CCP 1A-39 has been updated to reflect changes in 1905(a) of the Social Security Act for items and services furnished in connection with participation of Medicaid beneficiaries in qualifying clinical trials (CMS SMD#21-005 Mandatory Medicaid Coverage of Routine Patient Costs Furnished in Connection with Participation in Qualifying Clinical Trials), including:
- A change in the name of the title from “Routine Costs in Clinical Trial Services for Life Threatening Conditions” to “Routine Patient Costs Furnished in Connection with Participation in Qualifying Clinical Trials”
- Updating the definition of “qualifying clinical trial” as stated in Section 1905(gg)(2) of the Act
- Updating the definition of “routine costs” as stated in Section 1905(a)(30) and 1905(gg)(1) of the Act
- Adding a definition for “Principal Investigator”
- Adding a requirement that the referring health care provider and principal investigator of the qualifying clinical trial must complete the Medicaid Attestation Form on the Appropriateness of the Qualified Clinical Trial
Providers are encouraged to review Clinical Coverage Policy 1A-39, Routine Patient Costs Furnished in Connection with Participation in Qualifying Clinical Trials on the Program Specific Clinical Coverage Policies webpage for a detailed overview.
Contact
NCTracks Call Center: 800-688-6696