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Local Coverage Determination (LCD)

Infliximab

L35677

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Proposed LCD
Proposed LCDs are works in progress that are available on the Medicare Coverage Database site for public review. Proposed LCDs are not necessarily a reflection of the current policies or practices of the contractor.

Document Note

Note History

Contractor Information

LCD Information

Document Information

Source LCD ID
N/A
LCD ID
L35677
Original ICD-9 LCD ID
Not Applicable
LCD Title
Infliximab
Proposed LCD in Comment Period
N/A
Source Proposed LCD
DL35677
Original Effective Date
For services performed on or after 10/01/2015
Revision Effective Date
For services performed on or after 08/08/2024
Revision Ending Date
N/A
Retirement Date
N/A
Notice Period Start Date
12/22/2016
Notice Period End Date
02/05/2017

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Issue

Issue Description

This LCD outlines limited coverage for this service with specific details under Coverage Indications, Limitations and/or Medical Necessity.
Issue - Explanation of Change Between Proposed LCD and Final LCD

CMS National Coverage Policy

Title XVIII of the Social Security Act 1862(a)(1)(A) allows coverage and payment for only those services that are considered to be medically reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.

CMS Internet-Only Manual, Pub. 100-02, Medicare Benefit Policy Manual, Chapter 1, §30 Drugs and Biologicals, §30.1 Drugs Included in the Drug Compendia, §30.2 Approval by Pharmacy and Drug Therapeutics Committee, §30.3 Combination Drugs, §30.4 Drugs Specially Ordered for Inpatients, §30.5 Drugs for Use Outside the Hospital

CMS Internet-Only Manual, Pub. 100-02, Medicare Benefit Policy Manual, Chapter 15, §50 Drugs and Biologicals, §50.1 Definition of Drug or Biological, §50.4.1 Approved Use of Drug, §50.4.2 Unlabeled Use of Drug, §50.4.3 Examples of Not Reasonable and Necessary, §50.4.5 Off-Label Use of Drugs and Biologicals in an Anti-Cancer Chemotherapeutic Regimen

Coverage Guidance

Coverage Indications, Limitations, and/or Medical Necessity

Infliximab is a chimeric monoclonal antibody that binds specifically to tumor necrosis factor alpha (TNFa) and blocks its activity. Overproduction of TNFa, which is a key inflammatory mediator, leads to inflammation in conditions such as Crohn’s disease, rheumatoid arthritis and other autoimmune diseases.

The use of infliximab will be considered medically reasonable and necessary in the following circumstances:

• To reduce the signs and symptoms and induce and maintain clinical remission in adult and pediatric patients with moderately to severely active Crohn’s disease in patients who have had an inadequate response to conventional therapy (e.g., corticosteroids, aminosalicylates, and immunosuppressive agents).

• To reduce the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure for patients with fistulizing Crohn’s disease. Normally, the patient receives an infusion for this indication at weeks 0, 2 & 6. Subsequent treatments will be covered if the patient responds to the initial treatment as demonstrated by a reduction in signs and symptoms.

• To reduce the signs and symptoms of active arthritis, inhibiting the progression of structural damage and improving physical function, in patients with psoriatic arthritis. Normally, the patient receives an infusion for this indication at weeks 0, 2 & 6. Subsequent treatments will be covered if the patient responds to the initial treatment as demonstrated by a reduction in signs and symptoms.

• When used in combination with methotrexate, to reduce the signs and symptoms, inhibit the progression of structural damage and improve physical function in patients with moderately to severely active rheumatoid arthritis. Normally, the patient receives an infusion of infliximab for this indication at weeks 0, 2 & 6 and then approximately every 8 weeks.

• To reduce the signs and symptoms in patients with active ankylosing spondylitis. Normally the patient receives an infusion for this indication at 0, 2 & 6 weeks. Subsequent treatment will be covered if the patient responds to the initial treatment as demonstrated by a reduction in signs and symptoms.

• For the treatment of adult patients with chronic severe plaque psoriasis (as evidenced by plaques covering at least 10% of the body surface) who have failed prior treatment with psoralen-ultraviolet A (UVA), or ultraviolet B (UVB) light therapy; or are candidates for systemic therapy when other conventional systemic therapies have failed (methotrexate, cyclosporine, Soriatane®); or the patient has contraindications to these treatments. Infliximab should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician. Normally the patient receives an infusion at 0, 2 & 6 weeks and every 8 weeks thereafter.

