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Horizon BCBSNJ
Uniform Medical Policy ManualSection:Treatment
Policy Number:015
Effective Date: 08/21/2020
Original Policy Date:03/20/1998
Last Review Date:07/14/2020
Date Published to Web: 09/28/2017
Subject:
Sodium Hyaluronate Injections

Description:
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IMPORTANT NOTE:

The purpose of this policy is to provide general information applicable to the administration of health benefits that Horizon Blue Cross Blue Shield of New Jersey and Horizon Healthcare of New Jersey, Inc. (collectively “Horizon BCBSNJ”) insures or administers. If the member’s contract benefits differ from the medical policy, the contract prevails. Although a service, supply or procedure may be medically necessary, it may be subject to limitations and/or exclusions under a member’s benefit plan. If a service, supply or procedure is not covered and the member proceeds to obtain the service, supply or procedure, the member may be responsible for the cost. Decisions regarding treatment and treatment plans are the responsibility of the physician. This policy is not intended to direct the course of clinical care a physician provides to a member, and it does not replace a physician’s independent professional clinical judgment or duty to exercise special knowledge and skill in the treatment of Horizon BCBSNJ members. Horizon BCBSNJ is not responsible for, does not provide, and does not hold itself out as a provider of medical care. The physician remains responsible for the quality and type of health care services provided to a Horizon BCBSNJ member.

Horizon BCBSNJ medical policies do not constitute medical advice, authorization, certification, approval, explanation of benefits, offer of coverage, contract or guarantee of payment.

__________________________________________________________________________________________________________________________

Sodium hyaluronate injection is a sterile mixture that is made mostly of a natural, highly purified sodium hyaluronate that comes from rooster combs. Hyaluronate is natural chemical found in the body and it is present in a particularly high amount in joint tissues and in the fluid that fills the joints. The body's own hyaluronate acts like a lubricant and a shock absorber in the joint, and it is needed for the joint to function properly. In osteoarthritis, there may not be enough hyaluronate, and there may be a change in the quality of the hyaluronate in joint fluid and tissues.

In 1997, the Food and Drug Administration (FDA) approved two preparations of sodium hyaluronate, Synvisc (Wyeth-Ayerst) and Hyalgan (Sanofi), intended for intra-articular injection into the knee for patients with osteoarthritis. The FDA considered both products to fall into the category of an implantable prosthetic device due to their mechanical rather than pharmacologic action. Therefore, these products underwent a device approval, and not a drug approval process.

Other sodium hyaluronate injections that have been approved by the U.S. FDA include Supartz (Smith and Nephew) approved on January 24, 2001 and Orthovisc (Anika Therapeutics, Inc) approved on February 4, 2004. In 2005, the FDA approved Euflexxa (Ferring Pharmaceuticals, Inc). Supartz has since been discontinued in the US and Supartz FX (Bioventus LLC) was launched October 2015 with an expanded safety label for repeat injection cycles (efficacy of repeat treatment cycles has not been established). In September 2017 the FDA approved Durolane.

The labeled indications for these five products are similar, except that three (3) injections are recommended for Synvisc and Euflexxa, five (5) injections for Hyalgan and Supartz FX, and three (3) to four (4) injections for Orthovisc.

On February 26, 2009, the FDA approved Synvisc-One for the treatment of pain in osteoarthritis of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics e.g., acetaminophen. It is designed as a single intra-articular injection option for up to 26 weeks.

On March 22, 2011, the FDA approved a new sterile, viscoelastic gel known as Gel-One® (Seikagaku) for the treatment of knee pain in patients who have failed to respond adequately to non-pharmacologic therapy, non-steroidal anti-inflammatory drugs (NSAIDs) or analgesic e.g., acetaminophen. It is designed as a single intra-articular injection option for up to 13 weeks. The FDA considered this product to fall into the category of implantable prosthetic device.

On February 25, 2014, the FDA also approved a new viscoelastic supplement known as Monovisc® (Anika Therapeutics, Inc) for the treatment of knee pain due to osteoarthritis in patients who have failed to respond adequately to conservative non-pharmacologic therapy and analgesics. It is designed to be given as a single, intra-articular injection every 4-6 months.

On May 9, 2014, the FDA approved GELSYN-3® (Bioventus, Inc) 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). It is designed to be given as three (3) weekly injections.

On August 28, 2015, the FDA approved Hymovis® for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy or simple analgesics (e.g. acetaminophen). Hymovis® is supplied in a set of 2 single-use 5 mL syringes, each containing a 3mL dose of treatment to be injected one week apart. Hymovis is intended to be injected into the knee joint and is administered as a two intra-articular injection regimen.

