Informal Meetings or New LCD Requests

The New LCD Request Process is a mechanism by which interested parties within a contractor’s jurisdiction can request a new LCD. This process has different requirements from a LCD Reconsideration Request, the path by which an interested party requests modification of an existing, active LCD. The process for developing a new LCD is described below.

Informal Teleconference (Optional)
Prior to submitting a formal LCD request, Palmetto GBA encourages requestors to schedule an informal conference call to review the requirements for a valid LCD request. Request for a conference call may be submitted via email to
A.Policy@palmettogba.com, B.Policy@palmettogba.com or MolDX.Policy@palmettogba.com. In the request for an informal discussion, requestors should include the following information:

  • Include the following in the subject line of the email: "Request for New LCD Call – [Title of LCD]"
  • Several options for dates and times for a 30 minute - 1 hour conference call
  • Teleconference number with enough lines to accommodate 15 participants
  • Agenda for the call, including requestor participants and titles
  • Summary information (1-2 paragraphs, maximum) for the LCD request

Request Submission Criteria (Required)
Palmetto GBA will consider all new LCD requests from:

  • Beneficiaries residing or receiving care in a contractor’s jurisdiction
  • Health care professionals doing business in a contractor’s jurisdiction
  • Any interested party doing business in a contractor’s jurisdiction

Following the informal discussion, should the requestor wish to continue with a formal new LCD request, a complete request must:

  1. Clearly identify the statutorily-defined Medicare benefit category to which the requestor believes the item or service falls under and provide a rationale justifying the assignment;
  2. Identify the language that the requestor wants in a new LCD;
  3. Include a justification for the new LCD supported by peer-reviewed evidence. Full-text copies (not abstracts or meeting poster presentations) of published evidence from peer-reviewed literature must accompany the request. Failure to include full-text clinical literature invalidates the request;
  4. The request must include information that addresses the relevance, usefulness, clinical health outcomes, or the medical benefits of the item or service; and
  5. The request must include information that fully explains the design, purpose, and/or method, as appropriate, of using the item or service for which the request is made.

The level of evidence required for LCD development may be found in the CMS Program Integrity Manual, Chapter 13.

How to Submit Request
New LCD requests may be sent via one of three methods: email (preferred), hard copy by mail or fax. Below lists pertinent information for each of the three methods:

  1. Email (Preferred Method): A.Policy@palmettogba.com, B.Policy@palmettogba.com or MolDX.Policy@palmettogba.com
    • Electronic requests should be sent with "New LCD Request – [Name of LCD]" in the subject line
    • If the attachment size for clinical citations exceeds 15 MB, the requestor must send the articles and supporting documents via multiple, smaller emails
    • Please contact one of the email addresses above for alternative methods for submitting large electronic files or if you have difficulty submitting a NEW LCD request
  2. Fax:
    • JM Part A/HHH (803) 462-2652 or JM Part B (803) 382-2424
    • JJ Part A (803) 870-0133 or JJ Part B (803) 870-0137
    • Please address your fax cover sheet to New LCD – [Name of Proposed LCD] - Attn: Medical Affairs
  3. Mail:

Jurisdiction M
Palmetto GBA  
Attn: Medical Affairs
PO Box 100238 
Columbia, SC 29202-3238

Jurisdiction J
Palmetto GBA  
Attn: Medical Affairs
PO Box 100305
Columbia, SC 29202-3305

Please note that this information is for NEW Palmetto GBA LCD requests only. Information for submitting an LCD request for other Jurisdictions may be found on their websites.

Next Steps
Palmetto GBA will review materials received within 60 calendar days upon receipt and determine whether the request is complete or incomplete. If the request is incomplete, Palmetto GBA will respond, in writing, to the requestor explaining why the request was incomplete. 

If the request is complete, Palmetto GBA will follow the process outlined in the Program Integrity Manual, Chapter 13. A complete request response does not convey that a determination has been made whether or not the item or service will be covered or non-covered under 1862 (a)(1)(A) of the Act. The response to the requestor that the request is complete is simply an acknowledgement to the requestor of the receipt of a complete, formal meeting request.

If the request is complete and a new LCD is developed, Palmetto GBA will follow the process outlined in the Program Integrity Manual, Chapter 13. This involves:

  1. Consultation with the requestor or subject matter experts (if necessary)
  2. Contractor Advisory Committee (CAC) meeting to discuss the quality of evidence used to make a determination (if necessary)
  3. Publication of a proposed LCD
  4. Open Meeting to discuss the review of evidence and the rationale for the proposed LCDs
  5. Opportunity for public comment in writing (minimum of 45 days following the date of the Open meeting
  6. Publication of a final LCD, including:
    1. A response to public comments received
    2. Notice to public of new policy at least 45 days in advance of the effective date

Related Information: PIM, Chapter 13 (PDF, 217 KB)