• To reduce signs and symptoms, achieve clinical remission and mucosal healing, and eliminate corticosteroid use in patients with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy, such as aminosalicylates, corticosteroids, or immunosuppressants (unless the patient is unable to tolerate these drugs). Normally, the patient receives an infusion for this indication at 0, 2 & 6 weeks, and then every 8 weeks thereafter.

• As an off-label use for reactive arthritis and inflammatory bowel disease (e.g., Reiter’s Syndrome who have failed or are intolerant to non-steroidal anti-inflammatory drugs (NSAIDs), methotrexate and sulfasalazine).

• As an off-label use for hidradenitis suppurativa in the treatment of persons with severe disease refractory to systemic antibiotics and surgical treatments.

• As an off-label use for Behçet’s Disease (BD), also known as Behçet’s Syndrome, in patients without an adequate response to initial therapy, for the treatment of clinical manifestations of BD such as severe ocular involvement, major organ involvement, severe gastrointestinal or neurological involvement and resistant cases of joint or mucocutaneous involvement (i.e., painful oral and genital ulcers).

• As an off-label use for patients with chronic pulmonary sarcoidosis who remain symptomatic despite treatment for 3 or more months with steroids (10 mg per day or more) and immunosuppressants (such as azathioprine, cyclophosphamide or methotrexate) or have a contraindication or intolerance to 1 immunosuppressant (such as azathioprine, cyclophosphamide, or methotrexate) and the patient is not receiving infliximab in combination with either of the following: 1) Biologic disease-modifying anti-rheumatic drugs (DMARDs) [e.g., Enbrel® (etanercept), Humira® (adalimumab), Cimzia® (certolizumab), Simponi® (golimumab)] 2) Janus kinase inhibitor [e.g., Xeljanz® (tofacitinib)]. The current and prospective roles of infliximab in the treatment of pulmonary sarcoidosis do not currently have Food and Drug Administration (FDA) approval; therefore, it is recommended that providers consult the literature for proper dosing of infliximab.

Note: For patients, who are unable to tolerate methotrexate or in the rare instance that methotrexate is contraindicated for a patient, treatment with infliximab alone will be covered only if documentation is maintained in the patient’s record that clearly indicates the reason that the patient cannot take methotrexate.

Infliximab will only be covered for the above indications when no contraindications to its use exist including:

                a. Class III or IV congestive heart failure; or

            b. Untreated active or latent tuberculosis


LIMITATIONS

When used in combination with other biologics, such as Enbrel®(etanercept), Kineret® (anakinra), Orencia®(abatacept), Rituxan®(rituximab), Humira®(adalimumab), Cimzia® (certolizumab), Simponi® (golimumab), or a Janus kinase inhibitor [e.g. Xeljanz® (tofacitinib)], infliximab is considered not medically reasonable and necessary and therefore, not covered.
Summary of Evidence

N/A
Analysis of Evidence (Rationale for Determination)

N/A

Proposed Process Information

Synopsis of Changes
Changes Fields Changed
N/A
Associated Information
Sources of Information
Bibliography
Open Meetings
Meeting Date Meeting States Meeting Information
N/A
Contractor Advisory Committee (CAC) Meetings
Meeting Date Meeting States Meeting Information
N/A
MAC Meeting Information URLs
N/A
Proposed LCD Posting Date
Comment Period Start Date
Comment Period End Date
Reason for Proposed LCD
Requestor Information
This request was MAC initiated.
Requestor Name Requestor Letter
View Letter
N/A
Contact for Comments on Proposed LCD

Coding Information

Bill Type Codes

Code Description

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Revenue Codes

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CPT/HCPCS Codes

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N/A

ICD-10-CM Codes that Support Medical Necessity

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Group 1

Group 1 Paragraph:

N/A

 Group 1 Codes:

N/A

N/A

ICD-10-CM Codes that DO NOT Support Medical Necessity

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Group 1

Group 1 Paragraph:

N/A

 Group 1 Codes:

N/A

N/A

Additional ICD-10 Information

General Information

Associated Information

Documentation Requirements

Medical record documentation that is maintained by the performing physician must substantiate the medical necessity for the use of infliximab by clearly indicating the relevant clinical signs and symptoms related to the medical condition for which this drug is indicated. The documentation must also include all prior treatment regimens and the patient’s response to that therapy.

