National Medical Policy

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1 National Medical Policy Subject: Policy Number: Viscosupplementation of Shoulder NMP528 Effective Date*: February 2014 Updated: February 2016 This National Medical Policy is subject to the terms in the IMPORTANT NOTICE at the end of this document For Medicaid Plans: Please refer to the appropriate State s Medicaid manual(s), publication(s), citation(s), and documented guidance for coverage criteria and benefit guidelines prior to applying Health Net Medical Policies The Centers for Medicare & Medicaid Services (CMS) For Medicare Advantage members please refer to the following for coverage guidelines first: Use Source Reference/Website Link National Coverage Determination (NCD) National Coverage Manual Citation X Local Coverage Determination (LCD)* Intra-articular Injections of Hyaluronan: Article (Local)* Other None Use Health Net Policy Instructions Medicare NCDs and National Coverage Manuals apply to ALL Medicare members in ALL regions. Medicare LCDs and Articles apply to members in specific regions. To access your specific region, select the link provided under Reference/Website and follow the search instructions. Enter the topic and your specific state to find the coverage determinations for your region. *Note: Health Net must follow local coverage determinations (LCDs) of Medicare Administration Contractors (MACs) located outside their service area when those MACs have exclusive coverage of an item or service. (CMS Manual Chapter 4 Section 90.2) If more than one source is checked, you need to access all sources as, on occasion; an LCD or article contains additional coverage information than contained in the NCD or National Coverage Manual. If there is no NCD, National Coverage Manual or region specific LCD/Article, follow the Health Net Hierarchy of Medical Resources for guidance. Vicosupplementation of Shoulder Feb 16 1

2 Current Policy Statement (Please refer to Health Net NMP on Unicompartmental Knee Arthroplasty) Health Net, Inc. considers viscosupplementation (i.e., intra-articular injection of hyaluronic acid [IAHA]) of the shoulder investigational for the treatment of osteoarthritis, glenohumeral or shoulder impingement syndrome, or any other indication, since there is a paucity of peer-reviewed, long-term studies to determine the efficacy and safety of this procedure. Current evidence on this off-label use is limited, with short-term follow up only. Some RCTs on IAHA injections for OA of the shoulder have shown treatment benefits. However, these studies are not consistent in reporting improvements that are significantly greater than control or placebo treatments. Because of the limited and inconsistent available data, there is no evidence that viscosupplementation of the shoulder improves outcomes in the longterm. Key Words Definitions SIS Shoulder impingement syndrome RC Rotator cuff HA Hyaluronic acid OA Osteoarthritis IAHA Intra-articular injection of hyaluronic acid Codes Related To This Policy NOTE: The codes listed in this policy are for reference purposes only. Listing of a code in this policy does not imply that the service described by this code is a covered or noncovered health service. Coverage is determined by the benefit documents and medical necessity criteria. This list of codes may not be all inclusive. On October 1, 2015, the ICD-9 code sets used to report medical diagnoses and inpatient procedures have been replaced by ICD-10 code sets. ICD-9 Codes Osteoarthrosis of shoulder Other affections of shoulder regions, not elsewhere classified ICD-10 Codes M Primary osteoarthritis of shoulder M M Impingement syndrome of shoulder M75.42 CPT Codes Arthrocentesis, aspiration or injection; major joint or bursa (e.g., shoulder, hip, knee, subacromial bursa), without ultrasound guidance Vicosupplementation of Shoulder Feb 16 2

3 HCPCS Codes J7321 J7323 J7324 J7325 J7326 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 Scientific Rationale Update February 2016 Lee et al. (2015) completed a meta-analysis that included 4 RCTs and provided a summary of the current evidence on intra-articular HA administration for the treatment of shoulder adhesive capsulitis (AC). Two trials investigated the effectiveness of intra-articular hyaluronic acid (HA) administration in comparison with conventional therapies, and the other 2 investigated the effectiveness of intraarticular HA administration as an adjunct therapy. The scopes of these reports are reflective of clinical practice. Intra-articular HA administration is not superior to conventional therapies (intra-articular corticosteroid administration and physical therapy) for the treatment of patients with AC, and the