On September 2, 2015, the FDA approved GenVisc 850® 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. GenVisc 850® is administered by intra-articular injection. A treatment cycle consists of five injections given at weekly intervals. Some patients may experience benefit with three injections given at weekly intervals. The effectiveness of a single treatment cycle of less than 3 injections has not been established.

In December 2015, the FDA approved Visco-3 (Zimmer Biomet) for the treatment of pain in osteoarthritis of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics (e.g. acetaminophen). Visco-3 is administered by the intra-articular injection to the knee as a single dose given once weekly for 3 weeks.

On November 13, 2017, the FDA approved TriVisc® (OrthogenRx, Inc.) for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy or simple analgesics (e.g. acetaminophen). TriVisc® is administered by intra-articular injection in the knee as 3 doses (each dose is 2.5mL) one week apart. The effectiveness of a single treatment cycle of less than 3 injections has not been established nor has the effectiveness of repeat treatment cycles.

In March 2017, the FDA approved Durolane® (Bioventus, Inc.) for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacological therapy or simple analgesics (e.g. acetaminophen). Durolane is administered by the intra-articular injection in the knee as a single dose (3 mL).

On May 8, 2018, the FDA approved SynojoyntTM (Hanmi Pharm Co., LTd. For Teva Pharmaceuticals USA, Inc.) 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). SynojoyntTM is administered by intra-articular injection in the knees as 3 doses (each dose is 2mL) one week apart.

On March 26, 2019, the FDA approved TriluronTM (Fidia Farmaceutici S.p.A. for Fidia Pharma USA Inc.) for the treatment of pain in osteoarthritis (OA) of the knee in patients who have not responded to non-surgical treatments from physical therapy and simple pain medicines such as acetaminophen and non-steroidal anti-inflammatory drugs (NSAIDs). TriluronTM is administered directly into the patient’s knee and provides relief for up to six months. The treatment consists of three weekly doses of 2mL.

[INFORMATIONAL NOTE: In 2013, the American Academy of Orthopedic Surgeons (AAOS) conducted a systematic review of treatments for osteoarthritis (OA) of the knee. Included was a meta-analysis of 3 high-strength and 11 moderate-strength studies of IAHA for OA of the knee. Pain outcomes were significantly lower in the treatment group compared to placebo, but the difference was found to be not clinically important, since the lower bound of the confidence interval was higher than the minimal clinically important difference. This indicated a low likelihood that an appreciable number of patients achieved clinically important benefits. Similar results were obtained for functional outcomes. This meta-analysis found evidence that high molecular-weight preparations were more effective than those with low weights, indicating a possible clinically important difference for the higher molecular-weight preparations.]

Policy:
(NOTE: For Medicare Advantage, please refer to the Medicare Coverage Section below for coverage guidance)

The requirements of the Horizon BCBSNJ Non-preferred sodium hyaluronate injections (Hyalgan, Supartz FX, Gel-Syn, GenVisc 850, Hymovis, Gel-One, Durolane, Visco-3, TriVisc, Synojoynt, and Triluron) Program may require a precertification/prior authorization via MagellanRx Management. These requirements are member-specific: please verify member eligibility and requirements through the Horizon Provider Portal (www.horizonblue.com/provider). Ordering clinicians should request pre-certification from MagellanRx Management at ih.magellanrx.com or call 1-800-424-4508 (when applicable).

I. Preferred sodium hyaluronate injections (Synvisc, Synvisc-One, Orthovisc, Euflexxa, and Monovisc, are medically necessary for the treatment of pain in osteoarthritis of the knee in members when any of the following criteria are met:

    A. Diagnosis of mild to moderate osteoarthritis (grade 1-3) of the knee confirmed by a rheumatologist OR orthopedic surgeon OR orthopedist OR established by the criteria in Table 1, and all of the following are met:
      i. Member has failed to respond adequately to conservative nonpharmacologic therapy (e.g. physical activity and exercise); AND
      ii. Member has tried and has not resulted in functional improvement after at least 3 months, is intolerant or has contraindications to simple analgesics, (e.g., acetaminophen; NSAIDs; and/or topical capsaicin cream); AND
      iii. No contraindications to the injections (e.g., active joint infection, bleeding disorder, skin infections at the injection site).
    OR
    B. Diagnosis of severe osteoarthritis (grade 4) of the knee confirmed by a rheumatologist OR orthopedic surgeon OR orthopedist OR established by the criteria in Table 1, and all of the following are met:
      i. Member is not a candidate for total knee replacement due to the following risk factors for complications including, but not limited to:
        1. Obesity (BMI >30 kg/m2)
        2. Cardiovascular disease (including but not limited to uncontrolled diabetes, hypertension or hypercholesterolemia)
        3. Advance age (>90 years old)
      ii. Member has failed to respond adequately to conservative nonpharmacologic therapy (e.g. physical activity and exercise); AND
      iii. Member has tried and has not resulted in functional improvement after at least 3 months, is intolerant or has contraindications to simple analgesics, (e.g., acetaminophen; NSAIDs; and/or topical capsaicin cream); AND
      iv. No contraindications to the injections (e.g., active joint infection, bleeding disorder, skin infections at the injection site)