For fistulizing Crohn’s disease, episodic retreatment will be covered if the medical record substantiates that the patient had a reduction in the clinical signs and symptoms of the disease after the initial treatment.

For hidradenitis suppurativa, documentation should include: a listing of other differential diagnoses that have been ruled out and the history of failed antibiotic treatment, prior to the inception of infliximab treatment.

For rheumatoid arthritis, the medical record must clearly indicate:

• the patient is receiving infliximab in combination with methotrexate; or
• the patient is intolerant of methotrexate; or
• the patient has a medical condition that contraindicates the use of methotrexate.

For maintenance therapy, submit documentation of the start date for infliximab, the current status of the patient, their current response to therapy and current dosage.

Documentation must be legible, relevant and sufficient to justify the services billed. This documentation must be made available to the A/B MAC upon request.

Utilization Guidelines

It is expected that these services would be performed as indicated by current medical literature and/or standards of practice. When services are performed in excess of established parameters, they may be subject to review for medical necessity.
Sources of Information
N/A
Bibliography

1. Amin EN, Closser DR, Crouser ED. Current best practice in the management of pulmonary and systemic sarcoidosis. Ther Adv Respir Dis. 2014;8(4):111-132.


2. Baughman RP, Drent M, Kavuru M, et al. Infliximab therapy in patients with chronic sarcoidosis and pulmonary involvement. Am J Respir Crit Care Med. 2006;174(7):795-802.

3. Baughman RP, Lower EE. Medical therapy of sarcoidosis. Semin Respir Crit Care Med. 2014;35(3):391-406.

4. Davey-Ranasinghe N. Behcet Disease. Medscape. 2022. Accessed June 24, 2024. 

5. Doty JD, Mazur JE, Judson MA. Treatment of sarcoidosis with infliximab. Chest Jour. 2005;127(3):1064-1071.

6. Estrach C, Mpofu S, Moots RJ. Behcet's syndrome: Response to infliximab after failure of etanercept. Rheumat. 2002;41(10):1213-14.

7. Fardet L, Dupuy A, Kerob D, et al. Infliximab for severe hidradenitis suppurativa: Transient clinical efficacy in 7 consecutive patients. J Am Acad Dermatol. 2007;56(4):624-628. 

8. Fernandez-Vozmediano JM, Armario-Hita JC. Infliximab for the treatment of hidradenitis suppurativa. Dermatol. 2007;215(1):41-44.

9. Gottlieb AB, Evans R, Li S, et al. Infliximab induction therapy for patients with severe plaque-type psoriasis: A randomized, double blind, placebo-controlled trial. J Am Acad Dermatol. 2004;51(4):534-542.

10. Hoffman GS, Merkel PA, Brasington RD, Lenschow DJ, Liang P. Anti-tumor necrosis factor therapy in patients with difficult to treat Takayasu arteritis. Arthritis Rheum. 2004;50(7):2296-2304.

11. Janssen Biotech, Inc. (1998). REMICADE® (infliximab): Highlights of prescribing information. Horsham, PA: Author. Accessed June 24, 2024.

12. Judson MA, Baughman RP, Costabel U, et al. Efficacy of infliximab in extrapulmonary sarcoidosis: Results from a randomised trial. Eur Respir Jour. 2008;31(6):1189–1196.

13. Keino H, Okada AA, Watanabe T, Taki W. Decreased ocular inflammatory attacks and background retinal and disc vascular leakage in patients with Behcet's disease on infliximab therapy. Br J Opthalmol. 2011;95(9):1245-50.

14. Lipsky PE, Van Der Heijde DM, St Clair EW, et al. Infliximab and methotrexate in the treatment of rheumatoid arthritis. N Engl J Med. 2000;343(22):1594-1602.

15. Molloy ES, Langford CA, Clark TM, Gota CE, Hoffman GS. Anti-tumour necrosis factor therapy in patients with refractory Takayasu arteritis: Long-term follow-up. Ann Rheum Dis. 2008;67(11): 1567-1569.

