04/04/2024
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R22
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Under CMS National Coverage Policy revised second regulation to read “42 CFR §411.15(a) and (k) Particular services excluded from coverage”. Under Bibliography fixed broken hyperlink on reference #8 and changes were made to citations to reflect AMA citation guidelines.
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- Provider Education/Guidance
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05/18/2023
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R21
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Under CMS National Coverage Policy section headings were updated. Under Coverage Indications, Limitations and/or Medical Necessity broken hyperlink was fixed. Under Bibliography changes were made to citations to reflect AMA citation guidelines and fixed broken hyperlink for reference #27. Punctuation and typographical errors were corrected throughout the LCD.
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- Provider Education/Guidance
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07/07/2022
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R20
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Under CMS National Coverage Policy updated section headings for regulations. Under Coverage Indications, Limitations and/or Medical Necessity – Indications revised seventh bullet to read “Second-line treatment of certain autoimmune myopathies”.
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- Provider Education/Guidance
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10/04/2020
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R19
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This LCD is being presented for notice. No comments were received during the comment period; therefore, no changes have been made.
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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10/10/2019
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R18
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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. Regulations regarding billing and coding were removed from the CMS National Coverage Policy section of this LCD and placed in the related Billing and Coding: Intravenous Immunoglobulin (IVIG) A56718 article.
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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07/25/2019
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R17
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All coding located in the Coding Information section and all verbiage regarding billing and coding under the Associated Information section has been removed and is included in the related Billing and Coding: Intravenous Immunoglobulin (IVIG) A56718 article.
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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07/04/2019
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R16
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Under Bibliography changes were made to citations to reflect AMA citation guidelines. Formatting, punctuation and typographical errors were corrected throughout the LCD. Acronyms were inserted where appropriate throughout 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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07/26/2018
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R15
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Under Coverage Indications, Limitations and/or Medical Necessity Initial Treatment revised the first sentence to now read “Diagnosis of chronic inflammatory demyelinating polyneuropathy as confirmed by all of the following (a through c):” Under Coverage Indications, Limitations and/or Medical Necessity Initial Treatment “d” the verbiage was changed from “BOTH of the following findings on lumbar puncture18 i.White blood cell count less than 10/mm3” to now read “The following findings on lumbar puncture are not absolutely required but may support the diagnosis:18”. 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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05/31/2018
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R14
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Under CMS National Coverage Policy changed verbiage to now read “describes payment for services that may be furnished to a practitioner. Requests for payment, or bills submitted shall include the appropriate diagnosis code(s)” in the third regulation. The verbiage was changed from “must be reasonable and necessary” to now read “excluded from coverage” in the fourth regulation. The last two regulations were deleted from this section. Under Coverage Indications, Limitations and/or Medical Necessity - A. Initial treatment added the verbiage “American Academy of Neurology” in front of the acronym “AAN” and placed parentheses around the acronym. Under Bibliography changes were made to citations to reflect AMA citation guidelines. The initials of the third author was corrected to now read “van Doorn P” in the third reference. The reference date was changed from 2008 to 2014 in the fifth reference. The link was deleted and the title has changed to now read “Multiple sclerosis: management of multiple sclerosis in primary and secondary care. NICE; 2014” in the ninth reference. The access date was changed to May 21, 2018 in the sixteenth reference. Punctuation and typographical errors were corrected throughout the policy.
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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02/26/2018
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R13
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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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R12
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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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12/14/2017
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R11
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Under CMS National Coverage Policy added CMS Internet-Only Manual, Pub 100-02, Medicare Benefit Policy Manual, Chapter 15, §50.4.6; Less Than Effective Drug.
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- Provider Education/Guidance
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10/01/2017
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R10
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Under ICD-10 Codes That Support Medical Necessity added ICD-10 codes M33.03, M33.13 and M33.93. The code description was revised for M33.00, M33.01, M33.02, M33.09, M33.10, M33.11, M33.12 and M33.19. This revision is due to the 2017 Annual ICD-10 Updates.
