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The Centers for Medicare & Medicaid Services (CMS) recently announced changes to the Medicare Local Coverage Determination (LCD) process.  Under the 21st Century Cures Act, Congress required CMS to provide increased transparency and patient engagement throughout the LCD process. To that end, CMS solicited relevant stakeholder insight in the proposed 2018 Physician Fee Schedule Rule (82 FR 33950) and through additional meetings and correspondence with providers and healthcare associations.  Stakeholders raised concerns regarding the lack of local coverage process transparency, including the process to notify stakeholders of proposed revisions to, and drafting of, new LCDs.  They also raised concerns about ineffective Medicare Administrative Contractor processes for: soliciting and providing feedback to stakeholders on information surrounding open public meetings; the lack of non-physician representation on Contractor Advisory Committees (CAC); and the closed nature of CAC meetings.  These changes to the LCD process became effective as of October 3, 2018 and will be implemented on January 8, 2019. The CMS Administrator noted that the LCD process changes are part of the Administration’s broader effort to ensure that Medicare beneficiaries receive access to the latest medical technologies.

In its effort to modernize the LCD process, CMS revised Chapter 13 of the Medicare Program Integrity Manual (Manual).  The Manual includes instructions, policies and procedures, and guidance for stakeholder engagement in the LCD process.  Medicare Administrative Contractors (MACs) use this manual to administer the Medicare fee-for-service program.  MACs determine whether healthcare items and services have met the Medicare coverage requirements through LCDs.  They also consider the variation in medical practice across different geographical jurisdictions when making such determinations.  When National Coverage Determinations (NCD) do not exist, or when MACs must further define existing NCDs, LCDs are issued.  CACs are also involved in the LCD development process.  Specifically, CAC members serve in an advisory capacity to be informed of, and participate in, the development of an LCD.  They provide feedback to improve administrative policies and review the quality of evidence used in the LCD development process.  MACs determine when CAC meetings occur based on the appropriateness and volume of LCDs that would require input from CAC members.

The Chapter 13 revisions are the first Manual revisions since August 2015.  The revised Manual includes the following changes:

  • A roadmap for the LCD process;
  • A consistent, standardized summary of the clinical evidence supporting LCD decisions;
  • An option to request an informal meeting with MACs to discuss potential LCD requests;
  • A new LCD request process to enable interested parties in a MAC jurisdiction to request a new LCD;
  • Restructure of the CAC meetings to make them open to the public;
  • A change to the CAC structure to include beneficiary representation and other healthcare professionals in addition to physicians (e.g. nurses, social workers, epidemiologists);
  • Open public meetings in the MAC jurisdiction to present proposed coverage, including evidence and rationale for decisions;
  • Removal of “old” proposed policies, if not finalized within one year of the original posting date;
  • Removal and relocation of International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) and Current Procedure Terminology (CPT) codes from LCDs in the future;
  • Improved communication in which MAC responses to public comments are linked to the final LCD and remain in the Medicare Coverage Database indefinitely; and
  • A consistent reconsideration process in which the LCD reconsideration is consistent with the NCD reconsideration process.

To continue its commitment to improvement, CMS invites stakeholders to provide feedback on the revised LCD Process via submissions to LCDmanual@cms.hhs.gov.

The CMS fact sheet is available at:

https://www.cms.gov/newsroom/fact-sheets/summary-significant-changes-medicare-program-integrity-manual-chapter-13-local-coverage.

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