16. Remicade (infliximab). MedicalNewsToday web site. Accessed June 24, 2024.

17. Roberts SD, Wilkes DS, Burgett RA, Knox KS. Refractory sarcoidosis responding to infliximab. Chest J. 2003;124(5): 2028-2031.

18. Rosi YL, Lowe L, Kang S. Treatment of hidradenitis suppurativa with infliximab in a patient with Crohn’s disease. J Dermatolog Treat. 2005;16(1):58-61.

19. Roussomoustakaki M, Dimoulios P, Chatzicostas C, et al. Hidradenitis suppurativa associated with Crohn's disease and spondyloarthropathy: Response to anti-TNF therapy. J Gastroenterol. 2003;38(10):1000-1004.

20. Rutgeerts P, Feagan BG, Olson A, et al. A randomized placebo-controlled trial of infliximab therapy for active ulcerative colitis: Act I Trial. Gastroenterology. 2005;128:A-105.

21. Rutgeerts P, Sandborn WJ, Feagan BG, et al. Infliximab for induction and maintenance therapy for ulcerative colitis: Act 2 Trial. N Engl J Med. 2005;353(23):2462-76.

22. Saleh S, Ghodsian S, Yakimova V, Henderson J, Sharma OP. Effectiveness of infliximab in treating selected patients with sarcoidosis. Respir Med. 2006;100(11):2053-2059.

23. Sullivan TP, Welsh E, Kerdel FA, Burdick AE, Kirsner RS. Infliximab for hidradenitis suppurativa. Br J Dermatol. 2003;149(5):1046-1049.

24. Van den Bosch F, Kruithof E, Baeten D, et al. Randomized double-blind comparison of chimeric monoclonal antibody to tumor necrosis factor alpha (infliximab) versus placebo in active spondylarthropathy. Arthritis Rheum. 2002:46(3):755-765. 

Revision History Information

Revision History Date Revision History Number Revision History Explanation Reasons for Change
08/08/2024 R30

Under CMS National Coverage Policy updated section headings and the following regulation was removed and placed in the related Billing and Coding: Infliximab A56432 article: CMS Internet-Only Manual, Pub. 100-04, Medicare Claims Processing Manual, Chapter 17, §40 Discarded Drugs and Biologicals. Under Bibliography changes were made to reflect AMA citation guidelines. Formatting, punctuation, and typographical errors were corrected throughout the LCD.
  • Provider Education/Guidance
08/05/2021 R29

Under CMS National Coverage Policy revised and added verbiage. Under Bibliography changes were made to citations to reflect AMA citation guidelines. Formatting, punctuation and typographical errors were corrected throughout the LCD.

  • Provider Education/Guidance
10/31/2019 R28

This LCD is being revised in order to adhere to CMS requirements per chapter 13, section 13.5.1 of the Program Integrity Manual, to remove all coding from LCDs. There has been no change in coverage with this LCD revision. Title XVIII of the Social Security Act 1833(e) prohibits Medicare payment for any claim lacking the necessary documentation to process the claim was removed from the CMS National Coverage Policy section of this LCD and placed in the related Billing and Coding: Infliximab A56432 article.
  • Provider Education/Guidance
04/11/2019 R27

All coding located in the Coding Information section has been moved into the related Billing and Coding: Infliximab A56432 article and removed from the LCD. 

At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.
  • Provider Education/Guidance
02/07/2019 R26

Under Coverage Indications, Limitations and/or Medical Necessity a typographical error in the word “corticosteroids” was corrected. Under Bibliography updated versions of two articles and their URLs and removed FCSO reference LCD number L28890.

At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.
  • Provider Education/Guidance
  • Typographical Error
01/01/2019 R25

Under CPT/HCPCS Codes Group 1: Codes, CPT code Q5109 has been added. This revision is due to the Annual CPT/HCPCS Code Update. Under ICD-10 Codes that Support Medical Necessity Group 1: Codes, the following ICD-10 codes have been added: D86.1, D86.3, D86.81, D86.82, D86.83, D86.84, D86.85, D86.86, D86.87 and D86.89. This revision is due to a reconsideration request.

