Corporate

Requests for New LCD

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 an LCD Reconsideration Request, the path by which an interested party requests modification of an existing, active LCD.  Information for requesting an LCD Reconsideration may be found at the LCD Reconsideration Process page.

The process for developing a new LCD is described below.

Request Submission Criteria (Required)

CGS 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; and
  • Any interested party doing business in a contractor’s jurisdiction.

Should the requestor wish to continue with a formal new LCD request, a valid request must include:

  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 proposes in a new LCD;
  3. Include a justification for the new LCD supported by peer-reviewed evidence.  Full-text, English Language, 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 in the Medicare population;
  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, hard copy by mail, or fax. Below lists pertinent information for each of the three methods:

  1. Email: CMD.INQUIRY@cgsadmin.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 CMD.INQUIRY@cgsadmin.com for alternative methods for submitting large electronic files or if you have difficulty submitting an LCD Reconsideration request.
  2. Fax: 615.664.5971
    • Please address your fax cover sheet to J15 New LCD – [Name of Proposed LCD] - Attn: Chief  Medical Director
  3. Mail:

    CGS Administrators
    Attn: Chief Medical Director
    J15 A/B MAC LCD Reconsideration
    Two Vantage Way
    Nashville, Tennessee 37228

Please note that this information is for NEW J15MAC LCD requests only.

Next Steps

CGS will review materials received within 60 calendar days upon receipt and determine whether the request is valid or invalid.  If the request is invalid, CGS will respond, in writing, to the requestor explaining why the request was invalid. 

If the request is valid, CGS will follow the process outlined in the Program Integrity Manual, Chapter 13.  A valid 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 valid is simply an acknowledgement to the requestor of the receipt of a complete, valid request.
If the request is valid and a new LCD is developed, CGS 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. Open meeting to develop evidence on the proposed LCD (If necessary);
  3. Publication of a proposed LCD;
  4. Contractor Advisory Committee (CAC) meeting (if necessary);
  5. Opportunity for public comment in writing (minimum of 45 days following posting of proposed LCD);
  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.

CGS will post updates to the LCD Summary Sheet on the Medicare Coverage Database web siteExternal Website. Final LCDs will be finalized or retired within a rolling calendar year of publication date on the Medicare Coverage Database (365 days).

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