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 the DME MACs received a total of 6 comments.

Introduction to Responses

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

Pursuant to the CMS Program Integrity Manual (CMS Pub. 100-08) Chapter 13, the final policy and our response to comments are based on general acceptance by the medical community, as evidenced by published original research in peer-reviewed medical journals, systematic reviews and meta-analyses, evidence-based consensus statements and clinical guidelines.

Response To Comments


One commenter expressed support for the addition of Xembify® to the External Infusion Pumps LCD and supported finalization of DL33794 as proposed.

The final LCD has been published as it was proposed.


One commenter requested that Hizentra be removed from the Self-Administered Drug Exclusion list and covered under Medicare's home infusion therapy benefit which becomes effective January 1, 2021

The comment is outside the scope of this LCD reconsideration request.


Three commenters submitted questions and concerns regarding the reimbursement and billing guidelines for the newly assigned HCPCS for an insulin pump with glucose sensing (E0787) and related supplies (A4226).

The comments are outside the scope of this LCD reconsideration request.


One commenter suggested that coverage be extended to Cutaquig® (Immune Globulin Subcutaneous (Human) – hipp 16.5% solution) as part of the same Local Coverage Determination (LCD) reconsideration as Xembify®.

The comment is outside the scope of this LCD reconsideration request.

Associated Documents

Related Local Coverage Documents
L33794 - External Infusion Pumps
Related National Coverage Documents
Public Versions
Updated On Effective Dates Status
04/10/2020 04/16/2020 - N/A Currently in Effect You are here