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13.2.4 - Proposed LCD  (Rev:  854; Issued:  01-11-19; Effective: 09 -26-18; Implementation: 01 -08-19)  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, publica tion 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 sh all 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 Judges 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) .  13.2.4.1 - Proposed Determination & Posting of LCD Summary Sheet  (Rev:  854; Issued:  01-11-19; Effective: 09 -26-18; Implementation: 01 -08-19)  The Proposed LCD is the MACs proposed determination regarding coverage, non- coverage or limited coverage for a particular item or service.  The public announcement of the MACs proposed determination begins with the date the proposed LCD is published on the Medicare Coverage Database (MCD) .    The LCD Summary Sheet is a document that summarizes contractor actions related to the LCD and includes open meeting and CAC information, if applicable.  The LCD Summary Sheet will be posted to the MCD.    13.2.4.2 - Public Comment  (Rev:  854; Issued:  01-11-19; Effective: 09 -26-18; Implementation: 01 -08-19)  Once the proposed LCD is published MACs shall provide a minimum of 45 calendar days for public comment.  MACs shall contact CMS Business Function Lead (BFL) if they determine an extension to the comment period is needed.  13.2.4.3  Contractor Advisory Committee (CAC)  (Rev:  854; Issued:  01-11-19; Effective: 09 -26-18; Implementation: 01 -08-19)  MACs shall establish one CAC per state or have the option of establishing one CAC per jurisdiction or multi- jurisdictional CAC with  representation from each state. It is expected that if a MAC chooses to have one CAC per jurisdiction  or multi -jurisdictional CAC , the MAC shall endeavor to ensure that each state has a full committee and the opportunity to discuss the quality of evidence used to make a determination.   The purpose of the CAC is to provide a formal mechanism for healthcare professionals to be inform ed of the evidence used in developing the LCD and promote communications between the MAC and the healthcare community.  CAC members should 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 CAC is advisory in nature, with the final decision on all issues resting with MACs.  Accordingly, the advice rendered by the CAC is most useful when it results from a process of full scientific inquiry and thoughtful discuss ion with careful framing of recommendations and clear identification of the basis of those recommendations.   The CAC is to be composed of healthcare professionals, beneficiary representatives, and representatives of medical organizations.  The CAC is used to supplement the MACs internal expertise and to ensure an unbiased and contemporary consideration of "state of the art" technology and science.  CAC members are valued for their background, education, experience and/or expertise in a wide variety of sci entific, clinical, and other related fields.  The MAC shall endeavor to ensure each specialty that serves on the CAC shall have at least one member and a designated alternate approved by the MAC.  If the CAC member or alternate cannot attend the CAC meeting, a substitute may attend if the MAC is notified and approved at least 1 week prior to the meeting.  MACs shall work with CAC members to select a meeting location that will optimize participation. MACs shall keep a copy of the number of CAC attendees and make a copy available to CMS BFL and COR upon request. MACs shall record (video, audio or both) the CAC meetings and as part of the LCD record, assure the recording is maintained on their contractor website. Contractors have the option of hosting in- person  and/or telephonic/video/on- line conference/etc. meetings.  All CAC meetings will be open to the public to attend and observe  Portions of the meeting not discussing evidence for a proposed LCD, such as provider practice trend reporting or discussions relat ed to fraud and abuse, may be closed to the public.   Participation in the CAC is considered voluntary.  MACs do not provide an honorarium or other forms of compensation to members.  Expenses are the responsibility of the individuals or the associations they represent.   13.2.4.4 - Open Meeting  (Rev:  854; Issued:  01-11-19; Effective: 09 -26-18; Implementation: 01 -08-19)  After the proposed LCD is made public, MACs shall hold open meetings to discuss the review of the evidence and the rationale for the proposed LCD(s) with stakeholders in their jurisdiction. The open meeting should endeavor to accommodate some in- person att endance, subject to limitations based on venue.   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. MACs should provide an email address on their contractor website where all interested parties shall submit their presentation materials.  However, all formal comments must be submitted in writing to the MAC.  Contractors shall remain  sensitive to parties that may have an interest in an issue and endeavor to invite them to participate in meetings at which a related LCD is being discussed.  In recognition that the efficient use of resources may require several proposed LCDs to be discussed during one meeting, time for presentation by interested parties may be limited.  The presentation time shall be equally divided amongst the LCDs discussed at the meeting.  