      Table 1. Osteoarthritis/Degenerative joint disease is classified into the following categories based on radiographic evidence:

      StagingDescription
      Grade 1slight narrowing of the joint, minimum osteophyte formation, and slight sclerosis
      Grade 2-moderate joint space narrowing, spur formation, and sclerosis
      Grade 3-bone-on-bone changes and sclerosis but no loss of bone stock
      Grade 4complete obliteration of the joint, loss of joint stock and severe sclerosis (Hyaluronic acid derivatives are not recommended therapy in patients with grade 4 or severe DJD)

II. Non-preferred sodium hyaluronate injections (Hyalgan, Supartz FX, Gel-Syn, GenVisc 850, Hymovis, Gel-One, Durolane, Visco-3, TriVisc, Synojoynt, and Triluron) are medically necessary for the treatment of pain in osteoarthritis of the knee in members when the following criteria are met:
    A. Member has documentation of a previous trial and failure, contraindication, or hypersensitivity to at least one of the preferred sodium hyaluronate injections (Orthovisc, Synvisc, Synvisc-One, Monovisc, or Euflexxa);
    AND
    B. Diagnosis of mild to moderate osteoarthritis (grade 1-3) of the knee confirmed by a rheumatologist OR orthopedic surgeon OR orthopedist OR established by the criteria in Table 1, and all of the following are met:
      i. Member has failed to respond adequately to conservative nonpharmacologic therapy (e.g. physical activity and exercise); AND
      ii. Member has tried and has not resulted in functional improvement after at least 3 months, is intolerant or has contraindications to simple analgesics, (e.g., acetaminophen; NSAIDs; and/or topical capsaicin cream); AND
      iii. No contraindications to the injections (e.g., active joint infection, bleeding disorder, skin infections at the injection site).
    OR
    C. Diagnosis of severe osteoarthritis (grade 4) of the knee confirmed by a rheumatologist OR orthopedic surgeon OR orthopedist OR established by the criteria in Table 1, and all of the following are met:
      i. Member is not a candidate for total knee replacement due to the following risk factors for complications including, but not limited to:
        1. Obesity (BMI >30 kg/m2)
        2. Cardiovascular disease (including but not limited to uncontrolled diabetes, hypertension or hypercholesterolemia)
        3. Advance age (>90 years old)
      ii. Member has failed to respond adequately to conservative nonpharmacologic therapy (e.g. physical activity and exercise); AND
      iii. Member has tried and has not resulted in functional improvement after at least 3 months, is intolerant or has contraindications to simple analgesics, (e.g., acetaminophen; NSAIDs; and/or topical capsaicin cream); AND
      iv. No contraindications to the injections (e.g., active joint infection, bleeding disorder, skin infections at the injection site)
    [INFORMATIONAL NOTE: The use of these agents has not been tested in patients < 21 years of age and has not been tested in pregnant or nursing women. They also have has not been tested to show better pain relief or safety when combined with other injected medicines.]

III. When sodium hyaluronate injections are medically necessary, the initial treatment will be approved for 6 months at the following FDA approved dosing:
    One course of therapy constitutes either of the following:
    • Synvisc, Euflexxa, Gel-Syn, Visco-3, TriVisc, Synojoynt or Triluron administered by intra-articular injections once a week (one week apart) for a total of three (3) injections; or
    • Hyalgan, Supartz FX, or GenVisc 850 administered by intra-articular injections once a week (one week apart) for a total of up to five (5) injections; or
    • Orthovisc administered by intra-articular injections once a week (one week apart) for a total of three (3) or four (4) injections; or
    • Hymovis administered by intra-articular injection once a week for a total of two (2) injections
    • Synvisc-One, Gel-One, Durolane, and Monovisc are all administered as a single intra-articular injection

