LCD Reference Article Response To Comments Article

Response to Comments: External Infusion Pumps – DL33794

A60373

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Source Article ID
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Article ID
A60373
Original ICD-9 Article ID
Not Applicable
Article Title
Response to Comments: External Infusion Pumps – DL33794
Article Type
Response to Comments
Original Effective Date
12/11/2025
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During the 45-day comment period, which was open from July 24, 2025 through September 6, 2025, the DME MACs received comments from 6 commenters.

NOTE: DME MACs review all submitted comments and may choose to consolidate similar thematic comments or redact or withhold certain submissions (or portions thereof) such as those containing private or proprietary information, inappropriate language or duplicate/near duplicate submissions. As a result, there may be a discrepancy between the number of comments in the article and the actual number of comments received.

Introduction to Responses

The DME MACs appreciate the comments received from stakeholders during the open comment period for the proposed External Infusion Pump Local Coverage Determination (LCD) (DL33794).

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.

Response To Comments

Number Comment Response
1

Two commenters expressed support for the proposed expansion in coverage for blinatumomab to include all FDA approved indications of the drug in the External Infusion Pump (EIP) LCD.

The DME MAC Medical Directors would like to thank the commenters for offering support for the proposed expansion in coverage of blinatumomab in the proposed EIP LCD (DL33794).

2

Two commenters expressed support for the proposed change in coverage for infusion-based therapies for the treatment of Parkinson’s Disease (PD) in the EIP LCD.

The DME MAC Medical Directors would like to thank the commenters for offering support for the proposed expansion in coverage for infusion-based therapies to include foslevodopa/foscarbidopa for the treatment of PD in the proposed EIP LCD (DL33794).

3

One commenter noted foslevodopa/foscarbidopa is administered via a proprietary external infusion pump (i.e., Vyafuser) and requested clarification on whether suppliers have the option to utilize a different external infusion pump (coded as E0781) to administer foslevodopa/foscarbidopa in the event of supply chain issues for the proprietary pump.

Per FDA prescribing information, foslevodopa/foscarbidopa is administrated as a subcutaneous infusion with the Vyafuser pump. The safety and efficacy of utilizing an external infusion pump other than the FDA-approved pump for the administration of foslevodopa/foscarbidopa is outside the scope of the EIP LCD reconsideration.

4

One commenter expressed concern regarding a potential coverage gap for beneficiaries who are already being treated with an infusion-based PD therapy who need to transition to another infusion-based PD therapy. Specifically, if a beneficiary has been treated with levodopa/carbidopa enteral suspension, but is transitioned to foslevodopa/foscarbidopa, the commenter is concerned that old documentation will be required to demonstrate the beneficiary’s non-infusion-based PD therapy could not be further optimized prior to initially starting levodopa/carbidopa enteral suspension.

The DME MACs agree with the concern. In order to avoid gaps in access, the coverage criteria in the final EIP LCD have been updated to provide a clear pathway to coverage for a beneficiary who is transitioning from one infusion-based PD therapy to a different infusion-based PD therapy.

5

One commenter noted the home infusion therapy (HIT) services benefit does not provide payment for the services provided by DME pharmacies and requested reevaluation of the benefit. The commenter expressed concern that decisions to add coverage for new infusion drugs under the DME benefit are being made independently of consideration for sufficient beneficiary access to HIT services, particularly for drugs that require more complex and involved pharmacy services.

Coverage for infusion drugs for use in the home setting as supplies to covered durable infusion pumps falls under the DME benefit. A decision by the DME MACs to add coverage for a new infusion drug is based on an evaluation of the literature to determine if the drug is reasonable and necessary for the treatment of an illness. The HIT services benefit is separate from the DME benefit and is defined in statute; therefore, reevaluation of the benefit and concern for its lack of reimbursement of pharmacy services is outside the purview of the DME MACs and outside the scope of the EIP LCD reconsideration.

6

One commenter expressed concerns regarding the inability of home infusion providers to deliver and start long infusion drugs, such as fluorouracil and blinatumomab, in an office or outpatient infusion center setting. The commenter noted the logistical issues of finding nurses to go out to the home for timed visits to connect beneficiaries to their chemotherapy infusion.

As noted in the EIP LCD-related Policy Article (A52507), infusion drugs started in a practitioner’s office must be billed to the A/B MAC and not the DME MAC. In these cases, the drug or biological may be covered under section 1861(s)(2)(A) and (B) of the Social Security Act as an incident to benefit even though the entire administration of the drug or biological does not occur in the practitioner’s office or the hospital outpatient department. Equipment, such as an external infusion pump used to begin administration of the drug or biological that the patient takes home to complete the infusion, is not separately billable as DME.

7

One commenter requested clarification regarding whether the HIT service benefit per diem should apply daily regardless of the occurrence of a nurse visit.

Home infusion therapy service benefit reimbursement is outside the scope of the EIP LCD reconsideration.

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Associated Documents

Medicare BPM Ch 15.50.2 SAD Determinations
Medicare BPM Ch 15.50.2
Related Local Coverage Documents
LCDs
L33794 - External Infusion Pumps
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