studies that examined disability found statistically significant improvements in this measure. However, since two of the studies were uncontrolled and the controlled study did not involve a placebo control, the apparent benefits may have been due to a placebo effect. Moreover, the only controlled study did not randomize patients to treatment groups, all of the studies were relatively small, and none of the studies involved longterm follow-up to determine the durability of improvements in pain and disability. Further controlled studies with larger numbers of patients are needed to demonstrate that Synvisc injection is a safe and effective treatment for ankle OA. A particular concern is the development of immunological reactions to Synvisc since it is derived from an animal source and patients usually undergo repeated injection treatments. APPLICABLE CODES: The Current Procedural Terminology (CPT ) codes and HCPCS codes listed in this policy are for reference purposes only. Listing of a service or device code in this policy does not imply that the service described by this code is a covered or non-covered health service. The inclusion of a code does not imply any right to reimbursement or guarantee claims payment. Other medical policies and coverage determination guidelines may apply. HCPCS Code J7321 J7323 J7324 J7325 J7326 J7327 Description Hyaluronan or derivative, Hyalgan or Supartz, for intra-articular injection, per dose Hyaluronan or derivative, Euflexxa, for intra-articular injection, per dose Hyaluronan or derivative, Orthovisc, for intra-articular injection, per dose Hyaluronan or derivative, Synvisc or Synvisc-one, for intra-articular injection, 1 mg Hyaluronan or derivative, Gel-One, for intra-articular injection, per dose Hyaluronan or derivative, Monovisc, for intra-articular injection, per dose Page. 9 of 14

10 J7328 J3490 Q9980 Hyaluronan or derivative, Gel-Syn, for intra-articular injection, 0.1 mg Unclassified drugs Hyaluronan or derivative, Genvisc 850, for intra-articular injection, 1 mg CPT Code Arthrocentesis, aspiration and/or injection; intermediate joint or bursa (e.g., temporomandibular, acromioclavicular, wrist, elbow or ankle, olecranon bursa) Arthrocentesis, aspiration and/or injection, intermediate joint or bursa (e.g., temporomandibular, acromioclavicular, wrist, elbow or ankle, olecranon bursa); with ultrasound guidance, with permanent recording and reporting Arthrocentesis, aspiration and/or injection; major joint or bursa (e.g., shoulder, hip, knee joint, subacromial bursa) Arthrocentesis, aspiration and/or injection, major joint or bursa (e.g., shoulder, hip, knee, subacromial bursa); with ultrasound guidance, with permanent recording and reporting CPT is a registered trademark of the American Medical Association. ICD-9 Diagnosis Code Description Arthralgia of temporomandibular joint Articular disc disorder (reducing or non-reducing) of temporomandibular joint Other specified temporomandibular joint disorders Primary localized osteoarthrosis, lower leg Secondary localized osteoarthrosis, lower leg Localized osteoarthrosis not specified whether primary or secondary, lower leg Osteoarthrosis, unspecified whether generalized or localized, lower leg Unspecified polyarthropathy or polyarthritis, lower leg Other specified arthropathy, lower leg Unspecified arthropathy, lower leg Pain in joint, lower leg ICD-9 Procedure Code Description Injection of therapeutic substance into temporomandibular joint Injection of therapeutic substance into joint or ligament ICD-10 Diagnostic Code Description M Enteropathic arthropathies, right knee M Enteropathic arthropathies, left knee M Enteropathic arthropathies, unspecified knee M Other specific arthropathies, not elsewhere classified, right knee M Other specific arthropathies, not elsewhere classified, left knee M Other specific arthropathies, not elsewhere classified, unspecified knee M12.9 Arthropathy, unspecified M13.0 Polyarthritis, unspecified 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 Page. 10 of 14

