Local Coverage Determination Process & Timeline

An LCD, as defined in §1869(f)(2)(B) of the Act, is a determination by a Medicare Administrative Contractor (MAC) regarding whether or not a particular item or service is covered in a MAC’s jurisdiction in accordance with Section 1862(a)(1)(A) of the Act.

LCDs can be requested by beneficiaries residing in or receiving care within the MAC’s jurisdiction, health care professionals providing care in MAC’s jurisdiction, or any interested party doing business in the MAC’s jurisdiction. In general, LCD requests are similar to NCD requests in that the benefit category should be specified, evidence should be provided for review, and justification of medical use should be clear. Detailed guidelines for LCDs, how to request an LCD, and how to request changes to an LCD are described in the Medicare Program Integrity Manual (Chapter 13). Innovators are also encouraged to review any MAC specific requirement or guidelines. 

How to Request a Local Coverage Determination

Written Request Submission

Contractors shall consider new LCD Requests to be a complete, formal request if the following criteria are met. The request must:

• be in writing and can be sent to the MAC via e-mail, fax, or written letter;
• clearly identify the statutorily-defined Medicare benefit category to which the requestor believes the item or service falls under and provides a rationale justifying the assignment;
• identify the language that the requestor wants in an LCD;
• include a justification supported by peer-reviewed evidence. Full copies of published evidence to be considered shall be included and failure to include same invalidates the request;
• include information that addresses the relevance, usefulness, clinical health outcomes, or the medical benefits of the item or service; and
• 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.

For current maps of MAC jurisdictions, visit Who are the MACs. For information about contacting the appropriate MAC, visit the MAC Website List.

MAC Review of LCDs

In general, the MAC will review the request within 60 calendar days and will notify the requestor to indicate whether the request is complete or incomplete. If the request is complete and valid, the MAC will begin the LCD development process described in the Medicare Program Integrity Manual (Chapter 13, Section 13.2). During the development process the MAC has the discretion to consult with subject matter experts and/or the CAC, if necessary. The purpose of the CAC is to provide a formal mechanism for healthcare professionals to be informed of the evidence used in developing the LCD and promote communications between the MAC and the healthcare community. MACs may establish one CAC per state or have the option of establishing one CAC per jurisdiction or multi-jurisdictional CAC with representation from each state. CAC members are typically physicians, beneficiary representatives, or representatives of medical specialty organizations.

After the MAC has reviewed the request and completed consultation with experts and/or the CAC if necessary, the MAC publishes the proposed LCD on the Medicare Coverage Database (MCD) website at. MACs generally have 365 days from the publication date of the proposed LCD to finalize or retire all proposed LCDs.

Public Comment and Open Meeting

Once the proposed LCD is published, MACs provide at least 45-days in which the public may provide written comments. MACs respond to all comments received during the comment period of the proposed LCD by using the Response to Comment (RTC) article associated with the final LCD. The RTC Article is published on the start date of the notice period. Additionally, after publication of the proposed LCD, MACs hold open meetings to discuss the review of the evidence and the rationale for the proposed LCD with the public. Interested parties (generally those that would be affected by the LCD, including providers, physicians, vendors, manufacturers, beneficiaries, caregivers, etc.) can make presentations of information related to the proposed LCDs at the open meeting.

Publication of Final LCD

The date that MACs publish the final LCD marks the beginning of the required notice period of a minimum of 45 days before the LCD can take effect. MACs may use several tools at their disposal to notify the public, including the “What’s New Report” on the MCD, setting up email listservs, or other 508 compliant and accessible means to inform stakeholders. The Medicare Program Integrity Manual (Chapter 13) outlines the LCD development process followed by MACs.

How to Request Changes to a Local Coverage Determination

LCD Reconsideration Process

The process for requesting an LCD reconsideration may vary depending on the MAC, but requests generally must include two key criteria:

1. Be submitted in writing and shall identify the language that the requestor wants added to or deleted from an LCD; and
2. Include a justification supported by new evidence, which may materially affect the LCD's content or basis;

Copies of published evidence shall be included by the requestor when requesting changes to an LCD. LCD reconsiderations are available only for final effective LCDs.

LCD Challenge Process

The LCD challenge is an appeals process for an “aggrieved party” to challenge LCDs/LCD provisions that are in effect at the time of the challenge. “Aggrieved party” is defined in regulation as a Medicare beneficiary, or the estate of a Medicare beneficiary, who is entitled to benefits under Part A, enrolled under Part B, or both (including an individual enrolled in fee-for-service Medicare, in a Medicare Advantage plan (MA), or in another Medicare managed care plan), and is in need of coverage for an item or service that would be denied by an LCD, as documented by the beneficiary’s treating physician, regardless of whether the service has been received. An aggrieved party has obtained documentation of the need by the beneficiary’s treating physician.  MACs shall follow all LCD Challenge requirements outlined in 42 CFR part 426.