Payment for Qualifying Clinical Trial Services

69.2 - Payment for Qualifying Clinical Trial Services (Rev. 2998, Issued: 07-25-14, Effective: Upon implementation of ICD-10; 01-01-12 - ASC X12, Implementation: 08-25-2014 - ASC X12; Upon Implementation of ICD-10) For dates of service on or after September 19, 2000, pay for covered services furnished to beneficiaries participating in qualifying clinical trials. Payment is based on the payment methodology applicable for the service that was furnished (e.g., physician fee schedule, lab fee schedule, durable medical equipment fee schedule, reasonable charge, etc.). With the exception of managed care enrollees, applicable deductibles and coinsurance rules apply to clinical trial items and services. The Part A and Part B deductibles are assumed to be met for covered clinical trial services billed on a fee service basis for managed care enrollees. NOTE: Effective for claims with dates of service on or after January 1, 2014, it is mandatory to report a clinical trial number on claims for items/services provided in clinical trials/studies/registries, or under CED. This is the number assigned by the National Library of Medicine (NLM) ClinicalTrials.gov Web site when a new study appears in the NLM Clinical Trials data base. This number is listed prominently on each specific study’s page and is always preceded by the letters “NCT.” Contractors verify the validity of a trial/study/registry by consulting CMS’s clinical trials/registry web site at: http://www.cms.gov/Medicare/Medicare-General- Information/MedicareApprovedFacilitie/index.html. NOTE: Contractors shall ensure value code ‘D4’/amount data from their internal claims processing is mapped/populated to the 837 institutional claim format for a coordination of benefits 837 institutional claim.