    Max Units (per dose and over time)*

    Drug
    HCPCS
    1 Billable Unit (BU)
    BU per Admin
    No. Admins (per knee per 180 days)
    Max Units (per 180 days)*
    Euflexxa
    J7323
    1 dose
    1
    3
    6
    Durolane
    J7318/
    C9465
    1 mg/
    1 dose
    60/
    1
    1
    120/
    2
    Gel-One
    J7326
    1 dose
    1
    1
    2
    GelSyn-3
    J7328
    0.1 mg
    168
    3
    1008
    GenVisc 850
    J7320
    1 mg
    25
    5
    250
    Hyalgan; Supartz; Supartz FX
    J7321
    1 dose
    1
    5
    10
    Hymovis
    J7322
    1 mg
    24
    2
    96
    Monovisc
    J7327
    1 dose
    1
    1
    2
    Orthovisc
    J7324
    1 dose
    1
    4
    8
    Synojoynt
    J7331
    1 mg
    20
    3
    120
    Synvisc
    J7325
    1 mg
    16
    3
    96
    Synvisc-One
    J7325
    1 mg
    48
    1
    96
    Triluron
    J7332
    1 mg
    20
    3
    120
    Trivisc
    J7329
    1 mg
    25
    3
    150
    Visco-3
    J7333
    1 dose
    1
    3
    6
    *Max units are based on administration to both knees


    [INFORMATIONAL NOTE: The safety and efficacy of Synvisc One® was determined in a prospective, parallel-group, double-blind study in which 253 patients were randomized to receive either Synvisc One or saline via an intra-articular injection. Primary efficacy endpoint, change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain index, was assessed over a period of 26 weeks, and met pre-specified superiority with statistical significance. Patients who continued to have mild pain in the injected knee at week 26 were offered a second treatment of Synvisc-One at week 26, although they were only followed for 4 weeks for safety analysis, and no efficacy analysis is available after week 26.

    The safety and efficacy of Gel-One was established in a double blind, parallel-group study that randomized patients to receive Gel-One or saline intra-articular injection. Patients returned for evaluations at weeks 1, 3, 6, 9 and 13, and the primary efficacy endpoint was defined as change in WOMAC pain score from baseline at week 13. Although reduction in WOMAC pain score was statistically significant in the treatment arm compared to control, efficacy of Gel-One has not been tested with re-treatment after week 13.]

IV. For continuing therapy, intra-articular sodium hyaluronate injections to the knee is considered medically necessary and approved every 6 months when ALL of the following criteria are met:
    A. If the requested sodium hyaluronate injection is a non-preferred agent, the member has been previously approved by the plan for treatment with the requested agent (Hyalgan, Supartz FX, Gel-Syn, GenVisc 850, Hymovis, Gel-One, Durolane, Visco-3, TriVisc, Synojoynt, and Triluron), AND
    B. Administered by rheumatologist OR orthopedic surgeon OR orthopedist OR patient is diagnosed with OA grade 1-3 based on criteria outlined in Table 1 (above); OR
    C. Diagnosis of severe osteoarthritis (grade 4) of the knee confirmed by a rheumatologist OR orthopedic surgeon OR orthopedist OR established by the criteria in Table 1, and ALL of the following are met:
      i. Member is not a candidate for total knee replacement due to the following risk factors for complications including but not limited to:
        1. Obesity (BMI >30 kg/m2)
        2. Cardiovascular disease (including but not limited to uncontrolled diabetes, hypertension or hypercholesterolemia)
        3. Advance age (>90 years old)
    D. At least 6 months have elapsed since the previous course of therapy; AND
    E. Member experiences significant improvement with prior course of therapy, defined as:
      i. The medical record demonstrates a reduction in the dose of NSAIDS (or other analgesics or anti-inflammatory medication) during the 6-month period following the previous series of injections; AND
      ii. The medical record objectively documents significant improvement in pain and functional capacity as the result of the previous injections; AND
      iii. Absence of unacceptable toxicity from the previous injections
V. Sodium hyaluronate injections are considered investigational when administered to joints other than the knee in members with osteoarthritis, and when administered to any joints for other conditions or diseases.

[INFORMATIONAL NOTE: All products are specifically FDA-approved for use in patients with osteoarthritis (OA) of the knee. The P&T Committee at Horizon Blue Cross Blue Shield of New Jersey subjects each prescription drug being considered for formulary placement to a rigorous clinical analysis. Based on the decrease in administration burden for both members and physicians, the clinical and effective analysis, the P&T Committee recommends the placement of Synvisc, Synvisc-One, Euflexxa, Monovisc, and Orthovisc as preferred sodium hyaluronate injection agents. The clinical studies which were the basis for the FDA approval of these products utilized the following classification criteria for osteoarthritis of the knee by the American College of Rheumatology (ACR):

    Traditional format - knee pain, and radiographic osteophytes,
                    and
              at least 1 of the following:
                • age >50 years;
                • morning stiffness lasting 30 minutes or less;
                • crepitus on motion.
              OR

