MolDX Contractor Advisory Committee (CAC) Guidance Document

As part of the Local Coverage Determination (LCD) Process, Medicare Administrative Contractors (MACs) may hold a CAC meeting to assist with the evaluation of evidence as part of the LCD development process as defined by Pub 100-08, Medicare Program Integrity Manual (PIM), Chapter 13.  CAC information can be used to assist with the formulation of coverage rationale or criteria and can be cited in policy.

The purpose of this document is to outline how the MolDX program uses or intends to use CAC meetings as part of the LCD process, and to educate providers and stakeholders on the purpose and process of CAC meetings for MolDX-specific policy.

The MolDX program is not required to convene a CAC for policy generation but will do so when it believes that external subject matter expertise is necessary to better understand the peer-reviewed evidence in the appropriate context of clinical practice.  For this reason, a CAC is staffed with experts whom MolDX believes can help educate MolDX on the evidence, or more commonly on the clinical context, practices, or clinical perspectives which must be understood to properly evaluate the evidence to determine if reasonable and necessary standards for coverage are met.  CAC SMEs may also be asked their opinions as experts on either the evidence, tests or services in question, or the clinical context and practices necessary to evaluate the evidence. When a subject is expected to be controversial with services that are known to have proponents and opponents, MolDX will strive to ensure all relevant viewpoints are represented in the CAC.  

Experts will be recruited to the CAC whom MolDX believes can provide necessary perspectives on the subjects at hand.  As the CAC is intended to be a discussion, there will be a limited number of positions available, and not all applicants or qualified personnel can be accommodated.  Applicants will be evaluated for their demonstrated expertise on the subject matter, practice type and experience, and potential for conflicts of interest. 

The public and CAC members will be provided with literature relevant to the subject matter. They will also be provided with a list of questions that are intended to drive the discussion.  A transcript of the CAC will be publicly posted.  The discussions and education provided in the CAC serve and should be considered as a supplement to, and not a replacement for, the MAC’s judgement in rendering coverage and coverage criteria.