Medical Policy

 

Subject: Hyaluronan Injections in Joints Other Than the Knee
Document #: DRUG.00017 Publish Date:    12/27/2017
Status: Revised Last Review Date:    11/02/2017

Description/Scope

This document addresses the use of hyaluronan injections for the replacement or supplementation of naturally occurring intra-articular lubricants in individuals with musculoskeletal conditions in joints other than the knee, including osteoarthritis and temporomandibular joint disease. This therapy may also be referred to as viscosupplementation. 

Note: Please see the following related document for additional information:

Position Statement

Not Medically Necessary:

Intra-articular injections of hyaluronan for joints other than the knee, including but not limited to osteoarthritis of the ankle, shoulder or hip, or temporomandibular joint disorders are considered not medically necessary.

Rationale

Temporomandibular Joint Disorders (TMJ)

A small number of clinical trials have compared hyaluronan injection to placebo or corticosteroid injection;  however, these studies are limited by their small size, lack of methodological rigor, including inadequate control comparison, and short follow-up duration (Alpaslan, 2001; Bertolami, 1993; Bjornland, 2007; Hepguler, 2002).

A study by Li and colleagues (2015) reported observations of TMJ condylar changes and function of the joint for individuals with osteoarthritis of the TMJ who received hyaluronic acid injections. A total of 141 individuals were randomized to one of two study groups: the superior or inferior joint space injection group. The participants received hyaluronic acid injections once every 2 weeks for a total of 3 injections. Participants were evaluated at 3 and 9 months post injection with cone-beam computed tomography and clinical exam. TMJ function was assessed by mandibular movement, maximal mouth opening, protrusive and lateral excursion, tenderness of masticatory muscles, tenderness of the TMJ, and TMJ noise. At the 3-month visit, 126 participants were available for follow-up. In the superior group 44 participants and 51 participants in the inferior group showed reparative remodeling. Severe degenerative changes were noted in 13 participants in the superior group and 5 participants in the inferior group. No change was found in 8 participants in the superior group and 4 participants in the inferior group. Most of the participants showed improvement in TMJ function. A total of 74 participants were available at the 9-month follow-up and most of the available participants showed better condylar morphology than at the 3-month visit and most also had improved TMJ function. At the 3-month visit, new bone formation was noted in many of the participants. Some of the participants who were found to have severe degenerative changes at 3 months showed reparative remodeling at 9 months. While this study suggested that the use of hyaluronic acid injections of the joint space in treating TMJ osteoarthritis is effective, there are some limitations to the study including the large number of participants lost to follow-up and no placebo control.

A prospective trial by Korkmaz and colleagues (2016) studied 51 participants with temporomandibular joint derangements. Participants were assigned to one of three treatment arms: single injection of hyaluronic acid (n=13), double injection of hyaluronic acid (n=13), or splint therapy (n=12), and a self-selected control group (n=13). The purpose of the study was to evaluate pain, TMJ noise, quality of life, maximum mouth opening, and jaw movements. Participants were assessed 6 months following treatment. All treatment groups showed improvement in pain, noise, quality of life, and maximum mouth opening when compared to baseline. The participants who received double injections of hyaluronic acid showed more improvement for pain and maximum mouth opening compared to the splint therapy group. While improvement was noted across all treatment groups, the study is limited by a small number of participants, a short follow-up period and participation was at a single institution.

Current literature related to hyaluronic acid injections for use in temporomandibular joint disease is limited to small group sizes with short-term follow-up and inconsistent protocols when administering hyaluronic acid. Randomized trials with larger participant groups and longer follow-up are necessary to determine superiority of one specific treatment over another. Furthermore, the mechanism of potential therapeutic action remains unknown (Hepguler, 2002).

Hip
Qvistgaard and colleagues (2006) reported on the results of a randomized placebo-controlled trial of hyaluronan injections in 101 individuals with osteoarthritis of the hip compared to corticosteroid or saline injection. The researchers reported that over the 3-month evaluation period, the participants who received hyaluronan injections reported only a small reduction in pain with walking compared to those injected with corticosteroid who reported significant pain reductions with walking.

