Evidentiary Content

13.5.3 - Evidentiary Content (Rev. 863; Issued: 02-12-19; Effective: 10-03-18; 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, systematic 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 led to the LCD in the Bibliography. The citations shall be consistent with the American Medical Association (AMA) Manual of Style. 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. 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 the proposed LCD.