ph-0117
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Stelara (ustekinumab)

Policy Number: PH-0117

 

Intravenous/Subcutaneous

 

Last Review Date: 08/04/2020

Date of Origin: 02/15/2011

Dates Reviewed: 03/2011, 06/2011, 09/2011, 12/2011, 03/2012, 06/2012, 09/2012, 03/2013, 06/2013, 09/2013, 11/2013, 12/2013, 03/2014, 06/2014, 09/2014, 12/2014, 03/2015, 06/2015, 09/2015, 12/2015, 03/2016, 06/2016, 9/2016, 10/2016, 11/2016, 03/2017, 06/2017, 09/2017, 10/2017, 03/2018, 06/2018, 10/2018, 10/2019, 12/2019, 07/2020, 08/2020

  1. Length of Authorization

Crohn’s Disease and Ulcerative Colitis:

Coverage will be provided for 8 weeks initially and may be renewed in 6 month intervals thereafter.

All other indications:

Coverage will be provided for 6 months and may be renewed.

  1. Dosing Limits

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

Subcutaneous

  • Stelara 45 mg vial/prefilled syringe:
    • Loading: 1 syringe at weeks 0 & 4
    • Maintenance: 1 syringe every 12  weeks
  • Stelara 90 mg prefilled syringe:
    • Loading: 1 syringe at weeks 0 & 4
  • Maintenance: 1 syringe every 8 weeks

Intravenous

  • Stelara 130 mg (5 mg/mL) single-dose vial: 4 vials

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

Indication

Max Units

Plaque Psoriasis &

Psoriatic Arthritis with co-existent moderate-severe Plaque Psoriasis

Subcutaneous Loading (J3357):

  • 90 billable units at weeks 0 & 4; maintenance dosing 12 weeks later

Subcutaneous Maintenance (J3357):

  • 90 billable units every 12 weeks

Psoriatic Arthritis

Subcutaneous Loading (J3357):

  • 45 billable units at weeks 0 & 4; maintenance dosing 12 weeks later

Subcutaneous Maintenance (J3357):

  • 45 billable units every 12 weeks

Crohn’s Disease & Ulcerative Colitis

Intravenous Induction (J3358):

  • 520 billable units

Subcutaneous Maintenance (J3357):

  • 90 billable units 8 weeks after induction & every 8 weeks thereafter
  1. Initial Approval Criteria 1

If Stelara 90 mg is requested, ONE of the following:

  • The patient has a diagnosis of psoriasis AND weighs >100 kg AND the patient has failed (had an inadequate response to) a trial of 45 mg for at least 3 months; OR
  • The patient has a dual diagnosis of psoriasis AND psoriatic arthritis AND the patient is >100 kg

Coverage is provided in the following conditions:

  • Patient is at least 18 years of age (unless otherwise specified); AND
  • Physician has assessed baseline disease severity utilizing an objective measure/tool; AND
  • Patient is up to date with all vaccinations, in accordance with current vaccination guidelines, prior to initiating therapy; AND

Universal Criteria 1

  • Patient has been evaluated and screened for the presence of latent (tuberculosis) TB infection prior to initiating treatment and will receive ongoing monitoring for presence of TB during treatment; AND
  • Patient does not have an active infection, including clinically important localized infections; AND
  • Therapy will not be administered concurrently with live vaccines; AND
  • Patient is not on concurrent treatment with a TNF-inhibitor, biologic response modifier or other non-biologic agent (i.e., apremilast, tofacitinib, baricitinib); AND

