Last Review Date: 08/01/2024

Date of Origin: 01/01/2012

Dates Reviewed: 03/2012, 06/2012, 09/2012, 12/2012, 03/2013, 06/2013, 09/2013, 12/2013, 03/2014, 06/2014, 09/2014, 12/2014, 03/2015, 06/2015, 12/2015, 03/2016, 06/2016, 09/2016, 12/2016, 03/2017, 06/2017, 09/2017, 11/2017, 12/2017, 03/2018, 06/2018, 07/2018, 10/2018, 07/2019, 10/2019, 03/2020, 10/2020, 04/2021, 10/2021, 02/2022, 10/2022, 10/2023, 08/2024

1. Length of Authorization

Coverage will be provided for 6 months initially and may be renewed annually thereafter.

2. Dosing Limits

1. Quantity Limit (max daily dose) [NDC Unit]:

   Drug	Injections per knee	Injections both knees	Days Supply
   Durolane 60 mg/3 mL injection	1	2	180
   Euflexxa 20 mg/2 mL injection	3	6	180
   Gel-One 30 mg/3 mL injection	1	2	180
   GelSyn-3 16.8 mg/2 mL injection	3	6	180
   GenVisc 850 25mg/3 ml injection	5	10	180
   Hyalgan 20 mg/2 mL injection	5	10	180
   Hymovis 24 mg/3 mL injection	2	4	180
   Monovisc 88 mg/4 mL injection	1	2	180
   Orthovisc 30 mg/2 mL injection	4	8	180
   Supartz 25 mg/2.5 mL injection	5	10	180
   Supartz FX 25 mg/2.5 mL injection	5	10	180
   Synojoynt 20 mg/2 mL	3	6	180
   Synvisc 16 mg/2 mL injection	3	6	180
   Synvisc-One 48 mg/6 mL injection	1	2	180
   Triluron 20 mg/2 mL injection	3	6	180
   Trivisc 25 mg/2.5mL injection	3	6	180
   VISCO-3 25 mg/2.5 mL injection	3	6	180

2. Max Units (per dose and over time) [HCPCS Unit]:*

*Max units are based on administration to both knees

3. Initial Approval Criteria

Coverage is provided in the following conditions:

Universal Criteria ^1-15,23-25

• Patient does not have any conditions which would preclude intra-articular injections (e.g., active joint infection, unstable joint, bleeding disorders, etc.); AND
• Patient has not received therapy with intra-articular long-acting corticosteroid type drugs (i.e. Zilretta, etc.) within the previous 6 months of therapy; AND

Osteoarthritis of the knee † ^{1-15,23-25,27-29}

• Patient has a radiographically* confirmed diagnosis of osteoarthritis of the knee; AND
• The patient has had a trial and failure to BOTH of the following conservative methods which have not resulted in functional improvement after at least three (3) months:
  • Non-Pharmacologic (i.e., physical, psychosocial, or mind-body approach [e.g., exercise-land based or aquatic, physical therapy, tai chi, yoga, weight management, cognitive behavioral therapy, knee brace or cane, etc.]); AND
  • Pharmacologic Approach (e.g., topical NSAIDs, oral NSAIDs with or without oral proton pump inhibitors, COX-2 inhibitors, topical capsaicin, acetaminophen, tramadol, duloxetine, etc.); AND

• The patient has failed to adequately respond to aspiration and injection of intra-articular steroids; AND
• The patient reports pain which interferes with functional activities (e.g., ambulation, prolonged standing)

*Note: Imaging is not required to make the diagnosis in patients with a typical presentation of OA²⁷

† FDA Approved Indication(s); ‡ Compendia Recommended Indication(s); Ф Orphan Drug

4. Renewal Criteria ^{1-15,23-25,27-29}

Coverage can be renewed based upon the following criteria:

• Patient continues to meet the universal and other indication-specific relevant criteria identified in section III; AND
• Disease response with treatment as defined by improvement in signs and symptoms of pain and a stabilization or improvement in functional capacity during the 6-month period following the previous series of injections as evidenced by objective measures; AND
• Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include: severe joint swelling and pain, severe infections, anaphylactic or anaphylactoid reactions, etc.

5. Dosage/Administration (per knee per 180 days)

6. Billing Code/Availability Information

HCPCS Code & NDC:

7. References

1. Supartz/Supartz FX [package insert]. Durham, NC; Bioventus LLC; April 2015. Accessed July 2024.
2. Hyalgan [package insert]. Florham Park, NJ; Fidia Pharma USA Inc.; August 2017. Accessed July 2024.
3. Euflexxa [package insert]. Parsippany, NJ; Ferring Pharmaceuticals; July 2016. Accessed July 2024.
4. Synvisc/Synvisc-One [package insert]. Ridgefield, NJ; Genzyme Biosurgery; May 2023. Accessed July 2024.
5. Orthovisc [package insert]. Bedford, MA; Anika Therapeutics, Inc.; July 2023. Accessed July 2024.
6. Gel-One [package insert]. Warsaw, IN; Zimmer; May 2011. Accessed August 2023.
7. Monovisc [package insert]. Bedford, MA; Anika Therapeutics, Inc.; July 2023. Accessed July 2024.
8. GelSyn-3 [package insert]. Durham, NC; Bioventus LLC; December 2017; Accessed July 2024.
9. GenVisc 850 [package insert]. Doylestown, PA; OrthogenRx, Inc; November 2019; Accessed July 2024.
10. Hymovis [package insert]. Florham Park, NJ; Fidia Pharma USA Inc.; June 2021. Accessed July 2024.
11. VISCO-3 [package insert]. Durham, NC; Bioventus LLC; December 2015. Accessed July 2024.
12. Durolane [package insert]. Durham, NC; Bioventus LLC; September 2017. Accessed July 2024.
13. Trivisc [package insert]. Doylestown, PA; OrthogenRx, Inc; December 2017. Accessed August 2023.
14. Triluron [package insert]. Florham Park, NJ; Fidia Pharma USA Inc.; July 2019. Accessed July 2024.
15. Synojoynt [package insert]. North Wales, PA; Teva Pharmaceuticals USA, Inc.; January 2022. Accessed July 2024.
16. 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 Apr;64(4):465-74.
17. McAlindon TE, Bannuru RR, Sullivan MC, et al. OARSI guidelines for the non-surgical management of knee osteoarthritis. Osteoarthritis Cartilage. 2014 Mar;22(3):363-88. doi: 10.1016/j.joca.2014.01.003. Epub 2014 Jan 24.
18. Brown GA. AAOS clinical practice guideline: treatment of osteoarthritis of the knee: evidence-based guideline, 2^nd edition. J Am Acad Orthop Surg. 2013 Sep;21(9):577-9. doi: 10.5435/JAAOS-21-09-577.
19. Cooper C, Rannou F, Richette P, et al. Use of intra-articular hyaluronic acid in the management of knee osteoarthritis in clinical practice. Arthritis Care Res (Hoboken). 2017 Jan 24.
20. Bhadra AK, Altman R, Dasa V, et al. Appropriate use criteria for hyaluronic acid in the treatment of knee osteoarthritis in the United States. Cartilage. 2016 Aug 10.
21. National Institute for Health and Care Excellence. NICE 2014. Osteoarthritis-Care and management in adults. Published Feb 2014. Clinical guideline CG177. https://www.nice.org.uk/guidance/cg177/evidence/full-guideline-pdf-191761309. Accessed August 2018.
22. Strand V, Baraf H, Lavin P, et. al. Effectiveness and Safety of a Multicenter Extension and Retreatment Trial of Gel-200 in Patients with Knee Osteoarthritis. Cartilage. 2012 Oct; 3(4): 297–304.
23. Gandek B. Measurement properties of the Western Ontario and McMaster Universities Osteoarthritis Index: a systematic review. Arthritis Care Res (Hoboken). 2015 Feb;67(2):216-29. doi: 10.1002/acr.22415.
24. Bannaru RR, Osani MC, Vaysbrot EE, et al. OARSI guidelines for the non-surgical management of knee, hip, and polyarticular osteoarthritis. Osteoarthritis Cartilage. 2019 Jun;27(11):1578-1589. DOI:https://doi.org/10.1016/j.joca.2019.06.011.
25. Kolasinski SL, Neogi T, Hochberg MC, et al. 2019 American College of Rheumatology/Arthritis Foundation Guideline for the Management of Osteoarthritis of the Hand, Hip, and Knee Arthritis Rheumatol. 2020 Feb;72(2):220-233. doi: 10.1002/art.41142. Epub 2020 Jan 6.
26. Sakellariou G, Conaghan PG, Zhang W, et al. EULAR recommendations for the use of imaging in the clinical management of peripheral joint osteoarthritis. Annals of the Rheumatic Diseases 2017;76:1484-1494.
27. National Institute for Health and Care Excellence. NICE 2022. Osteoarthritis in over 16s: diagnosis and management. Published Oct 2022. Clinical guideline NG226. https://www. nice.org.uk/guidance/ng226. Accessed August 2023.
28. Brophy RH, Fillingham YA. AAOS Clinical Practice Guideline Summary: Management of Osteoarthritis of the Knee (Nonarthroplasty), Third Edition. J Am Acad Orthop Surg. 2022 May 1;30(9):e721-e729. doi: 10.5435/JAAOS-D-21-01233.
29. American Academy of Orthopaedic Surgeons Management of Osteoarthritis of the Knee (NonArthroplasty) Evidence-Based Clinical Practice Guideline. https://www.aaos.org/oak3cpg Published August 30, 2021.

30. Palmetto GBA. Local Coverage Article: Billing and Coding: Hyaluronic Acid Injections for Knee Osteoarthritis (A59030). Centers for Medicare & Medicaid Services, Inc. Updated on 01/10/2023 with effective date 01/01/2023. Accessed July 2024.
31. National Government Services, Inc. Local Coverage Article: Billing and Coding: Hyaluronans Intra-articular Injections of (A52420). Centers for Medicare & Medicaid Services, Inc. Updated on 07/23/2021 with effective date 08/01/2021. Accessed July 2024.
32. Wisconsin Physicians Service Insurance Corporation. Local Coverage Article: Billing and Coding: Intraarticular Knee Injections of Hyaluronan (A56157). Centers for Medicare & Medicaid Services, Inc. Updated on 8/23/2022 with effective date 09/01/2022. Accessed July 2024.

Appendix 1 – Covered Diagnosis Codes

Appendix 2 – Centers for Medicare and Medicaid Services (CMS)

The preceding information is intended for non-Medicare coverage determinations. Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determinations (NCDs) and/or Local Coverage Determinations (LCDs) may exist and compliance with these policies is required where applicable. Local Coverage Articles (LCAs) may also exist for claims payment purposes or to clarify benefit eligibility under Part B for drugs which may be self-administered. The following link may be used to search for NCD, LCD, or LCA documents: https://www.cms.gov/medicare-coverage-database/search.aspx. Additional indications, including any preceding information, may be applied at the discretion of the health plan.

Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCA/LCD):