January 16, 2019

Medicare Implements New Local Coverage Determination Rules

On January 8, 2019, the Centers for Medicare & Medicaid Services (CMS) implemented modifications to the rules governing Medicare Local Coverage Determinations (LCDs).

CMS issued additional changes January 11, 2019 to Chapter 13 of the Medicare Integrity Program Manual, where the LCD process is described. The revisions were made in response to a provision of the 21st Century Cures Act to improve transparency in the LCD process. The manual was reformatted for stakeholders to use a roadmap with a step-by-step description of the LCD process that is accessible to all stakeholders. Such transparency carries through to the reconsideration process. The revisions now enable stakeholders to ask a MAC to take a second look at an existing decision using evidence that has developed since its previous review. And, it also sets forth consistent requirements for provider/stakeholder communications, which now must occur at predictable milestones so anyone with an interest in a LCD’s development can stay informed as it moves through the process.

The update is the first for the manual since August 2015. A breakdown of the major changes are reported in the Local Coverage Determinations (LCDs) MLN Matters article MM10901 and summarized in a Local Coverage Determination Process document prepared by American College of Radiology staff.

Transmittal 829, dated October 3, 2018, is being rescinded and replaced by Transmittal 854, dated January 11, 2019, to update three business requirements (BR), i.e., BR10901.7, BR10901.7.1, BR10901.26 and their related chapter 13 manual instructions. Recent manual revisions include additional information on the Carrier Advisory Committee (CAC) structure, CAC recommendations and evidentiary content:

  • Section13.2.4.3: Medicare Administrative Contractors (MACs) have the discretion to host multi-jurisdictional CACs. MACs will establish one CAC per state or have the option of establishing one CAC per jurisdiction or multi-jurisdictional CAC with representation from each state. If a MAC chooses to have one CAC per jurisdiction or multi-jurisdictional CAC, the MAC must 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. MACs have the discretion to host multi-jurisdictional CACs.
  • Section 13.5.2.2: The summary of recommendations from the CAC regarding the policy shall be included in the final LCD. 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.
  • Section 13.5.3: MACs have the option of providing a hyperlink to the FDA clearance to market. 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.

MACs are beginning to communicate these changes to the existing CAC representatives via email communication and web postings. To locate your MAC information, visit CMS.gov. ACR staff and representatives of the ACR Carrier Advisory Committee (CAC) Network will continue to monitor these changes.

Please direct your questions about changes to the local coverage determination process to Alicia Blakey at ablakey@acr.org.