Billing and Processing Fee for Service Claims for Covered Clinical

69.9 - Billing and Processing Fee for Service Claims for Covered Clinical Trial Services Furnished to Managed Care Enrollees (Rev. 13551; Issued: 12-19-25; Effective: 01-21-26; Implementation: 01-21-26) Payment for Investigational Device Exemption (IDE) Studies Medicare Advantage Organizations (MAOs) are responsible for payment of claims related to the enrollees’ participation in both Category A and B IDE studies that are covered by the Medicare Administrative Contractor (MAC) with jurisdiction over the MA plan’s service area. The MAO is responsible for payment of routine care items and services in Centers for Medicare & Medicaid (CMS) approved Category A and Category B IDE studies. The MAO is also responsible for CMS approved Category B devices. CMS will not approve Category A devices because they are statutorily excluded from coverage. Payment for Clinical Studies Approved Under Coverage with Evidence Development (CED) In National Coverage Determinations (NCDs) requiring CED, Medicare covers items and services in CMS approved CED studies. MAOs are responsible for payment of items and services in CMS approved CED studies unless CMS determines that the significant cost threshold is exceeded for that item or service (see 42 CFR 422.109). Payment for Clinical Trial Services Per Publication 100-16, Chapter 4, Section 10.7.1- 10.7.3, Medicare Advantage Organizations (MAOs) are responsible for payment of services. For additional information regarding MAO benefits refer to: https://www.cms.gov/regulations-and- guidance/guidance/manuals/downloads/mc86c04.pdf The clinical trial coding requirements for MAO claims are the same as those for regular Medicare fee for service claims. However, for beneficiaries enrolled in a MAO plan, institutional providers must not bill outpatient clinical trial services and non-clinical trial services on the same claim. If covered outpatient services unrelated to the clinical trial are rendered during the same day/stay, the provider must split bill submitting only the clinical trial services on a single claim and billed as fee-for-service. (This allows the Medicare claims processing system to not apply the deductible when the patient is found to be in a MAO plan). Any outpatient services unrelated to the clinical trial should be billed to the MAO plan