MolDX Providers Liability Change Notification
January 3, 2023: notice that effective January 16, 2023, Noridian will be assigning liability to the provider for molecular diagnostic tests that fail to meet the requirements of the foundational policy of the MolDX program, when services are provided and billed without a valid advance beneficiary notice of non-coverage (ABN) 
. As these services do not meet the clinical validity and utility of Medicare’s reasonable and necessary requirement, they fall within the language of the CMS Internet Only Manual, Medicare Program Integrity Manual 100-8, Chapter 3, Section 3.3.3 which indicates in the absence of a policy, MACs shall determine if the service is covered based on the conditions in CMS Internet Only Manual, Medicare Program Integrity Manual 100-8, Chapter 3,Section 3.6.2.1 .
Claims Processing:
- Claims deny Provider liable if submitted without GA modifier
- Claims deny Beneficiary liable when submitted with GA modifier
Remittance Advices will reflect liability by displaying the following messages:
- CARC Code C0-50 Provider liable or PR-50 for Beneficiary liable
- RARC Code N372 – These are non-covered services because this is not deemed a ‘medical necessity’ by the payer.