CMS has issued two separate MLN Matters articles regarding new CPT code 80305 which became effective on January 1, 2017. CMS MLN Matters MM9946 states claims with dates of service January 1, 2017 are subject to CLIA Edits and only those providers with a CLIA certificate type code of 9, 1, or 3 can be reimbursed for this service. Claims with dates of service January 1, 2017 through March 31, 2017 will be denied if the billing provider’s CLIA certificate type is not one of those listed. CMS MLN Matters MM9956 states that effective with dates of service April 1, 2017 and after, CPT code 80305 was approved by the FDA as a waived test under CLIA and must be billed with the modifier QW. Claims with date of service prior to April 1, 2017 billed with the QW modifier will be denied.