LCD Reference Article Response To Comments Article

Response to Comments: Off-label Use of Rituximab and Rituximab Biosimilars

A58727

Expand All | Collapse All
Draft Article
Draft Articles are works in progress and not necessarily a reflection of the current billing and coding practices. Revisions to codes are carefully and thoroughly reviewed and are not intended to change the original intent of the LCD.

Document Note

Note History

Contractor Information

Article Information

General Information

Source Article ID
N/A
Article ID
A58727
Original ICD-9 Article ID
Not Applicable
Article Title
Response to Comments: Off-label Use of Rituximab and Rituximab Biosimilars
Article Type
Response to Comments
Original Effective Date
06/24/2021
Revision Effective Date
N/A
Revision Ending Date
N/A
Retirement Date
N/A

CPT codes, descriptions, and other data only are copyright 2023 American Medical Association. All Rights Reserved. Applicable FARS/HHSARS apply.

Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein.

Current Dental Terminology © 2023 American Dental Association. All rights reserved.

Copyright © 2024, the American Hospital Association, Chicago, Illinois. Reproduced with permission. No portion of the AHA copyrighted materials contained within this publication may be copied without the express written consent of the AHA. AHA copyrighted materials including the UB‐04 codes and descriptions may not be removed, copied, or utilized within any software, product, service, solution, or derivative work without the written consent of the AHA. If an entity wishes to utilize any AHA materials, please contact the AHA at 312‐893‐6816.

Making copies or utilizing the content of the UB‐04 Manual, including the codes and/or descriptions, for internal purposes, resale and/or to be used in any product or publication; creating any modified or derivative work of the UB‐04 Manual and/or codes and descriptions; and/or making any commercial use of UB‐04 Manual or any portion thereof, including the codes and/or descriptions, is only authorized with an express license from the American Hospital Association. The American Hospital Association (the "AHA") has not reviewed, and is not responsible for, the completeness or accuracy of any information contained in this material, nor was the AHA or any of its affiliates, involved in the preparation of this material, or the analysis of information provided in the material. The views and/or positions presented in the material do not necessarily represent the views of the AHA. CMS and its products and services are not endorsed by the AHA or any of its affiliates.

CMS National Coverage Policy

N/A

Article Guidance

Article Text

This policy addresses the off-labeled use of rituximab for non-anti-neoplastic conditions.

The following are comments received during open comment period February 11, 2021 thru March 28, 2021 for DL38920 Off-label Use of Rituximab abd Rituximab Biosimiliars. The policy iswill be in notice effective June 24, 2021, 2021 and become effective August 8, 2021.

Response To Comments

Number Comment Response
1

The American College of Rheumatology (ACR), representing over 7,700 rheumatologists and rheumatology interprofessional team members, appreciates the opportunity to provide comments on CGS proposed Local Coverage Determination (LCD) DL38920, “Off label use of Rituximab and Rituximab biosimilars.”

Rheumatologists treat patients with a variety of inflammatory and autoimmune conditions. Many of these patients with rare and debilitating diseases are not able to access treatment because the appropriate medication is not approved by the FDA for the intended indication, despite being standard of care. For treatments covered under Medicare Part D, patient access relies upon inclusion in one of the Medicare-approved compendia. However, for treatments covered under Medicare Part B, patients often have no option to access critical off-label treatments.

The ACR appreciates CGS recognizing the role of Rituximab in the treatment of off-label indications, and specifically, the inclusion of lupus nephritis in the proposed LCD. We would appeal for your consideration of two additional clinical states where Rituximab is both a) clinically accepted as standard of care for refractory patients and b) often available through appeal pathways from commercial insurance carriers. These are immune mediated myopathies and IgG4 related systemic disease. While the proposed LCD mentions immune mediated myopathies, it does not appear to propose coverage. Due to the rarity of these diseases, it is impractical to expect large scale randomized trials to be completed. For each indication, we would agree Rituximab treatment should only be considered when a patient is refractory to conventional (yet also non-FDA approved) treatments.

CGS has reviewed the additional literature submitted to support the use of Rituximab in refractory cases of immune mediated myopathies and IgG4 related systemic disease. The evidence review and limited coverage criteria has been incorporated into the final LCD. With additional supporting literature provided the immune mediated myopathy anti-synthetase syndrome was removed from non-covered and added to limited coverage. Thank you for your support of the policy.

N/A

Coding Information

Bill Type Codes

Code Description

Please accept the License to see the codes.

N/A

Revenue Codes

Code Description

Please accept the License to see the codes.

N/A

CPT/HCPCS Codes

Please accept the License to see the codes.

N/A

CPT/HCPCS Modifiers

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

N/A

ICD-10-CM Codes that Support Medical Necessity

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

N/A

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

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

N/A

ICD-10-PCS Codes

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

N/A

Additional ICD-10 Information

Bill Type Codes

Code Description

Please accept the License to see the codes.

N/A

Revenue Codes

Code Description

Please accept the License to see the codes.

N/A

Other Coding Information

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

N/A

Coding Table Information

Excluded CPT/HCPCS Codes - Table Format
Code Descriptor Generic Name Descriptor Brand Name Exclusion Effective Date Exclusion End Date Reason for Exclusion
N/A N/A
N/A
Non-Excluded CPT/HCPCS Ended Codes - Table Format
Code Descriptor Generic Name Descriptor Brand Name Exclusion Effective Date Exclusion End Date Reason for Exclusion
N/A

Revision History Information

Revision History Date Revision History Number Revision History Explanation
N/A

Associated Documents

Medicare BPM Ch 15.50.2 SAD Determinations
Medicare BPM Ch 15.50.2
Related National Coverage Documents
N/A
SAD Process URL 1
N/A
SAD Process URL 2
N/A
Statutory Requirements URLs
N/A
Rules and Regulations URLs
N/A
CMS Manual Explanations URLs
N/A
Other URLs
N/A
Public Versions
Updated On Effective Dates Status
06/17/2021 06/24/2021 - N/A Currently in Effect You are here

Keywords

N/A