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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.  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.  The MAC shall respond, in writing, to the requestor notifying the requestor of the acceptance, and if applicabl e, wait -listing, of the reconsideration request.    Contractors shall keep an internal list of the LCD Reconsideration Requests received and the dates, subject, and disposition of each one.  13.4 - Challenge of an LCD  (Rev:  854; Issued:  01-11-19; Effective : 09-26-18; Implementation: 01 -08-19)  In addition to creating the term Local Coverage Determination (LCD), section 1869(f) of the Social Security Act creates an appeals process for an aggrieved party to challenge LCDs/LCD provisions that are in effect  at the time of the challenge. Aggrieved party is defined in regulation as a Medicare beneficiary, or the estate of a Medicare beneficiary, who is entitled to benefits under Part A, enrolled under Part B, or both (including an individual enrolled in fee -for-service Medicare, in a Medicare Advantage  plan (MA), or in another Medicare managed care plan), and is in need of coverage for an item or service that would be denied by an LCD, as documented by the beneficiarys treating physician, regardless of whether the service has been received.  An aggrieved party has obtained documentation of the need by the beneficiarys treating physician.   Contractors shall follow all LCD Challenge requirements outlined in 42 CFR part 426.  As indicated in 42 CFR  426.415 if  appropriate, CMS may choose to participate as a party in the LCD Challenge process.   13.5  LCD Content  (Rev:  854; Issued:  01-11-19; Effective: 09 -26-18; Implementation: 01 -08-19)  13.5.1 - General Requirements  (Rev:  854; Issued:  01-11-19; Effective: 09 -26-18; Implementation: 01 -08-19)  The Medicare Coverage Database (MCD) is the central repository that houses proposed, and final LCDs, and LCD related articles.     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 must 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 must link from their MAC website to the MCD.   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 COR and LCD BFLs at least 21 business days before the one year expiration date.     The MAC shall ensure that all LCDs do not conflict with all statutes, rulings, regulations, and national coverage, payment, and coding policies.   For all new and revised LCDs MACs shall no longer include national policy language found in statute, regulati ons, 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. public ation number, Medicare title of manual, section of manual) without reiterating the text from the policy .    It is no longer appropriate to include Current Procedure Terminology (CPT) codes or International Classification of Diseases- Tenth Revision- Clinical Modification (ICD -10-CM) codes in the LCDs.  All CPT and ICD -10-CM codes shall be removed from LCDs and placed in billing & coding articles or Policy Articles that are to be published to the MCD and related to the LCD.  CMS will provide additional instruc tions on the date upon which this change will be effective.   13.5.2 - Consultation  (Rev:  854; Issued:  01-11-19; Effective: 09 -26-18; Implementation: 01 -08-19)  13.5.2.1 - Consultation Summary  (Rev:  854; Issued:  01-11-19; Effective: 09 -26-18; Implementation: 01 -08-19)  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.     13.5.2.2 - CAC Recommendations  (Rev:  854; Issued:  01-11-19; Effective: 09 -26-18; Implementation: 01 -08-19)  When a MAC determines that a CAC consultation should be sought for a proposed LCD, the summary of recommendations from the CAC regarding the policy shall be included in the Final LCD.    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.  The MAC shall also make available a means to accommodate reasonable requests for assistance from stakeholders who are hearing or visually impaired.  The frequency of the CAC meetings are at the discretion of the MAC and will be based on the appropriateness and on the volume of LCDs that require CAC consultat ion as part of the LCD process.   13.5.3 - Evidentiary Content  (Rev:  854; Issued:  01-11-19; Effective: 09 -26-18; Implementation: 01 -08-19)  In every proposed and final LCD, the MAC must 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 or service;   the target Medicare population; and   whether  the item or service is intended for use by health care providers or beneficiaries.    If the item or service is regulated by the FDA, and determined by the MAC to be reasonable and necessary, information regarding the use of the item or service subject to the FDA indication, as applicable, shall be included. MACs have the option of providing a hyperlink to the FDA clearance to market to meet this requirement.    In conducting a review, MACs shall use the available evidence of general acceptance by the medical community , such as published original research in peer -reviewed medical journals, sy stematic reviews and meta -analyses, evidence -based consensus statements and clinical guidelines.  Proprietary information, submitted by a requestor, not available to the public shall not be considered. Medicare data considered as part of the evidence review for an LCD shall be reported in the evidence summary. The reported data shall comply with Medicare Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule data disclosure requirements by using aggregate level information, such as aggregated statistics on Medicare beneficiary or provider utilization.  The review shall include a summary of all the evidence used to support the determination, which may be grouped by type of evidence evaluated.   MACs shall list all articles and sources that l ed to the LCD in the Bibliography.  The citations shall be consistent with the American Medical Association (AMA) Manual of Style.     MACs sh all 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.  If it is appropriate for a MAC to provide coding/billing information to help implement the coverage policy, MAC shall publish the coding/billing article at the same time they publish t he proposed LCD.    13.5.4  Reasonable and Necessary Provisions in LCDs  (Rev:  854; Issued:  01-11-19; Effective: 09 -26-18; Implementation: 01 -08-19)  An item or service may be covered by a contractor LCD if:    It is reasonable and necessary under 1862(a)( 1)(A) of The Act. Only reasonable and necessary provisions are considered part of the LCD.   Reasonable and Necessary   Contractors shall determine and describe in the LCD the circumstances under which the item or service is reasonable and necessary under 1862(a)(1)(A). Contractors shall determine if evidence exist 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 cos ts 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 c onsidered 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;    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.   13.5.5 - Public Comment  (Rev:  854; Issued:  01-11-19; Effective: 09 -26-18; Implementation: 01 -08-19)  MACs are required to provide a minimum of  45 calendar days for public comment on all proposed LCDs.  MACs shall respond to all timely received public comments, and may group similar comments and responses in logical categories in the RTC article .    13.5.6 - Final Decision  (Rev:  854; Issued:  01-11-19; Effective: 09 -26-18; Implementation: 01 -08-19)  MACs shall finalize or retire all proposed LCDs within a rolling year of publication date of the proposed LCD on the MCD (365 days). After the close of the comment period and the required meetings,  the MACs shall publish a final LCD to the MCD.  MACs shall link from their contractor website to the final LCD on the MCD.  As stated earlier, the MAC shall also respond to all comments received, via the RTC article which shall be published on the MCD and be related to the LCD.  The RTC article shall be displayed at the same time as the final LCD.    MACs shall notify the public that a final decision has been published and provide the Web link to the final decision.  MACs may use several tools at their disposal to educate providers, including the Whats New Report on the Medicare Coverage Database, setting up email listservs, or other 508 compliant and accessible means to inform stakeholders.   13.6 - LCD Record  (Rev:  854; Issued:  01-11-19; Effective: 09 -26-18; Implementation: 01 -08-19)  The LCD record shall be maintained by contractors for a minimum of 6 years and 3 months from the date the LCD is retired.  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.  After 6 years and 3 months from the date the LCD is retired, the LCD record shall be destroyed.  However, contractors shall not destroy the LCD record if it relates to a current investiga tion of litigation/negotiation; ongoing Workers Compensation set aside arrangements; or documents which prompt suspicions of fraud and abuse of items or services.  This will satisfy evidentiary needs and discovery obligations critical to the agencys liti gation interests.