CMS Pub. 100-04, ch. 32, § 69.9

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