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Last Modified: 11/26/2020 Location: FL, PR, USVI Business: Part A, Part B

The local coverage determination (LCD) development process

Local coverage determinations (LCDs) are a determination of whether or not a service or item is considered to be eligible for coverage on a contractor wide basis in accordance with Section 1862 (a)(1)(A) of the Social Security Act (SSA ); that is, the service is considered to be “reasonable and necessary”. LCDs must be consistent with all statutes, rulings, regulations, national coverage, payment and coding policies.
Detailed instructions regarding the LCD development process are found in the Centers for Medicare & Medicaid Services (CMS) Internet-Only Manual (IOM), Publication 100-08, Medicare Program Integrity Manual (PIM), Chapter 13. The process includes consultations with experts, publication of the proposed policy, opportunity for public comments in writing, publication of a final LCD, response to public comments and notice of the new policy.
First Coast Service Options publishes LCDs on the CMS Medicare Coverage Database (MCD) external link, to provide guidance to the public and medical community within our geographic jurisdictions. A listing of the LCDs with links to the policies can be found on the First Coast website at First Coast LCDs.
LCDs may be developed and/or revised in response to internal requests and external requests sent to First Coast at, or by fax to 1 (717) 526-6389. The topics submitted with the various requests will be added to the First Coast wait list and will undergo an internal prioritization process.

Coverage requirements

LCDs may allow coverage of a service or item if it meets all of the following conditions:
A benefit category exists for the service in Title XVIII of the SSA. Under the Medicare program, the scope of benefits available to eligible beneficiaries is prescribed by law and divided into several main parts. Part A is the hospital insurance program and Part B is the voluntary supplementary medical insurance program. Medicare rules, regulations, and guidance documents, including the IOM 100-02, The Medicare benefit policy manual, further describe the benefits available.
The service is not excluded by other sections of Title XVIII of the SSA. Such exclusions generally include, but are not limited to: routine physical exams, cosmetic surgery, hearing aids, eyeglasses, and most dental care.
The service is not already covered as a specified Medicare benefit, as an exception to the requirement for the service to be reasonable and necessary, e.g., pneumococcal, influenza, and hepatitis B vaccines.
The service is considered reasonable and necessary under Section 1862 (a)(1)(A) of the SSA. To be considered reasonable and necessary, the service must be:
Safe and effective;
Not experimental or investigational (exception: routine costs of qualifying clinical trial services with dates of service on or after September 19, 2000, which meet the requirements of the clinical trials national coverage determination (NCD))
Appropriate, including the duration and frequency that is considered appropriate for the item or service In terms of whether it is:
Furnished in accordance with accepted standards of medical practice for the diagnosis or treatment of the patient’s condition or to improve the function of a malformed body member;
Furnished in a setting appropriate to the patient’s medical needs and condition;
Ordered and furnished by qualified personnel;
One that meets, but does not exceed, the patient’s medical need; and
At least as beneficial as an existing and available medically appropriate alternative

Informal meeting requests

The LCD process may begin with informal meetings in which interested parties in the MAC’s jurisdiction can informally discuss potential new LCD requests. These meetings are for educational purposes only and are not pre-decisional negotiations. These meetings are permitted but are not required and the process allows requestors to communicate via conference call or in-person meeting before submitting a formal request. These meetings will assure that all relevant evidence needed for review for coverage is submitted with the request for a formal review. Detailed instructions regarding the LCD development process are found in the Centers for Medicare & Medicaid Services (CMS) internet-only manual (IOM), publication 100-08, Medicare program integrity manual (PIM), chapter 13. The process includes consultations with experts, publication of the proposed policy, opportunity for public comments in writing, publication of a final LCD, response to public comments and notice of the new policy.
Interested parties may request an informal meeting with the Medicare Administrative Contractor (MAC) for jurisdiction N (JN) by sending an email request to First Coast at

Supporting evidence

When developing LCDs, First Coast will use available evidence of general acceptance by the medical community including but not limited to: published original research in peer-reviewed medical journals, systematic reviews and meta-analyses, evidence-based consensus statements and clinical guidelines.

Comment period

First Coast provides a 45 day comment period for each proposed LCD. This comment period is scheduled to include time before and after the open meeting. The proposed LCDs, the proposed status page, and information about how to submit comments are provided on the website at: Submission of comments for proposed LCDs .

Contractor advisory committee

The contractor advisory committee (CAC) provides a formal mechanism for healthcare professionals to be informed of the evidence used in developing an LCD and promotes communications between the MAC and the healthcare community. CAC members will serve in an advisory capacity as representatives of their constituency to review the quality of the evidence used in the development of an LCD. The final decision on all issues rests with the contractor medical directors.
The CAC is used to supplement the MAC’s internal expertise and to ensure an unbiased and contemporary consideration of “state of the art” technology and science.

Open meeting

An open meeting will be held after the proposed LCD is published for comment. The intent of the open meeting is to discuss the review of the evidence and the rationale for the proposed LCD(s) and to provide an opportunity for interested parties to make presentations of information related to the proposed LCDs. When available, information about the location, date, and time of the open meeting; and how to register, is posted on our website, at Open meeting information.

Posting of final LCDs and notice period

After consideration of all comments received, and any necessary revision of the proposed LCD(s), the final LCD(s) are posted on the First Coast website and the Medicare Coverage Database (MCD) for a notice period of 45 days. A response to all comments in the form of a response to comments article will be posted at the same time as the final LCD on the MCD external link with links to the policies on the First Coast website at Future effective LCDs.
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.