Evidence record
Oversight of Services for Medicaid Members Enrolled in Clinical Trials
- Jurisdiction
- New York
- Publishing agency
- Office of the New York State Comptroller, Division of State Government Accountability
- Publication date
- June 4, 2026
- Source record
- Original document linked
Findings
4
Recommendations
3
Overall 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.
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.
Findings (4)
Each finding has a stable link.
- F-1302
DOH did not always receive an attestation form before members participated in a clinical trial.
- F-1303
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.
- F-1304
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).
- F-1305
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)
- R-1160
Remind Medicaid providers to submit the required attestation forms prior to starting clinical trial treatment for Medicaid members.
Related finding F-1302 - R-1161
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.
Related finding F-1304 - R-1162
Remind providers of the documentation requirements to support Medicaid payments.
Related finding F-1303