11 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 M Pain in right knee M Pain in left knee M Pain in unspecified knee M26.62 Arthralgia of temporomandibular joint M26.63 Articular disc disorder of temporomandibular joint M26.69 Other specified disorders of temporomandibular joint ICD-10 Procedure Code 3E0U3GC 3E0U36Z 3E0U37Z 3E0U3SF 3E0U3BZ 3E0U3HZ 3E0U3KZ 3E0U3NZ 3E0U3TZ Description Introduction of other therapeutic substance into joints, percutaneous approach Introduction of nutritional substance into joints, percutaneous approach Introduction of electrolytic and water balance substance into joints, percutaneous approach Introduction of other gas into joints, percutaneous approach Introduction of local anesthetic into joints, percutaneous approach Introduction of radioactive substance into joints, percutaneous approach Introduction of other diagnostic substance into joints, percutaneous approach Introduction of analgesics, hypnotics, sedatives into joints, percutaneous approach Introduction of destructive agent into joints, percutaneous approach CPT Code Arthrocentesis, aspiration and/or injection; intermediate joint or bursa (e.g., temporomandibular, acromioclavicular, wrist, elbow or ankle, olecranon bursa) Arthrocentesis, aspiration and/or injection; major joint or bursa (e.g., shoulder, hip, knee joint, subacromial bursa) REFERENCES: 1. Jevsevar, D. Treatment of Osteoarthritis of the Knee: Evidence-Based Guideline, 2nd Edition. J Am Acad Orthop Surg September 2013 ; 21: American Academy of Orthopaedic Surgeons (AAOS). 2. American College of Rheumatology (ACR). American College of Rheumatology Subcommittee on Osteoarthritis Guidelines. Recommendations for the Medical Management of Osteoarthritis of the Hip and Knee. Arthritis and Rheumatism. 2000; 43: Agency for Healthcare Research and Quality (AHRQ). Three Treatments for Osteoarthritis of the Knee: Evidence Shows Lack of Benefit. Clinician s Guide. April, Bannuru RR, Natov NS, Obadan I, et al. Therapeutic Trajectory of Hyaluronic Acid Versus Corticosteroids in the Treatment of Knee Osteoarthritis: A Systematic Review and Meta-Analysis. Arthritis Rheum Dec 15;61(12): Bertolami CN, Gay T, Clark GT, et al. Use of sodium hyaluronate in treating temporomandibular joint disorders: a randomized, double-blind, placebo-controlled clinical trial. J Oral Maxillofac Surg. 1993;51: Blaine T, Moskowitz R, Udell J, et al. Treatment of persistent shoulder pain with sodium hyaluronate: a randomized, controlled trial. A multicenter study. J Bone Joint Surg Am May;90(5): Page. 11 of 14

12 7. Bjornland T, Gjaerum AA, Moystad A. Osteoarthritis of the temporomandibular joint: an evaluation of the effects and complications of corticosteroid injection compared with injection with sodium hyaluronate. J Oral Rehabil Aug;34(8): Brander VA, Gomberawalla A, Chambers M, et al. Efficacy and safety of hylan G-F 20 for symptomatic glenohumeral osteoarthritis: a prospective, pilot study. PM R Apr;2(4): Caborn D, Rush J, Lanzer W, et al. A randomized, single blind comparison of the efficacy and tolerability of hylan G- F 20 and triamcinolone hexacetonide in patients with osteoarthritis of the knee. J Rheumatol. 