At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

 
  • Provider Education/Guidance
  • Revisions Due To CPT/HCPCS Code Changes
  • Reconsideration Request
08/06/2018 R24

Under Coverage, Indications, Limitations and/or Medical Necessity deleted the last sentence “See the Limitations for aortic arch syndrome [Takayasu] (ICD-10-CM code M31.4)”. Under Limitations deleted the verbiage in the first paragraph “1. Diagnosis code M31.4 (Aortic arch syndrome [Takayasu]…”. Under ICD-10 Codes that Support Medical Necessity Group 1: Codes added M31.4. Under ICD-10 Codes that Do Not Support Medical Necessity Group 1: Paragraph deleted the verbiage “Diagnosis code M31.4 (Aortic arch syndrome [Takayasu]…”. Under ICD-10 Codes that Do Not Support Medical Necessity Group 1: Codes deleted M31.4. Punctuation was corrected and acronyms were defined throughout the policy as appropriate. Under Bibliography changes were made to reflect AMA citation guidelines.

At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

 
  • Provider Education/Guidance
  • Public Education/Guidance
04/01/2018 R23

Under CPT/HCPCS Group 1: Paragraph the verbiage “Claims for Q5102 must use the appropriate modifier to identify the specific biosimilar used” has been removed and replaced with “The new biosimilar payment policy also makes the use of modifiers that describe the manufacturer of a biosimilar product unnecessary. Therefore, modifiers ZA, ZB, and ZC will be discontinued for dates of service on or after April 1, 2018. However, please note that HCPCS code Q5102 and the requirement to use applicable biosimilar modifiers remain in effect for dates of service prior to April 1, 2018”. Under CPT/HCPCS Group 1: Codes, HCPCS Q5102 has been deleted and replaced with HCPCS codes Q5103 and Q5104. This revision is due to Change Request 10515, Transmittal 3988 and Change Request 10454, Transmittal 3997.
  • Provider Education/Guidance
  • Public Education/Guidance
02/26/2018 R22 The Jurisdiction "J" Part B Contracts for Alabama (10112), Georgia (10212) and Tennessee (10312) are now being serviced by Palmetto GBA. The notice period for this LCD begins on 12/14/17 and ends on 02/25/18. Effective 02/26/18, these three contract numbers are being added to this LCD. No coverage, coding or other substantive changes (beyond the addition of the 3 Part B contract numbers) have been completed in this revision.
  • Change in Affiliated Contract Numbers
01/29/2018 R21 The Jurisdiction "J" Part A Contracts for Alabama (10111), Georgia (10211) and Tennessee (10311) are now being serviced by Palmetto GBA. The notice period for this LCD begins on 12/14/17 and ends on 01/28/18. Effective 01/29/18, these three contract numbers are being added to this LCD. No coverage, coding or other substantive changes (beyond the addition of the 3 Part A contract numbers) have been completed in this revision.
  • Change in Affiliated Contract Numbers
11/09/2017 R20

 Under LCD Title removed the wording “Remicade®” and under Coverage Indications, Limitations and/or Medical Necessity removed all wording titled “Remicade®”.

 

At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

 
  • Provider Education/Guidance
  • Public Education/Guidance
10/26/2017 R19

 

Under CPT/HCPCS Codes Group 1: Paragraph added Note: Claims for Q5102 must use the appropriate modifier to identify the specific biosimilar used. This revision was due to Change Request 10234, Transmittal 3850.

 
  • Provider Education/Guidance
  • Public Education/Guidance
09/21/2017 R18

Under Associated Information-Documentation Requirements added verbiage related to documentation requirements for maintenance therapy.
  • Provider Education/Guidance
  • Other
09/04/2017 R17

Under CPT/HCPCS Codes Group 1: Paragraph deleted the verbiage “Effective for dates of service on or after April 5, 2016 claims for Q5102 must use the ZB (Pfizer/hospira) modifier (Q5102ZB)”. Under ICD-10 Codes that do not Support Medical Necessity Group 1: Paragraph revised the verbiage to read “Diagnosis code M31.4 (Aortic arch syndrome [Takayasu]) is not a covered diagnosis given its use has not been demonstrated to be a standard of care and claims can be denied as not medically reasonable and necessary. In rare cases consideration may be given for coverage of diagnosis code M31.4 (Aortic arch syndrome [Takayasu]) when used as a third line therapy when other immunosuppressive therapies have failed. Supporting documentation will be required”.