Plaque Psoriasis † 1-5,25,26,30

  • Patient is at least 6 years of age; AND
  • Patient has moderate to severe plaque psoriasis for at least 6 months with at least one of the following:
  • Involvement of at least 3% of body surface area (BSA); OR
  • Psoriasis Area and Severity Index (PASI) score of 10 or greater; OR
  • Incapacitation or serious emotional consequences due to plaque location (i.e. hands, feet, head and neck, or genitalia) or with intractable pruritis; AND
  • Patient did not respond adequately (or is not a candidate) to a 3 month minimum trial of topical agents (i.e., anthralin, coal tar preparations, corticosteroids, emollients, immunosuppressives, keratolytics, retinoic acid derivatives, and/or vitamin D analogues); AND
  • Patient did not respond adequately (or is not a candidate) to a 3 month minimum trial of at least one systemic agent (i.e., immunosuppressives, retinoic acid derivatives, and/or methotrexate); AND
  • Patient did not respond adequately (or is not a candidate*) to a 3 month minimum trial of phototherapy (i.e., psoralens with UVA light [PUVA] or UVB with coal tar or dithranol)

Psoriatic Arthritis (PsA) † 1,6-9,15,16,17,27

  • Patient has documented moderate to severe active disease ; AND
  • For patients with predominantly axial disease OR active enthesitis and/or dactylitis, an adequate trial and failure of at least TWO (2) non-steroidal anti-inflammatory agents (NSAIDs), unless use is contraindicated; OR
  • For patients with peripheral arthritis, a trial and failure of at least a 3 month trial of ONE oral disease-modifying anti-rheumatic agent (DMARD) such as methotrexate, azathioprine, sulfasalazine, or hydroxychloroquine

Crohn’s Disease † 1,10-12,14,18,24

  • Documented moderate to severely active disease; AND
  • Documented failure, contraindication, or ineffective response at maximum tolerated doses to a minimum (3) month trial of corticosteroids or immunomodulators (e.g. azathioprine, 6-mercaptopurine, or methotrexate)

Ulcerative Colitis † 1,13,19-23,29

  • Documented moderate to severely active disease; AND
  • Documented failure, contraindication, or ineffective response at maximum tolerated doses to a minimum (3) month trial of corticosteroids or immunomodulators (e.g. azathioprine, 6-mercaptopurine, or methotrexate)

*Examples of contraindications to phototherapy (PUVA or UVB) include the following: 31,32

  • Xeroderma pigmentosum
  • Pregnancy or lactation (PUVA only)
  • Lupus Erythematosus
  • History of one of the following:  photosensitivity diseases (e.g., chronic actinic dermatitis, solar urticaria), melanoma, non-melanoma skin cancer, treatment with arsenic or ionizing radiation
  • Immunosuppression in an organ transplant patient

FDA Approved Indication(s); Compendia recommended indication(s); Ф Orphan Drug

  1. Renewal Criteria 1

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
  • Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include the following: serious infections, malignancy, severe hypersensitivity reactions, reversible posterior leukoencephalopathy syndrome (RPLS), non-infectious pneumonia, etc; AND

Plaque Psoriasis 15,16

  • Disease response as indicated by improvement in signs and symptoms compared to baseline such as redness, thickness, scaliness, and/or the amount of surface area involvement (a total BSA involvement ≤1%), and/or an improvement on a disease activity scoring tool [e.g. a 75% reduction in the PASI score from when treatment started (PASI 75) or a 50% reduction in the PASI score (PASI 50) and a four-point reduction in the DLQI from when treatment started].

Psoriatic Arthritis (PsA) 14

  • Disease response as indicated by improvement in signs and symptoms compared to baseline such as the number of tender and swollen joint counts and/or an improvement on a disease activity scoring tool [e.g. defined as an improvement in at least 2 of the 4 Psoriatic Arthritis Response Criteria (PsARC), 1 of which must be joint tenderness or swelling score, with no worsening in any of the 4 criteria].

Crohn’s Disease 13

  • Disease response as indicated by improvement in signs and symptoms compared to baseline such as endoscopic activity, number of liquid stools, presence and severity of abdominal pain, presence of abdominal mass, body weight compared to IBW, hematocrit, presence of extra intestinal complications, use of anti-diarrheal drugs, tapering or discontinuation of corticosteroid therapy, and/or an improvement on a disease activity scoring tool [e.g. an improvement on the Crohn’s Disease Activity Index (CDAI) score or the Harvey-Bradshaw Index score].

