Proposed Local Coverage Determinations (LCDs) Released for Comment - External Infusion Pumps and Knee Orthoses - JD DME
Proposed Local Coverage Determinations (LCDs) Released for Comment - External Infusion Pumps and Knee Orthoses
Joint DME MAC Publication
Posted July 24, 2025
The Centers for Medicare and Medicaid Services (CMS) assigned to the Durable Medical Equipment Medicare Administrative Contractors (DME MACs) the task of developing LCDs for Durable Medical Equipment, Prostheses, Orthoses, and Supplies (DMEPOS). The DME MACs are proposing two LCDs as described below:
External Infusion Pumps (DL33794) - Proposing to (1) expand coverage for blinatumomab to adult and pediatric beneficiaries one month and older with CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia (ALL) in the consolidation phase of multiphase chemotherapy; (2) clarify the existing blinatumomab criteria to include the age qualifier of "one month and older" to be consistent with the clinical literature and FDA prescribing information; (3) update coverage criteria for infusion-based therapy for the treatment of motor control symptoms associated with Parkinson’s Disease that are inadequately controlled by non-infusion-based therapy; and, (4) add code J7356 to the HCPCS array.
Knee Orthoses (DL33318) - Proposing modifications to the coverage criteria for knee orthoses with single or double upright, adjustable flexion and extension joint, medial-lateral and rotation control, with varus/valgus adjustment for the management or treatment of ambulatory Medicare beneficiaries with pain or reduction in mobility and/or function due to medial or lateral tibiofemoral osteoarthritis.
Stakeholders may read the details of each proposed LCD posted on the Medicare Coverage Database by referencing the LCD ID number in the search field. The entire proposed LCD(s) should be reviewed prior to the submission of written comments.
We are soliciting comments on the proposed LCDs from stakeholders (including, but not limited to, clinicians, manufacturers, suppliers, and other parties who care for Medicare beneficiaries). You should be very specific in your comments and, if possible, offer suggestions that may address your concerns. You should provide an evidence-based rationale for your comments and attach any full-text references from the published clinical literature (for example, peer-reviewed journals, clinical society guidelines, etc.) that were not included in the bibliography of the proposed LCD. We encourage a written response regardless of your agreement or disagreement with the proposed LCD.
In your comments, please be sure to disclose all conflicts of interest you have with any manufacturer(s) or supplier(s) of the DMEPOS items addressed in the proposed LCD.
All comments will be collected at a single point of contact for each proposed LCD. Comments that address more than one proposed LCD must be submitted to each LCD email address for which comments are being made. Do not include any protected health information (PHI) or personally identifiable information (PII). Submit your comments electronically to the DME MACs at the applicable email address(es) listed below no later than Saturday, September 6, 2025.
External Infusion Pumps (DL33794): EIPLCDCOMMENTS@cgsadmin.com
Knee Orthoses (DL33318): KOLCDCOMMENTS@cgsadmin.com
If the proposed LCD coverage criteria refer to an LCD-related Policy Article (PA), then a convenience copy of a draft PA document may be attached to the proposed LCD. A draft PA document attached to a proposed LCD is only provided for reference purposes.
Suppliers and clinicians are cautioned not to make any changes based upon information contained in a proposed LCD. The content of a proposed LCD may be revised based upon the written comments received during the comment period. When all written comments have been reviewed, revisions will be considered.
IMPORTANT: The DME MACs will host virtual open meetings to further solicit input from stakeholders for the proposed LCDs. The virtual meetings will take place on August 27, 2025. For details regarding participation in the virtual open meetings, refer to the open meeting announcement articles posted at Open Meeting Announcement - External Infusion Pumps Proposed Local Coverage Determination (LCD) and Open Meeting Announcement - Knee Orthoses Proposed Local Coverage Determination (LCD).
Refer to each DME MAC website for additional information, including access to the proposed LCDs.
Thank you for your participation in our policy development process.
Smitha M. Ballyamanda, MD, CAQSM
Medical Director, DME MAC Jurisdiction A
Noridian Healthcare Solutions, LLC
Sunil V. Lalla, MD, FACS, CPC
Medical Director, DME MAC Jurisdiction B
CGS Administrators, LLC
Robert D. Hoover, Jr., MD, MPH, FACP
Medical Director, DME MAC Jurisdiction C
CGS Administrators, LLC
Angela S. Jenny, DO, DABFM
Medical Director, DME MAC, Jurisdiction D
Noridian Healthcare Solutions, LLC
