LCD New Request Process - JF Part B

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. View information for requesting an LCD Reconsideration.

The process for developing a new LCD is described below.

Informal Teleconference (Optional)

Prior to submitting a formal LCD request, Noridian encourage requestors to schedule an informal conference call to review the requirements for a valid new LCD request. Request for a conference call are to be submitted via email.

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 - [Proposed Title of 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.

LCD: New Request Submission Criteria (Required)

Noridian 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.

Following the informal discussion, if held, should the requestor wish to continue with a formal new LCD request with or without an Informal Call), a valid request must:

1. Clearly identify the statutorily-defined Medicare benefit category to which the requestor believes the item or service falls under;
2. Provide a rationale justifying the proposed assignment of Medicare benefit category;
3. Identify the language that the requestor wants in a new LCD;
4. Include a justification for the new LCD supported by peer-reviewed scientific/medical evidence.  Full-text copies (i.e., not abstracts, meeting poster presentations, manuscripts or embargoed documents) of published evidence from peer-reviewed scientific/medical literature must accompany the request. Failure to include full-text clinical literature invalidates the request;
5. 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-eligible population; and,
6. 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 Internet Only Manual (IOM), Publication 100-08, Medicare Program Integrity Manual, Chapter 13.

How to Submit a New LCD Request

New LCD requests may be sent via one of three methods: email (preferred), hard copy by mail, or fax. View the three methods below.

1. Email (Preferred Method)
   • Electronic requests should be sent with "LCD; New LCD Request Process – [Proposed Name of LCD]" in subject line
   • If attachment size for clinical citations exceeds 15 MB, requestor must send articles and supporting documents via multiple, smaller emails. If multiple emails are needed, label with number of emails (example: 1 of 5, 2 of 5) to assure we receive them all
   • Contact Krista Babbitt, 701-715-9440, for alternative methods for submitting large electronic files or if you have difficulty submitting a New LCD request.
2. Fax
   • Address your fax cover sheet to Noridian LCD: New Request – [Name of Proposed LCD] -
3. Mail

NOTE: This information is for New LCD requests for Noridian only. View information for submitting an LCD reconsideration request on the LCD Reconsideration webpage.

Next Steps

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

If the request is valid, Noridian will follow the process outlined in the CMS IOM, Publication 100-08, Medicare 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, Noridian will follow the process outlined in the CMS IOM, Publication 100-08, Medicare 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.

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

Related Information

• CMS Internet Only Manual (IOM), Publication 100-08, Program Integrity Manual, Chapter 13