In a systematic review for osteoarthritis of the hip (Fernández López, 2006), two independent reviewers applied a series of inclusion and exclusion criteria to the studies located in the search, and selected only those that included more than 20 participants; had a follow-up period of more than 1 week; and exclusively assessed the efficacy and/or effectiveness of hyaluronan in those with confirmed osteoarthritis of the hip. A total of eight studies consisting of clinical trials and one review, met the inclusion criteria. Only two of the trials were controlled: one compared two hyaluronan products of different molecular weights; and the other compared hyaluronan injections with corticoids and a placebo. Pain relief was estimated to be around 40-50% by most studies, although the duration of this post-treatment effect was not known. The researchers concluded that based on available evidence, hyaluronan injections as a treatment of osteoarthritis of the hip should be used under careful supervision by the clinician and only in those instances where other treatments have failed. The researchers noted that methodological limitations include short follow-up periods, dissimilar ways of measuring outcomes and the absence of a control group in many of the studies.

Another systematic review (van den Bekerom, 2008) sought to identify studies relating to the use of viscosupplementation as a treatment for osteoarthritis of the hip. Sixteen articles addressing the efficacy of viscosupplementation in a total of 509 participants with osteoarthritis of the hip were included. The products evaluated included Hylan G-F 20, Hyalgan, Ostenil, Durolane, Fermatron and Orthovisc. While the researchers concluded that viscosupplementation might have a beneficial effect in relieving pain in individuals suffering with osteoarthritis of the hip, additional comparative studies are needed before it can be recommended as standard therapy in osteoarthritis of the hip.

Richette and colleagues (2009) reported the findings of a multicenter, randomized, parallel-group, placebo-controlled trial which evaluated the efficacy and tolerability of a single intra-articular injection of hyaluronic acid for the treatment of osteoarthritis of the hip. A total of 85 participants were randomized to either the hyaluronic acid group (n=42) or placebo group (n=43). At the end of 3 months no difference in efficacy was noted between the two groups. The findings indicated that a single intra-articular injection of hyaluronic acid was no more effective than placebo in treating the symptoms of osteoarthritis of the hip. However, the value of the study results were limited by the small number of participants included in each study arm and the fact that the hyaluronan injections were administered only once versus the multiple injections typically administered for other indications.

A retrospective review by Migliore and colleagues (2012) reported on 224 participants who received injections of hylan G-F 20 and who were then followed to see if total hip replacement was required. Of the study participants, 56 were classified as being candidates for total hip replacement and 168 participants were classified to not being candidates for a total hip replacement. Following injections, 84 participants later required total hip replacement (32 of these participants came from the non-surgical candidate group), Survival time (in months) was the amount of time between start of treatment with injections and total hip replacement, if performed. Twelve-month survival was achieved by 206 participants, 24-month survival was achieved by 170 participants, and 5-year survival was achieved by 69 participants. This study is limited by its retrospective design and lack of a control group. The authors also note that intra-articular treatment is known to have a placebo effect and additional studies are needed to gain further insight into functional and clinical improvement.

A 2016 study by Rivera reports on 207 participants with osteoarthritis of the hip who received a single intra-articular injection of hyaluronic acid. Participants were assessed prior to the injection, and at 3, 6, and 12 months following the injection. Primary outcome measure was the score on the Modified Brief Pain Inventory with a pain severity score of 0-10. Participants were also evaluated using the Harris Hip Score from 0-100 which addressed pain domain, function domain, range of motion domain, and no deformity domain. Visual analog scale was also used to assess pain scores. A total of 121 participants filled out the questionnaires for Modified Brief Pain Inventory and Harris Hip Score at 1 year following the injection while 104 participants completed the questionnaire for visual analog score. The Modified Brief Pain Inventory mean score at the initial assessment was 4.07 and 2.55 between 6-12 months. The mean Harris Hip Scores ranged from 68.35 at initial evaluation to 81.76 between 6-12 months. The visual analog scores were reported as “a statistically highly significant improvement” between initial evaluation and the 3 month follow-up. This study has limitations including a loss of participants from initial evaluation to the 12-month post injection follow-up, and lack of a control group. Randomized trials are needed.

