ph-0061
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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™, TriVisc™, VISCO-3™, Triluron™, sodium hyaluronate 1%

Policy Number: PH-0061

Intra-articular

Last Review Date: 04/01/2021

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

 

FOR PEEHIP Members Only -Coverage excludes the provider-administered medication(s) outlined in this drug policy from being accessed through a specialty pharmacy. It must be obtained through buy and bill.

 

  1. Length of Authorization

Coverage will be provided for six months and may be renewed.

  1. Dosing Limits

A.  Quantity Limit (max daily dose) [NDC unit]:

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

Drug

Injections per knee

Injections both knees

Days Supply

Euflexxa 20 mg/2 mL injection

3

6

180

Durolane 60 mg/3 mL injection

1

2

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

Supartz FX 25 mg/2.5 mL injection

5

10

180

Synvisc 16 mg/2 mL injection

3

6

180

Synvisc-One 48 mg/6 mL injection

1

2

180

Trivisc 25 mg/2.5mL injection

3

6

180

VISCO-3 25 mg/2.5 mL injection

3

6

180

Triluron 20 mg/2 mL injection

3

6

180

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

1 mg

60

1

120

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

sodium hyaluronate

J7331

1 dose

1

3

6

Synvisc

J7325

1 mg

16

3

96

Synvisc-One

J7325

1 mg

48

1

96

Trivisc

J7329

1 mg

25

3

150

VISCO-3

J7321

1 dose

1

3

6

Triluron

J7332

1 mg

20

3

120

*Max units are based on administration to both knees

  1. Initial Approval Criteria 1-16,24-26
  • Synvisc, Synvisc One and Orthovisc are the preferred products.
  • All other hyaluronic acid derivatives are not covered.

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
  • 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
  • The patient has had a trial and failure to BOTH of the following conservative methods which has 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 with 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)

FDA Approved Indication(s)

  1. 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
  • The patient shows disease response as indicated 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 previous injections. Examples of unacceptable toxicity include: severe joint swelling and pain, severe infections, anaphylactic or anaphylactoid reactions, etc.
  1. Dosage/Administration (per knee per 180 days)

Drug

Dose

Euflexxa

20 mg intra-articularly once weekly x 3 administrations

Durolane

60 mg intra-articularly x 1 administration

Gel-One

30 mg intra-articularly x 1 administration

GelSyn-3

16.8 mg intra-articularly once weekly x 3 administrations

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

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

Trivisc

25 mg intra-articularly once weekly x 3 administrations

VISCO-3

25 mg intra-articularly once weekly x 3 administrations

Triluron

20 mg intra-articularly once weekly x 3 administrations

  1. Billing Code/Availability Information

HCPCS Code & NDC:

Drug

HCPCS Code

1 Billable Unit

Dose per Injection

Injections (per knee per 180 days)

NDC

Euflexxa

J7323

1 dose

20 mg/2 mL

3

55566-4100-xx

Durolane

J7318

1 mg

60 mg/3 mL

1

89130-2020-xx

Gel-One

J7326

1 dose

30 mg/3 mL

1

87541-0300-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 dose

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

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

Trivisc

J7329

1 mg

25 mg/2.5 mL

3

50563-0006-xx

Visco-3

J7321

1 dose

25mg/2.5 mL

3

87541-0301-xx

Triluron

J7332

1 mg

20 mg/2 mL

3

89122-0879-xx

  1. References
  1. Sodium Hyaluronate 1% [package insert). North Wales, PA; Teva Pharmaceuticals; March 2019. Accessed September 2020.
  2. Supartz/Supartz FX [package insert]. Durham, NC; Bioventus LLC; April 2015. Accessed September 2020.
  3. Hyalgan [package insert]. Parsippany, NJ; Fidia Pharma USA Inc.; May 2014. Accessed September 2020.
  4. Euflexxa [package insert]. Parsippany, NJ; Ferring Pharmaceuticals; July 2016. Accessed September 2020.
  5. Synvisc/Synvisc-One [package insert]. Ridgefield, NJ; Genzyme Biosurgery; September 2014. Accessed September 2020.
  6. Orthovisc [package insert]. Raynham, MA; DePuy Mitek, Inc.; September 2014. Accessed September 2020.
  7. Gel-One [package insert]. Warsaw, IN; Zimmer; May 2011. Accessed September 2020.
  8. Monovisc [package insert]. Raynham, MA; DePuy Mitek, Inc.; February 2014. Accessed September 2020.
  9. GelSyn-3 [package insert]. Durham, NC; Bioventus LLC; February 2016; Accessed September 2020.
  10. GenVisc 850 [package insert]. Doylestown, PA; OrthogenRx, Inc; March 2016; Accessed September 2020.
  11. Hymovis [package insert]. Florham Park, NJ; Fidia Pharma USA Inc.; October 2015. Accessed September 2020.
  12. VISCO-3 [package insert]. Durham, NC; Bioventus LLC; December 2015. Accessed September 2020.
  13. Durolane [package insert]. Durham, NC; Bioventus LLC; September 2017. Accessed September 2020.
  14. Trivisc [package insert]. Doylestown, PA; OrthogenRx, Inc; December 2017. Accessed September 2020.
  15. Synojoynt [package insert]. North Wales, PA; Teva Pharmaceuticals USA, Inc; June 2018. Accessed September 2020.
  16. Triluron [package insert]. Florham Park, NJ; Fidia Pharma USA Inc.; July 2019. Accessed September 2020.
  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.
  19. Brown GA. AAOS clinical practice guideline: treatment of osteoarthritis of the knee: evidence-based guideline, 2nd 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.

  1. 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.
  2. 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.
  3. 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.
  4. 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.
  5. 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.
  6. First Coast Service Options, Inc. Local Coverage Article: Billing and Coding: Viscosupplementation Therapy For Knee (A57256). Centers for Medicare & Medicaid Services, Inc.  Updated on 07/22/2020 with effective date 07/01/2020. Accessed September 2020.
  7. National Government Services, Inc. Local Coverage Article: Billing and Coding: Hyaluronans Intra-articular Injections of (A52420). Centers for Medicare & Medicaid Services, Inc. Updated on 07/24/2020 with effective date 8/1/20120. Accessed September 2020.
  8. 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 7/24/2020 with effective date 7/01/2020. Accessed September 2020.

Appendix 1 – Covered Diagnosis Codes

ICD-10

ICD-10 Description

M17.0

Bilateral primary osteoarthritis of knee

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: http://www.cms.gov/medicare-coverage-database/search/advanced-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/LCD Document (s): A57256

https://www.cms.gov/medicare-coverage-database/search/lcd-date-search.aspx?DocID=L33767&bc=gAAAAAAAAAAAAA==

Jurisdiction(s): 6, K

NCD/LCD Document (s): A52420

https://www.cms.gov/medicare-coverage-database/search/article-date-search.aspx?DocID=A52420&bc=gAAAAAAAAAAAAA==  

Jurisdiction(s): H, L

NCD/LCD Document (s): A55036

https://www.cms.gov/medicare-coverage-database/search/article-date-search.aspx?DocID=A55036&bc=gAAAAAAAAAAAAA==

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

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

 

 

 

 

HYALURONIC ACID DERIVATIVES Prior Auth Criteria
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