Local Coverage Article Response to Comments

Response to Comments: External Infusion Pumps – DL33794


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Article ID
Article Title
Response to Comments: External Infusion Pumps – DL33794
Article Type
Response to Comments
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During the 45-day comment period, which was open from 04/30/2020 through 06/15/2020, the DME MACs received a total of 3 comments from 2 commenters.

Introduction to Responses

The DME MACs appreciate the comments received from stakeholders during the open comment period on the proposed External Infusion Pumps Local Coverage Determination (LCD).

Pursuant to the CMS Program Integrity Manual (CMS Pub. 100-08) Chapter 13:

In conducting a review, MACs shall use the available evidence of general acceptance by the medical community, such as published original research in peer-reviewed medical journals, systematic reviews and meta-analyses, evidence-based consensus statements and clinical guidelines.

Accordingly, the final policy and our response to comments are based on the best currently available published clinical evidence, to support optimal health outcomes in Medicare beneficiaries with a diagnosis of primary immunodeficiency diseases (PIDD).

Response To Comments


One commenter requested that the final LCD provide coverage of infusion pumps described by HCPCS codes E0779 and E0781 for the administration of Cutaquig®.

The DME MAC Medical Directors agree and the LCD will be finalized with the following language:

For the administration of subcutaneous immune globulins with the following HCPCS codes - J1555, J1559, J1561, J1562, and J1569 only an E0779 infusion pump is covered. If a different pump is used, it will be denied as not reasonable and necessary.

For the administration of subcutaneous immune globulin with HCPCS code J1558 and J7799 (Cutaquig) either an E0779 or an E0781 infusion pump is covered. If a different pump is used, it will be denied as not reasonable and necessary.


Two commenters requested that the unit of service (UOS) for Cutaquig be changed from 165mg to 100mg.

This comment is related to the UOS located in the policy article (A52507). Policy articles are not open to notice and comment as they are not part of the LCD reconsideration process; however, the DME MAC Medical Directors agree with the commenters and the policy article will be finalized with the following change: Claims for Cutaquig for dates of service on or after December 12, 2018 must be submitted using the HCPCS code J7799 (NOC DRUGS, OTHER THAN INHALATION DRUGS, ADMINISTERED THROUGH DME). One UOS equals one hundred (100) mg.


One commenter suggested minor technical changes to the Summary of Evidence.

The suggested changes were reviewed and are reflected in the final LCD. These minor technical changes do not affect the level of evidence evaluation or the conclusion.

Associated Documents

Related Local Coverage Documents
L33794 - External Infusion Pumps
Related National Coverage Documents
Public Versions
Updated On Effective Dates Status
07/17/2020 07/23/2020 - N/A Currently in Effect You are here