The American College of Rheumatology has no recommendation for the use of intraarticular hyaluronate injections for the management of osteoarthritis of the hip (Hochberg, 2012).

Shoulder
Blaine and colleagues (2008) reported on the results of a multi-institutional randomized study of 660 individuals with shoulder pain related to glenohumeral osteoarthritis, rotator cuff tear or adhesive capsulitis. All participants had failed prior management with physical therapy, at least one corticosteroid injection and the administration of oral pain medications. Baseline pain levels ranged from 40 to 90 mm on a 100 mm visual analog scale. Limitation of active range of motion in at least one of several directions was also required. Participants were randomized to either a course of 3 or 5 injections of hyaluronan or placebo injection. The primary outcome was improvement in shoulder pain at 13 weeks; the secondary outcome was the maintenance of pain relief through the 26-week follow-up. A total of 456 participants completed the 26 weeks of follow-up; 20% had discontinued the study at week 26. Using an intent-to-treat analysis, at week 13 (the primary outcome measure), all three groups showed significant reductions in pain from baseline that were not significantly different from one another. At week 26, the 3-injection hyaluronan group did show a small but statistically significant reduction in pain compared to the placebo group. Specifically, compared to the placebo group, the difference in mean reduction from baseline was 7.2 mm on a 100 mm scale for the 3-injection group. 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.

Another study reported on 39 individuals with osteoarthritis of the shoulder who received injections of Hylan G-F 20 (Noel, 2010). Baseline visual analog scores ranged from 40/100 to 90/100. Each participant received 1 intra-articular injection of Hylan G-F 20. Participants could be scheduled for a second injection at the 1-month, 2-month, or 3-month visit. Participants were reevaluated at 7 days and 1, 2, 3, and 6 months following the injection. Thirty-three individuals received an initial injection, and 16 individuals required a second injection. Four participants left the study due to unacceptable pain (which left 29 total participants). Visual analog score decreased from 61.2 mm at baseline to 37.1 mm at 3 months following an injection. In this particular study 52% of participants reported good pain relief following 1 injection; however the authors did state that “controlled trials are needed to confirm our results and determine optimal treatment schedule.”

Ankle
A study by DeGroot and colleagues (2012) enrolled 64 participants to randomly receive either a single injection of hyaluronic acid for ankle osteoarthritis or a single injection of normal saline solution. In this randomized, double-blind, placebo-controlled study, a total of 56 participants completed the study (8 participants withdrew from the study). The primary outcome measure was the change from baseline using the American Orthopaedic Foot & Ankle Society (AOFAS) clinical rating score. Participants were rated at baseline, 6 weeks following injection and 12 weeks following injection. Secondary outcome measures were the change from baseline in the Ankle Osteoarthritis Scale (AOS) score and a self-reported visual analog score. Both groups (active treatment and placebo) had improvements in the primary outcome measure at 12 weeks. The mean AOS scores in the active treatment group improved from baseline by 5.0 points at 6 weeks and 5.3 points at 12 weeks. The mean AOS scores in the placebo group improved by 8.4 points at 6 weeks and 14.8 points at 12 weeks. Using the visual analog score, the pain scores in the active group improved from baseline by 6.4 points at 6 weeks and 4.1 points at 12 weeks. In the placebo group, the visual analog scores improved by 3.0 points at 6 weeks and 11.1 points at 12 weeks. The authors noted that both the active treatment group and placebo group had improvements in scores at 12 weeks, but the improvements in the groups were not significantly different and a single dose of hyaluronic acid is not superior to a single dose of normal saline for the treatment of ankle osteoarthritis.