addition of intra-articular HA administration to conventional therapies is not expected to provide significant added benefits. Thus, the potential role of hyaluronic acid in the treatment of adhesive capsulitis remains controversial. In short-term follow-up assessments less than 3 months after administration, 2 of the included trials showed that the clinical effectiveness of intra-articular HA administration in terms of pain and shoulder function/disability was not superior to corticosteroid administration, and this conclusion is also supported by a recent systematic review by Harris et al. (2011). Intra-articular injections of either corticosteroids or HA reduce inflammation and pain in patients with AC and lead to functional improvement. The onset of the effects of corticosteroid administration is faster than HA administration, but the effects of HA may last longer than those of corticosteroids. Intra-articular administration of corticosteroids for the treatment of AC may be beneficial, although their effects may be relatively weak and only of short-term benefit. In this review, the long-term effects (>6 months) of HA injection for the treatment of AC could not be obtained because the included trials did not conduct long-term follow-up assessments. Scientific Rationale Update February 2015 Colen et al (2014) performed a systemic review that evaluated the current evidence regarding the efficacy of intra-articular (IA) infiltration treatment options in patients with glenohumeral osteoarthritis (GH-OA). Databases were searched and all IA injection products used for the treatment of shoulder OA in humans were included. A total of 8 studies could be included in this review. Hyaluronic acid (HA) showed effect sizes of 2.07, 2.02 and 2.11 at 6, 12 and 26 weeks follow-up, respectively. Placebo (1.60, 1.82 and 1.68) also showed stable effect sizes at the same time points. The efficacy of corticosteroids (CS) decreased rapidly at follow-up (1.08, 0.43 and 0.19). Although statistical significant, the maximum difference in effect sizes between HA and placebo was only 0.43 with absolute values between 2.0 and 6.4 on a 100-point visual analogue score for pain. The reviewers concluded IA treatment with HA has a good efficacy at follow-up compared to baseline. However, the difference in efficacy between HA and placebo never reaches the minimal clinically important difference at any of the follow-up points. The reviewers were not able to give clear recommendations for the use of IA CS injections in patients with Vicosupplementation of Shoulder Feb 16 3

4 GH-OA. In future research, the authors recommend focusing on sufficiently powered randomized trials to compare the efficacies of HA, CS, placebo and other IA treatment options in patients with GH-OA. Scientific Rationale Initial Viscosupplemention is an injection of an artificial joint fluid (e.g. Hyalgan [sodium hyaluronate], Synvisc [Hylan G-F 20], Supartz [highly purified sodium hyaluronate], Orthovisc [high molecular weight form of hyaluronic acid] or Euflexxa [an ultra-high purity hyaluronan]), into a joint. This procedure refers to the concept of synovial fluid replacement with intra-articular injections of hyaluronic acid (HA) for the relief of pain associated with osteoarthritis (OA). Hyaluronic Acid, intraarticular, with the device trade name of Synvisc-One, received U.S. FDA approval on February 26, 2009, 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). Osteoarthritis leads to changes in hyaluronan, a natural substance that helps provide the fluid within the joint with elasticity and viscosity. The goal of viscosupplementation is to supplement and restore the natural elastic and viscous properties of the synovial joint fluid. Osteoarthritis is a degeneration of joint cartilage and the underlying bone, most common from middle age onward. It causes pain and stiffness, affecting the knees and other joints and is characterized by deterioration and loss of the articular cartilage, subchondral sclerosis and osteophyte formation, and is often accompanied by inflammation of the synovium. This can cause pain and loss of function in the joint. Many treatments have a role in the management of the pain of OA. These include symptomatic pharmacological treatment with analgesics, non-steroidal anti-inflammatory drugs (NSAID) and intra-articular corticosteroid injections. Muscle strengthening exercises and weight loss has also been helpful in managing osteoarthritis. Starting from 2006, Synvisc was also approved in European countries for ankle and shoulder OA. Off-label use in degenerative arthritis of temporo-mandibular and carpo-metacarpal joint of the thumb seems to be increasing and a number of recent studies have attempted