Clinical Research Studies (Clinical Trials) Reimbursement Policy
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This policy governs Healthfirst reimbursement for routine patient care and related covered services when members participate in clinical research studies, and describes line-of-business specific applicability and exclusions. It applies to Healthfirst members across listed lines of business and follows NYS DOH, CMS, and ACA requirements.
No material clinical or coverage changes in this revision.
Coverage Criteria and Exclusions for Clinical Trials
Reimbursement criteria and exclusions
Healthfirst will reimburse clinical trial-related services when the following criteria are met; certain items are excluded.
ALL of the following
- Member is enrolled in a qualifying or approved clinical trial
- Services are covered under the member's benefit plan
- Services qualify as routine patient care costs or other covered services
- Claims are submitted with appropriate coding, including clinical trial modifiers (e.g., Q0, Q1)
Covered routine services include
- Standard services provided outside the clinical trial
- Services required to administer investigational items
- Monitoring, prevention, diagnosis, and treatment of complications
Exclusions (not reimbursed)
- Investigational drugs, devices, or services (unless otherwise covered under the benefit)
- Services performed solely for research or data collection
- Services provided free of charge by the study sponsor
- Non-healthcare or administrative research-related costs
Experimental/investigational services
- Experimental or investigational services may be covered on a case-by-case basis
- Such cases may be eligible for external appeal under Public Health Law §4910 when denial criteria and member conditions are met (e.g., life-threatening or disabling condition, no effective covered alternative, qualified physician recommendation)
ALL of the following
- For Medicare lines of business, the clinical trial must fall within a Medicare benefit category, have therapeutic intent, and meet CMS clinical trial qualification criteria
- Healthfirst will cover applicable cost-sharing and reimburse routine costs consistent with CMS rules and the member's benefit plan
ALL of the following
- For Integrated Benefit Dual Plan (dual eligible) members, Medicare is primary and Medicaid is secondary (coordination of benefits applies)
Coverage for clinical trial services
Healthfirst will reimburse routine patient care costs and other covered services consistent with the member's benefit plan for approved clinical trials; certain items and billing requirements apply.
Approved clinical trial requirements
- Trial phases: Phase I–IV
- Related to cancer or life‑threatening conditions
- Federally funded, approved, or FDA‑reviewed
Non-covered items
- Investigational items or services
- Research‑related administrative costs
- Services not covered under the member's benefit
Billing and documentation requirements
- Providers must submit claims using clinical trial modifiers (Q0, Q1) and appropriate diagnosis and procedure codes
- Providers must clearly distinguish covered routine costs from non‑covered research‑related services and maintain documentation of trial qualification and member eligibility
- Claims not adhering to policy will be denied or rejected; reimbursement is determined by provider contract and is subject to timely filing and appeal processes
Billing Codes and Timely Filing
| Q0 | Clinical trial modifier |
| Q1 | Clinical trial modifier |
| Q0 | Clinical trial per CMS — Investigational clinical service for research |
| Q1 | Clinical trial per CMS — Routine clinical service provided in a clinical trial |
Claims Submission, Documentation, and Appeals
Include clinical trial modifiers on claims
Submit claims with appropriate coding and include clinical trial modifiers (e.g., Q0, Q1).
- Use modifier Q0 or Q1 as applicable.
- Ensure diagnosis and procedure codes reflect the services billed.
Document and support claims; understand denial and appeal implications
Submit claims using clinical trial modifiers (Q0, Q1) and appropriate diagnosis and procedure codes; clearly identify covered routine services versus non‑covered research services and retain supporting documentation. Claims that do not adhere to these requirements will be denied or rejected; reimbursement is determined by provider contract and claims are subject to timely filing and appeal processes.
- Clearly distinguish covered routine costs from non‑covered research-related services on the claim.
- Maintain documentation supporting clinical trial qualification, member eligibility, and covered service determination.
- Adhere to timely filing requirements per provider contract and Healthfirst Provider Manual Subsection 17; non‑compliant claims may be denied or rejected.
Key Definitions
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