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Hyaluronic Acid Derivatives:
Durolane®, Euflexxa™, Gel-One®, GelSyn-3™, GenVisc 850®,
Hyalgan™, Hymovis®, Monovisc®, Orthovisc™,
Supartz/Supartz FX™, Synojoynt, Synvisc™, Synvisc-One™,
Triluron™, TriVisc™, VISCO-3™, & sodium hyaluronate 1%
(Intra-articular)
Document Number: OHSU HEALTHSERVICES-0061
Last Review Date: 02/01/2022
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
I. Length of Authorization
Coverage will be provided for six months and may be renewed.
II. Dosing Limits
A. 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
sodium hyaluronate 20 mg/2 mL injection
3
6
180
Supartz 25 mg/2.5 mL injection
5
10
180
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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
B. Max Units (per dose and over time) [HCPCS Unit]:*
Drug
HCPCS
1 Billable
Unit (BU)
BU per
Admin
Max Units
(per 180
days)*
Durolane
J7318
1 mg
60
120
Euflexxa
J7323
1 dose
1
6
Gel-One
J7326
1 dose
1
2
GelSyn-3
J7328
0.1 mg
168
1008
GenVisc 850
J7320
1 mg
25
250
Hyalgan; Supartz;
Supartz FX
J7321
1 dose
1
10
Hymovis
J7322
1 mg
24
96
Monovisc
J7327
1 dose
1
2
Orthovisc
J7324
1 dose
1
8
sodium hyaluronate
J7331
1 mg
20
120
Synojoynt
J7331
1 mg
20
120
Synvisc
J7325
1 mg
16
96
Synvisc-One
J7325
1 mg
48
96
Triluron
J7332
1 mg
20
120
Trivisc
J7329
1 mg
25
150
VISCO-3
J7321
1 dose
1
6
*Max units are based on administration to both knees
III. Initial Approval Criteria
Coverage is provided in the following conditions:
Universal Criteria
1-16,24-26
• Patient does not have any conditions which would preclude intra-articular injections (e.g., active
joint infection, unstable joint, bleeding disorders, etc.); AND
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• 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 †
• Documented symptomatic osteoarthritis of the knee; AND
• Trial and failure of conservative therapy (including physical therapy AND pharmacotherapy [e.g.,
non-steroidal anti-inflammatory drugs (NSAIDs), acetaminophen (up to 1g 4 times/day) and/or
topical capsaicin cream]) has been attempted and has not resulted in functional improvement
after at least 3 months; 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)
• Patient must try and have an inadequate response, contraindication, or intolerance to Euflexxa
† FDA Approved Indication(s)
IV. Renewal Criteria
1-16,24-26
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 the
following: severe joint swelling and pain, severe infections, anaphylactic or anaphylactoid
reactions, etc.
• Patient must try and have an inadequate response, contraindication, or intolerance to Euflexxa
V. Dosage/Administration (per knee per 180 days)
Drug
Dose
Durolane
60 mg intra-articularly x 1 administration
Euflexxa
20 mg intra-articularly once weekly x 3 administrations
Gel-One
30 mg intra-articularly x 1 administration
GelSyn-3
16.8 mg intra-articularly once weekly x 3 administrations
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GenVisc 850
25 mg intra-articularly once weekly x 5 administrations
Hyalgan
20 mg intra-articularly once weekly x 5 administrations
Hymovis
24 mg intra-articularly once weekly x 2 administrations
Monovisc
88 mg intra-articularly x 1 administration
Orthovisc
30 mg intra-articularly once weekly x 4 administrations
sodium hyaluronate
20 mg intra-articularly once weekly x 3 administrations
Synojoynt
20 mg intra-articularly once weekly x 3 administrations
Supartz/Supartz FX
25 mg intra-articularly once weekly x 5 administrations
Synvisc
16 mg intra-articularly once weekly x 3 administrations
Synvisc-One
48 mg intra-articularly x 1 administration
Triluron
20 mg intra-articularly once weekly x 3 administrations
Trivisc
