ph-0061
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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: 03/03/2020

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

  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

Synojoynt 20 mg/2 mL injection

3

6

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

J3490

1 dose

1

3

6

Synojoynt

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 J7333**

1 dose

1

3

6

Triluron

J7332

1 mg

20

3

120

*Max units are based on administration to both knees

**Effective 07/01/2020

  1. Initial Approval Criteria

Synvisc/Synvisc One are the preferred products.

  • The patient must have a documented intolerance, FDA labeled contraindication, or hypersensitivity to the preferred agents in order to receive Euflexxa.
  • All other hyaluronic acid derivatives are not covered.

Coverage is provided in the following conditions:

Osteoarthritis of the knee †

  • Documented symptomatic osteoarthritis of the knee; AND
  • Trial and failure of conservative therapy (including physical therapy, pharmacotherapy [e.g., non-steroidal anti-inflammatory drugs (NSAIDs), acetaminophen (up to 1 g 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
  • 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
  • The patient reports pain which interferes with functional activities (e.g., ambulation, prolonged standing); AND
  • There are no contraindications to the injections (e.g., active joint infection, bleeding disorder)

FDA Approved Indication(s)

  1. Renewal Criteria

Coverage can be renewed based upon the following criteria:

  • 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
  • The medical record objectively documents significant improvement in pain and functional capacity as the result of the previous injections; 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

Synojoynt

20 mg intra-articularly once weekly x 3 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

J3490

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

Synojoynt

J7331

1 dose

20 mg/2 mL

3

N/A

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

J7333*

1 dose

25mg/2.5 mL

3

87541-0301-xx

Triluron

J7332

1 mg

20 mg/2 mL

3

89122-0879-xx

* Effective 07/01/2020

  1. References
  1. Sodium Hyaluronate 1% [package insert). North Wales, PA; Teva Pharmaceuticals; March 2019. Accessed September 2019.
  2. Supartz/Supartz FX [package insert]. Durham, NC; Bioventus LLC; April 2015. Accessed June 2019.
  3. Hyalgan [package insert]. Parsippany, NJ; Fidia Pharma USA Inc.; May 2014. Accessed June 2019.
  4. Euflexxa [package insert]. Parsippany, NJ; Ferring Pharmaceuticals; July 2016. Accessed June 2019.
  5. Synvisc/Synvisc-One [package insert]. Ridgefield, NJ; Genzyme Biosurgery; September 2014. Accessed June 2019.
  6. Orthovisc [package insert]. Raynham, MA; DePuy Mitek, Inc.; September 2014. Accessed June 2019.
  7. Gel-One [package insert]. Warsaw, IN; Zimmer; May 2011. Accessed August 2018.
  8. Monovisc [package insert]. Raynham, MA; DePuy Mitek, Inc.; February 2014. Accessed June 2019.
  9. GelSyn-3 [package insert]. Durham, NC; Bioventus LLC; February 2016; Accessed June 2019.
  10. GenVisc 850 [package insert]. Doylestown, PA; OrthogenRx, Inc; March 2016; Accessed June 2019.
  11. Hymovis [package insert]. Florham Park, NJ; Fidia Pharma USA Inc.; October 2015. Accessed June 2019.
  12. VISCO-3 [package insert]. Durham, NC; Bioventus LLC; December 2015. Accessed June 2019.
  13. Durolane [package insert]. Durham, NC; Bioventus LLC; September 2017. Accessed June 2019.
  14. Trivisc [package insert]. Doylestown, PA; OrthogenRx, Inc; November 2017. Accessed June 2019.
  15. Synojoynt [package insert]. North Wales, PA; Teva Pharmaceuticals USA, Inc; June 2018. Accessed June 2019.
  16. Triluron [package insert]. Florham Park, NJ; Fidia Pharma USA Inc.; March 2019. Accessed February 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.
  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. Novitas Solutions, Inc. Local Coverage Determination (LCD): Hyaluronan Acid Therapies for Osteoarthritis of the Knee (DL35427). Centers for Medicare & Medicaid Services, Inc.  Updated on (proposed draft) with effective date (proposed draft). Accessed June 2019.
  25. Palmetto GBA. Local Coverage Determination (LCD): Hyaluronate Polymers (L33432).  Centers for Medicare & Medicaid Services, Inc. Updated on 12/13/2018 with effective date 01/1/2019. Accessed June 2019.
  26. First Coast Service Options, Inc. Local Coverage Determination (LCD): Viscosupplementation Therapy for Knee (L33767). Centers for Medicare & Medicaid Services, Inc.  Updated on 02/01/2019 with effective date 01/08/2019. Accessed June 2019.
  27. National Government Services, Inc. Local Coverage Article: Hyaluronans (e.g. Hyalgan ®, Supartz ®, Euflexxa™, Synvisc ®, Synvisc-One™, Orthovisc ®, Gel-One® ), Intra-articular Injections of - Related to LCD L33394 (A52420). Centers for Medicare & Medicaid Services, Inc. Updated on 12/19/2018 with effective date 1/1/2019. Accessed June 2019.
  28. Novitas Solutions, Inc. Local Coverage Article: HYALURONAN Acid Therapies for Osteoarthritis of the Knee- Related to LCD L35427 (A55036). Centers for Medicare & Medicaid Services, Inc. Updated on 3/29/2019 with effective date 5/20/2019. Accessed June 2019.

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) 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/LCD):

Jurisdiction(s): L, H

NCD/LCD Document (s): L35427

https://www.cms.gov/medicare-coverage-database/search/lcd-date-search.aspx?DocID=L35427&bc=gAAAAAAAAAAAAA==

Jurisdiction(s): J, M

NCD/LCD Document (s): L33432

https://www.cms.gov/medicare-coverage-database/search/lcd-date-search.aspx?DocID=L33432&bc=gAAAAAAAAAAAAA==

Jurisdiction(s): N

NCD/LCD Document (s): L33767

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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