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CGS Associates, LLC

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Request for a New LCD Process

The New LCD Request Process is a mechanism by which interested parties within a contractor's jurisdiction may 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 on the LCD Reconsideration page. The process for developing a new LCD is described below.

Informal Teleconference (Optional)

Prior to submitting a formal LCD request, the DME MACs encourage requestors to schedule an informal conference call to review the requirements for a valid LCD request. A request for a conference call may be submitted via email to LCDReconJC@cgsadmin.com. In the request for an informal discussion, requestors should include the following information:

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

Request Submission Criteria (Required)

Following the informal discussion, should the requestor wish to continue with a formal new LCD request, a valid request must include all of the following:

  1. Be submitted by one of the following:
    • 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.
  2. Clearly identify the statutorily-defined Medicare benefit category to which the requestor believes the item or service falls under;
  3. Provide a rationale justifying the proposed assignment of the Medicare benefit category;
  4. Identify the language which the requestor wants in a new LCD;
  5. Submission of all available evidence, as well as all related FDA approval correspondence, marketing designations, decision summaries pertinent to the product or service, 510(k)/PMA/De Novo notifications, SSED data sheet, FDA Panel Minutes and Post-Approval Study Result/Outcome Submissions.

    Submitted literature and references should be limited to published, full-text, peer-reviewed evidence, indexed in PubMed of the US National Library of Medicine, National Institutes of Health. The failure to include the specific literature with the request will render the LCD request incomplete.
  6. Must include information which addresses the relevance, usefulness, clinical health outcomes, or the medical benefits of the item or service in the Medicare-eligible population; and,
  7. Must include information which 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.

CGS has the discretion to consolidate valid requests if similar requests are received. Any request for a new LCD that, in the judgment of the contractor, does not meet these criteria is invalid.

How To Submit Request

New LCD requests may be sent via one of three methods: email (preferred), fax, or hard copy by mail. Pertinent information for each of the three methods is listed below:

Please note that this information is for NEW DME MAC LCD requests only. Information for submitting an LCD request for the Jurisdiction 15 A/B MAC may be found at the J15 website.

Next Steps

CGS will review the materials received to determine whether the request is valid. A valid request must meet criteria 1-7 listed above. CGS will respond to the request within 60 calendar days upon receipt.

If CGS determines that the request is not valid, CGS will notify the requestor in writing that the request is not valid and will provide the rationale for this decision.

If the request is valid, CGS will begin the LCD development process outlined in the Program Integrity Manual Chapter 13 (Internet-only Manual Pub.100-08). The response to the requestor is an acknowledgement by CGS of the receipt of a valid, complete request. CGS' request response does not convey that a determination has been made or the likelihood of coverage, or non-coverage, within a defined period of time under 1862 (a)(1)(A) of the Act, but is confirmation that CGS plans to proceed with development of a new LCD or place the requested LCD on the wait-list for development at a later time.

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. Contractor Advisory Committee (CAC) meeting (if necessary);
  3. Publication of a proposed LCD;
  4. Open meeting to solicit comments from the public on the proposed LCD;
  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.

Proposed LCDs will be finalized or retired within a rolling calendar year of publication date on the Medicare Coverage Database (365 days).

Related Information

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