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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.   X X X X      10901.15.4 Contractors shall keep an internal list of the LCD Reconsideration Requests received and the dates, subject, and disposition of each one.  X X X X      10901.16 Contractors shall follow all LCD Challenge requirements outlined in 42 CFR part 426.  X X X X      10901.17 The MACs shall publish all proposed and final LCDs and LCD related articles on the MCD. The public may access the MCD at http://www.cms.gov/medicare -coverage -database.     MACs shall ensure the accuracy of the information entered into the MCD.    If a MAC decides to have LCDs and related articles on their MAC web sites, then the MAC shall link from their MAC website to the MCD.    X X X X      10901.18 MACs shall finalize or retire all proposed LCDs within a rolling year of publication date of the proposed LCD on the MCD (365 days). If an unusual circumstance occurs and the MAC wishes to request an exception to this requirement, they shall notify their C OR and LCD BFLs at least 21 business days X X X X      Number  Requirement  Responsibility     A/B MAC  DME  MAC Shared -System Maintainers  Other A B HHH FISS MCS VMS CWF before the one year expiration date.   10901.19 The MAC shall ensure that all LCDs do not conflict with all statutes, rulings, regulations, and national coverage, payment, and coding policies.   X X X X      10901.20 For all new and revised LCDs, MACs shall no longer include national policy language found in statute, regulations, rulings, interpretive manual instructions, etc. in the coverage and indications section of their LCDs. If contractors need to  reference a national policy in the coverage and indications section of their LCD, they shall cite the reference (e.g., publication number, Medicare title of manual, section of manual).   X X X X      10901.21 MACs shall remove all codes from LCDs and plac e them in billing & coding articles that are linked to the LCD. CMS will provide additional instructions on the date upon which this change will be effective.   X X X X      10901.22 The MAC shall summarize the opinions received as a result of consultation  with healthcare professional expert(s), professional societies, etc. prior to the drafting of a proposed LCD, and include this information in the proposed LCD.   X X X X      10901.23 When a MAC determines that a CAC consultation should be sought for a proposed LCD, the MAC shall include the summary of recommendations from the CAC regarding the policy in the Final LCD.   X X X X      10901.24 Contractors shall clearly identify attendance information consisting of location, time and date for the CAC meeting(s) and ensure that these are clearly distinguished from the information for the Open meeting(s), even if they occur on the same day at the same location.   X X X X      10901.24.1 The MAC shall also make available a means to accommodate reasonable requests for assistance from stakeholders who are hearing X X X X      Number  Requirement  Responsibility     A/B MAC  DME  MAC Shared -System Maintainers  Other A B HHH FISS MCS VMS CWF or visually impaired.   10901.24.2 The MAC shall have the discretion to determine the frequency of the CAC meetings and shall base the meetings on the appropriateness and on the volume of LCDs that require CAC consultation as part of the LCD process.   X X X       10901.25 In every proposed and final LCD, the MAC shall summarize the evidence that supports coverage, limited coverage, maintenance of existing coverage in cases of LCD reconsideration or non- coverage. At a minimum, the summary should include the following:    a complete description of the item or service under review;    a narrative that describes the scientific evidence supporting the clinical indications for the item o r service;    the target Medicare population; and    whether the item or service is intended for use by health care providers or beneficiaries.   X X X X      10901.26 If the item or service is regulated by the Food and Drug Administration (FDA), and determined by the MAC to be reasonable and necessary, information regarding the use of the item or service subject to the FDA labeling requirements shall be included. MACs have the option of providing a hyperlink to the FDA clearance to market to meet this  requirement.   X X X       10901.27 In conducting a review, MACs shall use the available evidence, such as published original research, systematic reviews and meta -analyses, and evidence- based consensus statements and guidelines. Proprietary information, submitted by the requestor, not avail able to the public shall not be considered. The review shall include a summary of all the evidence used to support the determination and may be grouped by X X X X      Number  Requirement  Responsibility     A/B MAC  DME  MAC Shared -System Maintainers  Other A B HHH FISS MCS VMS CWF type of evidence evaluated.   10901.28 MACs shall list all articles and sources that led to the LCD in the Bibliography. The citations shall be consistent with the American Medical Association Manual of Style.   X X X X      10901.29 MACs shall explain the rationale that supports their coverage determination of covered, non- covered, or limited coverage. The rationale is the reasoning leading to the coverage determination.   