2004;31: Carruthers A, Carruthers J, Monheit GD, et al. Multicenter, randomized, parallel-group study of the safety and effectiveness of on a botulinum toxin A and hyaluronic acid dermal fillers (24-mg/ml smooth, cohesive gel) alone and in combination for lower facial rejuvenation. Dermatol Surg Dec;36 Suppl 4: Chevalier X, Jerosch J, Goupille P, et al. Single, intra-articular treatment with 6 ml hylan G-F 20 in patients with symptomatic primary osteoarthritis of the knee: a randomised, multicentre, double-blind, placebo controlled trial. Ann Rheum Dis Jan;69(1): Chou WY, Ko JY, Wang FS, et al. Effect of sodium hyaluronate treatment on rotator cuff lesions without complete tears: a randomized, double-blind, placebo-controlled study. J Shoulder Elbow Surg Jun;19(4): Conrozier T. Bertin P. Bailleul F. Mathieu P. Charlot J. Vignon E. Treves R. Chevalier X. Clinical response to intraarticular injections of hylan G-F 20 in symptomatic hip osteoarthritis: the OMERACT-OARSI criteria applied to the results of a pilot study. Joint, Bone, Spine: Revue du Rheumatism. 73(6):705-9, 2006 Dec. 14. Conrozier T, Jerosch J, Beks P, Kemper F, Euller-Ziegler L, Bailleul F, Chevalier X. Prospective, multi-centre, randomised evaluation of the safety and efficacy of five dosing regimens of viscosupplementation with hylan G-F 20 in patients with symptomatic tibio-femoral osteoarthritis: a pilot study. Arch Orthop Trauma Surg Mar;129(3): Dagenais P, Framarin A. Viscosupplementation for the treatment of osteoarthritis of the knee. Summary Montreal, QC: Agence d'evaluation des technologies et des modes d'intervention en santé (AETMIS); July Available at: Accessed December 11, DeLorenzi C, Weinberg M, Solish N, et al. The long-term efficacy and safety of a subcutaneously injected largeparticle stabilized hyaluronic acid-based gel of non animal origin in esthetic facial contouring. Dermatol Surg Feb;35 Suppl 1: Fernandez Lopez JC. Ruano-Ravina A. Efficacy and safety of intraarticular hyaluronic acid in the treatment of hip osteoarthritis: a systematic review. Osteoarthritis & Cartilage. 14(12): , 2006 Dec. 18. Firestein: Kelley's Textbook of Rheumatology, 8th ed.; Chapter 45 - Temporomandibular Joint Pain Frizziero I, Pasquali-Ronchetti I. Intra-articular treatment of osteoarthritis of the knee: an arthroscopic and clinical comparison between sodium hyaluronate ( kda) and methylprednisolone acetate. J Orthop Trauma. 2003: Goldberg VM, Buckwater MD. Hyaluronans in the treatment of osteoarthritis of the knee: evidence for disease modifying activity. Osteoarthritis and Cartilage March 2005;13(3): Hayes, Inc. Health Technology Brief. Intra-Articular Injection of Cross-Linked Hyaluronans for Treatment of Shoulder Osteoarthritis. July 3, Reviewed Jun 1, Available: Accessed Dec 11, Hayes, Inc. Health Technology Brief. Intra-Articular Injection of Non Cross-Linked Sodium Hyaluronate for Treatment of Shoulder Osteoarthritis. July 3, Reviewed June 1, Available at: Accessed December 11, Hayes, Inc. Health Technology Brief. Postoperative Intra-articular Viscosupplementation for Treatment of Knee Conditions. Nov 1, Reviewed Sep 24, Available at: Accessed December 11, Hayes, Inc. Medical Technology Directory. Sodium Hyaluronate for Osteoarthritis. November 23, Reviewed: October 14, Available at: Accessed December 11, Hepguler S, Akkoc YS, Pehlivan M, et al. The efficacy of intra-articular sodium hyaluronate in patients with reducing displaced disc of the temporomandibular joint. J Oral Rehab. 2002;29: Page. 12 of 14

13 26. Jiang G.Y., Ju Z.Q., Yang X.L., Xu Z.Q. Visco-elastic materials for joint cavity filling combined with exercise for power in the treatment of chondromalacia patellae in 120 patients. Journal of Clinical Rehabilitative Tissue Engineering Research. 11(5)(pp ), Date of Publication: 04 Feb Jorgensen A, Stengaard-Pedersen K, Simonsen O, et al. Intra-articular hyaluronan is without clinical effect in knee osteoarthritis: a multicentre, randomized, placebo-controlled, double-blind study of 337 patients followed for 1 year. Ann Rheum Dis Jun;69(6): Epub 2010 May Jubb RW, Piva S, Beinat L, et al. A one-year randomized placebo (saline) controlled clinical trial of kda sodium hyaluronate (Hyalgan ) on the radiological change in osteoarthritis of the knee. Int J Clin Pract. 