A prospective study by Lucas and colleagues (2013) reported on 18 individuals with osteoarthritis of the ankle who received a series of 3 injections of viscosupplementation. The participants were evaluated at 4 and 12 months and then annually using the AOFAS score. The AOFAS scores increased from 61.8 ± 15 before receiving the injections to 74.4 ± 14.5 after 4 months and 73.7 ± 16.6 after 12 months. Literature search identified trials focusing on osteoarthritis of the ankle, but trials remain limited to small group sizes (Cohen, 2008; Karatosun, 2008; Salk, 2006; Witteveen, 2010) and retrospective studies (Han, 2014).

A 2015 Cochrane report by Witteveen and colleagues assessed the benefits and harms of conservative treatment for osteoarthritis of the ankle. The conclusions were that since simple analgesics are recommended for osteoarthritis of the hip and knee it would be reasonable to use these to treat osteoarthritis of the ankle. Based on a low quality of evidence it was unclear if there is a benefit or harm to using hyaluronan as a treatment of osteoarthritis of the ankle compared to placebo at 6 months and results were inconclusive when hyaluronan was compared to other treatments.

Thumb
Similarly, randomized controlled trials comparing hyaluronan and corticosteroid injection in individuals with osteoarthritis of the thumb have reported superior results associated with the corticosteroid injection (Fuchs, 2006; Stahl, 2005).

The United States FDA has approved several different intra-articular injections as devices through their pre-market approval (PMA) process.

Background/Overview

Osteoarthritis is a degenerative condition of the joints and is the most common form of arthritis. Osteoarthritis commonly affects the hands and the weight-bearing joints, such as the knees, hips, feet and spine. Osteoarthritis affects an estimated 27 million Americans, mostly at or after 50 years of age, and occurs in women more commonly than men. Afflicted joints experience loss of synovial fluid, a protective substance which aids in absorbing shock and lubrication in the joints. Low synovial fluid levels and other mechanisms cause a progressive breakdown of the cartilage lining the ends of bones that are necessary for proper cushioning and smooth function of joints. Because of this breakdown of cartilage, bones rub against each other causing pain, loss of movement, and further destruction of the joint. The severity of osteoarthritis can range from very mild to very severe. 

Definitions

Intra-articular injections: A medical procedure using a hypodermic needle to inject a substance, such as a drug, into the space between two bones.

Osteoarthritis: A degenerative condition of the joints that causes destruction of the material in the joints that absorbs shock and allows proper movement.

Temporomandibular joint (TMJ): The joint where the lower jaw meets the skull.

Viscosupplementation: Intra-articular injections commonly used to treat osteoarthritis; thought to increase joint lubrication.

Coding

The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

When services are Not Medically Necessary:
For the following procedure codes for all other diagnoses except those listed below related to knee conditions (which are excluded from this document); or when the code describes a procedure indicated in the Position Statement section as not medically necessary.

HCPCS

 

J7320

Hyaluronan or derivative, GenVisc 850, for intra-articular injection, 1 mg

J7321

Hyaluronan or derivative, Hyalgan, Supartz or Visco-3, for intra-articular injection, per dose

J7322

Hyaluronan or derivative, Hymovis, for intra-articular injection, 1 mg

J7323

Hyaluronan or derivative, Euflexxa, for intra-articular injection, per dose

J7324

Hyaluronan or derivative, Orthovisc, for intra-articular injection, per dose

J7325

Hyaluronan or derivative, Synvisc or Synvisc-One, for intra-articular injection, 1 mg

J7326

Hyaluronan or derivative, Gel-One, for intra-articular injection, per dose

J7327

Hyaluronan or derivative, Monovisc, for intra-articular injection, per dose

J7328

Hyaluronan or derivative, Gel-Syn, for intra-articular injection, 0.1 mg

 

 

ICD-10 Diagnosis

 

 

For all other diagnoses except the following knee conditions (which are not addressed):