    Classification-tree format - knee pain, and radiographic osteophytes
                          or
                  knee pain, and age 40 years or older, and
                  morning stiffness lasting 30 minutes or less, and
                  crepitus on motion.]
Medicare Coverage:
There is no National Coverage Determination (NCD) for Sodium Hyaluronate Injections. Novitas Solutions, Inc, the Local Medicare Carrier for jurisdiction JL, has determined that Hyaluronan Acid Injections for Osteoarthritis of the Knee are covered when LCD L35427 and Article A55036 criteria are met. For eligibility and additional information, refer to Local Coverage Determination (LCD) L35427 and Local Coverage Article Hyaluronan Acid Therapies for Osteoarthritis of the Knee A55036. Available to be accessed at Novitas Solutions, Inc., Medical Policy Search page: https://www.novitas-solutions.com/webcenter/portal/MedicareJL/LcdSearch?_afrLoop=90769712476969#!%40%40%3F_afrLoop%3D90769712476969%26centerWidth%3D100%2525%26leftWidth%3D0%2525%26rightWidth%3D0%2525%26showFooter%3Dfalse%26showHeader%3Dfalse%26_adf.ctrl-state%3D63y7eftob_46.
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Horizon BCBSNJ Medical Policy Development Process:

This Horizon BCBSNJ Medical Policy (the “Medical Policy”) has been developed by Horizon BCBSNJ’s Medical Policy Committee (the “Committee”) consistent with generally accepted standards of medical practice, and reflects Horizon BCBSNJ’s view of the subject health care services, supplies or procedures, and in what circumstances they are deemed to be medically necessary or experimental/ investigational in nature. This Medical Policy also considers whether and to what degree the subject health care services, supplies or procedures are clinically appropriate, in terms of type, frequency, extent, site and duration and if they are considered effective for the illnesses, injuries or diseases discussed. Where relevant, this Medical Policy considers whether the subject health care services, supplies or procedures are being requested primarily for the convenience of the covered person or the health care provider. It may also consider whether the services, supplies or procedures are more costly than an alternative service or sequence of services, supplies or procedures that are at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of the relevant illness, injury or disease. In reaching its conclusion regarding what it considers to be the generally accepted standards of medical practice, the Committee reviews and considers the following: all credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, physician and health care provider specialty society recommendations, the views of physicians and health care providers practicing in relevant clinical areas (including, but not limited to, the prevailing opinion within the appropriate specialty) and any other relevant factor as determined by applicable State and Federal laws and regulations.

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Index:
Sodium Hyaluronate Injections
Hyalgan
Hyaluronate Injections
Intra-Articular Injections for Osteoarthritis
Osteoarthritis, Sodium Hyaluronate Injections for
Supartz
Supartz FX
Synvisc
Synvisc-One
Orthovisc
Euflexxa
Gel- One
GenVisc 850
Hymovis
Trivisc
Durolane
Visco-3
Synojoynt
Triluron

References:
1. FDA approval of Supartz issued on January 24, 2001. <www.fda.gov/cdrh/pdf/98004.html> (accessed 08/03/2001)

2. Information on Suparz received from Smith and Nephew on March 7, 2001.

3. Hyalgan (sodium hyaluronate) Package Insert. Fidia Pharma Inc. Parsippany, NJ. May 2014.

4. ECRI. Windows on Medical Technology: Hyaluronan-Based Therapy for Osteoarthritis of the Knee. September 2001. Issue No. 55.

5. Hochberg MC, Altman RD, Brandt KD, et al. Guidelines for the Medical Management of Osteoarthritis. Arthritis & Rheumatism. 1995 Nov;38(11):1541-1546.

6. Scali JJ. Intra-articular hyaluronic acid in the treatment of osteoarthritis of the knee: A long term study. Eur J Rheumatol Inflam 1995;15:57-62.

7. Kotz R, Kolarz G. Intra-articular hyaluronic acid: Duration of effect and results of repeated treatment cycles. Am J Orthop 1999:28(suppl 1S):5-7.

8. Carrabba M, Paresce E, Angeline M et al. The safety and efficacy of different dose schedules of hyaluronic acid in the treatment of painful osteoarthritis of the knee with joint effusions. Eur J Rheumatol Inflam 1995;15:25-31.

9. Lussier A, Cividino AA, McFarlane CA et al. Viscosupplementation with hylan for the treatment of osteoarthritis: Findings from clinical practice in Canada. J Rheumatol 1996;23:1579-85.

10. Simon L. Viscosupplementation therapy with intraarticular hyaluronic acid. Rheum Dis Clin North Am 1999;25:345-357.

11. Guarda-Nardini L, Tito R, Staffieri A, Beltrame A. Treatment of patients with arthrosis of the temporomandibular joint by infiltration of sodium hyaluronate: a preliminary study. Eur Arch Otorhinolaryngol 2002 May;259(5):279-84.