to evaluate its efficacy in joints other than the knee and the hip. Viscosupplementation (i.e., hylan G-F 20) is not approved by the U.S. Food and Drug Administration for the glenohumeral joint but may have a role in mild osteoarthritis. Off-label use in degenerative arthritis of the hip, ankle, shoulder, and carpometacarpal joint of the thumb seems to be increasing and a number of recent studies have attempted to evaluate its efficacy in joints other than the knee. Glenohumeral or shoulder impingement syndrome (SIS) is a chronic condition that develops when soft tissues are repeatedly compressed between the humeral head and the acromion when the arm is actively raised. A specific subtype of SIS is seen in overhead athletes (eg, pitchers, tennis players). This causes persistent pain and dysfunction. Initial management of shoulder impingement syndrome (SIS) is similar to that for rotator cuff (RC) tendinopathy. Conservative medical management is initiated with acute SIS, including treatments (i.e., cryotherapy, rest and a course of NSAIDs), and an appropriate physical therapy program. Little evidence exists to guide management of SIS. Properly designed and performed physical therapy programs effectively treat most patients. Successful completion of the SIS rehabilitation program generally requires from 8 to 16 weeks, but some improvement is usually noted within the first 3 to 4 weeks. An individual who has successfully completed a rehabilitation program for SIS should Vicosupplementation of Shoulder Feb 16 4

5 have complete, pain-free motion of the glenohumeral joint and should be able to perform all functional movements and exercises in the program without pain. It is important to instruct patients about proper posture, movement, and ergonomics to reduce the risk of recurrence. If therapies fail or are impossible because of pain, the patient has several treatment options. Periarticular injections may offer some help to control pain of associated problems, such as subacromial bursitis and rotator cuff tendinitis or tendinosis. Intra-articular glenohumeral joint injections may also afford some pain relief, particularly in the early stages. However, injections have not been shown to alter the underlying arthritis. Therefore, additional peer-reviewed and comparative studies with long-term outcomes are necessary before viscosupplementation is determined to be medically necessary for the shoulder. Arthritis of the glenohumeral joint can be the result of primary osteoarthritis, posttraumatic deformity, inflammatory arthritis, sepsis, or avascular necrosis. Studies There is a Clinical Trial on Comparative Analysis of Intra-articular Injection of Steroid and/or Sodium Hyaluronate in Adhesive Capsulitis, which has been completed but no study results are posted. The ClinicalTrials.gov Identifier is NCT , and it was last verified on December 17, The purpose of this study is to compare the efficacy of intra-articular steroid injection, sodium hyaluronate injection, a combination of the two, and placebo in the treatment of adhesive capsulitis of the shoulder. Kwon et al. (2013) reported a multicenter randomized double-blind placebocontrolled trial of intra-articular injection hyaluronic acid (IAHA) in 300 patients with glenohumeral OA. Intent-to-treat analysis found similar improvement in VAS for pain (19.88 mm for IAHA and mm for placebo) and in the Outcome Measures in Rheumatoid Clinical Trials-Osteoarthritis Research Society International (OMERACT- OARSI) high responder rate (40.8% for IAHA and 34.9% for sham). In a subset of patients there was a statistically significant difference in VAS of 4.0 mm on a 100- mm scale and 8.37% on the OMERACT-OARSI. However, the clinical significance of these differences is uncertain. Although data for a subset of HA patients without concomitant pathologies reached statistical significance, additional randomized trials are needed to confirm the clinical implication of this outcome. Kim et al. (2012) completed a study that assessed the hypothesis that injection of high-molecular weight hyaluronate in the treatment of subacromial impingement syndrome is effective and safe, compared with corticosteroid injection in the shoulder joint. One hundred five patients were allocated randomly into 2 groups: 1 group was injected once a week for 3 weeks with hyaluronate and the other group was injected once with corticosteroid. All injections were guided to the subacromial space by an ultrasound. Eighty patients were followed up for 12 weeks after the injection: 38 patients in the hyaluronate group and 42 patients in the corticosteroid group. The functional outcome was measured using the American Shoulder and Elbow Surgeons standardized shoulder