Clinical Trials
Clinical trials are interventional studies that assess treatments or diagnostics compromising experimental and control groups.
Medicare coverage in these trials is guided by strict CMS rules and is limited to FDA-approved trials or those automatically qualifying under CMS guidelines.
Medicare Part B coverage for clinical trials include routine services such as doctor visits, lab tests, surgeries and treatments that are usually covered by Medicare when provided outside a trial. It also covers FDA-approved IDE studies for Category B devices. This includes services needed to provide or administer the investigational item, as well as patient monitoring and lab tests.
Noncovered Services
Medicare Part B does not cover experimental drugs, items or devices unless they are typically covered by Medicare. It also excludes coverage for data collection and analysis done solely for study purposes (e.g., bi-monthly tests supported only bi-annually). Additionally, no payment is made for items and services provided free of charge to beneficiaries in a clinical trial.
Medicare Part B Claim Submissions for Clinical Trials
Medicare-enrolled providers submit claims for routine services provided under an approved clinical trial and/or IDE study to the Part B MAC, including claims for Medicare beneficiaries who are enrolled in an MA plan.
The Part B deductible for professional and outpatient services is waived, but beneficiaries bear the financial responsibility of the Part B coinsurance when applicable.
Modifiers Q0 and Q1
- Modifier Q0 is used for investigational items/services in a clinical research study. It is appended to the Category B IDE codes in conjunction with the IDE number on claims.
- Modifier Q1 applies to routine clinical services performed within a clinical trial context. It indicates services performed as part of clinical management related to the study and requires the trial name, sponsor and sponsor-assigned protocol number on the beneficiary’s medical record.
- For claims with modifier Q1 appended to the HCPCS or CPT code, ICD-10 code Z00.6 must be present, and, if routine services involve a Category A or B IDE device, the IDE number must also be on the claim.
Claim Documentation
The provider must report the clinical trial and IDE numbers. Claims lacking these identifiers will be rejected, requiring resubmission with the necessary information.
| 1500 Claim Field | ANSI 837 v5010 Loop and Segment | Information Required |
|---|---|---|
| 19 | 2300 REF02 and qualifier REF01 = P4 | Key the Clinical Trial Number, preceded by “CT” Example: CT XXXXXXXX |
| 23 | 2300, REF02 and qualifier REF01 =P4 | IDE number |
Related Content
- CMS IOM, Publication 100-04, Medicare Claims Processing Manual, Chapter 32, Sections 270.2, 68 and 69
- CMS IOM Publication 100-03, Medicare National Coverage Determinations (NCD) Manual, Chapter 4, 310-Clinical Trials
- Routine Costs in Clinical Trials NCD 310.1
- Medicare & Clinical Research Studies
Revised 4/23/2025