12. Brocq O, Tran G, Breuil V et al. Hip osteoarthritis: short-term efficacy and safety of viscosupplementation by hylan G-F 20. An open-label study in 22 patients. Joint Bone Spine 2002 Jun;69(4):388-91.

13. Petrella RJ, DiSilvestro MD, Hildebrand C. Effects of hyaluronate sodium on pain and physical functioning in osteoarthritis of the knee: a randomized, double-blind, placebo-controlled clinical trial. Arch Intern Med 2002 Feb 11;162(3):292-8.

14. Recommendations for the Medical Management of Osteoarthritis of the Hip and Knee: 2000 Update. American College of Rheumatology Subcommittee on Osteoarthritis Guidelines. Arthritis Rheum. 2000 Sep;43(9):1905-15.

15. Empire Medicare Services - New Jersey. Policy Number #I-15B: Hyaluronase Polymers. www.empiremedicare.com (accessed 8/19/03).

16. ECRI Hotline Response: Hyaluronan-Based therapy for the Treatment of Degenerative Joint Diseases of the Ankle. Updated 7/16/02.

17. Marshall KW. Intra-articular hyaluronan therapy. Foot Ankle Clin. 2003 Jun;8(2):221-32,vii.

18. Pleimann JH, Davis WH et al. Viscosupplementation for the arthritic ankle. Foot Ankle Clin. 2002 Sep;7(3):489-94.

19. ECRI. Health Technology Assessment Information Service (HTAIS). Custom Hotline Response: Hyaluronan-Based Therapy for Osteoarthritis of the Hip. Updated 02/04/2005.

20. Altman RD. Status of hyaluronan supplementation therapy in osteoarthritis. Curr Rheumatol Rep. 2003 Feb;5(1):7-14.

21. Lo GH, LaValley M et al. Intra-articular hyaluronic acid in treatment of knee osteoarthritis: a meta-analysis. JAMA. 2003 Dec 17;290(23):3115-21.

22. ECRI’s Health Technology Forecast. Perspectives & Predictions: Hyaluronan-based therapy for osteoarthritis of the hip. Content current as of 8/27/04.

23. Blue Cross Blue Shield Association. TEC Special Report: Intra-articular hyaluronan injections for the treatment of osteoarthritis of the knee. June, 2004.

24. Empire Medicare Services (NJ). Hyaluronase Polymers. LCD# I-15C. Effective 10/01/2003. [Available at: http://www.empiremedicare.com/combinedpolicies/policy/I15_DR009E_Final.htm (last accessed 8/31/04).

25. Euflexxa (sodium hyaluronate) Package Insert. Ferring Pharmaceutical, Inc., Suffern , NY. July 2016.

26. Bellamy N, Campbell J, Robinson V et al.Viscosupplementation for the treatment of osteoarthritis of the knee. Cochrane Database Syst Rev 2005; (2):CD005321.

27. Arrich J, Piribauer F, Mad P et al.Intra-articular hyaluronic acid for the treatment of osteoarthritis of the knee: systematic review and meta-analysis. Can Med Assoc J 2005; 172(8):1039-43.

28. Bellamy N, Campbell J, Robinson V et al. Viscosupplementation for the treatment of osteoarthritis of the knee. Cochrane Database Syst Rev 2006; (2):CD005321.

29. Pagnano M, Westrich G. Successful nonoperative management of chronic osteoarthritis pain of the knee: safety and efficacy of retreatment with intra-articular hyaluronans. Osteoarthritis Cartilage 2005; 13(9):751-61.

30. Qvistgaard E, Christensen R, Torp-Pedersen S et al. Intra-articular treatment of hip osteoarthritis: a randomized trial of hyaluronic acid, corticosteroid, and isotonic saline. Osteoarthritis Cartilage 2006; 14(2):163-70.

31. Stahl S, Karsh-Zafrir I, Ratzon N et al. Comparison of intraarticular injection of depot corticosteroid and hyaluronic acid for treatment of degenerative trapeziometacarpal joints. J Clin Rheumatol 2005; 11(6):299-302.

32. Fuchs S, Monikes R, Wohlmeiner A et al. Intra-articular hyaluronic acid compared with corticoid injections for the treatment of rhizarthrosis. Osteoarthritis Cartilage 2006; 14(1):82-8.

33. ECRI. Health Technology Assessment Information Service (HTAIS). Custom Hotline Response: Hyaluronan-based Therapy for Osteoarthritis of the Knee. Updated 11/30/2005.

34. American Academy of Orthopaedic Surgeons (AAOS). Osteoarthritis of the Hip. A Compendium of Evidence-based Information and Resources. October 2003. [Available at http://www.aaos.org/Research/documents/oainfo_hip.asp (accessed on 1/22/2007).]

