Last Modified: 10/16/2024
Location: FL, PR, USVI
Business: Part A, Part B
The process for requesting a new LCD is a mechanism by which interested parties within a contractor’s jurisdiction can request the development of a new LCD. This process has different requirements than an
LCD reconsideration request process, the path by which an interested party requests modification of an existing, active LCD.
LCDs are developed to convey under what circumstances an item/service is considered to be reasonable and necessary. We will consider
reasonable and necessary services for payment in the absence of an LCD, billing and coding article, NCD, or CMS manual instruction limiting coverage.
Requirements for requesting a new LCD:
1. Requests for a new LCD will be considered from:
• Beneficiaries residing or receiving care in First Coast’s jurisdiction (JN).
• Health care professionals doing business in First Coast’s jurisdiction (JN).
• Any interested party doing business in First Coast’s jurisdiction (JN).
2. First Coast will consider a request for a new LCD complete if:
• The request is submitted in writing (e-mail, facsimile or written letter);
• The statutorily defined Medicare benefit category to which the requester believes the item or service falls under is included and provides a rationale justifying the assignment is included;
• The request includes suggested language that the requester wants in an LCD;
• The request includes a justification supported by full text peer-reviewed evidence. Full text copies of the published evidence to be considered must be included with the request;
• Information is included that addresses the relevance, usefulness, clinical health outcomes, or the medical benefits of the item or service; and
• Information is included to fully explain the design, purpose, and/or method, as appropriate, of using the item or service for which the request is made.
Note: Failure to include any of the above invalidates the request.
3. How to submit a request for a new LCD:
First Coast LCDs apply to jurisdiction N (Florida, Puerto Rico, and U.S. Virgin Islands). New LCD requests may be sent via one of the three methods below:
• By email:
• If the attachment size for clinical citations exceeds 10MB, the requestor must send the articles and supporting documents via multiple, smaller e-mails.
• By fax:
Requests should be faxed to 717-526-6389. Please notate on your fax coversheet
Attention: Medical Affairs – New LCD Request – [Name of your proposed LCD].
• By U.S. Postal Service
Office of the Contractor Medical Director
First Coast Service Options
Medical Affairs Department
2020 Technology Parkway, Suite 100
Mechanicsburg, PA 17050
4. After a request for a new LCD received:
Within 60 calendar days of the date the request is received, First Coast will determine if the request is complete or incomplete:
• Any request for a new LCD that, in the judgment of First Coast, does not meet the criteria described above, is incomplete. If the request is incomplete, First Coast will respond, in writing, to the requestor explaining why the request was incomplete.
• A complete request 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 an acknowledgement only of the receipt and acceptance of a complete request.
• The request then goes on our waitlist to undergo our internal prioritization process which includes review of literature submitted. This process can take up to 12 months or more to complete. Topics are prioritized based on claims data, including how often a service is billed and the frequency a service is being denied. Access to care as well as associated health outcomes are also considered. Depending on the issue and/or procedure involved, a policy may or may not be developed.
• Our website will be used to notify requestors and all potentially interested parties if a topic is taken to our Contractor Advisory Committee (CAC) for evidentiary review by publishing a notice of the CAC meeting. If a proposed LCD is developed, it will go to an Open Meeting. Once a proposed LCD is posted for open comment period, we will publish notice of the
proposed LCD and
Open meeting.
MACs are to finalize or retire all proposed LCDs within a rolling year of publication date of the proposed LCD on CMS’ Medicare Coverage Database (MCD) (365 days).
An informal meeting is a mechanism solely to assist requestors with understanding the new LCD request process. Interested parties within First Coast’s jurisdiction may request a meeting to informally discuss a potential new LCD request.
• The meeting is for educational purposes only and is not for pre-decisional negotiations. A contractor medical director (CMD) does not participate in this meeting.
• An informal meeting is permitted but is not required and the process provides the requestor an opportunity to communicate with First Coast prior to submitting a new LCD request.
• The meeting assists in assuring that all relevant evidence needed for review for potential coverage is submitted with the formal new LCD request.
• No specific discussion or decision will be provided regarding coverage or non-coverage during the meeting.
• An informal meeting does not imply coverage or non-coverage if a new LCD is requested or developed.
First Coast Service Options (First Coast) strives to ensure that the information available on our provider website is accurate, detailed, and current. Therefore, this is a dynamic site and its content changes daily. It is best to access the site to ensure you have the most current information rather than printing articles or forms that may become obsolete without notice.
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