assessment form (ASES). The Visual Analogue Scale (VAS) score at 12 weeks was decreased significantly from 58.6 ± 19.3 to 24.6 ± 23.1 in the hyaluronate group (P <.0001) and from 57.2 ± 19.9 to 36.9 ± 26.5 (P <.0001) in the corticosteroid group. There was a significant difference in the VAS score between the hyaluronic acid group and corticoid group (P =.0180) at 12 weeks. The functional ASES scores in the hyaluronate and corticosteroid groups were increased from 17.6 ± 4.8 to 22.4 ± 6.5 and from 17.3 ± 4.9 to 21.7 ± 5.8, respectively, at 12 weeks (P =.4825). There was no difference in the number of patients requiring rescue medication between the hyaluronate group and corticosteroid group at 12 Vicosupplementation of Shoulder Feb 16 5

6 weeks (P =.9254). A subacromial hyaluronate injection to treat impingement syndrome produces similar pain and functional improvement to corticosteroid at a short-term follow-up of 12 weeks. Additional, long-term outcomes, with peer reviewed and comparative studies are necessary to determine efficacy and safety of hyaluronate injections to treat subacromial impingement syndrome. Penning et al. (2012) completed a study in which a total of 159 patients (84 women and 75 men, mean age of 53 (20 to 87)) with subacromial impingement were randomised to treatment with subacromial injections using lidocaine with one of hyaluronic acid (51 patients), corticosteroid (53 patients) or placebo (55 patients). Patients were followed up for 26 weeks. The primary outcome was pain on a visual analogue score (VAS), and secondary outcomes included the Constant Murley score, shoulder pain score, functional mobility score, shoulder disability questionnaire and pain-specific disability score. The different outcome measures showed similar results. After three, six and 12 weeks corticosteroid injections were superior to hyaluronic acid injections and only at six weeks significantly better than placebo injections. The mean short-term reduction in pain on the VAS score at 12 weeks was 7% (SD 2.7; 97.5% confidence interval (CI) to 1.55; p = 0.084) in the hyaluronic acid group, 28% (SD 2.8; 97.5% CI 1.86 to 3.65; p < 0.001) in the corticosteroid group and 23% (SD 3.23; 97.5% CI 1.25 to 3.26; p < 0.001) in the placebo group. At 26 weeks there was a reduction in pain in 63% (32 of 51) of patients in the hyaluronic acid group, 72% (38 of 53) of those in the corticosteroid group and 69% (38 of 55) of those in the placebo group. The authors were not able to show a convincing benefit from hyaluronic acid injections compared with corticosteroid or placebo injections. Corticosteroid injections produced a significant reduction in pain in the short term (three to 12 weeks), but in the long term the placebo injection produced the best results. Saito et al. (2010) completed a meta-analysis of 19 blinded RCTs that examined the use of viscosupplementation for chronic painful shoulder in a total of 2,120 patients. A variety of shoulder disorders were included, e.g., adhesive capsulitis, rotator cuff tear, shoulder impingement syndrome, and frozen shoulder. Sample size ranged from 20 to 660 patients, mean trial duration was 3.5 weeks, and mean Jadad score was 3.5 ± 1.5. Ten trials (1,435 patients) reported pain outcomes. The combined effect size (standardized mean difference) for categorical and continuous pain ratings favored IAHA (0.39). There was no heterogeneity and no evidence of publication bias. However, because the studies included in the meta-analysis were of short duration and included a variety of shoulder diseases, they do not provide conclusive evidence of the effectiveness of IAHA in OA of the shoulder. Conduah et al. (2009) reviewed the basic science and development of viscosupplementation and discussed the potential evidence in support of the efficacy and safety profile of hylan G-F 20. Recent evidence suggesting a disease-modifying effect of hylan G-F 20 is also assessed. Although the primary focus of this study is on treatment of osteoarthritis of the knee, the use of viscosupplementation in other joints, such as the hip, ankle, and shoulder, was reviewed. Recent clinical data have demonstrated that the anti-inflammatory and chondroprotective actions of hyaluronic acid (HA) viscosupplementation are proposed to reduce pain while improving patient function. Noel et al. (2009) completed an open-label, prospective, multicenter study with 39 patients to try to evaluate the feasibility, safety, and symptomatic efficacy of intraarticular Hylan G-F 20 in patients with shoulder osteoarthritis and an intact rotator cuff. The study included patients with pain scores on a visual analog scale (VAS) between 40/100 and 90/100. An intra-articular injection of 2 ml of Hylan G-F 20 was given under fluoroscopic guidance. A second injection was given after 1, 2, or 3 Vicosupplementation of Shoulder Feb 16 6