M08.861-M08.869

Other juvenile arthritis, knee

M08.961-M08.969

Juvenile arthritis, unspecified, knee

M12.561-M12.569

Traumatic arthropathy, knee

M12.861-M12.869

Other specific arthropathies, not elsewhere classified, knee

M13.161-M13.169

Monoarthritis, not elsewhere classified, knee

M13.861-M13.869

Other specified arthritis, knee

M17.0-M17.9

Osteoarthritis of knee

M21.061-M21.069

Valgus deformity, not elsewhere classified, knee

M21.161-M21.169

Varus deformity, not elsewhere classified, knee

M21.261-M21.269

Flexion deformity, knee

M22.00-M22.92

Disorder of patella

M23.000-M23.92

Internal derangement of knee

M24.361-M24.369

Pathological dislocation of knee, not elsewhere classified

M24.461-M24.469

Recurrent dislocation, knee

M24.561-M24.569

Contracture, knee

M24.661-M24.669

Ankylosis, knee

M25.361-M25.369

Other instability, knee

M25.561-M25.569

Pain in knee

M25.661-M25.669

Stiffness of knee, not elsewhere classified

M25.761-M25.769

Osteophyte, knee

M25.861-M25.869

Other specified joint disorders, knee

M66.0

Rupture of popliteal cyst

M67.361-M67.369

Transient synovitis, knee

M67.461-M67.469

Ganglion, knee

M67.50-M67.52

Plica syndrome

M67.861-M67.869

Other specified disorders of synovium and tendon, knee

M70.40-M70.42

Prepatellar bursitis

M70.50-M70.52

Other bursitis of knee

M71.20-M71.22

Synovial cyst of popliteal space

M71.561-M71.569

Other bursitis, not elsewhere classified, knee

M92.40-M92.42

Juvenile osteochondrosis of patella

M92.50-M92.52

Juvenile osteochondrosis of tibia and fibula

M94.261-M94.269

Chondromalacia, knee

S80.00XA-S80.02XS

Contusion of knee

S83.001A-S83.32XS

Subluxation and dislocation of knee

S83.401A-S83.92XS

Sprain of knee

S87.00XA-S87.02XS

Crushing injury of knee

Z96.651-Z96.659

Presence of artificial knee joint

References

Peer Reviewed Publications:

