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A/B MAC  DME  MAC Shared -System Maintainers  Other A B HHH FISS MCS VMS CWF     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.    10901.3.1 The MAC will review materials received within 60 calendar days upon receipt and determine whether the request is complete or incomplete.  X X X X      10901.3.2 If the request is incomplete, the contractor shall respond, in writing, to the requestor explaining why the request was incomplete.   X X X X      10901.3.3 If the request is complete, the MAC shall follow the process outlined in section 13.2 in chapter 13 of Pub.100- 08.  X X X X      10901.3.4 If the MAC requires an extension to the timeframes noted above, the MAC shall inform their COR and Business Function Lead (BFL) in writing. The MAC shall also provide their rationale for the extension request.   X X X X      10901.4  When a MAC consults with an expert, they shall inform and obtain consent from the expert that their opinion may be used and clearly identified within the proposed or final LCD.   X X X X      10901.5  For all proposed LCDs, with limited exceptions noted below, MACs shall follow the LCD process, consisting of consultation, X X X X      Number  Requirement  Responsibility     A/B MAC  DME  MAC Shared -System Maintainers  Other A B HHH FISS MCS VMS CWF 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 the  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 e xample, 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, National Coverage Determinations (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.   10901.5.1 Contractors shall obtain explicit approval from the CMS contracting officer and BFL in all other situations.   X X X X      10901.6  Once the proposed LCD is published, MACs shall provide a minimum of 45 calendar days for public comment.  X X X X      10901.6.1 MACs shall contact the CMS BFL if they determine an extension to the comment period is needed.  X X X X      10901.7  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.   X X X X      Number  Requirement  Responsibility     A/B MAC  DME  MAC Shared -System Maintainers  Other A B HHH FISS MCS VMS CWF 10901.7.1 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 the evidence used to make a determination.   X X X X      10901.7.2 The MAC shall endeavor to ensure each specialty that serves on the CAC shall have only at least one member and a designated alternate approved  by the MAC.   X X X       10901.7.3 MACs shall work with CAC members to select a meeting location that will optimize participation. Contractors have the option of hosting in -person or telephonic/video/on- line conference/etc. meetings.   X X X X      10901.7.4 MACs shall ensure all CAC meetings will be open to the public to attend and observe.   X X X X      10901.7.5 MACs shall keep a copy of the number of CAC attendees and make a copy available to CMS BFL and COR upon request.   X X X X      10901.7.6 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.   X X X X      10901.7.7 Participation in the CAC is considered voluntary. MACs shall not provide an honorarium or other forms of compensation to members.   X X X X      10901.8  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.   X X X X      10901.8.1 MACs should endeavor to accommodate some in -person attendance, subject to limitations based on venue.  X X X X      10901.8.2 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 X X X X      Number  Requirement  Responsibility     A/B MAC  DME  MAC Shared -System Maintainers  Other A B HHH FISS MCS VMS CWF discussed.   10901.8.2.1 MACs shall provide an email address on their contractor website where all interested parties shall submit their presentation materials.   X X X X      10901.8.3 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. MACs shall ensure the presentation time shall be equally divided amongst the LCDs discussed at the meeting.   X X X X      10901.8.4 MACs shall keep a copy of the number of attendees and make a copy available to CMS BFL and COR upon request.   X X X X      10901.8.5 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.   X X X X      10901.8.6 MACs shall notify the public about the dates, times, and location for the open meeting. MACs have the option of setting up email listservs to announce this information or may use other education methods to adequately inform the public.   X X X X      10901.8.6.1 The MACs shall ensure that the listserv or other method clearly identifies 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.   X X X X      10901.8.7 MACs shall post the planned agenda for the open meeting a minimum of two weeks prior to the event on their contractor website and shall inform the public that the agenda has been posted.   X X X X      10901.9  After the close of the comment period and the required meetings and consultation, the MACs shall publish the final LCD and the Response to Comment (RTC) Article on the X X X X      Number  Requirement  Responsibility     A/B MAC  DME  MAC Shared -System Maintainers  Other A B HHH FISS MCS VMS CWF Medicare Coverage Database (MCD).   10901.9.1 MACs shall respond to all comments received during the comment period of the proposed LCD by using the RTC article associated with the LCD. The RTC Article is published on the start date of the notice period. The RTC Article will remain publically available indefinitely on t he MCD or the MCD Archive.   X X X X      10901.10 The MACs shall publish the final LCD on the MCD. The date the 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.   X X X X      10901.10.1 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 after the notice period began  X X X X      10901.11 MACs shall add to their MAC Web sites information on the LCD Reconsideration Process.   X X X X      10901.11.1 The MACs shall ensure that this information is listed 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, including postal, e -mail, and fax addresses where requests may be submitted.  X X X X      10901.12 MACs shall consider all LCD reconsideration requests from:   X X X X      Number  Requirement  Responsibility     A/B MAC  DME  MAC Shared -System Maintainers  Other A B HHH FISS MCS VMS CWF  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   10901.13 MACs should only accept reconsideration requests for LCDs published as an effective final.  Requests shall not  be accepted for other documents including:    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   X X X X      10901.14 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 reconsideration process. Requestors can be referred to http://www.cms.gov/DeterminationProcess/01_overview.asp#regs.   X X X X      10901.15 Any request for LCD reconsideration that, after MAC review, is determined to not meet these criteria is invalid. MACs shall have the discretion to consolidate valid requests, if similar requests are received.   X X X X      10901.15.1 Within 60 calendar days of the day the request is received, the MAC shall determine X X X X      Number  Requirement  Responsibility     A/B MAC  DME  MAC Shared -System Maintainers  Other A B HHH FISS MCS VMS CWF whether the request is valid or invalid.   10901.15.1.1 If the request is invalid, the MAC shall respond in writing, to the requestor explaining why the request was invalid.   X X X X      10901.15.2 If the request is valid, the contractor shall follow the requirements below.  The MAC shall open the LCD and follow the LCD process as outlined  in section 13.2 of this manual or include the LCD on the MACs waiting list.   X X X X      10901.15.3 The MAC shall respond, in writing, to the requestor notifying the requestor of the acceptance, and if applicable, wait -listing, of the reconsideration request.