In December 2021, the Centers for Medicare and Medicaid Services (CMS) issued the UPDATED: Mandatory Medicaid Coverage of Routine Patient Costs Furnished in Connection with Participation in Qualifying Clinical Trials guidance to state programs requiring coverage of routine costs associated with qualifying clinical trials.  To comply with CMS directive, the New York State Department of Health (NYSDOH) shared the mandate and instructions in the New Attestation Form for New York State Medicaid Members Enrolled in Qualifying Clinical Trials article published in the July 2022 issue of the Medicaid Update.  Practitioners are reminded that the Medicaid Attestation Form On The Appropriateness Of The Qualified Clinical Trial must be submitted for each NYS Medicaid member enrolled in a qualifying clinical trial for whom NYS Medicaid reimbursement is requested.  The Medicaid Attestation Form On The Appropriateness Of The Qualified Clinical Trial must be completed and submitted prior to providing treatment in the trial.  For each clinical trial participant who is enrolled in either NYS Medicaid fee-for-service or Medicaid Managed Care, the fully completed Medicaid Attestation Form On The Appropriateness Of The Qualified Clinical Trial must be:

• submitted with the accurate clinical trial participant name and client identification number/NYS Medicaid number;
• signed by the Principal Investigator of the clinical trial;
• signed by the treating health care practitioner of the NYS Medicaid member; and
• submitted via the Secure File Transfer application within the Health Commerce System:
• HCS Recipient: Medicaid Clinical Trial

Upon receipt of the completed Medicaid Attestation Form On The Appropriateness Of The Qualified Clinical Trial, the NYS Department of Health will review it and issue a coverage determination within 72 hours of electronic submission.  The submitter will be notified of this determination electronically within the same 72-hour timeframe.  Practitioners are advised to maintain appropriate documentation to support NYS Medicaid reimbursement for all services.  Additional information regarding maintaining appropriate documentation, Practitioners should refer to the New York Codes, Rules and Regulations “Section 540.7 - Requirements for billing” web page.

Questions and Additional Information:

• Questions should be directed to: MedicaidClinTrials@health.ny.gov.
• For additional information, providers should refer to the NYS Department of Health “Medicaid Clinical Trials” web page.