35. The Medical Letter on Drugs and Therapeutics. Intra-Articular Injections for Osteoarthritis of the Knee. Volume 48: Issue 1231. March 27, 2006.

36. 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 Dec;14(12):1306-11.

37. Petrella RJ, Petrella M. A prospective, randomized, double-blind, placebo controlled study to evaluate the efficacy of intraarticular hyaluronic acid for osteoarthritis of the knee. J Rheumatol 2006 May;33(5):951-6.

38. ECRI Institute. Health Technology Assessment Information Service (HTAIS). Custom Hotline Response: Viscosupplementation for Joint Disease of the Knee. Updated 04/03/2007.

39. ECRI Institute. Health Technology Assessment Information Service (HTAIS). Custom Hotline Response: Viscosupplementation for Joint Disorders of the Hip. Updated 04/09/2007.

40. ECRI Institute. Health Technology Assessment Information Service (HTAIS). Custom Hotline Response: Viscosupplementation for Joint Diseases (other than the Hip and Knee). Updated 04/09/2007.

41. van den Bekerom MP, Lamme B, Sermon A, et al. What is the evidence for viscosupplementation in the treatment of patients with hip osteoarthritis? Systematic review of the literature. Arch Orthop Trauma Surg 2007 Sep 15 [Epub ahead of print].

42. Dagenais S. Intra-articular hyaluronic acid (viscosupplementation) for hip osteoarthritis. Issues Emerg Health Technol 2007 May;(98):1-4.

43. FDA Summary of Safety and Effectiveness Data for Synvisc-One. [Available at http://www.accessdata.fda.gov/cdrh_docs/pdf/P940015S012b.pdf (accessed on 06/05/2009).]

44. ECRI Institute. Health Technology Assessment Information Service (HTAIS). Hotline Response: Viscosupplementation for Osteoarthritis of the Hip. Updated 05/21/2008.

45. Migliore A, Granata M. Intra-articular use of hyaluronic acid in the treatment of osteoarthritis. Clin Interv Aging 2008;3(2):365-9.

46. Carpenter B, Motley T. The role of viscosupplementation in the ankle using hylan G-F 20. J Foot Ankle Surg 2008 Sep-Oct;47(5):377-84.

47. 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 Jul;29(7):657-63.

48. Westrich G, Schaefer S, Walcott-Sapp S, et al. Randomized prospective evaluation of adjuvant hyaluronic acid therapy administered after knee arthroscopy. Am J Orthop (Belle Mead NJ). 2009;38(12):612-6.

49. Saito S, Kotake S. Is there evidence in support of the use of intra-articular hyaluronate in treating rheumatoid arthritis of the knee? A meta-analysis of the published literature. Mod Rheumatol. 2009;19(5):493-501.

50. Altman RD, Rosen JE, Bloch DA, et al. A double-blind, randomized, saline-controlled study of the efficacy and safety of EUFLEXXA for treatment of painful osteoarthritis of the knee, with an open-label safety extension (the FLEXX trial). Semin Arthritis Rheum. 2009;39(1):1-9.

51. Bannuru RR, Natov NS, Obadan IE, et al. Therapeutic trajectory of hyaluronic acid versus corticosteroids in the treatment of knee osteoarthritis: a systematic review and meta-analysis. Arthritis Rheum. 2009;61(12):1704-11.

52. 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. 2010;69(1):113-9.

53. Richette P, Ravaud P, Conrozier T, et al. Effect of hyaluronic acid in symptomatic hip osteoarthritis: a multicenter, randomized, placebo-controlled trial. Arthritis Rheum. 2009;60(3):824-30.

54. MICROMEDEX® 1.0 (Healthcare Series). DRUGDEX® Evaluations. Hyaluronate. Available at: http://www.thomsonhc.com. Accessed February 15, 2011.

55. Gel-One® Prescribing Information. Seikagaku Corporation. Tokyo, Japan. 2011. Accessed at: http://www.accessdata.fda.gov/cdrh_docs/pdf8/P080020c.pdf.

56. Safety and Effectiveness Study of Hyaluronic Acid for Osteoarthritis of the Knee. Clinicaltrials.gov [NCT00653432]. Accessed 2014 March 5, 2014. Available at http://clinicaltrials.gov/ct2/show/NCT00653432

57. Monovisc. Drugs.com [website]. 2014 February. Available at http://www.drugs.com/history/monovisc.html

58. American Academy of Orthopaedic Surgeons (AAOS). Treatment of Osteoarthritis of the Knee: Evidence-based guidelines 2nd edition. May 18, 2013. [Available at http://www.aaos.org/Research/guidelines/TreatmentofOsteoarthritisoftheKneeGuideline.pdf (accessed on 03/05/2014).]

