New LCD Process, LCD Reconsideration Process and Other Important Changes

The key parts of the New LCD Process are summarized

13.2.2.3 – New LCD Request Requirements

(Rev: 829; Issued: 10-03-18; Effective: 10-03-18; Implementation: 01-08-19)

Contractors shall consider New LCD Requests to be a complete, formal request if the following are met:

• The request is in writing and can be sent to the MAC via e-mail, facsimile or written letter;

• The request clearly identifies the statutorily-defined Medicare benefit category to which the requestor believes the item or service falls under and provides a rationale justifying the assignment;

• The request shall identify the language that the requestor wants in an LCD;

• The request shall 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;

• The request shall include information that addresses the relevance, usefulness, clinical health outcomes, or the medical benefits of the item or service; and

• The request shall 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 MAC will review materials received within 60 calendar days upon receipt and determine whether the request is complete or incomplete. If the request is incomplete, the contractor shall respond, in writing, to the requestor explaining why the request was incomplete. If the request is complete, the MAC shall follow the process outlined in chapter 13 of Pub.100-08. 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 acknowledgment by the MAC of the receipt of a complete, valid request.

If the MAC requires an extension to the timeframes noted above, the MAC shall inform their COR and BFL in writing. The MAC shall also provide their rationale for the extension request.

MLN Matters: MM10901

CR#10901

Source: https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/2018Downloads/R829PI.pdf