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Last Modified: 10/1/2022 Location: FL, PR, USVI Business: Part A, Part B

Electronic submission

Avoid the wait, submit electronically

Requesting a new local coverage determination (LCD)

The new local coverage determination (LCD) request process 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 (LCD reconsideration request process), the path by which an interested party requests modification of an existing, active LCD.

New LCD request requirements

1. New LCD requests 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.
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.

How to submit a new LCD request

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:
Electronic requests should be sent to medicalaffairs@guidewellsource.com, with “New LCD Request – [Name of LCD]” in the subject line.
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 cover sheet
Attention: Medical Affairs – New LCD Request – [Name of your proposed LCD].
By mail
First Coast Service Options
Medical Affairs and Procedures
2020 Technology Parkway
Suite 100
Mechanicsburg, PA 17050-9419

After a new LCD request is 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.
If the request is complete, First Coast will notify the requestor of the acceptance of the new LCD request to the wait list and will follow the process detailed in the Centers for Medicare & Medicaid Services (CMS) Program Integrity Manual (Internet-only manual 100-08), Chapter 13 external link.
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 to the requestor of the receipt of a complete request.

Request for an informal meeting

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 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.
To request an informal meeting, please send an e-mail to medicalaffairs@guidewellsource.com with “Informal Meeting Request” in the subject line.
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.