  1. Alpaslan GH, Alpaslan C. Efficacy of temporomandibular joint arthrocentesis with and without injection of sodium hyaluronate in treatment of internal derangements. J Oral Maxillofac Surg. 2001; 59(6):613-618.
  2. 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(3):232-242.
  3. Bjornland T, Gjaerum AA, Moystad A. Osteoarthritis of the temporomandibular joint: an evaluation of the effects and complications of corticosteroid injections compared with injection with sodium hyaluronate. J Oral Rehabil. 2007; 34(8):583-589.
  4. 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):970-979.
  5. Cohen MM, Altman RD, Hollstrom R, et al. Safety and efficacy of intra-articular sodium hyaluronate (Hyalgan) in a randomized, double-blind study for osteoarthritis of the ankle. Foot Ankle Int. 2008; 29(7):657-663.
  6. DeGroot H 3rd, Uzunishvili S, Weir R, et al. Intra-articular injection of hyaluronic acid is not superior to saline solution injection for ankle arthritis: a randomized, double-blind, placebo-controlled study. J Bone Joint Surg Am. 2012; 94(1):2-8.
  7. Fernandez Lopez JC, Ruano-Ravina A. Efficacy and safety of intraarticular hyaluronic acid in the treatment of hip osteoarthritis: a systematic review. Osteoarthritis Cartilage. 2006; 14(12):1306-1311.
  8. Fuchs S, Monikes R, Wohlmeiner A, Heyse T. Intra-articular hyaluronic acid compared with corticoid injections for the treatment of rhizarthrosis. Osteoarthritis Cartilage. 2006; 14(1):82-88.
  9. Han SH, Park do Y, Kim TH. Prognostic factors after intra-articular hyaluronic acid injection in ankle osteoarthritis. Yonsei Med J. 2014; 55(4):1080-1086.
  10. 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 Rehabil. 2002; 29(1):80-86.
  11. Karatosun V, Unver B, Ozden A, et al. Intra-articular hyaluronic acid compared to exercise therapy in osteoarthritis of the ankle. A prospective randomized trial with long-term follow-up. Clin Exp Rheumatol. 2008; 26(2):288-294.
  12. Korkmaz YT, Alt?ntas NY, Korkmaz FM, et al. Is Hyaluronic acid injection effective for the treatment of temporomandibular joint disc displacement with reduction? J Oral Maxillofac Surg. 2016; 74(9):1728-1740.
  13. Lawrence RC, Felson DT, Helmick CG, et al. Estimates of the prevalence of arthritis and other rheumatic conditions in the United States. Part II. Arthritis Rheum. 2008; 58(1):26-35.
  14. Li C, Long X, Deng M, et al. Osteoarthritic changes after superior and inferior joint space injection of hyaluronic acid for the treatment of temporomandibular joint osteoarthritis with anterior disc displacement without reduction: a cone-beam computed tomographic evaluation. J Oral Maxillofac Surg. 2015; 73(2):232-244.
  15. Lucas Y Hernandez J, Darcel V, et al. Viscosupplementation of the ankle: a prospective study with an average follow-up of 45.5 months. Orthop Traumatol Surg Res. 2013; 99(5):593-599.
  16. Migliore A, Bizzi E, Massafra U, et al. The impact of treatment with hylan G-F 20 on progression to total hip arthroplasty in patients with symptomatic hip OA: a retrospective study. Curr Med Res Opin. 2012; 28(5):755-760.
  17. 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):670-673.
  18. Qvistgaard E, Christensen R, Torp-Pedersen S, Bliddal H. Intra-articular treatment of hip osteoarthritis: a randomized trial of hyaluronic acid, corticosteroid, and isotonic saline. Osteoarthritis Cartilage. 2006; 14(2):163-170.
  19. Richette P, Ravaud P, Conrozier T, et al. Effect of hyaluronic acid in symptomatic hip osteoarthritis: a controlled, randomized, double-blind pilot. Arthritis Rheum. 2009; 60(3):824-830.
  20. Rivera F. Single intra-articular injection of high molecular weight hyaluronic acid for hip osteoarthritis. J Orthop Traumatol. 2016; 17(1):21-26.
  21. Salk RS, Chang TJ, D'Costa WF, et al. Sodium hyaluronate in the treatment of osteoarthritis of the ankle: a controlled, randomized, double-blind pilot. J Bone Joint Surg Am. 2006; 88(2):295-302.
  22. Stahl S, Karsh-Zafrir I, Ratzon N, Rosenberg N. Comparison of intraarticular injection of depot corticosteroid and hyaluronic acid for treatment of degenerative trapeziometacarpal joints. J Clin Rheumatol. 2005; 11(6):299-302.
  23. van den Bekerom MP, Lamme B, Sermon A, Mulier M. What is the evidence for viscosupplementation in the treatment of patients with hip osteoarthritis? Systematic review of the literature. Arch Orthop Trauma Surg. 2008; 128(8):815-823.
  24. Witteveen AG, Sierevelt IN, Blankevoort L, et al. Intra-articular sodium hyaluronate injections in the osteoarthritic ankle joint: effects, safety and dose dependency. Foot Ankle Surg. 2010; 16(4):159-163.

Government Agency, Medical Society, and Other Authoritative Publications:

  1. Hochberg MC, Altman RD, April KT, et al. American College of Rheumatology 2012 recommendations for the use of nonpharmacologic and pharmacologic therapies in osteoarthritis of the hand, hip, and knee. Arthritis Care Res (Hoboken). 2012; 64(4):465-474. Available at: http://www.rheumatology.org/Practice/Clinical/Guidelines/Osteoarthritis_(Members__Only)/. Accessed on July 7, 2017.
  2. National Institute of Dental and Craniofacial Research of the National Institutes of Health. TMJ (Temporomandibular Joint and Muscle Disorders). Available at: http://www.nidcr.nih.gov/OralHealth/Topics/TMJ/. Accessed on July 7, 2017.
  3. U.S. Food and Drug Administration Premarket Notification Database. Euflexxa®. P010029. Rockville, MD: FDA. October 11, 2011. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf/p010029s008a.pdf. Accessed on July 7, 2017.
  4. U.S. Food and Drug Administration Premarket Notification Database. Gel-One®. P080020. Rockville, MD: FDA. March 22, 2011. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf8/p080020a.pdf. Accessed on July 7, 2017.
  5. U.S. Food and Drug Administration Premarket Notification Database. Gel-Syn. P110005. Rockville, MD: FDA. May 9, 2014. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf11/P110005a.pdf. Accessed on July 7, 2017.
  6. U.S. Food and Drug Administration Premarket Notification Database. Gen Visc 850®. P140005. Rockville, MD: FDA. September 2, 2015. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf14/p140005b.pdf. Accessed on July 7, 2017.
  7. U.S. Food and Drug Administration Premarket Notification Database. Hyalgan®. P950027. Rockville, MD: FDA. May 28, 1997. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf/P950027A.pdf. Accessed on July 7, 2017.
  8. U.S. Food and Drug Administration Premarket Notification Database. Hymovis®. P150010. Rockville, MD: FDA. August 28, 2015. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf15/P150010b.pdf. Accessed on July 7, 2017.
  9. U.S. Food and Drug Administration Premarket Notification Database. Monovisc®. P090031. Rockville, MD: FDA. February 25, 2014. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf9/P090031a.pdf. Accessed on July 7, 2017.
  10. U.S. Food and Drug Administration Premarket Notification Database. Orthovisc®. P030019. Rockville, MD: FDA. February 4, 2004. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf3/p030019a.pdf. Accessed on July 7, 2017.
  11. U.S. Food and Drug Administration Premarket Notification Database. Supartz FX. P980044. Rockville, MD: FDA. January 24, 2001. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf/P980044a.pdf. Accessed on July 7, 2017.
  12. U.S. Food and Drug Administration Premarket Notification Database. Synvisc/Synvisc-One®. No. P940015. Rockville, MD: FDA. February 26, 2009. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf/P940015S012a.pdf. Accessed on July 7, 2017.
  13. Witteveen AG, Hofstad CJ, Kerkhoffs GM. Hyaluronic acid and other conservative treatment options for osteoarthritis of the ankle. Cochrane Database Syst Rev. 2015(10):CD010643.
Websites for Additional Information
  1. Arthritis Foundation. Osteoarthritis: Available at: http://www.arthritis.org/about-arthritis/types/osteoarthritis/. Accessed on July 7, 2017.
  2. National Library of Medicine. Health Encyclopedia: Osteoarthritis. Available at: http://www.nlm.nih.gov/medlineplus/ency/article/000423.htm. Accessed on July 7, 2017.
  3. National Library of Medicine. Health Encyclopedia: TMJ disorders. Available at: http://www.nlm.nih.gov/medlineplus/ency/article/001227.htm. Accessed on July 7, 2017.
Index

Euflexxa
Gel-One
GelSyn 3
Gen Visc 850
Hyalgan
Hymovis
Monovisc
Orthovisc
Supartz FX
Synvisc
Synvisc-One
Viscosupplementation

The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

Document History

Status

Date

Action

Revised

11/02/2017

Medical Policy & Technology Assessment Committee (MPTAC) review. The document header wording updated from “Current Effective Date” to “Publish Date.” Updated Rationale, Background/Overview, Definitions, References, sections. Revision to Position Statement that all indications are NMN. Removed Clinically Equivalent Cost Effective Agents section. Updated Coding section to include 01/01/2018 HCPCS change to descriptor for J7321.

Reviewed

08/03/2017

MPTAC review.  Updated Rationale and References sections.