25 mg intra-articularly once weekly x 3 administrations
VISCO-3
25 mg intra-articularly once weekly x 3 administrations
VI. Billing Code/Availability Information
HCPCS Code & NDC:
Drug
HCPCS
Code
1 Billable
Unit
Dose per
Injection
Injections (per
knee per 180 days)
NDC
Durolane
J7318
1 mg
60 mg/3 mL
1
89130-2020-xx
Euflexxa
J7323
1 dose
20 mg/2 mL
3
55566-4100-xx
Gel-One
J7326
1 dose
30 mg/3 mL
1
50016-0957-xx
GelSyn-3
J7328
0.1 mg
16.8 mg/2 mL
3
89130-3111-xx
GenVisc 850
J7320
1 mg
25mg/2.5 ml
5
50653-0006-xx
Hyalgan
J7321
1 dose
20 mg/2 mL
5
89122-0724-xx
Hymovis
J7322
1 mg
24 mg/3 mL
2
89122-0496-xx
Monovisc
J7327
1 dose
88 mg/4 mL
1
59676-0820-xx
Orthovisc
J7324
1 dose
30 mg/2 mL
4
59676-0360-xx
sodium hyaluronate
J7331
1 mg
20 mg/2 mL
3
57844-0181-xx
Supartz
J7321
1 dose
25 mg/2.5 mL
5
89130-5555-xx
Supartz FX
J7321
1 dose
25 mg/2.5 mL
5
89130-4444-xx
Synojoynt
J7331
1 mg
20 mg/2 mL
3
82197-0721-xx
Synvisc
J7325
1 mg
16 mg/2 mL
3
58468-0090-xx
Synvisc-One
J7325
1 mg
48 mg/6 mL
1
58468-0090-xx
Triluron
J7332
1 mg
20 mg/2 mL
3
89122-0879-xx
Trivisc
J7329
1 mg
25 mg/2.5 mL
3
50563-0006-xx
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Visco-3
J7321
1 dose
25mg/2.5 mL
3
50016-0957-xx
VII. References
1. Sodium Hyaluronate 1% [package insert). North Wales, PA; Teva Pharmaceuticals; March 2019.
Accessed September 2021.
2. Supartz/Supartz FX [package insert]. Durham, NC; Bioventus LLC; April 2015. Accessed
September 2021.
3. Hyalgan [package insert]. Parsippany, NJ; Fidia Pharma USA Inc.; May 2014. Accessed September
2021.
4. Euflexxa [package insert]. Parsippany, NJ; Ferring Pharmaceuticals; July 2016. Accessed
September 2021.
5. Synvisc/Synvisc-One [package insert]. Ridgefield, NJ; Genzyme Biosurgery; September 2014.
Accessed September 2021.
6. Orthovisc [package insert]. Raynham, MA; DePuy Mitek, Inc.; September 2014. Accessed
September 2021.
7. Gel-One [package insert]. Warsaw, IN; Zimmer; May 2011. Accessed September 2021.
8. Monovisc [package insert]. Raynham, MA; DePuy Mitek, Inc.; February 2014. Accessed
September 2021.
9. GelSyn-3 [package insert]. Durham, NC; Bioventus LLC; December 2017; Accessed September
2021.
10. GenVisc 850 [package insert]. Doylestown, PA; OrthogenRx, Inc; November 2019; Accessed
September 2021.
11. Hymovis [package insert]. Florham Park, NJ; Fidia Pharma USA Inc.; September 2017. Accessed
September 2021.
12. VISCO-3 [package insert]. Durham, NC; Bioventus LLC; December 2015. Accessed September
2021.
13. Durolane [package insert]. Durham, NC; Bioventus LLC; September 2017. Accessed September
2021.
14. Trivisc [package insert]. Doylestown, PA; OrthogenRx, Inc; December 2017. Accessed September
2021.
15. Triluron [package insert]. Florham Park, NJ; Fidia Pharma USA Inc.; July 2019. Accessed
September 2021.
16. Synojoynt [package insert]. Naples, FL; Arthrex, Inc.; January 2022. Accessed January 2022.
17. 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.
18. 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.
OHSU Health Services ohsu.edu/healthshare Page | 6
19. 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.
20. 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.
21. 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.
22. 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.
23. 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.
24. American College of Rheumatology. Western Ontario & McMaster Universities Osteoarthritis
Index (WOMAC). Rheumatology.org. https://www.rheumatology.org/i-am-
a/rheumatologist/research/clinician-researchers/western-ontario-mcmaster-universities-
osteoarthritis-index-womac. Published 2015.
25. 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.
26. 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.
