08/05/2021
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R29
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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.
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- Provider Education/Guidance
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10/31/2019
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R28
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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.
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- Provider Education/Guidance
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04/11/2019
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R27
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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.
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- Provider Education/Guidance
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02/07/2019
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R26
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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.
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- Provider Education/Guidance
- Typographical Error
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01/01/2019
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R25
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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.
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- Provider Education/Guidance
- Revisions Due To CPT/HCPCS Code Changes
- Reconsideration Request
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08/06/2018
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R24
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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.
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- Provider Education/Guidance
- Public Education/Guidance
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04/01/2018
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R23
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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.
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- Provider Education/Guidance
- Public Education/Guidance
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02/26/2018
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R22
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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.
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- Change in Affiliated Contract Numbers
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01/29/2018
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R21
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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.
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- Change in Affiliated Contract Numbers
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11/09/2017
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R20
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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.
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- Provider Education/Guidance
- Public Education/Guidance
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10/26/2017
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R19
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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.
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- Provider Education/Guidance
- Public Education/Guidance
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09/21/2017
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R18
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Under Associated Information-Documentation Requirements added verbiage related to documentation requirements for maintenance therapy.
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- Provider Education/Guidance
- Other
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09/04/2017
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R17
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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.
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- Provider Education/Guidance
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09/04/2017
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R16
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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.
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- Provider Education/Guidance
- Typographical Error
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02/06/2017
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R15
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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.
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- Provider Education/Guidance
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02/06/2017
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R14
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No comments were received from the provider community; therefore, no revisions were made.
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- Provider Education/Guidance
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01/01/2017
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R13
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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.
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- Provider Education/Guidance
- Revisions Due To CPT/HCPCS Code Changes
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10/06/2016
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R12
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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.
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- Provider Education/Guidance
- Typographical Error
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08/22/2016
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R11
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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.
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- Provider Education/Guidance
- Revisions Due To CPT/HCPCS Code Changes
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02/19/2016
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R10
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Under ICD-10 Codes that Support Medical Necessity added K50.00, K50.011, K50.012, K50.013, K50.014, K50.018, K50.019.
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- Provider Education/Guidance
- Public Education/Guidance
- Request for Coverage by a Practitioner (Part B)
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01/03/2016
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R9
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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.
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- Provider Education/Guidance
- Public Education/Guidance
- Request for Coverage by a Provider (Part A)
- Reconsideration Request
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10/16/2015
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R8
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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.
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- Typographical Error
- Other (Annual validation)
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10/01/2015
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R7
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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.
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- Provider Education/Guidance
- Request for Coverage by a Provider (Part A)
- Reconsideration Request
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10/01/2015
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R6
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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.
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- Other (Bill type and/or revenue code removal)
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10/01/2015
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R5
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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.
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10/01/2015
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R4
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Under Bill Type Codes added TOB 023X.
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- Provider Education/Guidance
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10/01/2015
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R3
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Under Revision History Explanation Corrected the formatting of the Medical News Today source to correctly open hyperlink.
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10/01/2015
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R2
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In ICD-10 Codes that Support Medical Necessity corrected ICD-10 Code K50.012 to read correctly as K51.012.
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10/01/2015
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R1
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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.
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- Provider Education/Guidance
- Other (Removed all codes ranges.)
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