CMS Pub. 100-08, ch. 13, § 13.2.4

All proposed LCDs, with limited exceptions noted below, must follow the LCD process outlined

in 13.2 of this manual, consisting of consultation, publication of proposed LCD, open meeting

concerning the proposed policy, opportunity for public comment in writing, publication of a final

LCD that includes a response to public comments received and notice to public of new policy 45

days in advance of the effective date. These processes shall be used for all LCDs except in the

following situations:

• Revised LCD Being Issued for Compelling Reasons -

• Revised LCD that Makes a Non-Substantive Correction - For example, typographical or

grammatical errors that do not substantially change the LCD.

• Revised LCD that Makes a Non-Discretionary Coverage Update - Contractors shall

update LCDs to reflect changes in Statutes, Federal regulations, CMS Rulings, NCDs,

HCPCS code changes for DME, coverage provisions in interpretive manuals, and

payment policies.

• Revise LCD to effectuate an Administrative Law Judge’s decision to nullify an existing

LCD due to an LCD Challenge.

Contractors must obtain explicit approval from the CMS Contracting Officer Representative

(COR) and Business Function Lead (BFL) in all other situations (e.g. there is compelling new

evidence that a procedure/device is highly unsafe and coverage must be removed immediately).