 At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

 
  • Provider Education/Guidance
09/04/2017 R16

Under CMS National Coverage Policy Title XVIII of the Social Security Act, §1862(a)(1)(A) revised the verbiage to read “allows coverage and payment for only those services that are considered to be medically reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member”. Under ICD-10 Codes that Support Medical Necessity added M06.9 and D86.9.Under Sources of Information and Basis for Decision added and corrected author’s initials and names, added volume numbers and corrected capitalization for numerous journal titles.


 

 

 
  • Provider Education/Guidance
  • Typographical Error
02/06/2017 R15 Updated to include all revisions made under Revision 12 and 13 as the changes did not hold when this LCD was moved from comment to notice under Revision 14.
  • Provider Education/Guidance
02/06/2017 R14 No comments were received from the provider community; therefore, no revisions were made.
  • Provider Education/Guidance
01/01/2017 R13 Under CPT/HCPCS Codes the description was revised for CPT code J1745. This revision is due to the 2017 Annual CPT/HCPCS Code Update and becomes effective 1/1/17.
  • Provider Education/Guidance
  • Revisions Due To CPT/HCPCS Code Changes
10/06/2016 R12 Under CMS National Coverage Policy for Title XVIII of the Social Security Act, §1862(a)(1)(A) revised the verbiage to read “allows coverage and payment for only those services that are considered to be medically reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member”. For Title XVIII of the Social Security Act, §1833(e) revised the verbiage to read “prohibits Medicare payment for any claim lacking the necessary information to process that claim”. Under Sources of Information and Basis for Decision added author’s initials and names, added volume numbers and corrected capitalization for numerous journal titles.
  • Provider Education/Guidance
  • Typographical Error
08/22/2016 R11 Under CPT/HCPCS Codes Group 1: Paragraph added Note: Effective for dates of service on or after April 5, 2016 claims for Q5102 must use the ZB (Pfizer/hospira) modifier (Q5102ZB). Under CPT/HCPCS Codes Group 1: Codes added HCPCS code Q5102. Please refer to Change Request (CR) 9658 dated June 28, 2016.
  • Provider Education/Guidance
  • Revisions Due To CPT/HCPCS Code Changes
02/19/2016 R10 Under ICD-10 Codes that Support Medical Necessity added K50.00, K50.011, K50.012, K50.013, K50.014, K50.018, K50.019.
  • Provider Education/Guidance
  • Public Education/Guidance
  • Request for Coverage by a Practitioner (Part B)
01/03/2016 R9 Under Coverage Indications, Limitations and /or Medical Necessity added coverage for Behcet’s Disease as follows “As an off-label use for Behçet’s Disease (BD), also known as Behçet’s Syndrome, in patients without an adequate response to initial therapy, for the treatment of clinical manifestations of BD such as severe ocular involvement, major organ involvement, severe gastrointestinal or neurological involvement and resistant cases of joint or mucocutaneous involvement (i.e., painful oral and genital ulcers).”
Under ICD-10 Codes that Support Medical Necessity added Behcet’s Disease coverage M35.2.
Under Sources of Information and Basis for Decision added reference to F. Alnaimat’s Behcet Disease Treatment & Management, Keino, Okada and Watanabe’s Decreased ocular inflammatory attacks and background retinal and disc vascular leakage in patients with Behcet's disease on infliximab therapy, and Estrach C Mpofu S and Moots RJ Behcets Syndrome: response to infliximab after failure of etanercept.
  • Provider Education/Guidance
  • Public Education/Guidance
  • Request for Coverage by a Provider (Part A)
  • Reconsideration Request
10/16/2015 R8 Under Coverage Indications, Limitations and/or Medical Necessity made a few grammatical and punctuation corrections. In the paragraph for Reiter’s syndrome, moved the word “arthritis” to follow the word Reactive to make sentence read… Reactive arthritis and Inflammatory Bowel Disease… Added the statement “As an off-label use for” in the paragraph for pulmonary sarcoidosis.
  • Typographical Error
  • Other (Annual validation)
10/01/2015 R7 Under Coverage Indications, Limitations and/or Medical Necessity added the following language: As an off-label use for hidradenitis suppurativa in the treatments of persons with severe disease refractory to systemic antibiotics and surgical treatments.