Ulcerative Colitis 19-23

  • Disease response as indicated by improvement in signs and symptoms compared to baseline such as stool frequency, rectal bleeding, and/or endoscopic activity, tapering or discontinuation of corticosteroid therapy, normalization of C-reactive protein (CRP) or fecal calprotectin (FC), and/or an improvement on a disease activity scoring tool [e.g. an improvement on the Ulcerative Colitis Endoscopic Index of Severity (UCEIS) score or the Mayo Score].
  1. Dosage/Administration

Indication

Dose

Plaque Psoriasis &

Psoriatic Arthritis with co-existent moderate-severe Plaque Psoriasis

Adult Subcutaneous Loading Dose:

  • <100 kg: 45 mg at weeks 0 & 4, then begin maintenance dosing 12 weeks later
  • >100 kg: 90 mg at weeks 0 & 4, then begin maintenance dosing 12 weeks later

Adult Subcutaneous Maintenance Dose:

  • <100 kg: 45 mg every 12 weeks
  • >100 kg: 90 mg every 12 weeks

Pediatric Subcutaneous Loading Dose:

  • <60 kg: 0.75 mg/kg at weeks 0 & 4, then begin maintenance dosing 12 weeks later
  • 60 – 100 kg: 45 mg at weeks 0 & 4, then begin maintenance dosing 12 weeks later
  • >100 kg: 90 mg at weeks 0 & 4, then begin maintenance dosing 12 weeks later

Pediatric Subcutaneous Maintenance Dose:

  • <60 kg: 0.75 mg/kg every 12 weeks
  • 60 – 100 kg: 45 mg every 12 weeks
  • >100 kg: 90 mg every 12 weeks

Psoriatic Arthritis

Subcutaneous Loading Dose:

  • 45 mg at weeks 0 & 4, then begin maintenance dosing 12 weeks later

Subcutaneous Maintenance Dose:

  • 45 mg every 12 weeks

Crohn’s Disease & Ulcerative Colitis

Intravenous Induction Dose (one-time only):

  • ≤ 55 kg: 260 mg
  • > 55 kg to 85 kg: 390 mg
  • > 85 kg: 520 mg

Subcutaneous Maintenance Dose:

  • 90 mg given 8 weeks after the initial IV dose, then every 8 weeks thereafter
  1. Billing Code/Availability Information

HCPCS Code:

  • J3357 – Ustekinumab, for subcutaneous injection, 1 mg; 1 billable unit = 1 mg
  • J3358 – Ustekinumab, for intravenous injection, 1 mg; 1 billable unit = 1 mg

NDC:

  • Subcutaneous
    • Stelara 45 mg single-dose vial (SDV) and prefilled (PF) syringe: 57894-0060-xx
    • Stelara 90 mg prefilled (PF) syringe: 57894-0061-xx
  • Intravenous
    • Stelara 130 mg (5 mg/mL) single-dose vial (SDV): 57894-0054-xx
  1. References
  1. Stelara [package insert]. Horsham, PA; Janssen Biotech, Inc; March 2020. Accessed June 2020.
  2. Leonardi CL, Kimball AB, Papp KA, et al, “Efficacy and Safety of Ustekinumab, a Human Interleukin-12/23 Monoclonal Antibody, in Patients With Psoriasis: 76-Week Results from a Randomised, Double-Blind, Placebo-Controlled Trial (PHOENIX 1),” Lancet, 2008, 371(9625): 1665-74.
  3. Papp KA, Langley RG, Lebwohl M, et al, “Efficacy and Safety of Ustekinumab, a Human Interleukin-12/23 Monoclonal Antibody, in Patients With Psoriasis: 52-Week Results from a Randomised, Double-Blind, Placebo-Controlled Trial (PHOENIX 2),” Lancet, 2008, 371(9625): 1675-84.
  4. Hsu S, Papp KA, Lebwohl MG, et al. Consensus guidelines for the management of plaque psoriasis. Arch Dermatol. 2012 Jan;148(1):95-102.
  5. Papp KA, Griffiths CE, Gordon K, et al. Long-term safety of ustekinumab in patients with moderate-to-severe psoriasis: final results from 5 years of follow-up. Br J Dermatol. 2013 Apr;168(4):844-54.
  6. Menter A, Gottlieb A, Feldman SR, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis: Section 1. Overview of psoriasis and guidelines of care for the treatment of psoriasis with biologics. J Am Acad Dermatol. 2008 May;58(5):826-50. doi: 10.1016/j.jaad.2008.02.039.
  7. Gottlieb A, Korman NJ, Gordon KB, Feldman SR, Lebwohl M, Koo JY, Van Voorhees AS, Elmets CA, Leonardi CL, Beutner KR, Bhushan R, Menter A. Guidelines of care for the management of psoriasis and psoriatic arthritis: Section 2. Psoriatic arthritis: overview and guidelines of care for treatment with an emphasis on the biologics. J Am Acad Dermatol 2008 May;58(5):851-64.
  8. Gossec L, Smolen JS, Ramiro S, et al. European League Against Rheumatism (EULAR) recommendations for the management of psoriatic arthritis with pharmacological therapies: 2015 update. Ann Rheum Dis. 2015 Dec 7. pii: annrheumdis-2015-208337. doi: 10.1136/annrheumdis-2015-208337.
  9. Sing JA, Guyatt G, Ogdie A, et al. 2018 American College of Rheumatology/National Psoriasis Foundation Guideline for the Treatment of Psoriatic Arthritis. Arthritis Care Res, 71: 2-29. doi:10.1002/acr.23789.
  10. Lichtenstein GR, Hanauer SB, Sandborn WJ, Practice Parameters Committee of American College of Gastroenterology. Management of Crohn’s disease in adults. Am J Gastroenterol. 2009;104(2):465.
  11. Terdiman JP, Gruss CB, Heidelbaugh JJ, et al. American Gastroenterological Association Institute guideline on the use of thiopurines, methotrexate, and anti-TNF-α biologic drugs for the induction and maintenance of remission in inflammatory Crohn's disease. Gastroenterology. 2013 Dec;145(6):1459-63. doi: 10.1053/j.gastro.2013.10.047.