7 months in the event of inadequate pain relief. The primary evaluation criterion was the VAS pain score 3 months after the first injection. Follow-up was 6 months. Of 39 included patients, 33 received a first injection and, among these, 16 received a second injection; 29 patients completed the study. No serious or severe treatmentrelated adverse events were recorded. There were 10 mild or moderate adverse events in eight patients. The mean VAS pain score decreased from 61.2 mm at baseline to 37.1 mm after 3 months (P<0.001), and the decrease was larger in the subgroup that required a single injection. This prospective study shows that treatment with one or two intra-articular injections of Hylan GF 20 in patients who have shoulder osteoarthritis and an intact cuff seemed to be feasible, safe, and probably effective. Viscosupplementation using Hylan G-F 20 may constitute a helpful treatment option in patients who have shoulder osteoarthritis with an intact rotator cuff, however, additional larger, peer-reviewed and comparative studies are necessary with a long-term outcomes to determine the efficacy and safety of this procedure. Blaine et al. (2008) completed the largest trial, an industry-sponsored RCT of 660 patients with persistent shoulder pain due to glenohumeral joint OA, rotator cuff tear, and/or adhesive capsulitis compared 3 weekly injections versus 5 weekly injections of sodium hyaluronate (Hyalgan) versus 5 weekly injections of saline. Approximately 60% of patients had OA, although the majority of those with OA also had rotator cuff disorders or capsulitis. Sixty-nine percent (n=456) of the patients had a follow-up visit at 26 weeks. There was no significant difference among groups in the primary outcome measure, shoulder pain with movement at 13 weeks. Analysis of predefined, stratified subgroups revealed no significant differences in reported pain at 13 weeks but a statistically significant decrease of 7.5 and 7.8 mm (on a 100-mm VAS scale) in reported pain in both treatment groups at 26 weeks compared to placebo among patients with OA. In those without OA, there was no significant improvement with either regimen. This trial did not meet its primary outcome, and the questionable clinical significance of the modest improvements noted at other time points is another limitation of this study. Silverstein et al. (2007) completed a case series of thirty consecutive patients with idiopathic glenohumeral osteoarthritis who failed to respond to standard conservative measures were enrolled. Patients received 3 weekly intra-articular hylan G-F 20 injections in their affected shoulder and completed a visual analog scale for pain, the UCLA score, and the Simple Shoulder Test at baseline and at 1, 3, and 6 months after the third injection. Of the 30 patients, 3 withdrew during the washout period before treatment; the remaining patients (17 men and 10 women) had an average age of 62 years. The mean baseline visual analog scale score was 54, UCLA score was 15.7, and Simple Shoulder Test score was 5.7 (of 12 possible "yes" responses). At the 6-month follow-up, hylan G-F 20 significantly improved visual analog scale (mean 30, P <.001), UCLA (mean 24, P <.001), and Simple Shoulder Test (7.6 "yes" responses, P <.001) scores. More patients slept comfortably after treatment (56%) versus before treatment (15%). Nine patients had a visual analog scale improvement >40 points after 6 months. No device-related adverse events were observed. Hylan G-F 20 may have a beneficial therapeutic effect on some symptomatic patients with glenohumeral osteoarthritis. While hylan G-F 20 is an approved therapy for the treatment of knee osteoarthritis, there are few reports of its use in shoulder osteoarthritis. This was a very small study of only 30 patients with a short 6 month follow-up. (The Case series is noted in the National Institute of Health to be at a lower level of evidence). There was a large, double-blind, randomized, saline-controlled study of HA injection for persistent shoulder pain, by Altman et al. (2005).This study included 602 patients with shoulder pain of at least 6 months duration, caused by glenohumeral Vicosupplementation of Shoulder Feb 16 7