2003:57(6): Kwon YW, Eisenberg G, Zuckerman JD. Sodium hyaluronate for the treatment of chronic shoulder pain associated with glenohumeral osteoarthritis: a multicenter, randomized, double-blind, placebo-controlled trial. J Shoulder Elbow Surg. 2013;22(5): Leopold SS, Warme WJ, Pettis PD, PhottS. Increase frequency of acute local reaction to intraarticular Hylan GF-20 (Synvisc ) in patients receiving more than one course of treatment. J Bone Joint Surge. 2002; 840A(9): Long X, Chen G, Cheng AH, Cheng Y, Deng M, Cai H, Meng Q. A randomized controlled trial of superior and inferior temporomandibular joint space injection with hyaluronic acid in treatment of anterior disc displacement without reduction. J Oral Maxillofac Surg Feb;67(2): Majeed M. Relationship between serum hyaluronic acid level and disease activity in early rheumatoid arthritis. Ann Rheum Dis September 2004; 63(9): Matsuno H, Yudoh K, Kondo M, et al. Biochemical effect of intra-articular injections of high molecular weight hyaluronate in rheumatoid arthritis patients. Inflamm Res. 1999;48: Mei-Dan O, Kish B, Shabat S, et al. Treatment of osteoarthritis of the ankle by intra-articular injections of hyaluronic acid: a prospective study. J Am Podiatr Med Assoc Mar-Apr;100(2): Merolla G, Sperling JW, Paladini P, Porcellini G. Efficacy of Hylan G-F 20 versus 6-methylprednisolone acetate in painful shoulder osteoarthritis: a retrospective controlled trial. Musculoskelet Surg. 2011;95(3): Migliore A. Tormenta S. Martin Martin LS. Iannessi F. Massafra U. Carloni E. Monno D. Alimonti A. Granata M. The symptomatic effects of intra-articular administration of hylan G-F 20 on osteoarthritis of the hip: clinical data of 6 months follow-up. Clinical Rheumatology. 25(3):389-93, 2006 May. 37. Migliore A, Massafra U, Bizzi E, et al. Comparative, double-blind, controlled study of intra-articular hyaluronic acid (Hyalubrix) injections versus local anesthetic in osteoarthritis of the hip. Arthritis Res Ther. 2009;11(6):R National Institute for Health and Clinical Excellence (NICE). Osteoarthritis: care and management. NICE guidelines [CG177] February Available at: Accessed December 11, Noel E, Hardy P, Hagena FW, et al. Efficacy and safety of Hylan G-F 20 in shoulder osteoarthritis with an intact rotator cuff. Open-label prospective multicenter study. Joint Bone Spine Dec;76(6): Petrella RJ, DiSilvestro MD, Hildebrand C. Effects of hyaluronate sodium on pain and physical functioning in osteoarthritis of the knee. Arch Intern Med. 2002; Petrella RJ. Hyaluronic acid for the treatment of knee osteoarthritis: long-term outcomes from a naturalistic primary care experience. Am J Phys Med Rehabil Apr;84(4):278-83; quiz 284, Richette P, Ravaud P, Conrozier T, Euller-Ziegler L, et al. Effect of hyaluronic acid in symptomatic hip osteoarthritis: a multicenter, randomized, placebo-controlled trial. Arthritis Rheum Mar;60(3): Sato S, Goto S, Kasahar T et al. Effect of pumping with injection of sodium hyaluronate and the other factors related to outcome in patients with non-reducing disk displacement of the temporomandibular joint. Int J Oral Maxillofac Surg. 2001;30: Tascioglu F, Oner C. Efficacy of intra-articular sodium hyaluronate in the treatment of knee osteoarthritis. Clini Rheumatol. 2003;22: Wang JY. Glycosaminoglycans are a potential cause of rheumatoid arthritis. Proc Natl Acad Sci USA OCT-2002; Page. 13 of 14

14 99(22): Weil AJ. High molecular weight hyaluronan for treatment of chronic shoulder pain associated with glenohumeral arthritis. Med Devices (Auckl). 2011;4: POLICY HISTORY: DATE ACTION/DESCRIPTION New Policy. Reviewed by Interim Medical Policy Committee Reviewed and approved by the Pharmacy and Therapeutic Committee (P&T) Published to UCare.org 2/15/2016 Policy revised (2016M0010B) and approved by Medical Policy Committee (MPC). 2/25/2016 Approved by the Quality Improvement Advisory and Credentialing Committee (QIACC). Page. 14 of 14