  12. Gomollón F, Dignass A, Annese V, et al. EUROPEAN Evidence-based consensus on the diagnosis and management of Crohn's disease 2016: Part 1: Diagnosis and medical management. J Crohns Colitis. 2016 Sep 22. pii: jjw168.
  13. Harbord M, Eliakim R, Bettenworth D, et al. Third European Evidence-based Consensus on Diagnosis and Management of Ulcerative Colitis. Part 2: Current Management. J Crohns Colitis. 2017 Jan 28. doi: 10.1093/ecco-jcc/jjx009.
  14. National Institute for Health and Care Excellence. NICE 2012. Crohn’s Disease: Management. Published 10 October 2012. Clinical Guideline [CG152]. https://www.nice.org.uk/guidance/cg152/resources/crohns-disease-management-pdf-35109627942085.
  15. National Institute for Health and Care Excellence. NICE 2017. Certolizumab pegol and secukinumab for treating active psoriatic arthritis after inadequate response to DMARDs. Published 24 May 2017. Technology Appraisal Guidance [TA445]. https://www.nice.org.uk/guidance/TA445/chapter/1-Recommendations. Accessed August 2017.
  16. National Institute for Health and Care Excellence. NICE 2008. Infliximab for the treatment of adults with psoriasis. Published 23 January 2008. Technology Appraisal Guidance [TA134]. https://www.nice.org.uk/guidance/ta134/resources/infliximab-for-the-treatment-of-adults-with-psoriasis-pdf-82598193811141.
  17. Smith CH, Jabbar-Lopez ZK, Yiu ZK, et al. British Association of Dermatologists guidelines for biologic therapy for psoriasis 2017. Br J Dermatol. 2017 Sep;177(3):628-636. doi: 10.1111/bjd.15665.
  18. Lichtenstein GR, Loftus EV, Isaacs KI, et al. ACG Clinical Guideline: Management of Crohn’s Disease in Adults. Am J Gastroenterol 2018; 113:481–517; doi: 10.1038/ajg.2018.27
  19. Sands BE, Sandborn WJ, Panaccione R,et al. UNIFI Study Group. Ustekinumab as Induction and Maintenance Therapy for Ulcerative Colitis. N Engl J Med. 2019 Sep 26;381(13):1201-1214. doi: 10.1056/NEJMoa1900750.
  20. Lewis JD, Chuai S, Nessel L, et al. Use of the Non-invasive Components of the Mayo Score to Assess Clinical Response in Ulcerative Colitis. Inflamm Bowel Dis. 2008 Dec; 14(12): 1660–1666. doi:  10.1002/ibd.20520
  21. Paine ER. Colonoscopic evaluation in ulcerative colitis. Gastroenterol Rep (Oxf). 2014 Aug; 2(3): 161–168.
  22. Walsh AJ, Bryant RV, Travis SPL. Current best practice for disease activity assessment in IBD. Nature Reviews Gastroenterology & Hepatology  13, 567–579 (2016) doi:10.1038/nrgastro.2016.128
  23. Kornbluth, A, Sachar, DB; Practice Parameters Committee of the American College of Gastroenterology. Ulcerative colitis practice guidelines in adults: American College Of Gastroenterology, Practice Parameters Committee. Am J Gastroenterol. 2010 Mar;105(3):501-23.
  24. Feagan BG, Sandborn WJ, Gasink C, UNITI–IM-UNITI Study Group et al. Ustekinumab as Induction and Maintenance Therapy for Crohn's Disease. N Engl J Med. 2016 Nov 17;375(20):1946-1960.  doi: 10.1056/NEJMoa1602773. 