8 osteoarthritis, rotator cuff tear, or adhesive capsulitis. Patients who received 3 or 5 weekly HA injections experienced significant pain reduction compared to controls (P = and P = 0.012, respectively). Patients whose shoulder pain was secondary to glenohumeral osteoarthritis experienced the majority of benefit. At 6 months, pain reduction remained significant in this group. However, this was a very short followup period of only 6 months. Professional Societies The 2009 the American Academy of Orthopaedic Surgeons (AAOS) Clinical Practice Guideline on glenohumeral joint osteoarthritis includes a weak grade C limited recommendation that The use of injectable viscosupplementation is an option when treating patients with glenohumeral [shoulder] osteoarthritis. Grade C recommendations are based on poor-quality evidence. In this instance, the recommendation is based on a single case series, by Silverstein et al. (2007) noted above. A Limited recommendation means the quality of the supporting evidence that exists is unconvincing, or that well-conducted studies show little clear advantage to one approach versus another. Practitioners should be cautious in deciding whether to follow a recommendation classified as Limited, and should exercise judgment and be alert to emerging publications that report evidence. Patient preference should have a substantial influencing role. Summary Recent data suggest that multiple courses of hylan G-F 20 may be effective in maintaining osteoarthritis pain relief, and that this benefit may outweigh the associated risk of adverse events. However, further clinical studies are necessary to prove the potential disease-modifying effects of hylan G-F 20. Viscosupplementation as a whole must expand beyond pain relief and joint preservation, and evolve to encompass therapies that restore normal cartilage and joint homeostasis, arrest the progression of osteoarthritis, interfere with cartilage-degrading mechanisms, and reverse existing damage. In summary, there is a paucity of peer-reviewed, long-term evidence on the efficacy of viscosupplementation (i.e., intra-articular injection of hyaluronic acid [IAHA]) for joints other than the knee. Although IAHA continues to be investigated for off-label uses in other joints, the current evidence is limited, consisting of short-term studies only. While some studies show some benefit, others do not, and systematic reviews have not concluded that there is a clinically significant benefit. In addition, studies are not consistent in reporting improvements that are significantly greater than placebo or control treatments. Because of the limited and inconsistent available data, viscosupplementation of the shoulder is considered investigational at this time. Review History February 2014 Medical Advisory Council, initial approval February 2015 Update - no revisions. Code updates February 2016 Update no revisions. Code updates This policy is based on the following evidence-based guidelines: 1. American Academy of Orthopaedic Surgeons. The treatment of glenohumeral joint osteoarthritis: guideline and evidence report Available at: Vicosupplementation of Shoulder Feb 16 8

9 2. Hayes Health Technology Brief. Intra-Articular Injection of Cross-Linked Hyaluronans for Treatment of Shoulder Osteoarthritis. July Updated June 1, Hayes Health Technology Brief. Intra-Articular Injection of Non Cross-Linked Sodium Hyaluronate for Treatment of Shoulder Osteoarthritis. July Updated June 1, References Update February Kalunian KC. Treatment of osteoarthritis resistant to initial pharmacologic therapy. UpToDate. February 10, Legré-Boyer V. Viscosupplementation: techniques, indications, results. Orthop Traumatol Surg Res Feb;101(1 Suppl):S doi: /j.otsr Epub 2015 Jan Lee LC, 1 Lieu FK, Lee HL, et al. Effectiveness of Hyaluronic Acid Administration in Treating Adhesive Capsulitis of the Shoulder: A Systematic Review of Randomized Controlled Trials. Biomed Res Int. 2015: References Update February Abate M, Schiavone C, Salini V. The use of hyaluronic acid after tendon surgery and in tendinopathies. Biomed Res Int. 2014;2014: Colen S, Geervliet P, Haverkamp D, et al. Intra-articular infiltration therapy for patients with glenohumeral osteoarthritis: A systematic review of the literature. Int J Shoulder Surg Oct;8(4): Tagliafico A, Russo G, Boccalini S, et al. Ultrasound-guided interventional procedures around the shoulder. Radiol Med May;119(5): References - Initial 1. Altman RD, Moskowitz R, Jacobs S, et al. Double-blind, randomized trial of intraarticular injection of sodium hyaluronate (Hyalygan) for the treatment of chronic shoulder pain. Arthritis Rheum. 2005;52(Suppl):S Bearcroft PPW. Chapter 50 Joint Disease. Adam: Grainger & Allison's Diagnostic Radiology, 5th ed Churchill Livingstone, An Imprint of Elsevier. 3. 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. 