59. Waddell DD. Viscosupplementation with Hyaluronans for Osteoarthritis of the Knee: Clinical Efficacy and Economic Implications. Drug Aging. 2007; 24(8): 629-642.

60. Divine, JG. Shaffer MD. Use of Viscosupplementation for Knee Osteoarthritis: An Update. Current Sports Medicine Reports. 2011: 10(5): 279-284.

61. Das A, Neher J, Safranek S. Do hyaluronic acid injections relieve OA knee pain? J Fam Prac 2009; 58(5):281c-281e.

62. Synvisc-One (Hylan G-F 20) Package Insert. Genzyme Corporation. Ridgefield, NJ. Sep 2014.

63. Supartz FX (Sodium Hyaluronate) Package Insert. Bioventus LLC. Durham, NC. April 2015.

64. Gel-One (Sodium Hyaluronate) Package Insert. Zimmer. Warsaw, IN. May 2011.

65. Reuterse. Bioventus Luanches Supartz FX Now with Expanded Safety Label for Repeat Injection Cycles in Knee Osteoarthritis. October 12, 2015. [Available at http://www.reuters.com/article/nc-bioventus-idUSnBw125753a+100+BSW20151012]

66. FDA approval of Gel-Syn issued on May 9, 2014. http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm398349.htm and http://www.accessdata.fda.gov/cdrh_docs/pdf11/P110005d.pdf. Accessed on 7/20/2016.

67. Gel-Syn 3 (3 injection hyaluronic acid treatment) Package Insert. Bioventus LLC. Durham, NC. 2016.

68. FDA summary of safety and effectiveness data (SSED) GenVisc 850. http://www.accessdata.fda.gov/cdrh_docs/pdf14/P140005b.pdf. Accessed August 30, 2016

69. GenVisc 850 Package Insert. Doylestown, PA. Orthogen Rx, Inc; September 2015

70. FDA summary of safety and effectiveness data (SSED) Hymovis. http:/www.accessdata.fda.gov/cdrh_docs/pdf15/P150010B.pdf. Accessed August 30, 2016

71. Hymovis Package Insert. Terme Padova, Italy. Fidia Farmacertici. August 2015.

72. FDA approval of TriVisc issues on November 11, 2017. https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm587763.htm

73. FDA summary of safety and effectiveness data (SSED) TriVisc. https://www.accessdata.fda.gov/cdrh_docs/pdf16/P160057B.pdf. Accessed January 26, 2018.

74. TriVisc Package Insert. Doylestown, PA. Othrogen Rx, Inc; November 2017.

75. Durolane Package Insert. Durham, NC. Bioventus, LLC. March 2018.

76. Visco-3 Package Insert. Zimmer Biomet. Accessed June 2018.

77. Synojoynt Package Insert. North Wales, PA. Teva Pharmaceuticals USA, Inc. May 2018.

78. FDA summary of safety and effectiveness data (SSDED) Synojoynt. https://www.accessdata.fda.gov/cdrh_docs/pdf17/P170016B.pdf Accessed September 24, 2018.

79. FDA approval of Synojoynt issued on May 8, 2018. https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm609709.htm Accessed September 24, 2018.

80. FDA approval of Triluron issued on March 26, 2019. https://www.fda.gov/medical-devices/recently-approved-devices/trilurontm-p180040. Accessed August 20, 2019.

81. Triluron Package Insert. Florham Park, NJ. Fidia Pharma USA, Inc. March 2019.

Codes:
(The list of codes is not intended to be all-inclusive and is included below for informational purposes only. Inclusion or exclusion of a procedure, diagnosis, drug or device code(s) does not constitute or imply authorization, certification, approval, offer of coverage or guarantee of payment.)

CPT*

    20610

HCPCS
20606
J7320
    J7321
J7322
    J7323
    J7324
    J7325
    J7331
    J7326
    J7328
    J7318
J7327
    J7329
J7331
    J7332
    J7333
    C9465
* CPT only copyright 2020 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.

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Medical policies can be highly technical and are designed for use by the Horizon BCBSNJ professional staff in making coverage determinations. Members referring to this policy should discuss it with their treating physician, and should refer to their specific benefit plan for the terms, conditions, limitations and exclusions of their coverage.

The Horizon BCBSNJ Medical Policy Manual is proprietary. It is to be used only as authorized by Horizon BCBSNJ and its affiliates. The contents of this Medical Policy are not to be copied, reproduced or circulated to other parties without the express written consent of Horizon BCBSNJ. The contents of this Medical Policy may be updated or changed without notice, unless otherwise required by law and/or regulation. However, benefit determinations are made in the context of medical policies existing at the time of the decision and are not subject to later revision as the result of a change in medical policy

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