  25. Leonardi CL, Kimball AB, Papp KA, PHOENIX 1 study investigators.  Efficacy and safety of ustekinumab, a human interleukin-12/23 monoclonal antibody, in patients with psoriasis: 76-week results from a randomised, double-blind, placebo-controlled trial (PHOENIX 1). Lancet. 2008;371(9625):1665.
  26. Papp KA, Langley RG, Lebwohl M, PHOENIX 2 study investigators.  Efficacy and safety of ustekinumab, a human interleukin-12/23 monoclonal antibody, in patients with psoriasis: 52-week results from a randomised, double-blind, placebo-controlled trial (PHOENIX 2). Lancet. 2008;371(9625):1675.
  27. Landells I, Marano C, Hsu MC, et al. Ustekinumab in adolescent patients age 12 to 17 years with moderate-to-severe plaque psoriasis: results of the randomized phase 3 CADMUS study.  J Am Acad Dermatol. 2015;73(4):594.
  28. McInnes IB, Kavanaugh A, Gottlieb AB, PSUMMIT 1 Study Group.  Efficacy and safety of ustekinumab in patients with active psoriatic arthritis: 1 year results of the phase 3, multicentre, double-blind, placebo-controlled PSUMMIT 1 trial. Lancet. 2013;382(9894):780. Epub 2013 Jun 13.
  29. Ritchlin C, Rahman P, Kavanaugh A, PSUMMIT 2 Study Group.  Efficacy and safety of the anti-IL-12/23 p40 monoclonal antibody, ustekinumab, in patients with active psoriatic arthritis despite conventional non-biological and biological anti-tumour necrosis factor therapy: 6-month and 1-year results of the phase 3, multicentre, double-blind, placebo-controlled, randomised PSUMMIT 2 trial. Ann Rheum Dis. 2014;73(6):990. Epub 2014 Jan 30.
  30. Menter A, Strober BE, Kaplan DH, et al. Joint AAD-NPF guidelines of care for the management and treatment of psoriasis with biologics. J Am Acad Dermatol.  2019 Feb 13. pii: S0190-9622(18)33001-9.  https://doi.org/10.1016/j.jaad.2018.11.057.
  31. Richard EG. (2019). Psoralen plus ultraviolet A (PUVA) photochemotherapy. In Elmets CA, Corona R (Eds.), UptoDate. Available from https://www.uptodate.com/contents/psoralen-plus-ultraviolet-a-puva-photochemotherapy?sectionName=Skin%20cancer&search=psoriasis%20phototherapy&topicRef=5666&anchor=H31513976&source=see_link#H2099103.
  32. Honigsman H. (2018). UVB therapy (broadband and narrowband). In Elmets CA, Corona R (Eds.), UptoDate. Available from https://www.uptodate.com/contents/uvb-therapy-broadband-and-narrowband?sectionName=SHORT-%20AND%20LONG-TERM%20ADVERSE%20EFFECTS&search=psoriasis%20phototherapy&topicRef=5666&anchor=H10844620&source=see_link#H10844627.
  33. Noridian Healthcare Solutions, LLC. Local Coverage Articles (LCA): Chemotherapy Administration (A52991). Centers for Medicare & Medicaid Services, Inc. Updated on 12/16/2019 with effective date 1/01/2020. Accessed June 2020.
  34. Noridian Healthcare Solutions, LLC. Local Coverage Articles (LCA): Chemotherapy Administration (A52953). Centers for Medicare & Medicaid Services, Inc. Updated on 12/16/2019 with effective date 1/01/2020. Accessed June 2020.