X X X X      10901.30 If it is appropriate for a MAC to provide coding/billing information to help implement the coverage policy, the MAC shall publish the coding/billing article at the same time they publish the proposed LCD.   X X X X      10901.31 Contractors shall determine and describe in the LCD the circumstances under which the item or service is reasonable and necessary under section 1862(a)(1)(A) of the Act. Contractors shall determine if evidence exists to consider an item or service to be reasonable and necessary if the contractor determines that the service is:    Safe and effective;    Not experimental or investigational (exception: routine costs of qualifying clinical trial services with dates of service on or after September 19, 2000 which meet the requirements of the Clinical Trials NCD are considered reasonable and necessary); and    Appropriate, including the duration and frequency that is con sidered appropriate for the item or service, in terms of whether it is:   o Furnished in accordance with accepted standards of medical practice for the diagnosis or treatment of the patient's condition or to improve the function of a malformed body member;   X X X X      Number  Requirement  Responsibility     A/B MAC  DME  MAC Shared -System Maintainers  Other A B HHH FISS MCS VMS CWF o Furnished in a setting appropriate to the patient's medical needs and condition;   o Ordered and furnished by qualified personnel;   o One that meets, but does not exceed, the patient's medical need; and   o At least as beneficial as an existing and available medically appropriate alternative   10901.32 MACs shall provide a minimum of 45 calendar days for public comment on all proposed LCDs.   X X X X      10901.32.1 MACs shall respond to all timely received public comments, and may group similar comments and responses in logical categories in the RTC article.   X X X X      10901.33 After the close of the comment period and the required meetings, the MACs shall publish a final LCD to the MCD.   X X X X      10901.33.1 MACs shall link from their contractor website to the final LCD on the MCD.   X X X X      10901.33.2 The MAC shall respond to all comments received, via the RTC article which shall be published on the MCD at the same time as the publication of the final LCD.  MACs shall ensure the final LCD and RTC article are related on the MCD.    X X X X      10901.33.3 MACs shall notify the public that a final decision has been published and provide the Web link to the final decision. MACs shall use several tools at their disposal to educate providers, including the Whats New Report on the MCD, setting up email listservs, or other 508 compliant and accessible means to adequately inform stakeholders.   X X X X      10901.33.4 MACs shall notify the public that a final determination has been published and provide the Web link to the final decision. MACs may use several tools at their disposal X X X X      Number  Requirement  Responsibility     A/B MAC  DME  MAC Shared -System Maintainers  Other A B HHH FISS MCS VMS CWF to notify the public, including the "What's New Report" on the MCD, setting up listservs, or other 508 compliant and accessible means to inform stakeholders.   10901.34 The contractors shall maintain the LCD record for a minimum of 6 years and 3 months from the date the LCD is retired.   X X X X      10901.34.1 Contractors shall have a mechanism for archiving retired LCDs. This mechanism shall also allow the contractor to respond to requests and retrieve the LCD record.   X X X X      10901.35 After 6 years and 3 months from the date the LCD is retired, the contractors shall destr oy the LCD record. However, contractors shall not destroy the LCD record if it relates to a current investigation of litigation/negotiation; ongoing Workers Compensation set aside arrangements; or documents which prompt suspicions of fraud and abuse of it ems or services.   X X X X       III. PROVIDER EDUCATION TABLE   Number  Requirement  Responsibility     A/B MAC  DME   MAC  CEDI  A B HHH  10901.36  MLN Article: CMS will make available an MLN Matters provider education article that will be marketed through the MLN Connects weekly newsletter shortly after the CR is released. MACs shall follow IOM Pub. No. 100- 09 Chapter 6, Section 50.2.4.1, instructions for distributing MLN Connects information to providers, posting the article or a direct link to the article on your website, and including the article or a direct link to the article in your bulletin or newsletter. You may supplement MLN Matters articles with localized information benefiting your provider community in billing and administering the Medicare program correctly.  Subscribe to the MLN Matters listserv to get article release X X X X  Number  Requirement  Responsibility     A/B MAC  DME   MAC  CEDI  A B HHH  notifications, or review them in the MLN Connects weekly newsletter.   IV. SUPPORTING INFORMATION   Section A:  Recommendations and supporting information associated with listed requirements: N/A     "Should" denotes a recommendation.  X-Ref  Requirement  Number  Recommendations or other supporting information:   Section B:  All other recommendations and supporting information: N/A  V. CONTACTS