Members of the CAC may also attend these open meetings. MACs shall keep a copy o f the number of attendees and make a copy available to CMS BFL and COR upon request.  MACs shall record (video, audio or both) the Open Meetings and as part of the LCD record, assure the recording is maintained on their contractor website.   MACs are required to notify the public about the dates, times, and location for the open meeting.  MACs have the option of setting up email listservs to announc e this information or may use other education methods to inform the public.  The listserv or other method shoul d clearly identify the location, times, dates and telephone/video/on- line conference information for the open meeting to ensure that this information is clearly distinguished from the information for the CAC meetings.  MACs shall post the planned agenda for the open meeting a minimum of two weeks prior to the event on their contractor website and will inform the public that the agenda has been posted.   13.2.5 - Final Determination  (Rev:  854; Issued:  01-11-19; Effective: 09 -26-18; Implementation: 01 -08-19)  After the close of the comment period and the required meetings and consultation, the final LCD and the Response to Comment (RTC) Article shall be published on the MCD.    A.  Response to Public 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 LCD.  The RTC Article is published on the start date of the notice peri od.  The RTC Article will remain publicly  available indefinitely on the MCD or the MCD Archive.   13.2.6 - Notice Period  (Rev:  854; Issued:  01-11-19; Effective: 09 -26-18; Implementation: 01 -08-19)  The date the final LCD is published on the MCD, marks the beginning of the required notice period of a minimum 45 calendar days before the LCD can take effect.  If the MAC would like to extend the notice period, they shall seek approval from CMS BFL.  If the notice period is not extended by the contractor, the effective date of the LCD is the 46th calendar day aft er the notice period began.    13.3 - LCD Reconsideration Process (Rev:  854; Issued:  01-11-19; Effective: 09 -26-18; Implementation: 01 -08-19)  The LCD reconsideration process is a mechanism by which a beneficiary or stakeholder (including a medical professional society or physician) in the MACs jurisdiction can request a revision to an LCD.  The LCD reconsideration process differs from an initial request for an LCD in that it is available only for final effective LCDs.  The whole LCD or any provisio n of the LCD may be reconsidered.  In addition, MACs have the discretion to revise or retire th eir LCDs at any time on their own initiative.   13.3.1 - Web site Requirements for the LCD Reconsideration Process  (Rev:  854; Issued:  01-11-19; Effective: 09 -26-18; Implementation: 01 -08-19)  MACs shall add to their MAC Web sites information on the LCD Reconsideration Process.  This information should be on the LCD home page of the MACs Web site.  It shall be labeled "LCD Reconsideration Process" and shall include :   A description of the LCD Reconsideration Process; and    Instructions for submitting LCD reconsideration requests, i ncluding postal, e -mail, and fax addresses where requests may be submitted.   13.3.2 - Valid LCD Reconsideration Request Requirements  (Rev:  854; Issued:  01-11-19; Effective: 09 -26-18; Implementation: 01 -08-19)  MACs shall consider all LCD reconsideration requests from:    Beneficiaries residing or receiving care in a contractor's jurisdiction; and    Providers doing business in a contractor's jurisdiction.    Any interested party doing business in a contractor's jurisdiction.   MACs should only accept reconsideration requests for LCDs published as an effective final.  Requests shall not be accepted for other documents including:    National Coverage Determinations (NCDs);    Coverage provisions in interpretive manuals;    Proposed LCDs;    Template LCDs, unless or until they are adopted and in effect by the contractor;    Retired LCDs;    Individual claim determinations    Bulletins,  articles, training materials; and    Any instance in which no LCD exists, i.e., requests for development of an LCD.   If modification of the LCD would conflict with an NCD, the request would not be valid.  The MAC should refer the requestor to the NCD reco nsideration process.  Requestors can be referred to http://www.cms.gov/DeterminationProcess/01_overview.asp#regs . Requests shall be submitted in writing and shall identify the language that the requestor wants added to or deleted from an LCD.  Requests shall include a justification supported by new evidence, which may materially affect the LCD's content or basis.  Copies of published evidence shall be included.  Any request for LCD reconsideration that, after MAC review, is determined to not meet these criteria is invalid.  MACs have the discretion to consolidate va lid requests if similar requests are received.   13.3.3 - Process Requirements  (Rev:  854; Issued:  01-11-19; Effective:  09-26-18; Implementation: 01 -08-19)  The requestor shall submit a valid LCD reconsideration request to the appropriate MAC, following instructions on the MAC's Web site.   Within 60 calendar days of the day the request is received, the MAC shall determine whether the request is valid or invalid.  If the request is invalid, the contractor shall respond, in writing, to the requestor explaining why the request was invalid.  If the request is valid, the contractor shall follow the requirements below.