Appendix 1 – Covered Diagnosis Codes

Subcutaneous (J3357)

ICD-10

ICD-10 Description

K50.00

Crohn’s disease of small intestine without complications

K50.011

Crohn’s disease of small intestine with rectal bleeding

K50.012

Crohn’s disease of small intestine with intestinal obstruction

K50.013

Crohn’s disease of small intestine with fistula

K50.014

Crohn’s disease of small intestine with abscess

K50.018

Crohn’s disease of small intestine with other complication

K50.019

Crohn’s disease of small intestine with unspecified complications

K50.10

Crohn’s disease of large intestine without complications

K50.111

Crohn’s disease of large intestine with rectal bleeding

K50.112

Crohn’s disease of large intestine with intestinal obstruction

K50.113

Crohn’s disease of large intestine with fistula

K50.114

Crohn’s disease of large intestine with abscess

K50.118

Crohn’s disease of large intestine with other complication

K50.119

Crohn’s disease of large intestine with unspecified complications

K50.80

Crohn’s disease of both small and large intestine without complications

K50.811

Crohn’s disease of both small and large intestine with rectal bleeding

K50.812

Crohn’s disease of both small and large intestine with intestinal obstruction

K50.813

Crohn’s disease of both small and large intestine with fistula

K50.814

Crohn’s disease of both small and large intestine with abscess

K50.818

Crohn’s disease of both small and large intestine with other complication

K50.819

Crohn’s disease of both small and large intestine with unspecified complications

K50.90

Crohn’s disease, unspecified, without complications

K50.911

Crohn’s disease, unspecified, with rectal bleeding

K50.912

Crohn’s disease, unspecified, with intestinal obstruction

K50.913

Crohn’s disease, unspecified, with fistula

K50.914

Crohn’s disease, unspecified, with abscess

K50.918

Crohn’s disease, unspecified, with other complication

K50.919

Crohn’s disease, unspecified, with unspecified complications

K51.00

Ulcerative (chronic) pancolitis without complications

K51.011

Ulcerative (chronic) pancolitis with rectal bleeding

K51.012

Ulcerative (chronic) pancolitis with intestinal obstruction

K51.013

Ulcerative (chronic) pancolitis with fistula

K51.014

Ulcerative (chronic) pancolitis with abscess

K51.018

Ulcerative (chronic) pancolitis with other complication

K51.019

Ulcerative (chronic) pancolitis with unspecified complications

K51.20

Ulcerative (chronic) proctitis without complications

K51.211

Ulcerative (chronic) proctitis with rectal bleeding

K51.212

Ulcerative (chronic) proctitis with intestinal obstruction

K51.213

Ulcerative (chronic) proctitis with fistula

K51.214

Ulcerative (chronic) proctitis with abscess

K51.218

Ulcerative (chronic) proctitis with other complication

K51.219

Ulcerative (chronic) proctitis with unspecified complications

K51.30

Ulcerative (chronic) rectosigmoiditis without complications

K51.311

Ulcerative (chronic) rectosigmoiditis with rectal bleeding

K51.312

Ulcerative (chronic) rectosigmoiditis with intestinal obstruction

K51.313

Ulcerative (chronic) rectosigmoiditis with fistula

K51.314

Ulcerative (chronic) rectosigmoiditis with abscess

K51.318

Ulcerative (chronic) rectosigmoiditis with other complication

K51.319

Ulcerative (chronic) rectosigmoiditis with unspecified complications

K51.50

Left sided colitis without complications

K51.511

Left sided colitis with rectal bleeding

K51.512

Left sided colitis with intestinal obstruction

K51.513

Left sided colitis with fistula

K51.514

Left sided colitis with abscess

K51.518

Left sided colitis with other complication

K51.519

Left sided colitis with unspecified complications

K51.80

Other ulcerative colitis without complications

K51.811

Other ulcerative colitis with rectal bleeding

K51.812

Other ulcerative colitis with intestinal obstruction

K51.813

Other ulcerative colitis with fistula

K51.814

Other ulcerative colitis with abscess

K51.818

Other ulcerative colitis with other complication

K51.819

Other ulcerative colitis with unspecified complications

K51.90

Ulcerative colitis, unspecified, without complications

K51.911

Ulcerative colitis, unspecified with rectal bleeding

K51.912

Ulcerative colitis, unspecified with intestinal obstruction

K51.913

Ulcerative colitis, unspecified with fistula

K51.914

Ulcerative colitis, unspecified with abscess

K51.918

Ulcerative colitis, unspecified with other complication

K51.919

Ulcerative colitis, unspecified with unspecified complications

K52.1

Toxic gastroenteritis and colitis

L40.0

Psoriasis vulgaris

L40.50

Arthropathic psoriasis, unspecified

L40.51

Distal interphalangeal psoriatic arthropathy

L40.52

Psoriatic arthritis mutilans

L40.53

Psoriatic spondylitis

L40.59

Other psoriatic arthropathy

R19.7

Diarrhea, unspecified

Intravenous (J3358)

