Oversight of Services for Medicaid Members Enrolled in Clinical Trials
Learn how the AI-generated research projects were createdOverall Conclusion
DOH did not always receive attestation forms prior to members participating in clinical trials, and a limited number of improper Medicaid payments related to investigational services or services not covered by the member’s MCO or lacking prior authorization were identified. DOH officials indicated they will issue reminders to providers about the attestation process and documentation requirements, and OMIG is analyzing identified claims to determine recoveries where applicable.
Source Document
Audit Scope
Period July 2019 through June 2024; review of DOH oversight of Medicaid payments for services provided to members enrolled in clinical trials, including attestations, Q0 modifier usage, MCO guidance, and related claim data from eMedNY and the Medicaid Data Warehouse.
Key Findings Summary
DOH did not always receive an attestation form before members participated in a clinical trial.
A substantial number of claims related to clinical trials (32,578 claims totaling approximately $94 million for 7,447 members) lacked a corresponding attestation form.
Judgmental sampling identified instances where services should have been billed to clinical trial sponsors rather than Medicaid, and some corrected claims saved Medicaid money ($1,169 from corrected claims; $12,010 saved from one provider's corrections; remaining $113 awaiting adjustments).
View the Findings tab to see all 4 findings
AI-Assisted
AI Scope Summary
This audit found gaps in DOH oversight of clinical trial payments, including missing attestations and improper payments, within the July 2019–June 2024 period. Future audits should focus on attestation compliance, prior-authorization controls, sponsor billing alignment, MCO risk assessments, and the effectiveness of provider reminders and documentation standards to minimize improper Medicaid expenditures for clinical trial activities.
AI-Generated Insight
The audit identifies oversight gaps in clinical trial attestation and claims processing within New York State's Medicaid program. While DOH has implemented attestation requirements and provider reminders, the absence of universal use of Q0/Q1 modifiers and lack of formal MCO risk assessments create compliance and financial risk. Strengthening attestation enforcement, boosting data-sharing between DOH, MCOs, and sponsors, and tracking sponsor-billed costs will be key for more robust future audits.
Audit Objectives
The objective of our audit was to determine whether DOH has provided adequate oversight to ensure payments for services provided to Medicaid members enrolled in clinical trials were appropriate.
Audit Findings (4)
DOH did not always receive an attestation form before members participated in a clinical trial.
A substantial number of claims related to clinical trials (32,578 claims totaling approximately $94 million for 7,447 members) lacked a corresponding attestation form.
Judgmental sampling identified instances where services should have been billed to clinical trial sponsors rather than Medicaid, and some corrected claims saved Medicaid money ($1,169 from corrected claims; $12,010 saved from one provider's corrections; remaining $113 awaiting adjustments).
Claims with the Q0 modifier (4,813 claims totaling nearly $4 million) indicated investigational services; most were encounter claims; MCOs generally had guidance and system edits, but none performed a risk assessment of clinical trial claims or tracked costs between Medicaid and sponsors.
Recommendations (3)
Remind Medicaid providers to submit the required attestation forms prior to starting clinical trial treatment for Medicaid members.
Review the $23,631 ($113 + $23,518) in 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.