2008; 90(5): Chou WY, Ko JY, Wang FS, et al. Effect of sodium hyaluronate treatment on rotator cuff lesions without complete tears: a randomized, double-blind, placebocontrolled study. J Shoulder Elbow. Surg Jun; 19(4): Epub 2009 Dec Clinicaltrials.gov. Comparative Analysis of Intra-articular Injection of Steroid and/or Sodium Hyaluronate in Adhesive Capsulitis. ClinicalTrials.gov Identifier: NCT December 17, Available at: C+Intraarticular+to+shoulder&rank=1 6. Conduah AH, Baker CL, Baker CL. Managing joint pain in osteoarthritis: safety and efficacy of hylan G-F 20. J Pain Res. 2009;2: Available at: 7. Health Net Pharmaceutical Services (HNPS). EUFLEXXAR /HYALGANR / SUPARTZR(sodium hyaluronate), ORTHOVISCR(hyaluronan), SYNVISCR, SYNVISC-ONETM (hylan G-F 20). Revised January 3, Kim YS, Park JY, Lee CS, et al. Does hyaluronate injection work in shoulder disease in early stage? A multicenter, randomized, single blind and open comparative clinical study. J Shoulder Elbow Surg Jun;21(6): doi: /j.jse Epub 2012 Feb 25. Vicosupplementation of Shoulder Feb 16 9

10 9. Kwon Y, Eisenberg G, Zuckerman J. Sodium hyaluronate for the treatment of chronic shoulder pain associated with glenohumeral osteoarthritis: a multicenter, randomized, double-blind, placebo-controlled trial. Journal of Shoulder and Elbow Surgery. May 2013; 22 (5): Epub Jan. 18, Noël 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. 2009; 76(6): Parsons C. Rehabilitation principles and practice in shoulder impingement syndromes. UpToDate. November 1, Penning LI, de Bie RA, Walenkamp GH. The effectiveness of injections of hyaluronic acid or corticosteroid in patients with subacromial impingement: a three-arm randomised controlled trial. J Bone Joint Surg Br Sep;94(9): doi: / X.94B Saito S, Furuya T, Kotake S. Therapeutic effects of hyaluronate injections in patients with chronic painful shoulder: a meta-analysis of randomized controlled trials. Arthritis Care & Research 2010; 62 (7): Silverstein E, Leger R, Shea KP. The use of intra-articular hylan G-F 20 in the treatment of symptomatic osteoarthritis of the shoulder: a preliminary study. Am J Sports Med. 2007;35(6): Simmons SM, Kruse D, Dixon JB. Shoulder impingement syndrome. UpToDate. October 23, Stretanski MF. Chapter 17 Shoulder Arthritis. Frontera: Essentials of Physical Medicine and Rehabilitation, 2nd ed Saunders, An Imprint of Elsevier. 17. U.S. Food and Drug Administration (FDA). Summary of Safety and Effectiveness Data. Hyaluronic Acid, Intraarticular. February 26, Available at: Important Notice General Purpose. Health Net's National Medical Policies (the "Policies") are developed to assist Health Net in administering plan benefits and determining whether a particular procedure, drug, service or supply is medically necessary. The Policies are based upon a review of the available clinical information including clinical outcome studies in the peer-reviewed published medical literature, regulatory status of the drug or device, evidence-based guidelines of governmental bodies, and evidence-based guidelines and positions of select national health professional organizations. Coverage determinations are made on a case-by-case basis and are subject to all of the terms, conditions, limitations, and exclusions of the member's contract, including medical necessity requirements. Health Net may use the Policies to determine whether under the facts and circumstances of a particular case, the proposed procedure, drug, service or supply is medically necessary. The conclusion that a procedure, drug, service or supply is medically necessary does not constitute coverage. The member's contract defines which procedure, drug, service or supply is covered, excluded, limited, or subject to dollar caps. The policy provides for clearly written, reasonable and current criteria that have been approved by Health Net s National Medical Advisory Council (MAC). The clinical criteria and medical policies provide guidelines for determining the medical necessity criteria for specific procedures, equipment, and services. In order to be eligible, all services must be medically necessary and otherwise defined in the member's benefits contract as described this "Important Notice" disclaimer. In all cases, final benefit determinations are based on the applicable contract language. To the extent there are any conflicts between medical policy guidelines and applicable contract language, the contract language prevails. Medical policy is not intended to override the policy that defines the member s benefits, nor is it intended to dictate to providers how to practice medicine. Policy Effective Date and Defined Terms. The date of posting is not the effective date of the Policy. The Policy is effective as of the date determined by Health Net. All policies are subject to applicable legal and regulatory mandates and requirements for prior notification. If there is a discrepancy between the policy effective date and legal mandates