Objective

To determine whether the Department of Health (DOH) has provided adequate oversight to ensure payments for services provided to Medicaid members enrolled in clinical trials were appropriate. The audit covered the period from July 2019 through June 2024. 

About the Program

Clinical trials are research studies that evaluate the safety and effectiveness of medical care. New York’s Medicaid program generally does not cover investigational items or services that are the subject of the clinical trial, nor does it cover services provided solely for data collection. However, Medicaid covers the routine costs of items or services that are necessary for clinical trial participants and are typically covered outside of the trial under the state plan or waiver. These include costs related to preventing, diagnosing, monitoring, or treating complications arising from participation in the trial. Routine costs may also include any item or service required only for administering the investigational treatment, such as laboratory tests or medical imaging.

The Social Security Act requires state Medicaid programs to complete a Medicaid coverage determination for members participating in clinical trials within 72 hours of the request. In addition to verifying a member’s Medicaid status, a coverage determination must be based on an attestation of the appropriateness of the clinical trial by both the principal investigator and the health care provider responsible for the trial. States must use a streamlined form that captures reference information about the clinical trial for the attestation and coverage determination requirements. In April 2022, DOH began requiring providers to submit a Medical Attestation Form on the Appropriateness of Qualified Clinical Trial (attestation form) for Medicaid members participating in clinical trials. 

Key Findings

We found that DOH did not always receive an attestation form before members participated in a clinical trial, as required. Additionally, we identified a limited number of improper Medicaid payments for services that were the responsibility of the clinical trial sponsor, investigational services not covered by the member’s managed care organization (MCO), or services that lacked supporting prior authorization.

Key Recommendations

• Remind Medicaid providers to submit the required attestation forms prior to starting clinical trial treatment for Medicaid members.
• Review the improper payments for investigational claims that should have been billed to the sponsor instead of Medicaid, were not covered by the MCO, or lacked prior authorization, and recover as appropriate.
• Remind providers of the documentation requirements to support Medicaid payments.