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. The process for developing a new LCD is described below.
Informal Meeting (Optional)
Prior to submitting a formal New LCD request, Palmetto GBA encourages requestors to schedule an informal meeting review the requirements for a valid request.
- Subject line of the email should state "Request for New Informal Meeting"
- Several dates and times the requestor is available for a 30 minute conference call
- Agenda for the call, including requestor participants and titles
- Summary information (1-2 paragraphs, maximum) for the LCD request
New LCD Request Submission Criteria (Required)
A complete request must:
- 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;
- Identify the language that the requestor wants in a new LCD;
- 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;
- Include information that addresses the relevance, usefulness, clinical health outcomes, or the medical benefits of the item or service; and
- 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 email to A.Policy@palmettogba.com, B.Policy@palmettogba.com or MolDX.Policy@palmettogba.com. The subject line of the email should state: "New LCD Request — [Name of LCD].
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 as to whether the item or service will be covered or non-covered. It is simply an acknowledgement to the requestor of the receipt of a complete, formal 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:
- Consultation with the requestor or subject matter experts (if necessary)
- Contractor Advisory Committee (CAC) meeting to discuss the quality of evidence used to make a determination (if necessary)
- Publication of a proposed LCD
- Open Meeting to allow stakeholders the opportunity to present comments and/or concerns regarding the proposed LCDs
- Opportunity for public comment in writing (45 days following the publication date of the proposed LCD)
- Publication of a final LCD, including:
- A response to public comments received
- Notice to public of new policy at least 45 days in advance of the effective date
Related Information: PIM, Chapter 13 (PDF, 217 KB).