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 ICD-10-CM Code Changes
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04/03/2017
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R9
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Under ICD-10 Codes That Support Medical Necessity Group 1: Codes added G61.82.
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- Provider Education/Guidance
- Reconsideration Request
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07/07/2016
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R8
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This LCD is being made an A/B MAC LCD. No coverage changes were made.
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- Provider Education/Guidance
- Creation of Uniform LCDs Within a MAC Jurisdiction
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01/04/2016
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R7
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The description changed for HCPCS codes J1459, J1557, J1561, J1566, J1568, J1569, J1572 and J1599 under the CPT/HCPCS Codes section.
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- Revisions Due To CPT/HCPCS Code Changes
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01/04/2016
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R6
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Under Coverage Indications, Limitations and/or Medical Necessity added verbiage "for coverage criteria of Autoimmune Mucocutaneous Blistering Diseases, please see NCD 250.3". Under ICD-10 Codes that Support Medical Necessity added L10.0, L10.1, L10.2, L10.3, L10.4, L10.5, L10.81, L10.89, L10.9, L12.0, L12.1, L12.8, L12.9, L13.8 for reference. Under ICD-10 Codes that DO NOT Support Medical Necessity removed NOTE: as per CR 9252 Transmittal 1547 the bullous conditions are no longer covered effective January 4, 2016 as coverage for these codes is under NCD 250.3.
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- Provider Education/Guidance
- NCD Supplementation
- Typographical Error
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01/04/2016
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R5
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Under CMS National Coverage Policy added reference to Change Request 9252 Transmittal 1547. Under Coverage Indications, Limitations and/or Medical Necessity created a new section titled Off-label Indication, and added off-label coverage for Livedoid Vasculitis and Livedoid Vasculopathy for patients who are refractory to or have failed conventional therapies. Under ICD-10 Codes that Support Medical Necessity removed L10.0-L13.8 as per CR 9252 Transmittal 1547 NCD 250.3 (these codes are no longer valid for processing Medicare claims) and added off-label coverage for L95.0 and L95.9. Under ICD-10 Codes that DO NOT Support Medical Necessity added L10.0-L13.8 as per CR 9252 Transmittal 1547 the bullous conditions are no longer covered.
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- Provider Education/Guidance
- Public Education/Guidance
- Request for Coverage by a Provider (Part A)
- Reconsideration Request
- Other (Change Request 9252 updated NCD 250.3)
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10/29/2015
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R4
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Under Coverage Indications, Limitations and/or Medical Necessity formatting changes were made. Under Associated Information, sub-heading Utilization Guidelines 2nd paragraph added a space between (CARI) and the word "or". Under Sources of Information and Basis for Decision added the assess dates the web-sited were reviewed.
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- Provider Education/Guidance
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10/01/2015
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R3
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Under Coverage Indications, Limitations and/or Medical Necessity added updated coverage criteria for Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). Under Revenue Codes removed the statement "Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory; unless specified in the policy services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes" as all revenue codes have been removed from policies. Under ICD-10 Codes that Support Medical Necessity removed L14 per NCD 250.3. Under Sources of Information and Basis for Decision added sources for CIDP coverage.
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- Provider Education/Guidance
- Reconsideration Request
- Other (Per CR 9252 NCD 250.3 removed L14. )
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10/01/2015
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R2
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In Coverage Indications, Limitations and/or Medical Necessity made punctuation corrections. In Associated Information corrected Paraneoplastic spelling, removed “This is very rare” and added the sentence “Research has shown that the use of intravenous immunoglobulins for Paraneoplastic Visual Loss would be another treatment option.”
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- Provider Education/Guidance
- Other (Annual Validation)
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10/01/2015
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R1
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Under CMS National Coverage Policy removed a section from Publication 100-02, Chapter 15, section 50.2 as this reference was specific to Self-Administered Drugs and IVIG would never be self-administered.
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- Provider Education/Guidance
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