27. First Coast Service Options, Inc. Local Coverage Article: Billing and Coding: Viscosupplementation
Therapy For Knee (A57256). Centers for Medicare & Medicaid Services, Inc. Updated on
04/16/2021 with effective date 04/01/2021. Accessed September 2021.
28. 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 September 2021.
29. Novitas Solutions, Inc. Local Coverage Article: Billing and Coding: Hyaluronan Acid Therapies for
Osteoarthritis of the Knee (A55036). Centers for Medicare & Medicaid Services, Inc. Updated on
04/16/2021 with effective date 04/01/2021. Accessed September 2021.
Appendix 1 – Covered Diagnosis Codes
ICD-10
ICD-10 Description
M17.0
Bilateral primary osteoarthritis of knee
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M17.10
Unilateral primary osteoarthritis, unspecified knee
M17.11
Unilateral primary osteoarthritis, right knee
M17.12
Unilateral primary osteoarthritis, left knee
M17.2
Bilateral post-traumatic osteoarthritis of knee
M17.30
Unilateral post-traumatic osteoarthritis, unspecified knee
M17.31
Unilateral post-traumatic osteoarthritis, right knee
M17.32
Unilateral post-traumatic osteoarthritis, left knee
M17.4
Other bilateral secondary osteoarthritis of knee
M17.5
Other unilateral secondary osteoarthritis of knee
M17.9
Osteoarthritis of knee, unspecified
Appendix 2 – Centers for Medicare and Medicaid Services (CMS)
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 Determination (NCD),
Local Coverage Articles (LCAs), and Local Coverage Determinations (LCDs) may exist and compliance
with these policies is required where applicable. They can be found at: https://www.cms.gov/medicare-
coverage-database/search.aspx. Additional indications may be covered at the discretion of the health
plan.
Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCA/LCD):
Jurisdiction(s): N
NCD/LCA/LCD Document (s): A57256
https://www.cms.gov/medicare-coverage-database/new-search/search-
results.aspx?keyword=a57256&areaId=all&docType=NCA%2CCAL%2CNCD%2CMEDCAC%2CTA%2CMC
D%2C6%2C3%2C5%2C1%2CF%2CP
Jurisdiction(s): 6, K
NCD/LCA/LCD Document (s): A52420
https://www.cms.gov/medicare-coverage-database/new-search/search-
results.aspx?keyword=a52420&areaId=all&docType=NCA%2CCAL%2CNCD%2CMEDCAC%2CTA%2CMC
D%2C6%2C3%2C5%2C1%2CF%2CP
Jurisdiction(s): H, L
NCD/LCA/LCD Document (s): A55036
https://www.cms.gov/medicare-coverage-database/new-search/search-
results.aspx?keyword=a55036&areaId=all&docType=NCA%2CCAL%2CNCD%2CMEDCAC%2CTA%2CMC
D%2C6%2C3%2C5%2C1%2CF%2CP
Medicare Part B Administrative Contractor (MAC) Jurisdictions
Jurisdiction
Applicable State/US Territory
Contractor
E (1)
CA, HI, NV, AS, GU, CNMI
Noridian Healthcare Solutions, LLC
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Medicare Part B Administrative Contractor (MAC) Jurisdictions
Jurisdiction
Applicable State/US Territory
Contractor
F (2 & 3)
AK, WA, OR, ID, ND, SD, MT, WY, UT, AZ
Noridian Healthcare Solutions, LLC
5
KS, NE, IA, MO
Wisconsin Physicians Service Insurance Corp (WPS)
6
MN, WI, IL
National Government Services, Inc. (NGS)
H (4 & 7)
LA, AR, MS, TX, OK, CO, NM
Novitas Solutions, Inc.
8
MI, IN
Wisconsin Physicians Service Insurance Corp (WPS)
N (9)
FL, PR, VI
First Coast Service Options, Inc.
J (10)
TN, GA, AL
Palmetto GBA, LLC
M (11)
NC, SC, WV, VA (excluding below)
Palmetto GBA, LLC
L (12)
DE, MD, PA, NJ, DC (includes Arlington & Fairfax
counties and the city of Alexandria in VA)
Novitas Solutions, Inc.
K (13 & 14)
NY, CT, MA, RI, VT, ME, NH
National Government Services, Inc. (NGS)
15
KY, OH
CGS Administrators, LLC