Medicaid Clinical Trials

New York State Medicaid covers routine costs associated with qualifying clinical trials in which Medicaid members are enrolled, in compliance with the December 2021 Centers for Medicare and Medicaid Services (CMS) guidance (PDF) requiring state Medicaid programs to provide coverage of such routine costs.

Process

Per CMS requirements, the clinical trial's Principal Investigator must submit the Medicaid Attestation Form on the Appropriateness of the Qualified Clinical Trial (attestation form) for each Medicaid member enrolled in a qualifying clinical trial. For each trial participant who is enrolled in either New York State (NYS) Medicaid fee-for-service (FFS) or Medicaid Managed Care (MMC), the fully completed form must be:

  • submitted with the accurate clinical trial participant name and client identification number (CIN) / Medicaid number
  • signed by the clinical trial's principal investigator (PI)
  • signed by the member's health care provider
  • submitted via the Secure File Transfer (SFT) application within the Health Commerce System (HCS)
    • HCS Recipient: "Medicaid Clinical Trial"

Once a completed form is received, the NYS Department of Health (DOH) will review the attestation and make a coverage determination within seventy-two (72) hours of its electronic submission. A response, stating notification of the coverage determination, will be sent electronically to the submitter within seventy-two (72) hours. Additionally, DOH will inform the participant's health plan of the coverage determination and share the attestation form.

Note: Providers are advised to maintain appropriate documentation, to support Medicaid reimbursement for all services in accordance with the requirements for billing.

Medicaid Attestation Form

Health Commerce System (HCS)

The Department's clinical trials policy requires that the signed attestation form be submitted through the Secure File Transfer (SFT) application in the Health Commerce System (HCS). Submitters should be able to set up an HCS account—that is the preferred method for sharing these forms, which contain Protected Health Information (PHI), with the Department of Health. Register for an account here: https://hcsinfo.health.ny.gov/

Note: All NYS-licensed health facilities, providers, and practitioners, as well as other partner organizations, are required to have a Health Commerce System account to support health data reporting and distribution.

Out-of-State Organizations should contact the Bureau of Health Access, Policy, and Innovation for assistance with submissions and access to the Health Commerce System (HCS) at Medicaidclintrials@health.ny.gov

July 2022 Medicaid Update, Volume 38, Number 8

Contact Information

Medicaidclintrials@health.ny.gov
(518) 473-2160