Revised

02/02/2017

MPTAC review. Added new “Clinically Equivalent Cost Effective Agents” section. Removed Hylan G-F 20 from Position Statement. Updated Description/Scope, Background/Overview, References and Index sections.

 

01/01/2017

Updated Coding section to include 01/01/2017 HCPCS changes; removed codes C9471, Q9980 deleted 12/31/2016.

Reviewed

08/04/2016

MPTAC review. Updated Rationale and Reference sections. Updated Coding section with 10/01/2016 ICD-10-CM changes.

 

04/01/2016

Updated Coding section to include 04/01/2016 HCPCS changes.

 

01/01/2016

Updated Coding section with 01/01/2016 HCPCS changes; removed ICD-9 codes.

Revised

08/06/2015

MPTAC review. Spelled out temporomandibular joint in Position Statement. Updated Rationale, Background/Overview,  and Reference sections.

 

01/01/2015

Updated Coding section with 01/01/2015 HCPCS changes.

Reviewed

08/14/2014

MPTAC review. Updated Description/Scope, Rationale and References.

Reviewed

08/08/2013

MPTAC review. Updated Rationale, Definitions, References and Index.

Reviewed

08/09/2012

MPTAC review. Title changed to “Hyaluronan Injections in Joints Other Than the Knee.” Updated Rationale, References and Web Sites for Additional Information.

 

01/01/2012

Updated Coding section with 01/01/2012 HCPCS changes.

Reviewed

08/18/2011

MPTAC review. Updated Rationale and References.

Revised

08/19/2010

MPTAC review. Revised document to address musculoskeletal conditions in joints other than the knee. Updated the Description, Rationale, Background/Overview, Coding, References, Index and History sections.

Reviewed

05/13/2010

MPTAC review. Updated review date, Rationale, References and History sections of the document.

 

01/01/2010

Updated Coding section with 01/01/2010 HCPCS changes; removed HCPCS J7322 deleted 12/31/2009.

Revised

05/21/2009

MPTAC review. Modified position statements to: (1) include new hyaluronan product (Synvisc-One) as medically necessary (2) clarify that hyaluronan injections for other musculoskeletal conditions including but not limited to osteoarthritis of the ankle, shoulder and hip, are considered investigational and not medically necessary. Updated Rationale, Background/Overview, Coding, References, Index and History sections.

Revised

05/15/2008

MPTAC review. Medical necessity criteria revised to include the requirement that there is documentation that the patient has failed to respond adequately to conservative nonpharmacologic therapy (e.g., activity modification, home exercises, protective weight bearing) and to simple analgesics, e.g., acetaminophen. Updated review date, References and History sections.

 

01/01/2008

Updated Coding section with 01/01/2008 HCPCS changes; removed HCPCS Q4083, Q4084, Q4085, Q4086 deleted 12/31/2007. The phrase “investigational/not medically necessary” was clarified to read “investigational and not medically necessary.” This change was approved at the November 29, 2007 MPTAC meeting.

Reviewed

05/17/2007

MPTAC review. Updated References, review date and History section. Coding section updated; removed HCPCS J7319.

 

01/01/2007

Updated Coding section with 01/01/2007 CPT/HCPCS changes; removed HCPCS J7317, J7320 deleted 12/31/2006.

Revised

06/08/2006

MPTAC review. Revised language to (1) Remove brand names from Position Statement and the Background/Overview sections of the document. (2) Expanded the Index section to include generic names and Euflexxa™.

Reviewed

03/23/2006

MPTAC review.

Revised

04/28/2005

MPTAC review. Revision based on Pre-merger Anthem and Pre-merger WellPoint Harmonization. Updated coding: Removed HCPCS code J7316 deleted 12/31/2002.

Pre-Merger Organizations

Initial Effective Date

Document Number

Title

Anthem, Inc.

10/27/2004

DRUG.00017

Hyaluronan Injections for Musculoskeletal Conditions

WellPoint Health Networks, Inc.

12/02/2004

8.07.01

Intra-Articular Injections of Hyaluronan for the Treatment of Osteoarthritis

 

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