Under ICD-10 codes that support Medical Necessity added L73.2.
Under Associated Information in documentation requirements added the following language: For hidradenitis suppurativa documentation should include: a listing of other differential diagnoses that have been ruled out and the history of failed antibiotic treatment prior to the inception of infliximab treatment.
Under Sources of Information and Basis for Decision added citations for Sullivan, Welsh, Kerdel, et al; Fardet, Dupuy, Kerob, et al; Rosi, Lowe, Kang; roussomoustakaki, Dimoulios, Chatzicostas, et al; and Fernandez-ozmediano, Armario-Hita as references for hidradenitis suppurativa.
  • Provider Education/Guidance
  • Request for Coverage by a Provider (Part A)
  • Reconsideration Request
10/01/2015 R6 Per CMS Internet-Only Manual, Pub 100-08, Medicare Program Integrity Manual, Chapter 13, §13.1.3 LCDs consist of only “reasonable and necessary” information. All bill type and revenue codes have been removed.
  • Other (Bill type and/or revenue code removal)
10/01/2015 R5 Under CMS National Coverage Policy separated Pub 100-02 Chapter 1 and Chapter 15 into individual citations.
Under Coverage Indications, Limitations and/or Medical Necessity inserted coverage criteria for chronic pulmonary sarcoidosis: “Patients with chronic pulmonary sarcoidosis who remain symptomatic despite treatment for 3 or more months with steroids (10 mg per day or more) and immunosuppressants (such as azathioprine, cyclophosphamide, or methotrexate) or have a contraindication or intolerance to one immunosuppressant (such as azathioprine, cyclophosphamide, or methotrexate) and the patient is not receiving infliximab in combination with either of the following: 1) Biologic DMARD [e.g., Enbrel (etanercept), Humira (adalimumab), Cimzia (certolizumab), Simponi (golimumab)] 2) Janus kinase inhibitor [e.g., Xeljanz (tofacitinib)]. The current and prospective roles of infliximab in the treatment of pulmonary sarcoidosis do not currently have FDA approval; therefore, it is recommended that providers consult the literature for proper dosing of infliximab.” Under Limitations corrected the second paragraph to read “When used in combination with other biologics such as Enbrel®(etanercept), Kineret® (anakinra), Orencia®(abatacept), Rituxan®(rituximab), Humira®(adalimumab), Cimzia® (certolizumab), Simponi® (golimumab), or a Janus kinase inhibitor [e.g. Xeljanz® (tofacitinib)], Remicade© (Infliximab) is considered not medically reasonable and necessary and therefore not covered.”
Under ICD-10 Codes that Support Medical Necessity added ICD-10 codes D86.0 and D86.2 for coverage of pulmonary sarcoidosis.
Under Sources of Information and Basis for Decision added citations for Amin E, Closser D, Crouser E. Therapeutic Advances in Respiratory Disease; Baughman R, Lower E. Medical Therapy of Sarcoidosis; Judson MA, Baughman RP, et al. Efficacy of infliximab in extrapulmonary sarcoidosis: results from a randomized trial; Baughman R, Drent M, Kavuru M, et al. Infliximab Therapy in Patients with Chronic Sarcoidosis and Pulmonary Involvement; Doty J, Mazur J, Judson M. Treatment of Sarcoidosis With Infliximab; Saleh S, Ghodsian S, Yakimova V. et al. Effectiveness of infliximab in treating selected patients with sarcoidosis; and Roberts S, Wilkes D, Burgett R, et al. Refractory Sarcoidosis Responding to Infliximab. Citations were removed for package inserts 1999-2002, 2005 and 2006 and added for package insert 2013. All sources corrected to AMA formatting.
  • Reconsideration Request
10/01/2015 R4 Under Bill Type Codes added TOB 023X.
  • Provider Education/Guidance
10/01/2015 R3 Under Revision History Explanation Corrected the formatting of the Medical News Today source to correctly open hyperlink.
  • Typographical Error
10/01/2015 R2 In ICD-10 Codes that Support Medical Necessity corrected ICD-10 Code K50.012 to read correctly as K51.012.
  • Typographical Error
10/01/2015 R1 Removed Notice Period Dates as they were inadvertently placed in ICD-10 version. In ICD-10 Codes that support medical necessity broke out all code ranges in policy to show individual codes.
  • Provider Education/Guidance
  • Other (Removed all codes ranges.)
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Keywords

  • Infliximab
  • Biosimilar

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