ICD-10

ICD-10 Description

K50.00

Crohn’s disease of small intestine without complications

K50.011

Crohn’s disease of small intestine with rectal bleeding

K50.012

Crohn’s disease of small intestine with intestinal obstruction

K50.013

Crohn’s disease of small intestine with fistula

K50.014

Crohn’s disease of small intestine with abscess

K50.018

Crohn’s disease of small intestine with other complication

K50.019

Crohn’s disease of small intestine with unspecified complications

K50.10

Crohn’s disease of large intestine without complications

K50.111

Crohn’s disease of large intestine with rectal bleeding

K50.112

Crohn’s disease of large intestine with intestinal obstruction

K50.113

Crohn’s disease of large intestine with fistula

K50.114

Crohn’s disease of large intestine with abscess

K50.118

Crohn’s disease of large intestine with other complication

K50.119

Crohn’s disease of large intestine with unspecified complications

K50.80

Crohn’s disease of both small and large intestine without complications

K50.811

Crohn’s disease of both small and large intestine with rectal bleeding

K50.812

Crohn’s disease of both small and large intestine with intestinal obstruction

K50.813

Crohn’s disease of both small and large intestine with fistula

K50.814

Crohn’s disease of both small and large intestine with abscess

K50.818

Crohn’s disease of both small and large intestine with other complication

K50.819

Crohn’s disease of both small and large intestine with unspecified complications

K50.90

Crohn’s disease, unspecified, without complications

K50.911

Crohn’s disease, unspecified, with rectal bleeding

K50.912

Crohn’s disease, unspecified, with intestinal obstruction

K50.913

Crohn’s disease, unspecified, with fistula

K50.914

Crohn’s disease, unspecified, with abscess

K50.918

Crohn’s disease, unspecified, with other complication

K50.919

Crohn’s disease, unspecified, with unspecified complications

K51.00

Ulcerative (chronic) pancolitis without complications

K51.011

Ulcerative (chronic) pancolitis with rectal bleeding

K51.012

Ulcerative (chronic) pancolitis with intestinal obstruction

K51.013

Ulcerative (chronic) pancolitis with fistula

K51.014

Ulcerative (chronic) pancolitis with abscess

K51.018

Ulcerative (chronic) pancolitis with other complication

K51.019

Ulcerative (chronic) pancolitis with unspecified complications

K51.20

Ulcerative (chronic) proctitis without complications

K51.211

Ulcerative (chronic) proctitis with rectal bleeding

K51.212

Ulcerative (chronic) proctitis with intestinal obstruction

K51.213

Ulcerative (chronic) proctitis with fistula

K51.214

Ulcerative (chronic) proctitis with abscess

K51.218

Ulcerative (chronic) proctitis with other complication

K51.219

Ulcerative (chronic) proctitis with unspecified complications

K51.30

Ulcerative (chronic) rectosigmoiditis without complications

K51.311

Ulcerative (chronic) rectosigmoiditis with rectal bleeding

K51.312

Ulcerative (chronic) rectosigmoiditis with intestinal obstruction

K51.313

Ulcerative (chronic) rectosigmoiditis with fistula

K51.314

Ulcerative (chronic) rectosigmoiditis with abscess

K51.318

Ulcerative (chronic) rectosigmoiditis with other complication

K51.319

Ulcerative (chronic) rectosigmoiditis with unspecified complications

K51.50

Left sided colitis without complications

K51.511

Left sided colitis with rectal bleeding

K51.512

Left sided colitis with intestinal obstruction

K51.513

Left sided colitis with fistula

K51.514

Left sided colitis with abscess

K51.518

Left sided colitis with other complication

K51.519

Left sided colitis with unspecified complications

K51.80

Other ulcerative colitis without complications

K51.811

Other ulcerative colitis with rectal bleeding

K51.812

Other ulcerative colitis with intestinal obstruction

K51.813

Other ulcerative colitis with fistula

K51.814

Other ulcerative colitis with abscess

K51.818

Other ulcerative colitis with other complication

K51.819

Other ulcerative colitis with unspecified complications

K51.90

Ulcerative colitis, unspecified, without complications

K51.911

Ulcerative colitis, unspecified with rectal bleeding

K51.912

Ulcerative colitis, unspecified with intestinal obstruction

K51.913

Ulcerative colitis, unspecified with fistula

K51.914

Ulcerative colitis, unspecified with abscess

K51.918

Ulcerative colitis, unspecified with other complication

K51.919

Ulcerative colitis, unspecified with unspecified complications

K52.1

Toxic gastroenteritis and colitis

R19.7

Diarrhea, 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 Determinations (LCDs), and Local Coverage Articles (LCAs) 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/LCA):

J3358

Jurisdiction(s): E

NCD/LCD/LCA Document (s): A52953

https://www.cms.gov/medicare-coverage-database/search/article-date-search.aspx?DocID=A52953&bc=gAAAAAAAAAAA

Jurisdiction(s): F

NCD/LCD/LCA Document (s): A52991

https://www.cms.gov/medicare-coverage-database/search/article-date-search.aspx?DocID=A52991&bc=gAAAAAAAAAAA

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

 

 

 

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