and regulatory requirements, the requirements of law and regulation shall govern. * In some states, prior notice or posting on the website is required before a policy is deemed effective. For information regarding the effective dates of Policies, contact your provider representative. The Policies do not include definitions. All terms are defined by Health Net. For information regarding the definitions of terms used in the Policies, contact your provider representative. Policy Amendment without Notice. Health Net reserves the right to amend the Policies without notice to providers or Members. In some states, prior notice or website posting is required before an amendment is deemed effective. Vicosupplementation of Shoulder Feb 16 10

11 No Medical Advice. The Policies do not constitute medical advice. Health Net does not provide or recommend treatment to members. Members should consult with their treating physician in connection with diagnosis and treatment decisions. No Authorization or Guarantee of Coverage. The Policies do not constitute authorization or guarantee of coverage of particular procedure, drug, service or supply. Members and providers should refer to the Member contract to determine if exclusions, limitations, and dollar caps apply to a particular procedure, drug, service or supply. Policy Limitation: Member s Contract Controls Coverage Determinations. Statutory Notice to Members: The materials provided to you are guidelines used by this plan to authorize, modify, or deny care for persons with similar illnesses or conditions. Specific care and treatment may vary depending on individual need and the benefits covered under your contract. The determination of coverage for a particular procedure, drug, service or supply is not based upon the Policies, but rather is subject to the facts of the individual clinical case, terms and conditions of the member s contract, and requirements of applicable laws and regulations. The contract language contains specific terms and conditions, including pre-existing conditions, limitations, exclusions, benefit maximums, eligibility, and other relevant terms and conditions of coverage. In the event the Member s contract (also known as the benefit contract, coverage document, or evidence of coverage) conflicts with the Policies, the Member s contract shall govern. The Policies do not replace or amend the Member s contract. Policy Limitation: Legal and Regulatory Mandates and Requirements The determinations of coverage for a particular procedure, drug, service or supply is subject to applicable legal and regulatory mandates and requirements. If there is a discrepancy between the Policies and legal mandates and regulatory requirements, the requirements of law and regulation shall govern. Reconstructive Surgery CA Health and Safety Code requires health care service plans to cover reconstructive surgery. Reconstructive surgery means surgery performed to correct or repair abnormal structures of the body caused by congenital defects, developmental abnormalities, trauma, infection, tumors, or disease to do either of the following: (1) To improve function or (2) To create a normal appearance, to the extent possible. Reconstructive surgery does not mean cosmetic surgery," which is surgery performed to alter or reshape normal structures of the body in order to improve appearance. Requests for reconstructive surgery may be denied, if the proposed procedure offers only a minimal improvement in the appearance of the enrollee, in accordance with the standard of care as practiced by physicians specializing in reconstructive surgery. Reconstructive Surgery after Mastectomy California Health and Safety Code requires treatment for breast cancer to cover prosthetic devices or reconstructive surgery to restore and achieve symmetry for the patient incident to a mastectomy. Coverage for prosthetic devices and reconstructive surgery shall be subject to the co-payment, or deductible and coinsurance conditions, that are applicable to the mastectomy and all other terms and conditions applicable to other benefits. "Mastectomy" means the removal of all or part of the breast for medically necessary reasons, as determined by a licensed physician and surgeon. Policy Limitations: Medicare and Medicaid Policies specifically developed to assist Health Net in administering Medicare or Medicaid plan benefits and determining coverage for a particular procedure, drug, service or supply for Medicare or Medicaid members shall not be construed to apply to any other Health Net plans and members. The Policies shall not be interpreted to limit the benefits afforded Medicare and Medicaid members by law and regulation. Vicosupplementation of Shoulder Feb 16 11